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ORDERS OF THE MINISTER OF HEALTH

2020

ORDER no. 1418 of 7 August 2020 on amendment of the Annex to Order of the Minister of Health no. 487/2020 on approval of the protocol for treatment of the infection with the SARS-Cov-2 virus
Published in: the Official Gazette of Romania no. 719 of 10 August 2020
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ORDER no. 1353 of 30 July 2020 on amendment and supplementation of Order of the Minister of Health no. 861/2014 on approval of criteria and methodology for assessment of health technologies, of documentation to be submitted by applicants, methodological means used in the assessment for inclusion, extension of indications, non-inclusion into or exclusion from the List of International Non-proprietary Names of on-prescription medicinal products as provided to insurants, irrespective of personal contribution, in the frame of the health insurance system, as well as of International Non-proprietary Names of medicinal products provided in national health insurance programs, as well as the means for appeal thereof
Published in: the Official Gazette of Romania no. 687 of 31 July 2020
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ORDER no. 672 of 23 April 2020 on approval of the list of medical devices required in order to ensure the prevention and treatment of conditions associated with the SARS-CoV-2 infection, whose distribution is temporarily suspended, and of measures required to ensure medicinal products at high risk of discontinuation on the national market
Published in: The Official Gazette no. 332 of 23 April 2020
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Order no. 561 of 3 April 2020 on amendment and supplementation of Annex to Order of the Minister of Health no. 85/2013 on approval of the Rules for implementation of provisions of Article 703 (1) and (2) of Law 95/2006 on healthcare reform on medicinal products for special needs
Published in: The Official Gazette no. 286 of 6 April 2020
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Order no. 487 of 23 March 2020 on approval of the protocol for treatment of the infection with the SARS-Cov-2 virus
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2019

ORDER No. 522 of 4 April 2019 for amendment of Order of the Minister of Health no. 1.173/2010 on set up and operation of the group of experts responsible for technical standpoints on documents under EU debate, also ensuring representation in meetings of EU working entities
Published in: Official Journal of Romania No. 276 of 11 April 2019
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2018

Order no. 1473 of 22 November 2018 on setup of the framework for implementation of provisions of Commission Delegated Regulation (EU) 2016/161 of 2 October 2015 supplementing Directive 2001/83/EC of the European Parliament and of the Council by laying down detailed implementation rules for the features appearing on the packaging of medicinal products for human use
Published in: The Official Journal No. 1.031 of 5 December 2018
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2017

Order of the Minister of Health no. 272/2017 of 14 March 2017 on amendment and supplementation of Rules for implementation of provisions of articles 703 (1) and (2) of Law 95/2006 on healthcare reform on medicinal products for special needs, approved through Order of the Minister of Health no. 85/2013, published in the Official Gazette of Romania, Part I, no. 183 of 15 March 2017
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Order of the Minister of Health no. 269/2017 of 14 March 2017 on mandatory provision of medicinal product adequate and undisrupted stocks, published in the Official Gazette of Romania, No. 183 of 15 March 2017
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2016

Order of the Minister of Health no. 1345/2016 of 24 November 2016 on daily reporting of stocks and trade operations carried out with medicinal products for human use included in the National Catalogue of Prices for medicinal products authorised for marketing in Romania by medicinal product wholesalers, importers, authorised manufacturers and closed- and open-circuit pharmacies
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Order of the Minister of Health no. 1307 of 17 November 2016 on approval of the organisational structure of the National Agency for Medicines and Medical Devices
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Order of the Minister of Health no. 131 on approval of Rules on authorisation of human medicinal product wholesalers, Good Distribution Practice certification and registration of brokers of medicinal products for human use
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2015

Order no. 1295/2015 on manufacturing authorisation of manufacturers, importers of medicinal products for human use, investigational medicinal products included, of independent control sites and grant of Good Manufacturing Practice Certificates
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Order no. 874 of 10 July 2015 on approval of forms for declaration of sponsoring related to medical devices and healthcare materials
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ORDER No. 761/17. 06. 2015 for approval of the Guidelines on Good Distribution Practice of medicinal products for human use
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ORDER no. 387 of 31 March 2015 on amendment of Order of the Minster of Health no. 861/2014 for approval of criteria and methodology for assessment of health technologies, of documentation to be submitted by applicants, methodological means used in the assessment for inclusion, extension of indications, non-inclusion into or exclusion from the List of International Non-proprietary Names of on-prescription medicinal products as provided to insurants, irrespective of personal contribution, in the frame of the health insurance system, as well as of International Non-proprietary Names of medicinal products provided in national health insurance programmes, as well as the means for appeal thereof
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ORDER No. 355 of 24 March 2015 for supplementation of Order of the Minister of Health No. 888/2014 on approval of fees payable to the National Agency for Medicines and Medical Devices for services related to medicinal products for human use
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ORDER No. 194/23. 02. 2015 on Rules for assessment and approval of advertising of medicinal products for human use
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2014

ORDER no. 1575 of 22 December 2014 on amendment of Order of the Minister of Health no. 456/2013 on approval of the List of International Non-proprietary Names of medicinal products at high unavailability risk, as provided to insurants in the health insurance system and agreement on a measure to ensure their market availability in Romania
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ORDER no. 1018 of 3 September 2014 on approval of Conditions for authorisation of human medicinal products for compassionate use, in accordance with provisions of Article 83 of Regulation (EC) no. 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, as amended
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ORDER no. 888 of 25 July 2014 on approval of fees payable to the National Agency for Medicines and Medical Devices for services related to medicinal products for human use
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ORDER no. 861 of 23 July 2014 on approval of criteria and methodology for assessment of health technologies, of documentation to be submitted by applicants, methodological means used in the assessment for inclusion, extension of indications, non-inclusion into or exclusion from the List of International Non-proprietary Names of on-prescription medicinal products as provided to insurants, irrespective of personal contribution, in the frame of the health insurance system, as well as of International Non-proprietary Names of medicinal products provided in national health insurance programs, aswell as the means for appeal thereof (as amended).
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ORDER of the Minister of Health no. 860 of 22 July 2014 on approval of the organisational structure of the National Agency for Medicines and Medical Devices, published in: THE OFFICIAL GAZETTE of Romania, Part I, no. 560 of 29 July 2014
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Order no. 287 of 12 March 2014 on repeal of Order of the Minister of Health no. 912/2006 on approval of the Regulations for authorisation of medical facilities for conduct of clinical trials on medicinal products for human use, published in the OFFICIAL GAZETTE of Romania, Part I, no. 190 of 18 March 2014
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2013

Order no. 1359 of 13 November 2013 on amendment of Order of the Minister of Health No. 716/2009 on approval of the National Agency for Medicines and Medical Devices fees and fee for maintenance of marketing authorisation
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Order of the Minister of Health no. 502/11.04.2013 on approval of mandatory monthly reporting of placement on the market in Romania and of sales of medicinal products for human use, respectively, by authorised wholesale distributors/importers/manufacturers
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Order of the Minister of Health no. 456/02.04.2013 on approval of the List of International Non-proprietary Names of medicinal products at high unavailability risk, as provided to insurants in the health insurance system and agreement on a measure to secure their market availability in Romania
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Order of the Minister of Health no. 85/07.02.2013 on approval of the Norms for implementation of provisions of Article 699 (1) and (2) of Law No. 95/2006 on healthcare reform concerning medicinal products for special needs
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2012

Order of the Minister of Health no. 868/07.09.2012 on amendment of Order of the Minister of Health No. 716/2009 on approval of tariffs and amount of marketing authorisation maintenance fee required by the National Medicines Agency
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2011

Order of the Minister of Health no. 1252 of 12 August 2011 on amendment of the Norms concerning donations of medicinal products, medical supplies, medical devices, vaccines, sera and related supplies, approved through Minister of Health Order No. 1.032/2011
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Order of the Minister of Health no. 1032/14.06.2011 on approval of Norms concerning donations of medicinal products, medical supplies, medical devices, vaccines, sera and related supplies
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Order of the Minister of Health no. 29 of 14 January 2011 for supplementations 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 Minister of Health Order No. 312/2009
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2010

Order of the Minister of Health no. 1602 of 31 December 2010 on approval of the Norms on classification for release of medicinal products for human use
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Order of the Minister of Health no. 1483 of 9 December 2010 on approval of the Norms on the administrative procedure of the National Agency for Medicines and Medical Devices for handling of variations
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Order of the Minister of Health no. 1450/24 November 2010 on amendment of Annexes I � III to Order of the Minister of Health no. 399/2006 on approval of the 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 of the Minister of Health no. 1449 of 24 November 2010 on ammendment and supplementation of the Procedure for the grant of parallel import authorisations for medicinal products for human use, approved through Order of the Minister of Public Health no. 1.962/2008
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Order of the Minister of Health no. 1448 of 24 November 2010 on amendment of the Annex to the Minister of Public Health Order No. 895/2006 on approval of the Regulations regarding marketing authorisation and surveillance of medicinal products for human use
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Order of the Minister of Health no.1447 of 2010 on amendment of the Annex to Order of the Minister of Public Health no. 894/2006 on approval of Regulations regarding export of medicinal products for human use
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Order of the Minister of Health no. 1446/24 November 2010 on amendment of Annexes I-III to Order of the Minister of Health no. 400/2006 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 of the Minister of Health no. 1275/30.09.2010 on approval of the organisational structure of the National Agency for Medicines and Medical Devices
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Order of the Minister of Health no. 615/01.06.2010 on approval of the Analytical, pharmacotoxycological and clinical standards and protocols in respect of the testing of medicinal products, approved through Minister of Public Health Order No. 906/2006
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2009

Order of the Minister of Health no. 948/24.07.2009 on approval of the organisational structure of the National Medicines Agency
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Order of the Minister of Health 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 of the Minister of Health no. 504/24.04.2009 on approval of the structure of the Administrative Board of the National Medicines Agency
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Order of the Minister of Health no. 312/16.03.2009 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
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Order of the Minister of Health no. 173/17.02.2009 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.
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2008

Order of the Minister of Public Health 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 of the Minister of Public Health 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 of the Minister of Public Health no. 1962/02.12.2008 on approval of the procedure for the parallel import authorisation for medicinal products for human use, published in the Official Gazette of Romania, Part I, no. 867/22.12.2008 – Amended through Order of the Minister of Health no. 1449 of 24 November 2010, published in the Official Gazette of Romania, Part I, no. 836 of 14 December 2010
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Order of the Minister of Public Health 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, published in the Official Gazette of Romania, Part I, no. 836/11.12.2008
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Order of the Minister of Public Health no. 1733/14.10.2008 on repeal of Minister of Public Health Order No. 1.452/2005 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 of the Minister of Public Health 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 of the Minister of Public Health no. 1255/07.07.2008 on supplementation of Order of the Minister of Public Health no. 1.038/2008 on approval of tariffs and amount of marketing authorisation maintenance fee required by the National Medicines Agency
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Order of the Minister of Public Health no. 297/11.03.2008 on approval of the procedure on simplified authorisation for traditional herbal medicinal products
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Order of the Minister of Public Health no. 265/05.03.2008 on repeal of certain Orders of the Minister of Public Health
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2007

Order of the Minister of Public Health no. 816/10.05.2007 on approval of simplified authorisation procedure for certain homeopathic medicinal products
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Order of the Minister of Public Health no. 480/14.03.2007 on approval of the Index of Medicinal Products for Human Use, 2007
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2006

Order of the Minister of Public Health 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 of the Minister of Public Health 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 of the Minister of Public Health no. 1808/29.12.2006 on repeal of certain Orders of the Minister of Public Health
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Order of the Minister of Public Health 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 of the Minister of Public Health no. 1697/15.12.2006 on repeal of certain Orders of the Minister of Health
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Order of the Minister of Public Health no. 1206/02.10.2006 on approval of Norms relating to examination of an application for the transfer of a marketing authorisation
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Order of the Minister of Public Health 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
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Order of the Minister of Public Health no. 1204/02.10.2006 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 of the Minister of Public Health no. 1203/02.10.2006 on approval of the National Medicines Agency procedure for cancellation of marketing authorisation applications for medicinal products for human use
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Order of the Minister of Public Health 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
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Order of the Minister of Public Health no. 1201/02.10.2006 for approval of Guideline on the risk minimisation of animal spongiform encephalopathy agents transmission through medicinal products for human use
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Order of the Minister of Public Health 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
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Order of the Minister of Public Health no. 1199/02.10.2006 on withdrawal / suspension by the National Medicines Agency of certain marketing authorisations, prior to Accession
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Order of the Minister of Public Health no. 962/01.08.2006 on approval of the Norms for implementation of provisions of Article 699 (1) of Law No. 95/2006 on healthcare reform concerning medicinal products for special needs
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Order of the Minister of Public Health no. 906/25.07.2006 for approval of Analytical, pharmacotoxicological and clinical norms and protocols in respect of the testing of medicinal products, amended through Order of the Minister of Health no. 615/01.06.2010
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Order of the Minister of Public Health no. 905/25.07.2006 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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Order of the Minister of Public Health no. 904/25.07.2006 for approval of Norms 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 of the Minister of Public Health 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 of the Minister of Public Health no. 895/20.07.2006 on approval of Regulations regarding marketing authorisation and supervision of medicinal products for human use � Amended through Order of the Minister of Health no. 1448 of 24 November 2010, published in the Official Gazette of Romania, Part I, no. 4/4.1.2011
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Order of the Minister of Public Health no. 894/20.07.2006 on approval of Regulations regarding export of medicinal products for human use – published in the Official Gazette of Romania, Part I, no. 656 of 28 July 2006, amended through Order of the Minister of Health no. 1447 of 24 November 2010, published in the Official Gazette of Romania, Part I, no. 836 of 14 December 2010
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Order of the Minister of Public Health no. 891/20.07.2006 on approval of the Suspect Adverse Reaction Report Form
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Order of the Minister of Public Health no. 875/17.07.2006 on approval of Norms relating to the colouring matters which may be added to medicinal products for human use
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Order of the Minister of Public Health no. 873/17.07.2006 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 of the Minister of Public Health no. 872/17.07.2006 on approval of the 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 of the Minister of Public Health no. 751 din 23.06.2006 on repeal of Order of the minister of public health 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 Order of the minister of public health 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 of the Minister of Public Health no. 750 din 23.06.2006 on approval and publication of the 2006 Supplement of the Romanian Pharmacopoeia, the 10th edition
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Order of the Minister of Health no. 400 din 10.04.2006 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 � amended through Order of the Minister of Health no. 1446/24 November 2010,published in the Official Gazette of Romania, Part I, no. 825/9 December 2010
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Order of the Minister of Health no. 399 din 10.04.2006 on approval of European models of package leaflet, summary of product characteristics and label information for medicinal products authorised for marketing in Romania � amended through Order of the Minister of Health no. 1450/24 November 2010,published in the Official Gazette of Romania, Part I, no. 825/9 December 2010
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Order of the Minister of Health no. 398 din 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 of the Minister of Health no. 92 din 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 authorization of medicinal products for human use authorized in Romania in view of compliance with European Union requirements, published in the Official Gazette of Romania, Part I, no. 175 of 23 02 2006
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Order of the Minister of Health no. 90 din 08 02 2006 on approval of the Index of Medicinal Products for Human Use, 2006, published in the Official Gazette of Romania, Part I, no. 154 din 17 02 2006
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2005

Order of the Minister of Health no. 1453/2005 on approval of the Guidebook regarding “umbrella” brands
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Order of the Minister of Health no. 411/19.04.2005 on approval of Regulations on pharmacovigilance activities
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Order of the Minister of Health 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 of the Minister of Health 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 of the Minister of Health no. 280/30.03.2005 on approval of control of medicinal product quality and imported raw materials
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Order of the Minister of Health no. 279/30.03.2005 on approval of implementation of changes to marketing authorisations approved by the National Medicines Agency
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Order of the Minister of Health no. 104/16.02.2005 on approval of the Index of Medicinal Products for Human Use, 2005
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2004

Order of the Minister of Health no. 1442/5.11.2004 regarding approval of Guidelines for classification of deficiencies observed during Good Manufacturing Practice inspections
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Order of the Minister of Health no. 614/21.05.2004 regarding the approval and publishing the Supplement 2004 of the Romanian Pharmacopoeia, the 10th edition
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Order of the Minister of Health 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 of the Minister of Health 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 of the Minister of Health no. 181 din 21/02/2004 regarding the approval of the Regulations on the granting of marketing authorizations by NMA for medicinal products for human use already authorized in the European Union Member States following the decentralized procedure
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Order of the Minister of Health no.180 din 21/02/2004 regarding the approval of the Index of medicinal products for human use for the year 2004
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Order of the Minister of Health no. 179 din 21/02/2004 regarding the Pharmacovigilance Inspection at the Marketing Authorization Holder
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Order of the Minister of Health no. 160 din 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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2003

Order of the Minister of Health no. 1102 din 2003 regarding the approval of the Statute of the personnel with inspectors attributions from the National Medicines Agency
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Order of the Minister of Health no. 959 din 15.10.2003 regarding the approval of the classification for supply of certain medicinal products
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Order of the Minister of Health no. 759 din 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 of the Minister of Health and Family 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, 10th edition
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2002

Order of the Minister of Health and Family no. 251 din 08/04/2002 Published in the Official Gazette of Romania, Part I, no. 572 of 02/08/2002 on approval of the List containing medicinal products for human and veterinary use containing substances which fall under the scope of Law 143/2000 on illicit drug traffic and consumption control � amended through Order of the Minister of Health no. 848/2003
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