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The Medicines Act 1968 (Amendment) (No. 2) Regulations 1994
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- UK Statutory Instruments
- 1994 No. 276
- Regulation 7
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Section 86 of the Act—leaflets
7.—(1) After section 86(3) (leaflets), there is inserted—
“(4) No person shall, in the course of a business carried on by him, supply a product to which Chapters II to V of the 1965 Directive apply, unless—
(a)a leaflet enclosed in, or supplied with, the container or package of the product, or
(b)the container or package itself,
contains the particulars which a leaflet relating to the product is required by regulations under subsection (1) of this section to contain, and does so in the manner required by such regulations.”.
(2) The amendment made by this regulation has effect only in relation to products in respect of which product licences (as defined in section 7 of the Act) have been granted or renewed after the coming into force of these Regulations.
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