http://www.legislation.gov.uk/id/uksi/1996/2194/schedule/2

http://www.legislation.gov.uk/uksi/1996/2194/schedule/2/paragraph/8/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prescribed by the Medicines (Standard Provisions for Licences and Certificates) Regulations 1971, as amended, are superseded by these Regulations except in relation to a certificate issued in respect of an application made in accordance with the Medicines (Applications for Product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

SCHEDULE 2STANDARD PROVISIONS FOR CERTIFICATES

8

The certificate holder shall notify the licensing authority—

a

within 15 days of his becoming aware of it of any suspected adverse reaction occurring during the test, which in the view of the holder was the cause of any increase in mortality or serious ill-health in the treated animals, and

b

immediately of any other matter of which he becomes aware which may affect the safety of the product for the purposes of the test.