Citation, commencement and interpretation1
1
This Order may be cited as the Medicines (Products Other Than Veterinary Drugs) (Prescription Only) Amendment (No. 2) Order 1992, and shall come into force on 18th December 1992.
2
In this Order “the principal Order” means the Medicines (Products Other Than Veterinary Drugs) (Prescription Only) Order 19833.
Amendment of article 4 of the principal Order2
In article 4 of the principal Order (medicinal products that are not prescription only), the following paragraph is substituted for paragraph (1E):—
1E
Notwithstanding article 3(1)(a), a medicinal product shall not be a prescription only medicine by reason that it contains the substance carbenoxolone sodium where—
a
the medicinal product is in the form of granules;
b
the maximum strength of the carbenoxolone sodium in the medicinal product does not exceed one per cent calculated in terms of weight in weight;
c
the medicinal product is sold or supplied in a container or package containing not more than 560 milligrams of carbenoxolone sodium;
d
the container or package of the medicinal product is labelled to show a maximum daily dose of 80 milligrams of carbenoxolone sodium and a maximum dose of 20 milligrams of carbenoxolone sodium; and
e
the medicinal product is indicated only for treatment by mouthwash, in adults and in children over the age of 12 years;
and for the purposes of this paragraph “maximum daily dose” means the maximum quantity of the substance carbenoxolone sodium which it is recommended should be used as a mouthwash in a period of 24 hours and “maximum dose” means the maximum quantity of the substance carbenoxolone sodium which it is recommended should be used at any one time.
Amendment of article 5 of the principal Order3
In article 5 of the principal Order (exemption for parenteral administration to human beings of certain prescription only medicines) immediately after the words “Diphenhydramine Injection” are inserted the words “Glucagon Injection”.
Amendment of Part III of Schedule 3 to the principal Order4
At the end of Part III of Schedule 3 to the principal Order (exemptions for certain persons from the provisions of section 58(2)(b) of the Medicines Act 1968 concerning parenteral administration of prescription only medicines) there is inserted the paragraph set out in the Schedule to this Order.
Signed by authority of the Secretary of State for Health
In witness whereof the Official Seal of the Minister of Agriculture, Fisheries and Food is hereunto affixed on 24th November 1992.
Sealed with the Official Seal of the Department of Health and Social Services for Northern Ireland this 23rd day of November 1992.
Sealed with the Official Seal of the Department of Agriculture for Northern Ireland this 20th day of November 1992.