Post-Brexit UK Pharmacovigilance for European Veterinary Businesses

What Has Changed Since Brexit? 

With Brexit out of the way, the United Kingdom’s veterinary regulation became the sole responsibility of the Veterinary Medicines Directorate (VMD), granting the body full authority to publish new UK-specific guidelines and monitor veterinary practices in the country, independent of the EU’s regulations. Although at first glance these new and updated UK-specific guidelines may seem derivative of the EU’s regulations, it is important to highlight that the new pharmacovigilance guidelines  have been remodeled to fit the UK’s veterinary market’s specific needs. Hence, there is a need to focus on the UK guidelines as a separate legal framework and not assume they are simply a continuation or copy of the EU’s rules as some marketing authorisation holder would assume. What this means is that veterinary industries in the EU who have operations in the UK must now adhere to two parallel regulatory frameworks and stay up to date with changes in both markets to remain compliant with both regulatory bodies.  

One of the noticeable changes for EU MAH is the additional pharmacovigilance requirements, particularly concerning the Pharmacovigilance System Master File (PSMF). These new requirements, which include the need for companies to maintain a UK-specific PSMF section and ensure documents and information, including the relevant details of the resident Qualified Person responsible for Pharmacovigilance in the UK, are accessible electronically, represent a step further in ensuring that veterinary medicines meet the distinct regulatory and safety standards of the UK market. 

Since the UK lost access to the EU’s EudraVigilance system, it has developed its own homegrown, country-specific electronic reporting system for adverse events related to veterinary products. This system aims to simplify reporting for both UK and EU MAH operating in the country, covering events such as animal reactions, human exposure, and improper product administration. To ensure the continued safety of animals and humans who administer, handle, and interact with veterinary medicines, the UK has established its own risk management regulations. As for Europe MAH must record and report adverse events, including those in animals, humans, and the environment, within 30 days 

The new guidelines outlines pharmacovigilance requirements for veterinary medicines in Great Britain. It specifies the obligations of Marketing Authorisation Holders (MAHs), including maintaining a pharmacovigilance system, appointing a Qualified Person for Pharmacovigilance (QPPV), and ensuring risk management plans. The QPPV oversees safety monitoring, adverse event reporting, and system compliance. MAHs must ensure resources, training, and procedures for safety evaluation and take responsibility for their products' benefit-risk balance. 

According to the updated guidelines, UK Marketing Authorisation Holders (MAHs) are now required to submit detailed Risk Management Plans (RMPs). These plans must include a thorough assessment of potential risks not fully evaluated during product development to ensure the safety and efficacy of products available to UK consumers. Additionally, the RMP must address data limitations identified during product development and outline strategies for managing product safety during the initial years of commercialization. The UK veterinary regulatory authority is aware of the changes and the challenges they present; however, these regulations are enforced in the interest of public safety and hence must be adhered to by all players in the veterinary sector to ensure consistency and protect both animal and human lives. To ensure these regulations are being followed, the Veterinary Medicines Directorate (VMD) constantly conducts inspections to monitor compliance in the form of routine and targeted checks. While some inspections may be on-site, the good news is that a portion can also be conducted remotely to save administrative and logistical costs. 

Despite this flexibility, European veterinary product MAH in the UK should not be complacent, as compliance in the EU does not automatically mean compliance in the UK. They should remain vigilant and proactive in ensuring adherence to avoid costly and consequential penalties, which could include the withdrawal of marketing authorizations for severe offenses. 

To ensure continuity and avoid disruptions due to fines and penalties, these entities must ensure pharmacovigilance efforts are measurable and quantifiable using metrics, conduct yearly reviews, and introduce improvements along the way to remain fully compliant with the UK’s evolving regulatory requirements. There is no doubt juggling UK and EU pharmacovigilance is a challenge even for the most experienced professionals and businesses in the field, and this means that more often than not, companies can overlook some regulations or fail to fully comprehend what is required of them in the UK market. Luckily, PQE Group clients do not have to worry about this because our UK pharmacovigilance experts work around the clock to ensure you are not only adherent to current regulations but also prepared for new updates and changes in the regulatory landscape.