Volume 9 of "The rules governing medicinal products in the European Union" contained Pharmacovigilance guidelines for medicinal products for human use and for veterinary medicinal products but it no longer applies.
Good pharmacovigilance practice (GVP) guidelines
In the past, the European Commission also published pharmacovigilance guidance for human medicinal products (Volume 9A). The most recent of this guidance documents dates from September 2008: Pharmacovigilance for medicinal products for human use.
With the application of the new pharmacovigilance legislation as from July 2012 Volume 9A is replaced by the good pharmacovigilance practice (GVP) guidelines released by the European Medicines Agency. However, until the availability of the respective GVP modules Volume 9A remains the reference.
Pharmacovigilance for Veterinary Medicinal Products
Regulation (EU) 2019/6 sets out the requirements for pharmacovigilance for veterinary medicinal products in Section 5.
Article 77(6) of Regulation (EU) 2019/6 requires the Commission to establish measures on good pharmacovigilance practice. These are set out in Commission Implementing Regulation (EU) 2021/1281 of 2 August 2021 laying down rules for the application of Regulation (EU) 2019/6 of the European Parliament and of the Council as regards good pharmacovigilance practice and on the format, content and summary of the pharmacovigilance system master file for veterinary medicinal products.
The legal provisions are complemented by guidelines on veterinary good pharmacovigilance practice developed by the European Medicines Agency and the Member States competent authorities.
