The Medicines (Products for Human Use — Fees) Regulations 1995

6.  In relation to a marketing authorization (parallel import), the fee payable in respect of each such application shall be waived—

(a) where the authorization relates to a medicinal product in respect of which a separate marketing authorization has been granted pursuant to the provisions of Council Directive 65/65/EEC in more than one member State, those marketing authorizations are indicated on the marketing authorization (parallel import) as having been validly granted in those member States and the holder of that authorization applies for the grant of a separate marketing authorization (parallel import) in respect of each marketing authorization which has been granted and so indicated; or

(b) the holder of the authorization applies for a variation to the authorization solely relating to a change in the number of a marketing authorization referred to in sub-paragraph (a).

(3) Where a marketing authorization is varied so as to include the provisions of another marketing authorization in the circumstances set out in paragraph 4(4) of Part III of Schedule 3, the fee payable in respect of that variation under regulation 7(1) shall be refunded or, if it has not yet been paid, shall be waived.