Form

Sunset clause: request for public health exemption

Apply for a public health exemption from the sunset clause.

• From: Medicines and Healthcare products Regulatory Agency
• Published: 15 August 2011
• Last updated: 6 July 2023 — See all updates

Documents

Sunset clause: request for public health exemption from invalidation of a marketing authorisation

PDF, 112 KB, 2 pages

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.

Sunset Clause: notification of a change in the marketing status of a marketing authorisation

PDF, 60.8 KB, 1 page

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.

Interpretation of Article 23a and Article 24 (4-6) of Directive 2001/83EC – the so-called “Sunset Clause"

PDF, 22.8 KB, 3 pages

Details

You should complete and return 1 copy of this form for each product licence number that you want public health exemption for.

The form should be emailed to sunsetclause@mhra.gov.uk.

Sunset clause

Under the sunset clause Marketing authorisation (MA) owners must notify MHRA when they intend to market a medicinal product so that that our records are up-to-date. Owners should also notify us if the medicinal product is temporarily or permanently taken off the market.

The MA will no longer be valid for a product that hasn’t been placed on the market for 3 consecutive years. The time left to place a medicinal product on the market will be inherited by the new owner. See the interpretation of the directive document for more information.

The notification date for changes of marketing status should be made as close to the actual date to avoid multiple notifications of the same change of marketing of the product. The timelines for requests for exemptions to the Sunset Clause should follow the same timelines as the changes to marketing.

Please continue to notify DHSC to the timelines that they have suggested as these updates are required for future planning of supply contracts.

Retrospective exemption requests can not be made after the product expires under Sunset Clause.

Published 15 August 2011
Last updated 6 July 2023 + show all updates

1. 6 July 2023

   Updated 'Sunset clause: request for public health exemption from invalidation of a marketing authorisation' to reflect a change to some exemption reasons.

2. 14 April 2022

   Additional information regarding notification date for changes added

3. 26 September 2019

   Updated exemption form and added new notification form.

4. 15 August 2011

   First published.