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| - Directives and Regulations | |||
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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- repealed document |
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- Minister of Health Orders |
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2009 |
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- Order No. 716/11.06.2009 on approval of tariffs and amount of marketing authorisation maintenance fee required by the National Medicines Agency |
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- Order No. 312/16 March 2009 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, published in the Official Gazette of Romania, Part I, No. 198 of 30/03/2009 |
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- Order No. 173/17 February 2009 on repeal of Order of the minister of health No. 1.182/2004 on approval of List of International Non-Proprietary Names requiring bioequivalence studies, published in the Official Gazette of Romania, Part I, No. 107 of 23/02/2009 |
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- Order No. 172/17.02.2009 on approval of tariffs for certain activities performed by the Pharmaceutical Inspection Department of the National Medicines Agency, published in the Official Gazette of Romania, Part I, No. 113/25.02.2009 |
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2008 |
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- Order No. 1964/02.12.2008 on approval of the Norms on the set up, organisation and functioning of wholesale distribution units of medicinal products for human use - Published in the Official Gazette of Romania, Part I, No. 855/19.12.2008 |
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- Order No. 1963/02.12.2008 on approval of the Guideline on Good Distribution Practice of Wholesale Medicinal Products - Published in the Official Gazette of Romania, Part I, No. 865/22.12.2008 |
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- Order No. 1962/02.12.2008 on approval of the procedure for the parallel import authorisation for medicinal products for human use |
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- Order No. 1961/02.12.2008 on amendment of Minister of Public Health Order No. 1038/2008 on approval of tariffs and amount of marketing authorisation maintenance fee required by the National Medicines Agency. |
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- Order No. 1733/14.10.2008 on repeal of Minister of Public Health Order No. 1452/2005 on approval of the Guideline on the trade name of medicinal products for human use - Published in the Official Gazette of Romania, Part I, No. 717/22.10.2008 |
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- Order No. 1732/14.10.2008 on approval of the Norms concerning handling of modifications to the marketing authorisation during marketing authorisation renewal procedure |
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- Order No. 1038/26.05.2008 on approval of tariffs and amount of marketing authorisation maintenance fee required by the National Medicines Agency, modified through Minister of Public Health Order No. 1961/2008 – repealed through Minister of Minister of Health Order No. 716/11.06.2009Order No. 1038/26.05.2008 on approval of tariffs and marketing authorisation maintenance fees required by the National Medicines Agency- Repealed by Minister of Public Health Order No. 716/11.06.2009 |
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- Order No. 297/11.03.2008 on approval of the procedure on simplified authorisation for certain homeopathic medicinal products |
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2007 |
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- Order No. 1335/30.07.2007 on approval of tariffs for activities carried out by the Evaluation – authorisation department of the National Medicines Agency for medicinal products authorised through mutual recognition procedure or decentralised procedure - Repealed by Minister of Public Health Order No. 1038/26.05.2008 |
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- Order No. 816/10.05.2007 on approval of simplified authorisation procedure for certain homeopathic medicinal products |
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- Order No. 815/10.05.2007 on modification of Minister of Public Health Order No. 918/2006 on approval of regulations concerning the manufacturing/importation authorisation of the manufacturers and importers of medicinal products for human use, including investigational medicinal products, and of starting materials used in the manufacturing process of medicinal products for human use, including investigational medicinal products |
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2006 |
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- Order No. 1810/29.12.2006 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 |
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- Order No. 1809/29.12.2006 on approval of Norms concerning the approval of export declaration for medicinal products for human use |
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- Order No. 1807/29.12.2006 on approval of Norms on the enforcement of certain provisions of Regulation No. 141/2000/EC on orphan medicinal products |
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- Order No. 1779/28.12.2006 on approval of tariffs for performances of the Evaluation-Authorisation Department for products authorised through mutual recognition procedure or decentralised procedure and grant of parallel import authorisation - Repealed by Minister of Public Health Order No. 1038/26.05.2008 |
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- Order No. 1247/2006 on approval of the tariff for grant by the National Medicines Agency of the qualified person certificate |
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- Order No. 1206/02.10.2006 on approval of Norms relating to examination of an application for the transfer of a marketing authorisation, published in the Official Gazette of Romania, Part I, No. 836/11.10.2006 |
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- Order No. 1205/02.10.2006 for approval of the 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 Summary of Product Characteristics, other than caused by Type IA, IB and II variations, published in the Official Gazette of Romania, Part I, No. 836/11.10.2006 |
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- Order No. 1204/2006 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 |
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- Order No. 1203/02.10.2006 on cancellation manner by the National Medicines Agency of marketing authorisation applications for medicinal products for human use, published in the Official Gazette of Romania, Part I, No. 832/10.10.2006 |
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- Order No. 1202/02.10.2006 for approval of Guideline on excipients which must be specified in the label and package leaflet of medicinal products for human use, published in the Official Gazette of Romania, Part I, No. 840/12.10.2006 |
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- Order No. 1201/2006 for approval of Guideline on the risk minimisation of animal spongiform encephalopathy agents transmission through medicinal products for human use, published in the OfficialMonitor of Romania, Part 1, No. 835/10.02.2006 |
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- Order No. 1200/02.10.2006 for approval of Regulations regarding the National Medicines Agency attestation of the qualified person of the Manufacturing/Importation Marketing Authorisation Holder, published in the Official Gazette of Romania, Part I, No. 832/10.10.2006 |
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- Order No. 1199/02.10.2006 on withdrawal/suspension by the National Medicines Agency of certain marketing authorisations, prior to Accession, published in the Official Gazette of Romania, Part I, No. 832/10.10.2006 |
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- Order No. 918/27.07.2006 on approval of Regulations on manufacturing/importation authorisation of manufacturers and importers of medicinal products for human use, including investigational medicinal products, and of starting materials used in the manufacturing of medicinal products for human use, including investigational medicinal products |
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- Order No. 906/25.07.2006 on approval of the Analytical, pharmacotoxicological and clinical norms and protocols in respect of the testing of medicinal products |
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- Order No. 905/25.07.2006 on approval of the 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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- Order No. 904/25.07.2006 on approval of rules relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use |
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- Order No. 903/25.07.2006 on approval of the 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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- Order No. 895/20.07.2006 on approval of Regulations regarding marketing authorisation and supervision of medicinal products for human use |
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- Order No. 894/2006 on approval of Regulations regarding export of medicinal products for human use |
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- Order No. 891/2006 on approval of the Suspect Adverse Reaction Report Form |
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- Order No. 876/2006 on approval of tariffs due for certain activities carried out by the National Medicines Agency - Repealed by Minister of Public Health Order No. 1038/26.05.2008 |
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- Order No. 875/2006 on approval of Norms relating to the colouring matters which may be added to medicinal products for human use |
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- Order No. 874/2006 on approval of Norms of the National Medicines Agency administrative procedure for handling of variations |
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- Order No. 873/2006 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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- Order No. 872/2006 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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- Order No. 751/2006 on repeal of Minister of Public Health Order No. 1.180/2004 on approval of 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 and of Minister of Public Health Order No. 1.181/2004 on approval of 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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- Order No. 750/2006 on approval and publication of the 2006 Supplement of the Romanian Pharmacopoeia, the 10th edition |
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- Order No. 400/12.04.2006 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 |
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- Order No. 399/12.04.2006 on approval of European models of package leaflet, summary of product characteristics and label information for medicinal products authorised for marketing in Romania |
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- Order No. 398/12.04.2006 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 |
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- Order No. 384/10.04.2006 on approval of revocation/suspension by the National Medicines Agency of certain marketing authorisations before Romania’s Accession to the European Union |
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- Order No. 92/08.02.2006 on change and completion of Order of the Ministry of Health No. 1451/2005 regarding approval of the Guideline on update and change of documentation for the authorisation of medicinal products for human use authorised in Romania in view of compliance with European Union requirements |
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- Order No. 90/08.02.2006 on approval of the Index of Medicinal Products for Human Use, 2006 |
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2005 |
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- Order No. 1454/28.12.2005 on approval of certain tariffs for services performed by the National Medicines Agency |
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- Order No. 1453/28.12.2005 on approval of the Guidebook regarding "umbrella" brands |
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- Order No. 1452/28.12.2005 on approval of the Guidebook regarding the trade name of medicinal products for human use |
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- Order No. 411/19.04.2005 on approval of Regulations on pharmacovigilance activities |
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- Order No. 410/19.04.2005 on approval of the Guideline on clinical safety data management/the Periodic Safety Update Reports for marketed medicinal products |
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- Order No. 409/19.04.2005 regarding approval of the Guideline on clinical investigation of medicinal products in the paediatric population |
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- Order No. 408/19.04.2005 on approval of the Guideline on procedure to be pursued by competent authorities in carrying out pharmacovigilance activities |
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- Order No. 407/19.04.2005 concerning approval of tariffs and emergency tariffs for activities carried out by the National Medicines Agency - Repealed by Minister of Public Health Order No. 1038/26.05.2008 |
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- Order No. 406/19.04.2005 on approval of the Guideline on procedure to be pursued by marketing authorisation holders in carrying out pharmacovigilance activities |
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- Order No. 282/30.03.2005 concerning approval of Norms for the application of provisions of Minister of Health Order No. 1.127/2003 on approval of The Guideline related to content of Type IA and IB notification dossiers - Repealed by Minister of Public Health Order No. 874/2006 |
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- Order No. 281/30.03.2005 on approval of Norms regarding quality of raw materials used for manufacturing of Romanian medicinal products for human use |
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- Order No. 280/30.03.2005 on approval of control of medicinal product quality and imported raw materials |
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- Order No. 279/30.03.2005 on approval of implementation of changes to marketing authorisations approved by the National Medicines Agency |
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2004 |
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- Order No. 1444/05.11.2004 regarding approval of Rules related to quality of imported raw materials used for the manufacture of Romanian medicinal products for human use - published in the Official Gazette of Romania, Part 1, No. 1077/19.11.2004 - Repealed by Minister of Public Health Order No. 281/30.03.2005 |
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- Order No. 1443/05.11.2004 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 - published in the Official Gazette of Romania, Part 1, No. 1077/19.11.2004 - Repealed by Minister of Public Health Order No. 281/30.03.2005 |
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- Order No. 1442/05.11.2004 regarding approval of Guidelines for classification of deficiencies observed during Good Manufacturing Practice inspections - published in the Official Gazette of Romania, Part 1, No. 1116/27.11.2004 |
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- Order No. 1441/05.11.2004 regarding approval of Guidelines for carrying out Good Manufacturing Practice inspections - published in the Official Gazette of Romania, Part 1, No. 1145/03.12.2004 |
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- Order No. 1632/13.12.2004 regarding approval of Guidelines on general considerations for clinical trials - published in the Official Gazette of Romania, Part 1, No. 79/24.01.2005 |
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- Order No. 1631/13.12.2004 regarding approval of Guidelines on the trial master file and archiving - published in the Official Gazette of Romania, Part 1, No. 79/24.01.2005 |
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- Order No. 1630/13.12.2004 regarding aproval of the Guidelines on the qualification of inspectors who should verify compliance in clinical trials with the provisions of Good Clinical Practice Rules - published in the Official Gazette of Romania, Part 1, No. 79/24.01.2005 |
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- Order No. 1629/13.12.2004 regarding approval of Guidelines on inspection procedures for the verification of Good Clinical Practice compliance - published in the Official Gazette of Romania, Part 1, No. 79/24.01.2005 |
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- Order No. 1628/13.12.2004 regarding approval of Guidelines on the collection, verification and presentation of adverse reaction reports arising from clinical trials on medicinal products for human use - published in the Official Gazette of Romania, Part 1, No. 79/24.01.2005 |
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- Order No. 1300/14.10.2004 regarding approval of Guidance on application form and documentation to be submitted in application for Ethics Committee opinion on clinical trial on medicinal products for human use in Romania - published in the Official Gazette of Romania, Part 1, No. 70/20.01.2005 |
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- Order No. 1236/04.10.2004 regarding approval of Good Clinical Practice Rules in clinical trials - published in the Official Gazette of Romania, Part 1, No. 1132/30.11.2004 |
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- Order No. 1224/30.09.2004 for the approval of the Guidance on non-clinical safety studies necessary for the conduct of clinical trials for the evaluation of pharmaceuticals |
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- Order No. 1182/20.09.2004 for the approval of the list of International Non-proprietary Names necessitating bioequivalence studies |
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- Order No. 1181/20.09.2004 for the approval of 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 - Repealed by Minister of Public Health Order No. 715/23.06.2005 |
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- Order No. 1180/20.09.2004 for the approval of 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 - Repealed by Minister of Public Health Order No. 751/23.06.2005 |
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- Order No. 1179/20.09.2004 for the approval of regulations for NMA authorisation of clinical studies/NMA notification for non – interventional trials performed with medicinal products for human use in Romania - published in the Official Gazette of Romania, Part 1, No. 1042/11.11.2004 |
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- Order No. 1178/20.09.2004 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 - Repealed by Minister of Public Health Order No. 872/2006 |
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- Order No. 1177/20.09.2004 for the approval of the Guidance on the investigation of bioavailability and bioequivalence |
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- Order No. 1117/08.09.2004 for the approval of the Guidance for the request for authorisation of a clinical trial 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 |
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- Order No. 1022/17.08.2004 regarding the approval of the tariff value for the control activity, specific activity in vitro (polio viral titre), carried out by the Biological Products Evaluation and Control Department of the National Medicines Agency - Repealed by Minister of Public Health Order No. 407/19.04.2005 |
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- Order No. 615/21.05.2004 for the approval of the Regulations regarding the implementation of Good Clinical Practice in the conduct of clinical trials on medicinal products for human use - Repealed by Minister of Public Health Order No. 904/2006 |
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- Order No. 614/21.05.2004 regarding the approval and publishing of the Supplement 2004 of the Romanian Pharmacopoeia, the 10th edition |
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- Order No. 429/16.04.2004 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 the marketing authorisation is requested after the original medicinal product - Repealed by Minister of Public Health Order No. 1180/20.09.2004 |
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- Order No. 428/16.04.2004 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 - Repealed by Minister of Public Health Order No. 1444/05.11.2004 |
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- Order No. 427/16.04.2004 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 the marketing authorisation is requested after the original medicinal product - Repealed by Minister of Public Health Order No. 1181/20.09.2004 |
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- Order No. 294/19.03.2004 for the approval of the Declaration of Interests Form of the NMA Scientific Council members |
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- Order No. 293/19.03.2004 for the approval of the Declaration of Interests Form of the NMA Administrative Council members |
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- Order No. 181/21.02.2004 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 |
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- Order No. 180/2004 regarding the approval of the Index of medicinal products for human use for the year 2004 |
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- Order No. 179/21.02.2004 regarding the Pharmacovigilance Inspection at the Marketing authorisation Holder |
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- Order No. 160/17.02.2004 for the approval of the Ethics and Deontology Code for the personnel with inspection attributions in the National Medicines Agency |
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- Order No. 90/02.02.2004 for the approval of 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 - Repealed by Minister of Public Health Order No. 1204/2006 |
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- Order No. 89/2004 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 - Repealed by Minister of Public Health Order No. 874/2006 |
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2003 |
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- Order No.1153/11.12.2003 regarding the approval of the Regulations regarding the functioning authorisation of manufacturing units for medicinal products for human use - Repealed by Minister of Public Health Order No. 918/2006 |
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- Order No. 1127/2003 regarding the approval of the Guideline on dossier requirements for Type IA and IB notifications - Repealed by Minister of Public Health Order No. 874/2006 |
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- Order No. 1126/08.12.2003 regarding the approval of 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 - Repealed by Minister of Public Health Order No. 1205/2006 |
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- Order No. 1102/27.11.2003 regarding the approval of the Statute of the personnel with inspectors attributions from the National Medicines Agency |
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- Order No. 1076/24.11.2003 regarding the approval of the tariffs for activities performed by Pharmaceutical Inspection Department of the National Medicines Agency - Repealed by Minister of Public Health Order No. 407/19.04.2005 |
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- Order No. 1063/20.11.2003 regarding the approval of the Norms on the establishment of the criteria for designation of a medicinal product as an orphan medicinal product and the mode of its marketing authorisation |
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- Order No. 1062/20.11.2003 regarding the approval of the model for Standard Dossier of the Laboratory for Quality Control of Medicines (SDLQCM) - Repealed by Minister of Public Health Order No. 873/2006 |
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- Order No. 1058/2003 regarding the approval of the Good Manufacturing Practice Regulations for medicinal products |
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- Order No. 959/15.10.2003 regarding the approval of the classification for supply of certain medicinal products |
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- Order No. 922/08.10.2003 regarding the approval 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 - Repealed by Minister of Public Health Order No. 90/2004 |
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- Order No. 858/17.09.2003 regarding the approval of the model for Standard Report for quality evaluation of medicinal products |
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- Order No. 759/13.08.2003 regarding the change and completion of the Order of the Minister of Health and Family No. 87/2003 for approval of the medical diseases list incompatible with the quality of driver of vehicles or trams and of the list of substances with psychotropic effect contraindicated to drivers of vehicle and trams (narcotic products or substances or medicinal products with similar effect) |
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- Order No. 679/2003 for the approval of the Regulations regarding classification for supply of medicinal products for human use |
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- Order No. 267/2003 regarding approval of the tariffs and emergency tariffs for activities performed by the National Medicines Agency and of fee due for maintaining the Marketing authorisations - Repealed by Minister of Public Health Order No. 407/19.04.2005 |
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- Order No. 95/06.02.2003 for approval of the National Medicines Agency Scientific Council Decision No. 7 from the 17th of January 2003 regarding the change of the framing of certain pharmaceutical preparations from Separanda or Venena category, from the Romanian Pharmacopoeia, Xth edition |
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