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Actu Pharmacovigilance
L'actualité réglementaire de la pharmacovigilance en Europe
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European Medicines Agency - Regulatory information - European Medicines Agency revises rules on fees

EVELYNE PIERRON's insight:

The European Medicines Agency has revised the rules on fees payable to the Agency. The revised rules, which come into force on 4 August 2013, provide for full waiver of fees for pharmacovigilance-related type-IA (immediate-notification) variations to the terms of marketing authorisations with the following scopes:

  • C.I.8, i.e. introduction of, or changes to, a summary of pharmacovigilance system for medicinal products for human use;
  • C.I.10, i.e. change in the frequency or date of submission of periodic safety update reports (PSURs) for human medicinal products;
  • C.I.12, i.e. inclusion or deletion of the black symbol and explanatory statements for medicinal products in the list of medicinal products that are subject to additional monitoring;
  • C.I.z, i.e. inclusion of the statements of adverse-drug-reaction reporting.
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European Medicines Agency - Concept paper on fees for new pharmacovigilance activities released for public consultation

The European Commission has launched a three-month public consultation on a concept paper on the introduction of fees to be charged by the European Medicine Agency for new pharmacovigilance activities.

The deadline for comments on the paper is 15 September 2012.

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