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Statutory Instruments

1987 No. 674

MEDICINES

The Medicines (Products Other Than Veterinary Drugs) (Prescription Only) Amendment Order 1987

Made

6th April 1987

Laid before Parliament

9th April 1987

Coming into force

30th April 1987

The Secretary of State concerned with health in England, the Secretaries of State respectively concerned with health and with agriculture in Wales and in Scotland, 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 powers conferred by sections 58(1), (4) and (5) and 129(4) of the Medicines Act 1968(1) 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, interpretation and commencement

1.  This Order, which may be cited as the Medicines (Products Other Than Veterinary Drugs) (Prescription Only) Amendment Order 1987, amends the Medicines (Products Other Than Veterinary Drugs) (Prescription Only) Order 1983(3) (hereinafter referred to as “the principal Order”) and shall come into force on 30th April 1987.

Amendment of articles 1, 6 and 12 of the principal Order

2.—(1) In article 1(2) of the principal Order (interpretation) for the definition of “the Misuse of Drugs Regulations” there is substituted the following definition:

(2) In article 6(2)(d), (4)(c) and (5) of the principal Order (which refers to emergency sale or supply by a retail pharmacist) and in article 12(2)(b) of the principal Order (conditions relating to prescriptions), for the words, “Schedule 2, 3 or 4 to the Misuse of Drugs Regulations” there are substituted the words, “Schedule 1, 2 or 3 to the Misuse of Drugs Regulations”.

Amendment of articles 3 and 4 of, and Schedule 1 to, the principal Order

3.—(1) In article 3(1)(a) of the principal Order (medicinal products on prescription only), after the words “subject to article 4(1)” there are inserted the words “and (1A), and Part IV of Schedule 1”.

(2) In article 4 of the principal Order (medicinal products that are not prescription only), after paragraph (1) there is inserted the following paragraph—

“(1A) Notwithstanding article 3(1)(a), medicinal products specified in Part IV of Schedule 1 shall not be prescription only medicines.”

(3) In Part I of Schedule 1 to the principal Order (which lists substances which render a medicinal product a prescription only medicine except in circumstances also listed)—

(a)there are inserted in column 1, at the appropriate point in the alphabetical order of the substances listed, the substances specified in column 1 of Schedule 1 to this Order and in columns 2 and 3, so as to appear against the particular substance to which it relates, there is inserted as the case may be any entry appearing in columns 2 and 3 of Schedule 1 to this Order against that substance;

(b)there are deleted from column 1 the substances specified in Schedule 2 to this Order;

(c)for the entry in columns 2 and 3 relating to the substance Podophyllum Resin listed in column 1 there is substituted the entry relating to that substance set out in columns 2 and 3 of Schedule 3 to this Order;

(d)(i)in the footnote to the column 4 entries relating to the substances Atropine, Atropine Methobromide, Atropine Methonitrate, Atropine Oxide Hydrochloride, Atropine Sulphate, Hyoscine Butylbromide, Hyoscine Hydrobromide, Hyoscine Methobromide, Hyoscine Methonitrate, Hyoscyamine, Hyoscyamine Hydrobromide and Hyoscyamine Sulphate, after the words, “Subject to” there are inserted the words, “paragraph 1 of”; and

(ii)in column 2 opposite each of the substances Sodium Fluoride, Sodium Monofluorophosphate and Stannous Fluoride there is inserted “(b)” and at the foot of each page where such an insertion is made there are inserted the words, “(b) Subject to paragraph 2 of the note at the end of Part I of Schedule 1.”; and

(iii)after the word “Note:” where it appears at the end of that Part there is inserted the number “1.” and after the entry for the Note numbered 1. there is inserted the following new paragraph:

“2.  In relation to a medicinal product which contains more than one of the substances Sodium Fluoride, Sodium Monofluorophosphate and Stannous Fluoride combined in a dentifrice, the maximum strength of the combination for the purposes of column 2 shall not exceed 0.15 per cent calculated as Fluorine.”

(4) In Part III of Schedule 1 to the principal Order (medicinal products, specified by name and product licence number, which are prescription only medicines) there is deleted the entry “Debrisan 0009/0021”.

(5) After Part III of Schedule 1 to the principal Order there is added Part IV as set out in Schedule 4 to this Order.

Amendment of Schedule 2 to the principal Order

4.  From Schedule 2 to the principal Order (substances not to be contained in a prescription only medicine sold or supplied under the exemption conferred by article 6(3) of the principal Order), there are deleted the substances Phentermine Hydrochloride and Phentermine Resin Complex.

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

Tony Newton

Minister of State,

Department of Health and Social Security

1st April 1987

Nicholas Edwards

Secretary of State for Wales

31st March 1987

Malcolm Rifkind

Secretary of State for Scotland

31st March 1987

In witness whereof the official seal of the Minister of Agriculture, Fisheries and Food is hereunto affixed on 1st April 1987.

Michael Jopling

Minister of Agriculture, Fisheries and Food

Sealed with the official seal of the Department of Health and Social Services for Northern Ireland this 3rd day of April 1987.

Maurice N. Hayes

Permanent Secretary

Sealed with the official seal of the Department of Agriculture for Northern Ireland this 6th day of April 1987.

W. H. Jack

Permanent Secretary

Article 3(3)(a)

SCHEDULE 1ENTRIES INSERTED IN PART I OF SCHEDULE 1 TO THE PRINCIPAL ORDER(6)

CIRCUMSTANCES EXCLUDING MEDICINAL PRODUCTS FROM THE CLASS OF PRESCRIPTION ONLY MEDICINES
Column 1Column 2Column 3Column 4
SubstanceMaximum strengthUse, pharmaceutical form or route of administrationMaximum dose and maximum daily dose
Amsacrine
Betamethasone Dipropionate
Bromperidol
Ceftazidime
Ceftizoxime Sodium
Dipivefrin Hydrochloride
Enalapril Maleate
Epirubicin
Fluvoxamine Maleate
Gemfibrozil
Iohexol
Lachesine Chloride
Lithium Citrate
Lofepramine Hydrochloride
Meglumine Ioxaglate
Metronidazole Benzoate
Minoxidil
Mitozantrone Hydrochloride
Nicergoline
Plicamycin
Saralasin Acetate
Sulconazole NitrateExternal (except vaginal use)
Suprofen
Tetroxoprim
Tioconazole2.0 per centExternal (except vaginal use)
Tobramycin
Vecuronium Bromide

Article 3(3)(b)

SCHEDULE 2SUBSTANCES DELETED FROM PART I OF SCHEDULE 1 TO THE PRINCIPAL ORDER

Article 3(3)(c)

SCHEDULE 3ENTRY SUBSTITUTED IN COLUMNS 2 AND 3 OF PART I OF SCHEDULE 1 TO THE PRINCIPAL ORDER(7)

CIRCUMSTANCES EXCLUDING MEDICINAL PRODUCTS FROM THE CLASS OF PRESCRIPTION ONLY MEDICINES
Column 1Column 2Column 3Column 4
SubstanceMaximum strengthUse, pharmaceutical form or route of administrationMaximum dose and maximum daily dose
Podophyllum Resin2.0 per centExternal: ointment or impregnated plaster

Article 3(5)

SCHEDULE 4ADDITION OF PART IV OF SCHEDULE 1 TO THE PRINCIPAL ORDER

“PART IVname and product licence number of medicinal products that are not prescription only medicines

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.

The amendments made by this Order are as follows:

Article 2 amends the definition of the “Misuse of Drugs Regulations” in the principal Order and makes consequential amendments to the references to those Regulations in articles 6 and 12 of the principal Order.

Article 3 amends articles 3 and 4 of, and Schedule 1 to, the principal Order.

Article 3(1) and (2) makes provision whereby certain topical Hydrocortisone preparations and certain sustained release preparations of Ibuprofen shall not be prescription only medicines notwithstanding that they would otherwise be so by reason that they consist of or contain a substance specified in Part I of Schedule 1 to the principal Order. Such products are specified by name and product licence number in a new Part IV of Schedule 1 to the principal Order which is added by Article 3(5) of this Order.

Article 3(3) amends Part I of Schedule 1 to the principal Order. Article 3(3)(a) adds to the list of prescription only medicines those substances which are set out in Schedule 1 to this Order. Article 3(3)(b) deletes from that list those substances which are set out in Schedule 2 to this Order although such substances remain subject to the provisions of the principal Order by reason either of their being controlled drugs or because they have been relisted in Part I of Schedule 1 to the principal Order under a new approved name. Article 3(3)(c) substitutes a new entry in the list relating to the substance Podophyllum Resin. Article 3(3)(d) makes provision for the circumstances in which a medicinal product containing more than one of the substances Sodium Fluoride, Sodium Monofluorophosphate and Stannous Fluoride combined in a dentifrice shall be a prescription only medicine.

Article 3(4) amends Part III of Schedule 1 to the principal Order (medicinal products, specified by name and product licence number, which are prescription only medicines) by deletion of the entry “Debrisan 0009/0021”.

Article 4 amends Schedule 2 to the principal Order (substances not to be contained in a prescription only medicine sold or supplied under the exemption conferred by article 6(3) of the principal Order, which relates to emergency sale or supply by a retail pharmacist), by deleting certain substances which nonetheless remain excluded from the exemption conferred by article 6(3) by reason of their being controlled drugs.

(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) and 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, amended by S.I. 1984/756 and 1986/586.

(4)

S.I. 1985/2066.

(5)

S.R. (N. I.) 1986 No. 52.

(6)

Note: all columns appearing in Part I of Schedule 1 to the principal Order are set out in this Schedule, although no entries are inserted by this Schedule in column 4 of Part I of Schedule 1 to that Order.

(7)

Note: all columns appearing in Part I of Schedule 1 to the principal Order are set out in this Schedule, although no entries are inserted by this Schedule in column 4 of Part I of Schedule 1 to that Order.