The Medicines (Products Other Than Veterinary Drugs) (Prescription Only) Amendment (No. 2) Order 1995

• Citation: S.I. 1995/3174
• Sections: 5

Section 1 Citation, commencement and interpretation

(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 .

Section 2 Amendment of article 1 of the principal Order

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—

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

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

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;

Section 3 Amendment of article 3 of the principal Order

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)”.

Section 4 Amendment of article 4 of the principal Order

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.

Section 5 Amendment of Part I of Schedule 1 to the principal Order

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