The Medicines (Control of Substances for Manufacure and Exportation of Specified Products for Human Use) Amendment Order 1994
S.I. 1994/787 · Made 16 March 1994
MEDICINES
Made 16th March 1994
Laid before Parliament 17th March 1994
Coming into force 11th April 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 49 and 129(4) of the Medicines Act 1968f1 or, as the case may be, those conferred by the said provisions and now vested in themf2, and those Secretaries of State and that Department together with the Minister of Agriculture, Fisheries and Food, the Secretaries of State concerned with agriculture in Scotland and in Wales respectively and the Department of Agriculture for Northern Ireland, acting jointly in exercise of powers conferred upon them by sections 105(1)(a) and 129(4) of the Medicines Act 1968f3 or, as the case may be, those conferred by the said provisions and now vested in themf4, and in each case in exercise 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 Orderf5, hereby make the following Order:
Annotations to the whole text
Footnotes
- f1
-
1968 c. 67.The expression “the Health Ministers”, used in section 49, is defined in section 1(1)(a) of that Act as amended by Schedule 1 to S.I.1969/388.
- f2
-
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) and 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).
- f3
-
The expression “the Ministers”, used in section 105, is defined in section 1(1) of that Act as amended by S.I.1969/388.
- f4
-
In the case of the Secretary of State concerned with agriculture in Wales by virtue of article 2(3) of, and Schedule 1 to, the Transfer of Functions (Wales) (No.1) Order 1978 (S.I.1978/272); and in the case of the Department of Agriculture 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).
- f5
-
See section 129(6) of the Medicines Act 1968.
Contents
- 1Citation and commencement
- 2Amendment of the Medicines (Control of Substances for Manufacture) Order 1971
- 3Amendment of the Medicines (Control of Substances for Manufacture) Order 1985
- 4Revocation of the Medicines (Exportation of Specified Products for Human Use) Order 1971
- Signature
- Explanatory note
1Citation and commencement
This Order may be cited as the Medicines (Control of Substances for Manufacture and Exportation of Specified Products for Human Use) Amendment Order 1994 and shall come into force on 11th April 1994.
2Amendment of the Medicines (Control of Substances for Manufacture) Order 1971
The Medicines (Control of Substances for Manufacture) Order 1971f1 is amended in accordance with the following paragraphs of this article.
Schedule 1 is amended as follows—
in the paragraphs in Column 2 corresponding to paragraphs 1 to 19 in Column 1, the words “human beings or” are omitted;
in the paragraph in Column 2 corresponding to paragraphs 20 and 21 in Column 1, the words “human beings or” are omitted
in the paragraph in Column 2 corresponding to paragraph 22 in Column 1, the words “human or” are omitted
in the paragraphs in Column 2 corresponding to paragraphs 23 to 34 in Column 1, the words “human or” are omitted and
paragraph 35 in Column 1 and the paragraph in Column 2 corresponding to it are omitted.
In Schedule 2, the definition of “Preparations of blood” is omitted.
3Amendment of the Medicines (Control of Substances for Manufacture) Order 1985
Column 2 of Schedule 1 to the Medicines (Control of Substances for Manufacture) Order 1985f1 is amended as follows—
in the paragraphs corresponding to paragraphs 1 and 2 in Column 1, the words “human beings or” are omitted; and
in the paragraph corresponding to paragraph 3 in Column 1, the words “human or” are omitted.
4Revocation of the Medicines (Exportation of Specified Products for Human Use) Order 1971
The Medicines (Exportation of Specified Products for Human Use) Order 1971f1 is revoked.
Signature
Signed by authority of the Secretary of State for Health
Tom Sackville
Parliamentary Under Secretary of State
Department of Health
12th March 1994
John Redwood
Secretary of State for Wales
15th March 1994
Fraser of Carmyllie
Minister of State The Scottish Office
15th March 1994
In witness whereof the Official Seal of the Minister of Agriculture, Fisheries and Food is hereunto affixed on
L.S.
Gillian Shephard
Minister of Agriculture, Fisheries and Food
16th March 1994.
Sealed with the Official Seal of the Department of Health and Social Services for Northern Ireland this
L.S.
F. A. Elliott
Permanent Secretary
15th day of March 1994.
Sealed with the Official Seal of the Department of Agriculture for Northern Ireland this
L.S.
J. Murray
Permanent Secretary
15th day of March 1994.
Explanatory note
(This note is not part of the Order)
This Order amends the Medicines (Control of Substances for Manufacture) Orders 1971 and 1985, limiting the application of those Orders to substances for veterinary use. Those Orders extend the application of specified provisions of the Medicines Act 1968 to certain substances which are not themselves medicinal products but which are used as ingredients in the manufacture of medicinal products.
The Order revokes the Medicines (Exportation of Specified Products for Human Use) Order 1971, which excepted certain classes of medicinal products for human use (antigens, antitoxins, Sera, antisera, toxins and vaccines) from the postponement of the operation of sections 7 to 47 of the Medicines Act 1968. The effect of the revocation is that the operation of the restrictions in relation to the exportation of the medicinal products specified in that order is postponed under section 48 of that Act, and consequently exportation of such products need not be in accordance with a product licence granted under that Act (although for exportation of such products to a member State of the European Community, a wholesale dealer’s licence is required by virtue of section 49A of that Act).