The Animal Test Certificates (Revocation) Regulations 2003

Made18th December 2003

Laid before Parliament19th December 2003

Coming into force12th January 2004

The Secretary of State, the Department of Health, Social Services and Public Safety and the Department of Agriculture and Rural Development1, acting jointly in exercise of the powers conferred by sections 36(1), 38(3) (as read with section 36(1)), 47(1), 85(1) and (4), 86(1), 91(2) and (3) and 129(1) and (5) of the Medicines Act 19682, and now vested in them, 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 in accordance with section 129(6) of that Act, make the following Regulations:

Title and commencement1

These Regulations may be cited as the Animal Test Certificates (Revocation) Regulations 2003 and shall come into force on 12th January 2004.

Revocation of the Animal Test Certificates Regulations 19962

The Animal Test Certificates Regulations 19963 are revoked.

Consequential revocation3

Regulation 3(3) of and Part III of Schedule 1 to the Medicines (Standard Provisions for Licences and Certificates) Regulations 19714 are revoked insofar as they apply to animal test certificates.

Ben BradshawParliamentary Under Secretary of State,Department for Environment, Food and Rural Affairs8th December 2003

Sealed with the Official Seal of the Department of Health, Social Services and Public Safety

D. C. GowdyPermanent Secretary for theDepartment of Health, Social Services and Public Safety18th December 2003

Sealed with the Official Seal of the Department of Agriculture and Rural Development

Pat ToalPermanent Secretary for theDepartment of Agriculture and Rural Development18th December 2003

(This note does not form part of the Regulations)

These Regulations revoke, with effect from 12th January 2004, the Animal Test Certificates Regulations 1996, which provide for the procedure by which application is made for an animal test certificate issued under the Medicines Act 1968 and which also set out statutory standard provisions incorporated into such certificates under the Medicines Act. Statutory standard provisions which were superseded by the 1996 Regulations are revoked insofar as they take effect upon the revocation of the 1996 Regulations.

In consequence, standard provisions will not be set out in statute, but will survive so far as incorporated in existing certificates (Interpretation Act 1978, section 16). It remains open to the licensing authority to issue new certificates with individual provisions (Medicines Act 1968, sections 20 and 36).