Irene Cabani -

It is about one year, from the date of the outcome of the Brexit referendum, that Pharmaceutical Companies are trying to figure out the regulatory consequences of the United Kingdom withdrawal from the European Union. Now that, on 29 March 2017, the United Kingdom submitted the notification of its intention to withdraw from the Union, it is clear that, unless the withdrawal agreement establishes another date or the period is extended by the European Council, all Union primary and secondary law ceases to apply to the United Kingdom from 30 March 2019, and the United Kingdom will then become a ‘third country’. Brexit will have a high impact in several areas including regulatory, pharmacovigilance, batch release, manufacturing site.

Marketing authorisation holders of medicinal products for human use should conside certain legal consequences in a timely manner. To assist the Pharmaceutical Companies in their regulatory evaluations, a first list of Questions and Answers (Q&As), has been drafted by the CMDh taking into account the European Commission’s and EMA’s Questions and Answers on the same issues within the framework of the centralised procedure.

Regulatory Pharma Net team and experts have years of experiences in identifying the best solutions and are available to support companies to assess the impact of Brexit and prepare the best strategy to comply with the new requirements. We would be happy to respond to any of your inquiries.

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