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

Article 75 Access to the pharmacovigilance database

1. The competent authorities shall have full access to the pharmacovigilance database.

2. Marketing authorisation holders shall have access to the pharmacovigilance database with respect to data related to the veterinary medicinal products for which they hold a marketing authorisation and to other non-confidential data related to veterinary medicinal products for which they do not hold a marketing authorisation to the extent necessary for them to comply with their pharmacovigilance responsibilities as referred to in Articles 77, 78 and 81.

3. The general public shall have access to the pharmacovigilance database, without the possibility to change the information therein, as regards the following information:

(a) the number and at the latest within two years from 28 January 2022 the incidence of suspected adverse events reported each year, broken down by veterinary medicinal product, animal species and type of suspected adverse event;

(b) the results and outcomes referred to in Article 81(1) that arise from the signal management process performed by the marketing authorisation holder for veterinary medicinal products or groups of veterinary medicinal products.