Decision

Marketing authorisations: lists of products using derogations under Directive 2022/642/EC

Lists of products using derogations under the European Commission Directive 2022/642

From:
Medicines and Healthcare products Regulatory Agency
Published
30 November 2022
Last updated
5 July 2024 — See all updates

Documents

Medicinal products using derogations under Directive 2022/642/EC

MS Excel Spreadsheet, 1.6 MB

This file may not be suitable for users of assistive technology.

Request an accessible format.
If you use assistive technology (such as a screen reader) and need a version of this document in a more accessible format, please email webupdates@mhra.gov.uk. Please tell us what format you need. It will help us if you say what assistive technology you use.

Details

The European Commission Directive 2022/642 amends Directives 2001/20/EC and 2001/83/EC to enable derogations from certain obligations concerning medicinal products for human use made available in the UK in respect of NI. The Directive came into force on 20 April 2022, applying retroactively from 1 January 2022.

The derogations are (in summary):

  • Marketing Authorisation Holder may be based in GB for Marketing Authorisations that apply in NI.
  • Where there is an application for a Marketing Authorisation Application, or Authorisation already granted, in a EU Member State, a Marketing Authorisation Application can be made to the UK competent authority (UKCA) for that product and the UKCA can grant a national Marketing Authorisation.
  • For authorisations that apply in NI, batch testing and release by Qualified Person may be based in GB, the Qualified Person may reside in GB and the Qualified Person for Pharmacovigilance (QPPV) may reside in GB.
  • Products may be imported in NI without a Manufacturing and Import Authorisation (MIA), subject to an appropriate Wholesale Distribution Authorisation and quality control testing.

The Directive requires the competent authority of the United Kingdom to publish on their website a list of medicinal products making use of these derogations. This list will be updated every 6 months.

Updates to this page

Published 30 November 2022
Last updated 5 July 2024 + show all updates

  1. Updated list.

  2. Updated list of medicinal products using derogations under Directive 2022/642/EC - to January 2024.

  3. Derogations list has been updated

  4. First published.

Sign up for emails or print this page