PJI Biotech 

PJI Biotech

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Brexit and Pharma Industry

Posted on February 6, 2018 at 7:50 AM
The United Kingdom decided to withdraw from the European Union on 23 June, 2016. The two-year process of leaving the EU on 29 March, 2019 was triggered on 29 March, 2017. Medicines and Healthcare Products Regulatory Agency (MHRA) issued an updated briefing to pharmaceutical companies in January 2018, indicating that current regulatory relationship remains unaffected. The UK will continue to be full member state until March 2019 and will fulfill its responsibilities as a member state until then. MHRA will continue to work closely with EMA in planning for the UK's withdrawal and will ensure minimum burden and sufficient implementation time for companies (1). On the other hand, EMA has mapped out the process for handling the Brexit related changes to alleviate some of the regulatory uncertainty for Pharma companies. On 24 November 2017, EMA issued guidance procedures related to Brexit (2) for medicinal products of human and veterinary use. This guidance indicates that as of 30 March 2019, the UK will become a third country. Market Authorization Holders (MAH) and applicants currently established in the UK need to ensure that necessary changes are made by 30 March, 2019. This means that MAH established in UK will have to transfer from the current UK-based MAH to a different legal entity established in the European Economic Area. This imposes significant burden on EMA and Pharma companies to complete and fully implement all transfers by 30 March, 2019. (1) https://www.gov.uk/government/news/mhra-update-to-pharmaceutical-companies-on-exit-preparations (2) http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/general/general_content_001707.jsp&mid=WC0b01ac0580a809a7

Categories: Current Regulatory Trends

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