GOOD PHARMACOVIGILANCE PRACTICES (GVP) GUIDELINES
| Good pharmacovigilance practices (GVP) are a set of measures drawn up to facilitate the performance of pharmacovigilance in the European Union (EU). GVP 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. GVP are available for consultation in English on the EMA website: descarca documentul … |
REGULATIONS
| 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 descarca documentul … |
| 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 descarca documentul … |
| 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 descarca documentul … |
| 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 descarca documentul … |
| 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 descarca documentul … |
| 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 descarca documentul … |
DIRECTIVES
| 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 descarca documentul … |
| 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 descarca documentul … |
| DIRECTIVE 2012/26/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 25 October 2012 amending Directive 2001/83/EC as regards pharmacovigilance descarca documentul … |
LAWS
| Law no. 95/2006 on healthcare reform, as republished, as further amended and supplemented descarca documentul …  |
SCIENTIFIC COUNCIL DECISIONS
| DECISION No. 3/24.10.2018 on approval of the Romanian version of the Guideline on good pharmacovigilance practices (GVP) – Module XVI Addendum I – Educational materials descarca documentul … |
| DECISION No. 2/14.06.2018 on approval of the Romanian version of the Guideline on good pharmacovigilance practices (GVP) Module XVI – Risk minimisation measures: selection of tools and effectiveness indicators (Rev 2) descarca documentul … |
| NAMMDR Scientific Council Decision No. 30/30.09.2015 on adoption of the Guideline on Good Pharmacovigilance Practices (GVP) Module V – Risk management systems (Rev 1) descarca documentul … |
| NAMMDR Scientific Council Decision No. 12/26.02.2015 on adoption of the Guideline on Good Pharmacovigilance Practices – Module II – Pharmacovigilance Master File descarca documentul … |
| NAMMDR Scientific Council Decision No. 5/05.06.2014 on adoption of the Guideline on Good Pharmacovigilance Practices – Annex I – Definitions (Rev. 2) descarca documentul … |
| NAMMDR Scientific Council Decision No. 3/28.03.2014 on approval of the Guideline on Good Pharmacovigilance Practices, Module XV – Safety communication descarca documentul … |
| NAMMDR Scientific Council Decision No. 15/22.04.2013 on approval of the Guideline on Good Pharmacovigilance Practices – Module I – Pharmacovigilance systems and their quality systems descarca documentul … |