Brexit: UK To Change Drug Import And Export Rules From 2021
Guidance Explains When Written Confirmations Will Be Needed For APIs
New guidance documents issued by the UK regarding medicines regulation after the end of the Brexit transition period cover the import of medicinal products from countries on an approved list, trade in APIs between the UK and third countries, and the acceptance of batch testing under existing mutual recognition agreements.
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The Medicines and Healthcare products Regulatory Agency has outlined the various common scenarios that may occur when companies submit a UK pediatric investigation plan after the Brexit transition period has expired.
Companies marketing dexamethasone in Europe have been told they can use a CHMP endorsement to request the addition of COVID-19 to their product license.
A “powerful new vision” for the post-Brexit UK regulatory framework was unveiled at a conference organized by the BioIndustry Association and the medicines regulator, the MHRA.