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LAWS

2014

Law 132 of 9 October 2014 on approval of Emergency Government Ordinance no. 2/2014 on amendment of Law 95/2006 on healthcare reform and of certain regulatory acts
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2008

Law no. 266/2008 – The Law of pharmacy, republished in the Official Gazette of Romania, Part I, no. 448/30.06.2009
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2006

Law no. 95/2006 on healthcare reform, as republished
(Updated based on amending regulatory acts published in the Official Gazette of Romania, Part 1, before 30 September2016).
TITLE XVIII- The Medicinal Product
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2002

Law no. 300 of 17/05/2002 concerning the legal regime of the precursors used for illicit drug production – as amended through Law no. 505/2004
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2000

Law no. 143 din 26/07/2000 concerning the fight against illicit drug trafficking and use
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ORDINANCES

2014

Emergency Ordinance no. 23 of 13 May 2014 for amendment of Law 95/2006 on healthcare reform and amendment of certain legislation
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Emergency Ordinance no. 2 of 29 January 2014 on amendment of Law no. 95/2006 on healthcare reform and of certain regulatory acts
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2012

Emergency Ordinance no. 91/12.12.2012 as regards the prevention of the entry into the legal supply chain of falsified medicinal products
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Emergency Ordinance no. 35/2012 amending certain healthcare regulations, published in the Official Gazette of Romania, Part I, no. 434 of 30/06/2012
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IMPORTANT NOTIFICATION:
After the issuance of Emergency Ordinance no. 35/2012 amending certain healthcare regulations in the Official Gazette of Romania, Part I, no. 434/30.06.2012, some errors have been detected under section 49 on amendment of Article 739 of Law 95/2006 on healthcare reform, Title XVII – The medicinal product.
Therefore, the NAMMD shall contact the Official Gazette of Romania and undertake the steps required in view of correcting these errors, as soon as possible, by replacing section 49 with the text below.
Proofreading is marked in red.
49. Article 739 is amended as follows:
“Art. 739. – (1) Before any decision is reached on an application for a marketing authorisation or on the suspension or revocation of a marketing authorisation, or on any other variation of the marketing authorisation which appears necessary, in specific cases where the interests of the European Union are involved, the National Agency for Medicines and Medical Devices, Member States, the Commission, the applicant or the marketing authorisation holder shall refer the matter to the Committee for Medicinal Products for Human Use, for application of the procedure laid down in Articles 32, 33 and 34 of Directive 2001/83/EC.
(2) Where the referral results from the evaluation of data relating to pharmacovigilance of an authorised medicinal product, the Committee for Medicinal Products for Human Use notifies the Pharmacovigilance Risk Assessment Committee on the issues concerned and provisions of Article 81910 (2) shall apply. The Pharmacovigilance Risk Assessment Committee shall issue a recommendation according to the procedure laid down in Article 32 of Directive 2001/83/EC. The final recommendation shall be forwarded to the Committee for Medicinal Products for Human Use or to the Coordination group, as appropriate, and the procedure laid down in Article 81911 shall apply. Where urgent action is considered necessary, the procedure shall apply as laid down in Articles 8199-81911. The National Agency for Medicines and Medical Devices, the competent authority of any other Member State concerned or the European Commission shall clearly identify the question which is referred to the Committee for Medicinal products for Human Use for consideration and duly inform the applicant or marketing authorisation holder.
(3) The National Agency for Medicines and Medical Devices and the applicant or the marketing authorisation holder shall supply the Committee for Medicinal products for Human Use with all available information relating to the matter in question.
(4) Where the referral to the Committee for Medicinal products for Human Use concerns a range of medicinal products or a therapeutic class, the procedure may be limited to certain specific parts of the authorisation; in that event, Article 743 shall apply only if they were covered by the authorisation procedures referred to in this section.


2010

Emergency Ordinance no. 72 of 30 June 2010 on reorganisation of healthcare facilities and amendment of public health legislation, published in the Official Gazette of Romania, no. 452/02.07.2010
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2008

Emergency Ordinance no. 93 of 24 June 2008 on reorganisation of healthcare facilities and amendment of Law 95/2006 on healthcare reform
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GOVERNMENT DECISIONS

2014

DECISION OF THE GOVERNMENT No. 315/2014 on amendment of Decision of the Government no. 734/2010 on the organisation and operation of the National Agency for Medicines and Medical Devices
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2010

Government Decision no. 734 / 21.07.2010 on the organisation and operation of the National Agency for Medicines and Medical Devices, published in the Official Gazette of Romania, no. 531 / 29.07.2010 – as amended through Romanian Government Decision no. 37/2011
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2002

Government Decision no. 123/2002 for the approval of the methodological norms for the enforcement of Law 544/2001 on free access to public information, published in the Official Gazette of Romania, Part I, no. 167 of 08.03.2002
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