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 UK BioIndustry Association says the updated guidance will result in duplicative and costly repetition and dent industry’s confidence in the government’s competence.
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.
Industry representatives told a House of Lords committee about continuing Brexit-related problems such as the extra work involved in checking compliance with the EU Falsified Medicines Directive and the drawbacks of a proposed “dual regulatory regime.”