The Medicines for Human Use (Miscellaneous Amendments) Order 2010

Statutory Instruments

2010 No. 1136

Medicines

The Medicines for Human Use (Miscellaneous Amendments) Order 2010

Made

30th March 2010

Laid before Parliament

6th April 2010

Coming into force

1st June 2010

The Secretary of State and the Minister for Health and Social Services and Public Safety, acting jointly, make the following Order in exercise of powers conferred upon them by sections 15(1) and (2), 57(1) and (2), 58(4) and (5) and 129(4) and (5) of the Medicines Act 1968(1), or, in the case of the Minister, the powers conferred by those provisions now vested in the Minister(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).

Citation, commencement and interpretation

1.—(1) This Order may be cited as the Medicines for Human Use (Miscellaneous Amendments) Order 2010 and shall come into force on 1st June 2010.

(2) In this Order—

“the Pharmacy and General Sale Order” means the Medicines (Pharmacy and General Sale— Exemption) Order 1980(4);

“the POM Order” means the Prescription Only Medicines (Human Use) Order 1997(5).

Amendment of the Pharmacy and General Sale Order

2.—(1) The Pharmacy and General Sale Order is amended as follows.

(2) In article 1(2) (citation, commencement and interpretation) after the definition of “cosmetic” insert the following definitions—

““dental hygienist” means a person whose name is registered under the title of dental hygienist in the dental care professionals register;

“dental therapist” means a person whose name is registered under the title of dental therapist in the dental care professionals register;

“dental care professionals register” means the dental care professionals register established under section 36B of the Dentists Act 1984(6);”.

(3) In Schedule 3, Part 3 (classes of individual by whom supplies may be made)(7) before “Registered paramedics” insert—

“Dental hygienist.

Dental therapist.”.

Amendment of the POM Order

3.—(1) The POM Order is amended as follows.

(2) In article 1(2) (citation, commencement and interpretation) after the definition of “cyanogenetic substances” insert the following definitions—

““dental hygienist” means a person whose name is registered under the title of dental hygienist in the dental care professionals register;

“dental therapist” means a person whose name is registered under the title of dental therapist in the dental care professionals register;

“dental care professionals register” means the dental care professionals register established under section 36B of the Dentists Act 1984;”.

(3) In schedule 5 (exemption for certain persons from section 58(2) of the Act)—

(a) in Part 1 (exemption from restrictions on sale or supply), in column 2, for item 4 substitute—

“4 Prescription only medicines containing any of the following substances—

Diclofenac

Ergometrine maleate

Hydrocortizone Acetate

Lidocaine

Lidocaine Hydrochloride

Miconazole

Nystatin

Phytomenadione.”;

(b) in Part 3 (exemptions from restriction on administration), in column 2, for the substances listed in item 2 substitute—

“Adrenaline

Anti-D immunoglobulin

Carboprost

Cyclizine hydrochloride

Diamorphine

Ergometrine maleate

Gelofusine

Haemaccel

Hartmann’s solution

Hepatitis B vaccine

Hepatitis immunoglobulin

Lidocaine

Lidocaine hydrochloride

Morphine

Naloxone hydrochloride

Oxytocins, natural and synthetic

Pethidine hydrochloride

Phytomenadione

Prochloperazine

Sodium chloride 0.9%.”.

(4) In Schedule 7, Part 3 (classes of individual by whom prescription only medicines may be supplied or administered)(8) before “Registered paramedics” insert—

“Dental hygienist.

Dental therapist.”.

Signed by authority of the Secretary of State for Health

Mike O’Brien

Minister of State

Department of Health

30th March 2010

Michael McGimpsey

Minister for Health, Social Services and Public Safety

30th March 2010

EXPLANATORY NOTE

(This note is not part of the Order)

Articles 2 and 3 amend the Prescription Only Medicines (Human Use) Order 1997 (“the POM Order”) and the Medicines (Pharmacy and General Sale – Exemption) Order 1980 to include dental hygienists and dental therapists in the list of healthcare professionals that can sell, supply or administer medicines under a patient group direction.

Article 3 substitutes the list of substances in Parts 1 and 3 of Schedule 5 to the POM Order in order to expand and update the range of prescription only medicines that may be sold, supplied or administered by registered midwives.

An impact assessment has not been prepared for this instrument as there is no impact on the private and voluntary sectors.

(1)

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. Sections 15(1) and section 57(1) have been amended by 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). Section 129(5) was amended by the Health Act 2006 (c.28), section 83(7).

(2)

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).

(3)

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.

(4)

S.I. 1980/1924.

(5)

S.I. 1997/1830.

(6)

1984 c.24.

(7)

Schedule 3 was inserted by S.I. 2000/1919. Relevant amending instrument is S.I. 2003/1590.

(8)

Part 3 was inserted by SI 2000/1917. Relevant amending instruments are S.I. 2000/2899, 2003/1590.