Pharmacovigilance has been defined by the World Health Organisation as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem.

Article 106 of Directive 2001/83/EC specifically placed a requirement on the European Commission in consultation with the European Medicines Evaluation Agency (EMA – “the Agency”), Member States and interested parties to draw up guidance on the collection, verification and presentation of adverse reaction reports in order to facilitate the exchange of information about human pharmacovigilance within the Community. Similarly, Article 26 of Regulation (EC) No 726/2004 includes a requirement for the Commission, in consultation with the Agency, Member States and interested parties to draw up a guide. The resultant document is identified as “Volume 9A of The Rules Governing Medicinal Products in the European Union – Guidelines on Pharmacovigilance for Medicinal Products for Human Use” It includes technical requirements for the electronic exchange of pharmacovigilance information in accordance with internationally agreed formats.

It brings together general guidance on the requirements, procedures, roles and activities in this field, for both Marketing Authorisation Holders and Competent Authorities of medicinal products for human use; it incorporates international agreements reached within the framework of the International Conference on Harmonisation (ICH).

In addition, the European Commission is also required to publish a reference to an internationally agreed medical terminology.

Volume 9A replaces Volume 9 originally published in 2001 describing pharmacovigilance requirements for both human and veterinary medicinal products. The newer version (volume 9A) has been issued and brings the topic up-to-date and, amongst other things, places more stringent requirements on the reporting of adverse drug reactions whilst relaxing those for Periodic Safety Update Reports on generic products.