What is Volume 9 in EU Pharmacovigilance?

Volume 9 are the pharmacovigilance guidelines for medicinal products for humans and veterinary use and forms a part of ‘The rules governing medicinal products in the European Union’. The European Commission (EC) develops these guidelines in line with the European Medicines Agency (EMA), Member States and other interested stakeholders. Earlier there were 2 version of Volume 9; Volume 9A that was the pharmacovigilance guidance for human medicinal products and Volume 9B that is the guidelines on pharmacovigilance for medicinal products for veterinary use. After the new pharmacovigilance legislation, Volume 9A was replaced by the good pharmacovigilance practice (GVP) guidelines. However, the EC ensured that during the transition phase, Volume 9A still remained as the reference until the respective GVP modules became available.

What is Volume 9A and 9B?

Earlier Volume 9A delineated the technical requirements to facilitate the electronic exchange of information on pharmacovigilance as per globally-agreed formats. The EC also mandated that the reference to globally-agreed medical terminology should be published. With that in mind, EC, EMA (and its Member States) developed Volume 9A which brought together general guidelines for marketing authorization holders (MAHs) and National Competent Authorities (NCAs). These guidelines covered the roles & responsibilities, processes, and requirements for MAHs and NCAs with respect to medicinal products intended for human use and also incorporated information from the ICH framework.

Volume 9A was presented in 4 key parts where part I delt with guidelines for MAHs, part II for NCAs and EMA, part III for the electronic exchange of pharmacovigilance information in the EU, and part IV for pharmacovigilance related communication.

Volume 9B also follows a similar structure as Volume 9A but with respect to medicinal products that are intended for veterinary use. For example, part I provides guidelines for MAHs, part II provides guidelines for NCAs and EMA, part III provides MAH, NCAs, and EMA on the electronic exchange of pharmacovigilance in the EU, and part IV provides guidelines on public communication for products that are intended for veterinary use.