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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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