Extension of derogations for human and veterinary medicinal products impacted by Brexit

News Category: Regulatory news

Date: 17/12/2021

The European Commission has put forward proposals to ensure the continued long-term supply of medicines from Great Britain to Northern Ireland and to address outstanding supply concerns in Ireland, Cyprus and Malta. The existing derogations for human and veterinary medicinal products impacted by Brexit will be extended until the end of 2022, or until a legislative proposal is put in place.

Historically, many medicines in Ireland, Cyprus and Malta have been supplied through or from Great Britain. The UK's withdrawal from the EU has made it challenging for operators in these Member States to comply fully with EU law. In order to address this situation, prevent shortages of medicine, and ensure a high level of public health protection, Cyprus, Ireland and Malta will benefit from certain derogations for a three-year period. For example, during this period in these three countries, importers of medicines from the UK will not need to hold manufacturing authorisations, nor will these medicines need to be batch tested again if they have already been tested in the UK. In addition, Cyprus and Malta will be able, under certain conditions, and for justified public health reasons, to authorise the placing on their national market of a medicine authorised in the UK. This will give operators more time to adapt. Work on a long-term permanent solution is ongoing in the context of the EU's Pharmaceutical Strategy.

What are the next steps?

There will be an extension of the European Commission's interpretive note to ensure a continuation of the supply of medicines to Northern Ireland as well as Cyprus, Ireland and Malta. Existing arrangements will therefore last until the end of 2022, unless the legislative procedure is finalised sooner.

Does today's proposal cover veterinary medicines?

Today's legislative proposals do not cover veterinary medicines. Discussions on veterinary medicines will continue over the next months in order to gather information, identify any outstanding implementation issues and find the most appropriate way forward to ensure long-term continuity of veterinary medicines supply to Northern Ireland, as well as Cyprus, Ireland and Malta. For the short term, however, the extension of the Commission's interpretive notice includes veterinary medicines. Existing arrangements in this area will continue until the end of 2022.

Further information

More information is available at the links below:

European Commission press release
European Commission Q&A document 

HPRA information on Brexit is available at hpra.ie/brexit

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