Are you ready for the new regulations?
At the beginning of year 2022 Veterinary Regulation 2019/06 has come into force, introducing innovative approach to safety surveillance of veterinary medicinal products. Marketing Authorisation Holders (MAHs) will now face new challenges with regard to fulfilling legal obligations and maintaining their pharmacovigilance system up-to-date.
Below provided summary gives an overview on the upcoming changes and some guidance how to adapt to these novelties.
Pharmacovigilance system – new requirements and guidance
Long-awaited transformation has arrived in maintaining pharmacovigilance system. Previous legislation did not provide conclusive answers with regard to the content of Pharmacovigilance Master File (PSMF) (administrative data, QPPV and personnel, quality system) and guidance which processes should be monitored. For years European Medicines Agency (EMA) and local Competent Authorities (CAs) have observed MAH’s approaches to this issue, mainly during initial registration dossier evaluation and pharmacovigilance inspections. These conclusions have been presented in the new legislation. Regulation 2019/06 together with Commission Implementing Regulation 2021/1281 have introduced wide scope of obligations that have not been previously imposed. Marketing Authorisation Holders shall now implement quality management system, covering following issues:
- Resource management and training of personnel in veterinary pharmacovigilance,
- Written procedures of pharmacovigilance processes,
- Documentation management – maintaining procedures up to date and continuous improvements, change-control and archiving,
- Quality assurance by CAPA & change management, monitoring of critical performance indicators, continuous control.
List of information to be described in the pharmacovigilance master file has finally been specified and presented in Commission Implementing Regulation 2021/1281 as well as in supplemental documents and recordings, available on EMA website. From now on, MAHs should focus on expedited reporting of Adverse Reaction Reports, regardless of its seriousness, as well as on continuous signal management process, superseding periodic safety reports. General responsibilities of MAH and Qualified Person responsible for Pharmacovigilance remain unchanged.
Unequivocal instructions would make things easier for both sides – MAHs received tips what aspects should be fully covered by ongoing management and CAs may now focus on enforcement of these obligations.
Modern approach to public awareness
Another concept of the new regulation is providing people with better understanding and awareness of safety of veterinary medicines. General public will now be authorized to review databases run by EMA (without violating commercially confidential information) and access information such as product characteristics, quantity of adverse reactions for particular medicinal product and assessment reports. Emphasis will now be made to educate veterinarians and other staff on proper reporting of suspected adverse events and restriction on antimicrobial resistance. All of the undertaken measures are intended to involve society in the common goal – to serve public or animal health!
Facing new challenges
Even though Regulation 2019/06 was made public in June 2019 and since then EMA has been publishing periodic updates on new approach how veterinary medicinal products will be supervised, for many MAHs many issues remain unclear. All parties are invited to participate in Q&A sessions run by EMA. Guidelines are expected to be updated on an ongoing basis throughout the process, so that transition period would be as smooth as possible.
A few words at the end
Although challenging, applying to new regulations would enable better overview on products’ safety and prompt reaction to any benefit-risk disturbances. Upcoming months will hopefully answer many doubts and provide additional guidance. The most important issue for each MAH is to adjust its pharmacovigilance system and act due diligence.
SciencePharma monitors recent updates and is ready to assist in any necessary adjustments required in pharmacovigilance system of veterinary medicinal products.
Feel free to contact us and ask our Experts for details.
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