Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

The pharmacovigilance of veterinary medicinal products under Regulation (EU) 2019/6: introduction of the Pharmacovigilance System Master File ***

Magali Quetin (Abschlußjahr: 2022)

Summary
Language: English
With the implementation of the Regulation (EU) 2019/6, veterinary pharmaceutical companies are requested to create and maintain a new document describing their pharmacovigilance (PV) system: the Pharmacovigilance System Master File (PSMF). The PSMF itself is maintained in house while a short PSMF summary, containing administrative information and a few key items of the PV system is submitted with the application dossier. Any changes to the PSMF summary are easily notified to Competent Authorities via Variation Not Requiring an Assessment and the Union Product Database is updated. Competent Authorities in the Member States are expected to inspect regularly that the description of the PV system in the PSMF is adequately applied within the company.
The PSMF has a modular format, with a main text part organized in defined sections and supplemented by several annexes. The PSMF should be up-to-date and therefore companies should develop and implement processes to update main part and annexes regularly. The regulatory requirements made in the Regulation 2019/6 and its secondary legislation are high:

• the content of the annexes reaches a high level of details
• the scope of the information goes far beyond the data usually owned by PV
• the regular update should be sustained by a sound filing process, including version control

The PSMF increases the administrative burden for veterinary companies. The requirements are going far beyond the former Detailed Description of the PV System (DDPS). However, it may be a valuable tool for the oversight of the QPPV on the PV system, and the efforts invested by the PV teams to create and maintain the PSMF can be rewarded in this way.
Pages: 58
Annexes: 4, Pages: 35