Mission of the NAMMD

- Evaluation at the highest scientific competence of documentation for authorisation in view of marketing high quality, safe and effective medicinal products for human use;

- Surveillance of the safety of medicinal products for human use in therapeutic use by means of inspection and pharmacovigilance activities;
- Maintaining of a high level of performance and safety of medical devices in use in by healthcare networks throughout the country, irrespective of ownership;
- Most demanding assessment of service providing medical-technical units in the area of medical devices, for optimum delivery of competent and quality prosthetic and repair – maintenance services
- Ensuring access for patients and healthcare professionals to useful and accurate information on medicinal products for human use authorised for marketing in Romania;
- Ensuring institutional administrative effectiveness, efficiency and transparency of practices and procedures in use.
 

 

Vision of the NAMMD

- Strengthening of its status as reference national authority in the field of medicinal products for human use and control of the performance and safety of medical devices in use
- Strengthening of its status as expert and reliable source of accurate and timely information in the field of medicinal products for human use, provided to stakeholders.

Organisational strategy of NAMMD 2011-2015  

Communication strategy of NAMMD 2011-2015  

 

 

 



(13.01.2012)
NOTICE to the attention of Marketing Authorisation Holders/Applicants
We hereby inform you that, as of 16.01.2012, the marketing authorisation/MA renewal applications submitted through mutual recognition procedure (MRP) and decentralised procedure (DCP), the applications for variation/change in accordance with Art. 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 shall not be processed unless the letters of intent and the payment forms have been submitted in accordance with the legal provisions in force.

The procedure shall be renewed immediately after completion of the dossier.

(21.07.2010)
To the attention of Marketing Authorisation Holders (MAH) on applications for transfer of marketing authorisation for medicinal products for human use authorised through DCP and MRP

According to section C.I.8 of the “Guideline on the details of the various categories of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products” (2010/C 17/01) of Notice to Applicants, volume 2C  (
http://ec.europa.eu/health/documents/eudralex/vol-2/index_en.htm), in case of transfer of the marketing authorisation (MA) in one Member State, the description of the pharmacovigilance system of the new MAH has to be submitted to all member states concerned as type IB variation (in case the pharmacovigilance system has already been approved for a different product of the same MAH) or type II variation (when the pharmacovigilance system has not yet been assessed for a different product of the same MAH).
Applications for transfer of MA for medicinal products for human use approved through DCP and MRP are further handled through national procedure, in line with order of the minister of public health no 1206/02.10.2006.
Documentation in support of applications for transfer of MA for human use approved through DCP and MRP procedures will no more includes the Detailed description of the newly proposed MAH’s pharmacovigilence system.
The applications for MA transfer is accompanied by proof that the applicant has informed the Reference Member State on such submission in Romania as well as on his intention to submit an application for variation in all Concerned Member States, regarding introduction of a new pharmacovigilance system.  


(16.07.2010)
As of 16 July 2010, the National Agency for Medicines and Medical Devices is in operation, with the same assignments and activities in the field of medicinal products for human use and may therefore receive/release documents specific to such activities.

(27.11.2009)
Report from the CMDh meeting held on 16th, 17th and 18th November 2009
New variation regulation - transition period

Applicants are reminded that variation Regulations (EC) No 1234/2008 will apply to submissions as of 1st January 2010. Applicants have to make sure that all national competent authorities involved in the procedure will receive the applications submitted according to Regulation (EC) No 1084/2003 before 1st January 2010.
A Question & Answer will be published on the CMDh website to address the transition period and answer general questions in relation with the implementation of Regulation (EC) No 1234/2008.
In order to ease the transition, the CMDh strongly recommends not to submit any variation intended to be handled according to Regulation (EC) No 1084/2003 after 15th December 2009.

(21.04.2009)
Notice on change of access to information on centrally authorised medicinal products
The NMA hereby informs you on replacement of PDF files in the “Useful Information” section of the main menu, containing the Romanian version of the Summary of Product Characteristics (SPC) of centrally authorised medicinal products, with a table in Excel format including the following data: name of centrally authorised medicinal products, medicinal product registration number in the Community Register of centrally authorised medicinal products and the marketing authorisation holder (MAH). The table also provides links to the website of the Pharmaceuticals Unit in the Directorate-General for Enterprise and Industry of the European Commission (EC), including the Community Register of medicinal products that have received a marketing authorisation through the centralised procedure. This insures a much greater body of information for all parties interested on centrally authorized medicinal products, permanently updated by the EC, such as:
- Name of the medicinal product;
- International Non-Proprietary Name (INN) of the active substance contained in the respective medicinal product;
- Approved therapeutic indication(s);
- Approved presentation forms;
- Registration number in the Register of medicinal products for human use authorised by the Community under the centralised procedure;
- Authorisation date;
- Procedure closure date;
- Type of procedure;
- Procedure number as given by the European Medicines Agency (EMEA);
- Number of the EC decision;
- Historic progress of post-authorisation changes, with approval decisions: variations, renewals, transfers;
- Annexes to decisions:
   - Annex I - SPC
   - Annex II - Marketing Authorisation Holder and conditions for authorisation
   - Annex III – Leaflet and Labelling.
Links to the EMEA website also enable consultation of European Public Assessment Reports (EPARs) centrally authorised medicinal products.
The NMA also reminds interested parties that medicinal products authorised for marketing or undergoing changes after Romania’s accession to the European Union are provided with Romanian versions of approval decisions and specific annexes.
The NMA undertakes ongoing updating of the Excel table as posted on its website with medicinal products newly authorised for marketing through the centralised procedure.
EC approved changes are made available by means of the link to the European Commission website.


(02.04.2009)
Important notice to the attention of Marketing Authorisation Holders
The NMA hereby informs you on certain issues of importance in the CMD(h) Press Release on the Report from the CMD(h) meeting held on 16th, 17th and 18th March 2009 (
http://www.hma.eu/186.html)
word document ....

(10.03.2009)
Important notice to the attention of Marketing Authorisation Holders
The NMA hereby informs you on certain issues of importance in the CMD(h) Press Release on the Report from the CMD(h) meeting held on 16th 17th February 2009 (
http://www.hma.eu/186.html)
1.  Common request form for reference member state in a decentralised procedure
The Heads of Medicines Agencies have, in cooperation with the CMD(h), developed a common request form to be used by Applicants when requesting National Competent Authorities to act as Reference Member State in a decentralised procedure.
The common request form is published on the CMD(h) website,
http://www.hma.eu/fileadmin/dateien/
Human_Medicines/CMD_h_/Templates/MA_Application/CMDh_036_2009_Rev0_Request_Form.doc
, together with the link
http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/
procedural_guidance/Application_for_MA/CMDh_020_2009_Rev0_NCAs_Links.pdf
)
to National Competent Authorities Webpages where recommendations for requests to act as RMS are published.
2.  CMD(h)/EMEA Sub-Group on Paediatric Regulation
a)As requested in the CMD(h) meeting with representatives of Interested Parties, the CMD(h) has agreed an early publication of the list of active substances to be included in the third wave of the Article 45 work sharing procedure of the Paediatric Regulation.
http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/PaediatricData/Worksharing/
CMDh_014_2008_Rev3_AS_WS_Paed.pdf

Marketing Authorisation Holders will be requested in April 2009 to submit the paediatric studies for the active substances in the third wave to the appointed Rapporteur within one month of the request, with a view to starting the work-sharing procedure as of May 2009.
b)The CMD(h) has agreed a document with Recommendations for implementing Commission decisions following an Article 29 application under the Paediatric Regulation. The document will be published on the CMD(h) website.
http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/PaediatricData/Responsibilities/
Art_29/CMDh_019_2009_Rev0_Art29_Paed.pdf

3.  CMD(h) Best Practice Guide on the use of eCTD in the mutual recognition and decentralised procedures
http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/procedural_guidance/Application_for_MA/
eSubmissions/BPG_eCTD_MRP_DCP_Rev0.pdf

The CMD(h) has agreed to extend the period for consultation on the above mentioned document until the end of June 2009.
Any comments should be sent to the attention of the CMD(h) Secretariat (
HCMDhSecretariat@ emea.europa.eu) until the end of June 2009.
The aim of the BPG is to facilitate and encourage the use of eCTD as the submission format in MRP and DCP and is available for immediate use by Applicants.

(02.03.2009)
Important notice to the attention of Marketing Authorisation Holders
The NMA hereby informs you on certain issues of importance in the CMD(h) Press Release on the Report from the CMD(h) meeting held on 19th and 20th January 2009 (
http://www.hma.eu/186.html)
Question and Answer – Article 5 of Regulation (EC) No 1234/2008
The CMD(h) has agreed a Q&A (
http://www.hma.eu/120.html) to clarify that Article 5 of Regulation (EC) No 1234/2008, applicable as of 1st January 2009, can only be used to request the provision of a recommendation on the classification of a variation according to Commission Regulation (EC) No 1234/2008 and not according to the Commission Regulation (EC) No 1084/2003, in force until 31st December 2009.
Cover letter for Variation applications in MRP
The CMD(h) has agreed on a template for a cover letter for variation applications submitted through MRP, prepared by the Working group on Validation issues/National requirements. The CMD(h) has agreed that the use of the template for the cover letter is voluntary and it is published on the CMD(h) website
(
http://www.hma.eu/uploads/media/Cover_Letter_Variations_2009_01_Rev0.doc).
Number of application forms for registration of homeopathic medicinal products
The CMD(h) has agreed to accept the submission of one application form for several dilutions of a homeopathic stock for a pharmaceutical form. This agreement is reflected in a Q&A, which is published on the CMD(h) website, under Questions & Answers, Homeopathics (
http://www.hma.eu/214.html).
Request for Marketing Authorisation Holders for medicinal products presented as pressurised metered dose inhalers (pMDI)
Marketing Authorisation Holders are requested to review dossiers to ensure that storage orientation studies have been performed and the results of these studies are included in the registered dossier. If the results of the storage orientation studies show that there is a possibility for dose decrease/increase after storage in certain positions, an appropriate recommendation for storage orientation and/or re-priming of the product should be included in the product information.
If MAHs establish that their dossiers need to be updated with respect to either of the above points, an appropriate variation application should be submitted.
Marketing Authorisation Holders are requested to carry out the review of their dossiers and submit any necessary variation applications as soon as possible and not later than 30th June 2010.
A letter detailing this request is published on the CMD(h) website:
(
http://www.hma.eu/uploads/media/MAHs_storage_orientation_issue.pdf)
Reflection paper on advice to Applicants/Sponsors/CROs of Bioequivalence Studies
The CMD(h) would like to bring to the attention of Applicants/Sponsors/CROs of Bioequivalence Studies, the publication on the EMEA website, under Inspections – Good Clinical Practices (
http://www.emea.europa.eu/Inspections/GCPproc.html) of the reflection paper on advice to Applicants/Sponsors/CROs of Bioequivalence Studies.
This advisory document has been developed in order to underline the responsibilities of the parties involved, clarify expectations and reinforce steps taken by the applicants, sponsors and CROs themselves to ensure the quality of bioequivalence trials submitted in marketing authorisation dossiers.

(16.02.2009)
Important notice to the attention of Marketing Authorisation Holders
We hereby re-emphasize the need for Applicants’ compliance with all provisions of Decision 58/15.12.2006 on approval of the Guideline regarding management by the National Medicines Agency of marketing authorisation applications through mutual recognition procedure and decentralised procedure with Romania as Concerned Member State.
In that context, we particularly stress the need to submit the Letter of Intention together with the filled in payment form of the authorisation fee and tariff at least 15 days prior to Day -14 of the mutual recognition or decentralised procedures. The Letter of Intention is to be written according to the model provided in Annex 1 of Decision 58/15.12.2006. Both documents are to be submitted to the Samples-documents admission compartment within the NMA Evaluation authorisation department.
The amount for authorisation fee is specified in Article 854 of Law 95/2006 on healthcare reform, Title XVII, The medicinal product, and the authorization tariff is provided in Annex 1b of Order of the Minister of Public Health no.1038/04.06.2008, as amended through Order of the Minister of Public Health no. 1961/02.12.2008.
At the same time, we request greatest accuracy in filling in the relevant tariff in both marketing and variation applications, in order to avoid further greatly time consuming administrative regulations.


(09.09.2008)
To the attention of Holders of Marketing Authorisations granted through centralised procedure
Even though notification of the National Medicines Agency (NMA) on placement of the market of medicinal products authorised through centralised procedure is not mandatory (notification being made to the EMEA), the NMA is however interested in ensuring Romanian patients’ access to this category of medicinal products as well. Therefore, we think it to the benefit of all parties involved that Marketing Authorisation Holders also notify the NMA on placement, discontinuation or temporary cessation on the Romanian market of such medicinal products. Thank you for your collaboration.


(14.08.2008)
To the attention of clinical trial sponsors
In addition to the letter posted on the Eudravigilance web-site on National Medicines Agency request related to electronic reporting of Suspected Unexpected Serious Adverse Reactions  (SUSARs) in interventional clinical trials, please be informed on the following:
- double reporting (on paper and electronic) is discontinued as of 1 September 2008. As of this date, clinical trial sponsors shall only report SUSARs electronically, according to rules specified in the original letter
- should sponsors be unable to comply with this request, they should inform the NMA – the Clinical trials, pharmacovigilance bureau, at the same time providing data about ways to further carry out SUSARs reporting and the estimated time when SUSARs electronic reporting is feasible.


(30.06.2008)
To the attention of Marketing Authorisation Holders
In view of updating the National Medicines Agency’s (NMA) data base concerning representatives appointed by marketing authorisation holders (MAH) for relationships with the Agency, the NMA requires submission within 30 days as of posting of the present notification in the NMA website of the original official appointment letter, signed by the MAH.
The appointment letter shall specify the following identification data of the MAH representative:
    - name and surname
    - address
    - telephone number (mobile telephone number included)
    - fax number
    - e-mail address
Appointment letters are to be delivered by mail or submitted at the Documents, Samples Admissions Bureau within the timetable for work with the general public.

(19.05.2008)
To the attention of Clinical Trial Sponsors and Marketing Authorisation Holders
The National Medicines Agency (NMA) has started electronic reporting in the EudraVigilance data base. Therefore, the NMA finds it necessary to inform you on its requirements related to electronic transmission of Individual Case Safety Reports=ICSRs and Serious Unexpeted Suspected Adverse Reaction=SUSAR, available on the
EudraVigilance website.

(30.04.2008)
PRESS RELEASE regarding HEPARIN

(28.03.2008)
Notice on management by the National Medicines Agency of variations to marketing authorisation of medicinal products authorised in Romania through simplified CADREAC procedure for mutual recognition procedure before Accession to the EU, which have continued to be authorised through national procedure after Accession.
Reference Member State approved EU variations to marketing authorisation, not applicable in Romania, of medicinal products authorised in Romania through simplified CADREAC procedure for mutual recognition procedure before Accession to the EU, which have continued to be authorised through national procedure after Accession, should be notified to the National Medicines Agency. Notification should be accompanied by the document on variation approval by the Reference Member State and is not subject to fees to the National Medicines Agency. The purpose of the notification is to insure sameness of post-marketing information for medicinal products in question with medicinal products authorised through mutual recognition procedure in the European Union.
Variations applicable in Romania shall be handled according to regulations in force on variation to marketing authorisation as issued by the National Medicines Agency.


(28.03.2008)
To the attention of Marketing Authorisation Holders
We hereby remind Marketing Authorisation Holders that, according to Art. 24.2 of Directive 2001/83/EC (Art. 730 (2) of Law 95/2006 on healthcare reform, Title XVII-The medicinal product), applications for marketing authorisation renewal have to be submitted to the National Medicines Agency at least 6 months prior to expiry of marketing authorisation validity.

(28.03.2008)
To the attention of Marketing Authorisation Holders
The National Medicines Agency (NMA) will allow submission of applications for marketing authorisation through mutual recognition procedure (MRP) and decentralised procedure (DCP) having Romania as reference member state (RMS) as of the second half of 2008, for generic medicinal products (Art. 10.1 of Directive 2001/83/EC/Art. 704 (1) of Law 95/2006 on healthcare reform, Title XVII-The medicinal product) for which the reference medicinal product is authorised for marketing in Romania.
No applications shall be accepted concerning applications for generic medicinal products for medicinal product authorised through centralised procedure.
Applications will solely be accepted for molecules the NMA is sufficiently experienced in. this can only be determined after submission of letters of intention by applicants.
Applicants will be informed on NMA decision to initiate discussions for NMA involvement as RMS within 30 days as of receipt of letters of intention.
The NMA will regularly reconsider approach if its involvement as RMS in MRP and DCP.
For best scheduling the admission of applications, MAH are required to submit to the NMA a letter of intention and the attached application form, filled in with specific information, at least 6 months prior to the intended date for submission of the application for marketing authorisation in RMS and CMS.
Preliminary meetings in view of submission of application for authorisation are scheduled following submission to the NMA of letter of intention and application form.
Application to the National Medicines Agency Romania as Reference Member State in the mutual recognition (MRP)/decentralised (DC)

(08.01.2008)
To the attention of Marketing Authorisation Holders
As of 15.01.2008, the Documents, Samples Admissions Bureau will work according to the following timetable:
-   Admission of applications for variation: Monday and Friday, 10.00-14.00 hrs.
-   Admission of applications for authorisation/renewal of authorisation: Tuesday, Wednesday and Thursday, 10.00-14.00 hrs.
-   Admission of applications for advertising material approval, PSURs, adverse reaction reports, various addresses:  daily, 10.00-14.00 hrs.
-   Admission of applications for clinical trials approval: Monday and Wednesday, 12.00-15.00 hrs.

(07.11.2007)
Important notice to the attention of Marketing Authorization Holders
In order to include medicinal products into the Index of medicinal products for human use 2008, the annual fee for maintaining in force of Marketing Authorizations as provided in Government Ordinance nr. 125/1998, approved with changes and completions by Law nr. 594/2002 with further changes and completions, shall be paid until 01.02.2008.

(07.11.2007)
To the attention of Marketing Authorisation Holders (MAH)
For facilitation of submission to the National Medicines Agency (NMA) of information on medicinal products according to provisions of EC Paediatric Regulation no. 1901/2006 as amended, we hereby invite you to refer to the following links of the Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh):
http://www.hma.eu/213.html;
http://www.hma.eu/uploads/media/QA_Paed_Regulation_Art_45_46.pdf
for the following information:
1.  Procedural guidance concerning submission of information about medicinal products as requested by the EC Paediatric Regulation no. 1901/2006 as amended;
2.  Annex I – MAH Declaration concerning paediatric studies already submitted to the competent authority (NMA) according to provisions of Article 45 of EC Paediatric Regulation no. 1901/2006 as amended;
3.  Annex II –  Listing of products already authorised for paediatric use;
4.  Template for submission of information on paediatric studies from MAH to the NMA – line listing ;
5.  Sample for line listing of paediatric studies;
6.  Questions and Answers on the submission of Paediatric Studies according to Articles 45 and 46 of the EC Paediatric Regulation nr. 1901/2006 as amended and other paediatric information.

(31.10.2007)
To the attention of Marketing authorisation holders (MAH) for generic medicinal products of original medicinal products which have patent protected indications or pharmaceutical forms on end of a marketing authorisation procedure for a generic medicinal product
According to provisions of Art. 11 of Directive 2001/83/EC as amended, transposed in Romania through Art. 708 of Law no.95/2006 on healthcare reform, Title XVII-The medicinal product, the Summary of Product Characteristics (SPC) of medicinal products authorised in Romania based on Art 10 of Directive 2001/83/EC, Art. 704 of Law no.95/2006 on healthcare reform, Title XVII-The medicinal product, respectively, should not include those parts of the SPC of the reference medicinal product in Romania referring to indications or pharmaceutical forms still under patent protection on marketing authorisation of the generic medicinal product.
Observance of this obligation represents the responsibility of the holder of the respective generic medicinal product marketing authorisation.

(15.10.2007)
Important Notice !
The EudraPharm data base (www.eudrapharm.eu) managed by the European Medicines Agency (EMEA) has been officially launched. This can be accessed through the EMEA website (www.eudrapharm.eu) as well as via the NMA Home link.
The purpose of the EudraPharm data base is to provide healthcare professionals, competent authorities and the public/patients with information on medicinal products for human and veterinary use in the European Union and the European Economic Area (EEA).

(11.10.2007)
To the attention of Marketing Authorisation Holders (MAH)
The National Medicines Agency will allow submission of applications for marketing authorisation through mutual recognition procedure (MRP) and decentralised procedure (DCP) having Romania as reference member state (RMS) as of the second half of 2008, for generic medicinal products for which the reference medicinal product is authorised for marketing in Romania. No applications shall be accepted concerning applications for generic medicinal products for which the reference medicinal product is authorised through centralised procedure.
For best scheduling the admission of applications, MAH are required to submit to the NMA a letter of intention and the attached application form, filled in with specific information, at least 6 months prior to the intended  date for submission of the application for marketing authorisation in RMS and CMS.
Preliminary meetings in view of submission of application for authorisation are scheduled following submission to the NMA of letter of intention and application form.

Application to the National Medicines Agency Romania as Reference Member State in the mutual recognition (MRP)/decentralised (DC)

(28.09.2007)
Notification on publication on the NMA website of the list of orphan medicinal products valid in Romania
A list of orphan medicinal products valid in Romania is available in Excel format under “
Useful Information” on the NMA website. These medicinal products have been authorised through centralised procedure. Medicinal products are given in the alphabetical order of their trade names. Orphan medicinal products whose European Commission decision is provided with annexes in Romanian are marked *.

(10.09.2007)
Notification on publication on the NMA website of the list of on prescription medicinal products authorised for circulation in Romania
A List of on prescription medicinal products authorised for circulation in Romania is available in pdf. format under “Useful Information” on the NMA website.
Medicinal products are given in the alphabetical order of their trade names.


(20.08.2007)

Notification on submission of variations in the frame of the mutual recognition procedure with Romania as Concerned Member State
Notification on submission of variations in the frame of the mutual recognition procedure with Romania as Concerned Member State is carried out according to the same preliminary stages as required in the submission of applications for marketing authorisation through mutual recognition procedure with Romania as Concerned Member State (submission of cover letter, filling in of payment form, submission of the dossier in support of the variation).
Payment forms for variations in the frame of the mutual recognition procedure with Romania as Concerned Member State are available under “Forms” in the main menu of the NMA website


(19.07.2007)

Important notice to the attention of marketing authorisation holders
In view of complementation of the National Medicines Agency data bases regarding actual marketing of medicinal products authorised in Romania as well as temporary or permanent discontinuation of marketing of medicinal products authorised in Romania, we hereby resume related provisions of Law 95/2006 on Healthcare reform, Title XVII-The medicinal product and require that information provided by the law be promptly submitted to the National Medicines Agency:
 “Art. 729 – (1) After a marketing authorisation has been granted, the holder of the authorisation shall inform the National Medicines Agency of
the date of actual marketing of the medicinal product for human use in Romania, taking into account the various presentation forms authorised.
(2) The marketing authorisation holder shall also notify the National Medicines Agency
if the product ceases to be placed on the market, either temporarily or permanently; such notification shall, otherwise than in exceptional circumstances, be made no less than 2 months before the interruption in the placing on the market of the product.”

(06.07.2007)

Important Notice !
In order to insure the efficiency of its activities, the NMA requires that the documentation needed for development of its various services (marketing authorisation/renewal, variations, clinical trials etc.) be sent directly to the NMA offices by express mail or the office of the MAH’s representative in Romania, as the case may be. Should the above mentioned documentation be directed to customs authorities, this will be returned to the sender.

 

 

 


TO THE ATTENTION OF ALL INTERESTED PERSONS
1. The National Medicines Agency (NMA) is the competent authority in the field of medicinal products for human use and has the following legal tasks:
    - Marketing authorization of medicinal products for human use
    - Approval of variations to marketing authorization of medicinal products for human use
    - Inspection of good manufacturing practices, good laboratory practices, good analytic laboratory practices, good clinical practices and pharmacovigilance inspection
    - Authorization of clinical trials carried out on medicinal products for human use
    - Pharmacovigilance activities concerning medicinal products for human use
    - Approval of advertising material for medicinal products for human use
    - Establishment of classification for supply of medicinal products for human use (on medical prescription or over the counter)
    - Annual elaboration and editing of the Index of medicinal products for human use
    - Elaboration of the Romanian Pharmacopoeia
2. The NMA is not a manufacturer, importer or distributor of medicinal products for human use.
3. The NMA has no legal responsibilities in the following areas:
    - Reimbursment of medicinal products human use (assigned to the MH*/NHIH*)
    - National health programmes (assigned to the MH*- GDMCSSW*)
    - Set up of prices for medicinal products for human use (assigned to the MH*- GFDMD*)
    - Organisation of national tenders for purchase of medicinal products for human use and sanitary material (assigned to the MH*- SPP*)
    - Authorization of pharmacies and warehouses (assigned to the MS*- GFDMD*)
    - Inspection of good distribution and release practices (assigned to the MH*- GFDMD*)
    - Medical devices (assigned to the MH*- GFDMD*)
    - Cosmetics (assigned to the MH*- DPH*)
    - Nutritional supplements (assigned to the MH*- DPH*)
MH = the Ministry of Health
NHIH = the National Health Insurance House
GDMCSSW = the General Directorate for Medical Care, Sanitary Structures and Wages
GFDMD = the General Pharmaceutical Directorate and Medical Devices
SPP = the Service for Public Purchases
DPH = the Directorate for Public Health
4. Any questions related to the above-mentioned areas should be addressed to the institutions in charge of respective issues.
5. The ANM provides institutions mentioned above all information on medicinal products for human use authorized for marketing in Romania, as required for carrying out their tasks in compliance with legislation in force.

 

 

 


          - Title XVII - The medicinal product of Law nr. 95/2006 on healthcare reform
          - LAW No. 594/2002 regarding the approval of Government Ordinance No. 125/1998 on the setting up, organization and functioning of the National Medicines Agency
          - GOVERNMENT ORDINANCE No. 125/29.08.1998 n the setting up, organization and functioning of the National Medicines Agency ...
detail

 

 

 

National Medicines Agency
Bank accounts


IBAN accounts assigned to the National Medicines Agency by Trezoreria Sector 1 and B.C.R. Ag. Sala Palatului are as follows:
IBAN Account:
RO39TREZ7015032XXX011339 / LEI

B.C.R. Ag. Sala Palatului:
IBAN Account:
RO87RNCB0080117327430002/ EURO
SWIFT CODE (BIC)
RNCBROBU
 

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