1989 No. 1852
The Medicines (Prescription Only, Pharmacy and General Sale) Amendment Order 1989
Made
Laid before Parliament
Coming into force
The Secretary of State concerned with health in England, the Secretaries of State concerned with health and with agriculture in Wales and in Scotland, the Minister of Agriculture, Fisheries and Food, the Department of Health and Social Services for Northern Ireland and the Department of Agriculture for Northern Ireland, acting jointly, in exercise of powers conferred by sections 1, 57(1) and (2), 58(1), (4)(a) and (5), 129(4) and 132(1) of the Medicines Act 19681 and now vested in them2, and of all other powers enabling them in that behalf, after consulting in accordance with section 129(6) of that Act such organisations as appear to them to be representative of interests likely to be substantially affected by this Order, after consulting the Medicines Commission in accordance with section 58(6) of that Act so far as this Order is made under section 58 of that Act and after taking into account the advice of the Medicines Commission in accordance with section 129(7) of that Act, hereby make the following Order:–
Citation, commencement and interpretation1
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.
Amendment of article 1 of the Prescription Only Medicines Order2
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 19715 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 19646;
Amendment of article 4 of the Prescription Only Medicines Order3
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.
Amendment of Part 1 of Schedule 1 to the Prescription Only Medicines Order4
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.
Amendment of Table A of Part IV of Schedule 1 to the Prescription Only Medicines Order5
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.
Amendment of Schedule 3 to the Prescription Only Medicines Order6
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.
Amendment of article 1 of the Pharmacy and General Sale Exemption Order7
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 19717 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 19648;
Amendment of Schedule 1 to the Pharmacy and General Sale Exemption Order8
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
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
In witness whereof the official seal of the Minister of Agriculture, Fisheries and Food is hereunto affixed on 4th October 1989.
Sealed with the official seal of the Department of Health and Social Services for Northern Ireland this fifth day of October 1989.
Sealed with the official seal of the Department of Agriculture for Northern Ireland this 6th day of October 1989.
SCHEDULE 1ENTRIES SUBSTITUTED IN PART I OF SCHEDULE 1 TO THE PRESCRIPTION ONLY MEDICINES ORDER
CIRCUMSTANCES EXCLUDING MEDICINAL PRODUCTS FROM THE CLASS OF PRESCRIPTION ONLY MEDICINES
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 |
| |
Ibuprofen | Rheumatic and muscular pain, backache, neuralgia, migraine, headache, dental pain, dysmenorrhoea, feverishness, symptoms of cold and influenza:
|
| |
(2) 5.0 per cent. | (2) External |
SCHEDULE 2PARAGRAPHS INSERTED IN SCHEDULE 3 TO THE PRESCRIPTION ONLY MEDICINES ORDER
PART IPARAGRAPH INSERTED IN PART II OF SCHEDULE 3 TO THE PRESCRIPTION ONLY MEDICINES ORDER
Column 1 | Column 2 | Column 3 |
---|---|---|
Persons exempted | Prescription only medicines to which the exemption applies | Conditions |
|
|
|
PART IIPARAGRAPH INSERTED IN PART III OF SCHEDULE 3 TO THE PRESCRIPTION ONLY MEDICINES ORDER
Column 1 | Column 2 | Column 3 |
---|---|---|
Persons exempted | Prescription only medicines to which the exemption applies | Conditions |
|
|
|
SCHEDULE 3PARAGRAPH INSERTED IN PART II OF SCHEDULE 1 TO THE PHARMACY AND GENERAL SALE EXEMPTION ORDER
Column 1 | Column 2 | Column 3 |
---|---|---|
Persons exempted | Prescription only medicines to which the exemption applies | Conditions |
|
|
|
(This note is not part of the Order)