Pharmacovigilance

The responsibilities of marketing authorisation holders concerning pharmacovigilance are laid down in the Medicines Act, the Regulation 1/2005 of the National Agency for Medicines and EU regulations and guidelines.

Issues relating to pharmacovigilance are handled at the Department of  Safety and Drug Information.

News

The return address of the contact information form for persons responsible for pharmacovigilance has changed (word-format).

Updated 3.12.2007

Queistionnaire to Marketing Authorisation holders

The contact information form for persons responsible for pharmacovigilance