The new Great Britain (GB) veterinary medicines laws are largely pro-innovation and generally have been welcomed by industry following close engagement with the regulator during the consultation period. While the laws mostly align with new standards introduced in the EU (and Northern Ireland), thereby helping companies to implement similar changes across the region, they diverge in some favourable ways from EU law, e.g. the new GB laws create the possibility for valuable additional periods of data protection for existing active substances.
The new laws will nevertheless require stakeholders to make further investment and to implement changes to their processes in GB. For example, anyone advertising veterinary medicines, medicated feed or feed additives will have to comply with new advertising laws; manufacturers will need to comply with new labelling requirements; active substance manufacturers/ importers/ distributers will have to become registered and now have an explicit requirement to comply with good manufacturing practices (GMP); wholesalers will have to comply with good distribution practices (GDP);retailers will have to comply with storage and audit requirements; and veterinary groups will need to ensure they have adequate processes to enable their prescribers to comply with additional record-keeping requirements.
The new laws apply from 17 May 2024, but transition periods are available for some requirements, e.g. advertisers have up to 17 August 2024 to implement the new requirements, and manufacturers have up to 1 April 2029 to implement certain labelling requirements (provided conditions are met).
All stakeholders should familiarise themselves with the requirements that will affect their businesses and prioritise changes in accordance with the applicable transition periods.
Below are the non-exhaustive key takeaways closely focusing on topics of innovation, compliance, regulatory and antimicrobial resistance (AMR):
Pro-Innovation Takeaways
• Increased periods of data protection: This will help protect manufacturers’ investments in research and development by preventing generic companies from relying on the innovator’s data for the period of protection.
• New data protection periods for variations: New and separate periods of protection will be available where an existing product is varied to add a new pharmaceutical formulation or a new species, and where the new product is packaged separately and accorded its own marketing authorisation number. This is an innovative law that supports investment and moves away from a 20-year trend to limit the available data protection to a single ‘global marketing authorisation’ principle in the EU.
• Closing the parallel import route into GB: The new laws remove the ability for distributers to obtain ‘Marketing Authorisations for Parallel Import’, closing the parallel import supply channel into GB. The change means manufacturers will no longer have to compete with ‘parallel traded’ products (versions of their own products purchased in a lower price country and re-distributed to GB). Veterinary surgeons will still be able to prescribe and import small volumes of medicines for animals under their care in accordance with the ‘specials’ scheme
• Prohibition on compounded products that are a “pharmaceutical equivalent” of an authorised product: This measure, together with stricter controls on the promotion of the ‘prescription cascade’, will help ensure that licensed products are used where available rather than unlicensed compounded products. Compounded products must also make state on their label “this veterinary medicinal product does not hold a marketing authorisation”.
• Labelling and packaging: The new laws aim to ensure full alignment with the labelling and packaging requirements in the EU and Northern Ireland, with the option of providing an electronic package information leaflet.
• Location of marketing authorisation holder: The marketing authorisation holders can either be established in the UK or in a country demonstrated to have equivalent standards, e.g. the EU. In such instances, having a ‘local representative’ in GB will remain voluntary.
