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SCIENTIFIC COUNCIL DECISIONS

2017

DECISION No. 12/24.10.2017 on approval of the change of status as regards classification for supply of Vigantoletten 500 IU, tablets and Vigantoletten 1000 IU (colecalciferolum)
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DECISION No. 11/24.10.2017 on repeal of application for change of classification for release of Robitussin junior 3.75 mg/ 5 ml, oral solution and Robitussin antitussicum 7.5 mg / 5 ml oral solution (dextromethorphanum)
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DECISION No. 10/24.10.2017 on repeal of application for change of classification for release of OMACOR 1000 mg, soft capsules (Omega-3 Acid Ethyl Ester 90)
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DECISION No. 9/24.10.2017 on approval of change of classification for release of Lagosa 150 mg, drops (silibinum)
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DECISION No. 8/24.10.2017 on approval of change of classification for release of Erdomed 225mg, granules for oral suspension (ERDOSTEINUM)
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DECISION No. 7 /24.10.2017 on approval of the change of classification for release of Eptavit 2500 mg/880 IU, effervescent tablets (combinations)
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DECISION No. 6/19.12.2017 on approval of the change of status as regards classification for supply of Fucidin 20 mg/g, cream and Fucidin 20 mg/g, ointment (acidum fusidicum)
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DECISION No. 4/24.10.2017 on approval and revision of certain Romanian standard terms for administration devices, closure systems and packagings, as approved by the European Pharmacopoeia Commission
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DECISION No. 1/24.10.2017 on approval of amendment of SCD no. 4 of 27.03.2009 on approval of the Guideline on change of classification for supply of a medicinal product for human use
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Decision no. 3/26.06.2017 on amendment of SCD no. 19/12.08.2013 on approval of the Guideline on details concerning the various categories of variations to the terms of marketing authorisations and on their examination by the National Agency for Medicines and Medical Devices by the purely national procedure for authorisation of medicinal products for human use, in accordance with Regulation (EC) no. 1234/2008 of the Commission, as amended through Regulation (EU) no. 712/2012
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Decision no. 2/26.06.2017 on adoption of the Guideline on Good Manufacturing Practice for Medicinal Products for human use
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Decision no. 1/26.06.2017 on approval of the Communication strategy of the National Agency for Medicines and Medical Devices (2017-2020)
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2016

DECISION no. 3/21.11.2016 on approval of the 2015 annual report of the National Agency for Medicines and Medical Devices
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2015

DECISION no. 35/30.09.2015 on delayed adoption of a Decision on the application for change of classification for release, from release based on medical prescription to release without medical prescription for Lagosa 150 mg lozenges (silybin)
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DECISION no. 34/30.09.2015 on repeal of application for change of classification for release, from release based on medical prescription to release without medical prescription for Gingium 40 mg, 80 mg and 120 mg, film-coated tablets
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DECISION no. 33/30.09.2015 on approval of NAMMD principles for assessment of co-payment discount programmes to facilitate access to on-prescription medicinal products
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DECISION no. 32/30.09.2015 on approval of the Romanian version of Standard Terms for pharmaceutical dosage forms for pulmonary use, as approved by the European Pharmacopoeia Commission
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DECISION no. 31/30.09.2015 on basic criteria for NAMMD approval of supply of free samples, on establishment of conditions for grant of approval for supply of free samples of medicinal products for human use authorised for marketing in Romania and approval of the procedure for supply of free samples of medicinal products for human use authorised for marketing in Romania
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DECISION no. 30/30.09.2015 on adoption of the Guideline on good pharmacovigilance practices (GVP) Module V – Risk management systems (Rev 1)
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DECISION no. 29/30.09.2015 on adoption of the Guideline on the pharmacokinetic and clinical evaluation of modified release dosage forms
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DECISION No. 28/03.07.2015 on approval of switch of classification for release of Kitonail 80 mg/g medicated nail lacquer (ciclopirox)
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DECISION No. 27/03.07.2015 on approval of switch from classification for release of Lomexin 20 mg/gram cream (fenticonazole)
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DECISION no. 26/03.07.2015 on approval of the Romanian version of Standard Terms for pharmaceutical dosage forms for parenteral use, as approved by the European Pharmacopoeia Commission
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DECISION no. 25/03/07/2015 on approval of amendment to Annex to SCD no. 6/22.04.2014 on approval of Regulations for authorisation by the National Agency for Medicines and Medical Devices of clinical trials/notification to the National Agency for Medicines and Medical Devices of non-interventional studies on medicinal products for human use in Romania
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DECISION No. 24/03.07.2015 on approval of amendment of the Annex to SCD no. 2/22.04.2014 on approval of Regulations for authorisation of sites for conduct of clinical trials on medicinal products for human use
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DECISION no. 23/03.07.2015 on approval of the Guideline on Good Manufacturing Practice for Medicinal Products for human use (Annex 15 to the Guideline entries into force on 01.10.2015) – as repealed through SCD no. 2/26.06.2017
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DECISION No. 20/03.07.2015 on cancellation of SCD no. 13/15.06.2007, SCD no. 14/15.06.2007, SCD no. 24/28.09.2007 and SCD no. 25/28.09.2007 on conduct of pharmacovigilance activities
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DECISION No. 18/26. 02. 2015 on approval of the form for Report of adverse reactions to medicinal products for compassionate use
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DECISION No. 17/26. 02. 2015 for adoption of the Procedure for co-ordinating GMP inspections for centrally authorised products
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DECISION No. 16/26. 02. 2015 for adoption of the Request Form for exchange of information on Marketing Authorisation Holders or Manufacturing Authorisation Holders between competent authorities in the European Economic Area
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DECISION No. 15/26. 02. 2015 on adoption of the Guideline on Good Pharmacovigilance Practices, Module III – Pharmacovigilance inspections
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DECISION No. 14/26. 02. 2015 on adoption of the Model for risk-based planning for inspections of pharmaceutical manufacturers
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DECISION No. 13/26. 02. 2015 on approval of the Romanian version of Standard Terms approved by the European Pharmacopoeia Commission for routes of administration and uses of dose pharmaceutical forms for auricular, nasal, ocular, oropharyngeal and oral use
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DECISION No. 12/26. 02. 2015 on adoption of the Guideline on Good Pharmacovigilance Practice, Module II – Pharmacovigilance Master File
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DECISION No. 11/26. 02. 2015 on approval of the Form for Patient report of adverse reactions to medicinal products for human use
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DECISION No. 10/26. 02. 2015 on adoption of the Guideline on Good Manufacturing Practice (GMP) for medicinal products for human use – as repealed through SCD 23/03.07.2015, except for Annex 15 to the Guideline on Qualification and validation which remains into force until 01.10.2015
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DECISION No. 9/26. 02. 2015 for adoption of the Statement of non-compliance with GMP
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DECISION No. 8/26. 02. 2015 on adoption of the Procedure for dealing with serious GMP non-compliance requiring co-ordinated measures to protect public health
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DECISION No. 7/26. 02. 2015 for adoption of the GDP inspection procedure for medicinal products for human use
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DECISION No. 6/26. 02. 2015 for adoption of the Guideline on circumstances requiring conduct of inspection by the National Agency for Medicines and Medical Devices at the premises of manufacturers, importers and distributors of active substances and manufacturers or importers of excipients used as starting materials
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DECISION No. 5/26. 02. 2015 for adoption of the Procedure for issue and update of GDP Certificates for medicinal products for human use
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DECISION No. 4/26. 02. 2015 on adoption of the Guideline for interpretation of the Union Format for GMP certificate
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DECISION No. 3/26. 02. 2015 for adoption of the Guideline on Conduct of inspections of pharmaceutical manufacturers or importers
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DECISION No. 2/26. 02. 2015 on adoption of the Guideline for interpretation of the Union Format for manufacturer/importer authorisation
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DECISION No. 1/26. 02. 2015 on approval of the Organisational Strategy of the National Agency for Medicines and Medical Devices 2015 – 2017
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2014

DECISION no. 9/10.09.2014 on confirmation of adoption of NAMMD non-regulatory Scientific Council Decisions, approved through written procedure
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DECISION No. 6/05.06.2014 on approval of Regulations for authorisation by the National Agency for Medicines and Medical Devices of clinical trials/notification to the National Agency for Medicines and Medical Devices of non-interventional studies on medicinal products for human use in Romania – as amended through SCD no. 25/03.07.2015
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DECISION No. 5/05.06.2014 on adoption of the Guideline on Good Pharmacovigilance Practices – Annex I – Definitions (Rev. 2)
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DECISION No. 4/28.03.2014 on approval of abbreviated Romanian Standard Terms for labelling of oral, oromucosal, dental, cutaneous and transdermal, vaginal, rectal, inhalation and tracheopulmonary preparations, in line with European Pharmacopoeia approved terms
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DECISION No. 3/28.03.2014 on approval of the Guideline on Good Pharmacovigilance Practices, Module XV – Safety communication
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DECISION No. 2/22.04.2014 on approval of Regulations for authorisation of sites for conduct of clinical trials on medicinal products for human use – as amended through SCD no. 24/03.07.2015
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DECISION No. 1/28.03.2014 on approval of amendment of Scientific Council Decision no. 2 of 22/02/2011 on posting on the NAMMD website of certain data concerning NAMMD authorised clinical trials
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2013

Decision no. 27/11.10.2013 on approval of amendment to the revised version of the Guideline on assessment of advertising of medicinal products for human use, as approved through SCD no. 18/08.08.2013, as repealed through Order of the Minister of Health no. 194/23.02.2015 on Rules for assessment and approval of advertising of medicinal products for human use, published in the Official Gazette of Romania no. 168 of 11 March 2015
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Decision no. 26/11.10.2013 on approval of change of classification for release for Telfast 120 mg, film-coated tablets, box containing 1 blister x 10 film-coated tablets
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Decision no. 25/11.10.2013 on approval of the Guideline on Good Pharmacovigilance Practices, Module IV – Pharmacovigilance audits
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Decision no. 24/11.10.2013 on approval of the Implementation rules related to the NAMMD procedure for consultation by a notified body concerning grant of scientific opinion on the quality and safety of the ancillary medicinal substance incorporated as an integral part into a medical device
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Decision no. 23/11.10.2013 on approval of the manner of National Agency for Medicines and Medical Devices handling of applications by a notified body for NAMMD scientific opinion on the quality and safety of an ancillary medicinal substance incorporated, as an integral part, into a medical device
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Decision No. 22/12.08.2013 on approval of abbreviated Romanian Standard Terms for the labelling of parenteral, eye, ear and nasal preparations, in line with European Pharmacopoeia approved terms
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Decision No. 19/12.08.2013 on approval of the detailed Guideline concerning the various categories of variations to the terms of marketing authorisations and on their examination by the National Agency for Medicines and Medical Devices by the purely national procedure for authorisation of medicinal products for human use, in accordance with Regulation (EC) no. 1234/2008 of the Commission, as amended through Regulation (EU) no. 712/2012
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Decision No. 18/08.08.2013 on approval of the revised Guideline on evaluation of advertising of medicinal products for human use, as amended through SCD no. 27/11.10.2013, as repealed through Order of the Minister of Health no. 194/23.02.2015 on Rules for assessment and approval of advertising of medicinal products for human use, published in the Official Gazette of Romania no. 168 of 11 March 2015
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Decision no. 17/22.04.2013 on approval of amendment of SCD no. 8/5.04.2011 on supplementation of the Regulation on organisation and operation of the Scientific Council of the National Agency for Medicines and Medical Devices
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Decision no. 16/22.04.2013 on approval of new Romanian standard terms for pharmaceutical forms, primary packaging, closure systems and administration devices, routes and manners of administration, in line with terms adopted by the European Pharmacopoeia Commission
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Decision no. 15/22.04.2013 on approval of the Guideline on Good Pharmacovigilance Practices – Module I – Pharmacovigilance systems and their quality systems
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Decision no. 14/22.04.2013 on approval of the Guideline on Good Pharmacovigilance Practices – Annex I – Definitions – as repealed through SCD no. 5/05.06.2014
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Decision no. 12/22.04.2013 on approval of new templates of package leaflet, summary of product characteristics and label information for medicinal products authorised for marketing through national procedure in Romania, in accordance with European models
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Decision no. 11/22.04.2013 on approval of the formats concerning statements of serious non-compliance with Wholesale Distribution Practice and Good Distribution Practice for active pharmaceutical substances
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Decision no. 10/22.04.2013 on approval of the Guideline on training and qualification of inspectors performing inspections of wholesale distributors
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Decision no. 9/22.04.2013 on Procedure for dealing with serious good manufacturing practice (GMP) non-compliance information originating from third country authorities or international organisations
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Decision no. 8/22.04.2013 on Procedure for dealing with serious GMP non-compliance or voiding/suspension of CEPS thus requiring co-ordinated administrative action – as repealed through SCD no. 8/26.02.2015
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Decision no. 7/22.04.2013 on approval of the templates concerning authorisations and Good Manufacturing Practice and Good Distribution Practice certificates
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Decision no. 3/10.05.2013 on approval of the priority assessment of marketing authorisation applications through national procedure for International Non-proprietary Names (INNs) determined in short supply on the pharmaceutical market
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Decision no. 2/22.04.2013 on approval of the Communication Strategy of the National Agency for Medicines and Medical Devices (2013-2015)
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Decision no. 1/22.04.2013 on approval of the organisational strategy of the National Agency for Medicines and Medical Devices 2013 – 2015
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2012

Decision no. 9/10.07.2012 on approval of the mandatory monthly reporting of placement on the market in Romania, respectively of sales of medicinal products for human use by authorised wholesale distributors/importers/manufacturers, as approved through Order of the Minister of Health no. 502/11.04.2013
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Decision no. 8/17.04.2012 on approval of amendment of the Annex to Scientific Council Decision no. 29/16.12.2010 on approval of the Regulations on the authorisation by the National Agency for Medicines and Medical Devices of clinical trials/notification to the National Agency for Medicines and Medical Devices of non-interventional studies on medicinal products for human use in Romania – as repealed through SCD no. 6/05.06.2014
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Decision no. 7/07.03.2012 on repeal of Decision no. 7/09.03.2007 on approval of the content of the manufacturers batch certificate for a medicinal product exported to countries under the scope of a Mutual Recognition Agreement (MRA)
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Decision no. 5/07.03.2012 on approval of the Guideline on the Good Manufacturing Practice for Medicinal Products for human use, as repealed through SCD no. 10/26.02.2015
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Decision no. 4/07.03.2012 on approval of the Regulations on the manner of handling the proposals for umbrella trade names and other trade names for medicinal products for human use in relation to food supplements, cosmetics and medical devices
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Decision no. 3/07.03.2012 on approval of Guidelines for use by the National Agency for Medicines and Medical Devices of the EU Administrative Procedure for Official Batch Release of Biological Products
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2011

Decision No. 29/13.12.2011 on approval of the update of Annex 1 to Scientific Council Decision No. 33/13.12.2010 on approval of the Regulations for organisation and functioning of the Scientific Council of the National Agency for Medicines and Medical Devices
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Decision No. 28/13.12.2011 on approval of amendment of NAMMD Scientific Council Decision No. 13/05.04.2011 on approval of guidelines on consultations with target patient groups for the package leaflet and documentation on criteria for certification and inspection by the National Agency for Medicines and Medical Devices of operators performing consultations with target patient groups
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Decision No. 27/13.12.2011 on approval of the detailed guidance on collection, verification and presentation of adverse event/reaction reports arising from clinical trials on medicinal products for human use
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Decision No. 26/13.12.2011 on approval of amendment of Scientific Council Decision no. 29/16.12.2010 on approval of regulations on authorisation by the National Agency for Medicines and Medical Devices of clinical trials/notification to the National Agency for Medicines and Medical Devices of non-interventional studies conducted on medicinal products for human use in Romania
as repealed through SCD no. 6/05.06.2014
as amended through SCD no. 8/17.04.2012
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Decision No. 25/13.12.2011 on approval of amendment of Scientific Council Decision No. 1/22.02.2011 on accreditation of national Good Clinical Practice training providers
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Decision No. 23/13.12.2011 on approval of the guideline on the bioanalytical method validation
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Decision No. 21/31.08.2011 on approval of the Guideline on evaluation of advertising in medicinal products for human use
published on 13.09.2011 – as repealed through NAMMD SCD no. 18/08.08.2013

IMPORTANT:
The Guideline on evaluation of advertising in medicinal products for human use has been corrected by eliminating point b of Article 44 (3), page 16.
Paragraph (3) of Article 44 reads as follows:
3) the number of the approval and the date when it has been granted should be imprinted and presented. The modification of the imprinting of the approval number after having been granted the approval for its prolongement is not required.
Small advertising materials i.e. rest, wobbler etc. (these materials are detailed in Annex 1 to this Guideline) are exempted from the requirement to have the approval number imprinted.
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Decision No. 20/06.07.2011 on approval of the Guideline on the use of investigational medicinal products (IMPs) and non-investigational medicinal products (NIMPs) in clinical trials – published on 21.07.2011
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Decision No. 19/06.07.2011 on repeal of Decision No. 24/22.05.2006 on approval of drafts for assessment reports related to the enforcement of Good Manufacturing Practice provisions concerning the manufacturing/quality control of medicinal products – published on 21.07.2011
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Decision No. 18/06.07.2011 on approval of the Community format of the Good Manufacturing Practice (GMP) inspection report – published on 21.07.2011
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Decision No. 17/06.07.2011 on extension of term provided in Article 4 of 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 – published on 21.07.2011 – as repealed through NAMMD SCD no. 9/10.07.2012, as approved through Order of the Minister of Health no. 502/11.04.2013
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Decision No. 16/01.06.2011 on approval of amendment of NAMMD Scientific Council Decision No. 13/05.04.2011 on approval of guidelines on consultations with target patient groups for the package leaflet and documentation on criteria for certification and inspection by the National Agency for Medicines and Medical Devices of operators performing consultations with target patient groups – published on 02.06.2011
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Decision No. 15/12.05.2011 on approval of the Communication Strategy of the National Agency for Medicines and Medical Devices 2011-2015 – published on 18.05.2011
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Decision No. 14/12.05.2011 on approval of the Organisational Strategy of the National Agency for Medicines and Medical Devices 2011-2015 – published on 18.05.2011
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Decision No. 13/05.04.2011 on approval of Guidelines on consultations with target patient groups for the package leaflet and documentation on criteria for certification and inspection by the National Agency for Medicines and Medical Devices of operators performing consultations with target patient groups – published on 21.04.2011
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Decision No. 12/05.04.2011 on approval of new Romanian Standard Terms for certain pharmaceutical forms, primary packaging, closure systems and administration devices, administration routes and methods in line with European Pharmacopoeia approved terms – published on 21.04.2011
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Decision No. 11/05.04.2011 on approval of amendment to SCD No. 31/01.11.2010 on approval of Regulations for advertising of medicinal products for human use
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Decision No. 10/05.04.2011 on approval of Regulations for handling of proposed umbrella trade names and other trade names for medicinal products for human use, as related to food supplements and products for use
published on 07.06.2011
as repealed through SCD no. 4/07.03.2012
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Decision No. 8/05.04.2011 on approval of amendment of the Regulation on organisation and operation of the Scientific Council of the National Agency for Medicines and Medical Devices
published on 21.04.2011
as amended through NAMMD SCD no. 17/22.04.2013
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Decision No. 7/22.02.2011 on approval of Regulations on set up of documentation in support of applications for waiver from legal provisions in force on packaging/labelling of medicinal products for human use authorised for marketing, other than as mentioned in the Annex to Order of the Minister of Public Health No. 872/2006 – published on 18.03.2011
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Decision No. 5/22.02.2011 on approval of mandatory monthly reporting of marketing in Romania, i.e. of medicinal product for human use sales by authorised wholesale distributors – published on 18.03.2011 – as amended through SCD no. 17/06.07.2011 – as repealed through NAMMD SCD no. 9/10.07.2012, as approved through Order of the Minister of Health no. 502/11.04.2013
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Decision No. 4/22.02.2011 on approval of basic criteria for NAMMD inspectors – acceptance of free sample provision and approval of the Annex to Scientific Council Decision No. 3/23.03.2010 on approval of Implementation rules on provision of free samples of medicinal products for human use authorised for marketing in Romania, approved through SCD No. 17/27.11.2009 – published on 07.06.2011
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Decision No. 2/22.02.2011 on posting on the NAMMD website of certain data in clinical trials authorised by the NAMMD
published on 18.03.2011
as amended through Decision no. 1/28.03.2014
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Decision No. 1/22.02.2011 on accreditation of national Good Clinical Practice training providers
published on 07.06.2011
as amended through Decision no. 25/13.12.2011
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2010

Decision no. 35/13.12.2010 on amendment of Scientific Council Decision No. 16/07.06.2010 concerning change of the implementation date of the Guideline on conduct of consultation with target patient groups in view of the Summary of Product Characteristics, as approved through SCD no. 6/23.03.2010 – published on 14.12.2010 – as repealed through SCD no.13/05.04.2011
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DECISION No. 33/13.12.2010 on approval of the Regulation on the operation and organisation of the NAMMD Scientific Council
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Decision no. 32/18.11.2010 on approval of amendment of Scientific Council Decision No. 22/03.09.2010 on approval of the Detailed guideline on the request to the competent authorities for authorisation of a clinical trial on a medicinal product for human use, notification of substantial amendments and declaration of the end of the clinical trial in Romania – published on 18.11.2010
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DECISION No. 30/01.11.2010 on approval of the handling of implementation of Type IA and IB variations not affecting marketing authorisation terms for medicinal products authorised through national procedure – published on 06.11.2010
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DECISION No. 29/13.12.2010 on the approval of Regulations on the authorisation by the National Agency for Medicines and Medical Devices of clinical trials/notification to the National Agency for Medicines and Medical Devices of non-interventional studies on medicinal products for human use in Romania
as repealed through SCD no. 6/05.06.2014
published on 23.12.2010
as amended through SCD no. 26/13.12.2011
as amended and supplemented through SCD no. 8/17.04.2012
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DECISION No. 28/01.11.2010 on approval of the Guideline on Environmental risk assessment of medicinal products for human use – published on 06.11.2010
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DECISION No. 27/01.11.2010 on approval of the Guideline for elaboration of non-clinical documentation assessment report – published on 06.11.2010
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Decision no. 26/03.09.2010 on approval of the set up in Romania of a Medicinal Product National Traceability System – published on 21.09.2010
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DECISION No. 25/03.09.2010 on approval of the completion of the approval by Order of the Minister of Health procedure of regulatory decisions of the National Medicines Agency Scientific Council – published on 21.09.2010
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Decision no. 24/03.09.2010 regarding approval of the manner of resolution of applications for marketing authorisation for medicinal products for human use submitted to the National Medicines Agency (NMA) prior to 2007 – published on 21.09.2010
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DECISION No. 23/03.09.2010 on approval of the Guideline on the Good Manufacturing Practice
for medicinal products for human use – published on 21.09.2010, repealed through SCD no. 5/7.03.2012
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DECISION No. 22/03.09.2010 on approval of the Detailed guideline on the request to the competent authorities for authorisation of a clinical trial on a medicinal product for human use, notification of substantial amendments and declaration of the end of the clinical trial in Romania – published on 21.09.2010 as amended through SCD 32/18.11.2010
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DECISION No. 21/03.09.2010 on approval of the Guideline on the writing of the marketing authorisation and annexes to the marketing authorisation – published on 21.09.2010
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DECISION No. 19/03.09.2010 on approval of further enforcement before issuance of new regulations of all NAMMD Scientific Council Decisions issued prior to release of Government Decision No. 734/2010 on the organisation and operation of the National Agency for Medicines and Medical Devices – published on 21.09.2010
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DECISION No. 17/03.09.2010 on election of the President of the Scientific Council of the National Agency for Medicines and Medical Devices – published on 21.09.2010
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DECISION No. 15/07.06.2010 on approval of the Guideline on the investigation of bioequivalence
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Decision no. 14/07.06.2010 on approval of National Medicines Agency policy concerning resolution of proposed “umbrella” trade names and other trade names
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Decision no. 13/07.06.2010 on approval of Guidelines on Romanian specific blue box requirements for secondary packaging of medicinal products for human use authorised through centralised procedure
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Decision no. 11/07.06.2010 on approval of the Guideline on the expression of strength in the name of centrally authorised medicinal products for human use
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Decision no. 9/07.06.2010 on approval of the communication strategy of the National Medicines Agency (2010-2014)
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Decision no. 8/26.04.2010 on approval of amendment of the Annex to SCD No. 10/2006 on approval of the Analytical, pharmacotoxicological and clinical standards and protocols in respect of the testing of medicinal products, as regards advanced therapy medicinal products, as approved through Order of the Minister of Health no. 615/01.06.2010, published in the Official Gazette of Romania no. 376/07.06.2010
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Decision no. 7/23.03.2010 on approval of switch of classification for supply of certain medicinal products
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DECISION No. 4/23.03.2010 on approval of Norms of the National Medicines Agency administrative procedure for the handling of variations, as approved through Order of the Minister of Health no. 1483/9.12.2010, published in the Official Gazette of Romania, Part I, no. 5/4.1.2011
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Decision no. 3/23.03.2010 on approval of implementation rules for enforcement of SCD No. 17/27.11.2009 on supply of free medicine samples for human use authorised for marketing in Romania, as approved through SCD no. 17/27.11.2009
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Decision no. 1/23.03.2010 on approval of the organisational strategy of the National Medicines Agency 2010-2014
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2009

Decision no. 22/27.11.2009 on the approval of the Guideline on Summary of Product Characteristics (SmPC)
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DECISION No. 21/27.11.2009 on approval of the change of the wording of the package leaflet, summary of product characteristics and labelling information for medicinal products authorised for marketing in Romania, approved by Scientific Council Decision No. 3/27.01.2006
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DECISION No. 20/27.11.2009 on approval of amended European templates for package leaflet, summary of product characteristics and label information for medicinal products authorised for marketing in Romania, approved through SCD No. 2/27.01.2006 – As approved through Order of the Minister of Health no. 1450/24 November 2010, published in the Official Gazette of Romania, Part I, no. 825/9 December 2010
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Decision no. 19/27.11.2009 on the approval of the Guideline on allergen products: manufacture and quality aspects
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Decision no. 18/27.11.2009 on the approval of the Guideline on the viral safety evaluation of biotechnological investigational medicinal products
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Decision no. 17/27.11.2009 on the approval of the Rules concerning the supply of free samples of medicinal products for human use authorised for marketing in Romania
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Decision no. 15/26.06.2009 on approval of change of classification for release of certain medicinal products
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DECISION No. 13/26.06.2009 on approval of amendment of Regulations on the exportation of medicinal products for human use, approved through SCD No. 16/2006, as approved through Order of the Minister of Health no. 1447 of 2010, published in the Official Gazette of Romania, no. 836 of 14 December 2010
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DECISION No. 10/27.11.2009 on the approval of the consolidated version of the Romanian Standard Terms refering to formulations, primary packages, closure systems and administration systems, in accordance with the European Standard Terms approved by the European Pharmacopoeia Commission
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Decision no. 9/26.06.2009 on the approval of the new Romanian Standard Terms for pharmaceutical forms, primary packages, closure systems and routes of administration, in accordance with those adopted by the Commission of the European Pharmacopoeia
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Decision no. 8/26.06.2009 on the approval of the Guideline on the readability of the labelling and package leaflet of medicinal products for human use
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Decision no. 6/26.06.2009 on approval of the Guideline on the requirements for clinical documentation for orally inhaled products (OIP) including the requirements for demonstration of therapeutic equivalence between two inhaled products for use in the treatment of asthma and chronic obstructive pulmonary disease (COPD) in adults and for use in the treatment of asthma in children and adolescents
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Decision no. 5/27.03.2009 on approval of change of classification for supply of certain medicinal products for human use
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Decision no. 4/27.03.2009 on approval of the Guideline on change of classification for supply of a medicinal product for human use
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Decision no. 3/27.03.2009 on Procedure for dealing with serious GMP noncompliance or voiding/suspension of CEPS thus requiring co-ordinated administrative action, as repealed through NAMMD SCD no. 8/22.04.2013
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2008

Decision no. 25/07.11.2008 on repeal of Scientific Council Decision No. 12/18.10.2005 on approval of applications for exclusion of certain International Non-Proprietary Names (INNs) from the INN list requiring bioequivalence studies
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Decision no. 24/07.11.2008 on repeal of Scientific Council Decision no. 16/25.06.2004 on approval of the list of International Non-Proprietary Names requiring bioequivalence studies, as approved through Order of the Minister of Health no. 173/17.02.2009, published in the Official Gazette of Romania, Part 1, no. 107/23.02.2009
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Decision no. 23/07.11.2008 on approval of the new Romanian Standard Terms for pharmaceutical forms, routes of administration and primary packaging, in compliance with those adopted by the European Pharmacopoeia Commission
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Decision no. 22/07.11.2008 on approval of the Guideline on consultations with target patient groups – meeting the requirements of Article 59(3) of Directive 2001/83/EC without the need for a full test – recommendations for bridging
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Decision no. 21/07.11.2008 on approval of the Guideline on consultations with target patient groups for the package leaflet
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Decision no. 20/07.11.2008 on approval of the Guideline on laboratory testing during marketing authorisation/marketing authorisation renewal procedure and/or marketing surveillance
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Decision no. 19/07.11.2008 on approval of Regulations for manufacturing/importation authorisation of manufacturers and importers of medicinal products for human use, including investigational medicinal products and grant of the Good Manufacturing Practice certificate to manufacturers of medicinal products for human use and/or active substances, as approved through Order of the Minister of Health no. 312/16.03.2009, published in the Official Gazette of Romania, Part I, no. 198/30.03.2009, supplemented through Order of the Minister of Health no. 29 din 14 January 2011, published in the Official Gazette of Romania, Part I, no. 56/21.1.2011
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Decision no. 16/23.05.2008 on approval of changing the classification for the supply of certain medicinal products for human use
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Decision no. 15/23.05.2008 on approval of the Guideline on the requirements to the chemical and pharmaceutical quality documentation concerning investigational medicinal products in clinical trials
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Decision no. 14/23.05.2008 on the preparation of reports on GMP inspections requested by the CPMP in connection with applications for marketing authorisations and with medicinal products for human use authorised through the centralised procedure
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Decision no. 13/23.05.2008 on approval of the Procedure for co-ordinating foreign and community pre-authorisation inspections – as repealed through SCD no. 17/26.02.2015
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Decision no. 12/23.05.2008 on the delegation of responsibilities for GMP inspections for medicinal products for human use authorised via the centralised procedure
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Decision no. 11/23.05.2008 on approval of the Guideline on set up of risk based planning for inspections of pharmaceutical manufacturers – as repealed through SCD no. 14/26.02.2015
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Decision no. 10/29.02.2008 on approval of the Guideline on the marketing authorisation of medicinal products for human use on the basis of co-operations, starting from an existing marketing authorisation
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Decision no. 9/29.02.2008 on approval of changing the classification for the supply of medicinal products
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Decision no. 8/29.02.2008 on approval of new and revised Romanian standard terms for pharmaceutical forms, administration routes and primary packaging, in line with those adopted by the European Pharmacopoeia Commission
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Decision no. 6/29.02.2008 on approval of the Guideline on the role of pharmacokinetics in the development of medicinal products in the paediatric population
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Decision no. 5/29.02.2008 on approval of the Guideline on the evaluation of pharmacokinetics of medicinal products in patients with impaired hepatic function
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Decision no. 4/29.02.2008 on approval of the Guideline on pharmacokinetics: tissue distribution studies after repeated doses
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Decision no. 3/29.02.2008 on approval of the Guideline on Direct Healthcare Professional Communication – as repealed through SCD no. 3/28.03.2014
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Decision no. 2/29.02.2008 on approval of the Guideline on the trade name of medicinal products for human use
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2007

Decision no. 26/28.09.2007 on approval of Guideline on the collection, verification and presentation of adverse reaction reports arising from clinical trials on medicinal products for human use – as repealed through SCD no. 27/13.12.2011
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Decision no. 25/28.09.2007 on approval of Guideline on Rapid Alert and non-urgent information system in pharmacovigilance – as repealed through SCD 20/03.07.2015
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Decision no. 24/28.09.2007 on approval of Guideline for procedure to be followed by Competent Authorities on undertaking pharmacovigilance activities – as repealed through SCD 20/03.07.2015
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Decision no. 23/28.09.2007 on the approval of Guideline on the verification of the Good Manufacturing Practice (GMP) status of manufacturers in third countries
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Decision no. 22/28.09.2007 on approval of Guideline on the issue and update procedure of Good Manufacturing Practice certificates
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Decision no. 20/28.09.2007 on approval of Guideline on conduct of inspections of pharmaceutical manufacturers – as repealed through SCD no. 3/26.02.2015
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Decision no. 19/28.09.2007 on approval of Guideline on the application of certain provisions of Art. 729 and 730 of Law No. 95/2006 on Healthcare Reform, Title XVII – The medicinal product – published on 15.10.2007
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Decision no. 18/28.09.2007 on approval of a simplified authorisation of traditional herbal medicinal products – As approved through Order of the Minister of Public Health no. 297/11.03.2008
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Decision no. 17/15.06.2007 on approval of change of classification for release of certain medicinal products
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Decision no. 16/15.06.2007 on approval of Guidelines for use by the National Medicines Agency of the EC Administrative Procedure for Official Batch Release of Medicinal Products – as repealed through SCD no. 3/07.03.2012
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Decision no. 15/15.06.2007 on approval of Guideline on exchange of information between competent authorities in the European Economic Area and manufacturers and wholesale distributors authorisation – as repealed through SCD no. 16/26.02.2015
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Decision no. 14/15.06.2007 on approval of Guideline on Pharmacovigilance Systems, Monitoring of Compliance and Pharmacovigilance Inspections – as repealed through SCD 20/03.07.2015
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Decision no. 13/15.06.2007 on approval of Guideline on the procedure to be followed by marketing authorisation holders on undertaking the pharmacovigilance activities – as repealed through SCD 20/03.07.2015
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Decision no. 12/15.06.2007 on the approval of Guideline on the application of legal provisions concerning the Braille requirements for labelling and package leaflet of a medicinal product
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Decision no. 10/09.03.2007 on approval of change of classification for release of certain medicinal products
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Decision no. 9/09.03.2007 on approval of Guideline on handling of reports of suspected quality defects in medicinal products
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Decision no. 8/09.03.2007 on the approval of procedure for handling Rapid Alerts and recalls arising from quality defects
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Decision no. 7/09.03.2007 on the approval of the content of the manufacturers batch certificate for a medicinal product exported to countries under the scope of a Mutual Recognition Agreement (MRA) – as repealed through SCD no. 7/07.03.2012
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Decision no. 6/09.03.2007 on approval of Guideline on training and qualifications of GMP inspectors
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Decision no. 5/09.03.2007 on approval of Guideline on quality system framework for Good Manufacturing Practice inspectorates
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Decision no. 3/09.03.2007 on approval of Guidelines on replacement of chlorofluorocarbons in metered dose inhalation medicinal products
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Decision no. 2/09.03.2007 on approval of the release procedure for the parallel import authorisation for medicinal products for human use – As approved through Order of the Minister of Public Health no. 1962/02.12.2008 – As amended through SCD no. 14/26.06.2009
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Decision no. 1/09.03.2007 on approval of Guideline on Parallel imports of proprietary medicinal products for which marketing authorisations have already been granted
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