Regulation (EU) 2019/6 of the European Parliament and of the CouncilShow full title

Article 78 Qualified person responsible for pharmacovigilance

1. The qualified person responsible for pharmacovigilance as referred to in Article 77(8) shall ensure that the following tasks are carried out:

(a) elaborating and maintaining the pharmacovigilance system master file;

(b) allocating reference numbers to the pharmacovigilance system master file and communicating that reference number to the pharmacovigilance database for each product;

(c) notifying the competent authorities and the Agency, as applicable, of the place of operation;

(d) establishing and maintaining a system which ensures that all suspected adverse events which are brought to the attention of the marketing authorisation holder are collected and recorded in order to be accessible at least at one site in the Union;

(e) compiling the suspected adverse event reports referred to in Article 76(2), evaluating them, where necessary, and recording them in the pharmacovigilance database;

(f) ensuring that any request from the competent authorities or the Agency for the provision of additional information necessary for the evaluation of the benefit-risk balance of a veterinary medicinal product is answered fully and promptly;

(g) providing competent authorities or the Agency, as applicable, with any other information relevant to detecting a change to the benefit-risk balance of a veterinary medicinal product, including appropriate information on post-marketing surveillance studies;

(h) applying the signal management process referred to in Article 81 and ensuring that any arrangements for the fulfilment of responsibilities referred to in Article 77(4) are in place;

(i) monitoring the pharmacovigilance system and ensuring that if needed, an appropriate preventive or corrective action plan is prepared, implemented and, where necessary, ensuring changes to the pharmacovigilance system master file;

(j) ensuring that all personnel of the marketing authorisation holder involved in the performance of pharmacovigilance activities receives continued training;

(k) communicating any regulatory measure that is taken in a third country and is related to pharmacovigilance data to the competent authorities and to the Agency within 21 days of receipt of such information.

2. The qualified person referred to in Article 77(8) shall be the contact point for the marketing authorisation holder regarding pharmacovigilance inspections.