{"id":8233,"date":"2018-06-08T13:16:06","date_gmt":"2018-06-08T10:16:06","guid":{"rendered":"https:\/\/www.anm.ro\/en\/?page_id=8233"},"modified":"2026-06-08T07:39:28","modified_gmt":"2026-06-08T04:39:28","slug":"legislatie-specifica-pentru-farmacovigilenta","status":"publish","type":"page","link":"https:\/\/www.anm.ro\/en\/medicamente-de-uz-uman\/farmacovigilenta\/legislatie-specifica-pentru-farmacovigilenta\/","title":{"rendered":"Pharmacovigilance specific legislation"},"content":{"rendered":"

GOOD PHARMACOVIGILANCE PRACTICES (GVP) GUIDELINES<\/strong><\/p>\n\n\n\n
Good pharmacovigilance practices (GVP) are a set of measures drawn up to facilitate the performance of pharmacovigilance in the European Union (EU).
\nGVP apply to marketing authorisation holders, the European Medicines Agency (EMA) and medicines regulatory authorities in EU Member States. They cover medicinal products authorised centrally via the Agency as well as medicinal products authorised at national level.
\nGVP are available for consultation in English on the EMA website:
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\nREGULATIONS<\/strong><\/p>\n\n\n\n\n\n\n\n\n
REGULATION (EU) 2024\/568 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 7 February 2024 on fees and charges payable to the European Medicines Agency, amending Regulations (EU) 2017\/745 and (EU) 2022\/123 of the European Parliament and of the Council and repealing Regulation (EU) No. 658\/2014 of the European Parliament and of the Council and Council Regulation (EC) No. 297\/95
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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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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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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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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
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\nDIRECTIVES<\/strong><\/p>\n\n\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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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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DIRECTIVE 2012\/26\/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 25 October 2012 amending Directive 2001\/83\/EC as regards pharmacovigilance
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\nLAWS<\/strong><\/p>\n\n\n\n
Law no. 95\/2006 on healthcare reform, as republished, as further amended and supplemented
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\nSCIENTIFIC COUNCIL DECISIONS<\/strong><\/p>\n\n\n\n\n\n\n\n\n\n
DECISION No. 3\/24.10.2018 on approval of the Romanian version of the Guideline on good pharmacovigilance practices (GVP) \u2013 Module XVI Addendum I \u2013 Educational materials
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DECISION No. 2\/14.06.2018 on approval of the Romanian version of the Guideline on good pharmacovigilance practices (GVP) Module XVI \u2013 Risk minimisation measures: selection of tools and effectiveness indicators (Rev 2)
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NAMMDR Scientific Council Decision No. 30\/30.09.2015 on adoption of the Guideline on Good Pharmacovigilance Practices (GVP) Module V \u2013 Risk management systems (Rev 1)
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NAMMDR Scientific Council Decision No. 12\/26.02.2015 on adoption of the Guideline on Good Pharmacovigilance Practices \u2013 Module II \u2013 Pharmacovigilance Master File
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NAMMDR Scientific Council Decision No. 5\/05.06.2014 on adoption of the Guideline on Good Pharmacovigilance Practices \u2013 Annex I \u2013 Definitions (Rev. 2)
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NAMMDR Scientific Council Decision No. 3\/28.03.2014 on approval of the Guideline on Good Pharmacovigilance Practices, Module XV \u2013 Safety communication
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NAMMDR Scientific Council Decision No. 15\/22.04.2013 on approval of the Guideline on Good Pharmacovigilance Practices \u2013 Module I \u2013 Pharmacovigilance systems and their quality systems
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