18.04.2024
To the attention of interested persons
The NAMMDR would like to inform you about the 11th Romanian Pharmacovigilance Workshop which will be held in Bucharest, between 02-04 October 2024. This pharmacovigilance workshop aims to present EMA news, assessing PSURs by NCAs, artificial intelligence in pharmacovigilance, ISO IDMP, pharmacovigilance in the context of rare disease and more. The course will be presented in English by Dr. Calin A. Lungu and other speakers.
Detalied information is available in the Agenda și registration information.
Depending on registrations from different countries, this event may be held as a hybrid event.

01.11.2023
To the attention of marketing authorization holders
Regarding Direct healthcare professional communications, we want to inform you of the publication on the NAMMDR website of some support materials for marketing authorization holders. These materials contain important information to be considered by the MAHs in the development and submission for approval to NAMMDR of Direct healthcare professional communications.
Please consult the NAMMDR website, section Medicines for human use – Direct healthcare professional communications.

14.09.2023
To the attention of interested persons
Spikevax: EMA recommends approval of adapted COVID-19 vaccine targeting Omicron XBB.1.5
download document …

30.08.2023
To the attention of interested persons
Comirnaty: EMA recommends approval of adapted COVID-19 vaccine targeting Omicron XBB.1.5
download document …

20.04.2023
To the attention of interested persons
The NAMMDR would like to inform you about the 10th Romanian Pharmacovigilance Workshop which will be held in Bucharest, between 25 – 27 October 2023.
The topics are EMA computer systems news, IRIS, creating PSMFs, PSURs, RMPs, SPOR and more…, presented in English by Dr. Calin A. Lungu.
Detalied information are available in the Agenda and registration information.
Depending on registrations from different countries, this event may be held as a hybrid event.

30.03.2023
To the attention of interested persons
EMA recommends approval of Bimervax as a COVID-19 booster vaccine.
download document …

11.11.2022
To the attention of interested persons
EMA confirms recommendation to withdraw marketing authorisations for amfepramone medicines
download document …

28.10.2022
To the attention of interested persons
EMA recommends measures to minimise risk of serious side effects with Janus kinase inhibitors for chronic inflammatory disorders
download document …

28.10.2022
To the attention of interested persons
EMA confirms recommendation to withdraw marketing authorisations for amfepramone medicines
download document …

30.09.2022
To the attention of interested persons
New recommendations for terlipressin-containing medicines in the treatment of hepatorenal syndrome
download document …

12.09.2022
To the attention of interested persons
Adapted vaccine targeting BA.4 and BA.5 Omicron variants and original SARS-CoV-2 recommended for approval
download document …

11.05.2022
To the attention of interested persons
The NAMMDR would like to inform you about the 9th Romanian Pharmacovigilance Workshop which will be held in Bucharest, between 2-4 November 2022.
The topics: EudraVigilance news, Signal detection, PASS, PAES, Advanced therapy medicinal products, inspections and audits, SPOR and more… , presented in English by Dr. Calin A. Lungu.
Detalied information are available in the Agenda.
* Due to possible travel or meeting restrictions that might be in place, this workshop may be held online with the same agenda.

07.03.2022
To the attention of interested persons
ECDC and EMA issue advice on fourth doses of mRNA COVID-19 vaccines
download document …

07.03.2022
To the attention of interested persons
COVID-19: Joint statement from ECDC and EMA on the administration of a fourth dose of mRNA vaccines
download document …

11.03.2022
To the attention of interested persons
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 7-10 March 2022
download document …

01.03.2022
To the attention of interested persons
Regulation on EMA’s extended mandate becomes applicable
download document …

27.01.2022
To the attention of interested persons
COVID-19: EMA recommends conditional marketing authorisation for Paxlovid
download document …

14.01.2022
To the attention of interested persons
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 10 – 13 January 2022
download document …

11.01.2022
To the attention of interested persons
Preliminary data indicate COVID-19 vaccines remain effective against severe disease and hospitalisation caused by the Omicron variant
download document …

10.01.2022
To the attention of interested persons
EMA receives application for conditional marketing authorisation for Paxlovid (PF-07321332 and ritonavir) for treating patients with COVID-19
download document …

17.12.2021
To the attention of interested persons
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 13-16 December 2021
download document …

20.12.2021
To the attention of interested persons
Nuvaxovid – COVID-19 Vaccine (recombinant, adjuvanted)
download document …

16.12.2021
To the attention of interested persons
EMA recommends approval for use of Kineret in adults with COVID-19
download document …

07.12.2021
To the attention of interested persons
EMA and ECDC recommendations on heterologous vaccination courses against COVID-19
download document …

06.12.2020
To the attention of interested persons
Submission and receipt of messages by e-mail (e-mail@anm.ro)
In line with the NAMMDR IT&C security procedures and the European Commission’s recommendations to counter phishing attacks, message authentication, reporting and compliance will only be domain-based (Domain-based Message Authentication, Reporting and Conformance – DMARC).
Security issues required for e-mail delivery to the anm.ro domain:
✓ DMARC (Domain-based Message Authentication, Reporting and Conformance)
✓ SPF (Sender Policy Framework)
✓ Reverse DNS
✓ No Open Relay

06.12.2021
To the attention of interested persons
EMA recommends approval for use of RoActemra in adults with severe COVID-19
download document …

03.12.2021
To the attention of interested persons
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 29 November – 2 December 2021.
download document …

25.11.2021
To the attention of interested persons
Comirnaty COVID-19 vaccine: EMA recommends approval for children aged 5 to 11
download document …

23.11.2021
To the attention of interested persons
EMA receives application for marketing authorisation for Lagevrio (molnupiravir) for treating patients with COVID-19
download document …

22.11.2021
To the attention of interested persons
EMA evaluating data on booster dose of COVID-19 Vaccine Janssen
download document …

19.11.2021
To the attention of interested persons
EMA starts review of Paxlovid for treating patients with COVID-19
download document …

18.11.2021
To the attention of interested persons
EMA receives application for marketing authorisation for Xevudy (sotrovimab) for treating patients with COVID-19
download document …

17.11.2021
To the attention of interested persons
EMA receives application for conditional marketing authorisation of Novavax’s COVID-19 vaccine, Nuvaxovid
download document …

10.11.2021
To the attention of interested persons
EMA starts evaluating use of COVID-19 vaccine Spikevax in children aged 6 to 11
download document …

08.11.2021
To the attention of interested persons
COVID-19: EMA and Heads of Medicines Agencies update on molnupiravir; EMA starts review to support possible national decisions on early use
download document …

02.11.2021
To the attention of interested persons
EMA ends rolling review of the antibodies bamlanivimab and etesevimab for COVID-19 following withdrawal by Lilly
download document …

02.11.2021
To the attention of interested persons
Questions and answers on end of rolling review for antibodies bamlanivimab and etesevimab for COVID-19.
download document …

29.10.2021
To the attention of interested persons
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 25-28 October 2021
download document …

25.10.2021
To the attention of interested persons
Spikevax: EMA recommendation on booster
download document …

25.10.2021
To the attention of interested persons
COVID-19: EMA starts rolling review of molnupiravir
download document …

12.10.2021
To the attention of interested persons
Questions and answers on end of rolling review for CureVac’s COVID-19 vaccine (CVnCoV)
download document …

14.10.2021
To the attention of interested persons
EMA starts rolling review of Evusheld (tixagevimab and cilgavimab)
download document …

12.10.2021
To the attention of interested persons
EMA ends rolling review of CVnCoV COVID-19 vaccine following withdrawal by CureVac AG
download document …

11.10.2021
To the attention of interested persons
EMA receives application for marketing authorisation for Ronapreve (casirivimab / imdevimab) for treatment and prevention of COVID-19
download document …

07.10.2021
To the attention of interested persons
Additional manufacturing site for COVID-19 Vaccine Janssen
download document …

04.10.2021
To the attention of interested persons
Comirnaty and Spikevax: EMA recommendations on extra doses and boosters
download document …

04.10.2021
To the attention of interested persons
EMA receives application for marketing authorisation for Regkirona (regdanvimab) for treating patients with COVID-19
download document …

01.10.2021
To the attention of interested persons
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 27-30 September 2021
download document …

01.10.2021
To the attention of interested persons
EMA starts review of meningioma risk with nomegestrol- and chlormadinone-containing medicines
download document …

27.09.2021
To the attention of interested persons
EMA evaluating data on booster dose of COVID-19 vaccine Spikevax
download document …

09.09.2021
To the attention of interested persons
Increase in manufacturing capacity for COVID-19 vaccine from BioNTech/Pfizer
download document …

06.09.2021
To the attention of interested persons
EMA evaluating data on booster dose of COVID-19 vaccine Comirnaty.
download document …

03.09.2021
To the attention of interested persons
Shortage of RoActemra (tocilizumab)
download document …

02.09.2021
To the attention of interested persons
ECDC and EMA highlight considerations for additional and booster doses of COVID-19 vaccines
download document …

24.08.2021
To the attention of interested persons
Increase in vaccine manufacturing capacity for COVID-19 vaccines from BioNTech / Pfizer and Moderna
download document …

06.08.2021
To the attention of interested persons
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 5 August 2021
download document …

04.08.2021
To the attention of interested persons
ECDC and EMA update on COVID-19: Full vaccination is key to protecting against serious COVID-19, including disease caused by the Delta variant
download document …

23.07.2021
To the attention of interested persons
COVID-19 vaccine Spikevax approved for children aged 12 to 17 in EU
download document …

22.07.2021
To the attention of interested persons
COVID-19 Vaccine Janssen: Guillain-Barré syndrome listed as a very rare side effect
download document …

20.07.2021
To the attention of interested persons
EMA starts rolling review of COVID-19 vaccine Vidprevtyn
download document …

19.07.2021
To the attention of interested persons
EMA starts evaluating the use of Kineret in adult COVID-19 patients at increased risk of severe respiratory failure
download document …

09.07.2021
To the attention of interested persons
EMA finds no evidence linking viral vector in Zynteglo to blood cancer.
download document …

09.07.2021
To the attention of interested persons
EMA advises against use of COVID-19 Vaccine Janssen in people with history of capillary leak syndrome.
download document …

09.07.2021
To the attention of interested persons
Comirnaty and Spikevax: possible link to very rare cases of myocarditis and pericarditis.
download document …

11.06.2021
To the attention of interested persons
COVID-19 Vaccine Janssen: authorities in EU take steps to safeguard vaccine quality
download document …

11.06.2021
To the attention of interested persons
COVID-19 vaccines: update on ongoing evaluation of myocarditis and pericarditis.
download document …

11.06.2021
To the attention of interested persons
Vaxzevria: EMA advises against use in people with history of capillary leak syndrome
download document …

08.06.2021
To the attention of interested persons
EMA evaluating the use of COVID-19 Vaccine Moderna in young people aged 12 to 17
download document …

07.06.2021
To the attention of interested persons
EMA raises awareness of clinical care recommendations to manage suspected thrombosis with thrombocytopenia syndrome.
download document …

01.06.2021
To the attention of interested persons
Additional manufacturing capacity for BioNTech/Pfizer’s COVID-19 vaccine.
download document …

28.05.2021
To the attention of interested persons
First COVID-19 vaccine approved for children aged 12 to 15 in EU.
download document …

27.05.2021
To the attention of interested persons
Insufficient data on use of inhaled corticosteroids to treat COVID-19
download document …

21.05.2021
To the attention of interested persons
EMA issues advice on use of sotrovimab (VIR-7831) for treating COVID-19.
download document …

21.05.2021
To the attention of interested persons
Vaxzevria: further advice on blood clots and low blood platelets.
download document …

07.05.2021
To the attention of interested persons
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 3-6 May 2021.
download document …

07.05.2021
To the attention of interested persons
EMA starts rolling review of sotrovimab (VIR-7831) for COVID-19.
download document …

04.05.2021
To the attention of interested persons
EMA starts evaluating use of Olumiant in hospitalised COVID-19 patients requiring supplemental oxygen.
download document …

28.04.2021
To the attention of interested persons
AstraZeneca’s COVID-19 vaccine: benefits and risks in context.
download document …

28.04.2021
To the attention of interested persons
Annex to Vaxzevria Art.5.3 – Visual risk contextualisation.
download document …

21.04.2021
To the attention of interested persons
COVID-19 Vaccine Janssen: EMA finds possible link to very rare cases of unusual blood clots with low blood platelets:
EMA confirms overall benefit-risk remains positive.
download document …

15.04.2021
To the attention of interested persons
COVID-19 Vaccine Janssen: assessment of very rare cases of unusual blood clots with low platelets continues.
download document …

15.04.2021
To the attention of interested persons
AstraZeneca’s COVID-19 vaccine: EMA to provide further context on risk of very rare blood clots with low blood platelets.
download document …

31.03.2021
To the attention of interested persons
AstraZeneca COVID-19 vaccine: review of very rare cases of unusual blood clots continues
download document …

25.03.2021
To the attention of interested persons
EMA press release: COVID-19 Vaccine AstraZeneca – Update on ongoing evaluation of blood clot cases
download document …

25.03.2021
To the attention of interested persons
As announced in the Commission BREXIT Notice on medicines in January this year, the Commission had adopted and published the Delegated Regulation to amend the Falsified Medicines Directive in view of addressing the BREXIT outstanding issues on medicines.
In order to ensure that medicinal products are marketed with a unique identifier in the small markets currently dependent on the United Kingdom for their supplies of medicinal products, it is granted a temporary derogation until 31 December 2021 from the obligation of wholesalers to decommission the unique identifier of the products which they intend to distribute in the United Kingdom as those products may be re-exported to the Union.
This derogation should not affect the application of Union law to and in the United Kingdom in respect of Northern Ireland in accordance with Article 5(4) of the Protocol on Ireland/Northern Ireland to the Withdrawal Agreement in conjunction with Annex 2 to that Protocol.
Please find the link of that act:
https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv%3AOJ.L_.2021.091.01.0001.01.ENG&toc=OJ%3AL%3A2021%3A091%3ATOC
This has also been added to the DG SANTE BREXIT webpage:
https://ec.europa.eu/health/human-use/uk_withdrawal_en

22.03.2021
To the attention of interested persons
EMA press release: EMA advises against use of ivermectin for the prevention or treatment of COVID-19 outside randomised clinical trials.
download document …

18.03.2021
To the attention of interested persons
EMA press release: COVID-19 Vaccine AstraZeneca: benefits still outweigh the risks despite possible link to rare blood clots with low blood platelets
download document …

22.02.2021
To the attention of Marketing Authorisation Holders
UK withdrawal from the European Unit
On the 31st December 2020, the transitional period in which the EU pharmaceutical legislation stipulated in the ‘Community Acquis’ continued to be applicable in the United Kingdom has come to an end.
Marketing Authorisation Holders (MAHs) are kindly reminded that batch release and testing sites located in the UK should have been removed from medicinal product authorisation dossiers by the 31st of December 2020, through related variations.
The European Commission, the EMA and the CMDh have developed regulatory guidelines and procedures for situations arising from transition of the UK to the third country status.
MAHs are asked to consult the published and constantly updated documents, in order to apply the pharmaceutical legislation in a correct and timely manner. See also “Practical Guidance for procedures related to Brexit for medicinal products for human use approved via MRP/DCP Q/A 37” posted on the HMA website, under the Brexit section (https://www.hma.eu/535.html).
Consequently, MAHs should implement the required actions as soon as possible so that marketing authorisations (MAs) are compliant with the ‘Community Acquis’ and should immediately submit the required variations for removal / replacement / addition.
Failure to meet these conditions could have consequences such as MA suspension (until the situation is remedied) or withdrawal, as appropriate.
Please check the following links on the EMA websites as well: Brexit: the United Kingdom’s withdrawal from the European Union | European Medicines Agency (europa.eu) (https://www.ema.europa.eu/en/about-us/brexit-united-kingdoms-withdrawal-european-union) and HMA, the ‘Brexit’ section: Heads of Medicines Agencies: BREXIT (hma.eu) (https://www.hma.eu/542.html?&L=0).
Moreover, given the dynamics of the information, you are advised to weekly check the National Agency for Medicines and Medical Devices of Romania (NAMMDR) website (https://www.anm.ro/en/) for procedural updates.

04.02.2021
To the attention of interested persons
In order to deal with the consequences described in the opinion issued by the European Commission together with the European Medicines Agency, marketing authorisation holders, manufacturing authorisation holders and wholesale distributors of medicinal products are strongly advised:
− To take all measures in order to take account of the fact that, after the end of the transitional period, the United Kingdom will, in all respects, no longer observe the EU regulatory system for medicinal products (marketing authorisation procedures, import requirements, (co)labelling, medicinal product supply, etc.];
– To take into account, in all trade-related decisions, that after the end of the transitional period all goods, medicinal products included, shipped from the United Kingdom to the EU will be subject to procedures / controls regarding fiscal (customs duties, origin, VAT) and non-fiscal requirements (batch release).
download document…

04.02.2021
To the attention of interested persons
Commission Notice – Application of the Union’s pharmaceutical acquis in markets historically dependent on medicines supply from or through Great Britain after the end of the transition period (2021/C 27/08)
download document…

16.06.2020
To the attention of interested persons
The NAMMD would like to inform you about the 7th Romanian Pharmacovigilance Workshop which will be held in Bucharest, between 21- 23 September 2020 „EudraVigilance news, Signal detection, Covid-19 pharmacovigilance, MedDRA 23.1, inspections and audits, risk management plans and more…” presented in English by Dr. Calin A. Lungu, CEO, Drug Development Consulting Services S.A. (DDCS), Luxembourg. Detalied information are available at Agenda.
The event will take place at Crown Plaza Hotel, Bvd. Poligrafiei 1, sector 1, Bucharest.
For registration, please download the registration form (Registration Form) or contact the event organizer in Romania at the following contact data:
Mr. Alexandru Popescu, Business Travel Turism S.R.L.
Fax: +4021 3126708, Tel: +4021 2315615
Email: alexandru.popescu@businesstravel.ro
*Due to possible travel or meeting restrictions that might be in place, this workshop may be held online with the same agenda.

12.03.2020
To the attention of interested persons
Considering the current epidemiological context, in order to best possibly avoid trips for document exchange, the NAMMDR has decided on restriction, from 13 March to April 15 2020 (with possible extension should the situation so require), of the activity of the Registry service involving contact with the public. Therefore, documents may be submitted as follows:
Medicines for human use
– by regular mail, to Str. Av. Sănătescu nr. 48, sector 1, 011478 Bucharest, Romania
– by fax, to: + 4021-316.34.97
– by electronic mail, to:
– registratura@anm.ro
– CESP,
– the single electronic contact point (PCU-e).
Medical devices
– by regular mail, to: Bd. Nicolae Titulescu 58, Sector 1, 011144, Bucharest, Romania
– by fax, to: + 4021-222.86.83
– by electronic mail, to:
– dgdm@anm.ro,
– the single electronic contact point (PCU-e).
To receive documents issued by the NAMMDR during the same period, we recommended using courier services.
At the same time, all parties interested are advised that meetings requested shall be suspended during the specified period.
Thank you for your understanding and cooperation.

28.02.2020
To the attention of interested persons
Registry office hours
As a temporary reorganisation measure for improved user support specific activities, as of 02.03.2020, office hours of the Registry at the National Agency for Medicines and Medical Devices of Romania (NAMMDR) headquarters in Str. Mr. Ștefan Sănătescu no. 48, Sector 1, 011478, Bucharest, are 9.00 – 15.00, Monday to Friday.

24.02.2020
To the attention of interested persons
The NAMMD would like to inform about the organization in Romania of a training course regarding electronic transmission of individual case safety reports: “EudraVigilance Training on Electronic Reporting of ICSRs in the EEA”, to be held in Bucharest between 01-03 April 2020.
For registration and further information, please download the training programme with the registration form (EudraVigilance Training on Electronic Reporting of ICSRs in the EEA and agenda) and contact the organizer in Romania.

16.01.2020
To the attention of interested persons
Following the suspension by the EUROPEAN DIRECTORATE FOR THE QUALITY OF MEDICINES (EDQM) of Certificates of Suitability (CEP) to the Monographs of the European Pharmacopoeia for the active substance ranitidine hydrochloride, resulting from detection of nitrosamine impurities (NDMA), the National Agency for Medicines and Medical Devices of Romania (ANMDMR) has requested the barring from sale at pharmacy level of pharmaceutical forms for both oral administration and solution for injection of ranitidine containing medicinal products. This is a precautionary measure pending the European Commission decision on ranitidine containing medicines affected by this quality nonconformity.
In this respect, the NAMMDR has requested Marketing Authorisation Holders for these medicines to submit the following:
– an evidence of valid manufactured batches currently both held in their own warehouse and already distributed within the pharmaceutical network (warehouses and pharmacies), as well as of the batches manufactured and not yet released for sale;
– an inventory of distributors to whom the ranitidine containing batches have been distributed and the evidence of their notification on the barring from sale measure;
– an evidence of the quantities held in their own warehouse of the active substance ranitidine hydrochloride from manufacturers with suspended CEPs.
Under the circumstances, the NAMMDR advises healthcare professionals on the market availability of alternative treatments and recommends that patients see their doctor in this regard.

15.01.2020
To the attention of interested persons
Minister of Health Dr. Victor Costache, has appointed Ms. Roxana Stroe, MD, as President of the National Agency for Medicines and Medical Devices of Romania (NAMMDR) as of January 14, 2020.
Ms. Roxana Stroe, MD, is a Senior Physician in Clinical Pharmacology She has been working in the Agency since the end of 2010 and has been Coordinator of the Agency’s Pharmacovigilance and Risk Management Directorate. Since 2014, she has been a member of the European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee, and an alternate member of the EMA’s Management Board since March 2019.
According to the appointing Minister of Health Order, Dr. Roxana Stroe’s position as President is temporary, pending the contest for the President position or revocation, according to legislation in force.
The duties of the newly appointed President are both achievement of objectives within the NAMMDD scope and development of the strategy for transparent and fair conduct of competitions for filling the Agency’s President and Vice President positions, in line with a competition methodology validated by reputable specialists in the field.

19.11.2019
To the attention of Marketing Authorisation Holders
Notice on the Index of medicinal products for human use, 2020
Considering obligatory compliance with provisions of the Footnote under paragraph III, E, 52) of the Annex to the Order of the Minister of Health no. 888/2014 on approval of fees payable to the National Agency for Medicines and Medical Devices for activities conducted related to medicinal products for human, please be advised on the following:
By 29.11.2019, for update of the Index of medicinal products for human use 2020, Marketing Authorisation Holders (MAH) /MAH representatives shall submit to the NAMMDR the payment form related to the fee for setup and update of the Index of medicinal products for human use, available in both Romanian and English on the NAMMDR website under the heading “Forms and fees – Medicinal products for human use”, specifying the following:
– the list of all medicines included in the MAH portfolio (product name, pharmaceutical form, strength);
– the total fee amount in Euro, according to provisions of Order of the Minister of Health no. 888/2014, resulting from multiplication of the fee amount by the number of products proposed for inclusion into the Index.
Considering that respective invoices are issued for each MAH and not for each product, representatives of several MAHs shall submit a payment form for each individual MAH represented and the payment form shall specify the paying company, providing all necessary billing data and stating the currency intended.
Medicines for which the fee payment form is not submitted by 29.11.2019 and for which actual payment is not performed by 15.01.2020, are not included in the Index, i.e. shall be eliminated from the Index as of 15.01.2020.

08.11.2019
To the attention of all interested parties
Pursuant to the amendment of Article 893 of Law no. 95/2006, the National Agency for Medicines and Medical Devices of Romania (NAMMDR) amended the Payment Forms for the tariffs for marketing authorisation and marketing authorisation renewal for medicinal products submitted/authorised through Mutual Recognition Procedure and Decentralised Procedure. The Payment Forms are published on the NAMMDR website under the Section „Forms and tariffs – medicines for human use”.

13.08.2019
To the attention of all interested parties
The National Agency for Medicines and Medical Devices of Romania (NAMMDR) hereby advises on amendment of Article 893 of Law no. 95/2006, in accordance with ORDER no. 9 of August 8, 2019 for amendment of Law no. 95/2006 on healthcare reform and amendment of certain healthcare regulatory acts, of regulations for national government programs and regarding fiscal-budgetary measures (published in: the Official Gazette No. 668 of 9 August 2019),
as follows:
15. Article 893 is amended and shall read as follows:
“Article 893 – On submission of documentation for grant of marketing authorisation, applicants shall pay to the NAMMDR a marketing authorisation fee amounting to 5,000 EURO or its equivalent in LEI at the rate of the National Bank of Romania, which constitutes NAMMDR own revenue.”

22.07.2019
To the attention of all interested parties
The National Agency for Medicines and Medical Devices of Romania (NAMMDR), established by reorganisation of the former National Agency for Medicines and Medical Devices (NAMMD), under Law no. 134/2019, published in the Official Gazette of Romania no. 587 / 17.07.2019, hereby advises on continued work of the Agency; at the same time, the Agency’s Registry Office will operate according to the same schedule as before.
Until completion of mandatory steps required for implementation of Law no. 134/2019, bank transfers to the NAMMD account with the Sector 1 Treasury are also feasible.

10.05.2019
To the attention of interested persons
The NAMMD would like to inform you about the 6th Romanian Pharmacovigilance Workshop which will be held in Bucharest, between 11- 13 September 2019.
The topics: EudraVigilance news, Signal detection, pharmacovigilance inspections and audits, risk management plans, will be presented in English by Dr. Calin A. Lungu, CEO, Drug Development Consulting Services S.A. (DDCS), Luxembourg. Detalied information are available at Agenda.
The event will take place at Crown Plaza Hotel, Bvd. Poligrafiei 1, sector 1, Bucharest.
For registration, please download the registration form (Registration Form) or contact the event organizer in Romania at the following contact data:
Mr. Alexandru Popescu, Business Travel Turism S.R.L.
Fax: +4021 3126708, Tel: +4021 2315615
Email: alexandru.popescu@businesstravel.ro

06.03.2019
To the attention of Marketing Authorisation Holders (MAHs) concerned
The National Agency for Medicines and Medical Devices (NAMMD) hereby informs on the document conveyed by the European Commission at the end of February 2019 to all human and veterinary medicines agencies of the 27 EU Member States on regulations for quality control of medicinal product batches in the context of Great Britain’s (UK) withdrawal from the Union.
download document …

22.10.2018
To MAH attention
Given the need to reduce Brexit impact on medicine availability, please submit an updated status of applications for MA transfer and specific variations, both already and to be submitted to the NAMMD.
This information is to be submitted by e-mail to brexit@anm.ro, by November 15, 2018.

19.07.2018
To the attention of interested persons
The NAMMD would like to inform you about the 5th Romanian Pharmacovigilance Workshop which will be held in Bucharest, between 24- 25 October 2018.
The topics: EudraVigilance changes, EMA unique user account, Signal detection, daily use of EVDAS eRMRs, updating procedures for signal detection, pharmacovigilance audits and more), will be presented in English by Dr. Calin A. Lungu, CEO, Drug Development Consulting Services S.A. (DDCS), Luxembourg.
Detalied information are available at Agenda.
The event will take place at Crown Plaza Hotel, Bvd. Poligrafiei 1, sector 1, Bucharest.
For registration, please download the registration form (Registration Form) or contact the event organizer in Romania at the following contact data:
Mr. Alexandru Popescu, Business Travel Turism S.R.L.
Fax: +4021 3126708, Tel: +4021 2315615
Email: alexandru.popescu@businesstravel.ro

10.07.2018
To the attention of interested persons
The National Agency for Medicines and Medical Devices has requested precautionary recall from the Romanian market of all medicinal products containing valsartan manufactured by the Zhejiang Huahai Pharmaceuticals manufacturers in China, pursuant to recent identification of impurities introduced by the active substance manufacturing process.
descarca documentul …

23.04.2018
To the attention of interested persons
European Immunization Week
Vaccination is a right and responsibility for all
Vaccines protect people of all ages from potentially serious diseases
On 23–29 April 2018, European Immunization Week (EIW) is celebrated across the WHO European Region to raise awareness of the critical role vaccines play in protecting public health, and to remind each person to do their part to immunize Europe.
For more information, see:
http://www.euro.who.int/en/media-centre/events/events/2018/04/european-immunization-week-2018

15.02.2018
To the attention of wholesale distributors, parallel importers and wholesale/retail distributors of medicinal products
Please be advised that the implementation at national level of the National Medicines Verification System, as part of the European Medicines Verification System, was launched on 09 February 2018.
Please find relevant information related to the implementation project and the internal training of your company, in order to ensure operation according to the new legal conditions within the specialised sections of the website of the Organisation for Serialisation of Medicinal Products: https://osmr.ro/dapp/, https://osmr.ro/importator-paralel/ and https://osmr.ro/distribuitori/.
Your company may submit applications for assistance concerning the internal training of the company (dapp_mah@osmr.ro, distribuitor@osmr.ro, importator_paralel@osmr.ro) and has granted access for contributions to implementation or applications for classification concerning implementation via e-mail: implementare_clarificari@osmr.ro.
The materials presented at the conference “Patient Safety via Medicinal Product Safety – 1 year until operation”, marking the launching of implementation at national level, are available by accessing the download link at www.osmr.ro (at the end of the webpage of the conference material, under the “News” heading: https://osmr.ro/category/stiri/)

13.02.2018
To the attention of interested persons
The NAMMD has the pleasure to notify all its stakeholders on receipt of the final assessment reports of the Agency’s audit in the context of the HMA/EMA Joint Audit Program. The audit was conducted during 17-21 October 2016, together with the audit scheduled by the competent authority of Canada, as a state with which the EU has signed a Mutual Recognition Agreement (MRA), in view of assessment of the legislation implemented in Romania and of the GMP inspection system observed by the NAMMD, as a national competent authority in the field of the medicinal product for human use. Two auditors on behalf of the FDA (the US competent authority) have participated in this audit, as observers, and have surveyed the specific objectives established for the pharmaceutical sector, within the Transatlantic Trade and Investment Partnership.
The final assessment reports received from Health Canada (the Canadian authority) confirms the conclusion of an equivalence between the GMP-related national legislation and the GMP-related Canadian legislation, as well as between the inspection systems in this field. This is a result of the NAMMD activity and, by reciprocal recognition of GMP inspections, represents not only the reaffirmation of the efforts of NAMMD specialists, but also an access of Romanian medicinal product manufacturers to the Canadian market.

09.02.2018
To the attention of interested persons
A working meeting has taken place today at the site of the National Agency for Medicines and Medical Devices (NAMMD), with the participation of Sorina Pintea, Octavian Alexandrescu, Secretary of State within the Ministry of Health, Dr. Alexandru Velicu, NAMMD President, representatives of wholesale distributors of immunoglobulins and CN Unifarm SA, representatives of the NAMMD.
The Meeting’s theme was the crisis generated by the discontinuity in supply of the pharmaceutical market with immunoglobulins, medicinal products addressing the primary immunodeficiency disease, considering that manufacturers have benefitted from exemption from the clawback tax for two years.
The Minister of Health, Mrs. Sorina Pintea, has demanded accurate information about these medicinal products, as regards the possibility of ensuring the supply of immunoglobulins, in the coming period and hereinafter, in 2018.
Considering the extension of this crisis situation, MH representatives have announced the scheduling in February of a meeting with immunoglobulin manufacturers, who represent the first link in the supply chain of patients with such products.
According to the discussions, a certain amount of three types of immunoglobulins (IG Vena, Intratect and Gammanorm) is about to be marketed during the 1st quarter of 2018, with the possibility of ongoing supplementation.

22.01.2018
To the attention of pharmaceutical companies and interested persons
The NAMMD reminds about the organization in Bucharest of the following training course about the functionalities of the new EudraVigilance system, by the European Medicine Agency and Drug Information Association (DIA), between 26-28 February – “ The NEW EudraVigilance System and the electronic reporting of ICSRs in the ISO/ICH E2B(R3) format: Hands-on Training Course”.
For registration and further information, please download the training program which contains the registration details.

14.12.2017
To the attention of pharmaceutical companies and interested persons
The NAMMD would like to inform about the organization in Bucharest of the following training course about the functionalities of the new EudraVigilance system, organized by European Medicine Agency and Drug Information Association (DIA) between 26-28 February – “ The NEW EudraVigilance System and the electronic reporting of ICSRs in the ISO/ICH E2B(R3) format: Hands-on Training Course”.
For registration and further information, please download the training program which contains the registration details.

14.11.2017
To the attention of interested persons
The Romanian Association of International Medicine Manufacturers (ARPIM) addresses European Medicines Agency (EMA) staff in an open letter, in support of Romania’s candidacy.
download document …

17.10.2017
To the attention of interested persons
Information for sponsors of clinical trials regarding the electronic submission of SUSARs to NAMMD, Romania, during the cutover period 07-22 November 2017
The Romanian Agency (HQ ORG-ID NMA) will stop receiving SUSARs from sponsors from 8 (00:00) to 21 (24:00) November 2017.
SUSARs reports in CIOMS I format should be transmitted by email to the following address: farmacovigilenta@anm.ro
Any SUSARs from 7 November should be submitted by MAHs to EVCTM and NAMMD after 22 November along with the other cutover legacy SUSARs.
Detailed information is available in the document EudraVigilance go-live plan (for Romania please see option 2A, Table 7, page 51).
For further information please see EMA press release.

17.10.2017
To the attention of interested persons
Information for marketing authorization holders (MAHs) regarding alternative arrangements for electronic submission of ICSRs to NAMMD, Romania, during the cutover period 07-22 November 2017
The Romanian Agency (HQ ORG-ID NMA) will stop receiving ICSRs from MAHs as of 7 (00:00) November 2017.
The Romanian Agency (HQ ORG-ID NMA) will stop sending ICSRs to MAHs as of 7 (00:00) November 2017.
From 7 (00:00) to 21 (24:00) November 2017, MAHs have to report individual cases originating from the Romania in CIOMS I format to the following email address: farmacovigilenta@anm.ro
Any ICSRs from 7 November should be submitted by MAHs to EVPM after 22 November along with the other cutover legacy ICSRs (according to GVP Module VI, rev. 2 coming into effect on 22 November 2017).
Detailed information is available in the document EudraVigilance go-live plan (for Romania please see option 2B, Table 4, page 33).
For further information please see EMA press release.

17.10.2017
To the attention of interested persons
The NAMMD would like to inform about the organization in Romania of a pharmacovigilance training course – 4th Romanian Pharmacovigilance Workshop, containing the following topics: introduction to HL7, the ISO ICSR (E2B(R3)), the ISO IDMP standards, EudraVigilance changes – direct reporting, access policy, ICSR downloads, EVDAS and MAH signal detection , to be held in Bucharest between 11-13 December 2017.
For registration and further information, please download the training program, the registration form and contact the organizer in Romania.

13.04.2017
To the attention of all wholesale distributors of medicinal products
Please be informed that, on 13.04.2017, all notifications about intra-community supplies forwarded to the NAMMD by wholesale distributors during 21.03.2017 – 12.04.2017 have been reposted on the NAMMD website, since one of the distributors has sent misleading information.

21.03.2017
To the attention of all distributors of medicinal products
Given the entry into force of Order of the Minister of Health no. 269/2017, referring to implementation of Article 5 on wholesale distributors’ obligation to notify the NAMMD 10 working days prior to performance of an intracommunity delivery, please be advised that the notification mentioned in the Annex to the Order shall be submitted to the NAMMD in both electronic format and on paper, accompanied by a summary of the notified information, in Excel, which shall contain the following columns: Distributor, trade name (according to the MA), INN, pharmaceutical form, strength, packaging size, CIM code, ATC code, MAH name, batch, notified quantity, supplier, country of distribution, supply on date of notification (notified quantity excluded), date of notification, monthly average turnover/product (see attachment).
The summary in Excel shall also be forwarded by e-mail at raportaremedicamente@anm.ro, mentioning the notification’s registration number at the NAMMD Registry.
download document …

06.03.2017
To the attention of interested persons
The National Agency for Medicines and Medical Devices (NAMMD), member of the European network of National Competent Authorities (NCAs) coordinated by the European Medicines Agency (EMA) expresses its satisfaction due to the agreement signed between regulatory authorities in the EU and the US, concerning mutual recognition of inspections conducted at medicinal product manufacturing sites.
The agreement will enable both the EU authorities and the FDA to make better use of their inspection resources to help them to focus on other parts of the world where active pharmaceutical ingredients and medicinal products for the EU or US markets are manufactured. This will ensure that patients can rely on the quality, safety and efficacy of all medicinal products, no matter where they have been produced.
The agreement is underpinned by robust evidence that the EU and the US have comparable regulatory and procedural frameworks for inspections of manufacturers of human medicines. In this context, it is worth mentioning that the NAMMD complies with the procedural framework imposed by EU legislation for pharmaceutical inspections.
Teams from the European Commission, NCA, EMA and FDA have been audited and assessing the respective supervisory systems since May 2014, and have worked closely together to reach this agreement.
The Agreement is an Annex to the EU-US Mutual Recognition Agreement which was signed in 1998, but is not yet implemented. Many provisions of the agreement have already entered into force and others will enter into force on 1 November 2017. The text of the Agreement is now published on the website of the European Commission’s Directorate General for Trade.

27.01.2017
To the attention of interested persons
Please be advised that, as of 01.02.2017, all original signed documents issued by the Pharmaceutical Inspection Department may only be collected from 13:00 to 15:00 on Tuesdays and Thursdays.

20.01.2017
To the attention of interested persons
Please be informed that the NAMMD is not open during 23.01-24.01.2017.

18.01.2017
To the attention of interested persons
Considering the obligation, in accordance with legislation in force, of declaring sponsoring by manufacturers, MAHs or their representatives in Romania, wholesale and retail distributors of medicinal products in Romania, as well as by respective recipients, before 31 March 2017, the NAMMD recommends the use of electronic declaration forms and the Guidelines on completion of declaration forms, online for recipients and by e-mail for sponsors, available on the NAMMD website.

16.01.2017
To the attention of pharmaceutical companies and interested persons
The NAMMD would like to inform about the organization in Romania of the following two training courses organized by Drug Information Association (DIA):
– Training course regarding electronic transmission of individual case safety reports: “EudraVigilance Training on Electronic Reporting of ICSRs in the EEA”, organized by Drug Information Association (DIA) in Bucharest between 20-22 February 2017.
For registration and further information, please download the training programme with the registration form (EudraVigilance Training on Electronic Reporting of ICSRs in the EEA) and contact the organizer in Romania.”
– Training course regarding Signal Management in Pharmacovigilance: “Signal Management in Pharmacovigilance”, to be held in Bucharest between 23-24 February 2017.
Training is organized by Drug Information Association (DIA) and will be held by Calin A. Lungu, MD, CEO, Drug Development Consulting Services S.A. (DDCS), Luxembourg.
For registration and further information, please download the training programme with the registration form (Signal Management in Pharmacovigilance) and contact the organizer in Romania.

12.01.2017
To the attention of interested persons
Following finalisation of the assessment procedures, as well as of the notifications received from the National Health Insurance House on signing of cost-volume agreements, the National Agency for Medicines and Medical Devices has forwarded the List of International Non-proprietary Products proposed for inclusion into the reimbursement system to the Ministry of Health.
The proposals target the inclusion of 13 new INNs and amendment of 5 INNs in the List attached to Government Decision no. 720/2008.
Thus, the access to new therapeutic alternatives is ensured for:
– Oncology – for pulmonary neoplasm, prostate neoplasm, leukaemia, lymphoma, multiple myeloma
– Rare diseases – for Gaucher’s disease, immune thrombocytopenic purpura, Duchenne muscular dystrophy, hereditary angioedema
– Diabetes mellitus
– Pneumology – Chronic obstructive bronchopneumopathy (COBP) and pulmonary fibrosis.

04.01.2017
To the attention of all wholesale distributors of medicinal products
You are reminded that, in accordance with provisions of Article 31 (1) of Order of the Minister of Health no. 131/2016 on approval of Rules on authorisation of human medicinal product wholesalers, Good Distribution Practice certification and registration of brokers of medicinal products for human use, units authorised for wholesale distribution on entry into force of the Rules should obtain a Good Distribution Practice certificate in maximum 2 years.
Considering that this deadline expires on 11 February 2018, please be aware that you should submit in due time the applications for inspection planning, in order to allow finalisation of the procedure until the specified date.
Otherwise, the wholesale distribution unit shall discontinue its activity on 11 February 2018, until finalisation of the procedure with release of a Good Practice certificate for wholesale distribution.

23.12.2016

08.12.2016
To the attention of interested persons
The National Agency for Medicines and Medical Devices (NAMMD) would like to announce the launch of the online Form for reporting suspected adverse reactions to medicinal products, the fastest and most up-to-date manner of reporting. The online form has been elaborated with support from colleagues from the fellow medicinal product competent authority of the United Kingdom , in the context of the Joint action project „Strengthening Collaboration for Operating Pharmacovigilance in Europe –SCOPE Joint Action”, financed by the European Union Health Programme.
Reporting of suspected adverse reaction to medicinal products is important; it is the only way you can contribute to better medicinal product safety.

29.11.2016
To the attention of interested persons
Please be informed that the NAMMD is not working with the public during 30.11-4.12.2016.

17.10.2016
To the attention of interested persons
The National Agency for Medicines and Medical Devices (NAMMD) has concluded the assessment of therapeutic protocols received from special commissions within the Ministry of Health.
The proposed amendments target the introduction of 17 therapeutic protocols corresponding to INNs in the List approved through Government Decision no. 720/2008, as amended through Government Decision no. 877/2015 and Government Decision no. 552/2016, thus ensuring access to new therapeutic alternatives in:
– Oncology – for renal cell carcinoma, colorectal cancer, pulmonary neoplasm, ovarian cancer, leukaemia, multiple myeloma
– Neurology – for multiple sclerosis
– Cardiology – for angina, prevention of venous thromboembolism and hypercholesterolemia
– Pneumology – for chronic obstructive bronchopneumopathy (COBP) and pulmonary fibrosis
The NAMMD has submitted the situation of approved protocols to the Ministry of Health, for initiation of the procedure for approval of these protocols through Order of the Minister of Health.

13.10.2016
To the attention of interested persons
Please be informed that, in line with the fee for set up and update of the Index of Medicinal Products for Human Use, established according to Order no. 888 of 25 July 2014 on approval of fees payable to the National Agency for Medicines and Medical Devices for services related to medicinal products for human use, in the first quarter of 2017, the NAMMD will bill inclusion and maintenance in the Index for 2017. Therefore, MAH shall no longer have to submit the Payment Form related to this activity.

02.09.2016
To the attention of interested persons
Starting with 05.09.2016, you are required to also submit the documentation electronically (scanned and copied on a storage device).
– Documents related to any type of inspection (administrative documents for request of inspections, standard dossiers, applications forms for inspections, corrective measure plan, documents supporting various requests for changes of authorisations and annexes to authorisations issued by the PID).
– Documents accompanying other types of requests: approval of waiver from labelling, approval of medicinal product donations, approval of supply of medicinal product samples and any other type of requests requiring submission of supporting documents.
– Electronic documents shall accompany the cover letter, which must be submitted in its original form.
– Documents related to the authorisation of units allowed to perform clinical trials in the field of medicinal products for human use shall be submitted on paper and in electronic format (scanned and copied on a storage device).

02.09.2016
To the attention of interested persons
Please be informed that the following documents have been posted on Pharmaceutical inspection:
List of manufacturing units/wholesale distribution/marketing authorisation holders fined as of 01.06.2016.
The list shall be periodically updated.

26.08.2016
To the attention of interested persons
We inform you that, starting with 01.09.2016, the registry on the 58 Nicolae Titulescu, Sector 1, Bucharest, shall operate in the office of 48 Aviator Sănătescu, Sector 1, Bucharest.

26.07.2016
To the attention of interested persons
The NAMMD would like to inform about the working visit of Prof. Guido Rasi, Executive Director of the European Medicines Agency (EMA), and Ms. Silvia Fabiani, high ranking EMA official, between 25-27 July 2016.
The NAMMD expresses its firm confidence that the EMA top level visit would provide an opportunity for closer cooperation with the European Agency and to benefit from its expertise and support in achieving its role as competent national authority in the field of the medicinal product for human use, in order to reach established targets and identify action for support directed towards the NAMMD for active involvement in meeting the objectives of the EU Medicines Agencies Network Strategy to 2020, „Cooperation for health condition improvement”.

14.07.2016
To the attention of all wholesale distributors of medicinal products
Please be advised that the Spanish competent authority has issued a statement of non-compliance with Good Distribution Practice (GDP) requirements concerning ABASTECIMIENTOS FARMACEUTICOS DEL NOROESTE S.L. of Spain.
Suspension of the wholesale distribution authorisation of this operator shall be in force as of 15.06.2016.
Because of technical grounds, the statement of non-compliance with the Good Distribution Practice failed to be uploaded into the EudraGMP database.

30.06.2016
To the attention of interested persons
In line with provisions of Article 814 paragraph 4 of Law 95/2006 and Article 35 of Order of the Minister of Health no. 194/2015, as mentioned in Article 22 paragraph 2 of Law 677/2001, the NAMMD has posted on its own website, in Advertising, the Registry of declarations of sponsorship activities of 2015, for information purposes and available to the public or any person proving legitimate interest. The information included in the Registry are based on the declarations received by the NAMMD, in electronic form, on the NAMMD website or in written form, from manufacturers, MAHs or their representatives in Romania, as well as from wholesale and retail distributors of medicinal products and recipients of sponsorship activities, physicians, medical assistants, professional organisations, patient organisations and any type of organisation performing activities related to human health, medical/pharmaceutical assistance. Information forwarded by other means than those established in Annexes 1 and 2 of Order of the Minister of Health no. 194/2015 have not been posted (contracts, certificates, statutory declarations) because of non-compliance.

23.06.2016
To the attention of all wholesale distributors of medicinal products
Please be advised that the national Czech authority has issued a statement of non-compliance with Good Distribution Practice (GDP) requirements concerning WebCash s.r.o. of the Czech Republic.
The measure to withdraw this wholesale distribution authorisation for this operator entries into force as of 26.06.2016.
Please check http://eudragmdp.eudra.org/inspections/displayWelcome.do (the EudraGMP database, the “read only” version) for further details on non-compliances which have led to the conclusion of wholesale distributor non-compliance with GDP rules.

15.06.2016
To the attention of Marketing Authorisation Holders (MAHs)/MAH representatives
EMA press release on Periodic Safety Update Report (PSUR) repository mandatory use
http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2016/06/WC500208531.pdf

15.06.2016
To the attention of interested persons
Considering that, lately information related to the lack of efficacy of generics, explicitly referring to CEFORT (ceftriaxonum), powder for solution for injection/infusion, was publicly spread, the National Agency for Medicines and Medical Devices (NAMMD) has referred the matter to itself, immediately starting to sample the mentioned medicinal product for testing. One month after sampling, to the present day, physical-chemical and microbiological tests have been conducted in accordance with analysis methods of the European Pharmacopoeia and the specification for this medicinal product has been approved by the marketing authorisation.
The results of physical-chemical analyses, for qualitative and qualitative parameters, as well as the results of microbiological tests have confirmed the compliance of samples taken from CEFORT 1g, powder for solution for injection/infusion (ceftriaxonum) with requirements of the European Pharmacopoeia and with the specifications approved at authorisation.
To conclude, as opposed to the results of the tests performed, suspicions on the quality of this generic medicinal product have not been scientifically confirmed.
In addition, please be advised that, in accordance with NAMMD attributions, the authority’s 2016 Yearly Sampling and testing plan includes assessment of the quality of medicinal products, both generic and innovative.

25.05.2016
To the attention of interested persons
Following appearance in the media of the Notification on the outcome of the verifications performed by the Prime Minister’s Inspectorate related to the condition of children suffering from the Hemolytic-uremic syndrome (HUS), the NAMMD preliminarily informs that:
The notice has been communicated to the press without discussing the matter with the NAMMD to scientifically substantiate the conclusions shown in the respective document.
Consequently, we regretfully realize that the public has not been informed adequately, since, given the lack of proof based on legislative substantiation, the notification contains several issues showing a misunderstanding of the underlying mechanisms of the marketing of the hexavalent vaccine (commercial name – HEXAXIM).
Right from the start, we would like to remind you that there is no proof establishing a direct and unquestionable link between the vaccination scheme and children diagnosed with HUS. Thus, the epidemiological method performed in this case does not establish any connection between vaccine administration and disease onset.
In order to reject any doubt about the legality of placing HEXAXIM on the Romanian market, as an EU member state, we hereby inform public opinion that Romania, through the NAMMD, has made sure that the authorisation if performed in line with the legal framework, this aspect also being officially confirmed by the European Medicines Agency (EMA). Moreover, in similar cases, other EU member states such as Belgium and Poland, having to face the lack on the market of the hexavalent vaccine (HEXACIMA), have resorted to the same solution: ensuring the national vaccination programme through authorisation of HEXAXIM, as a vaccine fully identical with the already existing vaccine, in the initial scheme (HEXACIMA/HEXYON).
The NAMMD assures the population and the empowered bodies upon its willingness to provide help with technical and scientific information proving that the regulatory authority in the field of the medicinal product has managed, once again, to attain its primary scope of protecting public health in an emergency situation requiring rapid measures, yet fully compliant with legal provisions in force.

16.05.2016
To the attention of interested persons
The National Agency for Medicines and Medical Devices states the following, in accordance with Law 95/2006 on healthcare reform, republished, Title XVIII – The medicinal product, Article 704:
(1) No medicinal product can be marketed in Romania without a marketing authorisation issued by the NAMMD, in accordance with provisions of this Title, or without an authorisation released in line with the centralised procedure.
Moreover, the NAMMD reiterated its call on Romanian patients and the general public to not purchase medicinal products over the Internet because of the serious risk of counterfeit products.
The NAMMD recommends everyone suffering from various diseases requiring treatment to contact a healthcare professional and to only purchase medicinal products from authorised units.

06.04.2016
To the attention of Market Authorisation Holders (MAH) / MAH Representatives / Sponsors
Notification on electronic transmission of adverse reactions to the EudraVigilance, April 21 to April 25, 2016
Following notification by the European Medicines Agency (EMA) on unavailability of the EudraVigilance production environment, including EVWEB, Gateway and MLM services, from 11.00 hrs. (Romania time), April 21th, to 11.00 hrs. (Romania time), April 25th 2016, Market Authorisation Holders/ Sponsors are reminded that no E2B file format adverse reaction reports (ICSRs / SUSARs) may be submitted electronically to the NAMMD during this time.
The NAMMD recommends MAH / Sponsors timely processing of cases with reporting deadlines during this time and their electronic submission in E2B format, before 11:00 hrs. (Romania time), April 21th, 2016.
In case of MAH / Sponsor failure to process and electronically submit cases with reporting deadlines during the specified time (21 to 25 April 2016), submission may be done by either fax: +40 213 163 497 (CIOMS format) or e-mail: adr@anm.ro (CIOMS format).
MAH / Sponsor should keep in mind that, as soon as the EudraVigilance system has become functional, case reports submitted by fax/e-mail during this time shall also be submitted electronically in E2B format.

28.03.2016
To the attention of pharmaceutical companies and interested persons
To the attention of pharmaceutical companies and interested persons
The NAMMD would like to inform about the organisation of the 3 Romanian Pharmacovigilance Workshop on MedDRA 27th SOC, Medication errors, EudraVigilance changes, Medical Monitoring Services, Signal detection, ISO standards and more, to be held in Bucharest between 12-13 May 2016.
Training will be provided by Calin A. Lungu, MD, DDCS S.A., Luxemburg.
The workshop will be conducted in English and its venue is the Novotel Hotel, Calea Victoriei 37B, sector 1.
For registration and further information, please see the Workshop Agenda and Registration form and contact the organiser in Romania:
Madalina Nedelciu Business Travel Turism S.R.L.
Fax: +4021 3126708 Tel: +4021 2315615
Email: madalina.nedelciu@businesstravel.ro

02.03.2016
To the attention of healthcare professionals
During routine activities, an Italian physician discovered closure system issues in certain vials of DYSPORT 500IU, powder for solution for injection, batches no. A00703 (expiry date: 02.2017) and no. F05302 (expiry date: 11.2016) (difficult to open vials because of Aluminium lid over-adherence to the bottle). In addition, powder was found to spill from the vials.
The Marketing Authorisation Holder declared that the respective batch numbers were false.
If in possession of vials of DYSPORT 500 IU inscribed with the above mentioned batch numbers, contact the NAMMD promptly.

01.03.2016
To the attention of interested persons
Following complaints to the NAMMD concerning shortage of SINTROM 4 mg, tablets, please be informed that, according to available information, the product is currently in the manufacturer’s stock and may be purchased after completion of the Ministry of Health pricing procedure.
However, sufficient stocks of TROMBOSTOP 2 mg, tablets, containing acenocumarole, the same active substance as SINTROM, are available.

29.02.2016
To the attention of interested persons
For proper information of the media and the public, following press suppositions concerning immunisation with HEXAXIM, the National Agency for Medicines and Medical Devices declares the following:
HEXAXIM was authorised on 21 June 2012, according to provisions of Article 58 of Regulation (EC) no. 726/2004, following the same qualitative and quantitative assessment procedures as for HEXACIMA. The two products are owned by the same Marketing Authorisation Holder, and the European Medicines Agency warrants the equivalence of standards for assessment of respective documentation for authorisation.
Given the discontinuation of supply with HEXACIMA, Romania, as well as other EU member states, such as Belgium or Poland, has authorised HEXAXIM, by the same manufacturer, in accordance with legislation on marketing authorisation of medicinal products for special needs.
Similarly to all vaccines, in accordance with EU administrative procedure for official batch release, HEXAXIM as well is marketed only after prior batch-by-batch testing.
As regards press assumptions concerning potential association of cases of Haemolytic-Uremic Syndrome (HUS) and administration of HEXAXIM, please note that, in accordance with available records, not any of the children diagnosed with HUS has received a HEXAXIM vaccine.

24.02.2016
To the attention of interested persons
Related to NAMMD notification of 27 January 2016, on technical requirements for NAMMD acceptance (validation of submission) of electronic application forms for authorisation, renewal, variations (electronic Application Form, eAF) as of 01.03.2016, i.e.:
1. “active PDF” format;
2. Integrated XML;
3. Blocked by the applicant upon change/save, please consider the following:
– The Electronic Application Form (eAF) has to be included in the eCTD format and not submitted separately (such as by e-mail);
– An activated copy (saved prior to blocking) will be made available to applicants for inclusion of amendments required by the NAMMD upon validation of submission;
– Applicants can also use the electronic signature when signing applications in electronic format (eAF);
– Applicants’ technical questions may be submitted directly to the eAF Maintenance Group. Please be reminded of the following:
– Electronic forms and technical documentation are available at: http://esubmission.ema.europa.eu/eaf/index.html
– For full details, please see the eAF webpage, “Guidance documents”.

15.02.2016
To the attention of interested parties
The European Commission, the European Medicines Agency (EMA) and national competent authorities of EU Member States have adopted measures meant to help protect patients against the threat of falsified medicines, which may contain ingredients, active substances included, which are of low quality or in the improper dosage.
A new Commission Delegated Regulation establishes detailed standards for safety features to be placed on the packaging of medicines for human use. The safety features consist of a unique identifier (a 2-dimension barcode) and an anti-tampering device, to be placed on the packaging of certain medicines for human use, allowing for their identification and authentication.
Introduction of the safety features in question will prevent falsified medicines entering the legal supply chain, from manufacturers to distributors to pharmacies and hospitals, respectively, thus guaranteeing medicine authenticity.
Marketing-authorisation holders are required to place the safety features on the packaging of most prescription medicines as well as of certain non-prescription medicines no later than 9 February 2019.

28.01.2016
To the attention of interested persons
Based on provisions of Article 35 of Order of the Minister of Health no. 194/2015, please be advised on the availability for use of the reporting forms posted under Advertising. Before filling in the forms, please see the respective guidelines.

27.01.2016
To the attention of interested parties
Use of electronic forms for applications for authorisation, renewal, variations (electronic Application Form, eAF).
Please be advised that, as of 1 January 2016, use of electronic Application Forms (eAF) has become mandatory for applications related to authorisation, renewal and variations, respectively, (Centralised Procedure, MRP, DCP and National Procedure) for medicinal products for human use.
Therefore, please take into account the following aspects, in particular:
– eAFs and technical documentation are available at: http://esubmission.ema.europa.eu/eaf/index.html;
– as regards the National Procedure, on-paper Application Forms are only accepted in January and February;
– full details can be found on the eAF webpage, under “Guidance documents”

31.12.2015
To the attention of all wholesale distributors of medicinal products
Please be advised on provisions of:
– Order no. 502/2013 on approval of mandatory monthly reporting of placement on the market in Romania and of sales of medicinal products for human use, respectively, by authorised wholesale distributors/importers/manufacturers;
– Order no. 456 /2013 on approval of the List of International Non-proprietary Names of medicinal products at high unavailability risk, as provided to insurants in the health insurance system and agreement on a measure to secure their market availability in Romania, as amended.
Non-compliance with legal provisions above shall be sanctioned in accordance with Law 95/2006, republished – Title XVIII, The medicinal product, as follows:
– Civil penalty, in accordance with provisions of Article 875 (m);
– Civil penalty and suspension of wholesale distribution authorisation, in line with provisions of Article 875 (n).
The NAMMD has monitored distribution activities and taken immediate action for penalty of respective breaches (e.g. in 2015, penalties applied to Expert Med Import Export SRL, Pharma Storage SRL, Health Care Store SRL, Perfect Farma Distributie SRL, Biolife Pharmamed SRL, Triumph Pharma SRL).

27.11.2015
To the attention of all wholesale distributors of medicinal products
Please be informed on publication by the World Health Organisation of a press release concerning the falsified medicinal product POSTINOR-2 tablets 0.75mg, batch T38012 (expiry date 08.2018) found in Uganda.
If you own or receive an irregular offer for purchase of this batch of POSTINOR-2, please inform the NAMMD without delay. The WHO press release is available at: http://www.who.int/medicines/publications/drugalerts/en/

27.11.2015
To the attention of interested persons
The National Agency for Medicines and Medical Devices hereby informs on notification from the Marketing Authorisation Holder concerning restart of manufacturing of DIGOXIN ZENTIVA 0.25 mg tablets and DIGOXIN ZENTIVA 0.5 mg/2 ml solution for injection. According to the notification, the first batches have been released for distribution by the manufacturing unit starting with 26.11.2015.
Therefore, restart of the manufacturing process ends the period of temporary shortage of supply for these products.

23.11.2015
To the attention of Marketing Authorisation Holders
Please be advised that, as of 03.12.2015, in accordance with provisions of Order of the Minister of Health no. 888 of 25 July 2014, on approval of the fee for activities performed by the NAMMD in the field of the medicinal product for human use, the INDEX will only contain medicinal products for which the fee for set-up and update has been paid.

20.11.2015
To the attention of all wholesale distributors of medicinal products
Please be advised that one distributor in Germany has found 47 vials of MabThera 500 mg, concentrate for solution for infusion, batch number N7030B01 (expiry date 02/2017) suspected of falsification.
The batch number printed on 43 vials was N7030 and N7023 on 4 other vials; all secondary packagings were imprinted with batch number N7030B01.
The product was intended for the Romanian market. On grounds of suspicion of falsification, the German distributor has returned the respective vials to the Czech supplier, who has blocked these products from sale.
Please notify the NAMMD promptly if you have received an irregular offer for purchase of MabThera (for instance, at an unusually low price or with quality certificates different in aspect from those normally issued by ROCHE).
As regards batch no. N7030B01, each packaging thereof must be checked. Please inform the NAMMD forthwith in case of tampering signs.

10.11.2015
To the attention of interested persons
On invitation by the management of the Medicines and Medical Devices Agency of Serbia (ALIMS), NAMMD representatives took part in the 11th Traditional Symposium of the Serbian Agency.
Main focus of the scientific event, carried out with international participation, was changes and development trends of the regulations in force in the field of medicines and medical devices in Serbia, equally addressing the pharmaceutical industry, medicinal product marketing authorisation holders, manufacturers of medical devices, healthcare professionals as well as representatives of regulatory bodies and the academia.
Subjects of topical interest in the field have been discussed, such as “compassionate use of medicines”, “perspective of programs for early availability of new therapeutic options in the Republic of Serbia”, “interchangeability of medicines,” ” medical devices vigilance”, “falsified medicines and medical devices” and, last but not least, “advertising of medicines, medical devices and dietary supplements and their control”.
ALIMS management and NAMMD representatives have also discussed their future cooperation related to quality, efficacy and safety of medicinal products and medical devices, based on the Memorandum of Understanding signed between the two institutions on 19 August, 2015.

31.10.2015
To the attention of interested persons
In October, Zentiva, Marketing Authorisation Holder of Digoxin Zentiva 0.25 mg, tablets, in Romania, notified the National Agency for Medicines and Medical Devices (NAMMD) on temporary discontinuation of marketing of the product, because of manufacturing-related issues.
Consequently, to meet the required amount of tablets (0.25 mg digoxin) for the upcoming period, the Ministry of Health and SC Unifarm SA have identified a different manufacturer. In this respect, upon request by SC Unifarm SA, the NAMMD has issued an authorisation for resolution of special needs, in line with regulations approved through Order of the Minister of Health no. 85/2013.

23.09.2015
To the attention of stakeholders
Please be informed on publication on the European Commission website, in accordance with Article 5 of Regulation 1394/2007, of the Guideline on Good Manufacturing Practice for Advanced Therapy Medicinal Products available for public consultation. Public consultation is to be completed on 12 November 2015. The document is available at: http://ec.europa.eu/health/human-use/advanced-therapies/developments/index_en.htm

17.09.2015
To the attention of all wholesale distributors of medicinal products
On 7.09.2015, 4320 units of HUMIRA 40mg, solution for injection in pre-filled pen, batch number 1041670 (expiry date 31.03.2017) were stolen in Great Britain.
Please notify the NAMMD promptly if you have received an irregular offer for purchase of this HUMIRA batch.

09.09.2015
To the attention of interested persons
This is a reminder on submission of applications for clinical trial sites: Applications shall be submitted at least 3 months prior to expiry of the previous authorisation.
Documents to be submitted to the NAMMD are available in Scientific Council Decision no. 2 of 22 April 2014, as amended through Scientific Council Decision no. 24 of 3 July 2015, posted on the NAMMD website under section Legislation/Scientific Council Decisions.
Applications may be submitted every Friday, 9:45-13:45.

21.08.2015
To the attention of interested persons
On August 19, 2015, The National Agency for Medicines and Medical Devices of Romania ( NAMMD) and the Medicines and Medical Devices Agency of Serbia (ALIMS) concluded a Memorandum of understanding, the parties agreeing on support by the NAMMD concerning the quality, efficacy and safety of medicinal products for human use, aiming at ALIMS alignment with the EU legislation in the field.
The Memorandum of understanding was concluded in Belgrade by the top management of the two authorities, as represented by Dr. Marius Savu, NAMMD President and Dr. Sasa Jacovic, ALIMS Managing Director.
“Among other things, this Memorandum of understanding envisages establishing a network of correspondence for exchange of scientific and technical information in line with European and national legislations in force. Actually, the NAMMD specialists will be entirely available regarding expertise acquired after Romania’s EU accession.”- Dr. Marius Savu, NAMMD President has highlighted.
NAMMD top management hereby expresses its confidence that such joint efforts will enable the ALIMS, as the Serbian national competent authority in the field of medicinal products for human use and medical devices to best integrate in the EU Medicines Agencies network, following accession to the EU.

31.07.2015
To the attention of interested persons
The National Agency for Medicines and Medical Devices (NAMMD) implements decision of the European Commission (EC) no. C(2015) 5100 final, of 16.07.2015 to suspend marketing authorisation (MA) of medicinal products authorised based on bioequivalence studies carried out at the Hyderabad (India) site of the GVK Biosciences Company
In result of the European Commission decision on suspension of marketing authorisations for medicinal products for human use authorised based on bioequivalence studies carried out at the Hyderabad (India) site of the GVK Biosciences Company, the NAMMD hereby advises on the following:
On the occasion of an inspection conducted in 2014 by the French competent authority (Agence Nationale du Medicament et de sécurité des Produits de Santé – ANSM) at the Hyderabad (India) site of the GVK Biosciences company, critical non-compliances were found in conduct of bioequivalence studies carried out from 2008 to 2014. Lack of compliance with Good Clinical Practice Rules raised suspicions about the reliability of data supporting a positive benefit-risk ratio for these medicinal products.
Therefore, a referral procedure was triggered by the European Commission under Article 31 of Directive 2001/83/EC as amended. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has conducted an assessment of the potential impact of these findings on the benefit-risk balance of medicinal products authorised based on clinical studies carried out at the inspected site.
The decision of the European Commission is in line with the CHMP opinion and concerns suspension by Member States of marketing authorisations for medicinal products relying on inaccurate data related to bioequivalence with the EU reference products. For Romania, medicines proposed by the European Commission for MA suspension are provided in the table attached.
Under the European Commission decision, EU national competent authorities may opt for a maximum 24 months delay in implementation since issuance of the decision with regard to medicines considered critically important nationwide, based on assessment of potentially unmet medical needs. In such cases, the Member State shall require MA Holders to submit a bioequivalence study within 12 months since adoption of the European Commission decision.
In this context, the NAMMD has decided to suspend marketing authorisations for medicinal products only for which MA Holders have not yet submitted evidence of bioequivalence with an EU reference product and implicitly of positive benefit-risk ratio. For such medicinal products, therapeutic alternatives are available in Romania.
In line with the decision of the European Commission, the NAMMD revokes the MA suspension on submission by the MA Holder of evidence of bioequivalence with an EU authorised reference medicinal product based on a fresh bioequivalence study.
download document …

08.07.2015
To the attention of all wholesale distributors of medicinal products
Please be informed that falsified blisters of VIAGRA 100mg, 4 tablets, labelled with batch number B714830238/expiry date 04.2017 have been confiscated in Italy by the customs authority (the blisters had neither outer packagings nor leaflet). The batch number does not belong to an original product batch. The product is not distributed through authorised distribution channels. If in possession of such packaging, please contact the NAMMD.

03.06.2015
To the attention of all wholesale distributors of medicinal products
Medicinal products manufactured by Roche were stolen in Italy on 24.04.2015:
download document …

20.05.2015
To the attention of interested persons
On Wednesday, 20 May 2015, representatives of several patient associations met for discussion in a panel organised by the National Agency for Medicines and Medical Devices (NAMMD). Issues considered were EU pharmacovigilance activity, monitoring and review of the safety profile of certain medicinal products or medicinal products classes.
Agency specialists explained the procedures and stages allowing maintenance of marketing authorisations (MAs), with amendment of Product Information (therapeutic indications, manner of administration, doses, addition of new contraindications or special warnings etc.,) or, in certain cases, resulting in MA suspension or even withdrawal. Examples discussed included codeine, diclofenac, ibuprofen, combined contraceptives, medicinal products for the treatment of osteoporosis, metoclopramide, sibutramine etc. Accurate information was required, considering the recent media information potentially misleading patients.
Participants were representatives of the Association of Patients with Liver Diseases in Romania (APAH-RO), of the Give Life Association, the Federation of Associations of Diabetic Patients in Romania, the Association of Patients with Autoimmune Diseases, the Association for Rare Diseases, the Baylor Marea Neagra Foundation, the Romanian Transplant Association, the National Association of Haemophiliacs in Romania and the “Pavel” Association.
Representatives of patient associations stated their openness for sharing the information provided on the topics discussed with their respective members. Moreover, certain participants also proposed introduction of educational programmes for patients, developed with NAMMD support; the proposal was accepted by NAMMD management.
NAMMD representatives in the meeting were Dr. Marius Tanasa, vice-president of the Agency, specialists of the Pharmacovigilance and Risk Management Service, as well as representatives of the Policies and Strategies Department.
Concluding the meeting, NAMMD representatives reasserted their purpose to organise periodic meetings with representatives of patient associations on other issues of interest.

05.05.2015
To the attention of Marketing Authorisation Holders / MAH representatives
Please be informed that, in line with provisions of Article 787 (6) of Law 95/2006, as amended, submission is required of names of wholesale distributors ensuring distribution in Romania for each reimbursable medicinal product in your portfolio, reimbursed via the national social health insurance system. Respective information is to be forwarded to raportaremedicamente@anm.ro, in accordance with the template attached, until 11.05.2015. Information is also required on changes of the list of wholesale distributors.
download document …

27.03.2015
To the attention of all wholesale distributors of medicinal products
Please be informed that certain distributors in Germany and a pharmacy in the Czech Republic have been provided for sale batches of NEULASTA 6mg, pre-filled syringe x 0,6ml [batch numbers 1076277B, 1047277B, 1052487C (expiry date 03.2017), 1053673A (expiry date 06.2017)] suspected of being falsified. The medicinal product has been imprinted in German. On grounds of suspicion of falsification, the German distributors and the Czech pharmacy have not purchased the product concerned.
Please notify the NAMMD promptly if you have purchased any of the respective batches or if you have received an irregular offer for purchase of Neulasta (for instance, at an unusually low price or with quality certificates different in aspect from those normally issued by AMGEN).
Batch no. 1047277B must be blocked from sale without delay and withdrawn from patient use level, since this is not an AMGEN original batch number.
As regards batch no. 1046277B, each packaging thereof must be checked. Please inform the NAMMD forthwith in case of tampering signs.
A press release issued by the German competent authority (BfARM) is available here.

25.03.2015
To the attention of interested persons
On Wednesday, March 25th, 2015, the National Agency for Medicines and Medical Devices (NAMMD) organised a panel meeting with representatives of several patient associations, for discussion of pharmacovigilance issues and presentation of the adverse drug reaction reporting form for patient.
Participants in the meeting were representatives of the Association for Patient Protection, the Federation of Associations of Patients with Cancer, the Association of Patients with Liver impairment (APAH-RO), the Coalition of Organisations of Patients with Chronic Diseases (COPAC), the National Union of Organisations of HIV/AIDS Patients (UNOPA), the Daruieste Viata Association, the Federation of Associations of Romanian Diabetes Patients, the Association of Patients with Autoimmune Diseases, the Association for Rare Diseases and the Baylor Marea Neagra Foundation.
The NAMMD was represented by Dr. Marius Tãnase, Vice-President, specialists of the Pharmacovigilance and Risk Management Service, as well as of the Department for Policies and Strategies.
Participants representing patient associations expressed their openness to raise public awareness and promote the patient reporting form as well as their availability for posting it on their respective websites.
The NAMMD encourages both patients and healthcare professionals to report suspected adverse reactions to all medicines, vaccines included. By reporting adverse reactions, patients too can help improvement of the drug safety profile, thereby protecting public health.
The patient reporting form is available on the NAMMD website.
Concluding, NAMMD representatives expressed their availability for organising periodic meetings with representatives of patient associations on other topics of interest as well

04.03.2015
To the attention of interested persons
The National Agency for Medicines and Medical Devices (NAMMD) hereby informs on availability of a form for reporting of adverse reactions to medicinal products, including vaccines, by patients, patient relatives or caregivers. The form for reporting adverse reactions available to patients, by means of which patients, their relatives or caregivers can notify adverse reactions following administration of medicinal products, vaccines included. The suspected adverse reaction reporting form is posted on the NAMMD website, together with a number of related clarifications and pieces of information…
download document …

27.02.2015
To the attention of interested persons
The National Agency for Medicines and Medical Devices (NAMMD) expresses its concern with public access, at any time, to medicinal products authorised for the pharmaceutical market. Lately, signals have been received, particularly from patient associations, concerning unavailability of certain medicinal products. The NAMMD hereby calls on all stakeholders: healthcare professionals, patients, the public and the media, to inform the Agency on absence from the market of certain medicinal products. The NAMMD relays received messages to the Ministry of Health for necessary measures. Information on unavailability of medicinal products may be sent to: lipsamedicament@anm.ro

24.02.2015
To the attention of interested persons
The NAMMD hereby informs on results of tests conducted in NAMMD laboratories on samples of Imovax dT (marketing authorisation holder: Sanofi Pasteur SA, France), sampled from batches for which potential adverse reactions have been reported after vaccination in children aged 14, in accordance with the approved vaccination schedule in Romania.
No quality non-compliances have been detected and laboratory test results are compliant with manufacturer’s product specifications for the finished product and corresponding PhEur monograph from the European Pharmacopoeia.

05.02.2015
To the attention of pharmaceutical companies and interested persons
The NAMMD would like to inform about the organisation in Romania of a Pharmacovigilance Conference on risk management, electronic reporting, XEVMPD updates, audits, inspections and periodic reporting, to be held in Bucharest between 12-14 May 2015.
Training will be provided by Calin A. Lungu, MD, DDCS S.A., Luxemburg, Jan Petracek, MD, Pharminvent, Czech Republic, Jose Ortiz, PhD, Spain.
The workshop will be conducted in English and its venue is the Novotel Hotel, Calea Victoriei 37B, sector 1,.
For registration and further information, please see the Conference Agenda and contact the organiser in Romania as soon as possible,:
Madalina Nedelciu Events Projects Manager
Aleea Alexandru 9A 011821 Bucharest, 1st Distict, Romania
Mobil +40729 835337 Tel +4021 2315615 Fax +4021 3126708
E-mail: madalina.nedelciu@businesstravel.ro

05.02.2015
To the attention of pharmaceutical companies and interested persons
The NAMMD would like to inform about the organization in Romania of a training course regarding electronic transmission of individual case safety reports: “EudraVigilance – Electronic Reporting of ICSRs in the EEA”, to be held in Bucharest between 25 -27 March 2015.
Training is organized by Drug Information Association (DIA) and will be provided by Calin A. Lungu, MD, CEO, Drug Development Consulting Services S.A. (DDCS), Luxembourg.
For registration and further information, please see the Training Agenda (EudraVigilance – Electronic Reporting of ICSRs in the EEA) and contact the organizer in Romania:
Madalina Nedelciu Events Projects Manager
Aleea Alexandru 9A 011821 Bucharest, 1st Distict, Romania
Mobil +40729 835337 Tel +4021 2315615 Fax +4021 3126708
E-mail: madalina.nedelciu@businesstravel.ro

04.02.2015
To the attention of interested persons
The National Agency for Medicines and Medical Devices (NAMMD) hereby renews warnings to patients and the general public concerning purchase of medicinal products over the Internet because of the serious risk of counterfeit products of uncertain origin, composition and safety. The dose could be too high or too low, or the product may be contaminated.
download document …

28.01.2015
To the attention of interested persons
Please be informed on publication on the website of the National Agency for Medicines and Medical Devices (NAMMD) of the translation into Romanian of a press release of the European Medicines Agency (EMA): “EMA press release on GVK Biosciences: European Medicines Agency recommends suspending medicines over flawed studies”
In this respect, the NAMMD expects issuance of a European Commission (EC) Decision for implementation.
The EC Decision is to be adopted according to recommendations of the EMA Committee for Medicinal Products for Human Use (CHMP).

28.01.2015
To the attention of all authorised wholesale distributors of medicinal products
Please be informed that, following theft from the pharmacy of the Braila Emergency County Hospital, the following medicinal products are lacking from the pharmacy’s stock:
– AVASTIN 25mg/ml, vial x 4ml, batches B7110B01 (expiry date: 11.2015), B8000B02 (expiry date: 04.2016)
– AVASTIN 25mg/ml, vial x 16ml, batches B7031B03 (expiry date: 02.2016), B7050B06 (expiry date: 06.2016)
– HERCEPTIN 150 mg, batch H4450B03 (expiry date: 05.2018)
– NIVESTIM 30MU/0.5ml, batch 2861123B (expiry date: 31.03.2016)
– TORISEL 25mg/ml, batch AJ64/92 (expiry date: 30.04.2017)
In case you own or purchase packages from these batches, please ensure they come from legal and authorised sources.
In case of suspicion concerning the origin of certain packages, please inform the NAMMD immediately.

27.01.2015
To the attention of interested persons
Please be advised on the publication of the following European Medicines Agency (EMA) documents on public consultation on implementation of transparency requirements of the European Clinical Trial Regulation, on the website of the National Agency for Medicines and Medical Devices, under section “Press releases”:
– EMA press release on public consultation on application of transparency rules of EU Clinical Trial Regulation
– Questions and answers on public consultation on implementation of transparency requirements of the European Clinical Trial Regulation

09.01.2015
To the attention of all authorised wholesale distributors of medicinal products
Please be advised that the Norwegian competent authority has issued a Statement of non-compliance with Good Distribution Practice requirements concerning NORGES NATURMEDISINSENTRAL AS, relating to distribution of medicinal products requiring cold storage conditions. Statements of EU wholesale distributors’ non-compliance with Good Distribution Practice requirements are published in the EudraGMDP database, at: http://eudragmdp.ema.europa.eu/inspections/view/gdp/searchGDPNcr.xhtml?search=nonCompliance

18.12.2014
To the attention of Marketing Authorisation Holders
Please be informed that until 31 December 2014 all Marketing Authorisation Holders from the European Union and the European Economic Area should forward information to the European Medicines Agency (EMA) on authorised medicinal products and constantly update this information, in line with Article 57 (2) of Regulation (EC) no. 726/2004, as amended. This represents a mandatory requirement, in accordance with the law, of EU legislation on medicinal products for human use.
For more information, please visit the EMA website.

18.12.2014
To the attention of interested persons
Please be informed that the Registry Service is closed for information system testing between 24.12.2014 – 04.01.2015.
We hereby apologize for any inconvenience and wish you HAPPY HOLIDAYS!

05.11.2014
To the attention of Marketing Authorisation Holders
Please be advised that, as of 05.11.2014, in accordance with Order of the Minister of Health no. 888 of 25 July 2014, on approval of the fee for activities performed by the NAMMD in the field of the medicinal product for human use, the INDEX will only contain medicinal products for which the fee for set-up and update has been paid.

21.10.2014
To the attention of interested persons
Considering provisions of Order of the Minister of Health no. 1018/2014, the forms for authorisation of use of last-resort therapy medicinal products have been posted under section Forms and tariffs.

14.10.2014
To the attention of ASMF and MA Holders
Please be advised that, as of 15.10.2014, ASMFs may be submitted by regular procedure to both the Registry Office in the NAMMD headquarters and the Common European Submission Platform, CESP.

18.09.2014
To the attention of interested persons
Please be advised that reports resulted before 17.09.2014 following assessment of documentation submitted in accordance with Order of the Minister of Health no. 861/2014 are available under section “HEALTH TECHNOLOGIES ASSESSMENT”.

01.08.2014
To the attention of Marketing Authorisation Holders
Please be advised that applications for assessment of medical technologies in support of proposal for inclusion of new INNs, reimbursable INNs with extension of indication, generics with INNs not reimbursable in the List, biosimilars with INNS not reimbursable in the List and fixed-dose combinations in the List of International Non-proprietary Names of medicinal products as provided to insurants, irrespective of personal contribution, based on medical prescription, in the health insurance system frame, as well as of International Non-proprietary Names of medicinal products granted in national health insurance programs, may be submitted as of 04.08.2014.
Respective documentation shall be submitted in accordance with Order of the Minister of Health no. 861/2014 in both electronic format and on paper, accompanied by application and payment forms, as available under the “Fill-in forms and fees” heading, in two copies.
Schedule for submission: from 10:00 to 12:00, every Monday and Wednesday.

01.08.2014
E-mail communication technical issues solving
Following NAMMD e-mail technical issues solving, please be advised that these services are functional as of today, 01.08.2014, 8:00.
All @anm, technical and nominal, e-mail addresses are available.
The temporary e-mail addresses announced on 30.07.2014 are active until the end of this day, but we do not recommend their use to submit information.

30.07.2014
E-mail technical issues / Interim NAMMD e-mail addresses
Because of technical issues, communication with the NAMMD via @anm.ro e-mail addresses cannot be used until further notice. In the meantime, direct communication with NAMMD departments and services can be established via the following e-mail addresses:

27.06.2013
To the attention of all authorised wholesale distributors of medicinal products
Please be advised that, in accordance with Article 791 (b) of Law 95/2006 and Articles 13 and 101 of the Guideline on Good Distribution Practice of Wholesale Medicinal Products approved through Order of the Minister of Health no. 1963/2008, purchases performed by wholesale distributors of medicinal products from pharmacies are ILLEGAL.
In line with Article 836 (h) of the same law, the NAMMD shall sanction non-compliance with the aforementioned legal provisions by civil fine and suspension of the wholesale distribution authorisation.
The NAMMD closely monitors distribution activities and all breaches found are followed by immediate action.

26.06.2014
To the attention of pharmaceutical companies and insterested persons
The NAMMD would like to inform about the organisation in Romania of a Pharmacovigilance Workshop on Risk management, Electronic reporting, XEVMPD updates, to be held in Bucharest between 09.09.2014-10.09.2014.
Training will be provided by John J. Borg, PhD, representing the Medicines Authority, Malta and Calin Lungu, MD, DDCS S.A., Luxemburg.
The workshop will be conducted in English and its venue is the Novotel Hotel, Calea Victoriei 37B, sector 1,.
For registration and further information, please see the Workshop Agenda and contact the organiser in Romania as soon as possible,:
Madalina Nedelciu
Events Projects Manager
Aleea Alexandru 9A
Bucuresti, 011821, sector1
Mobil +4 0729 835337
Tel +4 021 2315615
Fax +4 021 3126708
E-mail: madalina.nedelciu@businesstravel.ro

12.06.2014
To the attention of Marketing Authorisation Holders
Please be advised that, as of 15.06.2014, in addition to the usual procedure (direct submission at the NAMMD headquarters), submission of documentation to the NAMMD Registration office may also be performed via the Common European Submission Platform (CESP).
The NAMMD recommends applicants to opt for one route only for submission of documentation within the same procedure.
ASMFs shall not be sent via the CESP.
It should be noted that, in case of CESP submission for all procedures types (DCP, MRP, MRP-Repeat-use, National) concerning authorisation, renewal and variation, a cover letter and corresponding filled-in payment form have to be submitted 15 days prior to submission of documentation.
Documentation to be submitted shall also include the NAMMD registration number for the cover letter and corresponding filled-in payment form provided on submission.
For CESP submission, national requirements for original signed documents in line with Romania specific NtA and published on the CMDh website, shall no longer apply.
Applicants are required to fill in the administrative details accurately.
The schedule for documentation receipt is available on the NAMMD website, under “CONTACT“.

11.06.2014
To the attention of Marketing Authorisation Holders
Please be advised that, in accordance with provisions of Article 2 of Order of the Minister of Health no. 716/2009, as amended by Order of the Minister of Health no.1359/2011, the fee for maintenance in the Medicinal Product Index is 230 euro/year and shall be paid every year to the National Agency for Medicines and Medical Devices until 31 December of the following year.
Medicinal products whose marketing authorisation holders do not comply with the requirement concerning payment of the 2014 maintenance fee before 1 July 2014, shall be suspended from the Medicinal Product Index until payment is performed.

02.06.2014
To the attention of the ASMF holders / Applicants who use the ASMF procedure

We inform you that, starting with 26.05.2014, submission of the Active Substance Master File (ASMF) will be accepted only if it is done according to the “Guideline on Active Substance Master File Procedures”
namely:
ASMF can only be submitted in support of an Marketing Authorisation Application (MAA) or Marketing Authorisation Variation (MAV) and must be synchronised to arrive at approximately the same time as the MAA or the MAV i.e. not more than one month before and not after the intended MAA/MAV submission date. Requirement applies to all types of application or variation, either a national or decentralised or mutual recognition procedures.
Any ASMF must be accompanied by a Submission Letter and Administrative Details, see Annex 3 to the guide.
Any update to the ASMF must be accompanied by a Submission Letter and Administrative Details along with the Table of Changes, see Annex 3 to the guide.
Any responses to deficiency letter from a competent authorities concerning the ASMF must be accompanied by a Submission Letter and Administrative Details, see Annex 3 to the guide.
The ASMF holder has to issue the Letter of access containing the acceptance that the EEA National Competent Authorities, the EMA including all CHMP and CVMP Members and their experts, and the Certification of Substances Division of the European Directorate for the Quality of Medicines & Healthcare may share the assessment reports of the above mentioned Active Substance Master File amongst themselves, see Annex 2 to the guide.
Withdrawal of access to the ASMF has to be announced by means of a Letter of Withdrawal submitted for different procedures, see Annex 4 to the guide.

06.05.2014
To the attention of interested persons
Please be advised that, as of 1 May 2014, clinical trial data are posted in accordance with provisions of SCD no. 1/2014, under section Clinical trials. Data herein are updated monthly.

24.04.2014
To the attention of stakeholders
Please be advised on approval of Scientific Council Decision no. 2/2014 on Regulations for authorisation of units able to perform clinical trials in the field of the medicinal product for human use on 22 April 2014.
Therefore, the applications for authorisation of units able to perform clinical trials on medicinal products for human use shall be submitted to the NAMMD at least 3 months prior to expiry of the previous authorisation validity. Schedule for submission of applications: Friday, 9:45-13:45.

07.04.2014
To the attention of Marketing Authorisation Holders
Please be advised that, in accordance with the provisions of Order of the Minister of Health no. 716/2009, as amended through Order of the Minister of Health no. 1359/2011, “Art. 2 – The marketing authorisation maintenance fee is 230 euro/year and is yearly paid to the National Agency for Medicines and Medical Devices until 31 December of the following year.”
For delayed payment of legal maintenance fee, penalties shall be applied covering the period 01.01.2014 and the actual date of payment.

10.03.2014
To the attention of all authorised wholesale distributors
Please be advised that the distribution outside Romania of certain medicinal products is prohibited until 30 June 2014, in accordance with Order of the Minister of Health no. 456/04.2013, as amended through Order of the Minister of Health no. 1443/11.2013 and Order of the Minister of Health no. 1554/12.2013.
Noncompliance with the provisions of this Order shall be sanctioned in accordance with Law 95/2006 on healthcare reform, as amended.

26.02.2014
To the attention of interested persons
NAMMD Press release on the situation ensued from non-compliance of influenza seasonal vaccine batches manufactured by the Cantacuzino Institute for 2013-2014.
download document …

28.01.2014
To the attention of authorised medicinal product wholesale distributors
Considering the unfavourable weather conditions and the large number of current requests in several hospitals, for suitable conduct of medical care and patient access to adequate and timely treatment, please be advised on the need to handle orders from healthcare units in affected areas as a priority.

20.12.2013
To the attention of pharmaceutical companies and interested persons
The NAMMD announces organisation in Romania by the Drug Information Association (DIA) of the following two training courses during 17.02.2014-21.02.2014:
Electronic Reporting of ICSRs in the EEA
(http://www.diahome.org/en-GB/Meetings-and-Training/Find-Meetings-and-Training/Meeting-Details.aspx?ProductID=3021072&EventType=EudraVigilance), during 17.02.2014 – 19.02.2014;
eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD)
(http://www.diahome.org/en-GB/Meetings-and-Training/Find-Meetings-and-Training/Meeting-Details.aspx?ProductID=3021102&EventType=EudraVigilance), during 20.02.2014 – 21.02.2014
trainer: Dr. Calin Lungu.
Participants enrolling in both sessions conducted in the mentioned period are entitled to a discount for the XEVMPD course participation fee.
For enrollment and additional information, interested bodies are invited to refer to the DIA website and contact the organising agent in Romania as soon as possible:
Madalina Nedelciu
Events Projects Manager
Bussiness Travel
Tel. +40212315619
Fax. +40212315622
Aleea Alexandru 9A
Bucuresti, 011821, sector1
www.businesstravel.ro

12.12.2013
To the attention of active substance manufacturers, importers and distributors
Please be advised that the European Medicines Agency, the Heads of Agencies and the European Commission have prepared a document and a flow chart for facilitation of a shared understanding of situations when active substances are imported in Member States without written confirmation as required by the law.
download document …

09.12.2013
To the attention of Marketing Authorisation Holders
Please be advised that notification of advertising material according to article 38 of the Guideline on advertising of medicinal products for human use may be performed directly, by e-mail to publicitate@anmdm.ro, daily.

09.12.2013
Customer Service Schedule
Information, logistics and electronic management of data department
Registry and archive as of 9 december 2013
Monday- friday: 9,45- 13,45
Monday: initial clinical trials, amendments, documentation for national procedure authorisation/renewal, authorisation for special needs, parallel import authorisation (based on appointment), psurs, adverse reaction reports, planned clinical trials.
Tuesday: variations, planned variations, supplemetnation of documentation for authorisation/renewal, response to requests and other notifications concerning the national procedure.
Wednesday: initial clinical trials, amendments, e e studii clinice, documentation for national procedure authorisation/renewal, authorisation for special needs, parallel import authorisation (based on appointment), advertising, educational material, planned clinical trials.
Thursday: variations, planned variations, supplemetnation of documentation for authorisation/renewal, response to requests and other notifications concerning the national procedure.
Friday: documentation for national procedure authorisation/renewal, authorisation for special needs, parallel import authorisation (based on appointment), psurs, adverse reaction reports

01.11.2013
To the attention of healthcare professionals and patients treated with PEGASYS
Following information received by the National Agency for Medicines and Medical Devices (NAMMD) concerning potential presence on the Romanian pharmaceutical market of counterfeit cartons labelled Pegasys 180 μg/0.5 ml solution for injection, pre-filled syringe (peginterferon alfa-2a), the NAMMD hereby informs you on the need to visually inspect the product prior to administration, because of obvious differences between the counterfeited and the original Pegasys
download document …

23.09.2013
To the attention of interested persons
Starting with 2 December 2013, The National Agency for Medicines and Medical Devices starts verification of compliance with provisions of Art. 611 of Decision No. 18/08.08.2013 on approval of the revised Guideline on evaluation of advertising of medicinal products for human use.

16.09.2013
To the attention of Marketing Authorisation Holders for codeine-containing medicinal products
For implementation of the agreement adopted by the Coordination Group following the referral procedure concerning codeine-containing medicinal products, Marketing Authorisation Holders shall submit to the NAMMD until 1 October 2013 IAIN C.I.1a variations for medicinal products only containing codeine, namely IB C.I.1a variations for medicinal products containing codeine in association with other active substances, leaving one of the conditions in the Guideline on variations unmet in such cases.
The List of Marketing Authorisation Holders and the formulation agreed for the Summary of Product Characteristics and for the leaflet can be found in the annex attached to this announcement.
download document …

29.08.2013
To the attention of contract-based research organisations
We hereby inform you that the following documents have been published on the NAMMD website, under heading “Clinical trials”, section “Information of interest for sponsors and Clinical Research Organisations”:
– Proposals for improvement of the dossiers submitted for support of the application for authorisation of a clinical trial;
– Proposals for improvement of the dossiers submitted for support of the application for approval by the NAMMD of an amendment to a clinical trial.
These have been issued following the identification of the need for publication of useful information for applicants.
Documents shall be updated in direct proportion with the identification of other proposals for dossier improvement.

27.08.2013
To the attention of pharmaceutical companies and interested persons
The NAMMD announces the organisation of the course “Electronic Reporting of ICSRs in the EEA” organised by the Drug Information Association (DIA) in Romania, between 02.10.2013 and 04.10.2013.– trainer Dr. Calin Lungu.
For sign up and additional information, interested persons are asked to browse the DIA website, (http://www.diahome.org/en-GB/Meetings-and-Training/Find-Meetings-and-Training/Meeting-Details.aspx?ProductID=2537176&EventType=EudraVigilance) and to contact the Romanian organiser as soon as possible:
Madalina Nedelciu
Events Projects Manager
Bussiness Travel
Telephone number: +40212315619
Fax number: +40212315622
9A Aleea Alexandru, sector1
www.businesstravel.ro

31.07.2013
NAMMD press release
Press release of the National Agency for Medicines and Medical Devices on withdrawal from the market of SUTENT 50 mg, capsules, batches T737E and U299B.
download document …

25.07.2013
To the attention of Marketing Authorisation Holders
The following are applied as of 5 August 2013 concerning applications for variations to marketing authorisations granted through national procedure:
1. Validation letters, applications for validation/invalidation are to be forwarded via e-mail to MAH contact persons;
2. Targeted answers (clarifications) to NAMMD requests for validation purposes are forwarded via e-mail by holder assigned persons to the official e-mail addresses below;
3. Supplements to documentation required for validation of variations are submitted to the NAMMD Registry in electronic format, together with the cover letter and the e-mail message requiring supplementation of documentation; these are recorded as supplements to initial documentation submitted;
4. NAMMD requests for clarification/supplementation of documentation during assessment are forwarded via e-mail to holder assigned persons;
5. Targeted answers (clarifications) to NAMMD requests throughout assessment are forwarded via e-mail by holder assigned persons to the official e-mail addresses specified below;
6. Supplements to the dossier during assessment are submitted to the NAMMD Registry in electronic format together with the cover letter and the e-mail message requiring dossier supplementation; these are recorded as supplements to the initial dossier submitted;
7. At the end of the assessment period, the NAMMD issues letters of approval/rejection concerning the variations in question, as required.
To ensure NAMMD-Holder proper communication, holders are invited to provide the names and e-mail addresses of the (preferably two) persons assigned for communication with the Agency. These are to be forwarded to the attention of the National Procedure Department, via manufacturer associations, as required.
NAMMD e-mail addresses for handling of variations through national procedure are as follows:
– variatii.calitate@anmdm.ro – for handling of changes to data and administrative data concerning synthesis products;
– variatii.biologice@anmdm.ro – for handling of changes to chemical-pharmaceutical biological data and administrative data related to biologicals;
– variatii.informatii@anmdm.ro – for handling of changes to medicinal product information, trade name and ATC code changes included;
– variatii.farmacovigilenta@anmdm.ro – for handling of pharmacovigilance changes.
As regards grouped variations, handling of changes is performed via the e-mail box assigned to the group defining variation. Applications for variation to marketing authorisation terms are submitted in accordance with Regulation 1234 of 2008, as amended, and Law 95/2006, as amended.
Type IA and IAIN variations may be implemented prior to submission of respective applications to the NAMMD.
At least 15 days prior to submission of the application for variation, the Holder is required to submit the letter of intent and the filled-in payment form.
As requested, the NAMMD regulates the tariff for variations to marketing authorisation terms.
Details on the handling of variations through national procedure are given in the Decision to be submitted to the NAMMD Scientific Council.

11.06.2013
To the attention of interested persons
Invoices are to be submitted within 5 working days by email (or by regular post in case an electronic mail service is not available).

05.06.2013
To the attention of interested persons
NAMMD press release on market withdrawal, at wholesale distributor level, of CILEST 0.250mg/0.035mg, tablets.
This is to inform you on NAMMD decision following information received from the Belgian competent authority and the Marketing Authorisation Owner (Johnson & Johnson d.o.o.) via the rapid alert system, on recall at wholesale distributor level, of all CILEST 0.250mg/0.035mg, tablets batches manufactured as of January 2011.
This decision has been triggered by the Belgian manufacturer finding a quality concern in certain product batches (out-of-specification outcome under the „dissolution time” parameter for one of the two medicinal product active substances). Though unlikely, this quality defect could lead to lower contraceptive effect, given that the tablet is administered once a day only and, moreover, company analysis between 1 January 2009 and 31 December 2012 showed diminished number of reports received on lack of efficacy and occurrence of pregnancies.
For reasons of this medicinal product possible unavailability for some time, patients taking Cilest (tablets) are recommended to discuss alternative treatment with their physician.
This precautionary recall at wholesale distributor level of all Cilest 0.250mg/0.035mg, tablets, batches manufactured as of January 2011 is performed in all countries where the product is distributed, as well as in other EU Member States.

05.06.2013
To the attention of interested persons
The NAMMD, in cooperation with ARPIM and APMGR announce the “Quality of the medicinal product” workshop held on 14 June 2013, in the Grand Platinium Hall of the Howard Johnson Hotel.
Interested persons are invited to confirm their participation via e-mail (office@arpim.ro), no later than Wednesday, the 12th of June.
download document …

05.06.2013
To the attention of interested persons
Press release of the National Agency for Medicines and Medical Devices on the recall of the batches of FERVEX – Granules for oral suspension (adults) and FERVEX – Granules for oral suspension (children)
The decision for recall of FERVEX for Adults – Granules for oral solution and FERVEX for Children – Granules for oral solution has been taken following the information received from the NAMMD via rapid alert system (from the French competent authority) and from the manufacturer (Bristol-Myers Squibb).
The decision concerning marketing recall has been taken due to the detection during routine control, performed by the French manufacturer, of microbial contamination of Fervex “Raspberry”. This product is not marketed in Romania.
Since the contamination source is an excipient used in Fervex formulations (saccharose), the company decided the recall of all batches of Fervex for Adults and Fervex for Children, granules for oral solution, manufactured with this excipient, as a precautionary measure. This recall is performed in all the states where these products are manufactured, including other EU member states.
Potential adverse reactions in case of ingesting the potentially contaminated product are not serious, e.g. abdominal pain, fever, vomiting, diarrhoea.
To this date, such adverse reactions have not been signalled via the Pharmacovigilance system.

07.05.2013
To the attention of Marketing Authorisation Holders
As regards medicinal products submitted for marketing authorisation renewal through national procedure, for which variations for harmonisation with QRD European templates have been approved, MAHs are encouraged to submit results of the consultations with target patient groups during conduct of the renewal procedure (not to be left for the final stage of the renewal process procedure).
Consultation results are submitted in accordance with provisions of Order of the Minister of Health No. 1205/2006.
Consultation results, submitted in electronic format on CD, are accompanied by the leaflet sample or mock-up on which the consultation has been achieved.

05.03.2013
To the attention of Marketing Authorisation Holders
Submission of the pharmacovigilance system summary for medicinal products undergoing marketing authorisation renewal through national procedure, submitted prior to 21 July 2012, is performed by means of a Type IAIN C.I.z variation.

29.01.2013
To the attention of interested persons
In January 2013, THE NATIONAL AGENCY FOR MEDICINES AND MEDICAL DEVICES (NAMMD) and the National Association for Consumer Protection and Promotion of Programs and Strategies IN Romania (ANPCPPS Romania) agreed on a collaboration protocol on consultation and mutual support for initiation and conduct of programs and campaigns for public education.

23.01.2013
Attention of Marketing Authorisation Holders
The National Agency for Medicines and Medical Devices hereby reminds you the 2 dedicated addresses related to management of variations to marketing authorisation submitted for evaluation through European procedures, as follows:
var.responses@anm.ro – for submission of documentation/supplementations to documentation/responses concerning variation procedures in progress
var.translations@anm.ro – for submission of Romanian versions of texts agreed on positive completion of a variation.
You are reminded that intermediary versions of Product information (Summary of Product Characteristics, Leaflet, Labelling information) submitted in response to comments during the procedure are considered documentation and are transmitted to the address dedicated to this type of documentation. In addition, information may be required at the mrp-dcp.info@anm.ro general address regarding the NAMMD allocatted number to grouped variations for procedures with Romania as reference Member State.

04.01.2013
To the attention of Marketing Authorisation Holders
The National Agency for Medicines and Medical Devices hereby reiterates the availabilityy of 2 dedicated addresses related to management of variations to marketing authorisation submitted for evaluation through European procedures, as follows:
var.responses@anm.ro – for submission of documentation/supplementations to documentation/responses concerning variation procedures in progress
var.translations@anm.ro – for submission of Romanian versions of texts agreed on positive completion of a variation.
You are reminded that intermediate versions of Product information (Summary of Product Characteristics, Leaflet, Labelling information) submitted in response to comments during the procedure are considered part of the documentation and as such they are forwarded to the address dedicated to this type of documentation. In addition, information may be required at the mrp-dcp.info@anm.ro general address regarding the NAMMD number allocated to grouped variations for procedures with Romania as reference Member State.

25.10.2012
To the attention of Marketing Authorisation Holders concerning trimetadizine-containing medicinal products
The NAMMD hereby emphasises the mandatory character of compliance with the following conditions for marketing authorisations of trimetazidine-containing medicinal products, as provided in the European Commission Decision for completion of Art. 31 referral procedure.
download document …

26.09.2012
To the attention of Marketing Authorisation Holders
Please be advised on change of the e-mail addresses for transmission of responses related to ongoing procedures, namely translations of MA Annexes for issuance of the authorisation. The current e-mail addresses are:
mrp-dcp.responses@anmdm.ro
mrp-dcp.translations@anmdm.ro
instead of:
mrp-dcp.responses@anm.ro
mrp-dcp.translations@anm.ro

19.09.2012
To the attention of interested persons
Please be advised that, on 06.09.2012, the European Commission initiated public consultation of the document concerning the “DELEGATED ACT ON THE CRITERIA TO BE CONSIDERED AND THE VERIFICATIONS TO BE MADE WHEN ASSESSING THE POTENTIAL FALSIFIED CHARACTER OF MEDICINAL PRODUCTS INTRODUCED IN THE UNION BUT NOT INTENDED TO BE PLACED ON THE MARKET”:
The document is available for consultation by all stakeholders at: http://ec.europa.eu/health/documents/new_en.htm.

23.08.2012
To the attention of interested pharmaceutical companies
The NAMMD, in cooperation with ARPIM and APMGR announce organisation of the Pharmacovigilance Workshop, at the Novotel Hotel, Bucharest, on 31.08.2012. The workshop will develop with participation of Dr. Calin Lungu, EudraVigilance, EVMPD and EVDAS trainer at the European Medicines Agency.
For enrolment and further information related to participation fees, interested persons are invited to contact the host of this event no later than 28.08.2012:
Madalina Nedelciu
Events Projects Manager
Business Travel
Tel. +4 021 2315619
Fax. +4 021 2315622
9A Aleea Alexandru
Bucharest, 011821, sector1
www.businesstravel.ro
www.decoleaza.ro

17.08.2012
To the attention of Marketing Authorisation Holders
Please be advised on change of the e-mail address for submission of IA and IB variations to MA terms or OUTSIDE such terms submitted in 2011, as follows variatii@anmdm.ro, instead of tanta.ulieru@anm.ro and simona.badoi@anm.ro, as published in the notification of 31.07.2012.

10.08.2012
To the attention of interested persons
After publication in the Official Gazette of Romania of Government Emergency Ordinance no. 35/2012 amending and supplementing certain healthcare regulations, Part I, No. 434/30.06.2012, errors have been detected under section 49, concerning amendment of Article 739 of Law 95/2006 on healthcare reform, Title XVII – The medicinal product.
As a consequence, the NAMMD will undertake the required steps in to rectify such errors in in the Official Gazette, as soon as possible, by replacement with the text below.
Rectifications are written in red.
49. Article 739 is amended and will read as follows:
“Article 739 – (1) Before any decision is reached on an application for a marketing authorisation or on the suspension or revocation of a marketing authorisation, or on any other variation of the marketing authorisation which appears necessary, in specific cases where the interests of the European Union are involved, the National Agency for Medicines and Medical Devices, Member States, the Commission, the applicant or the marketing authorisation holder shall refer the matter to the Committee for Medicinal Products for Human Use, for application of the procedure laid down in Articles 32, 33 and 34 of Directive 2001/83/EC.
(2) Where the referral results from the evaluation of data relating to pharmacovigilance of an authorised medicinal product, the National Agency for Medicines and Medical Devices refers the matter to the Pharmacovigilance Risk Assessment Committee and provisions of Article 81910 (2) shall apply. The Pharmacovigilance Risk Assessment Committee shall issue a recommendation according to the procedure laid down in Article 32 of Directive 2001/83/EC. The final recommendation shall be forwarded to the Committee for Medicinal Products for Human Use or to the Coordination group, as appropriate, and the procedure laid down in Article 81911 shall apply. Where urgent action is considered necessary, the procedure shall apply as laid down in Articles 8199-81911. The National Agency for Medicines and Medical Devices, the competent authority of any other Member State concerned or the European Commission shall clearly identify the question which is referred to the Committee for Medicinal Products for Human Use for consideration and duly inform the applicant or marketing authorisation holder.
(3) The National Agency for Medicines and Medical Devices and the applicant or the marketing authorisation holder shall supply the Committee for Medicinal Products for Human Use with all available information relating to the matter in question
(4) Where the referral to the Committee for Medicinal Products for Human Use concerns a range of medicinal products or a therapeutic class, the procedure may be limited to certain specific parts of the authorisation; in that event, Article 743 shall apply only if they were covered by the authorisation procedures referred to in this section.”

31.07.2012
To the attention of Marketing Authorisation Holders
1. Type IA and IB variations to MA terms or outside such terms, submitted in 2011, in accordance with Order of the Minister of Health No. 874/2006, are to be notified to the NAMMD starting with 15 August 2012
2. The period for notification submission is 2 months from the specified date and the deadline is 14 October 2012
3. Between 15 August and 1 November 2012, applications for expedited approval of other variations are no longer forwarded to the NAMMD
4. Type IA and IB variations to MA terms or outside such terms, submitted in 2011, will be initially sent to NAMMD e-mail addresses tanta.ulieru@anm.ro and simona.badoi@anm.ro; subsequently, for any type of submission at the Registry office, these will be sent to the official address; submission may be performed daily.
5. Notifications for variations are submitted separately. Two notifications are submitted for every variation to a medicinal product, as follows:
a. form for implementation of Type IA/IB variations to MA terms
and
b. form for notification of implementation, in accordance with Annex 1 to SCD No. 30/2010, of Type IA/IB variations outside MA terms
6. Variations are NOT to be sent as a group, for the entire company portfolio.
7. Prior to NAMMD notification, the following will be confirmed:
a. the fill-in status of applications for variation, with inclusion in the proper category and adequate fill-in in headings “Current”, “Proposed”
b. the payment form
c. compliance with conditions for documents submission, in accordance with the Guideline on the content of the dossier for Type IA and IB variations
8. Only the notification form /implementation form and the supplementations/responses to information requests are submitted to the Registry office.
9. Variations are submitted together with supporting documents (approvals in other Member States, regardless of procedure type, assessment reports)
10. For variations to MA terms, the NAMMD issues the approval letter and amending documents and the date for implementation by the MAH is the date of NAMMD approval.
11. For variations OUTSIDE MA terms as implemented by MAHs, which the NAMMD decides on assessment of other variations to need supplementation of the dossier and/or rectification of already implemented Annexes, such variations have to be withdrawn and implemented in accordance with NAMMD approved terms
12. Variations submitted at the end of December 2011, in accordance with Order of the Minister of Health No. 1483/2010, are NOT within the scope of the points above; these are to be handled subsequently.
13. Type IA and IB variations to MA terms/outside MA terms, consecutive to one or several Type II variations, are OUTSIDE the scope of the points above; these are considered on NAMMD assessment of the main variation.

19.07.2012
To the attention of Marketing Authorisation Holders
The meeting of 23.07.2012 organised by the NAMMD with MAH representatives OUTSIDE professional associationS, concerning the new pharmacovigilance legislation and aspects related to the handling of variations to MA terms submitted in 2011 through national procedure, is held in the Auditorium of the “Carol Davila” Faculty of Pharmacy, 6 Traian Vuia, Bucharest, between 14:00 and 16:00.
The NAMMD would like to thank members of the Faculty of Pharmacy of the “Carol Davila” University for their support.

18.07.2012
To the attention of Marketing Authorisation applicants and holders
Implications of the new pharmacovigilance legislation for marketing authorisation applicants/holders.
download document …

10.07.2012
To the attention of Marketing Authorisation Holders
Questions about pharmacovigilance legislation and the manner of variations handling through national procedure, submitted after the indicated deadline, i.e. after 9 July, specified in the NAMMD announcement posted on 28.06.2012, will not be a topic for discussion in the meeting of Monday, 23.07.2012. Answers to such questions will be included in the Q&A documents related to the respective topics and posted subsequently on the NAMMD website.

28.06.2012
To the attention of Marketing Authorisation Holders
On Monday, 23.07.2012, the NAMMD organises a meeting with MAH representatives (members of the Romanian Association of Medical Product Suppliers) and MAH representatives OUTSIDE professional associations. THE NAMMD suggests that persons involved in activities related to regulatory affairs and pharmacovigilance participate on behalf of the above entities. The agenda if the meeting is as follows: – The new pharmacovigilance legislation – Aspects related to the handling through national procedure of variations to MA terms, submitted in 2011– The various questions about pharmacovigilance legislation are to be submitted no later than 9 July, to the following e-mail addresses: daniela.pomponiu@anm.ro and nela.vilceanu@anm.ro. Questions related to variations through national procedure are to be submitted no later than 9 July, to the following e-mail addresses: tanta.ulieru@anm.ro and simona.badoi@anm.ro. The NNAMD looks forward to receiving nominal confirmation of participation until Monday, 16.07.2012, 14:00, at simona.badoi@anm.ro. The venue and time of the meeting depend on the number of participants. Information on such aspects will be published on the NAMMD website.

18.05.2012
To the attention of Marketing Authorisation Holders
In the context of implementation of the new pharmacovigilance activity, interested pharmaceutical companies will find the following announcement under the heading “Press releases” on the NAMMD website:
“The European Medicines Agency (EMA) announces the launch of a new e-learning course concerning mandatory requirements, in accordance with Article 57(2) of Regulation (EU) 1235/2010, for electronic submission of information on medicinal products for human use”
For further information please access: http://eudravigilance.ema.europa.eu/human/training7.asp.

08.05.2012
To the attention of Marketing Authorisation Holders
On the NAMMD website, under the heading “Medicinal products for human use/Pharmacovigilance/Special warnings”, interested pharmaceutical companies will find the Romanian version of agreed text of the Recommendations of the Pharmacovigilance Working Party (PhVWP) of the European Medicines Agency (EMA). These recommendations are implemented through variation.
The deadlines for variation submission will be specified by the National Procedure Department in the request for submission of the application for variation.”

09.03.2012
To the attention of Marketing Authorisation Holders
In the context of the implementation of the new pharmacovigilance legislation on the NAMMD website, under the heading “Press releases”, interested pharmaceutical companies will find the “EMA press release on publishing the updated set of mandatory Article 57(2) requirements for marketing authorisation holders”, accompanied by the document “Legal notice on the implementation of Article 57(2), second subparagraph of Regulation (EC) No. 726/2004, “Electronic submission of information on medicinal products for human use by marketing authorisation holders to the European Medicines Agency”.

09.03.2012
To the attention of interested persons
The opinion of the National Agency for Medicines and Medical Devices concerning the message of the “In premiera” TV show broadcasted on Sunday, 4 March 2012, 21:00, on Antena 3.
download document …

27.02.2012
To the attention of interested persons
Please be advised that the meeting of the Scientific Council of the National Agency for Medicines and Medical Devices will take place on 7 March 2012, at 10:00.

13.01.2012
To the attention of Marketing Authorisation Holders/ Applicants
Please be advised that, as of 16.01.2012, the marketing authorisation/MA renewal applications submitted through mutual recognition procedure (MRP) and decentralised procedure (DCP), applications for variation/change in accordance with Article 61 (3)/MA transfer/change in accordance with Order 1205/2006 for medicinal products authorised through European procedures, as well as variation applications submitted through national procedure in accordance with Order 1483/2010 are only processed on condition cover letters and payment forms have been submitted in accordance with legal provisions in force. The procedure will be renewed immediately after completion of the dossier.

10.01.2012
To the attention of interested persons
In 2011, the National Agency for Medicines and Medical Devices (NAMMD) approved variation to marketing authorisation (MA) terms concerning the trivalent purified inactivated influenza vaccine (Marketing authorisation holder – INCDMI Cantacuzino) as regards its composition in accordance with composition approved by the World Health Organisation for the 2011/2012 season.
Following NAMMD approval, the Cantacuzino Institute has performed monitoring and monthly reporting to the NAMMD of outcomes of tests for each viral strain strength of the three viral strengths included in the vaccine.
To this date, monthly outcomes recorded have been within the approved quality parameters. The NAMMD has been informed from the latest tests performed on decrease in strength below the approved limit of one of the three viral strains in the vaccine composition.
The non-compliance submitted to the Agency concerned 7 out of the 18 vaccine batches manufactured. At the same time, the Cantacuzino Institute informed the NAMMD about initiation of the procedure for discontinued use of the 7 batches affected in view of recall.
The NAMMD provided prompt reply to the Cantacuzino Institute concerning measures required under such circumstances. Such measures mainly involve mandatory NAMMD information on vaccine amounts recalled as compared to those manufactured and distributed, respectively, for each non-compliant batch. At the same time, it is the MAH’s obligation to destroy all amounts recalled, in compliance with legal provisions in the field.
The NAMMD will further monitor outcomes submitted by the Cantacuzino Institute on quantitative composition of influenza vaccine batches.

13.12.2011
To the attention of Marketing Authorisation Holders
Concerning the procedure for evaluation of IA/IB variations, please be advised that the new deadline for submission of the established dossier is 13.01.2012.

30.11.2011
To the attention of Marketing Authorisation Holders
1. Type IA and IB variations outside MA terms are to be notified to the NAMMD by 15 December 2011
2. These variations are to be sent initially at the NAMMD e-mail address, variatii@anm.ro; subsequently, any type of submission at the Registry office are to be submitted to the official address as well; submission may be performed daily.
3. Variations are no longer to be sent as a group, for the entire portfolio of a company, divided into 2 notifications: one notification for variations leading to change of MA terms and another not involving change of MA terms
a. To avoid crowds at the Registry office and/or blocking of the NAMMD server, variations are to be submitted as a group for each product, i.e. those to MA terms separately from those outside MA terms, not necessarily however in conjunction with all the other products included in the company’s portfolio (gradually, commensurate with their filling in status by the MAH representative).
b. Initially, the submission is performed by e-mail and afterwards at the Registry office (in accordance with section 2). Only the notification/ implementation form are to be submitted at the Registry office and possibly the supplementations/responses to requests as well.
4. Variations are submitted together with supporting documents (approvals in other Member States, regardless of procedure type, assessment reports,) only if currently available at the company’s local representative
a. The purpose of the waiver is to avoid delays in notification to the NAMMD
b. Only resubmission of the Application remains a priority, including the “Current/Proposed” heading and, where required, together with additional documentation/supplementations requested during assessment.
5. Variations leading to change of MA terms receive NAMMD the approval letter together with the amending documents, and the date of implementation by the MAH is the date of NAMMD approval.
6. Variations implemented by the MAH for which the NAMMD decides on assessment of other variations to need supplementation of the dossier and/or rectification of already implemented Annexes, such variations have to be withdrawn and implemented in accordance with NAMMD approved terms
7. Submission for variations assessment through national procedure is done in accordance with the classification specified in Order of the Minister of Health No. 1483/2010 and fees are in line with the current tariff system in force (in the same manner as for mutual recognition procedure)
8. Variations submitted between 5 January and 1 December 2011 will NOT fall under the scope of the aforementioned sections; these are assessed by the NAMMD
9. Type IA and IB variations to MA terms/outside MA terms, consecutive to one or several Type II variations, are OUTSIDE the scope of the points above; these are considered on NAMMD assessment of the main variation.

29.11.2011
To the attention of interested persons
Please be advised that the meeting of the Scientific Council of the National Agency of Medicines and Medical Devices will take place at 10:00, on 13 December 2011.

24.11.2011
To the attention of interested persons
To avoid any interpretations generated in response to press statements related to maintenance on the pharmaceutical market and on the list of free and compensated medicinal products of certain medicinal products whose marketing authorisation (MA) is no longer valid, the NAMMD declares the following:
download document …

24.11.2011
To the attention of interested persons
Please find attached the Standard form for implementation of Type IA and IB variations to MA terms.
Currently, two companies only (Fiterman, Stada Hemopharm) have sent notifications for Type IA/IB variations outside MA terms at variatii@anm.ro. In order to comply with the deadline established for this action and not to block the NAMMD server prior to expiry of this deadline, please forward the notifications/ implementation forms gradually, as established during the meetings.
download document …

11.11.2011
To the attention of interested persons
The NAMMD organises a meeting with MAH representatives OUTSIDE professional associations, i.e.: the Association of International Medicines Manufacturers, the Romanian Generic Medicines Association and the Association of Romanian Medicines Manufacturers. The meeting is to be held at 12:30, on Tuesday, 15.11.2011, at the NAMMD Headquarters at 48 Av. Sanatescu street. The NAMMD suggests that persons involved in regulatory affairs participate on behalf of these companies. Please find below the agenda of the meeting:
– Issues related to MA variations submitted between 01.01.2007 and 31.12.2010
– Medicinal product traceability
– Miscellanea
Please confirm your participation at nicolae.fotin@anm.ro no later than 14:00, Monday, 14.11.2011.

11.11.2011
To the attention of interested persons
The NAMMD organises a meeting with representatives of the Romanian Generic Medicines Association and the Association of Romanian Medicines Manufacturers. The meeting is to be held at 12:30, on Monday, 14.11.2011, at the NAMMD Headquarters at 48 Av. Sanatescu street. Please also inform product manufacturers affiliated to the mentioned associations about the event; The NAMMD suggests that persons involved in regulatory affairs participate on behalf of these associations. Please below the agenda of the meeting:
– Issues related to MA variations submitted between 01.01.2007 and 31.12.2010
– Medicinal product traceability
– Miscellanea
Please confirm your participation no later than 10:00, Monday, 14.11.2011, by e-mail, at nicolae.fotin@anm.ro.

07.11.2011
To the attention of interested persons
In accordance with Article 729 and Article 730 of Law 95/2006 on healthcare reform, Title XVII – The medicinal product, Marketing Authorisation Holders are required to forward to the National Agency for Medicines and Medical Devices updated information concerning placement on the market status (date of recall) of all medicinal products with valid authorisations included in their portfolio, within 15 days from the date of this notification.
Information is to be submitted in electronic format (e-mail address: cristian.sandulescu@anm.ro) and on paper, in accordance with the form for reporting of marketing authorisation status (Article 729 of Law 95/2006).

19.10.2011
To the attention of interested persons
The deadline for implementation of provisions of Scientific Council Decision No. 1/22.02.2011 on accreditation of national Good Clinical Practice training providers will be adjourned to a further date.

18.10.2011
To the attention of interested persons
The Guideline on the assessment of advertising of medicinal products for human use has been rectified by elimination of point b) of Article 44 (3) on page 16.
Section (3) of Article 44 reads as follows:
„3) the number of the approval and the date when it has been granted should be imprinted. The modification of the imprinting of the approval number after grant of the approval for extension is not required.
Small advertising materials i.e. rest, wobbler etc. (materials detailed in Annex 1 to this Guideline) are exempted from the requirement to have the approval number imprinted.

17.10.2011
To the attention of persons interested in training delivered by the NAMMD in the context of the CERF programme
In accordance with the previously announced schedule, training on authorisation and conduct of clinical trials in Romania will take place on 21 October.
The course dealing with pharmacovigilance regulations, scheduled for November 2011, will be postponed for a further date, to be announced on the NAMMD website in due time. The adjournment is caused by amendment of associated legislation, currently under implementation.

07.10.2011
To the attention of interested persons
GMP training scheduled for 4 November 2011 will be postponed to a further date, announced on the NAMMD website in due time.

07.10.2011
To the attention of interested persons
To the attention of participants in the training on 16 September delivered by the NAMMD in the context of the CERF programme.
Please be advised that a part of the diplomas for participation in this training are available from the NAMMD Registry starting with 7 October 2011.
Diplomas for pharmacists participating in this training will be provided as soon as possible.

23.09.2011
To the attention of interested persons
Payment for services provided will be performed only following submission of payment forms to the Registry Bureau and following NAMMD issuance of the invoice.
Deadline for payment:
– 90 days as of issuance of the invoice.
Invoices unpaid prior to the established deadline will be cancelled.
The requested service will only be performed after payment of the invoice.

14.09.2011
To the attention of interested persons
The workshop on the “Set up of the leaflet in accordance with the new QRD template and its readability testing” included in the topic “Legislative regulations in the field of the medicinal product – consultation with the target group for implementation of the leaflet and regulations for SmPC setup”, to be organised by the National Agency for Medicines and Medical Devices on 16 September 2011, will b e held in the council room of the “Carol Davila” University of Medicine and Pharmacy on Eroilor Sanitari Avenue, at 9:30.
Please find attached the schedule of the event.
download document …

12.09.2011
To the attention of interested persons
In order to ensure better communication concerning the workshop “Set up of the leaflet in accordance with the new QRD template and its readability testing”, delivered by the National Agency for Medicines and Medical Devices on 16 September 2011, in the context of the CERF project, please specify the full contact data of the company’s representative, professional training included (physician, pharmacist etc.), telephone number and e-mail address. Companies who have participated to previous training will attach to their application the filled-in addendum for this event.
Applications for participation will be forwarded no later than 15 September 2011 (final deadline).
Applications consist of a letter to that effect to the attention of the President of the National Agency for Medicines and Medical Devices, submitted to the Registry office.

28.07.2011
To the attention of interested persons
As regards rules for classification for release, approved through Order of the Minister of Health No. 1602/2010, medicinal products released by restrictive medical prescription, meant for use in certain special fields, can be released through:
a) open circuit pharmacies:
– medicinal products meant for in-patient use, but requiring medical prescription from a specialist and special monitoring throughout the treatment, since their use may lead to serious adverse reactions;
– administration of medicinal products and continuation of treatment with medicinal products can be performed in an in-patient facility, even if used in the treatment of diseases to be diagnosed in the hospital or in units with adequate diagnosis equipment;
b) in-house pharmacies:
– because of their pharmaceutical features / novelty / public health interests, medicinal products may only be used in the hospital.

28.07.2011
To the attention of interested persons
Penalisation has been applied to TERAPIA SA for broadcasting a TV advertising whose form, authorised by the NAMMD for ASPENTER – gastroresistant film-coated tablets, had been modified.

18.07.2011
To the attention of interested persons
NAMMD training on the inte740grated system use will take place at 9:30, 1-2 September 2011, in the Council Room of the “Carol Davila” University of Medicine and Pharmacy (at 8, Eroilor Sanitari Avenue). Applications for participation may be sent via e-mail: laura.bodor@medaltrading.ro. For further questions, please use this e-mail address.

11.07.2011
To the attention of interested persons
As regards the EU Pilot 1705/11/SNCO dossier concerning accreditation of foreign companies performing readability testing for the package leaflet, Article 59 (3) of Directive 2001/83 on setting up a Community code relating to medicinal products for human use, please be advised that the Commission services have approved Romanian authorities’ response and have closed the EU pilot application.

11.07.2011
To the attention of Marketing Authorisation Holders
Given implementation of the new pharmacovigilance legislation, pharmaceutical companies need to add to the “EudraVigilance Medicinal Product Dictionary”, in electronic format, information about medicinal products authorised for marketing in the European Union (Romania included), starting with September 2011, via the EudraVigilance Gateway (in .XSD compliant format) or from January 2012, via a programme to be provided by the European Medicines Agency starting with that date.
The process needs to be closed on 2 July 2012.
For further information, please access (and keep updated with) the following links:
http://eudravigilance.ema.europa.eu/
http://www.ema.europa.eu/

21.06.2011
To the attention of interested persons
The report containing the results of the readability testing are to be assessed on NAMMD approval of/agreement on the leaflet used for testing.
When the leaflet previously approved/agreed by the NAMMD has been amended (following preliminary testing, for example), testing of the new leaflet will be continued with NAMMD permission, in the context of the same variation.

16.06.2011
To the attention of medicinal products wholesale distributors/importers/manufacturers
Please be advised that the deadline specified in NAMMD Scientific Council Decision No. 5/22.02.2011 on compulsory monthly reporting of placement on the market in Romania, i.e. of sales of medicinal products for human use by authorised wholesale distributors will be extended by 6 months, until 01.11.2011.

16.06.2011
To the attention of interested persons
In accordance with European Commission Decision No. 11 of 29 November 2010 on the change of the status of the classification for release of ketoprofen-containing medicinal products (topical formulations), from release without medical prescription to release on medical prescription, all these medicinal products will be released in accordance with the European Commission Decision, starting with 1 August 2011.

15.06.2011
To the attention of interested persons
Participants in the training delivered by the NAMMD this year in the context of the CERF programme may receive participation certificates from the NAMMD Registry office.

08.06.2011
To the attention of interested persons
To the attention of participants in training organised by the NAMMD during 2010
Please be advised that diplomas for participation to such training are provided by the NAMMD Reception Office; these may be provided daily, between 9:00 and 15:00. Thank you for your attendance!

08.06.2011
To the attention of interested persons
The NAMMD training organised in the second half of 2011 will be conducted as follows:
1. Setup of the leaflet in accordance with the new QRD Guideline and its readability testing – 16 September 2011
2. Assessment of the chemical-pharmaceutical and biological documentation for medicinal products for human use – 23 September 2011
3. Legislative regulations on performance of clinical trials in Romania – 21 October 2011
4. Good Manufacturing Practice – 4 November 2011
5. Activities of the Competent Authority and of the MAH for implementation of provisions of the new European pharmacovigilance legislation – 11 November 2011.
For further details please contact Mrs. Laura Bodor: laura.bodor@medaltrading.ro

02.06.2011
To the attention of interested persons
Please be advised that the meeting of the Scientific Council of the National Agency for Medicines and Medical Devices is postponed on 6 July 2011 at 9:30

30.05.2011
To the attention of interested persons
Please be advised that the meeting of the Scientific Council of the National Agency for Medicines and Medical Devices will take place on 7 June 2011 at 8:00

27.05.2011
To the attention of interested persons
Please be advised that, starting with 10.05.2011, the manufacturing authorisation of ROMPHARM COMPANY SRL has been suspended for the flow of non-sterile products – oral solid forms.

12.05.2011
To the attention of interested persons
Please be advised that the scheduling of the training concerning NAMMD use of the integrated system will be postponed to a later date which.

11.05.2011
To the attention of interested persons
GMP training of 12 May 2011 will take place at 9:00, in the Council Room of the “Carol Davila” University of Medicine and Pharmacy (in the Eroilor Sanitari Avenue). Registered participants are required to specify their profession and fill in all blanks in the participation form provided at the entrance by the organisers. Thank you for your attendance!

06.05.2011
To the attention of interested persons
EMA statement on the Monitoring of products originating from Japan for potential radioactivity
download document …

04.05.2011
To the attention of interested persons
For setup of a working group for elaboration of the dictionary of terms for patients, please send the name and e-mail address of the persons assigned by companies at: simona.badoi@anm.ro.
You will be informed on the date of the first meeting by e-mail.

02.05.2011
To the attention of medicinal products wholesale distributors/importers/manufacturers
Please be advised that the Guideline on NAMMD fill in of the table required for monthly electronic reporting of medicinal products for human use by wholesale distributors/importers/manufacturers has been updated in accordance with the provisions of SCD No. 5/22.02.2011
Link to the Guideline …
Link to the electronic reporting …

19.04.2011
To the attention of interested persons
GMP training delivered by the NAMMD in the context of the CERF project will take place at 09:00, on 12 May 2011, in the Council Room of the “Carol Davila” University of Medicine and Pharmacy, Bucharest (at 8, Eroilor Sanitari Avenue).
For enrolment, please send an application containing the name and surname of the participant on behalf of your company, his/her profession (physician, pharmacist, other), personal identification number, telephone number and e-mail address. Registration is invalidated unless all required data are provided.

14.04.2011
To the attention of interested persons
Please be advised that the meeting of the Scientific Council of the National Agency for Medicines and Medical Devices will take place at 10:00, on 3 May 2011

07.04.2011
To the attention of Marketing Authorisation applicants and holders
Training related to “Legislative regulations concerning quality assessment of medicinal products for human use”, is delivered by the National Agency for Medicines and Medical Devices at 10:00, in the context of the CERF project, will be held on 15 April 2011, in the Council Room of the “Carol Davila” University of Medicine and Pharmacy, in Eroilor Sanitari Avenue,.
For proper communication, please specify all contact data of the company’s representative, including his/her professional status (physician, pharmacist, chemist etc.), telephone number and e-mail address. For this event, companies participating in previous training will also attach the filled-in additional document to their application.
Enrollment may only be performed until 14 April, via application to the attention of the President of the National Agency for Medicines and Medical Devices, submitted to the Registry office.
Please find attached the training schedule.
training schedule …

22.03.2011
To the attention of Marketing Authorisation applicants and holders
The workshop on the Summary of Product Characteristics, leaflet and consultation with target patient groups for the leaflet, delivered by the National Agency for Medicines and Medical Devices within the CERF project, will be held at 10:00, on 25 March 2011, in the Council Room of the “Carol Davila” University of Medicine and Pharmacy, in Eroilor Sanitari Avenue.
To ensure proper communication, please specify all contact data of the company’s representative, including his/her professional training (physician, pharmacist, chemist etc.), telephone number and e-mail address. For this event, companies participating in previous training will also attach the filled-in additional document to their application.
Enrollment may only be performed until 24 March via application to the attention of the President of the National Agency for Medicines and Medical Devices, submitted to the Registry office.

21.03.2011
To the attention of interested persons
Please be advised that the meeting of the Scientific Council of the National Agency for Medicines and Medical Devices will take place at 10:00, on 5 April 2011.

11.03.2011
NAMMD press release on off-label use of AVASTIN
download document …
download Annex …

08.03.2011
To the attention of interested persons
The updated information on medicinal products for human use –Summary of Product Characteristics, Leaflet, Labelling information – will be published on the new website of the National Agency for Medicines and Medical Devices, under:
– Section “National Procedure”, SmPC heading, for medicinal products authorised through the national procedure;
– Section “MRP DCP Procedures”, SmPC heading, for medicinal products authorised through the mutual recognition and the decentralised procedure.
Because of technical difficulties, the links to the Index of Medicinal Products cannot be created/updated.

02.03.2011
To the attention of Marketing Authorisation Holders
As regards imprinting with the number of NAMMD approval and date of release of advertising material to the general public, in accordance with SCD No. 31/01.11.2010, Article 5, please be advised that materials will only be imprinted with “No. ………/…………….”, ruling out the phrase “This advertising material has NAMMD approval”. Consequently, all material under assessment and yet to be submitted for assessment will contain the approval number and the date of release only (e.g. “20/01.03.2011”). Article 5 of SCD No. 31 will be brought to the attention of the SC in view of amendment at its next meeting.
As regards material meant for healthcare professionals, please be advised that the Guideline on advertising stipulates that these should contain a shortened version of the SmPC. In the following SC meeting, the NAMMD will propose a font for the SmPC information in order to ensure readability, i.e.: characters should be of minimum 3 mm in size.

25.02.2011
To the attention of interested persons
One of the topics of the Summary of Product Characteristics workshop to be delivered in the context of the CERF project, on 25 March, in Bucharest, in the Council Chamber of the “Carol Davila” University of Medicine and Pharmacy, will be the consultation with target patient groups as well as the terms for submission of the reports containing the summary of such consultations. The questions on these themes will be forwarded to informatii@anm.ro.

17.02.2011
To the attention of Marketing Authorisation Holders
Rules for the administrative procedure of the National Agency for Medicines and Medical Devices on handling of variations related to medicinal products authorised through „purely national” procedure, CADREAC/nCADREAC included, are to be applied after approval of fees for the various types of variations and groups of variations they provide for.

09.02.2011
To the attention of Marketing Authorisation applicants and holders
In March 2011, The National Agency for Medicines and Medical Devices will deliver, in the context of the CERF project, the following training courses:
10 March – Course: “Evaluation of the environmental risk”
25 March – Workshop: “Summary of Product Characteristics”
The events will take place in the Council Room of the “Carol Davila” University of Medicine and Pharmacy in Eroilor Sanitari Avenue.
To ensure proper communication, please specify the full contact data of the company’s representative, professional training included (physician, pharmacist, chemist etc.), telephone number and e-mail address. For this event, companies participating in previous training will also attach the filled-in additional document to their application.
Enrollment may be performed through letter to the attention of the President of the National Agency for Medicines and Medical Devices and submitted to the Registry.

09.02.2011
To the attention of interested persons
The NAMMD hereby informs on the joint meeting of the NAMMD with the representatives of the Romanian College of Pharmacists, of the pharmacy employers, manufacturers’ associations, Romanian and international importers / distributors of medicinal products for human use and of Marketing Authorisation Holders concerning compliance with regulations in force as regards the advertising of medicinal products for human use will take place at 11:00, 15.02.2011.

02.02.2011
To the attention of interested persons
Please be advised that the meeting of the Scientific Council of the National Agency for Medicines and Medical Devices will take place at 9:30, on 22 February 2011.

02.02.2011
Warning
The Irish regulatory authority has discovered an illegal product sold over the Internet, the MAGICREAM cream. This product contains clobetasol propionate, a steroid, and ketoconazole, used to treat infections. Products containing such substances must own a marketing authorisation and cannot be marketed via the Internet.
Magicream is marketed in a yellow tube with green writing.
Patients using this product illegally are advised to discontinue its use and consult a physician or pharmacist.

02.02.2011
To the attention of interested persons
Based on Scientific Council Decision (SCD) of the National Agency for Medicines and Medical Devices No. 7 of 23 March 2010 on approval of switch of classification for supply of certain metamizole-containing medicinal products, from over the counter release to release on medical prescription (retained by pharmacies), all such medicinal products are to be released in accordance with NMA SCD, starting with 1 April 2011.
It should be emphasised that this measure only refers to release on medical prescription retained in the pharmacy, for all metamizole-containing medicinal products, and not to change of the legal deadline for implementation of the respective authorisation (MA), as stipulated in Order of the Minister of Health No. 279/2005. This measure also applies to all batches manufactured prior to this Decision, which can continue on the market in packages compliant with procedures issued before the change of the respective MA.
Please find attached the list of all metamizole-containing medicinal products to be released on medical prescription only as of 1 April 2011.
download list …

27.01.2011
To the attention of interested persons
For medicinal products authorised through national/decentralised/ mutual recognition procedure, prior to entering into force of rules for classification for release, approved through Order of the Minister of Health No. 1602/2010, until renewal of authorisation or within one year from the entering into force of these Rules (for medicinal products with permanent authorisation), the wording used for classification subcategories will be assimilated to the wording adopted through these Rules, in accordance with the attached document.
As regards medicinal products authorised through centralised procedure, the wording employed for the subcategories for classification for release will be assimilated to the wording adopted through Scientific Council Decision No. 13/2010 (harmonising the classification for release of medicinal products authorised through centralised procedure with the one used for other types of procedures), in accordance with the attached document.
download Annex …

24.01.2011
To the attention of interested persons
According to Scientific Council Decision (SCD) of the National Medicines Agency No. 7 of 23 March 2010 on approval of the switch of classification for supply of metamizole-containing medicinal products, from over the counter release to release on medical prescription to remain in the pharmacy, all such medicinal products will be released in accordance with NMA SCD, starting with 1 April 2011.
It should be emphasised that this measure only refers to the release on medical prescription retained in the pharmacy, for all metamizole-containing medicinal products, and not to the change of the legal deadline for implementation of the respective authorisation (MA), as stipulated in Order of the Minister of Health No. 279/2005. This measure also applies to all batches manufactured prior to this Decision, which can continue on the market in packages compliant with procedures issued before change of the respective MA.

19.01.2011
To the attention of Marketing Authorisation applicants and holders
Between March and June 2011, the National Agency for Medicines and Medical Devices will deliver the following training, in the context of the CERF project:
07 – 11 March – Course on environmental risk evaluation
21 – 25 March – SmPC workshop
11 – 15 April – Course on quality – active substances, finished synthesis products, biological products
09 – 13 May – Course on integrated system use
23 – 27 May – Course on integrated system use
06 – 10 June – Course on Good Manufacturing Practice (GMP) 20 – 24 June – Course on integrated system use
To ensure proper communication, please specify the full contact data of the company’s representative, professional training included (physician, pharmacist, chemist etc.), telephone number and e-mail address. For this event, companies participating in previous training will also attach the filled-in additional document to their application.
Enrollment may be performed through letter to the attention of the President of the National Agency for Medicines and Medical Devices and submitted to the Registry.

13.01.2011
To the attention of Marketing Authorisation Holders
The rule on the administrative procedure of the National Agency for Medicines and Medical Devices on handling of variations for medicinal products authorised through “purely national” procedure, as well as through CADREAC/nCADREAC procedures are implemented following approval of the fees for variations and grouped variations stipulated.

07.01.2011
To the attention of Marketing Authorisation applicants and holders
On request of the Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human= CMDh), the National Agency for Medicines and Medical Devices has informed on its decision to receive dossiers for Marketing Authorisation (MA) renewal and the renewal of variations to MA in electronic format (non-eCTD/NeeS or eCTD) for the Mutual Recognition Procedure (MRP), the Decentralised Procedure (DCP) and the national procedure, in accordance with the attached document.
download Annex …

04.01.2011
To the attention of Marketing Authorisation Holders
In order to avoid submission of a large number of applications in a short period of time, applications for renewal of marketing authorisations of medicinal products with MAs issued in November and December 2006, through “purely” national procedure and through CADREAC/nCADREAC simplified procedures, may be submitted starting with 1 January 2011. To ensure proper coordination, submission of such applications to the Registry – document distribution and release Bureau within the Information, Logistics and Electronic Management of Data Department will be scheduled.