The Medicines (Products for Animal Use—Fees) Regulations 1998

Registration of Homoeopathic Veterinary Medicinal Products

14.—(1) A person who applies to the Ministers to register a product shall pay the relevant fee prescribed in Part II of Schedule 5.

(2) A person who applies to the Ministers to renew the registration of a product shall pay a fee of £75.

(3) A person who applies to the Ministers for authorisation to alter an Article 8 dossier relating to a registered product shall pay a fee of £85.

(4) No fee is payable in connection with an application for the registration of a product, for the renewal of a registration of a registered product, or for the authorisation to alter an Article 8 dossier relating to a registered product, which is made at the express written invitation of the Ministers.

(5) The Ministers shall waive or refund payment of any fee otherwise payable under paragraph (1) in the circumstances and to the extent specified in Part III of Schedule 5.

(6) For the purposes of this regulation and Schedule 5 the terms–

  • “Article 8 dossier”;

  • “the Board”;

  • “the Ministers”;

  • “product”; and

  • “registered”,

shall have the meanings respectively given to such terms by regulation 2(1) of the Registration of Homoeopathic Veterinary Medicinal Products Regulations 1997(1), as read, in the case of the expression “the Ministers”, with regulation 2(5) of those Regulations, and related expressions shall be construed accordingly.

(7) Part I of Schedule 5 shall have effect for the purpose of the interpretation of Schedule 5.

(1)

S.I. 1997/322.