
1 

(1) This Order, which may be cited as the Medicines (Prescription Only, Pharmacy and General Sale) Amendment Order 1989, shall come into force on 1st November 1989.
(2) In this Order–
 “the Pharmacy and General Sale Exemption Order” means the Medicines (Pharmacy and General Sale – Exemption) Order 1980;
 “the Prescription Only Medicines Order” means the Medicines (Products Other Than Veterinary Drugs) (Prescription Only) Order 1983;
2 
In article 1(2)(a) of the Prescription Only Medicines Order (interpretation), the following definition is inserted after the definition of “occupational health scheme”:–“
 “offshore installation” means an offshore installation within the meaning of the Mineral Workings (Offshore Installations) Act 1971 which is within–
(a) tidal waters and parts of the sea in or adjacent to Great Britain up to the seaward limit of territorial waters;
(b) waters in any area designated under section 1(7) of the Continental Shelf Act 1964;”.
3 
In article 4 of the Prescription Only Medicines Order (medicinal products that are not prescription only), the following paragraph is inserted after paragraph (1B):–“
(1C) Notwithstanding Article 3(1)(a), a medicinal product shall not be a prescription only medicine by reason of the fact that it consists of or contains the substance mebendazole where it is sold or supplied in a container or package containing only a single dose of not more than 100 mg of mebendazole for oral use and for the treatment of enterobiasis.”.
4 
In Part I of Schedule 1 to the Prescription Only Medicines Order (which lists substances which render a medicinal product a prescription only medicine except in circumstances also listed)–
(a) the following substances are inserted at the appropriate points in the alphabetical order of the substances listed in Column 1–
 Acipimox
 Aztreonam
 Bentiromide
 Bisoprolol Fumarate
 Buserelin Acetate
 Carboplatin
 Carteolol Hydrochloride
 Ceftriaxone Sodium
 Ceruletide Diethylamine
 Doxazosin Mesylate
 Enoximone
 Famotidine
 Felodipine
 Fenofibrate
 Flumazenil
 Fluorescein Dilaurate
 Fluoxetine Hydrochloride
 Ganciclovir
 Gestodene
 Goserelin Acetate
 Lisinopril
 Lofexidine Hydrochloride
 Lysuride Maleate
 Meglumine Gadopentetate
 Meglumine Iothalamate
 Metipranolol
 Misoprostol
 Naltrexone Hydrochloride
 Nimodipine
 Nizatidine
 Oxidronate Sodium
 Somatropin
 Sulbenicillin
 Sultamicillin Tosylate
 Tenoxicam
 Terazosin Hydrochloride
 Xamoterol Fumarate;
(b) for the entries relating to the substances Dextromethorphan Hydrobromide and Ibuprofen respectively there are substituted the entries relating respectively to those substances set out in Schedule 1 to this Order.
5 
In Table A of Part IV of Schedule 1 to the Prescription Only Medicines Order (medicinal products specified by name and product licence number which are not prescription only medicines), the following entries are deleted:–
 Femafen
 0188/0071;
 Oriel Capsules
 0073/0023;
 Proflex Sustained Relief Capsules
 0001/0109; and
 Suspren
 0188/0072.
6 
In Schedule 3 to the Prescription Only Medicines Order (exemptions for certain persons from the provisions of section 58(2) of the Medicines Act 1968)–
(a) in paragraph 5 in Column 2 of Part I, the following sub-paragraphs are substituted for sub-paragraph (a)–“
(a) are eye drops and are prescription only medicines by reason only that they contain not more than–
(i) 30.0 per cent Sulphacetamide Sodium, or
(ii) 0.5 per cent Chloramphenicol, or
(aa) are eye ointments and are prescription only medicines by reason only that they contain not more than–
(i) 30.0 per cent Sulphacetamide Sodium, or
(ii) 1.0 per cent Chloramphenicol, or”;
(b) at the end of Part II there is inserted the paragraph set out in Part I of Schedule 2 to this Order; and
(c) at the end of Part III there is inserted the paragraph set out in Part II of Schedule 2 to this Order.
7 
In article 1(2)(a) of the Pharmacy and General Sale Exemption Order (interpretation), the following definition is inserted after the definition of “occupational health scheme”:–“
 “offshore installation” means an offshore installation within the meaning of the Mineral Workings (Offshore Installations) Act 1971 which is within–
(a) tidal waters and parts of the sea in or adjacent to Great Britain up to the seaward limit of territorial waters;
(b) waters in any area designated under section 1(7) of the Continental Shelf Act 1964;”.
8 
In Schedule 1 to the Pharmacy and General Sale Exemption Order (exemptions for certain persons from the provisions of sections 52 and 53 of the Medicines Act 1968)–
(a) in paragraph 2 in Column 2 of Part I, the following sub-paragraphs are substituted for sub-paragraph (a)–“
(a) are eye drops and are prescription only medicines by reason only that they contain not more than–
(i) 30.0 per cent Sulphacetamide Sodium, or
(ii) 0.5 per cent Chloramphenicol, or
(aa) are eye ointments and are prescription only medicines by reason only that they contain not more than–
(i) 30.0 per cent Sulphacetamide Sodium, or
(ii) 1.0 per cent Chloramphenicol, or”; and
(b) at the end of Part II there is inserted the paragraph set out in Schedule 3 to this Order.
Signed by authority of the Secretary of State for Health
D. Mellor
Minister of State,
Department of Health
9th October 1989Peter Walker
Secretary of State for Wales
4th October 1989Malcolm Rifkind
Secretary of State for Scotland
9th October 1989In witness whereof the official seal of the Minister of Agriculture, Fisheries and Food is hereunto affixed on 4th October 1989.
John Selwyn Gummer
Minister of Agriculture, Fisheries and Food
Sealed with the official seal of the Department of Health and Social Services for Northern Ireland this fifth day of October 1989.
F. A. Elliott
Permanent Secretary
Sealed with the official seal of the Department of Agriculture for Northern Ireland this 6th day of October 1989.
W. J. Hodges
Permanent Secretary

SCHEDULE 1
Article 4(b)

Column 1 Column 2 Column 3 Column 4
Substances Maximum strength Use, pharmaceutical form or route of administration Maximum dose and maximum daily dose
Dextromethorphan Hydrobromide  Internal 
(a) In the case of a controlled release preparation:equivalent of 30 mg of Dextromethorphan (MD),equivalent of 75 mg of Dextromethorphan (MDD);
(b) in any other case:equivalent of 15 mg of Dextromethorphan (MD),equivalent of 75 mg of Dextromethorphan (MDD).
Ibuprofen  Rheumatic and muscular pain, backache, neuralgia, migraine, headache, dental pain, dysmenorrhoea, feverishness, symptoms of cold and influenza:
(1) Internal 
(1) 
(a) In the case of a controlled release preparation:600 mg (MD),1200 mg (MDD);
(b) in any other case:400 mg (MD),1200 mg (MDD).
 (2) 5.0 per cent. (2) External 
SCHEDULE 2
PART I
Article 6(b)

Column 1 Column 2 Column 3
Persons exempted Prescription only medicines to which the exemption applies Conditions

7 
Persons employed as qualified first-aid personnel on offshore installations. 
7 
All prescription only medicines. 
7 
The supply shall be only so far as is necessary for the treatment of persons on the installation.
PART II
Article 6(c)

Column 1 Column 2 Column 3
Persons exempted Prescription only medicines to which the exemption applies Conditions

8 
Persons employed as qualified first-aid personnel on offshore installations. 
8 
All prescription only medicines that are for parenteral administration. 
8 
The administration shall be only so far as is necessary for the treatment of persons on the installation.
SCHEDULE 3
Article 8(b)


Column 1 Column 2 Column 3
Persons exempted Prescription only medicines to which the exemption applies Conditions

13 
Persons employed as qualified first-aid personnel on offshore installations. 
13 
All medicinal products. 
13 
The supply shall be only so far as is necessary for the treatment of persons on the installation.