Frontpage  >  What's new  >  Revised regulation on pharmacovigilance of veterinary medicinal products
15.6.2012

Revised regulation on pharmacovigilance of veterinary medicinal products

The administrative regulation on the pharmacovigilance of veterinary medicinal products has been revised. Administrative regulation 1/2012 of the Finnish Medicines Agency will enter into force on 2 July 2012, thereby repealing administrative regulation 2/2010 of the Finnish Medicines Agency previously issued on the matter.

The administrative regulation applies to the pharmacovigilance of medicinal products intended for animal use. By this administrative regulation, the Finnish Medicines Agency implements nationally the requirements regarding pharmacovigilance of veterinary medicinal products in compliance with the European Union regulation.

The amendments made in the updated administrative regulation concern the reference to the guideline “Volume 9B of The Rules Governing Medicinal Products in the European Union – Guidelines on Pharmacovigilance for Medicinal Products for Veterinary Use”.

Read more:

Administrative regulation 1/2012 (pdf)

Further information:

Jonna Kumpulainen, Veterinary Officer, tel. +358 9 4733 4223

E-mail address format is firstname.lastname@fimea.fi.