The Medicines (Products Other Than Veterinary Drugs) (Prescription Only) Amendment Order 1991

• Citation: S.I. 1991/962
• Sections: 6

Section 1 Citation, commencement and interpretation

This Order, which may be cited as the Medicines (Products Other ThanVeterinary Drugs) (Prescription Only) Amendment Order 1991, amends theMedicines (Products Other Than Veterinary Drugs) (Prescription Only)Order 1983 (hereinafter referred to as“the principal Order”) and shall come into force on 1st May 1991.

Section 2 Amendment of article 3 of the principal Order

In article 3(1)(a) of the principal Order (medicinal products onprescription only), after the words“subject to article 4(1)” the words“and (1A)” are deleted and there are inserted the words“, (1A), (1B), (1C) and (1D),”.

Section 3 Amendment of article 4 of the principal Order

In article 4 of the principal Order (medicinal products that are notprescription only), the following paragraph is inserted after paragraph(1C):—

(1D) Notwithstanding Article 3(1)(a), a medicinal product shall notbe a prescription only medicine by reason that it consists of orcontains the substance Hyoscine Butylbromide where—

(a) its route of administration is internal otherwise than by inhaler;

(b) it is sold or supplied in a container or package containing notmore than 240 mg; and

(c) its container or package is labelled to show a maximum daily doseof 80 mg and a maximum dose of 20 mg.

Section 4 Amendment of Part I of Schedule 1 to the principal Order

In Part I of Schedule 1 to the principal Order (which listssubstances which render a medicinal product a prescription only medicineexcept in circumstances also listed)—

(a) the following substances are inserted at the appropriate points inthe alphabetical order of the substances listed in Column 1, and in thecase of Vaccines at the appropriate points in the list ofvaccines,—

Amlodipine Besylate

Anistreplase

Cefuroxime Axetil

Domperidone Maleate

Enoxacin

Flutamide

Isradipine

Levobunolol Hydrochloride

Loxapine Succinate

Metoprolol Succinate

Metoprolol Fumarate

Milrinone Lactate

Nedocromil Sodium

Octreotide

Pamidronate Disodium

Pentamidine Isethionate

Perindopril

Propofol

Quinapril

Teicoplanin

Temocillin Sodium

Terodiline Hydrochloride

Tribavirin

Vaccines – Hepatitis B Vaccine

Meningococcal Polysaccharide Vaccine

Rubella, Mumps, Measles Vaccine

Vigabatrin

Zopiclone

Zuclopenthixol Decanoate;

(b) the entry“Labetolol Hydrochloride” is substituted by the entry“Labetalol Hydrochloride”; and

(c) the entry“Hyoscine Butylbromide” is amended by the deletion in Column 3 (Use, pharmaceutical form orroute of administration) of the words“(b) otherwise than by inhaler”, and in Column 4 (Maximum dose and maximum daily dose) of the words“(b) 3 mg (MD) 9 mg (MDD) (b)”.

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

In Part III of Schedule 1 to the principal Order (medicinalproducts, specified by name and product licence number, which areprescription only medicines), the entry

Nicorette

0458/0020

0458/0021

is substituted by the entry

Nicorette Plus

0458/0021

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

In Table A of Part IV of Schedule 1 to the principal Order(medicinal products specified by name and product licence number whichare not prescription only medicines), immediately after the entry“Wasp-Eze Hydrocortisone Cream 0232/0058” the following entry shall be inserted

Wasp-Eze Hydrocortisone Cream

8452/0012