Europe – CMDh : Generic Applications – Questions & Answers

Submission of a description of Pharmacovigilance System and EU Risk Management Plans for Generic and Hybrid Applications

1. Is submission of a summary of a pharmacovigilance system required for
generic or hybrid applications?
The requirements for submission of the summary of a pharmacovigilance system are the same as for any marketing authorisation application, independent of the legal basis of the application. These requirements are described in Directive 2010/84/EU) amending Directive 2001/83/EC.
For further guidance consult the Guideline on good vigilance practices (GVP) Module II.

2. Should an EU Risk Management Plan be submitted as part of an application for a generic product?
The answer is indicated in the EMA / HMA Questions and answers on practical transitional measures for the implementation of the pharmacovigilance legislation, no.3.1. For further guidance consult the Guideline on good vigilance practices (GVP) Module V.

3. Are there special requirements regarding the submission of EU Risk Management Plans for hybrid applications?
The requirements for submission of EU Risk Management Plans for hybrid applications are the same as for any marketing authorisation application, independent of the legal basis of the application. These requirements are described in Directive 2010/84/EU) amending Directive 2001/83/EC…