The Medicines (Products Other Than Veterinary Drugs) (Prescription Only) Amendment (No. 2) Order 1992

Statutory Instruments

1992 No. 2937

MEDICINES

The Medicines (Products Other Than Veterinary Drugs) (Prescription Only) Amendment (No. 2) Order 1992

Made

24th November 1992

Laid before Parliament

26th November 1992

Coming into force

18th December 1992

The Secretary of State concerned with health in England, the Secretaries of State concerned with health and agriculture in Wales and in Scotland respectively, 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 the powers conferred upon them by sections 58(1) and (4) 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 sections 58(6) and 129(7) of that Act, hereby make the following Order:

Citation, commencement and interpretation

1.—(1) This Order may be cited as the Medicines (Products Other Than Veterinary Drugs) (Prescription Only) Amendment (No. 2) Order 1992, and shall come into force on 18th December 1992.

(2) In this Order “the principal Order” means the Medicines (Products Other Than Veterinary Drugs) (Prescription Only) Order 1983(3).

Amendment of article 4 of the principal Order

2.  In article 4 of the principal Order (medicinal products that are not prescription only), the following paragraph is substituted for paragraph (1E):—

“(1E) Notwithstanding article 3(1)(a), a medicinal product shall not be a prescription only medicine by reason that it contains the substance carbenoxolone sodium where—

(a) the medicinal product is in the form of granules;

(b) the maximum strength of the carbenoxolone sodium in the medicinal product does not exceed one per cent calculated in terms of weight in weight;

(c) the medicinal product is sold or supplied in a container or package containing not more than 560 milligrams of carbenoxolone sodium;

(d) the container or package of the medicinal product is labelled to show a maximum daily dose of 80 milligrams of carbenoxolone sodium and a maximum dose of 20 milligrams of carbenoxolone sodium; and

(e) the medicinal product is indicated only for treatment by mouthwash, in adults and in children over the age of 12 years;

and for the purposes of this paragraph “maximum daily dose” means the maximum quantity of the substance carbenoxolone sodium which it is recommended should be used as a mouthwash in a period of 24 hours and “maximum dose” means the maximum quantity of the substance carbenoxolone sodium which it is recommended should be used at any one time.”.

Amendment of article 5 of the principal Order

3.  In article 5 of the principal Order (exemption for parenteral administration to human beings of certain prescription only medicines) immediately after the words “Diphenhydramine Injection” are inserted the words “Glucagon Injection”.

Amendment of Part III of Schedule 3 to the principal Order

4.  At the end of Part III of Schedule 3 to the principal Order (exemptions for certain persons from the provisions of section 58(2)(b) of the Medicines Act 1968 concerning parenteral administration of prescription only medicines) there is inserted the paragraph set out in the Schedule to this Order.

Signed by authority of the Secretary of State for Health

Brian Mawhinney

Minister,

Department of Health

20th November 1992

David Hunt

Secretary of State for Wales

20th November 1992

Fraser of Carmyllie

Minister of State Scottish Office

24th November 1992

In witness whereof the Official Seal of the Minister of Agriculture, Fisheries and Food is hereunto affixed on 24th November 1992.

L.S.

Derek Andrews

Permanent Secretary, Ministry of Agriculture, Fisheries and Food

Sealed with the Official Seal of the Department of Health and Social Services for Northern Ireland this 23rd day of November 1992.

L.S.

F. A. Elliott

Permanent Secretary

Sealed with the Official Seal of the Department of Agriculture for Northern Ireland this 20th day of November 1992.

L.S.

W. J. Hodges

Permanent Secretary

Article 4

SCHEDULE PARAGRAPH INSERTED IN PART III OF SCHEDULE 3 TO THE PRINCIPAL ORDER

Column	Column	Column
Persons exempted	Prescription only medicines to which the exemption applies	Conditions
9.  Persons who hold a certificate of proficiency in ambulance paramedic skills issued by, or with the approval of, the Secretary of State	9.  The following prescription only medicines for parenteral administration— (a) Diazemuls (product licence number 10183/ 0001); (b) Gelofusine (product licence number 00183/ 5025R); (c) prescription only medicines containing one or more of the following substances, but no other active ingredient— Adrenaline Acid Tartrate Anhydrous Glucose Ergometrine Maleate Glucose Heparin Sodium Lignocaine Hydrochloride Nalbuphine Hydrochloride Naloxone Hydrochloride Polygeline Sodium Bicarbonate Sodium Chloride	9.  The administration shall be only for the immediate, necessary treatment of sick or injured persons and in the case of a prescription only medicine containing Heparin Sodium shall be only for the purpose of cannula flushing.

Explanatory Note

(This note is not part of the Order)

This Order further amends the Medicines (Products Other Than Veterinary Drugs) (Prescription Only) Order 1983 (the principal Order) which specifies descriptions and classes of prescription only medicines, that is to say, medicinal products which (subject to exemptions) may be sold or supplied by retail only in accordance with a prescription given by an appropriate practitioner and which may be administered only by or in accordance with the directions of such a practitioner.

Article 2 replaces paragraph (1E) of article 4 of the principal Order introduced by the Medicines (Products Other Than Veterinary Drugs) (Prescription Only) Amendment Order 1992 which exempts certain products containing Carbenoxolone Sodium 1% from being prescription only medicines, as the drafting of paragraph (1E) was ambiguous in certain respects.

Article 3 amends article 5 of the principal Order by adding Glucagon Injection to the list of prescription only medicines which may be administered to human beings for the purpose of saving life in an emergency.

Article 4 amends Part III of Schedule 3 to the principal Order (which contains exemptions from the restrictions on administration of prescription only medicines) by adding an exemption in respect of the administration of specified medicines by certain ambulance paramedics.

(1)

1968 c. 67; see the meaning assigned to “the appropriate Ministers” by sections 1(2) and 132(1) and to “the Ministers” by section 1(1) as amended.

(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 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); 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).

(3)

S.I. 1983/1212, as amended by S.I. 1984/756, 1986/586, 1987/674 and 1250, 1988/2017, 1989/1852, 1991/962 and 1992/1534.