Citation, commencement and interpretation

1.-(1) This Order may be cited as the Medicines (Products Other Than Veterinary Drugs) (Prescription Only) Amendment (No. 2) Order 1995 and shall come into force on 29th December 1995.

(2) In this Order "the principal Order" means the Medicines (Products Other Than Veterinary Drugs) (Prescription Only) Order 1983(3).

Amendment of article 1 of the principal Order

2. In article 1(2) of the principal Order (interpretation), for the definition of "maximum strength" there is substituted the following definition-

• ""maximum strength" means such of the following as may be specified-

  (i)

  the maximum quantity of a substance by weight or volume contained in a dosage unit of a medicinal product;

  (ii)

  the maximum number of units of activity contained in a dosage unit or a weight of a medicinal product; and

  (iii)

  the maximum percentage of a substance contained in a medicinal product calculated in terms of weight in weight, weight in volume, volume in weight or volume in volume, as appropriate;".

Amendment of article 3 of the principal Order

3. In article 3(1)(a) of the principal Order (medicinal products on prescription only), for "Article 4(1) to (1Z)" there is substituted "Article 4(1) to (1AA)".

Amendment of article 4 of the principal Order

4. In article 4 of the principal Order (medicinal products that are not prescription only)-

(a)in sub-paragraph (a) of paragraph (1K) before "treatment" there is inserted "prevention or";

(b)the following paragraph is inserted after paragraph (1Z)-

"(1AA) Notwithstanding article 3(1)(a), a medicinal product shall not be a prescription only medicine by reason that it contains the substance budesonide where-

(a)the medicinal product is indicated only for the prevention or treatment of seasonal allergic rhinitis in adults and in children aged not less than 12 years;

(b)it is in non-aerosol, aqueous form for nasal administration;

(c)it is sold or supplied in a container or package containing not more than 10 milligrams of the medicinal product; and

(d)the container or package is labelled to show a maximum dose, and a maximum daily dose, of 200 micrograms per nostril of budesonide.".

Amendment of Part I of Schedule 1 to the principal Order

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

(a)the following substances are inserted at the appropriate points in the alphabetical order of the substances listed in Column 1:

• Amorolfine Hydrochloride

• Calcipotriol

• Carbaryl

• Lodoxomide Trometamol

• Pancreatin;

(b)in relation to the substance Pancreatin, there are inserted in Column 2 the entries-

"(1) 21,000 European Pharmacopoeia units of lipase per capsule

(2) 25,000 European Pharmacopoeia units of lipase per gram";

(c)in relation to the substance Pancreatin, there are inserted in Column 3 the entries-

"(1) capsules

(2) powder".

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 (i.e. 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). Under the principal Order products are included in a class of such medicines by reason of the substances contained in them, subject to their being excluded in certain specified circumstances.

The amendments made by this Order are as follows:-

• an extension of the exclusion for products containing beclomethasone dipropionate (article 4(a));

• a new exclusion for products containing budesonide (article 4(b));

• the inclusion of products containing substances mentioned in article 5.