Masterarbeit
Comparison of veterinary pharmacovigilance in the European Union under Directive 2001/82/EC versus under Regulation (EU) 2019/6 with a focus on the administrative burden for MAHs before, during, and after implementation of Regulation (EU) 2019/6 ***
Dr. Anna Seydel (2025)
Summary
Language: English
Regulatory requirements in European veterinary pharmacovigilance were strongly modified by Regulation (EU) 2019/6 and its secondary legislation, Implementing Regulation (EU) 2021/1281. Particularly the change from Periodic Safety Update Reports (PSURs) to continuous signal management, the replacement of the Detailed Description of the Pharmacovigilance System (DDPS) by the more comprehensive Pharmacovigilance System master File (PSMF) and the extension of the quality management of pharmacovigilance systems pose challenges for marketing authorisation holders (MAHs). Contrary to the official aim of Regulation (EU) 2019/6 to reduce the administrative burden, marketing authorisation holders for veterinary medicinal products report an extremely increased workload, particularly in the area of pharmacovigilance.
To address the question of an increased administrative burden in connection with veterinary pharmacovigilance under the new veterinary regulation, this thesis provides an extensive comparative description of the highly complex requirements for marketing authorisation holders in the context of veterinary pharmacovigilance before, during, and after implementation of Regulation (EU) 2019/6.
Additionally, it attempts to quantify the actual additional efforts via a survey distributed within pharmacovigilance working groups of two associations of the European veterinary medicines industry and one association of veterinary consultants. Participants could choose to complete an anonymous online questionnaire or send a completed word document via email. Even if anonymity has some disadvantages for the verifiability of the data, this type of survey seems to lead to a considerably improved response rate. Notably, a moderate response rate was explained by one association by lack of time due to the current extreme workload caused by the new regulation’s requirements.
Results of the survey from sixteen MAHs and six veterinary consultants substantiate the trend of an increased administrative burden associated with pharmacovigilance activities that has previously been reported by industry associations. The high variation of quantitative and semi-quantitative data on human resources development and time required for individual tasks shows a great diversity of the European veterinary medicines industry.
At present, all data indicate a remarkable increase in the administrative burden of MAHs related to European veterinary pharmacovigilance. Even though some temporary tasks will be eliminated once the new requirements have been fully implemented and the new databases are fully functional, a clear majority of survey participants do not expect a reduction in the administrative work compared to the status prior to the new regulation. Whether this is justified by a general improved quality of the pharmacovigilance systems remains to be seen.
Pages: 75
Annexes: 3, Pages: 70