Regulation 6 Amendment of Schedule 3 to the principal regulations

In Schedule 3 to the principal regulations (standard provisions for wholesale dealer's licences) immediately after paragraph 5 there shall be added the following paragraphs:-

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(1)

Subject to the provisions of sub-paragraph (2) of this paragraph, no medicinal product to which the wholesale dealer's licence relates shall be sold or offered for sale by way of wholesale dealing by virtue of that licence unless there has been granted in respect of that medicinal product a product licence which is for the time being in force and any sale or offer for sale shall be in conformity with the provisions of such product licence.

(2)

The provisions of the preceding sub-paragraph of this paragraph shall not apply where—

(i)

by virtue of any provisions of the Act or of any order made thereunder, the sale (other than sale by way of wholesale dealing) of the medicinal product to which the wholesale dealer's licence relates is not subject to the restrictions imposed by section 7(2) of the Act, or

(ii)

the sale or offer for sale by way of wholesale dealing is of a medicinal product the dealings in which, at the time of its acquisition by the licence holder, were not subject to the said restrictions imposed by section 7(2) of the Act, or

(iii)

at the time of such sale or offer for sale, the licence holder does not know, or could not by reasonable diligence and care have known, that such sale or offer for sale is of a medicinal product, or believes, on reasonable grounds, that the provisions of sub-paragraphs (2)(i) or 2(ii) of this paragraph apply in relation to such sale or offer for sale.

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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.”.