The following Life Sciences practice note provides comprehensive and up to date legal information covering:
11 pm (GMT) on 31 December 2020 marked the end of the implementation period put in place to enable the UK to transition away from the EU’s laws and institutions. At this point in time (referred to in this document as ‘IP completion day’) there was an immediate and significant change in the UK’s legal regime. This Practice Note explains the implications of this change in relation to the following aspects of medicinal products:
Overview—what happened on 31 December 2020
How does Brexit impact the regulation of medicinal products?
What are the key legal authorities in this area (impacted by Brexit)?
What are the key items of retained EU law? Are they subject to amendment from IP completion day? Is anything revoked?
What are the key changes for medicines and medical products suppliers from IP completion day?
What are the key requirements for importation and batch testing from IP completion day?
What are the key requirements for marketing authorisations from IP completion day?
What are the key requirements for generics, biosimilars and advanced therapy medicinal products from IP completion day?
What are the key requirements for orphan medicinal products from IP completion day?
What are the key requirements for paediatric medicines from IP completion day?
What are the key requirements for pharmacovigilance from IP completion day?
What are the key requirements for safety features
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