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UK: MHRA publishes 48 guidance documents on new regulatory regime

2021/01/08  MHRA

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has
published 48 guidance documents on the processes that will apply now that the Brexit transition period has ended.

Throughout 2020, MHRA published guidance on how drugs and medical devices would be regulated in the UK after Brexit. In the days before and after the transition period ended on 31 December, the agency released a flurry of updates and new documents to replace its earlier advice on what to do once the UK completed its split from the European Union.

The documents cover all aspects of drug and device regulation in the UK. Half of the documents relate to licensing matters, such as renewing marketing authorizations, licensing biosimilars, handling active substance master files and registering new packaging information.

Another tranche of the documents cover importing and exporting. The agreement of a trade deal that gives UK companies tariff- and quota-free access to the EU market eliminated one potential set of problems for importers and exporters, but the arrangement still creates barriers. Many of the import and export documents address supplying products in Northern Ireland, which remains subject to EU law.

MHRA published its set of documents alongside guidance from the National Institute for Biological Standards and Control (NIBSC), one of the regulator’s three centers. The NIBSC guidance addresses the changes caused by Great Britain’s departure from the EU Official Control Authority Batch Release (OCABR) program.

Until 31 December, manufacturers could use an OCABR certificate to provide biological medicines in Great Britain. OCABR certificates issued up to that date remain valid in the UK but all future batches will need to undergo certification at NIBSC. The only exceptions are products tested in countries with which the UK has mutual recognition agreements, namely Israel and Switzerland. The agreement with Israel only covers vaccines.

The changes could affect the number of batches NIBSC need to certify. NIBSC said it “will endeavor to meet current batch release turnaround times.” The laboratory plans to continue to accept samples ahead of documentation to help manufacturers meet their targeted release dates.

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