2000 No. 2899
The Prescription Only Medicines (Human Use) Amendment (No. 2) Order 2000
Made
Laid before Parliament
Coming into force
As respects England, Scotland and Wales, the Secretary of State concerned with health in England, and, as respects Northern Ireland, the Minister of Health, Social Services and Public Safety, acting jointly, in exercise of the powers conferred upon them by sections 58(1), (4) and (5) and 129(4) of the Medicines Act 19681 or, as the case may be, those conferred by the said provisions and now vested in them2, and of all other powers enabling them in that behalf, after consulting such organisations as appear to them to be representative of interests likely to be substantially affected by this Order, pursuant to section 129(6) of that Act, and after consulting and taking into account the advice of the Committee on Safety of Medicines pursuant to sections 58(6) and 129(7) of that Act, and after taking into account the advice of the Medicines Commission pursuant to section 129(7) of that Act, hereby make the following Order:—
Citation, commencement and interpretation1
1
This Order may be cited as the Prescription Only Medicines (Human Use) Amendment (No. 2) Order 2000 and shall come into force on 16th November 2000.
2
In this Order, “the principal Order” means the Prescription Only Medicines (Human Use) Order 19973.
Amendment of article 5 of the principal Order2
In article 5(4) of the principal Order, after sub-paragraph (b), there is added—
, provided that, where the entry in column 3 contains a condition to the effect that the product is to be wholly or mainly for use in a specified class of persons, the product satisfies that condition where it is sold or supplied wholly or mainly for use in persons of that class
Amendment of article 12C of, and Schedule 7 to, the principal Order3
1
In article 12C of the principal Order4, after paragraph (2)(c), there is inserted—
cc
where the prescription only medicine is administered by the person lawfully conducting a retail pharmacy business within the meaning of section 69, the individual who administers the medicine belongs to one of the classes of individual specified in Part III of Schedule 7 to this Order, and is designated in writing, on behalf of the body with which an arrangement has been made as referred to in paragraph (1)(a), for the purpose of the administration of prescription only medicines under the Patient Group Direction; and
2
In the heading of Part III of Schedule 74 to the principal Order, for “BY WHOM SUPPLIES MAY BE MADE” there is substituted “BY WHOM PRESCRIPTION ONLY MEDICINES MAY BE SUPPLIED OR ADMINISTERED”.
Amendment of Schedule 1 to the principal Order4
In Schedule 1 to the principal Order (which specifies substances which, if included in medicinal products, make those products prescription only medicines, and exemptions from the restrictions on the sale and supply of prescription only medicines)—
a
in relation to the substance Azelastine Hydrochloride, in column 3, after “seasonal allergic rhinitis”, there is inserted “or perennial allergic rhinitis”, and for “12 years” there is substituted “5 years”;
b
in relation to the substance Domperidone, there are inserted the following entries—
in column 3—
For the relief of post-prandial symptoms of excessive fullness, nausea, epigastric bloating and belching, occasionally accompanied by epigastric discomfort and heartburn
in column 4—
10mg of Domperidone (MD)
40mg of Domperidone (MDD)
in column 5—
Container or package containing not more than 200mg of Domperidone
c
in relation to the substance Domperidone Maleate5, in column 5, for “100mg” there is substituted “200mg”;
d
in relation to the substance Ibuprofen6, in column 5, for “100g” there is substituted “50g”;
e
in relation to the substance Lodoxamide Trometamol—
i
in column 2, there is inserted “equivalent of 0.1 per cent Lodoxamide”; and
ii
in column 3, there is inserted “For the treatment of ocular signs and symptoms of allergic conjunctivitis, in adults and in children aged 4 years and over”;
f
in relation to the substance Paracetamol7—
i
in column 2, in the entry numbered “(1)”, for “120mg” there is substituted “250mg”;
ii
in column 3, in the entry numbered “(1)”, there is inserted after “capsules”, “wholly or mainly”; and
iii
in column 3, in the entry numbered “(2)”, there is inserted after “capsules”, “wholly or mainly”;
g
in relation to the substance Triamcinolone Acetonide, the entries in columns 2, 3 and 5 are each numbered “(1)”, and, after those entries, there are inserted the following entries—
in column 3—
2
In the form of a non-pressurised nasal spray, for the treatment of symptoms of seasonal allergic rhinitis in persons aged 18 years and over
in column 4—
2
110mcg per nostril (MD)
110mcg per nostril (MDD)
For a maximum period of 3 months
in column 5—
2
Container or package containing not more than 3.575mg of Triamcinolone Acetonide
h
there is inserted in column 1, at the appropriate place in the alphabetical order of the entries in that column, each of the following substances—
“Cabergoline”
“Cefprozil”
“Indapamide”
“Lansoprazole”
“Lercanidipine Hydrochloride”
“Meloxicam”
“Pantoprazole Sodium”
“Penciclovir”
“Tamsulosin Hydrochloride”
“Ticlopidine Hydrochloride”
“Tiludronate Disodium”
“Toremifene”.
Amendment of Schedule 5 to the principal Order5
In paragraph 9 of Part III of Schedule 5 to the principal Order—
a
in column 1, there is added, at the end, “or persons who are state registered paramedics”;
b
in column 2, after sub-paragraph (b), there is inserted—
bb
medicines containing the substances Ergometrine Maleate 500mcg per ml with Oxytocin 5 iu per ml, but no other active ingredient
c
in column 2, in sub-paragraph (c), there is inserted, at the appropriate place in the alphabetical order of the entries in that sub-paragraph, the following entries—
“Benzylpenicillin”
“Frusemide”
“Metoclopramide”
“Morphine Sulphate”
“Streptokinase”.
Signed by authority of the Secretary of State for Health
(This note is not part of the Order)