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Please note this is an extract of the original bulletin.

International Recognition Procedure*

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

Change made:
Added recording of ‘MHRA International Recognition Webinar November 2023’.

*Please note this update does not include medical and IVD devices.

Notify the MHRA about a clinical investigation for a medical device

Page summary:
How to notify the MHRA of your intention to carry out a clinical investigation for medical devices.

Change made:
Added a PDF on our electrical guidance for clinical investigations. Added information to the ‘Amendments’ section.

Labelling and packaging of medicinal products for human use following agreement of the Windsor Framework*

Page summary:
Information on the implementation of labelling and packaging requirements for medicinal products for human use under the Windsor Framework.

Change made:
Added glossary (see section 2). Updated terminologies to align with Windsor Framework licensing guidance – ‘PL’ is now referred to as ‘UK-wide MA’.Updated section 3 (Timelines) terminology – replaced ‘from date of guidance’ with ‘immediately’. Added new section 7 on supply of existing stock in existing packs, to provide clarity on where packs can be supplied.Updated section 8 (Early Release to Market) to reflect that PLGB packs with ‘UK Only’ labelling can be released to the GB market before 1 January 2025.Updated section 9 (Notification Process) with new third option for initially submitting new artwork changes without an eCTD.Added new section 11 on the packaging requirements for Traditional Herbal (THR) and Homeopathic (NR and HR) medicinal products.Updated section 13 (Joint EU/UK Packs) on requirements for using shared inner packaging components.

*Please note this update does not include medical and IVD devices.

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 include Extra Corporeal Membrane Oxygenation (ECMO) items produced by Getinge.

 

Tehelj