Update with comment from MHRA

Europe tells API firms UK will be a “third country” like India and China after Brexit

By Gareth Macdonald contact

- Last updated on GMT

iStock/egal
iStock/egal

Related tags: Active pharmaceutical ingredients, European union

The European Commission has confirmed that UK drug ingredient manufacturers will have to supply European customers with written confirmation their products are made in compliance with EU standards after Brexit.

The Commission made clear the UK will become a “third country” when it leaves the European Union (EU) in 2019 in a Q&A document​ published this week.

"As of the date of the withdrawal of the UK from the Union, active substances manufactured in the UK will be considered imported active substances​."

In 2011, the European Commission set out rules on the importation of active pharmaceutical ingredients (API) in Directive 2011/62/EU​ as part of a wider effort to stop fake and substandard ingredients entering the supply chain.

A central requirement is that APIs made outside the EU must be accompanied by written confirmation their production sites comply with European standards from the competent authority in the exporting country.

API firms in India, China and other “third countries” have needed to send these written confirmations with each batch shipped to Europe since July 2013.

The only exception is if the manufacturer in question is located​ in a country where standards have been deemed to be equivalent.

UPDATE:

The MHRA declined to comment when asked if the UK will seek exemption from the written confirmation requirment.

A spokesman told us "I’m sure you recognise it is too early to be able to comment fully. However, as the Prime Minister said in her letter triggering Article 50, “we want to be able to agree a deep and special partnership” with the European Union.

"We are working closely with stakeholders, industry, and other parts of government to analyse the best options and opportunities available for the safe and effective regulation of medicines and medical devices in the UK​."

He added "While negotiations continue, the UK remains a full and active member of the EU, with all the rights and obligations of EU membership firmly in place.​"

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