The Medicines (Fees Relating to Medicinal Products for Animal Use) Regulations 1989

PART I GENERAL

Citation, commencement and scope

1.—(1) These Regulations may be cited as the Medicines (Fees Relating to Medicinal Products for Animal Use) Regulations 1989 and shall come into force on 24th April 1989.

(2) These Regulations apply only to fees payable–

(a) in connection with applications for the grant, variation or renewal of licences or certificates under Part II of the Act relating wholly or partly to medicinal products for animal use; or

(b) in respect of inspections made in connection with applications for the grant, renewal or variation of, or during the currency of any such licence or certificate; or

(c) in respect of samples submitted for testing in connection with applications for the grant, renewal or variation of, or during the currency of a product licence.

Interpretation

2.—(1) In these Regulations, unless the context requires otherwise—

“the Act” means the Medicines Act 1968(1);

“annual fee” in relation to any product licence means the appropriate amount calculated in accordance with the provisions of Part II of Schedule 4;

“capital fee” means any fee (other than an annual fee) payable under the provisions of these Regulations;

“licence year” means the period beginning with the first day of April and ending with the last day of March of the year next ensuing;

“medicinal product” includes any substance or article specified in any Order made under (a) section 104 or 105(1)(a) of the Act which directs that Part II of the Act shall have effect in relation to such substance or article; or (b) section 130(3A) of the Act which provides that such substance or article shall, or shall not, be treated as a medicinal product.

(2) In these Regulations any reference to a regulation or a Schedule shall be construed as a reference to a regulation contained in these Regulations, or as the case may be, to a Schedule thereto, and any reference in a regulation or a Schedule to a paragraph shall be construed as a reference to a paragraph of the regulation or, as the case may be, Schedule.

(1)

1968 c. 67.