News about GMP/cGMP

03.09.2020

MHRA publishes numerous guidelines for post-brexit period

On 1 September 2020, the British MHRA (Medicines and Healthcare products Regulatory Agency) published numerous guidelines explaining how medicinal products, active ingredients, medical devices or clinical trials are to be regulated after the brexit transition period ends on 1 January 2021.

By that date, the MHRA will act as the UK's standalone regulatory authority for medicinal products and medical devices. This will allow regulatory decisions independent of the EU, both at national level and in cooperation with other international authorities.

Of interest for the area of GMP:

  • 2 documents on clinical trials containing information about registration of clinical trials and on how to deal with substantial amendments to a clinical trial.
  • 1 document on the regulation of medical devices describing what to do to place a medical device on the Great Britain, Northern Ireland and European Union (EU) markets. The guidance is divided into sections on the different rules that will apply within those areas.
  • 12 documents covering the area of licensing that show how the approval of pharmaceutical and biological products will work from 1.1.2020.
  • 6 documents explaining the import and export scenario for medicinal products, active ingredients and investigational medicinal products. This includes a list of all countries approved for import and also guidelines for the import of QP-certified medicinal products from the EEA under the supervision of a Responsible Person Import (RPi).
  • 2 general documents on IT systems dealing with the registration for submission of marketing authorization documents to the MHRA.

Source:

MHRA: Post transition period information; Guidance for industry and organisations to follow from 1 January 2021



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