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- Gwreiddiol (a wnaed Fel)
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1. 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 1983(1) (hereinafter referred to as “the principal Order”) and shall come into force on 16th December 1988.
2. 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.”.
3. The following article is inserted after article 11 of the principal Order:—
11A. 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.”.
4. 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.
5. 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”
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 —
Leo Laboratories Limited:
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Richard Daniel and Son Limited:
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Signed by authority of the Secretary of State for Health.
D. Mellor
Minister of State,
Department of Health
7th November 1988
Peter Walker
Secretary of State for Wales
9th November 1988
Malcolm Rifkind
Secretary of State for Scotland
10th November 1988
In Witness whereof the Official Seal of the Minister of Agriculture, Fisheries and Food is hereunto affixed on 16th November 1988.
John MacGregor
Minister of Agriculture, Fisheries and Food
Sealed with the Official Seal of the Department of Health and Social Services for Northern Ireland this 14th day of November 1988.
F. A. Elliott
Permanent Secretary
Sealed with the Official Seal of the Department of Agriculture for Northern Ireland this 14th day of November 1988.
W. H. Jack
Permanent Secretary
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