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Paragraph 3 Product licences

Changes not yet applied. Later legislation changes this provision in ways not yet written into the text below:

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;