Since January 2023, with the entry into force of Regulation (EU) 2019/6 on veterinary medicinal products and the implementation of Regulation (EU) 2021/1281 on the post-marketing surveillance of veterinary medicinal products, veterinary pharmaceutical companies, and especially Marketing Authorization Holders (MAH) and their local distributors/vendors, have seen an increase in the amount of tasks and activities to be performed in order to be compliant with the new regulations. In addition, the EMA has developed new Veterinary Good Pharmacovigilance Practices (VGVP) that describe the specific requirements for the various pharmacovigilance processes.
One of the VGVP guidelines, EMA/595115/2021 is, entitled: “Pharmacovigilance systems, their quality management systems and pharmacovigilance system master files,” a document that MAHs must comply with as requested by Implementing Regulation 2021/1281. For the companies, it means that they must develop a Quality Management System (QMS) covering all pharmacovigilance activities, including a risk management system covering all procedures and processes necessary to optimize safe use of their veterinary medicinal products, implementing a robust and efficient pharmacovigilance system.