Citation, commencement and interpretation

1.-(1) This Order may be cited as the Medicines (Exemption from Licences) (Wholesale Dealing in Confectionery) Order 1975 and shall come into operation on 1st June 1975.

(2) In this Order, unless the context otherwise requires, "the Act" means the Medicines Act 1968 and other expressions have the same meanings as in the Act.

(3) Except in so far as the context otherwise requires, any reference in this Order to any provision of any enactment shall be construed as a reference to that provision as amended or extended by any enactment or instrument and as including a reference to any provision which may re-enact or replace it.

(4) The rules for the construction of Acts of Parliament contained in the Interpretation Act 1889 shall apply for the purposes of the interpretation of this Order as they apply for the purposes of the interpretation of an Act of Parliament.

Temporary exemption from wholesale dealer's licences

2.-(1) Notwithstanding the provisions of Article 3 of this Order, during the periods set out in paragraph (2) below, the restrictions imposed by section 8(3) of the Act (wholesale dealing) shall not apply to the sale or offer for sale by way of wholesale dealing of a medicinal product, other than a veterinary drug, which is for sale as confectionery if, and so long as, the conditions specified in sub-paragraphs (b) and (c) of Article 3(2) of this Order are satisfied.

(2) The periods referred to in the preceding paragraph are as follows:-

(a)the period of six months from the date of the coming into operation of this Order;

(b)where an application for the grant of a product licence or an application to vary a product licence in respect of the medicinal product as aforesaid has been made during the period under (a) above and in the application it is stated that the product is to be sold or offered for sale by way of wholesale dealing by persons exempt from the need to hold a wholesale dealer's licence by virtue of this Order, the period until the application for such product licence has been finally disposed of or such longer period as the licensing authority may in any particular case allow.

(3) For the purposes of this Article an application shall be taken as finally disposed of on (but not before) the occurrence of whichever of the events specified in paragraphs (a) to (e) of section 27(7) of the Act last occurs.

(4) The exemption conferred by paragraph (1) of this Article shall not apply during the period referred to in paragraph (2)(b) above if, and so long as, the licensing authority are of the opinion that in the interests of safety the said exemption should not apply and if the licensing authority have in writing so notified the person whose activities in relation to the medicinal product in question would have been exempt by virtue of the said exemption but for the provisions of this paragraph and so long as such notification has not been withdrawn by the licensing authority.

Exemption from wholesale dealer's licences

3.-(1) Subject to the provisions of Article 2 of this Order, the restrictions imposed by section 8(3) of the Act shall not apply to the sale or offer for sale by way of wholesale dealing of a medicinal product, other than a veterinary drug, which is for sale as confectionery if, and so long as, the conditions specified in paragraph (2) of this Article are satisfied.

(2) The conditions referred to in paragraph (1) of this Article are-

(a)that the product licence in respect of the medicinal product as aforesaid provides that the product may be sold or offered for sale by way of wholesale dealing by persons exempt from the need to hold a wholesale dealer's licence by virtue of this Order,

(b)that the medicinal product as aforesaid is not sold or offered for sale accompanied by or having in relation to it any particulars in writing specifying that product's curative or remedial function in relation to a disease specified other than in relation to the relief of symptoms of coughs, colds or nasal congestion, and

(c)that the medicinal product as aforesaid may be lawfully sold by retail otherwise than in accordance with a prescription given by a doctor or dentist or from premises other than a registered pharmacy.

EXPLANATORY NOTE

This Order exempts from the restrictions imposed by section 8(3) of the Medicines Act 1968 as to wholesale dealing in medicinal products except in accordance with a licence granted under the Act, the sale or offer for sale by way of wholesale dealing of medicinal products which are for sale as confectionery. The exemption applies only if certain specified conditions are satisfied. The Order also provides temporary provisions for certain periods after the coming into operation of the Order during which periods not all of the conditions so specified are required to be satisfied.