The Medicines (Standard Provisions for Licences and Certificates) Amendment Regulations 1972

Amendment of Schedule 2 to the principal regulations

5.  In Schedule 2 to the principal regulations (standard provisions for manufacturer's licences) immediately after paragraph 11 there shall be added the following paragraphs:—

“12.— (1) The licence holder who is not the holder of a product licence in respect of the medicinal product to which the manufacturer's licence relates, shall comply with any provisions of such a product licence that relates to the sale of that medicinal product and shall, by means of a label or otherwise, communicate the particulars of such provisions as relate to mode of sale, or restriction as to sale, to any person to whom the licence holder sells or supplies that medicinal product.

(2) Where the manufacturer's licence relates to the assembly of a medicinal product, and the licence holder sells or supplies that medicinal product at such a stage of assembly that does not fully comply with the provisions of the relevant product licence that relates to labelling, that licence holder shall communicate the particulars of those provisions to the person to whom that medicinal product has been so sold or supplied.

   

13.   Where in his application for a manufacturer's licence the licence holder had specified a general classification of medicinal products in respect of which that licence was required or had given particulars of manufacturing operations and of substances or articles in accordance with paragraph 6 of Schedule 1 to the Medicines (Applications for Manufacturer's and Wholesale Dealer's Licences) Regulations 1971(1) and there has been, or it is proposed that there shall be, a change in such general classification or such particulars, the licence holder shall forthwith notify the licensing authority in writing of such change or proposed change.

   

14.   Where the manufacturer's licence relates to the assembly of a medicinal product and that medicinal product is not manufactured by the licence holder, and where particulars as to the name and address of the manufacturer of, or of the person who imports, that medicinal product had been given by the licence holder to the licensing authority, the licence holder shall forthwith notify the licensing authority in writing of any changes in such particulars.

   

15.   The licence holder, for the purpose of enabling the licensing authority to ascertain whether there are any grounds for suspending, revoking or varying any licence or certificate granted or issued under Part II of the Act, shall permit, and provide all necessary facilities to enable, any person duly authorised in writing by the licensing authority, on production if required of his credentials, to carry out such inspection or to take such samples or copies, in relation to things belonging to, or any business carried on by, the licence holder, as such person would have the right to carry out or take under the Act for the purpose of verifying any statement contained in an application for a licence or certificate.”.

(1)

S.I. 1971/974 (1971 II, p. 2836).