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The Medicines for Human Use (Prescribing) (Miscellaneous Amendments) Order 2008

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Statutory Instruments

2008 No. 1161

Medicines

The Medicines for Human Use (Prescribing) (Miscellaneous Amendments) Order 2008

Made

22nd April 2008

Laid before Parliament

29th April 2008

Coming into force

4th June 2008

The Secretary of State and the Minister for Health, Social Services and Public Safety, acting jointly, make the following Order in exercise of powers conferred upon them by sections 57(1) and (2), 58(1),(1A),(4),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 Commission on Human Medicines(3).

Citation, commencement and interpretation

1.  (1)  This Order may be cited as the Medicines for Human Use (Prescribing) (Miscellaneous Amendments) Order 2008 and shall come into force on 4th June 2008.

(2) In this Order —

“the POM Order” means the Prescription Only Medicines (Human Use) Order 1997(4); and

“the Pharmacy and General Sale Order” means the Medicines (Pharmacy and General Sale—Exemption) Order 1980(5).

Amendment of article 1 of the POM Order

2.  In article 1 of the POM Order (citation, commencement and interpretation), in paragraph (2) after the definition of “operator” insert the following definition—

“optometrist independent prescriber” means a person—

(a)

who is a registered optometrist, and

(b)

against whose name is recorded in the relevant register an annotation signifying that he is qualified to order drugs, medicines and appliances as an optometrist independent prescriber;.

Amendment of article 2 of the POM Order

3.  In article 2 of the POM Order (appropriate practitioners), after paragraph (b) insert the following paragraph—

(c)in relation to the descriptions and classes of medicinal products specified in article 3, other than medicinal products that are controlled drugs or for parenteral administration or both , optometrist independent prescribers..

Amendment of article 8 of the POM Order

4.  In article 8 of the POM Order (exemptions for emergency sale or supply)—

(a)in paragraph (2)—

(i)in sub-paragraph (a), after “a nurse independent prescriber ” insert “, an optometrist independent prescriber”,

(ii)in sub-paragraph (b), after “nurse independent prescriber” insert “, optometrist independent prescriber”, and

(iii)in sub-paragraph (c), after “nurse independent prescriber” insert “, optometrist independent prescriber”; and

(b)in paragraph (4), in sub-paragraph (a), in head (ii), after “nurse independent prescriber” insert “, optometrist independent prescriber”.

Amendment of article 15 of the POM Order

5.  In article 15 of the POM Order (prescriptions), in paragraph (2), in sub-paragraph (c)—

(a)in head (iii), after “a nurse independent prescriber” insert “, an optometrist independent prescriber”; and

(b)in head (iv), after “a nurse independent prescriber” insert “, an optometrist independent prescriber”.

Amendment of article 1 of the Pharmacy and General Sale Order

6.  In article 1 of the Pharmacy and General Sale Order (citation, commencement and interpretation), in paragraph (2), in sub-paragraph (a) after the definition of “operator” insert the following definition—

“optometrist independent prescriber” means a person—

(a)

who is a registered optometrist, and

(b)

against whose name is recorded in the relevant register an annotation signifying that he is qualified to order drugs, medicines and appliances as an optometrist independent prescriber;.

Amendment of article 4AA of the Pharmacy and General Sale Order

7.  In article 4AA of the Pharmacy and General Sale Order (exemption for sale, offer for sale or supply in hospitals and health centres), after “a pharmacist independent prescriber” insert “, an optometrist independent prescriber”.

Amendment of Schedule 3 to the Pharmacy and General Sale Order

8.  In Schedule 3 to the Pharmacy and General Sale Order, in Part III (classes of individual by whom supplies may be made), for “registered ophthalmic opticians” substitute “registered optometrists”.

Signed by authority of the Secretary of State for Health.

Dawn Primarolo

Minister of State,

Department of Health

22nd April 2008

Michael McGimpsey

Minister for Health, Social Services and Public Safety

16th April 2008

EXPLANATORY NOTE

(This note is not part of the Order)

This Order makes further amendments to—

(a)the Prescription Only Medicines (Human Use) Order 1997 (“the POM Order”) which specifies the descriptions and classes of medicines (“prescription only medicines”) which may be sold or supplied only in accordance with the prescription of an “appropriate practitioner” and may be administered only by or in accordance with the directions of such a practitioner ; and

(b)the Medicines (Pharmacy and General Sale—Exemption) Order 1980 (“the Pharmacy and General Sale Order”) which provides for exemptions from sections 52 and 53 of the Medicines Act 1968 (restrictions on the sale or supply of medicinal products).

Articles 2 to 5 amend the POM Order to make provision for optometrists who meet certain conditions (“optometrist independent prescribers”) to prescribe, administer and give directions for administration of certain prescription only medicines.

Articles 6 to 8 amend the Pharmacy and General Sale Order. In particular, article 7 amends article 4AA of that Order to provide an exemption from the restrictions on sale, offer for sale or supply in hospitals and health centres where such sale, offer for sale or supply is in accordance with the written directions of an optometrist independent prescriber.

An impact assessment has not been produced for this instrument as there is no significant impact on the private or 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 article 2(2) of, and Schedule 1 to, S.I. 1969/388, paragraph 1(1) of the Schedule to S.I. 1999/3142 and paragraph 2 of Part 1 of Schedule 8 to S.I. 2006/2407; section 57(1) of that Act was amended by paragraph 28(a) of Part 1 of Schedule 8 to S.I. 2006/2407; section 58 of that Act was amended by section 1 of the Prescription by Nurses etc. Act 1992 (c.28), by section 63 of the Health and Social Care Act 2001(c.15), by paragraph 2 of Schedule 5 to S.I. 2002/253, by paragraph 6 of Part 1 of Schedule 1 to S.I. 2003/1590, by paragraph 10 of Schedule 1 to S.I. 2005/1094 and by paragraph 29 of Part 1 of Schedule 8 to S.I. 2006/2407.

(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)

The expression “the appropriate committee”, referred to in section 58(6) of the Act, is defined in section 4(6) of the Act, as amended by S.I. 2005/1094.

(4)

S.I. 1997/1830; relevant amending instruments are S.I. 2002/549, 2003/696, 2005/765 and 848, 2006/915 and 2807 and 2008/464.

(5)

S.I. 1980/1924; relevant amending instruments are S.I. 2000/1919, 2004/1, 2005/1507 and 2006/915.

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