EMA regulatory guidance update to prepare for Brexit

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In preparation for the UK’s withdrawal from the European Union (EU), set to take place on 29 March 2019, the European Medicines Agency (EMA) and the European Commission have issued regulatory guidance to pharmaceutical companies. The EU wants to ensure that pharmaceutical companies plan for Brexit to avoid any impact on the continuous supply of medicines within the EU.

Regulation V13H16

This publication is an update to the questions-and-answers document published in May 2017. This update and others yet to come, will include additional information on how Brexit will affect marketing applications and authorizations for different types of medicinal products. The guidance relates to both human and veterinary medicines and, with this update, now includes new information for manufacturers of orphan drugs, generics and biosimilars, as well as hybrid medicines that rely on data from reference products and new clinical trial findings.

The guidance specifies that sponsors will no longer need to account for UK patients in the disease’s prevalence when calculating for orphan designations. They will only need to consider the requirement that the disease does not affect more than 5 in 10,000 people in the new EU of which the UK is not a part.

The EU urges companies to stay up-to-date and regularly check the EMA webpage dedicated to the consequences of Brexit.

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Source: EMA

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