The Medicines (Veterinary Drugs) (Renewal Applications for Licences and Animal Test Certificates) Regulations 1993

Product licences (other than product licences of right) and certificates

7.  In the case of the renewal of a product licence (other than a product licence of right) or a certificate, the following further particulars–

(a) particulars as to the specification and pharmaceutical form of the medicinal product to which the licence or certificate in respect of which the renewal application is made, relates, including the qualitative and quantitative composition of such medicinal product covering all active ingredients, all colouring matter, flavouring agents and perfumes and all other ingredients;

(b) particulars as to the manufacture of such medicinal product and of the active ingredients of such medicinal product;

(c) particulars of the quality control procedures and methods used to ensure compliance with the specification of such medicinal product;

(d) particulars as to the procedures for testing or ascertaining the purity, potency and stability of such medicinal product;

(e) particulars as to the containers and labelling of such medicinal product and as to the leaflets to be enclosed in the containers or packages of such medicinal product;

(f) particulars as to reports and evaluations of experimental and biological studies and of other preclinical and laboratory studies carried out with such medicinal product and its ingredients;

(g) particulars of the indications for the administration of such medicinal product, the dosage, methods and routes of administration, and of any contra-indications and warnings; and

(h) in the case of such medicinal product which is to be incorporated in any animal feeding stuff, particulars as to the feeding stuff in question, and in relation to the medicinal product in question, particulars as to its compatibility or incompatibility with other substances or articles, its stability in animal feeding stuffs, methods of incorporation and rates of inclusion in animal feeding stuffs and particulars as to the method of analysis in relation to such incorporation or inclusion.