Fimea’s guidance for marketing authorisation holders regarding the national implementation of Directive 2010/84/EU on pharmacovigilance
Work in the field of national legislation and the drafting of regulations of the Finnish Medicines Agency are currently under way with the entry into force of Directive 2010/84/EU on pharmacovigilance in July 2012. During the transitional period whilst national legislation is not yet in force, Fimea will take into account the provisions of the Directive. The principle is that any delay of the national implementation of the directive should not cause inconvenience for the marketing authorisation holders. In practice, however, questions will have to be solved on a case-by-case basis.
The changes to marketing authorisation procedures and pharmacovigilance activities as a result of the updated pharmacovigilance legislation will occur with transitional arrangements mainly for the period 21 July 2012 to 21 July 2015. Information and guidelines relating to legislative changes together with details about the application of transitional provisions and guidelines have been compiled on the European Medicines Agency’s website.
Fimea would like any questions concerning national implementation of the Directive to be sent centrally to Fimea’s mailbox: 201084EU@fimea.fi. Fimea will answer questions mainly by updating guidances and releases.