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Statutory Instrument 2006 No. 3373The National Health Service (Pharmaceutical Services) (Amendment) Regulations 2006(The document as of February, 2008) STATUTORY INSTRUMENTS2006 No. 3373NATIONAL HEALTH SERVICE, ENGLANDThe National Health Service (Pharmaceutical Services) (Amendment) Regulations 2006
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]. 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]. 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)—
(b) after the definition of "non-proprietary name" insert the following definition—
Amendment of regulation 8 of the Local Pharmaceutical Services Regulations
Amendment of regulation 15 of the Local Pharmaceutical Services Regulations
(b) omit "in writing". Amendment of Schedule 2 to the Local 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)—
(b) in the definition of "pharmacist independent prescriber",—
(ii) after sub-paragraph (b) add the following sub-paragraph—
(ii) employed or engaged by a person who is included in a pharmaceutical list, and the Primary Care Trust has made an arrangement with that person for the provision of a directed service which is an Independent Prescribing Service; (iii) employed or engaged by a GMS contractor, a PMS contractor, an APMS contractor or a PCTMS practice to provide services equivalent to a directed service which is an Independent Prescribing Service; (iv) a relevant GMS contractor, a relevant PMS contractor, or a relevant APMS contractor contracted to provide services equivalent to a directed service which is an Independent Prescribing Service; (v) employed or engaged by a relevant GMS contractor, a relevant PMS contractor, or a relevant APMS contractor to provide services equivalent to a directed service which is an Independent Prescribing Service; or (vi) employed or engaged by a Primary Care Trust or an LPS chemist to provide services equivalent to a directed service which is an Independent Prescribing Service; or (vii) employed or engaged by a NHS trust or NHS foundation trust to provide NHS services and is prescribing in that capacity;". Amendment of regulation 6 of the Pharmaceutical Services Regulations
(b) in paragraph (8), omit "in writing". Amendment of regulation 7 of the Pharmaceutical Services Regulations
(b) in paragraph (8), omit "in writing". Amendment of regulation 10 of the Pharmaceutical Services Regulations
(b) in paragraph (10), omit "in writing". Amendment of regulation 19 of the Pharmaceutical Services Regulations
(b) in paragraph (3), omit "in writing" at the first place where it occurs. Amendment of regulation 24 of the Pharmaceutical Services Regulations
(ii) before sub-paragraph (a), insert the following sub-paragraph—
(ii) any person who has made representations to the Primary Care Trust in accordance with regulation 23(2) or 23(3);", and (iii) in sub-paragraph (a), for "regulation 6,7," substitute "regulation 6(3),7(3),"; (b) in paragraph (2), after "involves" insert "either a minor relocation within a Primary Care Trust's area or between neighbouring Primary Care Trusts that falls to be dealt with under regulation 6(3), or 7(3) as appropriate or"; and Amendment of regulation 28 of the Pharmaceutical Services Regulations
(b) any person who—
(ii) made representations to the Primary Care Trust in accordance with regulation 23(2) or 23(3)."; (b) in paragraph (2)(a), for "regulation 6(1), 7(1)," substitute "regulation 6(3), 7(3),";
(e) in paragraph (19), omit "in writing". Amendment of regulation 31 of the Pharmaceutical Services Regulations
(b) for "pharmacist" substitute "chemist". Amendment of regulation 36 of the Pharmaceutical Services Regulations
(b) in paragraph (3)(a), before "check as far" insert "ensure that it has sight of all relevant documents and". Amendment of regulation 37 of the Pharmaceutical Services Regulations
(ii) for sub-paragraph (b) substitute—
(b) in paragraph (2), after "application" insert "under regulation 6(3), 7(3) or"; and Amendment of regulation 38 of the Pharmaceutical Services Regulations
(b) any person who—
(ii) made representations to the Primary Care Trust in accordance with regulation 33(4). (1B) Where a Primary Care Trust has determined an application to which regulations 33 to 36 applied, and regulation 6(3), 7(3), 8, 9, or 10 also applied to that application, or the Primary Care Trust has made a decision under regulation 39(8) in relation to that application, the persons who may appeal to the Secretary of State are—
(b) any person who was given notice of the decision under regulation 37(1)(a)(iv) or (v) or regulation 37(3)(c) or (d). (1C) Where a Primary Care Trust has determined an application to which regulations 33 to 36 applied, and regulation 12 also applied to that application or would have applied but for an exemption under regulation 13, the persons who may appeal to the Secretary of State are—
(b) except in the case of an application to which regulation 13(1) applies, any person who—
(ii) made representations to the Primary Care Trust in accordance with regulation 33(4). (1D) Paragraphs (1A), (1B) and (1C) do not apply to determinations of applications under regulation 18ZA or 36(2).". (2) For sub-paragraph (a) of paragraph (2) of regulation 38, substitute—
(3) In paragraph (3) of regulation 38—
(b) in sub-paragraph (a)(ii)(bb), for "regulation 33(2)(f), (h) or (i)" substitute "regulation 33(2)(f), (i) or (j)". Amendment of regulation 39 of the Pharmaceutical Services Regulations
(b) for sub-paragraph (a) of paragraph (10), substitute—
(ii) such lesser number of days as may be specified by the Primary Care Trust if it considers that there is good cause to reduce the number of days; or". Amendment of regulation 45 of the Pharmaceutical Services Regulations
(b) in paragraph (4), for "inform" substitute "notify". Amendment of regulation 50 of the Pharmaceutical Services Regulations
(b) in paragraph (4), for "inform" substitute "notify". Amendment of regulation 51 of the Pharmaceutical Services Regulations
(b) in paragraph (3), for "inform" substitute "notify". Amendment of regulation 54 of the Pharmaceutical Services Regulations
(b) in paragraph (13)(c), omit "in writing"; (c) in paragraph (14), omit "in writing"; (d) in paragraph (17), for "notify" substitute "inform"; (e) in paragraph (19), omit "in writing"; and (f) in paragraph (21)(d), omit "in writing". Amendment of regulation 55 of the Pharmaceutical Services Regulations
(b) after "shall additionally notify" insert "within 7 days of the request in writing". Amendment of regulation 58 of the Pharmaceutical Services Regulations
(6) If a chemist is dissatisfied with a decision of a Primary Care Trust ("the original decision")—
(b) to make a payment to, or in respect of, him in accordance with a determination under paragraph (2), but at a lower level than the level which he considers to be correct; or (c) in respect of recovery of what the Primary Care Trust considers to be an overpayment, he may ask the Primary Care Trust in writing to review the original decision and, if he does so, the Primary Care Trust shall reconsider that decision, and once it has done so, it must notify the chemist of the decision that is the outcome of its reconsideration of its original decision ("the reconsidered decision"), and give him notice of the reasons for its reconsidered decision.
(b) a copy of the reconsidered decision; and (c) a brief statement of the grounds for appeal. (9) The Secretary of State shall then send a written request to the parties to make, in writing and within a specified period, any representations they may wish to make about the matter (and the request to the Primary Care Trust shall include a copy of the chemist's brief statement of the grounds for appeal).
(b) request in writing a party to whom a copy of representations is given to make within a specified period any written observations which he or it wishes to make on those representations. (11) Once the period specified pursuant to paragraph (10)(b) has elapsed, the Secretary of State shall, as soon as is reasonably practicable, having taken into account any such representations or observations as are referred to in paragraphs (9) and (10) (if submitted within the specified periods) and such other evidence as he sees fit to consider–—
(b) give the Primary Care Trust such directions in writing, if any, on the matter as he thinks fit.". Amendment of regulation 60 of the Pharmaceutical Services Regulations
(b) in paragraph (15), omit "in writing". Amendment of regulation 61 of the Pharmaceutical Services Regulations
(b) in paragraph (2), for "33 to 38" substitute "33, 34, 36 to 38". Amendment of regulation 65 of the Pharmaceutical Services Regulations
(b) in paragraph (4)(a)(ii), for "dispensing services in" substitute "dispensing services to"; (c) in paragraph (5), for "The Primary Care Trust" substitute "The relevant Primary Care Trust"; (d) in paragraph (6), for "the Primary Care Trust" substitute "the relevant Primary Care Trust"; (e) in paragraph (7)(a), for "the Primary Care Trust" substitute "the relevant Primary Care Trust"; (f) in paragraph (8)—
(ii) for "the Primary Care Trust" substitute "the relevant Primary Care Trust"; and (g) in paragraph (9)—
(ii) for the words "temporary authority granted" substitute "temporary approval granted". Amendment of regulation 66 of the Pharmaceutical Services Regulations
(b) after "a doctor who" insert "is a party to the practice amalgamation and who". Amendment of Schedule 1 to the Pharmaceutical Services Regulations
(b) in sub-paragraph (6), omit "in writing"; and (c) in sub-paragraph (9), omit "in writing". (4) In paragraph 25 (determination of pharmacy opening hours instigated by the pharmacist)—
(b) in sub-paragraph (8), omit "in writing"; (c) in sub-paragraph (11), omit "in writing". (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".
Amendment of Schedule 2 to the Pharmaceutical Services Regulations
(b) in sub-paragraph (9), omit "in writing"; (3) In paragraph 13 (determination of opening hours instigated by the supplier of appliances)—
(b) in sub-paragraph (11), omit "in writing". (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".
(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—
(b) the appeal rights in connection with determinations in respect of controlled localities (regulation 27); (c) the procedure after the grant of an application so that an applicant can be included in a pharmaceutical list before 30 days have expired, where there is good cause (regulation 28); (d) the provisions relating to payments to suspended chemists (regulation 36). 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 -- Back --
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