UK will take unilateral action to protect medicines supply in case of no-deal Brexit
The UK will recognise medicine batch test results from EU member states in the event of a no-deal Brexit, the secretary of state for leaving the EU has said.
The UK government is proposing to take unilateral action in the event of a ‘no-deal’ Brexit in order to protect the medicines supply chain, Dominic Raab, secretary of state for exiting the EU, revealed on 23 August 2018.
Raab used the medicines supply chain as an example of the need to take unilateral action, with the hope of reciprocal action by the EU, in order to maintain continuity — at least in the short term — in the event of no deal.
He explained that the UK will recognise the batch testing results of medicines, which govern their safety and standards on medicines which are due to be imported from the EU, provided the work was carried out by a member state regulator.
Raab said he hoped the EU would take reciprocal action over batch testing results of products which are due to be exported from the UK to the EU.
He said: “We don’t want delays or disruption to supplies from the EU.
“So, we propose accepting the testing and safety approvals of existing medicines, if they’ve been carried out by a member state regulator.”
He added that approach was “sensible” because it “simplifies the planning for those businesses that are exporting from the EU, by avoiding the need, at short notice, to adapt to new regulations.”
He claimed it also “minimises any potential disruption for UK businesses or consumers relying on that particular source of supply, in this case medicines from the EU.”
Rabb said he hoped in response that the “EU would recognise medicines from this country with our regulatory approval.”
His comments came in a speech he made in Whitehall ahead of the release of the latest technical notices published by his department on 23 August 2018, which offer advice for business and the public in the event of a no-deal Brexit.
Panel 1: Medicines-related guidance on how to prepare if the UK leaves the EU without a deal
On 23 August 2018, the UK government released a guidance document on how to prepare for ‘no-deal’ Brexit. The document includes guidance on five areas relating to the regulation of medicines and medical equipment.
Medicines batch testing
- The UK will continue to accept batch testing of medicines carried out in countries named on a Medicines and Health products Regulatory Agency (MHRA) list, which would include coutries in the EU and European Economic Area (EEA), and third countries which have a mutual recognition agreement with the EU;
- The UK will continue to accept batch testing of substances used in medical trials manufactured in EU and EEA;
- The UK will require a UK-based qualified person to certify the batch testing and to ensure compliance with the product’s marketing authorisation and good manufacturing practice guidelines before they can be sold or supplied in the UK;
- The UK will continue to recognise certification, release and assurance of compliance with the marketing authorisation and with good manufacturing practice guidelines, if conducted by a qualified person in a country on the MHRA list.
- The MHRA will take over the regulatory functions for medicines on the UK market which were the remit of the European Medicines Agency. The MHRA will consult on changes in the autumn of 2018;
- The UK will recognise CE-marked medical devices approved for the EU market;
- The UK will “align where possible” with proposals in the new EU clinical trial regulations which are due to be introduced after 29 March 2019.
- Existing medicines on the UK market which already have a marketing authorisation are unaffected by Brexit;
- New medicines coming into the UK are authorised via the European Medicines Agency’s centrally authorised products (CAP) route. All CAP medicines will automatically be converted into UK marketing authorisations on 29 March 2019;
- Drug companies will have to apply directly to the MHRA for a marketing authorisation after 29 March 2019;
- The MHRA will continue to accept proposals for packaging and leaflets in the English language that include information from other jurisdictions (such as Ireland), as long as information complies with UK requirements;
- The MHRA will have responsibility for all pharmacovigilance in relation to UK marketing authorisations;
- The EU logo for online sellers may be replaced by a unique UK logo for UK-based sellers after 2021.
Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2018.20205357
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