The Medicines (Child Safety) Amendment Regulations 1994 No. 1402


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United Kingdom Statutory Instruments


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Statutory Instruments

1994 No. 1402

MEDICINES

The Medicines (Child Safety) Amendment Regulations 1994

Made

24th May 1994

Laid before Parliament

25th May 1994

Coming into force

15th June 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 87(1), 91(3) and 129(5) 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, 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 these Regulations, and after taking into account the advice of the Medicines Commission pursuant to section 129(7) of that Act, hereby make the following Regulations:

Citation and commencement

1. These Regulations may be cited as the Medicines (Child Safety) Amendment Regulations 1994 and shall come into force on 15th June 1994.

Amendment of regulation 2 of the Medicines (Child Safety) Regulations 1975

2.-(1) Regulation 2(3) of the Medicines (Child Safety) Regulations 1975(3) (child resistant containers for aspirin and paracetamol) shall be amended in accordance with the following paragraphs of this regulation.

(2) For sub-paragraph (b) there shall be substituted the following sub-paragraph-

"(b)reclosable containers which are opaque or dark-tinted, identical in all respects to containers which comply with the requirements of British Standard EN 28317 published by the British Standards Institution on 15 February 1993, or".

(3) For sub-paragraph (e) there shall be substituted the following sub-paragraph-

"(e)reclosable containers which are opaque or dark-tinted, identical in all respects to containers which comply with the requirements of British Standard 6652 published on 30 September 1985 as amended and re-published on 30 June 1989, and which-

(i)have been certified by the British Standards Institution as complying with those requirements, or

(ii)are part of a series of containers in respect of which the licensing authority has been furnished with a report by the British Standards Institution to the effect that such containers comply with the requirements of British Standard 6652 as amended.".

Signed by Authority of the Secretary of State for Health.

Tom Sackville

Parliamentary Under-Secretary of State

Department of Health

23rd May 1994

John Redwood

Secretary of State for Wales

24th May 1994

Fraser of Carmyllie

Minister of State The Scottish Office

24th May 1994

Sealed with the Official Seal of the Department of Health and Social Services for Northern Ireland this 24th day of May 1994.

F. A. Elliott

Permanent Secretary

Explanatory Note

(This note is not part of the Regulations)

These Regulations further amend the Medicines (Child Safety) Regulations 1975 which prohibit the sale or supply of certain aspirin or paracetamol other than in child resistant containers.

Regulation 2(2) provides that the standard to which containers covered by these Regulations must conform is now the British Standard EN 28317 (published in February 1993). Regulation 2(3) provides that it will be sufficient for containers to comply with the previous British Standard 6652 (published in 1985 and amended and republished in 1989) if a certificate of conformity with that Standard has been issued by the British Standards Institution (BSI), and makes special provision for containers which form part of a series.

The British Standards referred to in these Regulations may be obtained from any of the sales outlets operated by the BSI or by post from the BSI at Linford Wood, Milton Keynes MK14 6LE.

(1)

1968 c. 67. The expressions "the appropriate Ministers" and "the Health Ministers" are defined in section 1 of that Act as amended by S.I. 1969/388. See section 132(1) for the definition of "prescribed".

(2)

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).

(3)

S.I. 1975/2000, amended by S.I. 1976/1643 and 1987/877.


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URL: http://www.bailii.org/uk/legis/num_reg/1994/uksi_19941402_en.html