Citation, interpretation and commencement

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(3) (hereinafter referred to as "the principal Order") and shall come into force on 16th December 1988.

Amendment of article 4 of the principal Order

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.".

Insertion of article 11A into the principal Order

3. The following article is inserted after article 11 of the principal Order:-

"Exemption in the case of a forged prescription

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.".

Amendment of Part I of Schedule 1 to the principal Order

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.

Amendment of Part III of Schedule 1 to the principal 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"

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 B

RELEVANT 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".

Article 4(d)

SCHEDULEENTRY SUBSTITUTED IN PART I OF SCHEDULE 1 TO THE PRINCIPAL ORDER

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 makes two amendments to article 4 of the principal Order: it exempts certain products containing astemizole from being a prescription only medicine; and it exempts all preparations of insulin for parenteral administration from being prescription only medicines;

• Article 3 inserts a new article 11A into the principal Order which exempts from the restrictions on sale or supply of prescription only medicines contained in section 58(2)(a) of the Medicines Act 1968 the sale or supply by a pharmacist of such a medicine in accordance with a forged prescription but only in limited circumstances;

• Article 4 amends Part I of Schedule 1 to the principal Order which lists substances which render medicinal products a prescription only medicine except in circumstances also listed;

• Article 5 deletes an entry from Part III of Schedule 1 to the principal Order which lists the name and product licence number of medicinal products that are prescription only medicines;

• Article 6 inserts entries into Part IV of Schedule 1 to the principal Order which lists the name and product licence number of medicinal products that are not prescription only medicines and also inserts therein a new list of medicinal products identified by reference to the name of the relevant product licence holder as well as the name and product licence number of the product.