Regulatory information - European Medicines Agency revises rules on fees

News 31/07/2013

The European Medicines Agency has revised the PDF icon 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:

These variation scopes are listed in the European Commission's revised guidelines on the various categories of variations.

Further details are available in the PDF icon explanatory note on fees payable to the Agency .

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