The Prescription Only Medicines (Human Use) Amendment Order 2008
STATUTORY INSTRUMENTS
Made
Laid before Parliament
Coming into force
20th February 2008
29th February 2008
1st April 2008
The Secretary of State and the Minister for Health, Social Services and Public Safety, acting jointly, make the following Order in the exercise of powers conferred upon them by sections 58(1), (1A), (4), (4A), (4B) and (5) and 129(4) of the Medicines Act 1968(1), or, in the case of the Minister, the powers conferred by those provisions and now vested in him(2).
In accordance with section 129(6) of that Act, they have consulted such organisations as appear to them to be representative of interests likely to be substantially affected by this Order. In accordance with sections 58(6) and 129(7) of that Act, they have consulted and taken into account the advice of the Committee on Safety of Medicines(3) and the Commission on Human Medicines(4).
1-
Citation, commencement and interpretation
(1)
This Order may be cited as the Prescription Only Medicines (Human Use) Amendment Order 2008 and shall come into force on 1st April 2008.
(2)
In this Order, “the principal Order” means the Prescription Only Medicines (Human Use) Order 1997(5).
2-
Amendment of article 2 of the principal Order
In article 2 of the principal Order (appropriate practitioners)—
(a)
in paragraph (a), after “supplementary prescribers,” add “nurse independent prescribers, pharmacist independent prescribers,”; and
(b)
omit paragraphs (c) and (d).
3-
Amendment of article 3 of the principal Order
In article 3 of the principal Order (medicinal products on prescription only), after paragraph (g) insert the following paragraph—
“(h)
medicinal products in respect of which a marketing authorization has been granted consisting of or containing pseudoephedrine salts or ephedrine base or salts in all pharmaceutical forms which in the marketing authorization are classified as being pharmacy only medicines”.
4-
Omission of article 3A of the principal Order
Article 3A of the principal Order (prescribing and administration by nurse independent prescribers) is omitted.
5-
Amendment of article 3B of the principal Order
In article 3B of the principal Order (prescribing and administration by supplementary prescribers)(6), for paragraph (2) substitute the following paragraph—
“(2)
Paragraph (1) does not apply if the supplementary prescriber is a community practitioner nurse prescriber and the medicinal product prescribed or administered, or in respect of which he gives directions for administration, falls within a description or class of medicinal products specified in Schedule 3.”.
6-
Amendment of article 3C of the principal Order
In article 3C of the principal Order (exemptions from conditions in respect of the cases or circumstances in which a nurse independent prescriber or supplementary prescriber may administer a medicinal product)(7)—
(a)
in the heading, omit “ nurse independent prescriber or ” ; and
(b)
(i)
omit “article 3A(3) and in”, and
(ii)
omit “nurse independent prescriber or”.
7-
Insertion of article 5B in the principal Order
After article 5A of the principal Order, insert the following article—
5B.
“Exemption for products consisting of or containing pseudoephedrine salts or ephedrine base or salts
(1)
A medicinal product falling within article 3(h) shall be exempt from the restrictions imposed by section 58(2) (restrictions on sale, supply and administration) if the conditions in paragraph (2) are satisfied—
(2)
The conditions referred to in this paragraph are that—
(a)
the medicinal product sold or supplied to a person must not be sold or supplied at the same time as another medicinal product that consists of or contains—
(i)
in the case of pseudoephedrine salts, ephedrine base or salts;
(ii)
in the case of ephedrine base or salts, pseudoephedrine salts; and
(b)
the medicinal product or products sold or supplied to a person at any one time must not in total contain more than—
(i)
in the case of pseudoephedrine salts, 720mg pseudoephedrine salts;
(ii)
in the case of ephedrine base or salts, 180mg ephedrine base or salts. ”.
8-
Amendment of article 12 of the principal Order
In article 12 of the principal Order (exemption for sale and supply in hospitals)(8), in paragraph (3)—
(a)
omit “a nurse independent prescriber or”; and
(b)
omit “3A or”.
9-
Amendment of article 13A of the principal Order
In article 13A of the principal Order (exemptions relating to prescriptions given by certain health professionals)(9), in paragraph (2)—
(a)
omit in both places where it occurs “nurse independent prescriber or”; and
(b)
for “articles 3A(2) and (3) or” substitute “article”.
10-
Omission of Schedule 3A to the principal Order
Schedule 3A to the principal Order (controlled drugs which may be prescribed, administered or directed for administration by nurse independent prescribers and conditions for such prescription or administration) is omitted.
Signed by authority of the Secretary of State for Health.
Dawn Primarolo
Minister of State,
Department of Health
20th February 2008
Michael McGimpsey
Minister of Health, Social Services and Public Safety
