Regulation 2 Interpretation

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^f1 has been granted;

• “suspected adverse reaction” means—

  1. (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

  2. (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.

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.