http://www.legislation.gov.uk/id/uksi/1996/2194

http://www.legislation.gov.uk/uksi/1996/2194/regulation/3/made

The Animal Test Certificates Regulations 1996

English language

King's Printer of Acts of Parliament

2017-05-05

MEDICINES

These Regulations prescribe requirements in relation to applications for, and applications for renewal of, animal test certificates under the Medicines Act 1968, and prescribe standard provisions for such certificates (regulations 3, 4 and 5(1) and Schedules 1 and 2). The relevant standard provisions prescribed by the Medicines (Standard Provisions for Licences and Certificates) Regulations 1971, as amended, are superseded by these Regulations except in relation to a certificate issued in respect of an application made in accordance with the Medicines (Applications for Product Licences and Clinical Trial and Animal Test Certificates) Regulations 1971 (“the 1971 Applications Regulations”), as amended (regulation 5(2)). The 1971 Applications Regulations, as amended, and the Medicines (Veterinary Drugs) (Renewal Applications for Licences and Animal Test Certificates) Regulations 1994 are revoked in so far as they respectively relate to applications for, and applications for the renewal of, animal test certificates. The Medicines (Labelling) Regulations 1976, as amended, and the Medicines (Labelling of Medicinal Products for Incorporation in Animal Feeding Stuffs and of Medicated Animal Feeding Stuffs) Regulations 1988 (“the 1988 Regulations”), are revoked in so far as they relate to the labelling of containers and packages of medicinal products for administration in medicinal tests on animals, except for any such test the subject of a certificate issued in respect of an application made in accordance with the 1971 Applications Regulations. The 1988 Regulations also continue to apply to the labelling of containers and packages of medicated feeding stuffs (regulation 6 and Schedule 3).

The Animal Test Certificates Regulations 1996

The Animal Test Certificates (Revocation) Regulations 2003

reg 2

Applications for certificates3

1

An application for a certificate shall be made to the licensing authority in writing in the English language and be signed by the applicant.

2

A separate application shall be made in respect of each product, except that one application may be made in respect of more than one product if—

a

those products are to be administered in the same test, or

b

they have the same pharmaceutical form and contain the same active ingredient or ingredients which differ only as to their strengths, or

c

they are preparations of allergen extracts for the treatment of allergies, and they consist of two or more dilutions of the same allergen extract or of the same mixture of allergen extracts, or

d

they are products for testing for allergic responses to specific substances, and they consist of two or more allergen extracts manufactured by the same method, and the application states the substances from which the extracts are prepared.

3

The applicant shall supply four copies of the application, in a bound form, with the pages of each copy serially numbered.

4

The application shall contain the particulars specified in Schedule 1.