Instructions for marketing authorisation holders: Patient and reporter information to be submitted to EudraVigilance (EVPM)

The Finnish Medicines Agency Fimea has updated its instructions on the submission of patient data included in an adverse reaction report to the EudraVigilance (Post-authorisation Module, EVPM) database. Fimea finds that subsection 2 of section 30 f (1258/2021) of the Medicines Act (395/1987) should be interpreted in accordance with Regulation (EU) 2016/679 (General Data Protection Regulation) of the European Parliament and Council and the data protection principles set out in the Commission Implementing Regulation (EU) 520/2012 on the performance of pharmacovigilance activities. In Fimea's view, this means that marketing authorisation holders may be allowed to restrict certain parts of the personal data submitted to the EudraVigilance database with regard to the provision of the Medicines Act mentioned above. 

Fimea finds that marketing authorisation holders do not need to submit all personal data of a person who has experienced a suspected adverse reaction to the EudraVigilance (EVPM) database. Instead, marketing authorisation holders must submit such part of the following information on a case-by-case basis, that it is still possible to identify any overlapping/duplicate reports: date of birth, gender, age, age group, initials, name.

If Fimea later finds that the instructions described here hinder pharmacovigilance and the processing of adverse reaction reports excessively, the instructions will be updated if necessary.

Fimea has no special requirements for the reporter's information to be submitted to the EudraVigilance (EVPM) database but the Guideline on good pharmacovigilance practices (GVP) Module VI (EMA, HMA) should be followed.

Read more:

Guideline on good pharmacovigilance practices (GVP) Module VI (EMA, HMA) (pdf)