The Medicines (Cyanogenetic Substances) Order 1984

Statutory Instruments

1984 No. 187

MEDICINES

The Medicines (Cyanogenetic Substances) Order 1984

Laid before Parliament in draft

Made

20th February 1984

Coming into Operation

1st March 1984

The Secretaries of State respectively concerned with health in England, in Wales and in Scotland and the Department of Health and Social Services for Northern Ireland, acting jointly, in exercise of powers conferred by section 104(1) of the Medicines Act 1968 and now vested in them(1) and of all other powers enabling them in that behalf, after consulting pursuant to section 129(6) of that Act such organisations as appear to them to be representative of interests likely to be substantially affected by the order and after taking into account pursuant to section 129(7) of that Act the advice of the Committee on Safety of Medicines, hereby make the following order, a draft of which has been laid before Parliament pursuant to section 104(2) of that Act and has been approved by resolution of each House of Parliament:

Citation, commencement and interpretation

1.—(1) This order may be cited as the Medicines (Cyanogenetic Substances) Order 1984 and shall come into operation on the tenth day after the day on which it is made.

(2) In this order—

“the Act” means the Medicines Act 1968;

“cyanogenetic substances” means preparations which—

(a)

are presented for sale or supply under the name of, or as containing, amygdalin, laetrile or vitamin B17 or

(b)

contain more than 0.1 per cent by weight of any substance having the formula either α-Cyanobenzyl-6-O-Β-D-glucopyranosyl-Β-D-glucopyranoside or α-Cyanobenzyl-Β-D-glucopyranosiduronic acid.

Application of specified provisions of the Act

2.  For the purposes of section 104(1) of the Act, cyanogenetic substances which are intended for human consumption and are not manufactured, sold, supplied, imported or exported wholly or mainly in either of the ways specified in section 130(1) of the Act are hereby specified as substances which appear to the Health Ministers to be substances which are not medicinal products but which are manufactured, sold, supplied, imported or exported for use wholly or partly for a medicinal purpose and it is hereby directed that the provisions contained in Part I, sections 51, 52, 55(1), 57, 58, 61 to 67, 85 to 88, 91 to 93, 95 and 97 and Part VIII of the Act shall have effect in relation to such substances as those provisions have effect in relation to medicinal products.

Signed by authority of the Secretary of State for Social Services.

John Patten

Parliamentary Under-Secretary of State

Department of Health and Social Security

15th February 1984

Nicholas Edwards

Secretary of State for Wales

17th February 1984

George Younger

Secretary of State for Scotland

20th February 1984

Sealed with the official seal of the Department of Health and Social Services for Northern Ireland this 17th day of February 1984.

L.S.

Maurice N. Hayes

Permanent Secretary

EXPLANATORY NOTE

This Order extends the application of those provisions of the Medicines Act 1968 specified in Article 2 of the Order to preparations which are not medicinal products but are either presented for sale or supply as, or as containing, amygdalin, laetrile or vitamin B17 or contain the cyanide-producing substances mentioned in Article 1(2)(b) of the Order. The provisions which are so applied relate to the administration of the Act, dealings with products (including sale, supply and importation), the packaging and promotion of products, criminal offences created to enforce those provisions, and miscellaneous and supplementary provisions. Part II of that Act relating to the licensing of products is not applied.

(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), 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).