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United Kingdom Statutory Instruments |
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You are here: BAILII >> Databases >> United Kingdom Statutory Instruments >> The Medicines (Standard Provisions for Licences and Certificates) Amendment (No. 2) Regulations 1977 No. 1039 URL: http://www.bailii.org/uk/legis/num_reg/1977/uksi_19771039_en.html |
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Statutory Instruments
MEDICINES
Made
16th June 1977
Laid before Parliament
23rd June 1977
Coming into Operation
14th July 1977
The Secretaries of State respectively concerned with health in England and in Wales, the Secretary of State concerned with health and with agriculture 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 powers conferred by section 47(1) of the Medicines Act 1968 and now vested in them(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 regulations, hereby make the following regulations:-
1.-(1) These regulations may be cited as the Medicines (Standard Provisions for Licences and Certificates) Amendment (No. 2) Regulations 1977 and shall come into operation on 14th July 1977.
(2)
2. After paragraph 11 of Part I of Schedule 1 to the principal regulations (standard provisions for product licences including product licences of right) there shall be inserted the following paragraphs-
"12.-(1) Where the licence relates to a medicinal product which has been or is to be imported-
(a)where the licensing authority have required the production of an undertaking given by or on behalf of the manufacturer of the medicinal product in accordance with section 19(3)(a) of the Act the licence holder shall ensure that the medicinal product is not sold or supplied unless the medicinal product has been manufactured or assembled in the premises in respect of which the undertaking has been given;
(b)the licence holder shall ensure that the medicinal product is not sold or supplied unless the medicinal product has been manufactured or assembled in such premises and in such circumstances as to comply with the relevant conditions specified in the Schedule to the Medicines (Manufacturer's Undertakings for Imported Products) Regulations 1977(4) but so that for the purpose of this sub-paragraph references to those regulations shall not be construed as a reference to those regulations as amended by any regulations subsequent to the grant of the licence.
In this paragraph, "relevant conditions" means
(2) The licence holder shall inform the licensing authority of any information supplied to him pursuant to paragraphs 6 and 8 of the Schedule to the Medicines (Manufacturer's Undertakings for Imported Products) Regulations 1977.
13. Where the licence is a licence of right which has been renewed by the licensing authority and at any time after the licence has been renewed regulations are made which amend the principal regulations by inserting additional standard provisions in this Part of this Schedule the licence holder shall, before the end of the period of three months from the date upon which such regulations come into operation, apply to vary the provisions of the licence to incorporate provisions having the like effect as the provisions so inserted in this Part of this Schedule.".
David Ennals
Secretary of State for Social Services
30th May 1977
John Morris
Secretary of State for Wales
2nd June 1977
Bruce Millan
Secretary of State for Scotland
14th June 1977
In witness whereof the official seal of the Minister of Agriculture, Fisheries and Food is hereunto affixed on 10th June 1977.
L.S.
John Silkin
Minister of Agriculture, Fisheries and Food
Sealed with the official seal of the Department of Health and Social Services for Northern Ireland this 15th day of June 1977.
L.S.
N. Dugdale
Permanent Secretary
Sealed with the official seal of the Department of Agriculture for Northern Ireland this 16th day of June 1977.
L.S.
J. A. Young
Permanent Secretary
These Regulations further amend the Medicines (Standard Provisions for Licences and Certificates) Regulations 1971 and add to Schedule 1 of the principal regulations further standard provisions which may be incorporated in product licences. Paragraph 12 of Schedule 1 relates to imported medicinal products and paragraph 13 relates to product licences of right which have been renewed.
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(1969 I, p. 1070)), and in the case of the Northern Ireland Departments 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).
(1971 II, p. 2809).
The relevant amending instrument is S.I. 1974/1523 (1974 III, p. 5811).
S.I.1977/1038(1977 II, p. 2950).
