1992 No. 1534
The Medicines (Products Other Than Veterinary Drugs) (Prescription Only) Amendment Order 1992
Made
Laid before Parliament
Coming into force
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 the powers conferred upon them by sections 1(2), 58(1), 129(4) and 132(1) of the Medicines Act 19681 or, as the case may be, those conferred by the said provisions and now vested in them2, 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 interpretation1
1
This Order, which may be cited as the Medicines (Products Other Than Veterinary Drugs) (Prescription Only) Amendment Order 1992, shall come into force on 20th July 1992.
2
In this Order “the principal Order” means the Medicines (Products Other Than Veterinary Drugs) (Prescription Only) Order 19833.
Amendment of article 3 of the principal Order2
In article 3(1)(a) of the principal Order (medicinal products on prescription only), for the words “and (1D)” there are substituted the words “, (1D) and (1E),”.
Amendment of article 4 of the principal Order3
In article 4 of the principal Order (medicinal products that are not prescription only), the following paragraph is inserted after paragraph (1D):—
1E
Notwithstanding article 3(1)(a), a medicinal product shall not be a prescription only medicine by reason that it consists of or contains the substance carbenoxolone sodium where—
a
it is in the form of granules;
b
its maximum strength does not exceed one per cent calculated in terms of weight in weight;
c
it is sold or supplied in a container or package containing not more than 560mg;
d
its container or package is labelled to show a maximum daily dose of 80mg and a maximum dose of 20mg; and
e
it is indicated only for treatment, by mouthwash, in adults and in children over the age of 12 years.
Amendment of Part I of Schedule 1 to the principal Order4
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
the following substances are inserted in Column 1 at the appropriate points in the alphabetical order of the substances listed in Column 1—
Cisapride
Clozapine
Dopexamine Hydrochloride
Doxorubicin Hydrochloride
Esmolol Hydrochloride
Felbinac
Fluconazole
Foscarnet Sodium
Idarubicin Hydrochloride
Itraconazole
Mefloquine Hydrochloride
Mesna
Milrinone
Noscapine
Noscapine Hydrochloride
Olsalazine Sodium
Omeprazole
Podophyllotoxin
Propafenone
Ramipril
Simvastatin
Sulfametopyrazine
b
in the entry in Column 3 relating to “Clotrimazole” for the words “External: (1) cream (2) powder (3) solution” there are substituted the words “External, but in the case of vaginal use only external use for the treatment of vaginal candidiasis”; and
c
in the entries in Column 3 relating to “Econazole”, “Econazole Nitrate”, “Isoconazole Nitrate”, “Miconazole” and “Miconazole Nitrate” for the words “External (except vaginal use)” there are substitued the words “External, but in the case of vaginal use only external use for the treatment of vaginal candidiasis”.
Amendment of Table A of Part IV of Schedule 1 to the principal Order5
In Table A of Part IV of Schedule 1 to the principal Order (medicinal products specified by name and product licence number which are not prescription only medicines) immediately after the entry “Efcortelan P Ointment 1° 0004/0326” the following entry is inserted—
Eurax HC Cream 0001/5010R
Signed by authority of the Secretary of State for Health
In witness whereof the Official Seal of the Minister of Agriculture, Fisheries and Food is hereunto affixed on
Sealed with the Official Seal of the Department of Health and Social Services for Northern Ireland this
Sealed with the Official Seal of the Department of Agriculture for Northern Ireland this
(This note is not part of the Order)