Sunset clause: request for public health exemption

Apply for a public health exemption from the sunset clause.


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

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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

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