Over the last ten years, there have been some significant changes taking place, but I would probably focus on the last five years as being the most pivotal, certainly in my experience.

Regulation (EU) 2019 -6

Within the EU we've gone through a whole revision of our veterinary pharmaceutical legislation resulting in a completely new regulatory regime for us with the introduction of Regulation 2019-6. Although the industry had been consulting and preparing for some time the real impacts weren’t anticipated. When you replace a regime that’s been in place for over 20 years (Directive 2001/82/EC) there is bound to be an adjustment period from both the regulatory authorities and industry as we both adapt.

Regulation (EU) 2019 -6 is the guiding principle within Europe and the legal framework around the registration and authorisation of veterinary medicinal pharmaceutical (VMP) products. It's what we must adhere to in order to receive a marketing authorisation for our VMPs.

There have been several changes that have rolled out from that regulation, and more to follow. The major ones being the introduction of certain pivotal databases within Europe. These new databases centre around the Union Product Database (UPD) and interact with pharmacovigilance, administration of our Marketing Authorisations, and reporting of sales figures and eventually, we may have a specific one related to VMP manufacturing and distribution. This new, more centralised approach hopes to ease some of the regulatory burden on industry.

UK Regulation

We've touched on the European-level impact of legislation, but we shouldn’t forget the UK-specific aspects. Brexit has impacted UK-centred pharmaceutical companies, and companies wishing to do business with the UK. It's not just veterinary specific, it heavily impacted our human health and pharmaceutical colleagues as well. I think the double whammy for the UK though is that there's a new regulatory regime imminent.

In 2023, the UK VMD released a consultation on the UK veterinary regulations (The UK VMR 2013). Those regulations have been out for consultation, with industry having fed back and we are now expecting the new legislation to come into play potentially during 2024. The overall picture though suggests that the new UK regulations will align more closely with our European colleagues.

At Accord Animal Health we will be at the forefront of the veterinary pharmaceutical industry and one of our key drivers will be compliance.

We act diligently to ensure the quality, safety, and efficacy of all the medicines that we produce.  Regulation 2019/6 further supports these key tenets and ensures they act as our guiding principles as we look to when we're developing and registering a veterinary medicinal product.

In terms of quality, our pharmaceutical product must be of a suitable and continuous quality and all VMPs will be made in accordance with good manufacturing practice (GMP). From a safety perspective, we have additional considerations over and above our colleagues on the human pharmaceutical side namely, the products must be safe for the animals we intend to administer them to,  it must be safe for the environment, must be safe for the user (veterinarian, veterinary nurse, pet owner for example) as well, and it must be safe for the food chain if this is relevant

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For companion animal products the food chain is not a concern. However, where we treat species that may enter the human food chain then consideration of potential residues and any impact on human safety becomes a major concern. In terms of efficacy our R&D and registration process is rigorous and one of our key points is that we are providing products into the market that fully support veterinarians in their clinical settings.   

Our pharmacovigilance system is fully compliant with applicable guidance and provides us with continuous assurance and oversight of the suitability of the products we place in the market

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