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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- repealed document |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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- 2011 |
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- SCD 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 |
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- SCD 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 |
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- SCD 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 |
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- SCD No. 15/12.05.2011 on approval of the Communication Strategy of the National Agency for Medicines and Medical Devices 2011-2015 - published by 18.05.2011 |
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- SCD No. 14/12.05.2011 on approval of the Organisational Strategy of the National Agency for Medicines and Medical Devices 2011-2015 - published by 18.05.2011 |
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- SCD 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 by 21.04.2011 |
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- SCD 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 ways in line with European Pharmacopoeia approved terms – published by 21.04.2011 |
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- SCD 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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- SCD 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 cosmetic products - published by 07.06.2011 |
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- SCD 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 |
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- SCD 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 by 18.03.2011 |
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- SCD 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 by 18.03.2011, - modified by Decision No. 17/06.07.2011 |
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- SCD No. 4/22.02.2011 on approval of basic criteria for NAMMD inspectors’ acceptance of free samples 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, endorsed through Scientific Council Decision No. 17/27.11.2009 - published by 07.06.2011 |
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- SCD No. 2/22.02.2011 on posting on the NAMMD website of certain data in clinical trials authorised by the NAMMD – published by 18.03.2011 |
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- SCD No. 1/22.02.2011 on accreditation of national Good Clinical Practice training providers - published by 07.06.2011 |
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| - 2010 |
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- DECISION No.Decision No. 26/03.09.2010 on approval of the set up in Romania of a Medicinal Product National Traceability System |
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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 |
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- DECISION No.24/03.09.2010 regarding approval of the manner of resolution of applications for marketing authorisation/marketing authorisation renewal for medicinal products for human use submitted to the National Medicines Agency (NMA) prior to 2007 |
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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 |
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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 |
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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 marketing authorisation |
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- DECISION No.20/03.09.2010 on approval of the Guideline on evaluation on advertising in medicinal products for human use |
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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 |
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- DECISION No.18/03.09.2010 on approval of the Regulation on the organisation and operation of the Scientific Council of the National Agency for Medicines and Medical Devices |
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- DECISION No.17/03.09.2010 on the election of the President of the Scientific Council of the National Agency for Medicines and Medical Devices |
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- DECISION No.16/07.06.2010 on change of the implementation date of the Guideline on conduct of consultation with target patient groups in view of the Summary of Product Characteristics, approved through SCD No. 6/23.03.2010 |
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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 tesing of medicinal products, as regards advanced therapy medicinal products |
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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. 6/23.03.2010 on approval of the Guideline on consultations with target patient groups for the package leaflet |
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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 |
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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 |
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- DECISION No. 22/27.11.2009 on the approval of the Guideline on Summary of Product Characteristics (SPC) |
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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. 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. 10/27.11.2009 on the approval of the consolidated version of the Romanian Standard Terms referring 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. 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. 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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- 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. 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. 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. 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. 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. 21/22.05.2006 on approval of the Guideline for elaboration of 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. 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. 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. 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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- 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. 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. 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. 21/25.06.2004 regarding the approval of the applications for evaluation in emergency regime |
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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. 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. 3/27.02.2004 regarding the marketing authorisation of Romanian medicinal products necessitating bioequivalence studies |
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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. 40/19.12.2003 regarding the approval of the Standard Report for quality evaluation of biological products |
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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. 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. 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. 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. 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. 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. 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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- 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. 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. 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. 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. 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. 28/15.11.2002 regarding the publishing of medicinal products withdrawn as a consequence of quality non-conformities |
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