The Veterinary Medicines Regulations 2013

Marketing authorisations in exceptional circumstancesU.K.

This section has no associated Explanatory Memorandum

26.—(1) In exceptional circumstances, and if there is no other product with a full marketing authorisation for the indicated condition in the target species, the Secretary of State may grant an exceptional marketing authorisation consisting of—

(a)a provisional marketing authorisation subject to a requirement for the applicant to provide further data; or

(b)a limited marketing authorisation for a product with a limited market.

(2) The Secretary of State must reassess each provisional or limited marketing authorisation annually.