News about GMP/cGMP


UK Government Prepares for "No-deal Scenario" with EU

Even though it is unlikely to happen, the UK government has got its plan B if, in any case, a no deal scenario for leaving the EU might materialise. Guidance thereto was published by the Department for Exiting the European Union on August 23, 2018.

If there is no deal after 29 March 2019

The documents “How medicines, medical devices and clinical trials would be regulated if there’s no Brexit deal” outline 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. This includes

  • regulations in general,
  • batch testing medicines and,
  • the submittance of regulatory information on medical products.

The MHRA is planning to publish further guidance on the regulatory framework including biological medicines, IT systems requirements, manufacturing, and import licensing in early autumn this year. This includes a public consultation on the required changes of the UK Human Medicines Regulations of 2012. Medicines on the UK market that have a UK Marketing Authorisation (MA) will not be affected by Brexit. New medicines will also need a UK MA once the UK is no longer participating in the EU. Therefore, centrally authorised products which come to the market via a licencing route overseen by the EMA so far, will be automatically converted to UK MA after Brexit. An initial MA application to market a product in the UK will be required for an MHRA assessment.

For batch testing the MHRA will continue to

  • accept batch testing of human medicines carried out in countries on a list from the Medicines and Healthcare products Regulatory Agency (MHRA)
  • require a UK, EU or EEA-based qualified person (QP) to certify batch testing.

If no deal is reached for submitting regulatory information on medical products,

  • the UK would no longer be part of the EU medicines and medical devices regulatory networks, and
  • regulatory information relating to human medicines, medical devices and e-cigarettes would have to be submitted directly to the MHRA.