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Guidances for regulatory changes, batch testing, and reporting address situations resulting from “no-deal” Brexit scenario.
With the deadline for the United Kingdom’s exit from the European Union (EU) seven months away, the Department for Exiting the European Union on 23 Aug. 2018 issued guidance documents that outlined changes for human medicines regulations that would no longer be subject to EU rules should the UK leave the EU without a Brexit deal in March 2019.
The technical notices stressed that negotiations are progressing and “A scenario in which the UK leaves the EU without agreement (a ‘no deal’ scenario) remains unlikely given the mutual interests of the UK and the EU in securing a negotiated outcome.”
The guidance documents addressed pharma-specific topics including regulations, batch testing, and submitting regulatory information. Other guidance documents address blood and blood products, organ, tissue, and cell safety. Additional guidance on the regulatory framework including biological medicines, IT systems requirements, manufacturing, and import licensing will be published later this year.
Post Brexit, the UK will no longer be part of the EU medicines regulatory network (EMRN), including the European Medicines Agency (EMA); the Medicines and Healthcare products Regulatory Agency (MHRA) would take on the functions currently handled by the EU for medicines on the UK market.
A UK law, the Human Medicines Regulations (2012) (HMRs), which defines a regime for the authorization, manufacture, import, distribution, sale and supply, labelling, advertising and pharmacovigilance of medicines would require changes; the MHRA is planning a public consultation in early autumn on proposed legislative changes.
Medicines on the UK market that have a UK Marketing Authorisation (MA) will not be affected by Brexit. New medicines that come to market via a licensing route overseen by the EMA, known as Centrally Authorised Products (CAPs), will automatically be converted into UK MAs on 29 March 2019.
To market a product in the UK after the EU exit, an initial MA application must be submitted to the MHRA for assessment will take a streamlined approach, “that places no greater burden on industry and ensures that patients can access new and innovative medicines at the same time as EU patients,” the guidance states.
Other actions include the following:
Other guidelines define expectations for paediatric medicines, packaging, leaflets, advance therapy medicinal products, pharmacovigilance, online sellers, and parallel distribution and parallel imports.
In a “no-deal” scenario, the UK will accept batch testing of human medicines carried out in countries on a list from the MHRA and will require a UK, EU, or European Economic Area-based qualified person to certify batch testing.
If no deal is reached, access to the EU regulatory networks shared processes and systems would no longer be available for the UK market. New systems to manage UK human medicines and devices regulatory activities and document submission are being developed for March 2019, the guidance states. Applications for both the EU and the UK would need to be submitted separately through EU systems and UK portals. More guidance is expected in later 2018.