Point of Care Manufacturing Consultation

Consultation opened on 12 August 2021. Closing date 23 September 2021.


The Medicines and Healthcare products Regulatory Agency (MHRA) have launched a UK wide consultation on Point of Care (POC) manufacturing which, if accepted, will require amendments to the UK Human Medicines Regulations 2012.

Consultation description

The MHRA is seeking views on the proposed changes to the UK Human Medicines Regulations 2012 (Human Medicines Regulations 2012). The proposed POC framework is specifically designed to create and regulate a step change in the range of manufacturing options to enable the supply and increase the availability of innovative new medicinal products to patients. This new manufacturing and supply system in the UK healthcare system will benefit patients that currently have no or few treatment options by improving the availability of innovative medicines.

Point of Care Consultation - GOV.UK (www.gov.uk), and the response form can be accessed here

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