The Medicines (Exemptions from Licences and Animal Test Certificates) (Amendment) Order 1991

Made: 8th March 1991

Laid before Parliament: 13th March 1991

Coming into force: 3rd April 1991

The Secretary of State concerned with health in England, the Secretaries of State respectively concerned with health and with agriculture in Scotland and in Wales, 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, in exercise of the powers conferred by sections 15(1) and (2) and 35(8)(b) and (9) of the Medicines Act 1968[^f00001] and now vested in them[^f00002], 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 the following Order in accordance with section 129(6) of that Act, hereby make the following Order:

Title and commencement

1

This Order may be cited as the Medicines (Exemptions from Licences and Animal Test Certificates) (Amendment) Order 1991 and shall come into force on 3rd April 1991.

Amendments

2

The Medicines (Exemptions from Licences and Animal Test Certificates) Order 1986[^f00003] shall be amended in accordance with the following provisions.

3

In article 2 (Interpretation) at the end of paragraph (1)(a) there shall be added the following definition—

• ‘withdrawal period’ means the period from cessation of medication of an animal with a veterinary drug or immunological veterinary drug to slaughter of that animal for human consumption or to the taking of products derived from such an animal for human consumption.

4

In article 4(1) (conditions) for sub-paragraph (b) there shall be substituted the following sub-paragraph—

(b) the licensing authority have issued to the supplier, before the end of the specified period, an animal test (confirmation of exemption) certificate; and

5

For article 5 (application of exemption) there shall be substituted the following article—

(5) The exemption conferred by article 3(a) shall not apply to the sale,supply or importation, or to the procuring of the sale, supply, manufacture or assembly of— (a) a live immunological veterinary drug, in respect of which a product licence has not been granted; or (b) a verterinary drug containing an active ingredient being a substance which is not contained in any veterinary drug in respect of which a product licence has been granted (not being a product licence of right) unless the supplier has given to the licensing authority— (i) a notice stating that the drug is not for use by being administered to animals intended for human consumption or to animals whose produce is intended for human consumption; or (ii) sufficient toxicological information for the licensing authority to determine whether or not the withdrawal period notified pursuant to paragraph 10 of Schedule 1 is adequate.

6

For Schedules 1 and 2 to the Order there shall be substituted the two Schedules set out in the Schedule to this Order.

SCHEDULE

Signed

Stephen Dorrell — Parliamentary Under Secretary of State for Health — 6th March 1991

Strathclyde — Parliamentary Under Secretary of State, Scottish Office — 5th March 1991

David Hunt — Secretary of State for Wales — 5th March 1991

In witness whereof the Official Seal of the Minister of Agriculture, Fisheries and Food is hereunto affixed on

John Selwyn Gummer — Minister of Agriculture, Fisheries and Food — 7th March 1991.

Sealed with the Official Seal of the Department of Health and Social Services for Northern Ireland this

F. A. Elliott — Permanent Secretary — 7th day of March 1991.

Sealed with the Official Seal of the Department of Agriculture for Northern Ireland this

W. J. Hodges — Permanent Secretary — 8th day of March 1991.

Explanatory note

(This note is not part of the Order)

This Order amends the Medicines (Exemptions from Licences and Animal Test Certificates) Order 1986 as follows—

• (1) applicants for an exemption to carry out medicinal tests on animals were formerly notified by the licensing authority within 35 days that it was acceptable to carry out the tests; now applicants must apply for an animal lest (confirmation of exemption) certificate which will be issued by the licensing authority within the 35 days or such further period as the licensing authority determines (article 4);

• (2) the exemption from the need for a licence did not apply to the sale, supply or importation of an immunological veterinary drug: for that type of drug there has been substituted an unlicensed live immunological drug. The request for an exemption from the need for a licence for a veterinary drug containing an active ingredient being a substance which is not contained in any licensed veterinary drug must now be accompanied by sufficient toxicological information for the licensing authority to be able to assess the adequacy of the proposed withdrawal period (article 5);

• (3) an applicant for an animal test (confirmation of exemption) certificate has to provide the licensing authority with specified items of information. The information required includes: in respect of immunological veterinary drugs, the designation or description of each active ingredient and specified detailed information according to whether it is or is not a licensed medicinal product; in respect of all veterinary drugs, details of the shelf-life and a draft of the product literature; the address of all sites of testing, the number of animals involved and notification of the withdrawal period to be observed (article 6).

Footnotes

[^f00001]: 1968 c. 67; “the appropriate Minisiers” referred to in sections 15 and 35 is defined in section 1 (see also the following footnote).

[^f00002]: In the case of the Secretaries of State concerned with health in England and in Wales by virtue of S.I. 1969/388, in the case of the Secretary of State concerned with agriculture in Wales by virtue of S.I. 1978/272 and in the case of the Northern Ireland Departments by virtue of the Northern Ireland Constitution Act 1973 (c. 36), section 40 and Schedule 5, and the Northern lreland Act 1974 (c. 28), section 1(3) and Schedule 1, paragraph 2(1)(b).

[^f00003]: S.I. 1986/1180.