The Medicines (Products for Human Use — Fees) Regulations 1991

Product licences

3.  Subject to paragraph 4 below, where a licence is held in respect of a derivative of a new active substance, the fee payable under regulation 14(3) shall be—

(a) where it is of the same dosage form as, but of a different strength of active ingredient or different combination of active ingredients than, that relating to the new active substance, £3,000;

(b) where it is of a different dosage form to the new active substance, £5,000;