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Tanvi Shah

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Tanvi Shah is an Associate in Baker McKenzie's London office.

With the changes to the regulation of veterinary medicines in the UK as a result of Brexit, the Veterinary Medicines Directorate has created a helpful information hub pulling together its communications on current and future regulatory changes. Access the Hub here, including useful explainers on “Application and authorisation“, “Manufacturing and distribution“, and “Pharmacovigilance“, and see below for a summary of some key points.

Following petition by The Association of the British Pharmaceutical Industry (ABPI), the BioIndustry Association (BIA) and others within the industry, the UK Government has changed its position on when protection will begin for a number of regulatory exclusivities post-Brexit. Such changes demonstrate that the UK Government is receptive of industry views – and also the power of collective lobbying.

In a judgment delivered on 9 July 2020, the CJEU held that a new therapeutic application for an authorised medicinal product cannot be the subject of a supplementary protection certificate (SPC).  This clarifies the position on an issue that has been unclear for nearly a decade, but will be unwelcome to companies in the healthcare and life sciences sector who have invested, and continue to invest, in the development of new therapeutic applications for authorised products. It will have a significant impact on pending SPC applications relating to second medical uses.