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- Legend |
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- word document |
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- attachment |
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- modified or completed document |
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- repealed document |
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- N.M.A. Scientific Council Decisions |
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- 2009 |
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- DECISION No. 22/05.06.2009 on approval of tariffs and marketing authorisation maintenance fee in use by the National Medicines Agency, approved through Order of the minister of health No. 716 of 11 June 2009, published in the Official Gazette of Romania No. 422/19.06.2009 |
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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. 11/26.06.2009 on the approval of modifications of Regulations on the authorisation by the NMA of clinical trials/notification to the National Medicines Agency of non-interventional studies on medicinal products for human use in Romania, approved through SCD No. 52/2006 |
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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. 7/26.06.2009 on approval of the Guidance on Investigational Medicinal Products (IMPs) and other medicinal products used in Clinical Trials |
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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 |
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- DECISION No. 2/27.03.2009 on approval of Community format of the Good Manufacturing Practice (GMP) inspection report |
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- DECISION No. 1/27.03.2009 on approval of the Guideline on Good Manufacturing Practice for medicinal products for human use |
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- 2008 |
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- DECISION No. 25/7.11.2008 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. 24/7.11.2008 on repeal of Scientific Council Decision No. 16/25.06.2004 on approval of the list of International Non-Proprietary Names requiring bioequivalence studies, approved through Order of the Minister of Health No. 173/17 February 2009, published in the Official Gazette of Romania, Part I, No. 107 of 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 packages, 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, approved through Order of the Minister of Health No. 312/16 March 2009, published in the Official Gazette of Romania, Part I, No. 198 of 30/03/2009 |
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- DECISION No. 18/07.11.2008 on approval of the Regulation on the functioning and organisation of the NMA Scientific Council |
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- DECISION No. 17/23.05.2008 on the election of the President, Vice-president and the NMA Scientific Council Secretariat |
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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 |
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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 |
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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. 7/29.02.2008 on approval of the Guideline on the information specific to Romania which must appear in the “Blue Box” on the secondary package of medicinal products for human use authorised through the centralised procedure |
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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 |
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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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- DECISION No. 1/29.02.2008 on approval of the Norms concerning handling of modifications to the marketing authorisation during marketing authorisation renewal procedure - Approved through Minister of Public Health Order No. 1732/14.10.2008, published in the Official Gazette of Romania, Part I, No. 712/20.10.2008 |
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- 2007 |
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- DECISION No. 27/28.09.2007 on approval of amendment to the Annex to Scientific Council Decision No. 49/15.12.2006 on approval of guidance for the request for authorisation of a clinical trial on a medicinal product for human use to the competent authority, notification of substantial amendments and declaration of the end of the clinical trial in Romania |
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- 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 |
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- DECISION No. 25/28.09.2007 on approval of Guideline on Rapid Alert and non-urgent information system in pharmacovigilance |
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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 |
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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. 21/28.09.2007 on the approval of the community format of the GMP inspection report |
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- DECISION No. 20/28.09.2007 on approval of Guideline on conduct of inspections of pharmaceutical manufacturers |
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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 |
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- DECISION No. 18/28.09.2007 on approval of a simplified authorisation for certain homeopathic medicinal products, approved through Minister of Public Health Order No. 297 of 11 March 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 |
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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 |
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- DECISION No. 14/15.06.2007 on approval of Guideline on Pharmacovigilance Systems, Monitoring of Compliance and Pharmacovigilance Inspections |
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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 |
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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 |
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- DECISION No. 11/15.06.2007 on the approval of the Guideline on the definition of a potential serious risk to public health in the context of Article 29 (1) and (2) of Directive 2001/83/EC |
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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 manufacturer’s batch certificate for a medicinal product exported to countries under the scope of a Mutual Recognition Agreement (MRA) |
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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 - Approved through Minister of Public Health Order No. 1962/02.12.2008, published in the Official Gazette of Romania, Part I, No. 867/22.12.2008. |
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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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- 2006 |
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- DECISION No. 59/15.12.2006 on approval of the Guideline on inclusion in the Repeat Use mutual recognition procedure of medicinal products authorised in Romania through CADREAC/nCADREAC simplified procedure or national procedure following 01.01.2007 |
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- DECISION No. 58/15.12.2006 on approval of the Guideline on the administration, in case Romania is a Concerned Member state, of the applications for marketing authorisation through mutual recognition procedure and decentralised procedure, by the National Medicines Agency |
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- DECISION No. 57/15.12.2006 on the modification of the Scientific Council Decision No. 15/2006 on the approval of regulations on manufacturing/importation authorisation for the manufacturers and importers of medicinal product for human use, including investigational medicinal products and starting materials used in the manufacturing of medicinal products for human use, including investigational medicinal products - Approved through Minister of Public Health Order No. 815/10.05.2007, published in the Official Gazette of Romania, Part I, No. 358/25.05.2007 |
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- DECISION No. 56/15.12.2006 on approval of a simplified authorisation procedure for certain homeopathic medicinal products - Approved through Minister of Public Health Order No. 816/10.05.2007, published in the Official Gazette of Romania, Part I, No. 345/22.05.2007 |
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- DECISION No. 55/15.12.2006 on approval of Guideline circumstances appropriate for National Medicines Agency conduct of inspections at the premises of manufacturers of active substances used as starting materials |
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- DECISION No. 54/15.12.2006 on approval of Guideline on the investigation of bioavailability and bioequivalence |
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- DECISION No. 53/15.12.2006 on approval of Guidance on non-clinical safety studies for the conduct of human clinical trials for medicinal product assessment |
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- DECISION No. 52/15.12.2006 on approval of regulations for authorisation by the National Medicines Agency of clinical trials/notification to the National Medicines Agency of non-interventional studies on medicinal products for human use in Romania |
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- DECISION No. 51/15.12.2006 on approval of Guidance on the content of the trials master file and archiving |
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- DECISION No. 50/15.12.2006 on approval of Guidance on the application format and documentation to be submitted in an application for an Ethics Committee opinion on the clinical on medicinal products for human use in Romania |
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- DECISION No. 49/15.12.2006 on approval of Guidance for the request for authorisation of a clinical trial on a medicinal product for human use to the competent authority, notification of substantial amendments and declaration of the end of the clinical trial in Romania |
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- DECISION No. 48/15.12.2006 on approval of Guidelines on the qualifications of inspectors verifying compliance in clinical trials with the provisions of Good Clinical Practice |
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- DECISION No. 47/15.12.2006 on approval of Guidelines on inspection procedures for the verification of good clinical practice compliance |
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- DECISION No. 46/27.10.2006 on approval of norms on the enforcement of certain provisions of Regulation No. 141/2000/EC on orphan medicinal products - Approved through Minister of Public Health Order No. 1807/29.12.2006, published in the Official Gazette of Romania, Part I, No. 58/24.01.2007 |
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- DECISION No. 45/27.10.2006 on approval of the Guideline on replacement of chlorofluorocarbons in medicinal products |
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- DECISION No. 44/27.10.2006 on the introduction into Romania and preservation in the therapeutic circuit of medicinal products manufactured prior to the National Medicines Agency’s approval of a marketing authorisation transfer - Approved through Minister of Public Health Order No. 1810/29.12.2006, published in the Official Gazette of Romania, Part I, No. 70/30.01.2007 |
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- DECISION No. 43/27.10.2006 on approval of norms concerning the export declaration for medicinal products for human use - Approved through Minister of Public Health Order No. 1809/29.12.2006, published in the Official Gazette of Romania, Part I, No. 20/12.01.2007 |
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- DECISION No. 42/27.10.2006 on approval of Guidelines on classification of inspection findings in verification of good clinical practice compliance |
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- DECISION No. 41/27.10.2006 on approval of Guideline on clinical investigation of medicinal products in the paediatric population |
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- DECISION No. 40/27.10.2006 on approval of Guideline on general considerations on clinical trials |
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- DECISION No. 39/27.10.2006 on approval of Guidelines on Good Clinical Practice |
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- DECISION No. 37/14.07.2006 on approval of new and revised Romanian Standard Terms for pharmaceutical forms, routes of administration and primary packages, in compliance with those adopted by the European Pharmacopoeia Commission in the session of June 2006 |
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- DECISION No. 36/14.07.2006 on amendment to Scientific Council Decision No. 15/2006 on approval of Regulations regarding manufacturing/importation authorisation for the manufacturers and importers of medicinal products for human use, including investigational medicinal products, and starting materials used in the manufacturing of medicinal products for human use, including investigational medicinal products - Approved through Minister of Public Health Order No. 918/27.07.2006, published in the Official Gazette of Romania, Part I, No. 719/22.08.2006 |
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- DECISION No. 35/14.07.2006 on approval of Regulations relating to attestation by the National Medicines Agency of qualified person of the Manufacturing/Importation Authorisation Holder - Approved through Minister of Public Health Order No. 1200/02.10.2006, published in the Official Gazette of Romania, Part I, No. 832/10.10.2006 |
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- DECISION No. 34/14.07.2006 on withdrawal/suspension by the National Medicines Agency of certain marketing authorisations, prior to Accession - Approved through Minister of Public Health Order No. 1199/02.10.2006, published in the Official Gazette of Romania, Part I, No. 832/10.10.2006 |
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- DECISION No. 33/14.07.2006 on cancellation by the National Medicines Agency of marketing authorisation applications for medicinal products for human use - Approved through Minister of Public Health Order No. 1203/02.10.2006, published in the Official Gazette of Romania, Part I, No. 832/10.10.2006 |
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- DECISION No. 32/14.07.2006 on approval of norms relating to examination of an application for the transfer of a marketing authorisation - Approved through Minister of Public Health Order No. 1206/02.10.2006, published in the Official Gazette of Romania, Part I, No. 836/11.10.2006 |
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- DECISION No. 31/14.07.2006 related to management of applications for proposed changes in design and wording of the package of medicinal products for human use, as well as changes in leaflet and the Summary of Product Characteristics, other than caused by Type IA, IB and II variations - Approved through Minister of Public Health Order No. 1205/02.10.2006, published in the Official Gazette of Romania, Part I, No. 836/11.10.2006 |
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- DECISION No. 30/14.07.2006 on approval of norms regarding examination of applications for changes to a marketing authorisation leading to an extension application for medicinal products for human use approved through national procedure in Romania - Approved through Minister of Public Health Order No. 1204/02.10.2006 |
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- DECISION No. 29/14.07.2006 on approval of Guideline on excipients in the label and package leaflet of medicinal products for human use - Approved through Minister of Public Health Order No. 1202/02.10.2006, published in the Official Gazette of Romania, Part I, No. 840/12.10.2006 |
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- DECISION No. 28/14.07.2006 on approval of Guideline on the risk minimisation of animal spongiform encephalopathies transmission through medicinal products for human use - Approved through Minister of Public Health Order No. 1201/02.10.2006, published in the Official Gazette of Romania, Part I, No. 835/10.02.2006 |
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- DECISION No. 27/14.07.2006 on approval of Guideline regarding elaboration of the overview for a medicinal product for which a marketing authorisation application is submitted to the National Medicines Agency |
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- DECISION No. 26/14.07.2006 on approval of The Guideline elaboration of the Assessment report on chemical-pharmaceutical and biological documentation |
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- DECISION No. 25/22.05.2006 on approval and publication of the 10th edition of the 2006 Supplement of the Romanian Pharmacopoeia |
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- DECISION No. 24/22.05.2006 on approval of Reporting format on evaluation of compliance with good manufacturing practice guidelines relating to medicinal product manufacture/quality control |
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- DECISION No. 23/22.05.2006 on approval of norms on the procedure for grant of exemption of specific medicinal products label and package leaflet from the obligation that certain particulars shall appear and that the leaflet must be in Romanian, when the product is not intended to be delivered to the patient for self-administration |
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- DECISION No. 22/22.05.2006 on approval of norms of the National Medicines Agency administrative procedure for handling of variations - Approved through Minister of Public Health Order No. 874/17.07.2006 |
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- DECISION No. 21/22.05.2006 on approval of the Guideline for elaboration of clinical documentation assessment report |
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- DECISION No. 20/22.05.2006 on approval of the Guideline for elaboration of non-clinical documentation assessment report |
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- DECISION No. 19/22.05.2006 on approval of norms relating to the colouring matters which may be added to medicinal products for human use |
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- DECISION No. 18/31.03.2006 on approval of Regulations relating to the contract-based control of medicinal product quality, as drawn between the manufacturer and a control unit outside the manufacturing site, in case of certain special testing |
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- DECISION No. 17/31.03.2006 on approval of Suspect Adverse Reaction Report Form |
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- DECISION No. 16/31.03.2006 on approval of Regulations regarding export of medicinal products for human use |
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- DECISION No. 14/31.03.2006 on approval of norms relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use - Approved through Minister of Health Order No. 904/25.07.2006 |
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- DECISION No. 13/31.03.2006 on approval of Principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products |
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- DECISION No. 12/31.03.2006 on approval of Principles and guidelines for good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use |
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- DECISION No. 11/31.03.2006 on approval of Regulations regarding marketing authorisation and supervision of medicinal products for human use |
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- DECISION No. 10/31.03.2006 on approval of the Analytical, pharmacotoxicological and clinical norms and protocols in respect of the testing of medicinal products - Approved through Minister of Health Order No. 906/25.07.2006, published in the Official Gazette of Romania, Part 1, No. 706/17.08.2006 |
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- DECISION No. 9/27.01.2006 on approval of applications for expedited evaluation |
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- DECISION No. 8/27.01.2006 on revocation/suspension by the National Medicines Agency of certain marketing authorisations before Accession, Approved by Minister of Health Order No. 384/2006 |
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- DECISION No. 7/27.01.2006 on approval of repeal of Scientific Council Decision No. 19/25.06.2004 dossier required in support of marketing authorisation application in Romania in emergency regime for first generics for which marketing authorisation is applied for after the original medicinal product |
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- DECISION No. 6/27.01.2006 on approval of repeal of Scientific Council Decision No. 18/25.06.2004 on dossier required in support of marketing authorisation application in Romania for first generics for which marketing authorisation is applied for after the original medicinal product |
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- DECISION No. 5/27.01.2006 on approval of Regulations for the marketing authorisation procedure used by the National Medicines Agency in view of marketing authorisation of medicinal products for human use already authorised through mutual recognition procedure in Member States of the European Union, approval of variations and renewal of marketing authorisation for such medicinal products |
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- DECISION No. 4/27.01.2006 on approval of Regulations for the marketing authorisation procedure used by the National Medicines Agency for medicinal products for human use already authorised in EU Member States following the centralised procedure and the variation and renewal of such marketing authorisations, approval of variations and renewal of marketing authorisation for such medicinal products, Approved by Minister of Health Order No. 398/2006 |
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- DECISION No. 3/27.01.2006 on approval of Statements for use in the wording of package leaflet, summary of product characteristics and label information for medicinal products authorised for marketing in Romania, Approved by Minister of Health Order No. 400/2006 |
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- DECISION No. 2/27.01.2006 on approval of European models of package leaflet, summary of product characteristics and label information for medicinal products authorised for marketing in Romania, Approved by Minister of Health Order No. 399/2006 |
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- 2005 |
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- DECISION No. 13/18.10.2005 on approval of change of classification for supply of certain medicinal products |
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- 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. 11/18.10.2005 on approval of applications for emergency evaluations |
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- DECISION No. 10/30.09.2005 on approval of change of classification for supply of certain medicinal products |
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- DECISION No. 8/30.09.2005 regarding the approval of the Guideline on updating and amendment of the authorisation documentation of medicinal products for human use authorised in Romania, in order to comply with the requirements of European Union - Approved through Minister of Health Order No. 92/08.02.2006, published in the Official Gazette of Romania, Part 1, No. 175/23.02.2006 |
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- DECISION No. 4/02.06.2005 on election of the President, Vice-President and Secretary of the Scientific Council of the National Medicines Agency - Repealed by Decision No. 17/23.05.2008 |
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- DECISION No. 3/02.06.2005 on approval of the Guidebook regarding “umbrella” brands - Approved through Minister of Health Order No. 1453/28.12.2005, published in the Official Gazette of Romania, Part 1, No. 26/11.01.2006 |
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- DECISION No. 2/02.06.2005 on approval of the Guidebook regarding trade name of medicinal products for human use - Approved through Minister of Health Order No. 1452/28.12.2005, published in the Official Gazette of Romania, Part 1, No. 26/11.01.2006 |
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- DECISION No. 1/02.06.2005 on approval of the new structure of the marketing authorisation and norms for marketing authorisation writing |
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- 2004 |
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- DECISION No. 41/10.12.2004 on approval of norms regarding quality of raw materials used for manufacturing of Romanian medicinal products for human use - Approved by Minister of Health Order No. 281/30.03.2005, published in the Official Gazette of Romania, Part 1, No. 294/07.04.2005 |
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- DECISION No. 40/10.12.2004 on approval of norms for the application of Decision of the Scientific Council No. 28/24.10.2003 concerning approval of the Guideline related to content of Type IA and IB notification dossiers, approved through Order of the Minister of Health No. 1127/08.12.2003 - Approved by Minister of Health Order No. 282/30.03.2005, published in the Official Gazette of Romania, Part 1, No. 294/07.04.2005 - Repealed by Minister of Public Health Order No. 874/2006 |
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- DECISION No. 39/10.12.2004 Regarding approval to change classification for release of certain medicines |
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- DECISION No. 38/10.12.2004 regarding implementation of changes to marketing authorisations approved by the National Medicines Agency - Approved by Minister of Health Order No. 279/30.03.2005, published in the Official Gazette of Romania, Part 1, No. 294/07.04.2005 |
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- DECISION No. 37/10.12.2004 regarding control of medicinal product quality and imported raw materials - Approved by Minister of Health Order No. 280/30.03.2005, published in the Official Gazette of Romania, Part 1, No. 294/07.04.2005 |
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- DECISION No. 36/10.12.2004 regarding approval of the Guideline on clinical safety data management/the Periodic Safety Update Reports for marketed medicinal products - Approved by Minister of Health Order No. 410/19.04.2005, published in the Official Gazette of Romania, Part 1, No. 461/31.05.2005 |
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- DECISION No. 35/10.12.2004 regarding approval of The Guideline on procedure to be pursued by marketing authorisation holders in carrying out pharmacovigilance activities - Approved by Minister of Health Order No. 406/19.04.2005, published in the Official Gazette of Romania, Part 1, No. 461/31.05.2005 - Repealed by Decision No. 13/15.06.07 |
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- DECISION No. 34/10.12.2004 regarding approval of the Guideline on procedure to be pursued by competent authorities in carrying out pharmacovigilance activities - Approved by Minister of Health Order No. 408/19.04.2005, published in the Official Gazette of Romania, Part 1, No. 461/31.05.2005 |
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- DECISION No. 33/10.12.2004 regarding approval of Regulations on pharmacovigilance activities - Approved by Minister of Health Order No. 411/19.04.2005, published in the Official Gazette of Romania, Part 1, No. 461/31.05.2005 |
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- DECISION No. 32/10.12.2004 regarding approval of the Guideline on clinical investigation of medicinal products in the paediatric population - Approved by Minister of Health Order No. 409/19.04.2005, published in the Official Gazette of Romania, Part 1, No. 461/31.05.2005 - Repealed by Decision No. 41/27.10.2006 |
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- DECISION No. 31/1.10.2004 regarding the approval of the switch of classification for supply of certain medicinal products |
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- DECISION No. 30/01.10.2004 regarding approval of Rules related to quality of imported raw materials used for the manufacturing of Romanian medicinal products for human use - Approved by Minister of Health Order No. 1444/05.11.2004, published in the Official Gazette of Romania, Part 1, No. 1077/19.11.2004 - Repealed by Minister of Public Health Order No. 1281/30.03.2005 |
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- DECISION No. 29/01.10.2004 regarding approval of Rules for the application of provisions of Emergency Government Ordinance No. 152/1999 regarding medicinal products for human use, approved with changes and completions through Law No. 336/2002 with further changes and completions, concerning data exclusivity - Approved by Minister of Health Order No. 1443/05.11.2004, published in the Official Gazette of Romania, Part 1, No. 1077/19.11.2004 - Repealed by Law No. 95/2006 |
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- DECISION No. 28/01.10.2004 regarding approval of Guidelines for carrying out Good Manufacturing Practice inspections - Approved by Minister of Health Order No. 1441/05.11.2004, published in the Official Gazette of Romania, Part 1, No. 1145/03.12.2004 - Repealed by Decision No. 20/28.09.07 and Decision No. 21/28.09.07 |
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- DECISION No. 27/01.10.2004 regarding approval of Guidelines for classification of deficiencies observed during Good Manufacturing Practice inspections - Approved by Minister of Health Order No. 1442/05.11.2004, published in the Official Gazette of Romania, Part 1, No. 1116/27.11.2004 |
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- DECISION No. 26/01.10.2004 regarding approval of Guidelines on inspection procedures for the verification of Good Clinical Practice compliance - Approved by Minister of Health Order No. 1629/13.12.2004, published in the Official Gazette of Romania, Part 1, No. 79/24.01.2005 |
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- DECISION No. 25/01.10.2004 regarding approval of Guidelines on the qualification of inspectors who should verify compliance in clinical trials with the provisions of Good Clinical Practice Rules - Approved by Minister of Health Order No. 1630/13.12.2004, published in the Official Gazette of Romania, Part 1, No. 79/24.01.2005 |
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- DECISION No. 24/01.10.2004 regarding approval of Guidelines on the trial master file and archiving - Approved by Minister of Health Order No. 1631/13.12.2004, published in the Official Gazette of Romania, Part 1, No. 79/24.01.2005 |
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- DECISION No. 23/01.10.2004 regarding approval of Guidelines on general considerations for clinical trials - Approved by Minister of Health Order No. 1632/13.12.2004, published in the Official Gazette of Romania, Part 1, No. 79/24.01.2005 - Repealed by Decision No. 40/27.10.2006 |
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- DECISION No. 22/01.10.2004 regarding approval of Guidelines on the collection, verification and presentation of adverse reaction reports arising from clinical trials on medicinal products for human use - Approved by Minister of Health Order No. 1628/13.12.2004, published in the Official Gazette of Romania, Part 1, No. 79/24.01.2005 |
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- DECISION No. 21/25.06.2004 regarding the approval of the applications for evaluation in emergency regime |
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- DECISION No. 20/25.06.2004 regarding the approval of the application norms of the provisions of the Government Emergency Ordinance No. 152/1999 regarding medicinal products for human use, approved with changes and completions through Law No. 336/2002, with further changes and completions, on the exception from labelling in the Romanian language of imported medicinal products - Approved by Minister of Health Order No. 1178/20.09.2004, published in the Official Gazette of Romania, Part 1, No. 870/23.09.2004 - Repealed by Decision No. 23/2006 |
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- DECISION No. 19/25.06.2004 regarding the necessary documentation for the support of the application for evaluation in emergency regime for medicinal products that represent the first generic for which the marketing authorisation in Romania is requested after the original medicinal product - Approved by Minister of Health Order No. 1180/20.09.2004, published in the Official Gazette of Romania, Part 1, No. 870/23.09.2004 - Repealed by Minister of Public Health Order No. 751/23.06.2006 |
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- DECISION No. 18/25.06.2004 regarding the necessary documentation for the support of the marketing authorisation application for medicinal products that represent the first generic for which marketing authorisation in Romania is requested after the original medicinal product - Approved by Minister of Health Order No. 1181/20.09.2004, published in the Official Gazette of Romania, Part 1, No. 870/23.09.2004 - Repealed by Minister of Public Health Order No. 751/23.06.2006 |
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- DECISION No. 17/25.06.2004 regarding the approval of the new and revised Romanian Standard Terms for pharmaceutical forms, routes of administration and primary packages, in accordance with those adopted by the Commission of the European Pharmacopoeia in the Session of november 2003 |
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- DECISION No. 16/25.06.2004 regarding the approval of the list with International non-Proprietary Names necessitating bioequivalence studies - Approved by Minister of Health Order No. 1182/20.09.2004, published in the Official Gazette of Romania, Part 1, No. 870/23.09.2004 |
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- DECISION No. 15/25.06.2004 regarding the approval of the Guidance on the investigation of bioavailability and bioequivalence - Approved by Minister of Health Order No. 1177/20.09.2004, published in the Official Gazette of Romania, Part 1, No. 1042/11.11.2004 |
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- DECISION No. 14/25.06.2004 Regarding approval of regulations for NMA authorisation of clinical studies/NMA notification for non – interventional trials performed with medicinal products for human use in Romania - Approved through Minister of Health Order No. 1179/20.09.2004, published in the Official Gazette of Romania, Part 1, No. 1042/11.11.2004 |
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- DECISION No. 13/25.06.2004 regarding the approval of the Guidance on non-clinical safety studies necessary for the conduct of clinical trials for the evaluation of pharmaceuticals - Approved by Minister of Health Order No. 1224/30.09.2004, published in the Official Gazette of Romania, Part 1, No. 945/15.10.2004 |
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- DECISION No. 12/25.06.2004 on approval of Guidance on application format and documentation to be submitted in application for Ethics Committee opinion on clinical trial on medicinal products for human use in Romania - Approved through Minister of Health Order No. 1300/14.10.2004, published in the Official Gazette of Romania, Part 1, No. 70/20.01.2004 |
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- DECISION No. 11/25.06.2004 regarding the approval of the Guidance for the request for authorisation of a clinical study on a medicinal product for human use, submitted to the competent authority, approval of substantial amendments and declaration of the end of a clinical trial in Romania - Approved by Minister of Health Order No. 1117/08.09.2004, published in the Official Gazette of Romania, Part 1, No. 1041/10.11.2004 |
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- DECISION No. 10/25.06.2004 regarding approval of Good Clinical Practice Rules in clinical trials - Approved through Minister of Health Order No. 1236/04.10.2004, published in the Official Gazette of Romania, Part 1, No. 1132/30.11.2004 - Repealed by Decision No. 39/27.10.2006 |
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- DECISION No. 9/27.02.2004 regarding the approval of applications for evaluation in emergency regime |
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- DECISION No. 8/27.02.2004 regarding the approval of applications for evaluation in emergency regime |
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- DECISION No. 7/27.02.2004 regarding the approval of the additional documentation that should be presented by the applicants in order to support the applications for authorisation of medicinal products that represent the first generic for which marketing authorisation is requested after the original medicinal product - Approved by Minister of Health Order No. 427/16.04.2004, published in the Official Gazette of Romania, Part 1, No. 387/03.05.2004 - Repealed by Decision No. 18/25.06.2004 |
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- DECISION No. 6/27.02.2004 regarding the approval of the Declaration of Interests Form of the NMA Scientific Council members - Approved by Minister of Health Order No. 294/19.03.2004, published in the Official Gazette of Romania, Part 1, No. 268/26.03.2004 |
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- DECISION No. 5/27.02.2004 regarding the approval and publishing the Supplement 2004 of the Romanian Pharmacopoeia, the 10th edition - Approved by Minister of Health Order No. 614/21.05.2004, published in the Official Gazette of Romania, Part 1, No. 522/10.06.2004 |
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- DECISION No. 4/27.02.2004 regarding the approval of the way of issuance of import authorisation for starting materials used in the manufacturing of Romanian medicinal products for human use - Approved by Minister of Health Order No. 428/16.04.2004, published in the Official Gazette of Romania, Part 1, No. 387/03.05.2004 - Repealed by Decision No. 30/01.10.2004 |
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- DECISION No. 3/27.02.2004 regarding the marketing authorisation of Romanian medicinal products necessitating bioequivalence studies |
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- DECISION No. 2/27.02.2004 regarding the approval of the additional documentation that should be presented by the applicants in order to support the applications for evaluation in emergency regime of medicinal products that represent the first generic for which marketing authorisation is requested after the original medicinal product - Approved by Minister of Health Order No. 429/16.04.2004, published in the Official Gazette of Romania, Part 1, No. 387/03.05.2004 - Repealed by Decision No. 19/25.06.2006 |
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- DECISION No. 1/27.02.2004 regarding the approval of Regulations on the implementation of Good Clinical Practice in the conduct of clinical trials on medicinal products for human use - Approved by Minister of Health Order No. 615/21.05.2004, published in the Official Gazette of Romania, Part 1, No. 603/05.07.2004 - Repealed by Decision No. 14/2006 |
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- 2003 |
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- DECISION No. 44/19.12.2003 regarding the approval of applications for evaluation in emergency regime |
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- DECISION No. 43/19.12.2003 regarding the extension of PIC/S |
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- DECISION No. 42/19.12.2003 regarding the approval of the switch of classification for supply of certain medicinal products |
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- DECISION No. 41/19.12.2003 regarding the approval of the application norms of the NMA Scientific Council Decision No. 3/2001, concerning data exclusivity, modified by the NMA Scientific Council Decision No.12/2002 - Repealed by Decision No. 29/01.10.2004 |
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- DECISION No. 40/19.12.2003 regarding the approval of the Standard Report for quality evaluation of biological products |
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- DECISION No. 39/19.12.2003 regarding the Pharmacovigilance Inspection at the Marketing authorisation Holder - Approved by Minister of Health Order No. 179/21.02.2004, published in the Official Gazette of Romania, Part 1, No. 198/05.03.2004 |
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- DECISION No. 38/24.10.2003 regarding the approval of the applications for evaluation in emergency regime |
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- DECISION No. 37/24.10.2003 regarding the approval of the Ethics and Deontology Code for the personnel with inspection attributions in the National Medicines Agency - Approved by Minister of Health Order No. 160/17.02.2004, published in the Official Gazette of Romania, Part 1, No. 153/20.02.2004 |
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- DECISION No. 36/24.10.2003 regarding the approval of the Statute of inspectors from the National Medicines Agency - Approved by Minister of Health Order No. 1102/27.11.2003 |
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- DECISION No. 35/24.10.2003 regarding the approval of the Regulations on the functioning authorisation of manufacturing units for medicinal products for human use - Approved by Minister of Health Order No. 1153/11.12.2003 - Repealed by Decision No. 36/2006 |
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- DECISION No. 34/24.10.2003 regarding the approval of the criteria for approval of the applications for evaluation in emergency regime |
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- DECISION No. 33/ 24.10.2003 regarding the approval of the Regulations on orphan medicinal products - Approved by Minister of Health Order No. 1063/20.11.2003 |
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- DECISION No. 32/24.10.2003 regarding the approval of the Romanian Standard Terms for pharmaceutical forms, routes of administration and primary packaging, in accordance with the ones adopted by the European Pharmacopoeia, 4th edition and by European Council |
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- DECISION No. 31/24.10.2003 regarding the approval of the evaluation performed by the Commission for Coordination of Romanian Pharmacopoeia of the materials elaborated for publication as Supplements to Romanian Pharmacopoeia, X edition |
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- DECISION No. 30/24.10.2003 regarding the modality to solve the applications regarding changes of the design and imprinting of packaging as well as changes of the leaflet other than those due to variations type IA, IB and II - Approved by Minister of Health Order No. 1126/08.12.2003 - Repealed by Minister of Public Health Order No. 1205/2006 |
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- DECISION No. 29/24.10.2003 regarding the way of solving the applications on changes that represent line extensions for medicinal products for human use authorised in Romania by national procedure after 01.01.2001 - Approved by Minister of Health Order No. 90/02.02.2004, published in the Official Gazette of Romania, Part 1, No. 122/11.02.2004 - Repealed by Minister of Public Health Order No. 1204/2006 |
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- DECISION No. 28/24.10.2003 regarding the approval of the Guideline on dossier requirements for Type IA and IB notifications - Approved by Minister of Health Order No. 1127/08.12.2003 - Repealed by Decision No. 22/2006 |
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- DECISION No. 27/24.10.2003 regarding the approval of the Regulations on the evaluation procedure of variations to the terms of a Marketing authorisation for medicinal products for human use - Approved by Minister of Health Order No. 89/02.02.2004 - Repealed by Minister of Public Health Order No. 874/2006 |
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- DECISION No. 26/13.06.2003 regarding the approval of the change of the classification for supply of certain medicinal products - Approved by Minister of Health Order No. 959/15.10.2003 |
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- DECISION No. 25/13.06.2003 regarding the approval of the distinctive sign, that should be applied on secondary packaging of medicinal products, contraindicated to vehicle drivers - Approved by Minister of Health Order No. 759/13.08.2003 |
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- DECISION No. 24/13.06.2003 regarding the approval of the applications for evaluation in emergency regime |
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- DECISION No. 23/13.06.2003 regarding the adherence of the National Medicines Agency to the International Database of Medicines Inspectorates (IMID) |
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- DECISION No. 22/13.06.2003 regarding the approval of the model of Evaluation report for implementing the Good Practice Regulations for Medicines Control Laboratory - Repealed by Decision No. 24/22.05.2006 |
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- DECISION No. 21/13.06.2003 regarding the approval of the model for Standard Dossier of the Laboratory for Quality Control of Medicines (SDLQCM) - Approved by Minister of Health Order No. 1062/20.11.2003 - Repealed by Decision No. 18/2006 |
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- DECISION No. 20/13.06.2003 Regarding the approval of the Good Manufacturing Practice Regulations for medicinal products - Approved by Minister of Health Order No. 1058/19.11.2003 - Repealed by Decision No. 38/27.10.2006 |
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- DECISION No. 19/13.06.2003 regarding the approval of the models of Evaluation reports for implementing the Good Manufacturing Practice Regulations for non-sterile and sterile drugs - Repealed by Decision No. 24/22.05.2006 |
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- DECISION No. 18/13.06.2003 regarding establishing of the timeframe in which the National Medicines Agency solves the applications for marketing authorisation, which represent line extensions with a new strength for medicinal products authorised in Romania by national procedure after 01.01.2001 - Approved by Minister of Health Order No. 922/08.10.2003 - Repealed by Minister of Public Health Order No. 90/2004 |
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- DECISION No. 17/ 13.06.2003 regarding the approval of the Regulations on the granting of marketing authorisations by NMA for medicinal products for human use already authorised in the European Union Member States following the decentralised procedure - Approved by Minister of Health Order No. 181/21.02.2004, published in the Official Gazette of Romania, Part 1, No. 240/18.03.2004 - Repealed by Decision No. 5/27.01.2006 |
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- DECISION No. 16/13.06.2003 regarding the approval of changes to the Standard Report for quality evaluation approved by the National Medicines Agency Scientific Council Decision No. 29/2000 - Approved by Minister of Health Order No. 858/17.09.2003 |
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- DECISION No. 15/21.02.2003 regarding the approval by the National Medicines Agency Scientific Council of changes to Regulations which transpose European Directives following the observations made by the European Integration Ministry |
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- DECISION No. 14/21.02.2003 regarding the application accepted by the National Medicines Agency for medicinal products authorised in the European Union through Centralized Procedure |
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- DECISION No. 13/21.02.2003 regarding the establishment of the authorisation fee type for medicinal products for which the Marketing authorisation Holder is different from the manufacturer |
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- DECISION No. 12/21.02.2003 regarding the evaluation under emergency procedure of the authorisation application for medicinal products for human use |
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- DECISION No. 11/21.02.2003 regarding the approval of the “Guideline for pre-marketing authorisation inspections” |
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- DECISION No. 10/21.02.2003 regarding the inspection conducted before marketing authorisation |
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- DECISION No. 9/21.02.2003 regarding the establishment of the deadlines for acceptance of applications for authorisation/renewal/transfer approval or variations for medicinal products for human use from the Romanian manufacturers which do not hold Good Manufacturing Practice Certificate |
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- DECISION No. 8/21.02.2003 regarding the approval of the Regulations regarding classification for supply of medicinal products for human use - Approved by Minister of Health Order No. 679/16.07.2003 |
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- DECISION No. 7/17.01. 2003 regarding the change of the framing of certain pharmaceutical preparations from Separanda or Venena category, from the Romanian Pharmacopoeia, X th edition - Approved by Minister of Health Order No. 95/06.02.2003 |
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- DECISION No. 6/17.01.2003 regarding the election of the Vice-President of the National Medicines Agency Scientific Council - Repealed by Decision No. 4/02.06.2005 |
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- DECISION No. 5/17.01.2003 regarding the approval of the Regulations for organization and functioning of the National Medicines Agency Scientific Council |
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- DECISION No. 4/17.01.2003 regarding the approval of administrative procedure of updated authorisation documentation submitted by applicants for “old” medicinal products for completion of the authorisation documentation in order to comply with authorisation regulations in force, harmonised with European legislation |
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- DECISION No. 3/17.01.2003 regarding the approval of Regulations on package leaflet and labeling of medicinal products for human use - Approved by Minister of Health Order No. 263/25.03.2003 - Repealed by Law No. 95/2006 on healthcare reform, Title XVII - The Medicinal Product |
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- DECISION No. 2/17.01.2003 regarding the approval of Regulations on advertising of medicinal products for human use - Approved by Minister of Health Order No. 263/25.03.2003 - Repealed by Decision No. /2006 - Repealed by Law No. 95/2006 on healthcare reform, Title XVII - The Medicinal Product |
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- DECISION No. 1/17.01.2003 regarding the approval of Regulations on marketing authorisation and surveillance of medicinal products for human use - Approved by Minister of Health Order No. 263/25.03.2003 - Repealed by Law No. 95/2006 on healthcare reform, Title XVII - The Medicinal Product |
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- 2002 |
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- DECISION No. 1/11.02.2002 regarding the statute of solutions for peritoneal dialysis |
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- DECISION No. 2/14.02.2002 regarding the election of the President of the NMA Scientific Council and of the Secretariat of the NMA Scientific Council - Repealed by Decision No. 4/02.06.2005 |
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- DECISION No. 3/14.02.2002 regarding the mode of entering into force of the decisions of the Scientific Council for which the Minister of Health and Family requests information |
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- DECISION No. 4/14.02.2002 regarding the publishing of the NMA Scientific Council Decisions in the Informative Bulletin |
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- DECISION No. 5/14.02.2002 regarding the approval of the model of the Evaluation Report for implementing the good manufacturing practice regulations - Repealed by Decision No. 19/13.06.2003 |
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- DECISION No. 6/14.02.2002 regarding the extension of PIC/S - Completed by Decision No. 43/19.12.2003 |
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- DECISION No. 7/14.02.2002 regarding the exception from the laboratory control during authorisation procedure of some medicinal products manufactured in PIC/S member countries - Repealed by Decision No. 24/15.11.2002 |
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- DECISION No. 8/17.05.2002 regarding the approval of Guideline on the implementation of the WHO certification scheme on the quality of medicinal products moving in international commerce |
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- DECISION No. 9/17.05.2002 regarding the approval of the model of the application for marketing authorisation transfer |
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- DECISION No. 10 /17.05.2002 regarding the approval for issuing by the NMA of provisional marketing authorisation valid for 1 year for old original medicinal products submitted for authorisation/renewal and for which the submitted authorisation documentation was No.t fully in accordance with the NMA Scientific Council Decision No. 27/2000 on the Regulations regarding marketing authorisation and surveillance of medicinal products for human use and of the No.rms regarding the documentation required for marketing authorisation or renewal of marketing authorisation of medicinal products for human use |
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- DECISION No. 11/17.05.2002 regarding the change of the leaflet and summary of product characteristics for medicinal products containing NIMESULIDE |
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- DECISION No. 12/17.05.2002 regarding the amending of the Scientific Council of the NMA Decision No. 3/02.03.2001 regarding the approval of Regulations on data exclusivity for medicinal products for human use - Repealed by Decision No. 29/01.10.2004 |
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- DECISION No. 13/11.07.2002 regarding the advertising for medicinal products for human use - Repealed by Decision No. 2/17.01.2003 |
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- DECISION No. 15/11.07.2002 regarding the modification of the list of colouring matters that may be added for colouring medicinal products, approved by Scientific Council Decision No. 19/02.06.2000 - Repealed by Decision No. 19/2006 |
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- DECISION No. 16/27.09.2002 regarding the regulation of the quality of starting materials and immediate packaging used in the manufacturing of Romanian medicinal products - Completed by Decisions No. 4/27.02.2004 and 30/01.10.2004 |
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- DECISION No. 17/27.09.2002 regarding the updating of OTC products list and the establishment of the opportunity of their release through drug stores |
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- DECISION No. 18/27.09.2002 regarding the approval of the Guideline on the stability testing for type II variations to a Marketing authorisation |
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- DECISION No. 19/27.09.2002 regarding the approval of the Regulations on the changes which lead to the granting of a new Marketing authorisation - Repealed by Minister of Health Order No. 89/02.02.2004 |
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- DECISION No. 20/27.09.2002 regarding the approval of the Regulations on the evaluation procedure for type I variations applications to a Marketing authorisation - Repealed by Minister of Health Order No. 89/02.02.2004 |
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- DECISION No. . 21/27.09.2002 regarding the approval of the Regulations on the evaluation procedure for type II variations applications to a Marketing authorisation - Repealed by Minister of Health Order No. 89/02.02.2004 |
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- DECISION No. 22/27.09.2002 a authorisation of medicinal products for human use on the basis of co-operations which lead to the granting of a new Marketing authorisation |
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- DECISION No. 23/27.09.2002 regarding the approval of the Guideline on the inspection of the physico-chemical laboratories for quality control |
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- DECISION No. 24/15.11.2002 regarding the laboratory control within marketing authorisation/renewal of marketing authorisation procedure |
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- DECISION No. 25/15.11.2002 regarding the quality control of medicinal products and starting materials - Repealed by Decision No. 37/10.12.2004 |
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- DECISION No. 26/15.11.2002 regarding the approval of Regulations on the notification procedure for changes to Marketing authorisation - Repealed by Minister of Health Order No. 89/02.02.2004 |
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- DECISION No. 27/15.11.2002 regarding the update of Good Clinical Practice Regulations and norms regarding Regulations for Good Clinical Practice in conducting of clinical trial of medicinal products, approved through the Scientific Council Decision of the National Medicine Agency No. 18/1999 in order to harmonise them with the Directive 2001/20 of the European Parliament and Council from April 4th, 2001 regarding harmonization of legislation, regulations and administrative measures of the Member States regarding implementation of Good Clinical Practice Regulations for conducting clinical trials for medicinal products for human use - Repealed by Decision No. 10/25.06.2004 |
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- DECISION No. 28/15.11.2002 regarding the publishing of medicinal products withdrawn as a consequence of quality non-conformities |
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- 2001 |
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- DECISION No. 1/02.03.2001 regarding the approval of the Guideline on qualification and validation of facilities, equipment and/or manufacturing processes - Repealed by Decision No. 20/13.06.2003 |
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- DECISION No. 2/02.03.2001 regarding the approval of general monographs “Friability of uncoated tablets", "Resistance to crushing of tablets”, “Density of solids”, “Apparent volume” and “Herbal drugs” from the III rd edition 1997 of the European Pharmacopoeia and the 2001 Addendum, as supplements to the Xth edition of the Romanian Pharmacopoeia |
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- DECISION No. 3/02.03.2001 regarding the approval of Regulations on data exclusivity for medicinal products for human use - Modified by Decision No. 12/17.05.2002 |
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- DECISION No. 4/02.03.2001 regarding the approval of the measures which should be taken on the distribution in Romania of medicinal products for human use containing cisapride |
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- DECISION No. 5/02.03.2001 regarding the approval of Regulations on authorisation of medicinal products having well-established medicinal use |
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- DECISION No. 6/02.03.2001 regarding the authorisation of food supplements by the National Medicines Agency |
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- DECISION No. 7/04.05.2001 regarding the approval of updated procedure for granting the Marketing authorisation by central and eastern European countries for medicinal products for human use authorised in the European Union following the centralized procedure and the variations and renewals of such Marketing authorisations |
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- DECISION No. 8/04.05.2001 regarding the approval of procedure on the granting of Marketing Authorisations by CADREAC Competent Authorities for medicinal products for human use already authorised in European Union Member States following the decentralised procedure - Repealed by Decision No. 17/13.06.2003 and Minister of Health Order No. 181/21.02.2004 |
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- DECISION No. 9/04.05.2001 regarding the common CADREAC procedure for retrospective inclusion of centrally authorised medicinal products for human use in the common CADREAC simplified system - Repealed by Decision No. 4/27.01.2006 |
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- DECISION No. 10/04.05.2001 regarding the approval of general monographs "Uniformity of mass of single-dose preparations", "Uniformity of content of single-dose preparations", "Pharmaceutical sieves", "Granulometric clasification of powders by sieving" and " Flowability of powders and granules" from the IIIrd edition 1997 of the European Pharmacopoeia and the 2001 Addendum, as supplements to the xth edition of Romanian Pharmacopoeia |
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- DECISION No. 12/04.05.2001 regarding the completion of list with International nonproprietary Names which requires bioequivalence studies, approved by Scientific Council Decision No. 5/02.03.2000 - Repealed by Decision No. 16/25.06.2004 |
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- DECISION No. 13/04.05.2001 regarding the modification of the Import Technical Sheets validity, approved by Scientific Council Decision No. 11/17.06.1999 - Repealed by Decision No. 25/25.11.2002 |
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- DECISION No. 14/23.06.2001 regarding the approval of the Guideline on herbal medicinal products with traditional therapeutic use |
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- DECISION No. 15/23.06.2001 regarding the approval of general monographs "Uniformity of mass of delivered doses from multidose containers", "Test for deliverable mass or volume of liquid and semi-solid preparations", "Extractable volume", "Pycnometric density of solids", " Softening time determination of lipophilic suppositories" and of the individual monograph "Purified water" from the European Pharmacopoeia IIIrd edition 1997 and the 2001 Addendum, as supplements to the Romanian Pharmacopoeia x th edition |
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- DECISION No. 16/23.06.2001 regarding the transfer of Marketing authorisations of Romanian manufacturers which will nothave the Good Manufacturing Practices Regulations implemented by 31.12.2001 |
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- DECISION No. 17/14.08.2001 regarding the possibility of granting derogation for certain products |
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- DECISION No. 18/14.08.2001 regarding the approval of good manufacturing practice regulations for active substances drawn up by the ICH Q7a and adopted by the European Community and PIC/S - Repealed by Decision No. 20/13.06.2003 |
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- DECISION No. 19/05.10.2001 regarding the approval of changes to "Good manufacturing practices regulations for medicinal products" - Repealed by Decision No. 20/13.06.2003 |
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- DECISION No. 20/05.10.2001 regarding the approval of the Romanian version of "Good manufacturing practice regulations for active pharmaceutical substances" drawn up by the ICH and approved by the European Community and PIC/S - Repealed by Decision No. 20/13.06.2003 |
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- DECISION No. 21/05.10.2001 regarding the approval of individual monograph “Water for injectable preparations" and general monographs "Microbiological quality of pharmaceutical preparations", Clarity and opalescence degrees of liquids", "Coloration degrees of liquids" and "Resistance to rupture of suppositories and pessaries" from the European Pharmacopoeia III rd edition 1997 and the 2001 Addendum, as supplements to the Romanian Pharmacopoeia x th edition |
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- DECISION No. 22/05.10.2001 regarding the approval of Regulations on acceptance of the documentation for marketing authorisation in the "Common Technical Document" format too, adopted by ICH and accepted in the European Union |
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- DECISION No. 23/05.10.2001 regarding the approval of Regulations on the updating of the information for medicinal products authorised for marketing or submitted for authorisation prior the entering into force of the decision No. 10/02.03.2000 of the NMA Scientific Council regarding the measures for minimizing the risk of transmitting animal spongiform encephalopathy via medicinal products |
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- DECISION No. 24/14.12.2001 regarding the approval of general monographs "Disintegration of tablets and capsules", "Disintegration of suppositories and pessaries", "Contamination with particles: visible particles", "Particulate contamination: microscopic method", "Llimit test of particle size by microscopy", "Measurement of consistency by penetrometry", " Relationship between reaction of solution, approximate pH and color of certain indicators" from the European Pharmacopoeia III rd edition 1997 and the 2001 Addendum, for their officializing in the 2001 supplement of the Romanian Pharmacopoeia x th edition |
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- DECISION No. 25/14.12.2001 regarding the approval of changes of the general chapter "Minimizing the risk of transmitting infectious agents responsible for animal spongiform encephalopathy via medicinal products" in the 2001 Addendum of the European Pharmacopoeia III rd edition 1997, for their officializing in the 2001 supplement of the Romanian Pharmacopoeia xth edition |
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- DECISION No. 26/14.12.2001 regarding the approval of updated model of the Inspection Report for Good Manufacturing Practice - Repealed by Decision No. 28/01.10.2004 |
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- DECISION No. 27/14.12.2001 regarding the approval of the model of the Evaluation Report for implementing the good manufacturing practice regulations - Repealed by Decision No. 5/14.02.2002 |
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- 2000 |
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- DECISION No. 1/02.03.2000 regarding the approval of the Guideline on non-clinical (preclinical) safety studies required with the view of performing clinical trials for medicinal products evaluation in Romania - Repealed by Decision No. 13/25.06.2004 |
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- DECISION No. 2/02.03.2000 regarding the approval of the Guideline on the non-clinical (preclinical) evaluation of anticancer medicinal products with a view to be granted with marketing authorisation |
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- DECISION No. 3/02.03.2000 regarding the approval of the Guideline on evaluation of anticancer medicinal products in man |
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- DECISION No. 4/02.03.2000 regarding the approval of the Guideline on requested documentation to be attached to the notification/approval application for type I variations to the marketing authorisation of medicinal products - Repealed by Decision No. 20/23.09.2002 |
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- DECISION No. 5/02.03.2000 regarding the approval of the list of International Non-Proprietary Names that require bioequivalence studies, in completion of the Scientific Council Decision No. 14/14.10.1999 - Completed by Decision No. 12/04.05.2001 - Repealed by Decision No. 16/25.06.2004 |
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- DECISION No. 6/02.03.2000 regarding the approval of the Regulations on advertising of medicinal products for human use - Repealed by Decision No. 2/17.01.2003 and Minister of Health and Family Order No. 263/2003 |
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- DECISION No. 7/02.03.2000 regarding the package of medicinal products |
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- DECISION No. 8/02.03.2000 regarding the extension of PIC/PICS Convention - Completed by Decision No. 6/14.01.2002 |
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- DECISION No. 9/02.03.2000 regarding the withdrawal of marketing authorisation for certain Romanian medicinal products |
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- DECISION No. 10/02.03.2000 regarding the measures for minimizing the risk of transmitting animal spongiform encephalopathy agents via medicinal products - Repealed by Decision No. 25/14.12.2001 |
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- DECISION No. 11/24.03.2000 regarding the approval of the Regulations on marketing authorisation of biological products for human use - Repealed by Decision No. 27/06.10.2000 |
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- DECISION No. 12/24.03.2000 regarding the approval of the Regulations on pharmacovigilance activity and the reporting form for adverse reactions to medicinal - Repealed by Decision No. 33/10.12.2004 |
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- DECISION No. 13/24.03.2000 regarding the approval of the Guideline on the declaration of storage conditions for medicinal products in the leaflet and the label of the product |
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- DECISION No. 14/24.03.2000 regarding the approval of the norms on Site Master File elaboration - Repealed by Decision No. 36/2006 |
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- DECISION No. 15/24.03.2000 regarding the inspections for evaluation of implementation stage of Good Manufacturing Practice into manufacturing units of Romania - Repealed by Emergency Ordinance No. 152/1999 approved with modifications and completed by Law No. 123/2004 |
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- DECISION No. 16/24.03.2000 regarding the Regulation on marketing authorisation of medicinal products for human use originating from countries which are not PIC/S members |
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- DECISION No. 17/24.03.2000 regarding the summary of product characteristics for medicinal products containing the same active substance |
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- DECISION No. 18/02.06.2000 regarding the approval of General Chapter “Materials used in the manufacturing of recipients for pharmaceutical use” of the IIIrd edition of European Pharmacopoeia, Addendum 2000, as a supplement of the Xth edition of Romanian Pharmacopoeia |
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- DECISION No. 19/02.06.2000 regarding the approval of Regulations on colouring matters which may be added for colouring medicinal products - Repealed by Decision No. 15/11.07.2002 - Repealed by Decision No. 19/2006 |
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- DECISION No. 20/02.06.2000 regarding the approval of the Guideline on stability testing of new medicinal substances and finished products that contain them |
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- DECISION No. 21/02.06.2000 regarding the approval of the Guideline on stability testing of existing medicinal substances and finished products that contain them |
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- DECISION No. 22/02.06.2000 regarding the approval of the Guideline on photostability testing of new medicinal substances and finished products that contain them |
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- DECISION No. 23/02.06.2000 regarding the approval of the Guideline on the procedure to be followed by Competent Authorities when undertaking the pharmacovigilance activities - Repealed by Decision No. 34/10.12.2004 |
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- DECISION No. 24/02.06.2000 regarding the approval of the Guideline on the procedure to be followed by the Marketing authorisation Holder when undertaking pharmacovigilance activities - Repealed by Decision No. 35/10.12.2004 |
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- DECISION No. 25/02.06.2000 regarding the approval of the Guideline on clinical safety data management: Definitions and standards for urgent report |
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- DECISION No. 26/02.06.2000 regarding the approval of the granting of Provisional Marketing authorisations valid for 1 year, by the National Medicines Agency, for the medicinal products submitted for reauthorisation before 1.01.2000 |
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- DECISION No. 27/06.10.2000 regarding the approval of Regulations on Marketing authorisation and surveillance of medicinal products for human use and of the norms on the documentation required for Marketing authorisation or renewal of Marketing authorisation of medicinal products for human use - Repealed by Decision No. 1/17.01.2003 and Minister of Health and Family Order No. 263/2003 |
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- DECISION No. 28/06.10.2000 regarding the approval of the Guideline on single dose toxicity studies |
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- DECISION No. 29/06.10.2000 regarding the approval of the Standard report for quality evaluation - Modified by Decision No. 16/13.06.2003 and Minister of Health Order No. 858/2003 |
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- DECISION No. 30/06.10.2000 regarding the approval as an addendum to the X th edition of Romanian Pharmacopoeia of the general chapters “Containers for pharmaceutical use” and “Reagents and standard solutions” necessary for the control of “Materials for manufacturing the containers for pharmaceutical use” and “Containers for pharmaceutical use” from the III rd edition of European Pharmacopoeia and Addendum on 2000 |
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- DECISION No. 31/06.10.2000 regarding the harmonization of the national legislation in the field of GMP with the communitary one (CD 75/319/CEE, Art. 21-25). Amendment regarding the definition of qualified person as key responsible person to release the manufacturing batches, mentioned in the National Medicines Agency regulations as authorised person - Repealed by Decision No. 20/13.06.2003 and Emergency Ordinance No. 152/1999 approved with modifications and completed by Law No. 123/2004 |
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- DECISION No. 32/06.10.2000 regarding the approval of the minimum admitted size for a manufacturing batch of a medicinal product, imposed by the capacity of manufacturing equipment |
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- DECISION No. 33/06.10.2000 regarding the approval of the GMP inspection sheet which will be the basis for concluding the GMP inspection report |
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- DECISION No. 34/15.12.2000 regarding the authorisation of starting materials for pharmaceutical use |
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- DECISION No. 35/15.12.2000 regarding the approval of the Standard report for quality evaluation of starting materials for pharmaceutical use |
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- DECISION No. 36/15.12.2000 regarding the approval of Regulations regarding the evaluation of the requests for transfer of Marketing authorisation - Completed by Decision No. 9/17.05.2002 |
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- DECISION No. 37/15.12.2000 regarding the approval of documents for release of certificates of suitability for each batch of biological product for human use |
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- DECISION No. 38/15.12.2000 regarding the quality of immediate packaging used by the manufacturers at conditioning of medicinal products |
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- SCD Archives 1999 - All Scientific Council Decisions since 1999 repealed through later regulatory acts |
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