Medicines Healthcare Products Regulatory Agency
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 hasnt 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.