Statutory Instruments
1998 No. 107

MEDICINES
The Medicines (Pharmacy and General Sale—Exemption) Amendment Order 1998

Made
23rd January 1998

Laid before Parliament
23rd January 1998

Coming into force
13th February 1998

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 pursuant to section 129(6) of that Act, and after consulting and taking into account the advice of the Medicines Commission pursuant to section 129(7) of that Act, 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 1998 and shall come into force on 13th February 1998.

(2) In this Order, “the principal Order” means the Medicines (Pharmacy and General Sale—Exemption) Order 1980(3).

Amendment of Schedule 1 to the principal Order

2.  After the paragraph numbered 1 in each of Columns 1, 2 and 3 of Part I of Schedule 1 to the principal Order there is inserted the paragraph numbered 1A as it appears in the corresponding column of the Schedule to this Order.

Signed by authority of the Secretary of State for Health

Jay
Minister of State,
Department of Health
16th January 1998

Win Griffiths
Parliamentary Under Secretary of State
The Welsh Office
23rd January 1998

Sam Galbraith
Parliamentary Under Secretary of State
The Scottish Office
20th January 1998

Sealed with the Official Seal of the Department of Health and Social Services for Northern Ireland on

L.S.
D. C. Gowdy
Permanent Secretary
19th January 1998

Article 2
THE SCHEDULE

Column 1
Column 2
Column 3

Persons exempted
Medicinal products to which the exemption applies
Conditions

1A.  State registered chiropodists who hold a certificate of competence in the use of the medicines specified in Column 2 issued by or with the approval of the Chiropodists Board.

1A.—(a) The following prescription only medicines—

(i)Co-dydramol 10/500 tablets;

(ii)Amorolfine hydrochloride cream where the maximum strength of the Amorolfine in the cream does not exceed 0.25 per cent by weight in weight;

(iii)Amorolfine hydrochloride lacquer where the maximum strength of the Amorolfine in the lacquer does not exceed 5 per cent by weight in volume; and

(iv)Topical hydrocortisone where the maximum strength of the hydrocortisone in the medicinal product does not exceed 1 per cent by weight in weight; and

(b)Ibuprofen, other than preparations of ibuprofen which are prescription only medicines.

1A.  The sale or supply shall be only in the course of their professional practice, and the medicinal product must have been made up for sale or supply in a container elsewhere than at the place at which it is sold or supplied. The quantity to be sold or supplied to a person at any one time shall not exceed—

(a)(i)in the case of Co-dydramol 10/500 tablets an amount sufficient for 3 days' treatment to a maximum of 24 tablets;

(b)in the case of Ibuprofen an amount sufficient for 3 days' treatment where the maximum dose is 400 mg, the maximum daily dose is 1,200 mg and the maximum pack size is 3,600 mg.

Explanatory Note

(This note is not part of the Order)
This Order amends the Medicines (Pharmacy and General Sale—Exemption) Order 1980 which specifies exemptions from the general requirements as to retail sale or supply set out in sections 52 and 53 of the Medicines Act 1968. The amendment extends the range of products which may be sold or supplied by state registered chiropodists to include ibuprofen, co-dydramol 10/500, amorolfine hydrochloride and topical hydrocortisone, where those chiropodists hold an appropriate certificate of competence in the use of medicines.


(1)
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.

(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); 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. 1980/1924, relevant amending instrument is S.I. 1982/27.