The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) is preparing to ensure that if the UK leaves the EU without a deal, pharmaceutical companies can continue to submit regulatory and notification information to the UK.
“If the UK leaves the EU with no deal, the UK would no longer be part of the EU medicines and medical devices regulatory networks. Submissions related to human medicines would need to be submitted directly to the MHRA,” the agency said.
As per the MHRA’s contingency plan, the agency is looking to deliver new IT systems and processes if access to the EU systems is lost. “Where feasible, we are trying to minimise additional administrative burdens and are trying to make any changes as simple to use as possible,” MHRA said.
The agency has put together a new webinar for pharmaceutical companies that make regulatory submissions and conduct vigilance activities.
According to the presentation slides, MHRA stresses that if a no deal EU exit occurs, the pharmaceutical industry can no longer submit data relevant to the UK to the MHRA via the Common European Submission Portal (CESP) or other EU portals.
“Therefore, we are building a UK equivalent of these, but the EU portals will still be available for EU transactions. This UK portal is referred to as the eSubmissions Portal throughout the presentation,” MHRA said.
The webinar also warns that it is not possible to move existing CESP administrative details over to our new portal. “We will be giving more detail on the registration process over the next two months,” the slides say.
The webinar focuses on submissions for human medicines, pediatric investigation plans, periodic safety update reports and individual case safety reports.
Upcoming communications will also provide tailored information on what medical device and medicinal product brokers will need to know, MHRA said.
First published here. Regulatory Focus is the flagship online publication of the Regulatory Affairs Professionals Society (RAPS), the largest global organization of and for those involved with the regulation of healthcare and related products, including medical devices, pharmaceuticals, biologics and nutritional products. Email email@example.com for more information.
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