PXL/HO/Cir-001/2018-19 Date: 04.04.2019
Subject: MHRA Update on Brexit- Legislation to allow the continued sale of, and access to, Medicines, Medical Devices and Clinical Trials.
We are glad to inform that Pharmexcil is in receipt of the important regulatory updates of MHRA in the light of Brexit from the British Deputy High Commission and we are happy to share the updates with member companies.
MHRA Updates on Brexit-No deal Scenario:
In case of a Brexit- no-deal scenario, the UK MHRA and the UK Government will enact new pieces of legislation that will ensure continued sale of, and access to, Medicines, Medical Devices and Clinical Trials in the UK, in order to alleviate concerns with the global Pharma, Medical Device and Clinical Trial industry.
The links to the amended legislation are given below.
1. The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019
2. The Human Medicines (Amendment) Regulations 2019
3. The Medicines for Human Use (Clinical Trials) (amendment) (EU exit) Regulations 2019
Guidance on operational changes
MHRA is publishing a series of guidance documents for industry and other stakeholders covering their proposed arrangements for the regulation of medicines, medical devices and clinical trials, if UK leave the EU with no deal. The agency published guidance on operational changes and is available on GOV.UK and one can sign up for the agencies alerts here.
MHRA recently published following Guidance documents
· Conditional Marketing Authorisations, Exceptional circumstances Marketing Authorisations and National Scientific Advice in a no deal scenario.
· Updates to packaging components and instructions on submissions if the UK leaves the EU without a deal for those marketing authorisations (MA) issued following conversion of EU MA. This guidance explains the steps companies will need to take to register new artwork for medicines packaging as a result of new marketing authorisations being issued in the event the UK leaves the EU without a deal.
No-deal systems contingency programme update:
Please visit GOV.UK for webinars on making submissions to the MHRA if the UK leaves the EU with no deal. The latest webinar about the MHRA Submissions portal will be going live shortly.
EU Exit no-deal contact points:
MHRA has created list of regulatory contacts for enquiries relating to the Agency’s planning and procedures in a no deal scenario.
Members may please write to email@example.com any queries regarding MHRA updates on Brexit.
With Best Regards