The Veterinary Medicines Regulations 2013

Assessment of a variation of an authorisation to manufacture an autogenous vaccine

30B

The fee for the scientific assessment of an application for the variation of an authorisation to manufacture an autogenous vaccine is—

• (a) £2,895 if the variation requires complex scientific or pharmaceutical assessment;

• (b) £885 if the variation requires simple scientific or pharmaceutical assessment;

• (c) £455 in relation to an administrative variation.

Annual fee (manufacturing authorisations)

Site inspections – type of site

Inspection of a site where immunological veterinary medicinal products are manufactured

Inspection of a site where sterile veterinary medicinal products are manufactured

Inspection of a site where no immunological or sterile veterinary medicinal products are manufactured

Inspection of a site where veterinary medicinal products are assembled

Test sites

Animal blood bank or non-food animal stem cell centre authorisations

Inspection of a wholesale dealer’s sites

Fees for applications for authorisation and annual fees relating to feedingstuffs in Great Britain

Provision of scientific advice

54A

The fee for an application for written advice from the Secretary of State in relation to scientific matters is £4,487.

Appeals to the Veterinary Products Committee

Fee relating to an appointed person

Fees relating to a veterinary ... practice premises

Fee in relation to verifying destruction of controlled drug

57A

The fee for verifying the destruction of a controlled drug listed in Schedule 2, 3 or 4 to the Misuse of Drugs Regulations 2001 is—

• (a) £142; or

• (b) £31 (where the verification takes place during the course of an inspection for other purposes).

Pharmacovigilance inspections

57B

• (1) In relation to a pharmacovigilance inspection the fee is—

• (a) £3,600 in the case of a large marketing authorisation holder; and

• (b) £1,650 in the case of a small marketing authorisation holder.

• (2) In sub-paragraph (1)—

• “large marketing authorisation holder” means a marketing authorisation holder who holds 30 or more marketing authorisations;

• “small marketing authorisation holder” means a marketing authorisation holder who holds fewer than 30 marketing authorisations.

Refund of fees relating to the Veterinary Products Committee or appointed persons

Fees relating to an improvement notice

Non-payment of fees

Waiver or reduction of fees

Reduction of fees when an application is withdrawn