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EMA sets out implications of Brexit on pharmaceutical industry

The Brexit implications for the UK pharmaceutical industry have been spelt out by the European medicines safety watchdog in the first of a series of guidance published on 31 May.

Designed in a question-and-answer format, the guidance published by the European Medicines Agency (EMA) looks at issues including company location and the regulatory procedures on orphan designation, manufacturing and batch release sites, as well as the position of qualified persons for pharmacovigilance.

The guidance — drawn up in conjunction with the European Commission — includes nine questions and focuses on both human and veterinary medicines.

The publication follows official notice of the UK’s intention to withdraw from the European Union and the EMA’s announcement on 2 May about what Brexit will mean for UK companies that hold marketing authorisation of medicinal products. More guidance documents for the UK industry are planned and companies are being advised to regularly check the EMA’s dedicated Brexit web page to keep themselves up to date.

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2017.20202932

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