Pharma: The Impact of Brexit on Pharma Drug Regulations
17 Total results for product and free and sample content found
From next year, owners of trademarks and other rights in the European Economic Area will be able to prevent the parallel export of medicines from the UK to the EEA. But those owning similar rights in the UK will not be able to stop parallel imports from EEA countries.
Joining the international regulatory collaboration could become a key route for the UK to remain an early and priority market for global launches after the end of the Brexit transition period, says the industry group, BIA.
With still no guarantee of what kind of access the UK will have to the EU’s all-important Article 57 database after the Brexit transition period ends, drug companies will have to provide key information about their pharmacovigilance systems directly to the UK medicines regulator.
The UK medicines regulator has written to pharmaceutical companies outlining the actions they need to take regarding products with a centralized EU approval that will be converted to Great Britain marketing authorizations next year.
Updated guidance from the UK regulator, the MHRA, outlines the rules on orphan drug applications, criteria and exclusivity periods that will apply in Great Britain after the end of the Brexit transition period
The Medicines and Healthcare products Regulatory Agency has put procedures in place to renew UK marketing authorizations that are grandfathered from the EU system after the Brexit transition period ends.
With time running out on the UK-EU trade deal negotiations, the UK life sciences industry looks at the fine print of the new guidance on medicines regulation and explains why a mutual recognition agreement is urgently needed.
The UK’s approach to pharmacovigilance system requirements in the post-Brexit transition period will allow companies to leverage some of the existing structures put in place for EU systems.
No Records Found
Getting a demo tailored to your needs is the best way to see how our solutions will help you gain an advantage.
Request live demo now:
Our team is always happy to hear from you. Please call us at:
Have an immediate and specific information need?
Browse and buy from 1000s of analysis and research reports now: