The Medicines (Retail Pharmacists—Exemptions from Licensing Requirements) Order 1971

Statutory Instruments

1971 No. 1445

MEDICINES

The Medicines (Retail Pharmacists—Exemptions From Licensing Requirements) Order 1971

Laid before Parliament in draft

Made

27th August 1971

Coming into Operation

1st September 1971

The Secretaries of State respectively concerned with health in England and Wales, the Secretary of State concerned with health and with agriculture in Scotland, the Minister of Health and Social Services for Northern Ireland, the Minister of Agriculture, Fisheries and Food and the Minister of Agriculture for Northern Ireland, acting jointly in exercise of their powers under section 15(3) of the Medicines Act 1968, as having effect subject to the provisions of article 2(2) of and Schedule 1 to the Transfer of Functions (Wales) Order 1969(1) and of all other powers enabling them in that behalf, after consulting such organisations as appear to them to be representative of interests likely to be substantially affected by the following order hereby make the following order, a draft of which has been laid before Parliament and has been approved by resolution of each House of Parliament:—

Citation and commencement

1.  This order may be cited as the Medicines (Retail Pharmacists—Exemptions from Licensing Requirements) Order 1971 and shall come into operation on 1st September 1971.

Interpretation

2.—(1) In this order unless the context otherwise requires “ the Act” means the Medicines Act 1968 and other expressions have the same meaning as in the Act.

(2) The Interpretation Act 1889 shall apply to the interpretation of this order as it applies to the interpretation of an Act of Parliament.

Modifications of exemptions for pharmacists

3.  The provisions of section 10 of the Act (exemptions for pharmacists from licensing requirements) shall have effect as modified as follows:—

(a) by the addition in subsection (1)(b) after the words “medicinal product” of the words

“provided that where the assembling takes place in a registered pharmacy—

(i) it shall be in a registered pharmacy at which the business in medicinal products carried on is restricted to retail sale or to supply in circumstances corresponding to retail sale and the assembling is done with a view to such sale or supply either at that registered pharmacy or at any other such registered pharmacy forming part of the same retail pharmacy business, and

(ii) the medicinal product has not been the subject of an advertisement”;

(b) by the addition at the end of subsection (4)(b) after the words “of this subsection” of the words “provided that such stock is prepared with a view to retail sale or to supply in circumstances corresponding to retail sale and the preparation is done with a view to such sale or supply either at that registered pharmacy or at any other registered pharmacy forming part of the same retail pharmacy business”;

(c) by the addition after subsection (4) of the following subsections—

“(5) Without prejudice to the preceding subsections, the restrictions imposed by section 7 of this Act do not apply to the preparation or dispensing in a registered pharmacy of a medicinal product by or under the supervision of a pharmacist where—

(a) the medicinal product is prepared or dispensed otherwise than in pursuance of an order from any other person, and

(b) the medicinal product is prepared with a view to retail sale or supply in circumstances corresponding to retail sale at the registered pharmacy at which it is prepared, and

(c) the medicinal product has not been the subject of an advertisement.

(6) Without prejudice to the preceding subsections, the restrictions imposed by section 8(2) of this Act do not apply to anything which is done in a registered pharmacy by or under the supervision of a pharmacist and consists of preparing a medicinal product with a view to retail sale or to supply in circumstances corresponding to retail sale at that registered pharmacy.

(7) Without prejudice to the preceding subsections, the restrictions imposed by section 8(3) of this Act do not apply to anything which is done in a registered pharmacy by or under the supervision of a pharmacist and amounts to wholesale dealing, where such dealing constitutes no more than an inconsiderable part of the business carried on by the pharmacist at that pharmacy.

(8) For the purposes of this section “advertisement” shall have the meaning assigned to it by section 92 of this Act, except that it shall not include words inscribed on the medicinal product, or on its container or package.”.

4.—(1) So long as section 12 of the Pharmacy and Poisons Act 1933.remains in force in its application to Great Britain, section 10 of the Act, as it has effect subject to the exceptions or modifications specified in this order, in so far as that section relates to a registered pharmacy shall apply to anything that is done in the premises of an authorised seller of poisons within the meaning of the Pharmacy and Poisons Act 1933, being premises that are entered in the register kept under section 12 of that Act.

(2) So long as section 17 of the Pharmacy and Poisons Act (Northern Ireland) 1925 remains in force, section 10 of the Act, as it has effect subject to the exceptions or modifications specified in this order, in so far as section 10 relates to a registered pharmacy, shall apply to anything that is done in premises for which an annual licence is in force under the said section 17.

Keith Joseph

Secretary of State for Social Services

10th August 1971

Signed by authority of the Secretary of State for Wales.

David Gibson-Watt

Minister of State

Welsh Office

27th August 1971

Gordon Campbell

Secretary of State for Scotland

25th August 1971

W. K. Fitzsimmons

Minister of Health and Social Services for Northern Ireland

16th August 1971

In witness whereof the official seal of the Minister of Agriculture, Fisheries and Food is hereunto affixed on 24th August 1971.

L.S.

J. M. L. Prior

Minister of Agriculture, Fisheries and Food

H. W. West

Minister of Agriculture for Northern Ireland

17th August 1971

EXPLANATORY NOTE

This order modifies section 10 of the Medicines Act 1968, which provides exemptions for pharmacists from the need to hold licences.

The amendment to section 10(1)(b) ensures that the exemptions in the case of the assembling of medicinal products shall apply only where the assembling is with a view to sale at the retail pharmacy at which it occurs or at other retail pharmacies forming part of the same business, and that the product has not been advertised. The exemption provided by section 10(4)(b) is modified by restricting it to cases in which the stocks are prepared for retail sale or supply at that pharmacy or another forming part of the same business.

Four new subsections are added. These exempt from the requirement to hold a product licence a retail pharmacist who prepares a medicinal product on his own initiative for retail sale at his pharmacy, provided that the product is not advertised, exempt from the requirement to hold a manufacturer's licence a retail pharmacist who prepares at his retail pharmacy medicinal products for retail sale or supply at that pharmacy, and exempt from the need to hold a wholesale dealer's licence a retail pharmacist whose wholesale dealings form no more than an inconsiderable part of his business.

The order provides that section 10 shall apply to anything done on the registered premises of an authorised seller of poisons, and contains like provisions relating to Northern Ireland.

(1)

(1969 I, p. 1070).