{"id":1139,"date":"2017-02-21T12:33:19","date_gmt":"2017-02-21T12:33:19","guid":{"rendered":"http:\/\/wwwro.anm.ro\/?page_id=1139"},"modified":"2026-04-30T11:57:42","modified_gmt":"2026-04-30T08:57:42","slug":"directive-si-regulamente","status":"publish","type":"page","link":"https:\/\/www.anm.ro\/en\/medicamente-de-uz-uman\/legislatie\/directive-si-regulamente\/","title":{"rendered":"Directives and regulations \u2013 Medicines for human use"},"content":{"rendered":"

> Laws, ordinances and government decisions<\/a>
\n> Orders of the minister of health<\/a>
\n> Directives and regulations<\/a>
\n> Scientific council decisions<\/a><\/p>\n

DIRECTIVES<\/strong><\/span><\/p>\n

2011<\/strong><\/p>\n\n\n\n
DIRECTIVE 2011\/62\/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 8 June 2011 amending Directive 2001\/83\/EC on the Community code relating to medicinal products for human use, as regards the prevention of the entry into the legal supply chain of falsified medicinal products
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\n2010<\/strong><\/p>\n\n\n\n
Directive 2010\/84\/EU of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance, Directive 2001\/83\/EC on the Community code relating to medicinal products for human use
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\n2001<\/strong><\/p>\n\n\n\n
Directive 2001\/83\/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use
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\nREGULATIONS<\/span><\/strong>
\n
\n2024<\/strong><\/p>\n\n\n\n
COMMISSION DELEGATED REGULATION (EU) 2024\/1701 of 11 March 2024 amending Regulation (EC) No 1234\/2008 as regards the examination of variations to the terms of marketing authorisations for medicinal products for human use
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\n2022<\/strong><\/p>\n\n\n\n\n
COMMISSION IMPLEMENTING REGULATION (EU) 2022\/20 of 7 January 2022 laying down rules for the application of Regulation (EU) No 536\/2014 of the European Parliament and of the Council as regards setting up the rules and procedures for the cooperation of the Member States in safety assessment of clinical trials, which is in force since 30.01.2022 and which applies from 31.01.202
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REGULATION (EU) 2022\/123 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 25 January 2022 on a reinforced role for the European Medicines Agency in crisis preparedness and management for medicinal products and medical devices
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\n2016<\/strong><\/p>\n\n\n\n
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 rules for the safety features appearing on the packaging of medicinal products for human use
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\n2014<\/strong><\/p>\n\n\n\n\n\n
COMMISSION DELEGATED REGULATION (EU) No 1252\/2014 of 28 May 2014 supplementing Directive 2001\/83\/EC of the European Parliament and of the Council with regard to principles and guidelines of good manufacturing practice for active substances for medicinal products for human use
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REGULATION (EU) No. 658\/2014 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 15 May 2014 on fees payable to the European Medicines Agency for the conduct of pharmacovigilance activities in respect of medicinal products for human use
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REGULATION (EU) NR. 536\/2014 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001\/20\/EC
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\n2013<\/strong><\/p>\n\n\n\n
COMMISSION IMPLEMENTING REGULATION (EU) NO. 198\/2013 of 7 March 2013 on the selection of a symbol for the purpose of identifying medicinal products for human use that are subject to additional monitoring
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\n2012<\/strong><\/p>\n\n\n\n\n
REGULATION (EU) No 1027\/2012 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 25 October 2012 amending Regulation (EC) No 726\/2004 as regards pharmacovigilance
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COMMISSION IMPLEMENTING REGULATION (EU) No 520\/2012 of 19 June 2012 on the performance of pharmacovigilance activities provided for in Regulation (EC) No 726\/2004 of the European Parliament and of the Council and Directive 2001\/83\/EC of the European Parliament and of the Council
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\n2010<\/strong><\/p>\n\n\n\n
REGULATION (EU) No 1235\/2010 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 15 December 2010 amending, as regards pharmacovigilance of medicinal products for human use, Regulation (EC) No 726\/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, and Regulation (EC) No 1394\/2007 on advanced therapy medicinal products
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\n2004<\/strong><\/p>\n\n\n\n
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, last consolidated version: 28.01.2022
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