Regulation (EU) 1235/2010 and Directive 2010/84/EU amending the legal framework regarding pharmacovigilance for medicinal products will enter into force in the European Union in July 2012.
Norway is not a member of the European Union, and the Regulation and Directive must first be incorporated into the EEA Agreement and then be implemented into national law to enter into effect nationally. This will happen when the Regulation on Medicinal Products is amended.
However, the Norwegian Medicines Agency has stated that until the amendments are implemented, the Agency will accept the new routines and formats that follow as a result of the new legal framework in the EU.
The Agency states on its website that no additional or specific national requirements will be implemented. Specifically, there is no requirement that a Qualified Person for Pharmacovigilance (QPPV) must have residency in Norway.
Please click here to view original article.
About the authors:
Inga Kaasen is an attorney-at-law and partner at the Norwegian law firm Grette. She also holds a PhD. in biotechnology. She is the leader of Grette's Life Sciences team, and has extensive experience with patent disputes, pharmaceutical law, IP transactions and R&D agreements.
Håkon Austdal is an associate at the Norwegian law firm Grette. He also holds a Bachelor of Pharmacy. He is a member of Grette's Life Sciences team, working with patent disputes and pharmaceutical law.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.