The Veterinary Medicines Regulations 2005

Application for a marketing authorisation involving other aspects not previously authorised in a veterinary medicinal product in the UK

7.—(1) The fee for an application for a marketing authorisation where all the active substances of the veterinary medicinal product have previously been included in a veterinary medicinal product authorised in the United Kingdom but which has an element within the application and supporting data that has not previously been successfully assessed in relation to any of the active substances is £14,795.

(2) This is referred to in this Schedule as a “complex application”.

(3) Examples of applications covered by sub-paragraph (1) are the following relating to any of the active substances—

(a) a different target species;

(b) a different indication for the target species;

(c) a different route of administration;

(d) a different adjuvant or excipient;

(e) a different method of sterilisation, synthesis or manufacture;

(f) the product has a controlled release preparation which is new for that active substance;

(g) in the case of an immunological product, the product uses a different growth medium;

(h) the active substance in the product is manufactured by a different manufacturer;

(i) the active substance is in a different dosage form.

(4) If additional applications are submitted at the same time for different strengths of the same active ingredient in the same dosage form, the fee for each additional strength is £6,390.