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The National Health Service (Pharmaceutical Services) (Scotland) Regulations 2009

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Regulation 3(2)

SCHEDULE 1STERMS OF SERVICE FOR PHARMACISTS AND PHARMACY CONTRACTORS

InterpretationS

1.  In these terms of service unless the context otherwise requires–

(a)except in relation to a pharmacy contractor who has notified the Board under regulation 3(5) that such pharmacy contractor wishes to be excluded from the arrangements for the supply of contraceptive substances and appliances referred to in regulation 3, “drugs” includes contraceptive substances and “appliances” includes contraceptive appliances;

(b)any reference to a numbered paragraph is a reference to the paragraph bearing that number in these terms of service and any reference to a numbered sub-paragraph is a reference to the sub-paragraph bearing that number in that paragraph.

Commencement Information

I1Sch. 1 para. 1 in force at 1.7.2009, see reg. 1

Division of responsibilities between individuals and corporate bodiesS

2.—(1) To the extent that this Schedule imposes a requirement on a pharmacy contractor in respect of an activity which could only, or would normally, be undertaken by a natural person–

(a)if the pharmacy contractor is a pharmacist–

(i)that pharmacy contractor must comply with that requirement; and

(ii)if such pharmacy contractor employs or engages a pharmacist in connection with the provision of pharmaceutical services, that pharmacy contractor must secure compliance with that requirement by such pharmacists, and such pharmacists must also comply with that requirement; and

(b)if the pharmacy contractor is not a natural person, that pharmacy contractor must secure compliance with that requirement by the pharmacists whom it employs or engages, and those pharmacists must comply with that requirement,

and references in this Schedule must be construed accordingly.

(2) Where this Schedule imposes a requirement on the director or superintendent of a body corporate that is on the pharmaceutical list, breach of that requirement shall be deemed to be a breach by the body corporate of its terms of service.

Commencement Information

I2Sch. 1 para. 2 in force at 1.7.2009, see reg. 1

Incorporation of provisions of regulations, etc.S

3.  Any provisions of the following affecting the rights and obligations of pharmacists and pharmacy contractors shall be deemed to form part of the terms of service:–

(a)these Regulations;

(b)the Drug Tariff;

(c)any scheme made under regulation 11;

(d)so much of the National Health Service (Discipline Committees) (Scotland) Regulations 2006 as relates to–

(i)the investigation of disciplinary matters relating to pharmacists and pharmacy contractors and other investigations to be made by the pharmaceutical discipline committee and the joint discipline committee and the action which may be taken by the Board as a result of such investigations, including the withholding of remuneration from pharmacists and pharmacy contractors where there has been a breach of the terms of service;

(ii)appeals to the Scottish Ministers from decisions of the Board; F1...

(e)the National Health Service (Tribunal) (Scotland) Regulations 2004 [F2; and

(f)the Patient Rights (Scotland) Act 2011 and any regulations or directions made under that Act, so far as relevant to pharmacists and pharmacy contractors as providers of services under the health service.]

Provision of pharmaceutical servicesS

4.—(1) Subject to the other provisions of these Regulations where–

(a)any person presents a non-electronic prescription form which contains–

(i)an order for drugs, not being scheduled drugs, or for appliances, not being restricted availability appliances, signed by a prescriber; or

(ii)an order for a drug specified in any directions given by the Scottish Ministers under section 17N(6) of the Act as being a drug which can only be ordered for specified patients and specified purposes in the provision of primary medical services under a general medical services contract signed by and endorsed on its face with the reference “SLS” by a prescriber; or

(iii)an order for a restricted availability appliance, signed by and endorsed on its face with the reference “SLS” by a prescriber; or

(iv)an order for listed drugs signed by a dentist; or

[F3(b)subject to sub-paragraphs (4) and (9), the pharmacist receives from the ePharmacy service an electronic prescription form which contains an order of a kind specified in sub sub-paragraph (a)(i)-(iv);

and the patient named on the form or a person on the patient’s behalf, requests the provision of drugs and appliances in accordance with that prescription and, in the case of a form provided and issued under arrangements having effect in England, completes and signs a declaration of entitlement to exemption or a statement that a charge has been paid, a pharmacist shall, with reasonable promptness, provide the drugs so ordered, and such of the appliances so ordered as the pharmacist supplies in the normal course of business and any drugs so specified shall be in a suitable container.]

[F4(1A) In furtherance of the obligations in sub-paragraphs (1) and (3), a pharmacist, when providing drugs or appliances ordered in accordance with those sub-paragraphs must—

(a)use all reasonable endeavours to provide those drugs or appliances with reasonable promptness;

(b)refrain from taking any action which may delay or prevent the dispensing of those drugs or appliances; and

(c)contact the prescriber or dentist to discuss alternative arrangements where there is likely to be, in that pharmacist’s opinion, a clinically significant delay in the dispensing of those drugs or appliances.]

[F5(1B) A pharmacist is under no obligation to provide pharmaceutical services in respect of a prescription form issued under arrangements having effect in England unless the patient has paid any charge due to be paid by virtue of the National Health Service (Free Prescriptions and Charges for Drugs and Appliances) (Scotland) Regulations 2011.]

[F6(2) In this paragraph–

(a)[F7Medicines: Care and Review Service]” means a directed service provided by a pharmacy contractor with whom a Health Board has made arrangements in accordance with directions issued by the Scottish Ministers relating to the provision of a [F8service to assist patients with drugs, medicines and appliances and the management of long term illnesses, diseases or health conditions];

[F9(aa)“prison” means—

(i)a prison within the meaning of section 43 of the Prisons (Scotland) Act 1989,

(ii)a remand centre within the meaning of section 19(1)(a) of that Act, or

(iii)a young offenders institution within the meaning of section 19(1)(b) of that Act,]

(b)“serial prescriber” means a doctor [F10, pharmacist independent prescriber or independent nurse prescriber other than a supplementary prescriber] who in the course of the provision of primary medical services in terms of the Act orders drugs, medicines or listed appliances for–

(i)a registered patient within the meaning of regulation [F113](1) of the GMS Contracts Regulations where the doctor [F10, pharmacist independent prescriber or independent nurse prescriber other than a supplementary prescriber] is providing primary medical services in terms of a general medical services contract under section 17J of the Act;

(ii)a registered patient within the meaning of [F12regulation 3 of the National Health Service (Primary Medical Services Section 17C Agreements) (Scotland) Regulations 2018] where the doctor [F10, pharmacist independent prescriber or independent nurse prescriber other than a supplementary prescriber] is providing primary medical services in terms of an agreement under section 17C of the Act; or

(iii)a patient registered to receive [F13those] primary medical services in terms of the Act, other than as in (i) and (ii), except where that patient is a temporary resident, being a person who is resident in Scotland for more than 24 hours and less than 3 months, [F14or where that patient receives primary medical services in prison,]

and such patient has [F15a long-term illness, disease or health condition that requires ongoing management over a period of a year or longer,]

(c)“serial prescription” means an order for drugs, medicines or listed appliances which comprises:

(i)a non-electronic prescription form generated by a computer and signed in ink by a serial prescriber containing the following information:

(aa)the drugs, medicines or listed appliances ordered for a patient;

(bb)the total quantity or period for which the drugs, medicines or listed appliances are ordered, which period shall not exceed [F1656] weeks from the date of issue of the prescription;

(cc)the quantity of the drugs, medicines or listed appliances which are to be dispensed to the patient at any one time; and

(dd)the instructions for use of the drugs, medicines or listed appliances; and

(ii)an electronic copy of that prescription form transmitted through the ePharmacy service to [F17a] pharmacy contractor F18....

(d)“relevant pharmacist” means:

(i)the pharmacy contractor, where the pharmacy contractor is a pharmacist; or

(ii)any pharmacist employed or engaged by, that pharmacy contractor; and

(iii)where the pharmacy contractor is not a pharmacist, any pharmacist employed or engaged by that pharmacy contractor.]

[F19(2A) A pharmacy contractor must ensure that drugs or appliances ordered on a serial prescription are not supplied to a patient unless the patient has registered with that pharmacy contractor for the provision of the Medicines: Care and Review Service.]

(3) Where a person [F20is] registered with a pharmacy contractor for the provision of the [F21Medicines: Care and Review Service], that pharmacy contractor shall ensure that a relevant pharmacist, with reasonable promptness, shall provide the drugs, medicines or listed appliances ordered on a serial prescription in the quantities and at the intervals specified on the serial prescription in accordance with the provisions in sub-paragraph (2)(c)(i)(aa) to (dd).

(4) The patient or a person acting on behalf of the patient shall present the non-electronic copy of the serial prescription to the relevant pharmacist on the first occasion that the patient asks to be supplied with drugs, medicines or listed appliances ordered for the patient on a serial prescription.

(5) When the patient or a person acting on behalf of the patient asks to be supplied with drugs, medicines or listed appliances ordered for the patient on a serial prescription at any subsequent interval specified on the serial prescription, the relevant pharmacist shall supply the drugs, medicines or appliances in accordance with the serial prescription in accordance with the provisions in sub-paragraph (2)(c)(i)(aa) to (dd) only after drawing down the electronic copy of that serial prescription from the ePharmacy service to check that the serial prescriber has not cancelled that serial prescription.

(6) A relevant pharmacist shall not provide under a serial prescription a controlled drug within the meaning of the Misuse of Drugs Act 1971(1), other than a drug which is for the time being specified in Schedule 5 to the Misuse of Drugs Regulations 2001(2).

(7) A relevant pharmacist shall not supply any drugs, medicines or listed appliances ordered on a serial prescription if–

(a)the serial prescription was presented for dispensing for the first time more than 24 weeks after the date the serial prescription was signed by the serial prescriber;

(b)in the pharmacist’s professional judgement the supply is not appropriate for the patient;

(c)the non-electronic prescription form is not signed by the serial prescriber; or

(d)the pharmacist has been informed by the serial prescriber that the serial prescription has been cancelled.

(8) A relevant pharmacist shall ensure on each occasion that drugs, medicines or appliances are supplied on a serial prescription that such supply is appropriate for the patient.

(9) Where a relevant pharmacist reasonably believes that a form presented as a prescription form under sub-paragraph (1) or a form presented as serial prescription under sub-paragraph (4) is not a genuine order for the person named on the form the pharmacist shall refuse to supply the order for drugs or appliances on the form.

(10) A relevant pharmacist shall not provide under an electronic prescription form a controlled drug within the meaning of the Misuse of Drugs Act 1971, other than a drug which is for the time being specified in Schedules 4 [F22or] 5 to the Misuse of Drugs Regulations 2001(3).

(11) A relevant pharmacist may refuse to supply drugs or appliances [F23in accordance with these Regulations] where–

(a)the pharmacist or other person is subjected to or threatened with violence by the person F24... requesting the provision of drugs or appliances in accordance with [F25these Regulations], or by any person accompanying that person; or

(b)the person F26... requesting the provision of drugs or appliances in accordance with [F27these Regulations], or any other person accompanying that person, commits or threatens to commit a criminal offence.

(12) [F28Subject to sub-paragraph (13A),] a relevant pharmacist shall not, except for the duration of an emergency requiring the flexible provision of pharmaceutical services, accept for dispensing any prescription form or serial prescription transmitted from or received at a registered pharmacy which is not included in the pharmaceutical list.

(13) [F29Subject to sub-paragraph (13A),] a relevant pharmacist shall not, except for the duration of an emergency requiring the flexible provision of pharmaceutical services, supply any drugs or listed appliances ordered on a prescription form or serial prescription other than at a registered pharmacy which is included in the pharmaceutical list.

[F30(13A) Sub-paragraphs (12) and (13) do not apply to the acceptance of a prescription form or serial prescription, or to the supply of medicinal products ordered on such a form or serial prescription, which form part of a collection and delivery arrangement.]

[F31(14) (a) For the purposes of this sub-paragraph—

“prescription form” is limited to a prescription form provided and issued under arrangements having effect in England;

2011 Regulations” means the National Health Service (Free Prescriptions and Charges for Drugs and Appliances) (Scotland) Regulations 2011;

2003 Regulations” means the National Health Service (Travelling Expenses and Remission of Charges) (Scotland) (No. 2) Regulations 2003.

(b)

Subject to paragraphs (c) and (d), a pharmacist before supplying a prescribed item to any person presenting a prescription form which—

(i)

has a declaration in terms of regulation 4(2)(a) of the 2011 Regulations claiming charge exemption; or

(ii)

has a declaration claiming charge remission under the 2003 Regulations,

shall request evidence of a patients entitlement to such exemption or remission.

(c)

Paragraph (b) shall not apply in respect of claims for exemption under regulation 4(1)(a) or (c) of the 2011 Regulations where the person’s date of birth has been printed by means of a computer on the prescription form.

(d)

Paragraph (b) shall not apply in respect of a declaration relating to a claim for exemption under regulation 4(1)(a)-(h) of the 2011 Regulations where the pharmacist has information in the pharmacist’s possession at the time of supplying the item which confirms the patient is entitled to the exemption claimed.

(e)

Where the person presenting the prescription form does not show evidence of entitlement and the pharmacist, in respect of a declaration relating to a claim for exemption made under regulation 4(1)(a)-(h) of the 2011 Regulations does not have evidence in the pharmacist’s possession to confirm that the patient is entitled to make that claim, the pharmacist shall mark that patient’s prescription form accordingly before supplying the prescribed item.]

(15) (a) A pharmacist independent prescriber shall not supply any item ordered on a prescription form by that pharmacist independent prescriber unless the conditions specified in paragraph (b) are met.

(b)The conditions referred to in paragraph (a) are–

(i)the item has been ordered in accordance with the arrangements which a Health Board has made pursuant to Directions issued by the Scottish Ministers in respect of pharmacist independent prescribers; and

(ii)the pharmacist independent prescriber reasonably considers that either–

(aa)exceptional circumstances exist whereby it is in the best interests of the patient to whom the item is to be supplied that the pharmacist independent prescriber who orders the item should supply it; or

(bb)the patient to whom the item is to be supplied, or the patient’s representative, is otherwise unlikely to be able to obtain the item without suffering excessive inconvenience or delay.

(c)A pharmacist independent prescriber who supplies an item which such pharmacist independent prescriber has ordered must endorse the prescription form for that item with the words “self-dispensed”.

(16) Where an order, not being an order to which F32... the Misuse of Drugs Regulations 2001, except Schedules 4 and 5 to those regulations, apply, issued by a prescriber or a dentist on a prescription form for drugs or listed drugs does not prescribe the quantity, strength or dosage thereof, a pharmacist may supply such strength and dosage of drugs or listed drugs so ordered as the pharmacist shall consider to be appropriate, and, subject to the provisions of sub-paragraph (23), in such quantity as the pharmacist considers to be appropriate for a course of treatment of the patient to whom the order relates, for a period not exceeding five days.

(17) Where an order to which sub-paragraph (16) applies is for–

(a)an oral contraceptive; or

(b)a drug or listed drug which is available for supply as part of pharmaceutical services only together with one or more drugs or listed drugs; or

(c)an antibiotic in a liquid form for oral administration in respect of which pharmaceutical considerations require supply in an unopened package,

which is not available for supply as part of pharmaceutical services except in such packages that the minimum available package contains a quantity appropriate to a course of treatment for a patient for a period of more than five days, the pharmacist may supply for the patient to whom the order relates, such minimum available package.

(18) Where any drug, not being one to which the Misuse of Drugs Regulations 2001, except Schedule 5 to those regulations, apply, ordered by a prescriber or a dentist on a prescription form, or a by a serial prescriber on a serial prescription, is available for provision by a pharmacist in a pack in a quantity which is different to the quantity which has been so ordered, and that drug is–

(a)sterile;

(b)effervescent or hygroscopic;

(c)a liquid preparation for addition to bath water;

(d)a coal tar preparation;

(e)a viscous preparation; or

(f)packed at the time of its manufacture in a calendar pack or special container,

the pharmacist shall, subject to sub-paragraph (19), provide the drug in the pack whose quantity is nearest to the quantity which has been so ordered.

(19) A pharmacist shall not provide, pursuant to sub-paragraph (18), a drug in a calendar pack where in the pharmacist’s professional judgement, it was the intention of the prescriber or dentist who ordered the drug that it should be provided only in the exact quantity ordered.

(20) In this paragraph–

(a)“calendar pack” means a blister or strip pack showing the days of the week or month against each of the several units in the pack; and

(b)“special container” means any container with an integral means of application or from which it is not practicable to dispense an exact quantity.

(21) All drugs and preparations supplied by pharmacists shall, where a standard or formula is specified in the British Pharmacopoeia, the British Pharmaceutical Codex, the British National Formulary (including any Appendix published as part of that Formulary), or the Drug Tariff, conform to the standard or formula so specified, and in any other case shall be of a grade or quality not lower than the grade or quality ordinarily used for medicinal purposes.

(22) All appliances supplied by pharmacists shall conform to the specifications included in the Drug Tariff.

(23) Subject to any regulations in force under the Weights and Measures Act 1985(4), a pharmacist shall provide pharmaceutical services only in response to and, subject to sub-paragraphs (16), (17), (18) and (29) [F33to [F34(43)]], in accordance with an order on a non-electronic prescription form signed as specified in sub-paragraph (1)(a), or in accordance with an electronic prescription form received in accordance with sub-paragraph (1)(b), or in accordance with a serial prescription in accordance with the provisions in sub-paragraph (2)(c) or in accordance with the terms of a Patient Group Direction issued by a Board in accordance with [F35 regulation 233 (exemption for supply etc under a PGD by person conducting a retail pharmacy business) of the Human Medicines Regulations 2012], except that in a case of urgency where a prescriber personally known to a pharmacist requests that pharmacist to dispense a drug or appliance the pharmacist may supply that drug or appliance before receiving such a prescription form, only if–

(a)that drug is not a scheduled drug;

(b)that drug is not a controlled drug within the meaning of the Misuse of Drugs Act 1971, other than a drug which is for the time being specified in Schedule 4 or 5 to the Misuse of Drugs Regulations 2001;

(c)that appliance is not a restricted availability appliance; and

(d)in any case the prescriber undertakes to furnish the pharmacist, within 72 hours, with such a prescription form.

(24) Except as provided in sub-paragraph (25), a pharmacist shall not supply, by way of pharmaceutical services under the Act or otherwise, any scheduled drug which is ordered by name, formula or other description on a prescription form or a serial prescription.

(25) Where a drug has an appropriate non-proprietary name and it is ordered on a prescription form or a serial prescription either by that name or by its formula, a pharmacist may supply a drug which has the same specification notwithstanding that it is a scheduled drug.

(26) Where a drug which is ordered as specified in sub-paragraph (23) combines more than one drug, that sub-paragraph shall apply only if the combination has an appropriate non-proprietary name, whether the individual drugs which it combines do so or not.

(27) A pharmacist or pharmacy contractor shall not give, promise or offer to any person any gift or reward (whether by way of a share of or dividend on the profits of the business or by way of discount or rebate or otherwise) as an inducement to or in consideration of a person presenting an order for drugs or appliances on a prescription form or serial prescription.

(28) A pharmacist or pharmacy contractor shall not, except with the consent of the Scottish Ministers, provide at a health centre services other than pharmaceutical services in accordance with section 27 of the Act.

(29) A pharmacist may dispense a drug where the conditions for urgent supply specified in [F36regulation 225 (emergency sale etc by pharmacist: at patient's request) of the Human Medicines Regulations 2012] are satisfied, before receiving a prescription form, if the pharmacist is satisfied that it is appropriate to do so.

[F37(30) This sub-paragraph applies where—

(a)a person requests a prescription only medicine—

(i)from a person lawfully conducting a retail pharmacy business in accordance with section 69 of the 1968 Act, and

(ii)in accordance with a prescription form or serial prescription, and

(b)a SSP has effect in respect of—

(i)the requested prescription only medicine, or

(ii)prescription only medicines of a specified description, and the requested prescription only medicine is of that description.

(31) Where sub-paragraph (30) applies, a pharmacist may supply a prescription only medicine in accordance with a SSP where—

(a)the conditions specified in regulation 226A of the Human Medicines Regulations 2012 are satisfied, and

(b)the pharmacist is able to do so with reasonable promptness.

(32) This sub-paragraph applies where—

(a)a person requests a drug or appliance—

(i)from a person lawfully conducting a retail pharmacy business in accordance with section 69 of the 1968 Act, and

(ii)in accordance with a prescription form or serial prescription, and

(b)a Scottish SSP has effect in respect of—

(i)the requested drug or appliance, or

(ii)drugs or appliances of a specified description, and the requested drug or appliance is of that description.

(33) Where sub-paragraph (32) applies, a pharmacist may supply a different drug or appliance or quantity or strength of a drug or appliance to that ordered on the prescription form or serial prescription where—

(a)the pharmacist is able to do so with reasonable promptness,

(b)to do so is in accordance with the Scottish SSP, and

(c)the pharmacist is of the opinion, in the exercise of their professional skill and judgement, that the supply of a different drug or appliance or quantity or strength of a drug or appliance to that ordered by the prescriber or dentist is reasonable and appropriate.

(34) Where sub-paragraph (30) or (32) applies—

(a)a pharmacist is of the opinion, in the exercise of their professional skill and judgement, that it is unreasonable or inappropriate to supply in accordance with the SSP or the Scottish SSP, and

(b)the pharmacist is able to supply the prescription only medicine or other drug or appliance ordered by the prescriber or dentist within a reasonable timescale, but not with reasonable promptness,

the requirements to act with reasonable promptness in sub-paragraphs (1), (1A)(a) and (3) are to be read as requirements to act within a reasonable timescale.

(35) A pharmacist must refuse to supply a prescription only medicine or other drug or appliance ordered on a prescription form or serial prescription where—

(a)sub-paragraph (30) or (32) applies, and

(b)alternative supply has already taken place in accordance with the SSP or the Scottish SSP.

(36) A pharmacist may refuse to supply a prescription only medicine or other drug or appliance ordered on a prescription form or serial prescription where—

(a)sub-paragraph (30) or (32) applies,

(b)the pharmacist is of the opinion, in the exercise of their professional skill and judgement, that it is unreasonable or inappropriate to supply in accordance with the SSP or the Scottish SSP, and

(c)the pharmacist is unable to provide the prescription only medicine or other drug or appliance ordered by the prescriber or dentist within a reasonable timescale.

(37) Where a pharmacist refuses to supply a prescription only medicine or other drug or appliance under sub-paragraph (36), the pharmacist must contact the prescriber or dentist to discuss alternative arrangements.

(38) Where a pharmacist supplies a prescription only medicine in accordance with a SSP or other drug or appliance in accordance with a Scottish SSP the pharmacist must—

(a)include in the dispensing label on the packaging of the prescription only medicine or other drug or appliance, for the patient’s benefit, information to the effect that the prescription only medicine or other drug or appliance is being supplied in accordance with a SSP or a Scottish SSP, identifying the particular SSP or Scottish SSP, and

(b)supply the prescription only medicine or other drug or appliance in a suitable container.]

[F38(39) A pharmacist may supply a prescription only medicine in accordance with a PTP where—

(a)a PTP has effect in respect of the prescription only medicine,

(b)the requirements specified in the PTP are satisfied, and

(c)the pharmacist is able to supply the prescription only medicine with reasonable promptness.

(40) A pharmacist may refuse to supply a prescription only medicine in accordance with a PTP where in the pharmacist’s professional judgement it is unreasonable or inappropriate to do so.

(41) Where a pharmacist supplies a prescription only medicine in accordance with a PTP the pharmacist must—

(a)include in the dispensing label on the packaging of the prescription only medicine, for the patient’s benefit, information to the effect that the prescription only medicine is being supplied in accordance with a PTP, identifying the particular PTP, and

(b)supply the prescription only medicine in a suitable container.

(42) A pharmacist may provide pharmaceutical services in accordance with the terms of a protocol approved by the Scottish Ministers under regulation 247A (protocols relating to coronavirus and influenza vaccinations and immunisations) of the Human Medicines Regulations 2012 where the conditions specified in that regulation are satisfied.

(43) A pharmacist may provide pharmaceutical services in response to an announcement of the Secretary of State and arrangements made in accordance with regulation 10A (directions of a practitioner while a disease is, or in anticipation of a disease being imminently, pandemic etc.) or 15(5) (form of prescriptions) of the Misuse of Drugs Regulations 2001.]

Textual Amendments

Commencement Information

I4Sch. 1 para. 4 in force at 1.7.2009, see reg. 1

Directed servicesS

5.  A pharmacy contractor with whom a Health Board makes an arrangement for the provision of any directed service shall comply with the terms and conditions of the arrangement and any terms contained in the relevant Directions.

Commencement Information

I5Sch. 1 para. 5 in force at 1.7.2009, see reg. 1

Premises and hours of businessS

6.—(1) Subject to regulation 11(5), pharmaceutical services shall be provided from the premises specified in the application made by the pharmacy contractor for inclusion in the Board’s list, and the premises shall be open for the supply of pharmaceutical services during the hours specified in the scheme to be made by the Board for that purpose under the Regulations.

(2) At every premises from which pharmaceutical services are provided there shall be exhibited a notice to be provided by the Board in the form prescribed in Schedule 2. There shall also be exhibited at such premises, at times when those premises are not open, and in such a manner as to be visible at such times, a notice in a form approved by the Board, indicating the facilities available for securing the dispensing of medicines urgently required.

(3) Pharmaceutical services shall not, except with the consent of the Board, or on appeal, of the Scottish Ministers, be provided by a pharmacy contractor in premises occupied by a doctor other than at a health centre.

(4) Subject to regulation 6 [F39and sub-paragraph (4A)], no pharmacy contractor shall provide pharmaceutical services from any pharmacy or other premises which are not included in the pharmaceutical list in respect of that pharmacy contractor.

[F40(4A) Sub-paragraph (4) does not apply to the provision of pharmaceutical services which form part of a collection and delivery arrangement.]

Dispensing of medicinesS

7.—(1) The dispensing of medicines shall be performed either by or under the direct supervision of a pharmacist.

(2) Where the pharmacist referred to in sub-paragraph (1) is employed, the pharmacist must not be one–

(a)who has been disqualified under sections 29B(2) or 30(2) or (5) of the Act (or under any corresponding provision in force in England and Wales or Northern Ireland) from inclusion in the pharmaceutical list of any Board or any equivalent body while the disqualification remains in force; or

(b)who is suspended by direction of the Tribunal or any corresponding decision in England, Wales or Northern Ireland while the suspension remains in force.

Commencement Information

I7Sch. 1 para. 7 in force at 1.7.2009, see reg. 1

Names of pharmacistsS

8.  A pharmacy contractor shall, if so required by the Board, furnish to the Board the name or names of pharmacists employed by that pharmacy contractor in providing pharmaceutical services and directed services.

Commencement Information

I8Sch. 1 para. 8 in force at 1.7.2009, see reg. 1

Drugs, etc. to be supplied without chargeS

9.—(1) Subject to the provisions of any Regulations made under section 69 of the Act all drugs, containers and appliances supplied under these terms of service shall be supplied free of charge.

(2) Where a pharmacy contractor supplies an oxygen container or oxygen equipment, other than equipment specified in the Drug Tariff as not returnable to the pharmacy contractor, the container and equipment shall remain the property of the pharmacy contractor who shall have no claim against the Board in the event of the loss of, or damage to, such container or equipment except as may be provided in the Drug Tariff.

Commencement Information

I9Sch. 1 para. 9 in force at 1.7.2009, see reg. 1

Method of paymentS

10.—(1) A pharmacy contractor is required to furnish to the Board or Agency or to such other person or body as it may direct, on dates to be appointed by the Scottish Ministers after consultation with an organisation which is in their opinion representative of the general body of pharmacy contractors, the prescription forms, serial prescription forms, supply forms and other forms (including electronic copies and electronic claim messages) upon which the orders for drugs and appliances supplied by or on behalf of such pharmacy contractor were given, arranged in such manner as the Board or Agency may direct, together with a statement of accounts containing such particulars relating to the provision by the pharmacy contractor of pharmaceutical services as the Board, with the approval of the Scottish Ministers, may from time to time require.

(2) A pharmacy contractor whose name is included in the pharmaceutical list shall supply, in response to a request from the Scottish Ministers and within one month of the notification of the request, any information which the Scottish Ministers may require for the purpose of conducting any inquiry into the prices, payments, fees, allowances and remuneration specified in these Regulations or the Drug Tariff.

(3) The Board or Agency shall, if any pharmacy contractor so requires, afford the pharmacy contractor reasonable facilities for examining all or any of the forms on which the drugs or appliances supplied by such pharmacy contractor were ordered, together with particulars of the amounts calculated to be payable in respect of such drugs and appliances and if the pharmacy contractor takes objection thereto, the Board or Agency shall take such objection into consideration.

(4) The Board or Agency shall, if so required by an organisation which is recognised by the Scottish Ministers as representative of the general body of pharmacy contractors, afford the said organisation similar facilities for examining such forms and particulars relating to all or any of the pharmacy contractors and shall take into consideration any objection made thereto by the said organisation.

(5) Payment will be made for drugs and appliances in the Drug Tariff at the prices specified therein and for drugs or appliances not in the Drug Tariff in the manner set forth therein subject in either case to any deduction required to be made by regulations made under section 69 of the Act.

(6) Where the Board or Agency is satisfied that adequate reasons have been given, payment may be made to a pharmacy contractor in respect of forms submitted by such pharmacy contractor outwith any set time-limits.

(7) If the Scottish Ministers, after consultation with such organisation as is mentioned in sub-paragraph (4), is satisfied at any time that the method of payment herein before provided for in this paragraph is such that undue delay in payment may be caused thereby, they may direct that the amounts to be payable to a pharmacy contractor shall be calculated by such other method, whether by averaging the amounts payable to a pharmacy contractor or otherwise, as appears to them designed to secure that–

(a)payment may be made within a reasonable time; and

(b)payments to a pharmacy contractor shall, as nearly as may be, remain the same as if the payments had been calculated in accordance with the first mentioned method of payment,

and payments calculated by any such other method shall be deemed for all purposes to be payments made in accordance with these Regulations.

[F41(8) No pharmacy contractor will be paid in respect of the supply of drugs or appliances—

(a)indicated on a prescription form or serial prescription,

(b)in terms of regulation 225 (emergency sale etc by pharmacist: at patient’s request) of the Human Medicines Regulations 2012,

(c)in terms of a Patient Group Direction issued by a Health Board in accordance with regulation 233 (exemption for supply etc under a PGD by person conducting a retail pharmacy business) of the Human Medicines Regulations 2012,

(d)in accordance with the terms of a protocol approved by the Scottish Ministers under regulation 247A (protocols relating to coronavirus and influenza vaccinations and immunisations) of the Human Medicines Regulations 2012,

(e)in accordance with a SSP or a Scottish SSP,

(f)in accordance with a PTP, or

(g)in response to an announcement by the Secretary of State and arrangements made in accordance with regulation 10A (directions of a practitioner while a disease is, or in anticipation of a disease being imminently, pandemic etc.) or 15(5) (form or prescriptions) of the Misuse of Drugs Regulations 2001,

unless that supply takes place at a registered pharmacy included in the pharmaceutical list in respect of that pharmacy contractor [F42or takes place in accordance with a collection and delivery arrangement].]

(9) Where a payment had been made to a pharmacy contractor to which such pharmacy contractor was not due, the Agency or Board shall draw that over-payment to the attention of such pharmacy contractor and unless the Scottish Ministers direct otherwise the amount overpaid shall be repaid by the pharmacy contractor to the Board or Agency.

Withdrawal from pharmaceutical listS

11.—(1) Subject to sub-paragraph (2) a pharmacy contractor may at any time give notice in writing to the Board that such pharmacy contractor desires to withdraw such pharmacy contractor’s name from the pharmaceutical list and such pharmacy contractor’s name shall be removed therefrom at the expiration of three months from the date of such notice or of such shorter period as the Board may agree.

(2) Where representations are made to the Tribunal under the provisions of section 29 of the Act (the NHS Tribunal), or a request for a review has been made to the Tribunal or a review is to be made by the Tribunal under section 30 of the Act (review etc. of disqualification), such pharmacy contractor shall not, except with the consent of the Scottish Ministers and subject to such conditions as the Scottish Ministers may impose, be entitled to withdraw such pharmacy contractor’s name from the list pending the termination of the proceedings on such representations, request for review or review.

(3) The name of any pharmacy contractor whose business is carried on by representatives in accordance with the provisions of the 1968 Act, shall not be removed from the list so long as the business is carried on by them in accordance with the provisions of that Act, and the representatives agree to be bound by the terms of service of the pharmacy contractor.

Commencement Information

I11Sch. 1 para. 11 in force at 1.7.2009, see reg. 1

[F43Complaints, concerns, comments, feedback;S

12.  A pharmacy contractor must have arrangements in place which operate in accordance with section 15 of the Patient Rights (Scotland) Act 2011, and any regulations or directions made under that Act.]

13.—(1) A pharmacy contractor shall cooperate with any investigation of a complaint by the Board in accordance with the procedures which it operates in accordance with [F44section 15 of the Patient Rights (Scotland) Act 2011] whether the investigation follows one under the pharmacy contractor’s complaints procedure or not.

(2) The cooperation required by sub-paragraph (1) includes–

(a)answering questions reasonably put to the pharmacy contractor by the Board;

(b)providing any information relating to the complaint reasonably required by the Board; and

(c)attending any meeting to consider the complaint (if held at a reasonably accessible place and at a reasonable hour, and due notice has been given), if the pharmacy contractor’s presence at the meeting is reasonably required by the Board.

RecordsS

14.—(1) A pharmacy contractor shall keep proper, complete, accurate and up-to-date records in respect of the pharmaceutical services they provide.

(2) A pharmacy contractor shall retain all such records for a minimum period of seven years.

(3) A pharmacy contractor shall, when requested to do so by any authorised officer of the Scottish Ministers, the Agency or the Board during the period in which the contractor is required to retain such records produce them or make them available to such authorised officer of the Scottish Ministers, the Agency or the Board.

(4) A pharmacy contractor shall not be obliged to make records available to a person referred to in sub-paragraph (3) unless they produce, on request, written evidence that they are authorised by the Scottish Ministers, the Agency or the Board, to act on their behalf.

(5) A pharmacy contractor shall designate a person engaged by that pharmacy contractor to take responsibility for practices and procedures relating to the confidentiality of patient data held by them.

Commencement Information

I14Sch. 1 para. 14 in force at 1.7.2009, see reg. 1

Professional standardsS

15.  Without prejudice to any rule or implication of law to that effect, a pharmacist who provides pharmaceutical services in accordance with arrangements made in these Regulations shall do so in conformity with standards generally accepted in the pharmaceutical profession.

Commencement Information

I15Sch. 1 para. 15 in force at 1.7.2009, see reg. 1

Regulations 5(2) and (11) and 8(3) and Schedule 1, paragraph 6

[F45SCHEDULE 2S

Textual Amendments

Commencement Information

I16Sch. 2 in force at 1.7.2009, see reg. 1

F46FORM A (1)Application for inclusion in the pharmaceutical list to provide pharmaceutical services – relocation or new application.Regulation 5(2)
FORM A (2)Application for inclusion in the pharmaceutical list to provide pharmaceutical services – change of provider.Regulation 5(2)
FORM BNotification of information not given on form A1/A2.Regulation 8(4)
FORM CNotification of date of entry on pharmaceutical list.Regulation 5(11)
FORM DNotification of date of inclusion in provisional pharmaceutical list.Regulation 8(3)
Form of notice to be exhibited at premises from which pharmaceutical services are provided.Schedule 1 paragraph 6]

Regulation 5(10)

SCHEDULE 3STHE BOARD

Receipt and notification of applicationsS

1.[F47(1) Upon receipt of an application to which regulation 5(10) applies, or receiving further information submitted under regulation 5(2E), the Board shall—

(a)assess whether the boundaries of the neighbourhood within which the applicant intends to provide pharmaceutical services, or any part of it, falls within a controlled locality; and

(b)within 10 working days of an assessment being made, give written notice of the application and any assessment that it is within a controlled locality to—

(i)the Area Pharmaceutical Committee;

(ii)the Area Medical Committee;

(iii)any person whose name is included in the pharmaceutical list or the provisional pharmaceutical list and whose interests may, in the opinion of the Board, be significantly affected if the application were granted;

(iv)any Board whose boundary is within two kilometres of the proposed premises; and

(v)any nominated community representative that covers the neighbourhood within which the applicant intends to provide pharmaceutical services, or any part of it,

and any person or body so notified may, within 30 days from the date on which the notification was sent to such person or body, make written representations about the application to the Board.]

(2) Any Board which is notified under sub-paragraph (1)(d) above shall, within 5 working days, give written notice of the application to–

(a)its Area Pharmaceutical Committee;

(b)its Area Medical Committee;

(c)any person whose name is included in its pharmaceutical list or the provisional pharmaceutical list and whose interests may, in the opinion of the said Board be significantly affected if the application were granted,

and any person so notified may, within 30 days from the date on which the notification was sent to the said Board, make written representations to the Board to whom the application was made.

(3) Any notice given under sub-paragraph (1) or (2) above shall include a statement of the right to make representations in accordance with that sub-paragraph.

[F48Applications relating to areas of a prescribed descriptionS

1A.(1) For the purpose of section 27(4)(d) of the Act, a controlled locality is an area within a Health Board, which is remote or rural in character, and which is served by a dispensing doctor.

(2) The boundary of a controlled locality area is that of the dispensing doctor’s practice area under sub-paragraph (1) on the day before the day on which the application under regulation 5(2) is made.

(3) Upon identifying any areas which are a controlled locality in accordance with this paragraph, the Board must, as soon as reasonably practicable—

(a)give written notice to the dispensing doctor serving that controlled locality and to the person or body listed at paragraph 1 informing them of the identification of the controlled locality;

(b)delineate the boundaries of the controlled locality on a map; and

(c)record that controlled locality in its pharmaceutical care services plan.

Review of controlled localityS

1B.(1) The Board shall, subject to sub-paragraph (2) and regulation 5(10B), no earlier than 3 years from the date of notification of a controlled locality in accordance with paragraph 1A, review that controlled locality designation.

(2) If the Board is satisfied that within that 3 year period there has been a substantial change in circumstances in relation to the controlled locality area then it may reconsider the controlled locality designation.

(3) Following a review, prior to a decision to keep or change the controlled locality designation, the Board must, as soon as practicable, give written notice to the dispensing doctor serving that controlled locality and to the persons or body mentioned in paragraph 1 informing them of—

(a)the proposal and the reasons for it; and

(b)their right, within 30 days from the date on which the notification was sent, to make written representations about that change to the Board containing a statement of reasons why that proposal should be reconsidered.

(4) Following consideration of any representations received in accordance with sub-paragraph (3) the Board must make their final decision and where applicable—

(a)delineate on a map the new boundaries of the controlled locality; or

(b)remove from the map, the delineated boundary of an area that has ceased to be a controlled locality.]

Public consultationS

F492.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

[F50Dispensing doctor notificationS

2A.  The Board shall, at the same time as giving written notice of the application under paragraph 1(1), give written notice of the application to any dispensing doctor who dispenses from premises in the neighbourhood to which the application relates.]

[F51Determination of applicationsS

3.(1) In considering an application to which regulation 5(10)(a) applies, the Board shall have regard to—

(a)the pharmaceutical services already provided in the neighbourhood of the premises named in the application by persons whose names are included in a pharmaceutical list;

(b)pharmaceutical services to be provided in the neighbourhood at these premises by any person whose name is included in the provisional pharmaceutical list;

(c)any representations received by the Board under paragraph 1;

(d)any information available to the Board which, in its opinion, is relevant to consideration of the application;

(e)the consultation analysis report submitted in accordance with regulation 5A;

(f)the pharmaceutical care services plan; and

(g)the likely long term sustainability of the pharmaceutical services to be provided by the applicant.

(2) The Board may, if it considers that oral representations are unnecessary, determine the application without hearing oral representations.

(3) In any case in which the Board decides to hear oral representations, the Board must—

(a)give the applicant and any person from whom it received representations under paragraph 1 reasonable notice of the meeting at which such representations are to be heard;

(b)permit the applicant and any person making representations at the hearing to be assisted by another person;

(c)permit the applicant or any person making representations at the hearing either to—

(i)speak to their own representations; or

(ii)nominate the person assisting them to speak on their behalf; and

(d)confirm that any person assisting the applicant or any person making representations at the hearing is not appearing in the capacity of counsel, solicitor or paid advocate.

(4) The Board shall, subject to sub-paragraph (5), make a determination on the application within 6 weeks of the date that they received the consultation analysis report under regulation 5A.

(5) A 6 week determination period under sub-paragraph (4) may be extended in exceptional circumstances and in such an event the Board must inform the applicant and any person or body notified under paragraph 1 or 2A, of the extended time period and the reasons for it.

(6) The Board’s determination of an application must include—

(a)a summary of the consultation analysis report submitted in accordance with regulation 5A;

(b)an explanation of how the consultation analysis report was taken into account in arriving at the decision, with regard to the tests under regulation 5(10), as applicable; and

(c)the reasons for its decision.

(7) The functions of the Board under this paragraph shall be exercised on its behalf by the Pharmacy Practices Committee in accordance with Part I of Schedule 4.]

Notification of decisionsS

[F524.(1) The Board shall, within 5 working days of having been notified in accordance with paragraph 6 of Part I of Schedule 4, intimate the decision on the application [F53and the information required under paragraph 3(6)], and any right of appeal applicable under paragraph 5, to the applicant and the persons or bodies mentioned in paragraph 1.

(2) The Board shall within 5 working days of such intimation publish on its website the decision on the application [F53and the information required under paragraph 3(6)].]

AppealsS

5.—(1) Subject to sub-paragraph (2) the applicant or any person mentioned in paragraph 1 may appeal against the decision of the Board on the application, and must give notice of any such appeal to the Board within 21 days from the date on which notification of the Board’s decision was sent to the applicant or person mentioned in paragraph 1.

(2) Any person mentioned in paragraph 1 who was notified of an application under that paragraph but made no written representations to the Board about it shall not be entitled to appeal against a decision of the Board in relation to that application.

[F54(2A) The grounds of appeal are limited to where the circumstances in sub-paragraph (2B) have occurred or where the Board has erred in law in its application of the provisions of these Regulations.

(2B) The circumstances are—

(a)there has been a procedural defect in the way the application has been considered by the Board;

(b)there has been a failure by the Board to properly narrate the facts or reasons upon which their determination of the application was based; or

(c)there has been a failure to explain the application by the Board of the provisions of these Regulations to those facts.]

[F55(3) Any notice of appeal under this paragraph shall contain a concise statement detailing the circumstances in sub-paragraph (2B) or other points of law in respect of which the appellant contends that the decision of the Board is erroneous.]

(4) The Board shall refer a notice of appeal under this paragraph to the chair of the National Appeal Panel [F56together with the decision of the Board on the application].

[F57(5) The Chair, after considering the notice of appeal and the decision of the Board, shall—

(a)dismiss the appeal, if the Chair is of the opinion that:

(i)the notice discloses no reasonable grounds of appeal; or

(ii)the appeal is otherwise frivolous or vexatious; or

(b)remit the decision back to the Board for reconsideration if the Chair is of the opinion that any of the circumstances in sub-paragraph (2B) have occurred,

and the Chair’s decision is final.]

(6) In any other case the National Appeal Panel shall be convened in accordance with Part II of Schedule 4 and the said Panel shall thereafter determine the appeal.

[F58(7) Where the Chair remits an application back to the Board for reconsideration—

(a)the Chair shall give to the Board such advice as appears to the Chair to be desirable with a view to remedying the defect or failure that has led to the decision to remit;

(b)the Chair shall send a copy of the remitted application and the advice issued to the Scottish Ministers; and

(c)the Board shall reconsider the application.]

[F59(7A) The National Appeal Panel shall, subject to sub-paragraph (7B), make a decision under sub-paragraph (5) or a determination under sub-paragraph (6) within 3 months of the date of receipt of a notice of appeal under sub-paragraph (4).

(7B) The 3 month period in sub-paragraph (7A) may be extended in exceptional circumstances and in such an event the National Appeal Panel must inform the interested parties of the extended time period and the reasons for it.

(7C) In this paragraph “interested parties” means the appellant, the applicant and any person mentioned in paragraph 1 who makes written representations to the Board about the application.]

F60(8) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

[F61Form of AppealS

6.(1) If it appears to the National Appeal Panel that an appeal can properly be determined without a hearing, it may determine the appeal without a hearing.

(2) If the National Appeal Panel determines that a hearing is required, it shall take place at such time and place as the National Appeal Panel may direct and notice shall be sent by post to the interested parties and the Board not less than 14 days before the date fixed for the hearing.

(3) The interested parties may attend and be heard in person or be represented by counsel or a solicitor or other representative at the hearing and the Board may attend and be represented at the hearing by any duly authorised official or by counsel or a solicitor.

F62(4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(5) Subject to the provisions of these Regulations, the National Appeal Panel shall determine an appeal (including its procedure) as it thinks fit and its decision in respect of an appeal shall be final.

(6) In this paragraph “interested parties” means the appellant, the applicant and any person [F63or body] mentioned in paragraph 1 who makes written representations to the Board about the application.]

Schedule 3, paragraphs 3(6) and 5

SCHEDULE 4S

PART ISPHARMACY PRACTICES COMMITTEE

Pharmacy Practices CommitteeS

1.  The Board shall, in accordance with regulation 7 of the Health Boards (Membership and Procedure) (Scotland) Regulations 2001(5) and the provisions of this Schedule establish a committee (to be known as “the Pharmacy Practices Committee”).

Commencement Information

I22Sch. 4 para. 1 in force at 1.7.2009, see reg. 1

FunctionsS

2.  The Pharmacy Practices Committee shall on behalf of the Board exercise the functions of the Board in terms of regulation 5(10) and paragraph 3 of Schedule 3.

Commencement Information

I23Sch. 4 para. 2 in force at 1.7.2009, see reg. 1

MembershipS

3.—(1) The Pharmacy Practices Committee shall consist of seven members of whom–

(a)one shall be the chair appointed as such by the Board; the chair shall be a member of the Board but shall not be an officer of the Board nor shall the chair be, nor previously have been, a doctor, dentist, ophthalmic optician or pharmacist or the employee of a person who is a doctor, dentist, ophthalmic optician or pharmacist;

(b)three shall be pharmacists of whom–

(i)one shall be a pharmacist whose name is not included in any pharmaceutical list and who is not the employee of a person whose name is so listed; and such pharmacist shall be appointed by the Board from persons nominated by the [F64Area Pharmaceutical Committee]; and

(ii)two shall be pharmacists each of whom is included in a pharmaceutical list or is an employee of a person whose name is so listed; and each shall be appointed by the Board from persons nominated by the Area Pharmaceutical Committee; and

(c)three shall be persons appointed by the Board otherwise than from the members of the Board but none shall be nor previously have been a doctor, dentist, ophthalmic optician or a pharmacist, or an employee of a person who is a doctor, dentist, ophthalmic optician or pharmacist.

[F65(1A) In the circumstances described in sub-paragraph (1B) the Pharmacy Practices Committee shall have an additional member appointed by the Board from persons nominated by the Area Medical Committee.

(1B) The circumstances are where the premises that are the subject of the application are located in the same neighbourhood as premises from which a dispensing doctor dispenses.]

(2) Persons to act as deputies for, and corresponding in number to, each of those categories of person appointed pursuant to sub-paragraph (1) [F66and, as the case may be, sub-paragraph (1A)] shall, provided they satisfy the criteria specified in that sub-paragraph, be appointed by the Board and in the absence of any of those persons a deputy from the appropriate category shall be entitled to act in the absent person’s place.

(3) If a nomination sought for the purposes of sub-paragraph (1)(b)(i) or (ii) [F67or sub-paragraph (1A)] above is not made before such date as the Board may determine, the Board may appoint as a member a person who satisfies the criteria specified in the relevant sub-paragraph.

(4) The Board shall prepare and maintain lists of the persons who have been appointed, in accordance with paragraph 3(1)(a), (b)(i) [F68or (ii), (c) or (1A)], as the case might be, and who currently serve as members of the Pharmacy Practices Committee, and shall provide the Scottish Ministers with a copy of such lists from time to time.

Declaration of interestS

4.—(1) Before any meeting of the Pharmacy Practices Committee begins the chair, or in the chair’s absence, the person acting as chair, shall ask the members intending to be present whether, in respect of any matter to be considered at the meeting, any of them–

(a)has an interest to declare; or

(b)is associated with a person who has any personal interest,

and any such member who has or, as the case may be, is associated with a person who has, any such interest shall disclose it accordingly.

(2) Any member who has, pursuant to the provisions of sub-paragraph (1) above, disclosed an interest or who, in the opinion, expressed to the meeting, of the chair or in the chair’s absence, the person acting as chair as the case may be, should have disclosed such an interest, shall not be present at the consideration or discussion of that matter or the voting on it, and a deputy who has no such interest may act in that member’s place.

Commencement Information

I25Sch. 4 para. 4 in force at 1.7.2009, see reg. 1

QuorumS

5.  No business shall be transacted at a meeting of the Pharmacy Practices Committee unless the chair or in the chair’s absence, the person acting as chair, one member appointed under each of paragraph 3(1)(b)(i) and (ii), and two other members appointed under paragraph 3(1)(c) are present.

Commencement Information

I26Sch. 4 para. 5 in force at 1.7.2009, see reg. 1

[F69Independent legal assessorS

5A.(1) The Board may appoint an independent legal assessor to assist them in their deliberations, including voting.

(2) The independent legal assessor’s role is to provide legal and technical advice and support.]

VotingS

6.—(1) Subject to sub-paragraphs (2), (3) and (4) below, every application considered by the Pharmacy Practices Committee shall be considered by all members present, but shall be determined only by a majority of votes of the members present who are entitled to vote.

[F70(2) Except in the circumstances set out in paragraph (4) only a member appointed by virtue of paragraph 3(1)(c) is entitled to vote.]

(3) A member appointed by virtue of paragraph [F713(1)(b) or 3(1A)] is not entitled to vote and shall withdraw immediately before a decision on an application by voting takes place.

(4) The chair, or in the chair’s absence the person acting as chair, shall not be entitled to vote at any meeting except in the case of an equality of votes of the other persons present and voting, in which case the chair shall have a casting vote.

(5) The Pharmacy Practices Committee shall within ten working days of taking its decision give written notification [F72to the Board of that decision and the information required under paragraph 3(6) of Schedule 3].

Standing ordersS

7.  Subject to the provisions of these Regulations, the Board may make, vary or revoke standing orders with respect to the terms of office of members of the Pharmacy Practices Committee, the procedure of that committee and the making of reports of its proceedings to the Board.

Commencement Information

I28Sch. 4 para. 7 in force at 1.7.2009, see reg. 1

VacancyS

8.  The proceedings of the Pharmacy Practices Committee shall not be invalidated by any vacancy in its membership, or any defect in a member’s appointment.

Commencement Information

I29Sch. 4 para. 8 in force at 1.7.2009, see reg. 1

PART IISNATIONAL APPEAL PANEL

Nominees for the National Appeal PanelS

9.—(1) The Board shall submit the names of its nominees for the National Appeal Panel to the Scottish Ministers and shall advise them from time to time of any changes in such nominees.

[F73(2) The persons nominated by the Board under sub-paragraph (1) must not be, nor have been previously, a doctor, dentist, ophthalmic optician or pharmacist nor a person employed by a doctor, dentist, ophthalmic optician or pharmacist.]

[F74Chair of National Appeal PanelS

10.(1) After consultation with all Health Boards, the Scottish Ministers shall appoint a Chair and a substitute Chair of the National Appeal Panel.

(2) Each person so appointed—

(a)shall be an advocate, a solicitor or a solicitor-advocate; but

(b)shall not be, nor previously have been, a doctor, dentist, ophthalmic optician, pharmacist, or person, or employee of a person, whose name is on the pharmaceutical list.

(3) Where the person appointed as Chair is unable for whatever reason to fulfil the duties of the Chair, the person appointed as substitute Chair shall take the place of that person and all references to the Chair in these Regulations shall be deemed to refer to the person appointed as substitute Chair]

MembershipS

11.—(1) In any case in which paragraph 5(6) of Schedule 3 falls to be applied, the Scottish Ministers shall arrange to convene in accordance with this paragraph the National Appeal Panel, the members of which shall be drawn from–

[F75(a)the lists maintained, in accordance with paragraph 3(4), of persons falling within paragraph 3(1)(b)(i); and]

(b)the nominees proposed in accordance with paragraph 9.

(2) No member of the National Appeal Panel shall be a member of–

(a)the Board or the Pharmacy Practices Committee of the Board which considered the application; or

(b)any Board which was notified in terms of paragraph 1(1)(d) of Schedule 3 and which submitted representations in accordance with that paragraph.

[F76(3) The National Appeal Panel shall consist of three members of whom—

(a)one shall be chair appointed as provided for in paragraph 10;

(b)one shall be a pharmacist; and

(c)one shall be nominated by the Board under paragraph 9.]

Declaration of interestS

12.—(1) Before the start of any meeting of the National Appeal Panel the chair F77... shall ask the members intending to be present whether, in respect of the appeal to be considered at the meeting, any of them–

(a)has an interest to declare;

(b)is associated with a person who has any personal interest,

and any such member who has or, as the case may be, is associated with the person who has, any such interest shall disclose it accordingly.

(2) Any member who has, pursuant to the provisions of sub-paragraph (1) disclosed an interest or who, in the opinion, expressed to the meeting, of the chair F78... should have disclosed such an interest, shall not be present at the consideration or discussion of that appeal or the voting on it.

QuorumS

F7913.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

Commencement Information

I34Sch. 4 para. 13 in force at 1.7.2009, see reg. 1

[F80VotingS

14.  Every appeal must be considered by all members of the National Appeal Panel convened for that purpose and determined by a majority of the votes of those members.]

[F81Notice of decision of National Appeal PanelS

15.(1) The National Appeal Panel shall, within 5 working days of taking its decision, give written notification of that decision with reasons for it to the Board to whom the original application was made.

(2) The Board shall—

(a)within 5 working days of receipt of such notification, intimate to the applicant and all persons mentioned in paragraph 1 of Schedule 3 that decision and the reasons for it; and

(b)within 5 working days of such intimation, publish that decision and the reasons for it on its website.]

Regulation 17

SCHEDULE 5SREVOCATIONS

Commencement Information

I37Sch. 5 in force at 1.7.2009, see reg. 1

(1)(2)(3)
Regulations revokedReferencesExtent of revocation
The National Health Service (Pharmaceutical Services) (Scotland) Regulations 1995S.I. 1995/414The whole regulations
The National Health Service (Pharmaceutical Services) (Scotland) Amendment Regulations 1996S.I. 1996/840The whole regulations
The National Health Services (General Medical Services, Pharmaceutical Services and Charges for Drugs and Appliances) (Scotland) Amendment Regulation 1996S.I. 1996/1504Regulation 3
The National Health Service (Pharmaceutical Services) (Scotland) Amendment Regulations 1997S.I. 1997/696The whole regulations
The National Health Service (Pilot Schemes for Person Dental Services: Miscellaneous Provisions and Consequential Amendments) Regulations 1998S.I. 1998/2224Regulation 8
The National Health Service (Pharmaceutical Services) (Scotland) Amendment Regulations 1998S.I. 1998/3031The whole regulations
The National Health Service (Pharmaceutical Services) (Scotland) Amendment Regulations 1999S.S.I. 1999/57The whole regulations
The National Health Service (Pharmaceutical Services) (Scotland) Amendment Regulations 2001S.S.I. 2001/70The whole regulations
The National Health Service (General Medical and Pharmaceutical Services) (Scotland) Amendment Regulations 2002S.S.I. 2002/111Regulation 2
The National Health Service (General Medical and Pharmaceutical Services) (Scotland) Amendment (No. 2) Regulations 2002S.S.I. 2002/153Regulation 2(2)
The National Health Service (Pharmaceutical Services) (Scotland) Amendment Regulations 2003S.S.I. 2003/296The whole regulations
The National Health Service (Pharmaceutical Services) (Scotland) Amendment Regulations 2004S.S.I. 2004/39The whole regulations
The Primary Medical Services (Consequential and Ancillary Amendments) (Scotland) Order 2004S.S.I. 2004/212Schedule 1, paragraph 4
The Health Act 1999 (Consequential Amendments) (Nursing and Midwifery) Order 2004S.I. 2004/1771Schedule, paragraph 43
The National Health Service (Pharmaceutical Services) (Scotland) Amendment Regulations 2005S.S.I. 2005/327The whole regulations
The National Health Service (Pharmaceutical Services) (Scotland) Amendment (No. 2) Regulations 2005S.S.I. 2005/618The whole regulations
The National Health Service (Pharmaceutical Services) (Scotland) Amendment Regulations 2006S.S.I. 2006/143The whole regulations
The National Health Service (Pharmaceutical Services) (Scotland) Amendment (No. 2) Regulations 2006S.S.I. 2006/245The whole regulations
The National Health Service (Pharmaceutical Services (Scotland) Amendment (No. 3) 2006S.S.I. 2006/320The whole regulations
The National Health Service (Pharmaceutical Services) (Scotland) Amendment Regulations 2007S.S.I. 2007/208The whole regulations
The Pharmacists and Pharmacy Technicians Order 2007S.I. 2007/289Schedule 1, Part 2, paragraph 18
The National Health Service (Pharmaceutical Services) (Scotland) Amendment (No. 2) Regulations 2007S.S.I. 2007/390The whole regulations
The National Health Service (Pharmaceutical Services) (Scotland) Amendment (No. 3) Regulations 2007S.S.I. 2007/500The whole regulations
The National Health Service (Charges for Drugs and Appliances) (Scotland) Regulations 2008S.S.I. 2008/27Schedule 3, paragraph 1
The National Health Service (Pharmaceutical Services, Charges for Drugs and Appliances and Charges to Overseas Visitors) (Scotland) Amendment Regulations 2009S.S.I. 2009/177Regulation 2

Regulation 18

SCHEDULE 6SCONSEQUENTIAL AMENDMENTS

National Health Service (General Dental Services) (Scotland) Regulations 1996S

1.—(1) The National Health Service (General Dental Services) (Scotland) Regulations 1996(6) are amended as follows.

[F82(2) In regulation 2 (interpretation), for the definition of “Drug Tariff” substitute–

“Drug Tariff” means the statement prepared by the Scottish Ministers under regulation 12 of the National Health Service (Pharmaceutical Services) (Scotland) Regulations 2009;]

Nurses and Midwives (Part of and Entries in the Register) Order of Council in Session 2004S

2.—(1) The Nurses and Midwives (Part of and Entries in the Register) Order of Council in Session 2004(7) is amended as follows.

[F83(2) In article 1 (citation, commencement and interpretation), in the definition of “Drug Tariff” part (b) for “regulation 9 (payments to pharmacists and standards of drugs and appliances) of the National Health Service (Pharmaceutical Services) (Scotland) Regulations 1995” substitute “regulation 12 (payments to pharmacy contractors and standards of drugs and appliances) of the National Health Service (Pharmaceutical Services) (Scotland) Regulations 2009”.]

The National Health Service (Primary Medical Services Section 17C Agreements) (Scotland) Regulations 2004S

F843.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

The National Health Service (General Medical Services Contracts) (Scotland) Regulations 2004S

F854.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

The National Health Service (Discipline Committees) (Scotland) Regulations 2006S

5.—(1) The National Health Service (Discipline Committees (Scotland) Regulations 2006(8) are amended as follows.

(2) In regulation 2 (interpretation) in the definition of “Pharmaceutical Services Regulations”, for “the National Health Service (Pharmaceutical Services) (Scotland) Regulations 1995” substitute “the National Health Service (Pharmaceutical Services) (Scotland) Regulations 2009”.

Commencement Information

I40Sch. 6 para. 5 in force at 1.7.2009, see reg. 1

The Administrative Justice and Tribunals Council (Listed Tribunals) (Scotland) Order 2007S

F866.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

The National Health Service (Charges for Drugs and Appliances) (Scotland) Regulations 2008S

7.—(1) The National Health Service (Charges for Drugs and Appliances) (Scotland) Regulations 2008(9) are amended as follows.

(2) In regulation 2 (interpretation) in the entry for “terms of service” for “the National Health Service (Pharmaceutical Services) (Scotland) Regulations 1995” substitute “the National Health Service (Pharmaceutical Services) (Scotland) Regulations 2009”.

Commencement Information

I42Sch. 6 para. 7 in force at 1.7.2009, see reg. 1

(2)

S.I. 2001/398. Schedule 5 was amended by S.I. 2005/2864.

(3)

Schedule 4 was amended by S.I. 2003/1432, 2005/3372 and 2007/2154.

(5)

SS.I. 2001/302. Amended by S.S.I. 2004/212 and 2005/108.

(7)

S.I. 2004/1765.

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