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STATUTORY INSTRUMENTS


2006 No. 3373

NATIONAL HEALTH SERVICE, ENGLAND

The National Health Service (Pharmaceutical Services) (Amendment) Regulations 2006

  Made 13th December 2006 
  Laid before Parliament 18th December 2006 
  Coming into force 19th January 2007 

The Secretary of State for Health makes the following Regulations in exercise of the powers conferred by sections 41, 42, 43 and 126(4) of, and paragraph 3 of Schedule 8A to, the National Health Service Act 1977[1].



PART 1

GENERAL

Citation, commencement and application
     1. —(1) These Regulations may be cited as the National Health Service (Pharmaceutical Services) (Amendment) Regulations 2006 and shall come into force on 19th January 2007.

    (2) These Regulations shall apply in relation to England only[
2].



PART 2

Amendment of the Local Pharmaceutical Services Regulations

Amendment of the Local Pharmaceutical Services Regulations
     2. The National Health Service (Local Pharmaceutical Services etc.) Regulations 2006[3] are amended in accordance with the provisions of this Part.

Amendment of regulation 2 of the Local Pharmaceutical Services Regulations
     3. In paragraph (1) of regulation 2 (interpretation)—

Amendment of regulation 8 of the Local Pharmaceutical Services Regulations
    
4. In regulation 8 (reasons), omit "in writing".

Amendment of regulation 14 of the Local Pharmaceutical Services Regulations
    
5. In paragraph (1) of regulation 14 (LPS schemes: general) for sub-paragraph (a), substitute—

Amendment of regulation 15 of the Local Pharmaceutical Services Regulations
    
6. In paragraph (5) of regulation 15 (right of return to pharmaceutical lists)—

Amendment of Schedule 2 to the Local Pharmaceutical Services Regulations
    
7. In sub-paragraph (10) of paragraph 22 of Schedule 2 (contract terms), omit "in writing".



PART 3

Amendment of the Pharmaceutical Services Regulations

Amendment of the Pharmaceutical Services Regulations
    
8. The National Health Service (Pharmaceutical Services) Regulations 2005[4] are amended in accordance with the provisions of this Part.

Amendment of regulation 2 of the Pharmaceutical Services Regulations
     9. In paragraph (1) of regulation 2 [5] (interpretation)—

Amendment of regulation 6 of the Pharmaceutical Services Regulations
     10. In regulation 6[6] (applications involving a minor relocation within a Primary Care Trust's area)—

Amendment of regulation 7 of the Pharmaceutical Services Regulations
     11. In regulation 7[7] (applications involving a minor relocation between neighbouring Primary Care Trusts)—

Amendment of regulation 10 of the Pharmaceutical Services Regulations
     12. In paragraph (9) of regulation 10[8] (right of return to pharmaceutical lists), omit "in writing".

Amendment of regulation 14 of the Pharmaceutical Services Regulations
     13. In regulation 14 (variation of directed services in respect of exempted premises)—

Amendment of regulation 19 of the Pharmaceutical Services Regulations
    
14. In paragraph (4)(f) of regulation 19 [9](refusal: fitness to practise grounds), for "Part 1" substitute "Part 2".

Amendment of regulation 21 of the Pharmaceutical Services Regulations
     15. In paragraph (4) of regulation 21 (conditional inclusion relating to fitness to practise matters), for "in writing as soon as is practicable of any" substitute "within seven days of the date of a decision to impose any conditions of the".

Amendment of regulation 23 of the Pharmaceutical Services Regulations
    
16. In regulation 23 (notification of applications)—

Amendment of regulation 24 of the Pharmaceutical Services Regulations
    
17. In sub-paragraph (a) of paragraph (2) of regulation 24 [10](determination of applications), before "check as far" insert "ensure that it has sight of all relevant documents and".

Amendment of regulation 26 of the Pharmaceutical Services Regulations
     18. In paragraph (3) of regulation 26[11] (deferral of consideration of applications on fitness to practise grounds), omit "in writing".

Amendment of regulation 27 of the Pharmaceutical Services Regulations
     19. In regulation 27 (notification of decision)—

Amendment of regulation 28 of the Pharmaceutical Services Regulations
    
20. In paragraph (4)(b) of regulation 28[12] (notifications by Primary Care Trusts to other persons), for "the name and registered office" substitute "the name, registration number, registered office and telephone number relating to that office of the body corporate together with the name and address of any director or superintendent".

Amendment of regulation 29 of the Pharmaceutical Services Regulations
     21. In regulation 29 (appeals)—

Amendment of regulation 31 of the Pharmaceutical Services Regulations
    
22. In paragraph (12) of regulation 31[13] (determination that an area is a controlled locality), omit "in writing".

Amendment of regulation 32 of the Pharmaceutical Services Regulations
     23. In paragraph (11) of regulation 32 (appeals relating to rurality of an area), omit "in writing".

Amendment of regulation 34 of the Pharmaceutical Services Regulations
    
24. In paragraph (1)(b) of regulation 34[14] (decision not to consider an application in respect of premises in a controlled locality)—

Amendment of regulation 36 of the Pharmaceutical Services Regulations
     25. In regulation 36[15] (determination of applications in respect of controlled localities),—

Amendment of regulation 37 of the Pharmaceutical Services Regulations
     26. In regulation 37 (notification of decision in respect of applications in controlled localities)—

Amendment of regulation 38 of the Pharmaceutical Services Regulations
    
27. —(1) Before paragraph (2) of regulation 38[16] (appeals in connection with determinations in respect of controlled localities etc) insert the following paragraphs—

    (2) For sub-paragraph (a) of paragraph (2) of regulation 38, substitute—

    (3) In paragraph (3) of regulation 38—

Amendment of regulation 39 of the Pharmaceutical Services Regulations
     28. In regulation 39 (procedure after grant of application)—

Amendment of regulation 45 of the Pharmaceutical Services Regulations
    
29. In paragraph (11) of regulation 45[17] (removal from pharmaceutical lists), omit "in writing".

Amendment of regulation 46 of the Pharmaceutical Services Regulations
     30. In paragraph (2)(f) of regulation 46 (criteria for decisions on removal), for "Part 1" substitute "Part 2".

Amendment of regulation 48 of the Pharmaceutical Services Regulations
    
31. In regulation 48 (procedure on removal)—

Amendment of regulation 50 of the Pharmaceutical Services Regulations
    
32. In regulation 50[18] (procedure on suspension)—

Amendment of regulation 51 of the Pharmaceutical Services Regulations
     33. In regulation 51 (procedure on review of Primary Care Trust decision)—

Amendment of regulation 54 of the Pharmaceutical Services Regulations
    
34. In regulation 54[19] (temporary provision of services during a period of suspension)—

Amendment of regulation 55 of the Pharmaceutical Services Regulations
     35. In paragraph (1) of regulation 55 (notifications),—

Amendment of regulation 58 of the Pharmaceutical Services Regulations
    
36. After paragraph (4) of regulation 58 (payments to suspended chemists) add the following paragraphs—

Amendment of regulation 60 of the Pharmaceutical Services Regulations
    
37. In regulation 60[20] (arrangement for provision of pharmaceutical services by doctors)—

Amendment of regulation 61 of the Pharmaceutical Services Regulations
     38. In regulation 61 (outline consent and premises approval)—

Amendment of regulation 65 of the Pharmaceutical Services Regulations
    
39. In regulation 65 (premises approval: additional and new premises after outline consent has taken effect)—

Amendment of regulation 66 of the Pharmaceutical Services Regulations
    
40. In paragraph (3) of regulation 66 (premises approval: practice amalgamations)—

Amendment of Schedule 1 to the Pharmaceutical Services Regulations
    
41. —(1) Schedule 1[21] (terms of service of pharmacists) is amended in accordance with this regulation.

    (2) In sub-paragraph (1)(a) of paragraph 22 (pharmacy opening hours: general), omit "not less than".

    (3) In paragraph 24 (determination of pharmacy opening hours instigated by the Primary Care Trust)—

    (4) In paragraph 25 (determination of pharmacy opening hours instigated by the pharmacist)—

    (5) In sub-paragraph (4) of paragraph 29 (duty to provide information about fitness to practise matters: pharmacists on pharmaceutical lists on 1st April 2005), for "of the of the Police Act" substitute "of the Police Act".

    (6) In sub-paragraph (1) of paragraph 34 (information to be supplied), for paragraph (c) substitute—

Amendment of Schedule 2 to the Pharmaceutical Services Regulations
     42. In sub-paragraph (4)(b) of paragraph 7 of Schedule 2[22] (terms of service of dispensing doctors – refusal to provide drugs or appliances ordered), for "has altered" substitute "has not altered".

Amendment of Schedule 3 to the Pharmaceutical Services Regulations
     43. —(1) Schedule 3[23] (suppliers of appliances) is amended in accordance with this regulation.

    (2) In paragraph 12 (determination of opening hours instigated by the Primary Care Trust)—

    (3) In paragraph 13 (determination of opening hours instigated by the supplier of appliances)—

    (4) In sub-paragraph (4) of paragraph 16 (duty to provide information about fitness to practise matters: suppliers of appliances on pharmaceutical lists on 1st April 2005), for "of the of the Police Act" substitute "of the Police Act".

    (5) In sub-paragraph (1) of paragraph 21 (information to be supplied), for paragraph (c) substitute—



Signed by authority of the Secretary of State for Health


Andrew Burnham
Minister of State Department of Health

13th December 2006



EXPLANATORY NOTE

(This note is not part of the Regulations)


These Regulations make amendments to Regulations relating to community pharmaceutical services.

Part 2 of these Regulations makes amendments to the National Health Service (Local Pharmaceutical Services etc.) Regulations 2006 ("the 2006 Regulations"). Regulation 3 adds a definition of "notice" to make it clear that notices have to be in writing. Consequential amendments are made to regulations 8 and 15(5)(b) and paragraph 22(10) of Schedule 2 to the 2006 Regulations.

Regulation 5 also amends regulation 14(1)(a) of the 2006 Regulations to make it clear that an LPS scheme (a type of arrangement for providing community pharmaceutical services) must include dispensing services as set out in paragraph 3 of Schedule 2 to the 2006 Regulations.

Part 3 of these Regulations makes miscellaneous amendments to the National Health Service (Pharmaceutical Services) Regulations 2005. Together with miscellaneous drafting improvements and corrections, the amendments include amendments of—

A full regulatory impact assessment has not been produced for this instrument as no additional impact on the private or voluntary sectors is foreseen.


Notes:

[1] 1977 c.49. ("the Act"). Section 41 was substituted by the Health and Social Care Act 2001 (c.15) ("the 2001 Act"), section 42(1), and amended by the National Health Service Reform and Health Care Professions Act 2002 (c.17) ("the 2002 Act"), Schedule 2, paragraph 13, and by S.I. 2003/1590 and 2004/1771. Section 42 was substituted by the National Health Service (Amendment) Act 1986 (c.66), section 3(1), extended by the Health and Medicines Act 1988 (c.49), and then amended by: S.I. 1987/2202; the National Health Service Community Care Act 1990 (c.19) ("the 1990 Act"), section 12(3); the Health Authorities Act 1995 (c.17), Schedule 1, paragraph 30; the 2001 Act, sections 20(6), 40(3), 43(2) to (4), and Schedule 6, Part 1; the 2002 Act, Schedule 2, paragraph 16; and S.I. 2002/2469. Section 126(4) has been amended by: the 1990 Act, section 65(2); the Health Act 1999 (c.8), Schedule 4, paragraphs 3, 4 and 37; the 2001 Act, section 67(1) and Schedule 5, paragraphs 5 and 13; the 2002 Act, sections 6(3)(c) and 37(1) and Schedule 8, paragraph 10(a); and the Health and Social Care (Community Health and Standards) Act 2003 (c. 43) ("the 2003 Act"), section 184 and Schedule 11, paragraphs 7 and 38, and Schedule 14, Part 4. Schedule 8A was inserted by section 40 of, and Schedule 3 to, the 2001 Act, and has been amended by: the 2002 Act, Schedule 2, paragraph 81, and Schedule 9, Part 1; and the 2003 Act, Schedule 4, paragraph 44, and Schedule 11, paragraph 41. See section 128(1) of the Act, as amended by the 1990 Act, section 26(2)(g) and (i), for definitions of "prescribed" and "regulations" which are relevant to the powers being exercised.back

[2] As regards Wales, the functions of the Secretary of State under these provisions are, so far as exercisable in relation to Wales, transferred to the National Assembly for Wales by article 2(a) of the National Assembly for Wales (Transfer of Functions) Order 1999, S.I. 1999/672, as amended by section 66(5) of the Health Act 1999 (c.8).back

[3] S.I. 2006/552; amended by S.I. 2006/913.back

[4] S.I. 2005/641, as amended by S.I. 2005/1015, 1501 and 3315, and 2006/913 and 1501.back

[5] The relevant amending instruments are S.I. 2005/1501 and 3315, and 2006/552, 913 and 1501.back

[6] The relevant amending instrument is S.I. 2005/1501.back

[7] The relevant amending instrument is S.I. 2005/1501.back

[8] The relevant amending instruments are S.I. 2005/1501 and 2006/552.back

[9] The relevant amending instrument is S.I. 2006/552.back

[10] The relevant amending instrument is 2006/552.back

[11] The relevant amending instrument is 2006/552.back

[12] The relevant amending instruments are S.I. 2005/1501 and 2006/552.back

[13] The relevant amending instrument is S.I. 2005/1501.back

[14] The relevant amending instrument is S.I. 2005/1501.back

[15] The relevant amending instrument is S.I. 2006/552.back

[16] The relevant amending instrument is S.I. 2006/552.back

[17] The relevant amending instrument is S.I. 2006/552.back

[18] The relevant amending instrument is S.I. 2005/1501.back

[19] The relevant amending instruments are S.I. 2005/1501 and 2006/552.back

[20] The relevant amending instrument is S.I. 2005/1015.back

[21] The relevant amending instruments are S.I. 2005/1501 and 2006/552.back

[22] The relevant amending instrument is S.I. 2005/1501.back

[23] The relevant amending instrument is S.I. 2005/1501.back



ISBN 0 11 075530 8


 © Crown copyright 2006

Prepared 20 December 2006


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