Medical Device Regulation – Article 117 Action Required
Pharma’s Predicament
Pharma’s predicament is the uncertainty and the sheer magnitude of the task that Brexit faces it with. The prospect of the UK becoming a so-called ‘third country’, after so many years of immersion in the EU regulatory system for Pharma, is daunting. Pharma has a lot to prepare for and reconfigure to ensure the on-going validity of its Marketing Authorisations, the compliance of its supply chain, manufacturing and procurement, as well as in many cases, the integrity of its orphan medicinal product designations and SME registrations. PharmaLex has established a dedicated Brexit task force to provide pragmatic advice to mitigate the uncertainty and risks. As a global consultancy, PharmaLex is ideally placed to implement/review your tactical or strategic Brexit contingency plans Contact our team to discuss more – please contact us at +353 1 846 47 42 or contactirl@pharmalex.com. Download our PDF version BREXIT – We help you to prepare
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