Statutory Instruments
Medicines
Made
16th December 2010
Laid before Parliament
20th December 2010
Coming into force
17th January 2011
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(4), (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 Commission on Human Medicines(3).
1.—(1) This Order may be cited as the Prescription Only Medicines (Human Use) Amendment Order 2010 and shall come into force on 17th January 2011.
(2) In this Order, “the principal Order” means the Prescription Only Medicines (Human Use) Order 1997(4).
2. In article 7 of the principal Order (exemption for parenteral administration in an emergency to human beings of certain prescription only medicines)(5) for “Glucose Injection 50%” substitute “Glucose Injection”.
3. In Part 3 of Schedule 5 to the principal Order (exemptions from restriction on administration)(6), in the list in column 2 of entry 9, under item (c), after “Adrenaline Acid Tartrate” add “Adrenaline Hydrochloride”.
Signed by authority of the Secretary of State for Health.
Earl Howe
Parliamentary Under-Secretary of State,
Department of Health
16th December 2010
Michael McGimpsey
Minister for Health, Social Services and Public Safety
16th December 2010
(This note is not part of the Order)
This Order amends the Prescription Only Medicines (Human Use) Order 1997 (“the principal Order”) which specifies the description and classes of medicines which, subject to exemptions specified in the principal Order, may be administered in an emergency or by paramedics.
Article 2 amends the principal Order to ensure that, in an emergency, glucose is available for parenteral administration at any level of dilution.
Article 3 amends Part 3 of Schedule 5 to the principal Order to ensure that Adrenaline Hydrochloride is added to the list of medicines that are available for parenteral administration by paramedics.
An impact assessment has not been prepared for this instrument as there is no impact on the private and voluntary sectors.
1968 c.67. The expression “the Ministers”, which is relevant to the powers being exercised in the making of this Order, is defined in section 1 of the Act as amended by S.I. 1999/3142 and S.I. 2006/2407. Section 58(4) was amended by the Medicinal Products: Prescription by Nurses etc. Act 1992 (c.28), section 1; the Health and Social Care Act 2001 (c.15), section 63(1) and (4) and by S.I. 2002/253 and 2006/2407. Section 58(5) was amended by the Medicinal Products: Prescription by Nurses etc. Act 1992, section 1 and by the Health and Social Care Act 2001, section 63(1) and (6).
By virtue of section 95(5) of, and paragraph 10 of Schedule 12 to, the Northern Ireland Act 1998 (c.47); the Department for which the Minister was responsible was renamed by virtue of article 3(6) of S.I. 1999/283 (N.I.1).
In section 58(6) of the Act, the expression “the appropriate committee” is defined in section 4(6) of the Act, as amended by S.I. 2005/1094; the word “Ministers” was substituted by S.I. 2006/2407.
Relevant amending instrument is S.I. 2005/1507.
Relevant amending instruments are S.I. 1998/1178, 2000/2899, 2004/1189 and 2693.