EudraLex - Volume 9 Pharmacovigilance guidelines

Volume 9 of "The rules governing medicinal products in the European Union" contains Pharmacovigilance guidelines for medicinal products for both human and veterinary use.

Such guidelines are drawn up by the European Commission in consultation with the European Medicines Agency, Member States and interested parties in accordance with Article 77 of Directive 2001/82/ECpdf[397 KB] as amended and Article 51 of Regulation (EC) 726/2004pdf.

Volume 9B - Pharmacovigilance for Medicinal Products for Veterinary Use

Guidelines on Pharmacovigilance for Medicinal Products for Veterinary Use (645 KB) pdf(645 KB) (Volume 9B - version October 2011)

 

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(2 MB)pdf(2 MB).

With the application of the new pharmacovigilance legislation as from July 2012 Volume 9A is replaced by the good pharmacovigilance practice guidelines(GVP) released by the European Medicines Agency. However, until the availability of the respective GVP modules Volume 9A remains the reference.