Public comment: pharmacovigilance activities.

The proposals are intended to harmonize the pharmacovigilance system provided for in Regulation (EU) No. 1235/2010 and Directive 2010/84/EU.

To this end, implementing measures have been developed by the European Commission in the following areas:

• the content and maintenance of the pharmacovigilance system master file by the marketing authorization holder,
• the minimum requirements for the quality system for the performance of pharmacovigilance activities by national competent authorities, the European Medicines Agency (EMA) and the marketing authorization holder,
• the use of internationally accepted terminology, formats and standards for the conduct of pharmacovigilance activities,
• the minimum requirements for checking the data in the EudraVigilance database for new or changed risks,
• the format and content of electronic reporting of suspected adverse reactions by Member States and the marketing authorization holder,
• the format and content of electronic periodic safety update reports and risk management plans,
• the format of post-authorization safety study protocols, abstracts, and final reports.

The deadline for submitting comments is 07.11.2011. All citizens and organizations (public and private) can participate in this consultation. Comments should preferably be sent to the European Commission by e-mail sanco-pharmaceuticals@ec.europa.eu.

Further information:

Concept Paper

Further inquiry note

basg@basg.gv.at