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United Kingdom Statutory Instruments
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2002 No. 549

MEDICINES

The Prescription Only Medicines (Human Use) Amendment Order 2002

  Made 7th March 2002 
  Laid before Parliament 11th March 2002 
  Coming into force 1st April 2002 

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), (4A) and (5), 59, 103(2) and 129(4) of the Medicines Act 1968[1], or, as the case may be, those conferred by the said provisions and now vested in them[2], 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 the Safety of Medicines, pursuant to sections 58(6) and 129(7) of that Act, and 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 interpretation
     1.  - (1) This Order may be cited as the Prescription Only Medicines (Human Use) Amendment Order 2002 and shall come into force on 1st April 2002.

    (2) In this Order, "the principal Order" means the Prescription Only Medicines (Human Use) Order 1997[3].

Amendment of article 1 of the principal Order
     2.  - (1) Article 1 of the principal Order (citation, commencement and interpretation) is amended as follows.

    (2) In paragraph (1) - 

    (3) In paragraph (5)[10], for "Schedules 1, 2 and 5" substitute "Schedules 1, 2, 3A and 5".

Amendment of article 2 of the principal Order
     3. In article 2 of the principal Order (appropriate practitioners), for paragraph (b) substitute the following paragraphs - 

Amendment of article 3 of the principal Order
     4. For article 3 of the principal Order (which specifies classes of prescription only medicines), substitute the following article - 

Insertion of article 3A in the principal Order
     5. After article 3 of the principal Order, insert the following article - 

Amendment of article 8 of the principal Order
     6. Article 8 of the principal Order (exemptions for emergency sale or supply) is amended as follows - 

Insertion of article 13A into the principal Order
     7. After article 13 of the principal Order (exemption in cases involving another's default) insert the following article - 

Amendment of article 15 of the principal Order
     8. In article 15 (prescriptions)[11], in paragraph (2)(c) - 

Insertion of Schedule 3A in the principal Order
     9. After Schedule 3 to the principal Order, insert the following Schedule - 




Amendment of Schedule 7 to the principal Order
     10. In Part III of Schedule 7 to the principal Order[12] (Patient Group Directions - classes of individuals by whom supplies may be made), for the last three entries substitute the following entries - 

Revocations
     11. Articles 4 and 6 of the principal Order are revoked.



Signed by authority of the Secretary of State for Health


Hunt
Parliamentary Under Secretary of State Department of Health

7th March 2002


Bairbre de Brún
Minister of Health, Social Services and Public Safety

7th March 2002


EXPLANATORY NOTE

(This note is not part of the Order)


This Order amends the Prescription Only Medicines (Human Use) Order 1997 ("the principal Order").

Articles 2, 3, 5 and 9 make provision for nurses meeting certain conditions ("extended formulary nurse prescribers") to prescribe certain prescription only medicines. Article 2 amends article 1 of the principal Order, so as to insert definitions of "extended formulary nurse prescriber" and "district nurse/health visitor prescriber", and makes changes consequential on the Nursing and Midwifery Order 2001 (S.I. 2002/253). Article 3 amends article 2 of the principal Order, so as to provide that such persons are "appropriate practitioners" for the purposes of section 58 of the Medicines Act 1968 (restrictions on sale and supply), as amended by section 63 of the Health and Social Care Act 2001. Article 5 inserts a new article 3A into that Order, which makes provision for prescribing by extended formulary nurse prescribers; in particular, for the descriptions and classes of product which they may prescribe and the conditions as to the cases or circumstances in which such a person may prescribe. Article 9 inserts Schedule 3A into that Order; the Schedule lists the substances which such persons are able to prescribe and the requirements which must be complied with in relation to each substance. Articles 6 and 8 make consequential amendments.

Articles 2(2)(h) and (i) and 10 make amendments consequential on the Health Professions Order 2001 (S.I. 2002/254), which makes provision for the regulation of certain health professions, including chiropodists, paramedics, orthoptists, physiotherapists and radiographers.

Article 4 amends article 3 of the principal Order (which specifies classes of products which are prescription only medicines) to provide that medicinal products which have been granted a United Kingdom or Community marketing authorization will be prescription only medicines if so classified in their marketing authorization. Medicinal products for which no marketing authorization has been granted will continue to be classified as prescription only if they contain a substance listed in column 1 of Schedule 1. Article 10 revokes articles 4 and 6 of the principal Order as a consequence of these changes.

Article 7 inserts article 13A into the principal Order, which provides for exemptions from the restrictions in section 58 of the 1968 Act (restrictions on sale and supply) in cases where a pharmacist supplies a medicinal product in accordance with a prescription by a nurse or midwife.

A Regulatory Impact Assessment in relation to this Order has been placed in the libraries of both Houses of Parliament and copies may be obtained from the Department of Health, Medicines Control Agency, Information Centre, Room 10-202, Market Towers, 1 Nine Elms Lane, London SW8 5NQ.

Notes:

 [1] 1968 c.67; the expression "the appropriate Ministers" and the expression "the Health Ministers", which are relevant to the powers being exercised in the making of this Order, are defined in section 1 of that Act as amended by article 2(2) of, and Schedule 1 to, S.I. 1969/388, and by articles 2(1) and 5 of, and the Schedule to, S.I. 1999/3142; section 58 of that Act was amended by section 1 of the Prescription by Nurses etc. Act 1992 (c.28) and by section 63 of the Health and Social Care Act 2001 (c.15).back

[2] In the case of the Secretary of State concerned with health in England, by virtue of article 2(2) of, and Schedule 1 to, S.I. 1969/388, and articles 2(1) and 5 of, and the Schedule to, S.I. 1999/3142; and in the case of the Minister of Health, Social Services and Public Safety, by virtue of section 95(5) of, and paragraph 10 of Schedule 12 to, the Northern Ireland Act 1998 (c.47).back

[3] S.I. 1997/1830, amended by S.I. 1997/2044, 1998/108, 1178 and 2081, 1999/1044 and 3463, 2000/1917, 2899 and 3231, and 2001/2777, 2889 and 3942.back

[4] The rules were approved by S.I. 1983/873; there are amendments to the rules which are not relevant to this Order.back

[5] Inserted by article 2(a) of S.I. 2000/1917.back

[6] See article 3 of the Nursing and Midwifery Order 2001, S.I. 2002/253.back

[7] S.I. 2002/253.back

[8] See article 3 of the Health Professions Order 2001, S.I. 2002/254.back

[9] S.I. 2002/254.back

[10] Paragraph (5) was amended by article 2 of S.I. 2001/2777.back

[11] Article 15 was amended by S.I. 2001/2889.back

[12] Schedule 7 was inserted by article 2(e) of S.I. 2000/1917.back


ISBN 0 11 039 674 X


  Prepared 12 April 2002

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