Statutory Instruments
1997 No. 1350

MEDICINES
The Medicines (Pharmacy and General Sale—Exemption) (Amendment) Order 1997

Made
23rd May 1997

Laid before Parliament
9th June 1997

Coming into force
30th June 1997

The Secretary of State concerned with health in England, the Secretaries of State respectively concerned with health and with agriculture in Wales and in Scotland, the Minister of Agriculture, Fisheries and Food, the Department of Health and Social Services for Northern Ireland and the Department of Agriculture for Northern Ireland, acting jointly, in exercise of the powers conferred on them by sections 57(1) and (2), and 129(4) of the Medicines Act 1968(1) (“the Act”), and now vested in them(2), after consulting such organisations as appear to them to be representative of interests likely to be substantially affected by the following Order in accordance with section 129(6) of the Act(3), and after taking into account the advice of the Medicines Commission in accordance with section 129(7) of the Act(4), hereby make the following Order:

Title and commencement

1.  This Order may be cited as the Medicines (Pharmacy and General Sale—Exemption) (Amendment) Order 1997 and shall come into force on 30th June 1997.

Amendment of the Medicines (Pharmacy and General Sale—Exemption) Order 1980

2.  The Medicines (Pharmacy and General Sale—Exemption) Order 1980(5) shall be amended as follows—

(a)in article 1(2)(a)—

(i)after the definition of “parenteral administration”, the following definition shall be inserted—

““person responsible for marketing” has the same meaning as in Council Directive 92/74/EEC widening the scope of Directive 81/851/EEC on the approximation of the provisions laid down by law, regulation or administrative action relating to veterinary medicinal products and laying down additional provisions on homeopathic veterinary medicinal products(6)”, and

(ii)after the definition of “prescription only medicine”, the following definition shall be inserted—

““registered homoeopathic veterinary medicinal product” means a homoeopathic veterinary medicinal product registered under the Registration of Homoeopathic Veterinary Medicinal Products Regulations 1997(7);”,

(b)in article 5(3), for the words “by the holder of a product licence granted under Part II of the Act or a marketing authorisation to which the Marketing Authorisations for Veterinary Medicinal Products Regulations 1994 apply in respect of the veterinary drug in question and”, there shall be substituted the following words—

“by—

(a)
the holder of a product licence granted under Part II of the Act or a marketing authorisation to which the Marketing Authorisations for Veterinary Medicinal Products Regulations 1994 apply in respect of the veterinary drug in question, or

(b)
in the case of a registered homoeopathic veterinary medicinal product, the person responsible for marketing such product, and,” and

(c)in Part I of Schedule 1, after item 11, the following item shall be inserted—

“in column 1
in column 2
in column 3

(Persons Exempted)—
(Medicinal products to which the exemption applies)—
(Conditions)—

12.  A person responsible for marketing a registered homoeopathic veterinary medicinal product

The registered homoeopathic veterinary medicinal product that such person is responsible for marketing
As item 11 above.”

Signed by authority of the Secretary of State for Health

Baroness Jay
Minister of State,
Department of Health
20th May 1997

Signed by authority of the Secretary of State for Wales

Win Griffiths
Parliamentary Under Secretary of State, Welsh Office
20th May 1997

Sewel
Parliamentary Under Secretary of State, Scottish Office
21st May 1997

Jeff Rooker
Minister of State, Ministry of Agriculture, Fisheries and Food
16th May 1997

Sealed with the Official Seal of the Department of Health and Social Services for Northern Ireland this

L.S.
D. C. Gowdy
Permanent Secretary
23rd day of May 1997

Sealed with the Official Seal of the Department of Agriculture for Northern Ireland this

L.S.
P. J. Small
Permanent Secretary
21st day of May 1997

Explanatory Note

(This note is not part of the Order)
This Order comes into force on 30th June 1997. It further amends the Medicines (Pharmacy and General Sale—Exemption) Order 1980 (S.I. 1980/1924) (“the 1980 Order”) which specifies exemptions from the general requirements as to the retail sale or supply of medicinal products set out in sections 52 and 53 of the Medicines Act 1968 (“the Act”). Section 52 of the Act provides that (subject to any exemption) medicinal products not on a general sale list shall not be sold or supplied elsewhere other than on premises which are a registered pharmacy and by or under the supervision of a pharmacist. Section 53 of the Act provides that (subject to any exemption) medicinal products on a general sale list may not be sold elsewhere other than at a registered pharmacy unless certain conditions are fulfilled.
The principal amendments made to the 1980 Order by this Order are as follows:
(a)article 2(b) amends article 5(3) of the 1980 Order to extend the scope of an exemption from the requirement to fulfil the conditions in section 53(3) of the Act in respect of the sale or supply by a person responsible for marketing a homoeopathic veterinary medicinal product registered under the Registration of Homoeopathic Veterinary Medicinal Products Regulations 1997 (S.I. 1997/322) (“a registered homoeopathic veterinary medicinal product”) to a person who has in his charge or maintains animals for the purposes of and in the course of carrying on a business, and
(b)article 2(c) adds, as item 12 at the end of Part I of Schedule 1 to the 1980 Order, an exemption from the restrictions imposed by section 52 of the Act, in respect of certain sales or supplies of a registered homoeopathic veterinary medicinal product by a person responsible for marketing the product to a pharmacist to enable him to prepare an entry relating to the product in a tablet or capsule identification guide or similar publication.
In amending the 1980 Order, the Order supplements the 1997 Regulations in implementing the classification provisions of the second paragraph of Article 7.1 of Council Directive 92/74/EEC widening the scope of Directive 81/851/EEC on the approximation of provisions laid down by law, regulation or administrative action relating to veterinary medicinal products and laying down additional provisions on homeopathic veterinary medicinal products (OJ No. L297, 13.10.92, p. 12).


(1)
1968 c. 67; “the appropriate Ministers” referred to in section 57(1) are defined in section 1 (see also the following footnote). Sections 57 and 129 were applied in relation to the homoeopathic veterinary medicinal products with which the amendments effected by this Order are concerned by regulation 34(1) of, and Schedule 5 to, S.I. 1997/322.

(2)
In the case of the S ecretaries of State concerned with health in England and in Wales, by virtue of S.I. 1969/388, in the case of the Secretary of State concerned with agriculture in Wales, by virtue of S.I. 1978/272, and, in the case of the Northern Ireland Departments, by virtue of the Northern Ireland Constitution Act 1973 (c. 36), section 40 and Schedule 5, and the Northern Ireland Act 1974 (c. 28), section 1(3) and Schedule 1, paragraph 2(1)(b).

(3)
As regards the application of section 129 to homoeopathic veterinary medicinal products, see footnote (a) above.

(4)
As regards the application of section 129 to homoeopathic veterinary medicinal products, see footnote (a) above.

(5)
S.I. 1980/1924, relevant amending instrument is S.I. 1994/3142.

(6)
OJ No. L297, 13.10.92, p. 12.

(7)
S.I. 1997/322.