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Statutory Instrument 1991 No. 632

The Medicines (Fees Relating to Medicinal Products for Animal Use) Regulations 1991

(The document as of February, 2008)

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STATUTORY INSTRUMENTS

1991 No. 632

MEDICINES

The Medicines (Fees Relating to Medicinal Products for Animal Use) Regulations 1991

Made12th March 1991
Laid before Parliament13th March 1991
Coming into force3rd April 1991

    The Secretary of State concerned with health in England, the Secretaries of State respectively concerned with health and with agriculture in Wales and in Scotland, the Minister of Agriculture, Fisheries and Food, the Department of Health and Social Services for Northern Ireland and the Department of Agriculture for Northern Ireland, acting jointly, with the consent of the Treasury, in exercise of the powers conferred by section 1(1) and (2) of the Medicines Act 1971[1] and now vested in them[2] and of all other powers enabling them in that behalf, after consulting such organisations as appear to them to be representative of interests likely to be substantially affected by these Regulations[3], hereby make the following Regulations:


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 1991 and shall come into force on 3rd April 1991.

        (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;
       (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 any reference to the Veterinary Products Committee or to the Medicines Commission in connection with an application for the grant of a product licence under Part II of the Act relating wholly or partly to medicinal products for animal use.

    Interpretation
        2.—(1)  In these Regulations, unless the context requires otherwise—
      "the Act" means the Medicines Act 1968[4];

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

      "biological medicinal product" includes an antigen, toxin, antitoxin, toxoid serum, antiserum or vaccine or a fraction of any such product;

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

      "emergency vaccines" means vaccines manufactured or assembled only from material obtained from the particular animal, flock or herd intended to be vaccinated in circumstances in which no other suitable licensed vaccines are readily available for such use;

      "inactive biological medicinal product" means a product which is not currently being manufactured or sold and in respect of which there is no current intention to recommence the manufacture or sale;

      "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 (1) 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 (ii) section 130(3A) of the Act[5] which provides that such substance or article shall 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.


Notes:

[1] 1971 c. 69 as amended by section 21 of the Health and Medicines Act 1988 (c. 49); by virtue of section 1(3) of the 1971 Act expressions in that section have the same meaning as in the Medicines Act 1968 (c. 67) as amended by the Transfer of Functions (Wales) Order 1969 (S.I. 1969/388). The expression "the Ministers" is defined in section 1(1) of the 1968 Act as so amended.

[2] In the case of the Secretaries of State concerned with health in England and in Wales by virtue of article 2(2) of, and Schedule 1 to, the Transfer of Functions (Wales) Order 1969; in the case of the Secretary of State concerned with agriculture in Wales by virtue of article 2(3) of, and Schedule 1 to, the Transfer of Functions (Wales) (No. 1) Order 1978 (S.I. 1978/272); in the case of the Northern lreland Departments by virtue of section 40 of, and Schedule 5 to, the Northern Ireland Constitution Act 1973 (c. 36) and section 1(3) of, and paragraph 2(1)(b) of Schedule 1 to, the Northern Ireland Act 1974 (c. 28).

[3] See section 129(6) of the Medicines Act 1968 as extended to include Regulations made under the Medicines Act 1971 by section 1(3)(b) of that latter Act.

[4] 1968 c. 67.

[5] Section 130 was extended by section 13(2) Animal Health and Welfare Act 1984 (c. 40).

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