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Please note this is an extract of the original bulletin.

Access Consortium

Page summary:
The MHRA is part of the Access Consortium along with the Therapeutic Goods Administration, Health Canada, Health Sciences Authority of Singapore and Swissmedic.

Change made:
Added details of the Access Consortium’s Advanced Therapy Medicinal Products Working Group.

Medical devices given exceptional use authorisations during the COVID-19 pandemic

Page summary:
List of manufacturers and their medical devices which have been granted an exemption by the MHRA. The list also includes manufacturers whose exemption expired or was cancelled. This information will be listed for 2 months after expiry or cancellation.

Change made:
The list of medical devices given exceptional use authorisations has been updated to state to indicate that the extension is granted exclusively to the ‘Bolus Cable’ product.

MHRA joins global regulatory partners in celebrating ten years of international medicines regulatory cooperation

Page summary:
As a founding member and former chair of the International Coalition of Medicines Regulatory Authorities (ICMRA), the Medicines and Healthcare products Regulatory Agency (MHRA) is joining global partners in celebrating ten years of strategic leadership and cooperation.

Change made:
First published.

International Recognition Procedure*

Page summary:
How to use this new procedure for medicines licensing applications.

Change made:
Additional guidance added to address common queries about the International Recognition Procedures.

*This update does not cover medical and IVD devices.

Tehelj