Regulatory information - European Medicines Agency revises rules on fees

31 July 2013

The European Medicines Agency has revised the . 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.

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

Further details are available in the Explanatory note on fees payable to the European Medicines Agency.