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United Kingdom Statutory Instruments |
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You are here: BAILII >> Databases >> United Kingdom Statutory Instruments >> The National Health Service (Primary Medical Services) (Miscellaneous Amendments) (No. 2) Regulations 2005 No. 3315 URL: http://www.bailii.org/uk/legis/num_reg/2005/20053315.html |
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Made | 1st December 2005 | ||
Laid before Parliament | 9th December 2005 | ||
Coming into force | 6th January 2006 |
(d) in paragraph (c), after "an annotation" insert "or entry".
Amendment of regulation 5 of the GMS Contracts Regulations
3.
In regulation 5(2) (general condition relating to all contracts) of the GMS Contracts Regulations, in sub-paragraph (k), before "he has been", insert, "within the period of five years prior to signing the contract or commencement of the contract, whichever is the earlier,".
Amendment of regulation 22 of the GMS Contracts Regulations
4.
In regulation 22 (finance) of the GMS Contracts Regulations, in paragraph (1), for "the Primary Care Trust to make payments to the contractor", substitute, "payments to be made".
Amendment of regulation 26 of the GMS Contracts Regulations
5.
In regulation 26 (other contractual items), in paragraph (1), after "36(5) to (17)," insert "48(2) and (4), 48A(6) (in so far as it relates to a determination by the Secretary of State of an appeal) and (15) (in so far as it relates to an appeal to the Secretary of State), 48C(4), 48D (in so far as this paragraph relates to a Primary Care Trust which is not a party to the contract or an appeal to the Secretary of State), 49A(8),".
Omission of Schedule 1 to the GMS Contracts Regulations
6.
Schedule 1 (repeat dispensing forms) to the GMS Contracts Regulations shall be omitted.
Amendment of Schedule 6 to the GMS Contracts Regulations
7.
—(1) Schedule 6 (other contractual terms) to the GMS Contracts Regulations shall be amended as provided in the following paragraphs.
(2) For paragraphs 47 (provision of dispensing services) to 49 (contractors who previously provided etc) substitute—
(3) The conditions referred to in sub-paragraph (2)(a) are that the patient—
and all of the conditions in sub-paragraph (4) are satisfied in his case; or
(d) is one to whom paragraph (a) or (b) applies and at the time of the request the patient is living as a member of the household, other than as a temporary resident, of another person in respect of whom a contractor has residual premises approval.
(4) The conditions referred to in sub-paragraphs (3)(b) and (c) are that—
(b) there is in effect premises approval in relation to the premises from which the contractor will dispense to the patient; and
(c) any conditions imposed in connection with that grant under regulation 20(2) or 38(14)(b) of the Pharmaceutical Regulations as they apply pursuant to paragraph 48(4) are such as to permit dispensing services to be provided under this paragraph by that contractor to the patient.
(5) If a contractor which has been requested to provide dispensing services by a patient who satisfies one of the conditions in sub-paragraph (3)—
(6) An application granted by the Primary Care Trust under sub-paragraph (5)(a) shall, with effect from the date of the patient's request to the contractor, enable that contractor to provide dispensing services at listed premises in the case of a patient falling within sub-paragraph (3)(b) or (c) or practice premises in the case of a patient falling within sub-paragraph (3)(a) to that patient, so long as the contract remains in effect.
(7) A Primary Care Trust shall not, under sub-paragraph (5)(b), require a contractor to provide dispensing services at listed premises or practice premises to a patient if the contractor satisfies the Primary Care Trust that—
(8) A Primary Care Trust shall give the contractor reasonable notice—
(9) A notice under sub-paragraph (8)(b)—
(10) A contractor which has been granted the right under this paragraph to provide dispensing services to some or all of its registered patients may provide any necessary dispensing services to a person whom that contractor has accepted as a temporary resident.
(11) In this paragraph and in paragraphs 48 to 51 "controlled locality", "distance selling chemist", "pharmacy", "premises approval", "reserved location" and "residual premises approval" have the same meanings as in the Pharmaceutical Regulations, and "listed premises" means the premises specified in relation to the contractor in the dispensing contractor list.
Consent to dispense and premises approval
48.
—(1) A contractor which wishes to be granted the right under paragraph 47 to secure the provision of dispensing services to some or all of its registered patients may apply to the Primary Care Trust in writing for—
in relation to which it wishes the consent to dispense to be granted; and
(b) premises approval, specifying—
(2) An application under sub-paragraph (1) shall be determined in accordance with paragraph 48A and regulations 18, 20(2), 33, 34 and 36 to 38 of the Pharmaceutical Regulations (as modified in accordance with sub-paragraph (4)), as though it were an application for outline consent or premises approval under regulation 61 of those Regulations.
(3) The Primary Care Trust may refuse an application in respect of some of the premises for which approval is sought (notwithstanding that it would, if determining the application for those premises in isolation, grant it) where the number of applications for premises approval are such, or the circumstances in which they are made are such, that to grant all or some of them would prejudice the proper provision of primary medical services, dispensing services, local pharmaceutical services or pharmaceutical services in any locality.
(4) Regulations 18, 20(2), 33, 34 and 36 to 38 of the Pharmaceutical Regulations shall apply as if—
(f) in regulation 38(2)(c), for the references to "regulation 60" there were substituted a reference to paragraph 47;
(g) in regulation 38(2)(e)(i), for the reference to "regulation 62(8)" there were substituted a reference to paragraph 48A(8);
(h) in regulation 38(2)(e)(ii), for "paragraph (13)(a) of that regulation" there were substituted " paragraph 48A(13)(a);"; and
(i) in regulation 38(2)(e)(iii), for "paragraph (13)(b) of that regulation" there were substituted "paragraph 48A(13)(b)".
(5) Any reference in paragraphs 48A, 48C, 48D or 49A to regulations 18, 20(2), 33, 34 and 36 to 38 shall apply as modified by sub-paragraph (4).
Taking effect of consent to dispense and premises approval
48A.
—(1) When granting consent to dispense, the Primary Care Trust shall determine in accordance with sub-paragraph (2) when the consent to dispense is to take effect.
(2) The consent to dispense shall take effect—
(3) This sub-paragraph applies to premises for which consent to dispense is sought and—
(b) in relation to which, on the day before the date on which the application for consent to dispense is granted, there are no outstanding applications.
(4) This sub-paragraph applies where, on the day before the date on which the application for outline consent is granted, there are outstanding applications.
(5) For the purposes of sub-paragraphs (3), (4), (6), (9) and (10) and paragraphs 48C and 48D, an "outstanding application" means an application by a pharmacist under regulation 5 or 40 of the Pharmaceutical Regulations which—
(6) Where sub-paragraph (2)(b) applies, notification of the determination of the application for consent to dispense by the Primary Care Trust or, on appeal, by the Secretary of State, shall give details of—
(7) The provisional date is the day after the end of a period of one year beginning with the date of—
(8) The Primary Care Trust may, at any time before the provisional date, for good cause determine that the provisional date shall be extended for a period not exceeding three months beginning with the date specified in sub-paragraph (7)(a) or (b), and any reference in this paragraph or in paragraph 48C to the provisional date shall include a reference to the provisional date as extended under this sub-paragraph.
(9) The Primary Care Trust shall—
(10) The consent to dispense shall lapse if, before the provisional date, pharmaceutical services are provided from premises which were the subject of an outstanding application which has been granted.
(11) On, or as soon as reasonably practicable after, the provisional date, the Primary Care Trust shall notify the contractor who made the application under paragraph 48 and—
(12) Where, on the date of the determination under sub-paragraph (11), the premises are practice premises, the Primary Care Trust shall determine that the consent to dispense and premises approval in respect of those premises shall come into effect on that date.
(13) Where, on the date of the determination under sub-paragraph (11), the premises are not practice premises—
(14) The Primary Care Trust shall notify its determination under sub-paragraph (11) to the contractor and those persons to whom notice of the application under paragraph 48 was required to be given under regulation 33(2) and (3) of the Pharmaceutical Regulations.
(15) Where the Primary Care Trust has determined that—
the contractor may appeal to the Secretary of State against any such determination by giving notice of appeal in accordance with regulation 38(5) of the Pharmaceutical Regulations, and such appeal shall be determined in accordance with regulation 38 of the Pharmaceutical Regulations.
(16) Premises approval shall take effect when the related consent to dispense takes effect.
Lapse of consent to dispense and premises approval
48B.
—(1) A consent to dispense shall cease to have effect—
(2) Premises approval shall cease to have effect in relation to—
(3) Premises approval shall cease to have effect where the related consent to dispense ceases to have effect.
Premises approval: change of premises before consent to dispense takes effect
48C.
—(1) Where—
the contractor may apply to the Primary Care Trust in writing for the Primary Care Trust to determine whether premises approval should be given in relation to the new premises, and the Primary Care Trust shall make the determination in accordance with sub-paragraph (2).
(2) If the Primary Care Trust is satisfied that the change of premises is a minor relocation it may grant premises approval for those premises, but if it is not so satisfied the application for the premises approval to be given in relation to the new premises shall be refused.
(3) The Primary Care Trust shall notify those persons to whom notice of the application under paragraph 48 was required to be given and applicants in relation to the outstanding applications, of its determination under sub-paragraph (2).
(4) The determination by the Primary Care Trust under sub-paragraph (2) may be appealed to the Secretary of State by the contractor, and such appeal shall be determined in accordance with regulation 38 of the Pharmaceutical Regulations.
Premises approval: additional and new premises after consent to dispense has taken effect
48D.
—(1) A contractor who has been granted consent to dispense which has taken effect and who wishes to be granted premises approval in relation to premises in addition to those in respect of which premises approval has been given ("additional premises") may apply to all the appropriate Primary Care Trusts and—
(2) For the purposes of this paragraph—
(3) A contractor wishing to be granted premises approval in relation to premises ("new premises") where it wishes to dispense instead of listed premises may apply to all the appropriate Primary Care Trusts and the application shall be determined by the relevant Primary Care Trust in accordance with sub-paragraph (4).
(4) The relevant Primary Care Trust shall—
provided that no further applications shall be granted under this sub-paragraph for a period of 12 months beginning with the date on which the contractor commenced providing services from the new premises unless the Primary Care Trust shall for good cause allow; and
(b) in any other case determine the application in accordance with sub-paragraph (1) as if the references to additional premises were to new premises.
(5) The relevant Primary Care Trust shall notify its determination under sub-paragraph (4)(a) to the persons to whom the notice is required to be given under regulation 33(2) and (3) of the Pharmaceutical Regulations and to the appropriate Primary Care Trusts.
(6) A determination by the relevant Primary Care Trust may be appealed to the Secretary of State by the contractor and any of the persons notified under sub-paragraph (5) apart from any Local Pharmaceutical Committee or any Local Medical Committee, and such appeal shall be determined in accordance with regulation 38 of the Pharmaceutical Regulations.
(7) Subject to sub-paragraph (8), when granted in relation to new or additional premises, the premises approval shall take effect from the date of notification of the grant and for this purpose the date of the notification of a grant of any application shall be—
(8) Where—
the premises approval shall provisionally take effect on the date which is the day after the end of a period of one year, or such longer period (not exceeding three months) as the relevant Primary Care Trust may for good cause allow before the expiration of that year, from the final resolution of any outstanding application.
(9) The relevant Primary Care Trust may grant temporary premises approval to a contractor who has consent to dispense and premises approval in relation to additional or new premises where it considers it desirable to do so to secure the adequate provision of dispensing services in the area served by the premises, and renew any such temporary approval granted, to secure such adequate provision, and where it does so it shall—
(10) Temporary premises approval may be granted for a period not exceeding 12 months, and may be renewed for a further period not exceeding three months.
Premises approval: practice amalgamations
48E.
—(1) "A practice amalgamation" occurs where two or more providers of primary medical services merge as a result of which two or more patient lists are combined and the contract is varied.
(2) If, following a practice amalgamation, all the practice premises of the new practice are premises in respect of which premises approval was in effect immediately prior to the practice amalgamation, then consent to dispense and premises approval shall continue to have effect.
(3) Where there is, or will be, a practice amalgamation and none or not all of the practice premises of the contractor are, or will be, premises in respect of which premises approval was in effect immediately prior to the practice amalgamation, the contractor if it has been granted consent to dispense and premises approval which is in effect either immediately before the practice amalgamation or the date of the application under this sub-paragraph, may make an application for premises approval, and it shall be determined as provided in paragraph 48D as if it were an application from a contractor with premises approval to have the right to dispense from—
and the Primary Care Trust may grant temporary premises approval under paragraph 48D(9).
(4) An application mentioned in sub-paragraph (3) may be made before or after the practice amalgamation takes place, and where the practice amalgamation takes effect before the application has been finally determined—
(5) When the practice amalgamation takes effect the contractor shall notify all Primary Care Trusts in whose area the amalgamated practice is situated that the practice amalgamation has taken place.
(6) Subject to sub-paragraph (7), where an application made under sub-paragraph (3) was granted before the practice amalgamation takes place, premises approval shall take effect from the date of the practice amalgamation.
(7) Where an application was made under sub-paragraph (3) before the practice amalgamation takes place and the practice amalgamation has not taken place before the end of a period of one year beginning with the date that premises approval was granted under that sub-paragraph, that grant shall lapse.
(8) Where an application under sub-paragraph (3) for premises approval is refused either for all or any of the premises specified in the application, whether before or after the practice amalgamation takes place, the contractor, if it had premises approval prior to making the application, shall have residual premises approval.
(9) For the purposes of this paragraph "residual premises approval" means approval to dispense—
(10) For the purposes of sub-paragraph (9), paragraph 47(3)(b) or (c) shall be read as if the words "and all of the conditions in sub-paragraph (4) are satisfied in his case" were omitted.
Contractors who previously provided dispensing services under section 28C arrangements
49.
—(1) This paragraph applies where the contractor was, immediately before the commencement of the contract, providing primary medical services in the area of the Primary Care Trust in accordance with section 28C arrangements and—
(2) In a case to which this paragraph applies the contractor shall be regarded as—
(b) having been granted consent to dispense in relation to the contract under paragraph 48 in relation to the area for which it had such consent under the section 28C arrangements; and
(c) having been granted premises approval in relation to the contract under paragraph 48 for those premises from which it had, immediately before the commencement of the contract, authority to provide dispensing services in accordance with the section 28C arrangements.
Transitional provisions
49A.
—(1) This paragraph applies where the contractor has been granted, prior to 6th January 2006 consent to dispense in accordance with paragraph 48 and that consent is in effect on 6th January 2006.
(2) For the purposes of this paragraph, "relevant premises" means—
(3) The Primary Care Trust shall determine whether or not to grant premises approval to relevant premises in accordance with sub-paragraphs (4) to (6).
(4) Before 5th February 2006 the Primary Care Trust shall notify the contractor that—
(5) The Primary Care Trust shall—
(6) The Primary Care Trust shall grant premises approval under sub-paragraph (3) where it is satisfied that the relevant premises were, prior to 6th January 2006, being routinely used to provide dispensing services.
(7) The Primary Care Trust shall not refuse to grant premises approval under sub-paragraph (3) by reason of the relevant premises being within 1.6 kilometres of any pharmacy.
(8) The Primary Care Trust's determination under sub-paragraph (5)(c) may be appealed to the Secretary of State by a person notified of the determination under sub-paragraph (5)(d) except the Committees mentioned in sub-paragraph (5)(a), and regulations 38(5) to (15) of the Pharmaceutical Regulations shall apply to such appeals except that, for this purpose, regulation 38 shall be read as if—
(9) Until—
whichever is the later, a contractor shall be deemed to have been granted premises approval for the relevant premises, but it may not make any application to which paragraph 48C or 48D applies.".
(3) In paragraph 50 (terms relating to the provision of dispensing services), after sub-paragraph (8), insert
(4) In paragraph 51 (dispensing contractor list)—
(e) state the area in relation to which there is consent to dispense and premises approval; and
(f) include and identify separately, any premises in relation to which the contractor has undetermined applications for premises approval,
on a list of such contractors (to be called the dispensing contractors list) which it shall prepare, maintain and publish."; and
(5) For paragraph 66 (signing of documents), substitute—
(b) that the documents specified in sub-paragraph (3) include the clinical profession of the health care professional who signed the document.
(2) The documents referred to in sub-paragraph (1)(a) are—
(3) The documents referred to in sub-paragraph (1)(b) are batch issues, prescription forms and repeatable prescriptions.".
(6) In paragraph 73 (patient records), in sub-paragraph (4)(c), for ""Good Practice Guidelines for General Practice Electronic Patient Records" published on 26th September 2003", substitute, ""Good Practice Guidelines for General Practice Electronic Patient Records (Version 3.1)" published on 29th July 2005[8]".
(7) In paragraph 124 (gifts), in sub-paragraph (2)(f), after "spouse", insert, "or civil partner".
(d) in paragraph (c), after "an annotation", insert, "or entry".
Amendment of regulation 5 of the PMS Agreements Regulations
9.
In regulation 5(3) (general condition relating to all agreements) of the PMS Agreements Regulations, in sub-paragraph (j), before "he has been", insert, "within the period of five years prior to signing the agreement or commencement of the agreement, whichever is the earlier,".
Amendment of regulation 13 of the PMS Agreements Regulations
10.
In regulation 13 (finance) of the PMS Agreements Regulations, in paragraph (1), for "the relevant body to make payments to the contractor", substitute, "payments to be made".
Amendment of regulation 18 of the PMS Agreements Regulations
11.
In regulation 18 (other contractual terms), in paragraphs (1) and (2), after "35(5) to (17)" insert "47(2) and (4), 47A(6) (in so far as it relates to a determination by the Secretary of State of an appeal) and (15) (in so far as it relates to an appeal to the Secretary of State), 47C(4), 47D (in so far as this paragraph relates to a Primary Care Trust which is not a party to the agreement or an appeal to the Secretary of State), 48A(8),".
Omission of Schedule 1 to the PMS Agreements Regulations
12.
Schedule 1 (repeat dispensing forms) to the PMS Agreements Regulations shall be omitted.
Amendment of Schedule 5 to the PMS Agreements Regulations
13.
—(1) Schedule 5 (other contractual terms) to the PMS Agreements Regulations shall be amended as provided in the following paragraphs.
(2) In paragraph 44 (excessive prescribing), in sub-paragraph (2), for the word "shall" substitute the words "may, if the contractor consents,".
(3) In paragraph 45 (dispensing services: general), for "Paragraphs 46 to 48" substitute "Paragraphs 46 to 48A".
(4) For paragraphs 46 (provision of dispensing services by contractors other than Primary Care Trusts) to 49 (provision of dispensing services by Primary Care Trusts) substitute—
(3) The conditions referred to in sub-paragraph (2)(a) are that the patient—
and all of the conditions in sub-paragraph (4) are satisfied in his case; or
(d) is one to whom paragraph (a) or (b) applies and at the time of the request the patient is living as a member of the household, other than as a temporary resident, of another person in respect of whom a contractor has residual premises approval.
(4) The conditions referred to in sub-paragraphs (3)(b) and (c) are that—
(b) there is in effect premises approval in relation to the premises from which the contractor will dispense to the patient; and
(c) any conditions imposed in connection with that grant under regulation 20(2) or 38(14)(b) of the Pharmaceutical Regulations as they apply pursuant to paragraph 47(4) are such as to permit dispensing services to be provided under this paragraph by that contractor to the patient.
(5) If a contractor which has been requested to provide dispensing services by a patient who satisfies one of the conditions in sub-paragraph (3)—
(6) An application granted by the Primary Care Trust under sub-paragraph (5)(a) shall, with effect from the date of the patient's request to the contractor, enable that contractor to provide dispensing services at listed premises in the case of a patient falling within sub-paragraph (3)(b) or (c), or practice premises in the case of a patient falling within sub-paragraph (3)(a) to that patient, so long as the agreement remains in effect.
(7) A Primary Care Trust shall not, under sub-paragraph (5)(b), require a contractor to provide dispensing services at listed premises or practice premises to a patient if the contractor satisfies the Primary Care Trust that—
(8) A Primary Care Trust shall give the contractor reasonable notice—
(9) A notice under sub-paragraph (8)(b)—
(10) A contractor which has been granted the right under this paragraph to provide dispensing services to some or all of its registered patients may provide any necessary dispensing services to a person whom that contractor has accepted as a temporary resident.
(11) In this paragraph and in paragraphs 47 to 51 "controlled locality", "distance selling chemist", "pharmacy", "practice premises", "premises approval", "reserved location" and "residual premises approval" have the same meanings as in the Pharmaceutical Regulations, and "listed premises" means the premises specified in relation to the contractor in the dispensing contractors list.
Consent to dispense and premises approval
47.
—(1) A contractor which wishes to be granted the right under paragraph 46 to secure the provision of dispensing services to some or all of its registered patients may apply to the Primary Care Trust in writing for—
in relation to which it wishes the consent to dispense to be granted; and
(b) premises approval, specifying—
(2) An application under sub-paragraph (1) shall be determined in accordance with paragraph 47A and regulations 18, 20(2), 33, 34 and 36 to 38 of the Pharmaceutical Regulations (as modified in accordance with sub-paragraph (4)), as though it were an application for outline consent or premises approval under regulation 61 of those Regulations.
(3) The Primary Care Trust may refuse an application in respect of some of the premises for which approval is sought (notwithstanding that it would, if determining the application for those premises in isolation, grant it) where the number of applications for premises approval are such, or the circumstances in which they are made are such, that to grant all or some of them would prejudice the proper provision of primary medical services, dispensing services, local pharmaceutical services or pharmaceutical services in any locality.
(4) Regulations 18, 20(2), 33, 34 and 36 to 38 of the Pharmaceutical Regulations shall apply as if—
(f) in regulation 38(2)(c), for the references to "regulation 60" there were substituted a reference to paragraph 46;
(g) in regulation 38(2)(e)(i), for the reference to "regulation 62(8)" there were substituted a reference to paragraph 47A(8);
(h) in regulation 38(2)(e)(ii) for "paragraph (13)(a) of that regulation" there were substituted " paragraph 47A(13)(a);"; and
(i) in regulation 38(2)(e)(iii), for "paragraph (13)(b) of that regulation" there were substituted "paragraph 47A(13)(b)",
(5) Any reference in paragraphs 47A, 47C, 47D or 48A to regulations 18, 20(2), 33, 34 and 36 to 38 shall apply as modified by sub-paragraph (4).
Taking effect of consent to dispense and premises approval
47A.
—(1) When granting consent to dispense, the Primary Care Trust shall determine in accordance with sub-paragraph (2) when the consent to dispense is to take effect.
(2) The consent to dispense shall take effect—
(3) This sub-paragraph applies to premises for which consent to dispense is sought and—
(b) in relation to which, on the day before the date on which the application for consent to dispense is granted, there are no outstanding applications.
(4) This sub-paragraph applies where, on the day before the date on which the application for outline consent is granted, there are outstanding applications.
(5) For the purposes of sub-paragraphs (3), (4), (6), (9) and (10) and paragraphs 47C and 47D, an "outstanding application" means an application by a pharmacist under regulation 5 or 40 of the Pharmaceutical Regulations which—
(6) Where sub-paragraph (2)(b) applies, notification of the determination of the application for consent to dispense by the Primary Care Trust or, on appeal, by the Secretary of State, shall give details of—
(7) The provisional date is the day after the end of a period of one year beginning with the date of—
(8) The Primary Care Trust may, at any time before the provisional date, for good cause determine that the provisional date shall be extended for a period not exceeding three months beginning with the date specified in sub-paragraph (7)(a) or (b), and any reference in this paragraph or in paragraph 47C to the provisional date shall include a reference to the provisional date as extended under this sub-paragraph.
(9) The Primary Care Trust shall—
(10) The consent to dispense shall lapse if, before the provisional date, pharmaceutical services are provided from premises which were the subject of an outstanding application which has been granted.
(11) On, or as soon as reasonably practicable after, the provisional date, the Primary Care Trust shall notify the contractor who made the application under paragraph 47 and—
(12) Where, on the date of the determination under sub-paragraph (11), the premises are practice premises, the Primary Care Trust shall determine that the consent to dispense and premises approval in respect of those premises shall come into effect on that date.
(13) Where, on the date of the determination under sub-paragraph (11), the premises are not practice premises—
(14) The Primary Care Trust shall notify its determination under sub-paragraph (11) to the contractor and those persons to whom notice of the application under paragraph 47 was required to be given under regulation 33(2) and (3) of the Pharmaceutical Regulations.
(15) Where the Primary Care Trust has determined that—
the contractor may appeal to the Secretary of State against any such determination by giving notice of appeal in accordance with regulation 38(5) of the Pharmaceutical Regulations, and such appeal shall be determined in accordance with regulation 38 of the Pharmaceutical Regulations
(16) Premises approval shall take effect when the related consent to dispense takes effect.
Lapse of consent to dispense and premises approval
47B.
—(1) A consent to dispense shall cease to have effect—
(2) Premises approval shall cease to have effect in relation to—
(3) Premises approval shall cease to have effect where the related consent to dispense ceases to have effect.
Premises approval: change of premises before consent to dispense takes effect
47C.
—(1) Where—
the contractor may apply to the Primary Care Trust in writing for the Primary Care Trust to determine whether premises approval should be given in relation to the new premises, and the Primary Care Trust shall make the determination in accordance with sub-paragraph (2).
(2) If the Primary Care Trust is satisfied that the change of premises is a minor relocation it may grant premises approval for those premises, but if it is not so satisfied the application for the premises approval to be given in relation to the new premises shall be refused.
(3) The Primary Care Trust shall notify those persons to whom notice of the application under paragraph 47 was required to be given and applicants in relation to the outstanding applications, of its determination under sub-paragraph (2).
(4) The determination by the Primary Care Trust under sub-paragraph (2) may be appealed to the Secretary of State by the contractor, and such appeal shall be determined in accordance with regulation 38 of the Pharmaceutical Regulations.
Premises approval: additional and new premises after consent to dispense has taken effect
47D.
—(1) A contractor who has been granted consent to dispense which has taken effect and who wishes to be granted premises approval in relation to premises in addition to those in respect of which premises approval has been given ("additional premises") may apply to all the appropriate Primary Care Trusts and—
(2) For the purposes of this paragraph—
(3) A contractor wishing to be granted premises approval in relation to premises ("new premises") where it wishes to dispense instead of listed premises may apply to all the appropriate Primary Care Trusts and the application shall be determined by the relevant Primary Care Trust in accordance with sub-paragraph (4).
(4) The relevant Primary Care Trust shall—
provided that no further applications shall be granted under this sub-paragraph for a period of 12 months beginning with the date on which the contractor commenced providing services from the new premises unless the Primary Care Trust shall for good cause allow; and
(b) in any other case determine the application in accordance with sub-paragraph (1) as if the references to additional premises were to new premises.
(5) The relevant Primary Care Trust shall notify its determination under sub-paragraph (4)(a) to the persons to whom the notice is required to be given under regulation 33(2) and (3) of the Pharmaceutical Regulations and to the appropriate Primary Care Trusts.
(6) A determination by the relevant Primary Care Trust may be appealed to the Secretary of State by the contractor and any of the persons notified under sub-paragraph (5) apart from any Local Pharmaceutical Committee or any Local Medical Committee, and such appeal shall be determined in accordance with regulation 38 of the Pharmaceutical Regulations.
(7) Subject to sub-paragraph (8), when granted in relation to new or additional premises, the premises approval shall take effect from the date of notification of the grant and for this purpose the date of the notification of a grant of any application shall be—
(8) Where—
the premises approval shall provisionally take effect on the date which is the day after the end of a period of one year, or such longer period (not exceeding three months) as the relevant Primary Care Trust may for good cause allow before the expiration of that year, from the final resolution of any outstanding application.
(9) The relevant Primary Care Trust may grant temporary premises approval to a contractor who has consent to dispense and premises approval in relation to additional or new premises where it considers it desirable to do so to secure the adequate provision of dispensing services in the area served by the premises, and renew any such temporary approval granted, to secure such adequate provision, and where it does so it shall—
(10) Temporary premises approval may be granted for a period not exceeding 12 months, and may be renewed for a further period not exceeding three months.
Premises approval: practice amalgamations
47E.
—(1) "A practice amalgamation" occurs where two or more providers of primary medical services merge as a result of which two or more patient lists are combined and the agreement is varied.
(2) If, following a practice amalgamation, all the practice premises of the new practice are premises in respect of which premises approval was in effect immediately prior to the practice amalgamation, then consent to dispense and premises approval shall continue to have effect.
(3) Where there is, or will be, a practice amalgamation and none or not all of the practice premises of the contractor are, or will be, premises in respect of which premises approval was in effect immediately prior to the practice amalgamation, the contractor if it has been granted consent to dispense and premises approval which is in effect either immediately before the practice amalgamation or the date of the application under this sub-paragraph, may make an application for premises approval, and it shall be determined as provided in paragraph 47D as if it were an application from a contractor with premises approval to have the right to dispense from—
and the Primary Care Trust may grant temporary premises approval under paragraph 47D(9).
(4) An application mentioned in sub-paragraph (3) may be made before or after the practice amalgamation takes place, and where the practice amalgamation takes effect before the application has been finally determined—
(5) When the practice amalgamation takes effect the contractor shall notify all Primary Care Trusts in whose area the amalgamated practice is situated that the practice amalgamation has taken place.
(6) Subject to sub-paragraph (7), where an application made under sub-paragraph (3) was granted before the practice amalgamation takes place, premises approval shall take effect from the date of the practice amalgamation.
(7) Where an application was made under sub-paragraph (3) before the practice amalgamation takes place and the practice amalgamation has not taken place before the end of a period of one year beginning with the date that premises approval was granted under that sub-paragraph, that grant shall lapse.
(8) Where an application under sub-paragraph (3) for premises approval is refused either for all or any of the premises specified in the application, whether before or after the practice amalgamation takes place, the contractor if it had premises approval prior to making the application, shall have residual premises approval.
(9) For the purposes of this paragraph "residual premises approval" means approval to dispense—
(10) For the purposes of sub-paragraph (9), paragraph 46(3)(b) or (c) shall be read as if the words "and all of the conditions in sub-paragraph (4) are satisfied in his case" were omitted.
Contractors who previously provided dispensing services under a general medical services contract
48.
—(1) This paragraph applies where the contractor was, immediately before the commencement of the agreement, providing primary medical services in the area of the Primary Care Trust under a general medical services contract and—
(2) In a case to which this paragraph applies the contractor shall be regarded as—
(b) having been granted consent to dispense in relation to the agreement under paragraph 47 in relation to the area for which it had such consent under the general medical service contract; and
(c) having been granted premises approval in relation to the agreement under paragraph 47 for those premises from which it had, immediately before the commencement of the agreement, authority to provide dispensing services under the general medical services contract.
Transitional provisions
48A.
—(1) This paragraph applies where the contractor has been granted, prior to 6th January 2006, consent to dispense in accordance with paragraph 47 and that consent is in effect on 6th January 2006.
(2) For the purposes of this paragraph, "relevant premises" means—
(3) The Primary Care Trust shall determine whether or not to grant premises approval to relevant premises in accordance with sub-paragraphs (4) to (6).
(4) Before 5th February 2006 the Primary Care Trust shall notify the contractor that—
(5) The Primary Care Trust shall—
(6) The Primary Care Trust shall grant premises approval under sub-paragraph (3) where it is satisfied that the relevant premises were, prior to 6th January 2006, being routinely used to provide dispensing services.
(7) The Primary Care Trust shall not refuse to grant premises approval under sub-paragraph (3) by reason of the relevant premises being within 1.6 kilometres of any pharmacy.
(8) The Primary Care Trust's determination under sub-paragraph (5)(c) may be appealed to the Secretary of State by a person notified of the determination under sub-paragraph (5)(d) except the Committees mentioned in sub-paragraph (5)(a), and regulations 38(5) to (15) of the Pharmaceutical Regulations shall apply to such appeals except that, for this purpose, regulation 38 shall be read as if—
(9) Until—
whichever is the later, a contractor shall be deemed to have been granted premises approval for the relevant premises, but it may not make any application to which paragraph 47C or 47D applies.
Provision of dispensing services by Primary Care Trusts
49.
—(1) A Primary Care Trust may provide dispensing services under the agreement to its registered patients with the consent of the Strategic Health Authority.
(2) A Primary Care Trust may provide dispensing services to a registered patient only if that patient—
(3) The conditions referred to in sub-paragraph (2)(a) are that the patient—
(d) is one to whom paragraph (a) or (b) applies and at the time of the request the patient is living as a member of the household, other than as a temporary resident, of another person in respect of whom the Primary Care Trust has consent to dispense.
(4) A Primary Care Trust which provides dispensing services to some or all of its registered patients may provide any necessary dispensing services to a person whom it has accepted as a temporary resident.".
(5) In paragraph 50 (terms relating to the provision of dispensing services), after sub-paragraph (8) insert—
(6) In paragraph 51(dispensing contractor list)—
(f) state the area in relation to which there is consent to dispense and premises approval; and
(g) include and identify separately, any premises in relation to which the contractor has undetermined applications for premises approval,
in its dispensing contractors list which it prepares and maintains under paragraph 51 of Schedule 6 to the General Medical Services Contracts Regulations (dispensing contractor list)."; and
(7) For paragraph 66 (signing of documents), substitute—
(b) that the documents specified in sub-paragraph (3) include the clinical profession of the health care professional who signed the document.
(2) The documents referred to in sub-paragraph (1)(a) are—
(3) The documents referred to in sub-paragraph (1)(b) are batch issues, prescription forms and repeatable prescriptions.".
(8) In paragraph 70 (patient records), in sub-paragraph (5)(c), for ""Good Practice Guidelines for General Practice Electronic Patient Records" published on 26th September 2003", substitute, ""Good Practice Guidelines for General Practice Electronic Patient Records (Version 3.1)" published on 29th July 2005[12]".
(9) In paragraph 117 (gifts), in sub-paragraph (2)(e), after "spouse", insert, "or civil partner".
Part 3 makes amendments to the National Health Service (Personal Medical Services Agreements) Regulations 2004 ("the PMS Agreements Regulations") which mirror those made to the GMS Contracts Regulations. In addition, regulation 13(2) amends the provision concerning seeking the views of the Local Medical Committee in considering whether a contractor has prescribed drugs or appliances in excess of what is reasonably necessary.
Part 4 makes amendments to the definitions of "batch issue" and "repeatable prescription" in the National Health Service (Pharmaceutical Services) Regulations 2005 ("the Pharmaceutical Regulations") to reflect the changes made to the definitions of those terms in the GMS Contracts Regulations and the PMS Agreements Regulations.
Part 5 revokes certain disapplication provisions in relation to repeatable prescriptions and batch issues which are no longer required in the light of the amendments made in these Regulations.
[2] S.I. 2004/291, as amended by S.I. 2004/906 and 2694 and 2005/28 and 893.back
[3] S.I. 2004/627, as amended by S.I. 2004/906 and 2694 and 2005/28 and 893.back
[4] S.I. 2005/641 as amended by S.I. 2005/1015 and 1501.back
[5] The overprint specification can be found at www.ppa.org.uk/ppa/prescform_overspec.html#gpssback
[6] 1989 c.44, as amended by S.I. 2005/848.back
[7] Paragraph 48 of Schedule 5 to the National Health Service (Personal Medical Services Agreements) Regulations 2004 (S.I. 2004/627 as amended by S.I. 2004/906 and 2694 and S.I. 2005/28 and 893) makes provision in relation to consent to dispense and premises approval where a contractor moves from a general medical services contract to a personal medical services agreement.back
[8] This document is available on the following website address: www.dh.gov.uk/PolicyAndGuidance/OrganisationPolicy/PrimaryCare/PrimaryCareComputing.back
[9] The overprint specification can be found at www.ppa.org.uk/ppa/prescform_overspec.html#gpss.back
[10] 1989 c.44, as amended by S.I. 2005/848.back
[11] Paragraph 49 of the National Health Service (General Medical Services Contracts) Regulations 2004 (S.I. 2004/291, as amended by S.I. 2004/906 and 2694 and 2005/28 and 893) makes provision in relation to consent to dispense and premises approval where a contractor moves from a personal medical services agreement to a general medical services contract.back
[12] This document is available on the following website address: www.dh.gov.uk/PolicyAndGuidance/OrganisationPolicy/PrimaryCare/PrimaryCareComputing.back
[13] The overprint specification can be found at www.ppa.org.uk/ppa/prescform_overspec.html#gpssback
[14] S.I. 2004/865. Article 105 was amended by S.I. 2005/518.back