2. The Medicines (Applications for Product Licences and Clinical Trail and Animal Test Certificates) Regulations 1971 shall be amended as follows—
(a)in regulation 2(1) (interpretation) after the definition of “proprietary designation” there shall be inserted the following definition—
““proprietary medicinal product” and “ready-made veterinary drug” have the same meanings as in sections 7(7) and 8(4) of the Act(1);”;
and
(b)for paragraph 26 of Part I of Schedule 1 (particulars required on an application for the grant of a product licence) there shall be substituted the following paragraph—
“26.—(a) Any directions, contra-indications and warnings proposed (and in the case of a veterinary drug which is a proprietary medicinal product or a ready-made veterinary drug the reasons for them), and the basic particulars of the information proposed to be included on the container label, on the package label and in any leaflet to be inserted in the package, or in other informative literature, and
(b)in the case of a veterinary drug which is a proprietary medicinal product or a ready-made veterinary drug, particulars of the withdrawal period necessary before an animal which has been treated with the drug is slaughtered for the production of food and before products derived from such an animal are used as food.”
Sections 7(7) and 8(4) were inserted by S.I. 1977/1050 and S.R. (N.I.) No. 170 and amended by S.I. 1983/1724.