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Statutory Instruments
1994 No. 2409
MEDICINES
The Medicines (Pharmacy and General Sale- Exemption) Amendment Order 1994
Made
7th September 1994
Laid before Parliament
13th September 1994
Coming into force
12th October 1994
The Secretaries of State concerned with health in England, in Wales and in Scotland respectively and the Department of Health and Social Services for Northern Ireland, acting jointly, in exercise of powers conferred upon them by sections 57(1) and (2) and 129(4) of the Medicines Act 1968(1) or, as the case may be, those conferred by the said provisions and now vested in them(2), 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 this Order and after consulting and taking into account the advice of the Medicines Commission(3), hereby make the following Order:
Citation, commencement and interpretation
1.-(1) This Order may be cited as the Medicines (Pharmacy and General Sale- Exemption) Amendment Order 1994 and shall come into force on 12th October 1994.
(2) In this Order, "the principal Order" means the Medicines (Pharmacy and General Sale- Exemption) Order 1980(4).
Amendment of article 2 of the principal Order
2. After paragraph (2) of article 2 of the principal Order (temporary exemption for certain products for human use) there shall be inserted the following paragraphs-
"(3) The restrictions imposed by section 52 shall not apply during the period specified in paragraph (4) to the sale, offer or exposure for sale or supply of any medicinal product-
(a)in respect of which a certificate of registration, granted pursuant to the Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994(5), is in force;
(b)which is neither of a description nor in a class specified in an order under section 58(1) (medicinal products on prescription only) which is for the time being in force;
(c)which is not a controlled drug;
(d)which does not fall within a class specified in Schedule 3 to the Medicines (General Sale List) Order 1984(6);
if and so long as either the medicinal product is sold, offered or exposed for sale or supplied by or under the supervision of a pharmacist or the conditions specified in section 53 (sale or supply of medicinal products on general sale list) are fulfilled.
(4) The period referred to in paragraph (3) is that of two years from the date of the grant of the certificate of registration.".
Signed by authority of the Secretary of State for Health
Tom Sackville
Parliamentary Under Secretary of State,
Department of Health
6th September 1994
John Redwood
Secretary of State for Wales
6th September 1994
Allan Stewart
Parliamentary Under Secretary of State, The Scottish Office
6th September 1994
Sealed with the Official Seal of the Department of Health and Social Services for Northern Ireland on
L.S.
F. A. Elliott
Permanent Secretary
7th September 1994.
Explanatory Note
(This note is not part of the Order)
This Order amends the Medicines (Pharmacy and General Sale- Exemption) Order 1980 ("the principal Order") which provides certain exemptions from the restrictions imposed by sections 52 and 53 of the Medicines Act 1968. Section 52 provides that medicinal products not on a general sale list shall be sold or supplied only on premises that are a registered pharmacy and by or under the supervision of a pharmacist.
Article 2 of this Order amends article 2 of the principal Order to grant a temporary exemption (subject to conditions) from the restrictions in section 52 to medicinal products in respect of which certificates of registration have been granted under the Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994 but which are not prescription only medicines, controlled drugs or within a class specified in Schedule 3 to the Medicines (General Sale List) Order 1984. The amendment provides that the exemption is to last two years from the date of grant of the certificate.
1968 c. 67. The expressions "the appropriate Ministers" and "the Health Ministers" are defined in section 1(1)(a) and (2) of that Act as amended by S.I. 1969/388, Schedule 1.
In the case of the Secretaries of State concerned with health in England and in Wales by virtue of article 2(2) of, and Schedule 1 to, the Transfer of Functions (Wales) Order 1969 (S.I. 1969/388); in the case of the Department of Health and Social Services for Northern Ireland by virtue of section 40 of, and Schedule 5 to, the Northern Ireland Constitution Act 1973 (c. 36) and section 1(3) of, and paragraph 2(1)(b) of Schedule 1 to, the Northern Ireland Act 1974 (c. 28).
See section 129(6) and (7) of the Medicines Act 1968.