Form

Sunset clause: request for public health exemption

Apply for a public health exemption from the sunset clause.

Documents

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

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Request an accessible format.
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Sunset Clause: notification of a change in the marketing status of a marketing authorisation

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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

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.

Published 15 August 2011
Last updated 26 September 2019 + show all updates
  1. Updated exemption form and added new notification form.

  2. First published.