1988 No. 2017
The Medicines (Products Other Than Veterinary Drugs) (Prescription Only) Amendment Order 1988
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 powers conferred by sections 58(1), (4) and (5) and 129(4) of the Medicines Act 19681, and now vested in them2 and of all other powers 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 commencement1
This Order, which may be cited as the Medicines (Products Other Than Veterinary Drugs) (Prescription Only) Amendment Order 1988, amends the Medicines (Products Other Than Veterinary Drugs) (Prescription Only) Order 19833 (hereinafter referred to as “the principal Order”) and shall come into force on 16th December 1988.
Amendment of article 4 of the principal Order2
In article 4 of the principal Order (medicinal products that are not prescription only) —
a
the following paragraph is inserted after paragraph (1A) —
1B
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 astemizole where—
a
it is for oral use;
b
it is not a sustained release preparation;
c
it is sold or supplied in a container or package containing not more than 100mg;
d
it is indicated only for the treatment of hay fever in adults or in children over the age of 12 years; and
e
its container or package is labelled to show a maximum daily dose of 10mg.
b
the following paragraph is substituted for paragraph (3) —
3
Notwithstanding Article 3(1)(d), any preparation of insulin for parenteral administration to human beings shall not be a prescription only medicine.
Insertion of article 11A into the principal Order3
The following article is inserted after article 11 of the principal Order:—
Exemption in the case of a forged prescription11A
The restrictions imposed by section 58(2)(a) (restrictions on sale and supply) shall not apply to the sale or supply of a prescription only medicine by a pharmacist in accordance with a forged prescription where the pharmacist, having exercised all due diligence, believes on reasonable grounds that the prescription is genuine.
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 at the appropriate point in the alphabetical order of the substances listed in Column 1—
Alclometasone Dipropionate
Astemizole
Auranofin
Buspirone Hydrochloride
Ciprofloxacin
Ciprofloxacin Hydrochloride
Clavulanic Acid
Danthron
Desogestrel
Disodium Etidronate
Etodolac
Gemeprost
Mesalazine
Metergoline
Mupirocin
Nabumetone
Nicardipine Hydrochloride
Potassium Clavulanate
Somatrem
Sulbactam Sodium
Thiabendazole
Trientine Dihydrochloride
Zidovudine
Zuclopenthixol Hydrochloride
b
the following substances in Column 1 are deleted —
Chlordiazepoxide Hydrochloride
Etidronate Disodium
Potassium Clorazepate
c
in Column 3 of the entry relating to Amodiaquine Hydrochloride, the words “Prophylaxis of malaria” are deleted;
d
for the entry relating to Ibuprofen there is substituted the entry set out in the Schedule to this Order.
Amendment of Part III of Schedule 1 to the principal Order5
In Part III of Schedule 1 to the principal Order (medicinal products, specified by name and product licence number, which are prescription only medicines), the following entry is deleted:—
Cedocard 20
0424/0036
Amendment of Part IV of Schedule 1 to the principal Order.6
In Part IV of Schedule 1 to the principal Order (specified medicinal products that are not prescription only medicines) —
a
the heading “TABLE A” is inserted above the words “NAME AND PRODUCT LICENCE NUMBER OF MEDICINAL PRODUCTS THAT ARE NOT PRESCRIPTION ONLY MEDICINES”;
b
the following entries are inserted at the appropriate point in the alphabetical order of medicinal products already listed therein —
Anflam Cream 0.5%
0142/0263
Anflam Ointment 0.5%
0142/0262
Dermacort Hydrocortisone Cream
8265/0002
c
the following Table is inserted at the end of the list of medicinal products already listed therein —
TABLE BRELEVANT PRODUCT LICENCE HOLDER AND NAME AND PRODUCT LICENCE NUMBER OF MEDICINAL PRODUCTS THAT ARE NOT PRESCRIPTION ONLY MEDICINES
Leo Laboratories Limited:
Hydrocortisone Acetate Cream BP 0.5%
— 0043/0150
Hydrocortisone Acetate Cream BP 1.0%
— 0043/0151
Richard Daniel and Son Limited:
Hydrocortisone Cream BP 1.0%
— 0842/0011
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 16th November 1988.
Sealed with the Official Seal of the Department of Health and Social Services for Northern Ireland this 14th day of November 1988.
Sealed with the Official Seal of the Department of Agriculture for Northern Ireland this 14th day of November 1988.
SCHEDULEENTRY SUBSTITUTED IN PART I OF SCHEDULE 1 TO THE PRINCIPAL ORDER
CIRCUMSTANCES EXCLUDING MEDICINAL PRODUCTS FROM THE CLASS OF Prescription only Medicines | |||
---|---|---|---|
Column 1 | Column 2 | Column 3 | Column 4 |
Substance | Maximum strength | Use, pharmaceutical form or route of administration | Maximum dose and maximum daily dose |
(2) 5.0 per cent | (2) External | ||
Ibuprofen | Rheumatic and muscular pain, backache, neuralgia, migraine, headache, dental pain, dysmenorrhoea, feverishness, symptoms of colds and influenza: | ||
(1) Internal | (1) 400 mg (MD) 1200 mg (MDD) |
(This note is not part of the Order)