# The Animal Test Certificates Regulations 1996, Regulation 2: Interpretation


(1) In these Regulations, unless the context otherwise requires—
“the Act” means the Medicines Act 1968;
“approved dossier” means all the particulars submitted in an application for a certificate, or at any subsequent time in connection with a certificate, which have been or which are deemed to have been approved by the licensing authority;
“certificate” means an animal test certificate;
“biological product” includes an antigen, toxin, antitoxin, toxoid, serum, antiserum or vaccine or a fraction of any such product;
“new molecule” means an active ingredient which has not at any time been included in a product in respect of which a product licence under the Act, or marketing authorisation within the meaning of the Marketing Authorisations for Veterinary Medicinal Products Regulations 1994 has been granted;
“suspected adverse reaction” means—
(a) a reaction in an animal treated with a product during a test which is suspected to have been caused by the product, and which has resulted in harm to the animal, or
(b) a suspected lack of efficacy of a product in an animal so treated; and
“test” means a medicinal test on animals the subject of a certificate or of an application for the grant thereof.
(2) Any reference in these Regulations to a numbered regulation or Schedule shall, unless the context otherwise requires, be construed as a reference to the regulation or Schedule bearing that number in these Regulations.

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Source: https://www.legislation.gov.uk/uksi/1996/2194/regulation/2 (the official version)
Page: https://openlegislation.uk/animal-test-certificates-regulations-1996/regulation-2
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.