The Medicines (Products Other Than Veterinary Drugs) (Prescription Only) Amendment Order 1996

• Citation: S.I. 1996/1514
• Sections: 6

Section 1 Citation, commencement and interpretation

(1) This Order may be cited as the Medicines (Products Other Than Veterinary Drugs) (Prescription Only) Amendment Order 1996 and shall come into force on 5th July 1996.

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

Section 2 Amendment of article 3 of the principal Order

In article 3(1) of the principal Order (medicinal products on prescription only)—

(a) in sub-paragraph (a), for “Article 4(1) to (1AA)” there is substituted “Article 4(1) to (1AC)”;

(b) after sub-paragraph (g) there is inserted the following sub-paragraph—

(h) radioactive medicinal products, as defined in regulation 1(2) of the Medicines (Administration of Radioactive Substances) Regulations 1978 , other than products which fall within that definition only because they are substances or articles specified in the Medicines (Dental Filling Substances) Order 1975 or in the Medicines (Radioactive Substances) Order 1978 .

Section 3 Amendment of article 4 of the principal Order

In article 4 of the principal Order (medicinal products that are not prescription only) the following paragraphs are inserted after paragraph (1AA)—

(1AB) Notwithstanding article 3(1)(a), a medicinal product shall not be a prescription only medicine by reason that it contains the substance azelastine hydrochloride where—

(a) the medicinal product is indicated only for the 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 36 doses, each of which contains not more than 140 micrograms of azelastine hydrochloride; and

(d) the container or package is labelled to show a maximum dose of 140 micrograms per nostril of azelastine hydrochloride and a maximum daily dose of 280 micrograms per nostril of azelastine hydrochloride.

(1AC) Notwithstanding article 3(1)(a), a medicinal product shall not be a prescription only medicine by reason that it contains the substance nizatidine where—

(a) the medicinal product is indicated only for the prevention of the symptoms of food-related heartburn in persons aged not less than 16 years; and

(b) the container or package is labelled to show a maximum dose of 75 milligrams of nizatidine and a maximum of 4 such doses in any period of 14 days.

Section 4 Amendment of Part I to 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), in Column 1—

(a) after the entry “Fenoterol Hydrobromide” there is inserted the entry “Fenticonazole Nitrate”;

(b) after the entry “Tolmetin Sodium” there is inserted the entry “Tramadol Hydrochloride”;

(c) in the entry for Vaccines, after “Bacillus Calmette-Guerin Vaccine” there is inserted“Bacillus Salmonella Typhi Vaccine”.

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

In Part II of Schedule 1 to the principal Order (which lists circumstances which exclude specified controlled drugs from the class of prescription only medicines), in the entries in columns 2 and 4 appearing against the entry in column 1 which relates to “Codeine; its salts”, for the word“Codeine” in both places in which it appears there are substituted the words “Codeine Monohydrate”.

Section 6 Amendment of Table A of Part IV of Schedule 1 to the principal Order

In Table A of Part IV of Schedule 1 to the principal Order (name and product licence number of medicinal products that are not prescription only medicines), after the entry for Lanacort Ointment there is inserted the following entry—