In accordance with Article 76 (3) and (4) of Regulation (EU) 2019/6 marketing authorisation holders (and holders of registrations) may be requested by EMA or national competent authorities to collect certain pharmacovigilance data and to conduct post-marketing surveillance studies (PMS studies) in addition to the collection of suspected adverse events. The requesting authority (hereinafter BVL) must provide good justification for the need for a PMS study and allow a reasonable period of time for it to be conducted.

The marketing authorisation holder first drafts a study protocol, which must be approved by BVL at least two months before start of the study. All EU Member States on whose territory the study is to take place are informed in good time. The authorities involved receive the study protocol, the final report and a summary of the final report after completion of the study. All relevant documents should be written in a language commonly used in medical science (usually English). If a veterinary medicinal product is authorised in only one Member State and is the subject of a PMS study, at least the study title and summaries of the study protocol and final report should be submitted in translation.

The BVL informs the marketing authorisation holder of its evaluation of the study results. In the event that the risk-benefit balance of the veterinary medicinal product is no longer positive, risk mitigation measures shall be initiated in accordance with Articles 129, 130 and 134 of Regulation (EU) 2019/6.

A PMS study may also be conducted on the marketing authorisation holder's own initiative. It must be notified to BVL immediately after its beginning. A final report including the study protocol should be submitted no later than one year after data collection.

Marketing authorisation holders should keep all data and information on their PMS studies in such a way that they can be correctly reproduced and verified. The data material and the statistical programmes used should be electronically secured and available for internal and external audits and inspections.

Contact: pharmacovigilance@bvl.bund.de