The Veterinary Medicines Regulations 2005

Application for a marketing authorisation for a product with an active substance not contained in a veterinary medicinal product previously authorised in the United Kingdom

6.—(1) The fee for an application for a marketing authorisation for a veterinary medicinal product that contains an active substance which has not previously been included in an authorised veterinary medicinal product in the United Kingdom is £25,500.

(2) This is referred to in this Schedule as an “application for a new active substance”.

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

(4) If an additional application is submitted at the same time for another dosage form the fee for that additional dosage form is £14,795 and the fee for additional applications for the same dosage form is £ 6,390.

(5) The fee for immunological products submitted at the same time with lesser combination of antigens is £6,390 for each application.