The European Medicines Agency introduced the concept of PSMf, and it became effective in July 2012. Until then, the marketing authorization holders (MAH) maintained a detailed description of the Pharmacovigilance system (DDPS). However, the requirement was restricted to human medicinal products (HMP). For veterinary medicinal products (VMP), the requirement continued to be the maintenance of DDPS until January 2022, when the veterinary good pharmacovigilance practice (vGVP) guidelines became effective.

The PSMF for VMP differs from that for HMP (GVP Module 2). One common thing is that we have a main body of the PSMF and the annexes. However, the number of annexes differs; the PSMF for HMP has eight, while the PSMF for VMP has five.

Following the structure of the PSMF for VMP:

Main body

Annexes

Annex A – QPPV, Assisting veterinary surgeon, and backup procedures

Annex B – Document management system (including record management system for adverse event recording)

Annex C – Quality management system for pharmacovigilance activities

Annex D – Contractual arrangements between marketing authorisation holders and third parties concerning pharmacovigilance activities

Annex E – Logbook or the history of changes

While the PSMF for VMP seems sleeker compared to that for HMP, this is not entirely true. This is because some of the annexes have been merged into one. E.g., Annex C and Annex D in the PSMF for HMP pertain to sources of safety information and safety systems, respectively, and these have been clubbed into a single Annex B for the VMP.

As we saw for the PSMF for HMP, it started from the EEA, and today, most countries are asking for a PSMF. Hopefully, this will also happen for the VMP as veterinary safety awareness increases!