The legal requirement for marketing authorisation holders to maintain and make available upon request a pharmacovigilance system master file (PSMF) was introduced by Directive 2010/84/EU amending Directive 2001/83/EC (Recitals (7) and (35), Article 23(4), Article 104(3)(b)) and Regulation (EU) No 1235/2010 amending Regulation (EC) No 726/2004 (Recitals (22) and (25), Article 16(4), to harmonise and strengthen the conduct of pharmacovigilance activities in the EU.
Article 8(3)(ia) of Directive 2001/83/EC requires a summary of the applicant’s pharmacovigilance system to be included in the marketing authorisation application.
Keep these dates in mind:
- PSMF for all MAHs having centrally authorized products: latest by 02 July 2015.
- PSMF for all MAHs having products authorized in non-centralized procedure, latest by 21 July 2015.
For more information please contact us at: info@revipharm.es
Other related links:
- Literature review
- Pharmacovigilance audits
- Qualified person responsible for pharmacovigilance in the EU
- Pharmacovigilance responsibilities of the MAH at EU
- Safety Data Exchange Agreements (SDEAs)
- Persona de contacto de Farmacovigilancia en España
Update date: 14-04-2015
Para los medicamentos autorizados antes de la entrada en vigor del Real Decreto 577/2013, la obligación por parte del titular de autorización de comercialización de disponer y mantener un archivo maestro del sistema de farmacovigilancia y de presentar el resumen del mismo, se realizará en el momento de la renovación de la autorización de comercialización o en todo caso, con anterioridad al 21 de julio de 2015.
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