The National Health Service (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013

to produce satisfactory evidence of such entitlement, unless the declaration is in respect of entitlement to exemption by virtue of sub-paragraph (a), (c), (d), (e), (f) or (g) of regulation 10(1) of the Charges Regulations or in respect of entitlement to remission by virtue of regulation (5)(1)(e) or (2) of the Remission of Charges Regulations, and at the time of the declaration C already has such evidence available to C.

• (3ZA) For the purposes of sub-paragraph (3), satisfactory evidence includes evidence derived from a check, known as a real time exemption check, of electronic records that are managed by the NHS BSA for the purposes (amongst other purposes) of providing advice, assistance and support to patients or their representatives in respect of whether a charge is payable under the Charges Regulations.

• (3A) In any case where no satisfactory evidence, as required by sub-paragraph (3), is produced to C, C must ensure before the drugs or appliances are provided that the person who was asked to produce that evidence is advised, in appropriate terms, that checks are routinely undertaken to ascertain entitlement to—

• (a) exemption under the Charges Regulations; or

• (b) remission of charges under the Remission of Charges Regulations,

where such entitlement has been claimed, as part of the arrangements for preventing or detecting fraud or error in relation to such claims.

• (4) If, in the case of a non-electronic prescription form or non-electronic repeatable prescription, no satisfactory evidence, as required by sub-paragraph (3), is produced, C must endorse the form on which the declaration is made to that effect.

• (5) In the case of an electronic prescription, C must ensure that the following information is duly entered into the records managed by NHS England that are accessible as part of the Electronic Prescription Service (if either it is not already recorded in those records or a check, known as a real time exemption check, has not produced satisfactory evidence as mentioned in sub-paragraph (3))—

• (a) in a case where exemption from or remission of charges is claimed for all or some of the items included in the prescription, a record of—

• (i) the exemption category specified in regulation 10(1) of the Charges Regulations or the ground for remission under regulation 5 of the Remission of Charges Regulations which is claimed applies to the case, and

• (ii) whether or not satisfactory evidence was produced to C as required by sub-paragraph (3);

• (b) in any case where a charge is due, confirmation that the relevant charge was paid; and

• (c) in a case of a prescription for or including contraceptive substances, confirmation that no charge was payable in respect of those substances.

• (6) Sub-paragraphs (3) to (5) apply to the provision of a drug or appliance in accordance with a SSP as they apply to the provision of a drug or appliance in accordance with a prescription form or a repeatable prescription (or an associated batch issue), and for these purposes the prescription for product reimbursement purposes, as mentioned in paragraph 3A(4)(a), is treated as being the prescription in accordance with which the drug or appliance is provided (even though the supply is not in pursuance of that prescription).

Providing ordered drugs or appliances

6

• (1) Where the LPS contractor (C) is presented with, or receives from the Electronic Prescription Service, a prescription form or a repeatable prescription, C must only provide the drugs or appliances so ordered—

• (a) if the prescription form or repeatable prescription is duly signed and completed as described in paragraph 3(1) or (2); and

• (b) in accordance with the order on the prescription form or repeatable prescription,

subject to any regulations in force under the Weights and Measures Act 1985 and the following provisions of this Schedule.

• (1A) Subject to sub-paragraphs (1B) to (1E) and without prejudice to sub-paragraphs (8) and (9), for the purposes of sub-paragraph (1)(b), a drug is provided in accordance with the order on a prescription form or repeatable prescription if (in addition to where the provision is exactly in accordance with the order)—

• (a) a different quantity is provided to that ordered on the prescription form or repeatable prescription in order to allow for the provision of the drug in its manufacturer’s original outer packaging; and

• (b) the provision is otherwise in accordance with the order.

• (1B) In the case of an order for a prescription only medicine, sub-paragraph (1A) only applies if sub-paragraph (6) applies or one of the following applies—

• (a) the provision is in accordance with regulation 217B(1) to (3) of the Human Medicines Regulations 2012 (original pack dispensing), and accordingly, regulation 217B(1) to (3) of those Regulations is expressly applied to such supplies; or

• (b) the medicine must be provided in the manufacturer’s original outer packaging in order to comply with regulation 217C of the Human Medicines Regulations 2012 (original pack dispensing: medicinal products containing a relevant substance).

• (1C) In the case of an order for a drug that is not a prescription only medicine, sub-paragraph (1A) only applies if sub-paragraph (6) applies or the provision of a different quantity to that ordered on the prescription is in circumstances where—

• (a) the different quantity is no more than 10% greater or no more than 10% less than the quantity ordered; and

• (b) the registered pharmacist carrying out or directly supervising the provision does not consider, in the exercise of their professional skill and judgement, that the provision of a different quantity to that ordered may mean that the patient does not, or is not able to, follow the medication regimen as intended by the prescriber.

• (1D) Where C may, pursuant to sub-paragraph (1A) and sub-paragraph (1B)(a) or (1C)(a) and (b), provide a different quantity of a drug to that ordered on a prescription form or a repeatable prescription, C must consider, in the exercise of their professional skill and judgement, whether it is reasonable and appropriate to do so, having regard to the benefits to patients where they are provided with drugs in their manufacturer’s original outer packaging.

• (1E) Sub-paragraphs (1B)(a) and (1C)(a) and (b) do not apply to the provision of any drug which is—

• (a) for the time being specified in Schedules 2 to 4 of the Misuse of Drugs Regulations 2001 (which relate to controlled drugs excepted from certain provisions under the Regulations); or

• (b) a special medicinal product for the purposes of regulation 167 of the Human Medicines Regulations 2012 (supply to fulfil special patient needs).

• (2) If the order is for , or a product to be provided in accordance with a SSP is, an appliance of a type requiring measuring and fitting by C (for example a truss), C shall make all necessary arrangements for—

• (a) measuring the person named on the prescription form or repeatable prescription for the appliance; and

• (b) fitting the appliance.

• (3) If the order is for , or a product to be provided in accordance with a SSP is, a drug or appliance included in the Drug Tariff, the British National Formulary (including any Appendix published as part of that Formulary), the Dental Practitioner's Formulary, the European Pharmacopoeia or the British Pharmaceutical Codex, the drug or appliance provided must comply with the relevant standard or formula specified therein.

• (4) If the order—

• (a) is an order for a drug; but

• (b) is not an order for 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 of the Misuse of Drugs Regulations 2001 (which relate to controlled drugs excepted from certain prohibitions under the Regulations),

and does not prescribe its quality, strength or dosage, C (in practice, a registered pharmacist) may provide the drug in such strength and dosage as in the exercise of C's professional skill, knowledge and care C considers to be appropriate and, subject to sub-paragraph (5), in such quantity as C considers to be appropriate for a course of treatment for a period not exceeding 5 days.

• (5) Where an order to which sub-paragraph (4) applies is for—

• (a) an oral contraceptive substance;

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

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

which is not available for provision as part of local pharmaceutical services except in such packages that the minimum size available contains a quantity appropriate to a course of treatment for a period of more than 5 days, C may provide the minimum size available package.

• (6) Where any drug to which this sub-paragraph applies (that is, a drug that is not one to which the Misuse of Drugs Act 1971 applies, unless it is a drug for the time being specified in Schedule 5 to the Misuse of Drugs Regulations 2001), ordered by a prescriber on a prescription form or repeatable prescription, is available for provision by C 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 special container,

C must provide the drug in the pack whose quantity is nearest to the quantity which has been so ordered.

• (7) In this paragraph, “special container” means any container with an integral means of application or from which it is not practicable to dispense an exact quantity.

• (8) Subject to sub-paragraph (9), where a drug is ordered by a prescriber on a prescription form or repeatable prescription , or is to be provided in accordance with a SSP, in a quantity that is, or is a multiple of a quantity that is, readily available in a pack size manufactured for a holder of a UK marketing authorisation for the drug, C must provide the drug in an original pack (or in original packs) of that size which has been assembled by a manufacturer of the drug for such a holder of a UK marketing authorisation, unless—

• (a) it is not possible for C to obtain such a pack (or packs) with reasonable promptness in the normal course of business; or

• (b) it is not practicable for C to provide such a pack (or packs) in response to the order (for example, because of patient needs or the method of administration of the drug).

• (9) In the case of oral liquid methadone, C (in practice, a registered pharmacist) must decide whether it would be most appropriate to provide—

• (a) each dose in a separate container;

• (b) an original pack (or original packs); or

• (c) the oral liquid methadone in some other way,

and C must then provide it in packaging that accords with that decision.

• (10) C must only provide a Scheduled drug in response to an order by name, formula or other description on a prescription form or repeatable prescription if—

• (a) it is ordered as specified in sub-paragraph (11); or

• (b) in the case of a drug specified in Schedule 2 to the Prescription of Drugs Regulations (drugs, medicines and other substances that may be ordered only in certain circumstances), it is ordered in the circumstances prescribed in that Schedule.

• (11) A Scheduled drug that is a drug with an appropriate non-proprietary name may be provided in response to an order on a prescription form or repeatable prescription for a drug (“the prescribed drug”) that is not a Scheduled drug but which has the same non-proprietary name as the Scheduled drug if—

• (a) the prescribed drug is ordered by that non-proprietary name or by its formula;

• (b) the prescribed drug has the same specification as the Scheduled drug (so the Scheduled drug may be dispensed generically); and

• (c) the Scheduled drug is not in a pack which consists of a drug in more than one strength, and providing it would involve the supply of part only of the pack.

• (12) If a Scheduled drug is a combination of more than one drug, it can only be ordered as specified in sub-paragraph (11) if the combination has an appropriate non-proprietary name, whether or not the drugs in the combination each have such names.

• (13) C must provide any drug which it is required to provide under paragraph 3 or 3B , or provides under paragraph 3A, in a suitable container.

• (14) Where C provides a drug or appliance under paragraph 3A, C must include in the dispensing label on the packaging of the product, for the patient’s benefit, information to the effect that the product is being supplied in accordance with a SSP, identifying the particular SSP.

• (15) Sub-paragraphs (3) to (8) apply to the provision of a drug in accordance with a LPIV as they apply to the provision of a drug in accordance with a prescription form or a repeatable prescription (or an associated batch issue).

Refusal to provide drugs or appliances ordered

7

• (1) The LPS contractor (C) may refuse to provide the drugs or appliances ordered on a prescription form or repeatable prescription where—

• (a) C reasonably believes that it is not a genuine order for the person named on the prescription form or the repeatable prescription (for example because C reasonably believes it has been stolen or forged);

• (b) it appears to C that—

• (i) there is an error on the prescription form or on the repeatable prescription, or in the case of a non-electronic repeatable prescription, its associated batch issue (including a clinical error made by the prescriber), or

• (ii) in the circumstances, providing the drugs or appliances would be contrary to the C's (in practice, a registered pharmacist's) clinical judgement;

• (c) C or other persons on the premises are subjected to or threatened with violence by the person presenting the prescription form or repeatable prescription or requesting the provision of drugs or appliances in accordance with an electronic prescription form or a repeatable prescription, or by any person accompanying that person;

• (d) the person presenting the prescription form or repeatable prescription or requesting the provision of drugs or appliances in accordance with an electronic prescription form or a repeatable prescription, or any person accompanying that person, commits or threatens to commit a criminal offence; or

• (e) the prescription form or repeatable prescription is incomplete because it does not include the information relating to the identification of the prescriber that NHS England (or a person exercising its functions) requires in order to perform its functions relating to—

• (i) the remuneration of persons providing local pharmaceutical services, and

• (ii) any apportionment of, or any arrangements for recharging in respect of, that remuneration,

unless C is to receive no pharmaceutical remuneration of any kind in respect of the drug or appliance.

• (2) C must refuse to provide a drug ordered on a prescription form or repeatable prescription where the order is for a prescription only medicine which the prescriber was not entitled to prescribe.

• (2A) C may refuse to provide a drug or appliance ordered on an electronic prescription if the access that C has to the Electronic Prescription Service is not such as to enable C to dispense that prescription promptly (or at all) , but where C does so, C must take all reasonable steps to ensure that the product ordered by the prescriber is supplied within a reasonable timescale, which may include (depending on what steps or combination of steps the circumstances require)—

• (a) providing details of other LPS chemists or NHS pharmacists whose premises are situated in the same area and who may be able to provide the product ordered by the prescriber;

• (b) urgent supply without a prescription in accordance with paragraph 4;

• (c) arranging for the urgent provision of a non-electronic prescription form by the prescriber.

• (2B) C must refuse to provide a drug or appliance ordered on a prescription form or a repeatable prescription where—

• (a) a 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; and

• (b) alternative provision has already taken place in accordance with the SSP.

• (2C) C may refuse to provide a drug or appliance ordered on a prescription form or a repeatable prescription where—

• (a) a 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;

• (b) a registered pharmacist is of the opinion, in the exercise of his or her professional skill and judgement, that supplying a different product or quantity of product to that ordered by the prescriber is unreasonable or inappropriate; and

• (c) C is unable to provide the drug or appliance within a reasonable timescale,

but if C does refuse to do so, C must provide the patient or the person requesting the drug or appliance on behalf of a patient with appropriate advice, as necessary, about reverting to the prescriber for the prescriber to review the patient’s treatment.

• (3) C must refuse to provide drugs or appliances ordered on a repeatable prescription where—

• (a) C has no record of that prescription;

• (b) C does not, in the case of a non-electronic repeatable prescription, have any associated batch issue and it is not presented to C;

• (c) it is not signed by a prescriber;

• (d) to do so would not be in accordance with any intervals specified in the prescription;

• (e) it would be the first time a drug or appliance had been provided pursuant to the prescription and the prescription was signed (whether electronically or otherwise) more than 6 months previously;

• (f) the repeatable prescription was signed (whether electronically or otherwise) more than one year previously;

• (g) the expiry date on the repeatable prescription has passed; or

• (h) C has been informed by the prescriber that the prescription is no longer required.

• (4) Where a patient requests the supply of drugs or appliances ordered on a repeatable prescription (other than on the first occasion that he makes such a request), C must only provide the drugs or appliances ordered if C is satisfied—

• (a) that the patient to whom the prescription relates—

• (i) is taking or using, and is likely to continue to take or use, the drug or appliance appropriately, and

• (ii) is not suffering from any side effects of the treatment which indicates the need or desirability of reviewing the patient's treatment;

• (b) that the medication regimen of the patient to whom the prescription relates has not altered in a way which indicates the need or desirability of reviewing the patient's treatment; and

• (c) that there have been no changes to the health of the patient to whom the prescription relates which indicate the need or desirability of reviewing the patient's treatment.

• (5) C may refuse to provide a prescription item that is or is purportedly ordered on a LPIV where—

• (a) C reasonably believes it is not a genuine order for the person who requests, or on whose behalf is requested, the provision of the prescription item;

• (b) providing it would be contrary to C’s clinical judgement;

• (c) C or other persons are subjected to or threatened with violence by the person who requests the provision of the prescription item, or by any person accompanying that person; or

• (d) the person who requests the provision of the prescription item, or any person accompanying that person, commits or threatens to commit a criminal offence.

• (6) C must refuse to provide a prescription item that is or is purportedly ordered on a LPIV where C is satisfied that C is not entitled to provide it or the prescriber was not entitled to prescribe it.

• (7) C may refuse to provide a prescription item ordered on a prescription form or repeatable prescription where—

• (a) more than one prescription item has been ordered on the prescription form or repeatable prescription;

• (b) at least one of those prescription items is a listed HRT prescription item and at least one of those prescription items is not; and

• (c) the person named on the prescription form or repeatable prescription is claiming entitlement to exemption under regulation 10(1)(j) of the Charges Regulations (exemptions) in respect of any of those prescription items which is a listed HRT prescription item.

Further activities to be carried out in connection with the provision of dispensing services

8

In connection with the services provided under paragraphs 3 to 7, the LPS contractor (C) must—

• (a) ensure that appropriate advice is given to patients about any drugs or appliances provided to them—

• (i) to enable them to utilise the drugs or appliances appropriately, and

• (ii) to meet the patient's reasonable needs for general information about the drugs or appliances;

• (b) provide appropriate advice to patients to whom they provide drugs or appliances on—

• (i) the safe keeping of the drugs or appliances, and

• (ii) returning unwanted drugs or appliances to the scheme premises for safe destruction;

• (c) provide a patient with a written note (which may be in an electronic form) of any drug or appliance which is owed, and inform the patient when it is expected that the drug or appliance will become available;

• (d) keep and maintain records—

• (i) of drugs and appliances provided, in order to facilitate the continued care of the patient,

• (ii) in appropriate cases, of advice given and any interventions or referrals made (including clinically significant interventions in cases involving repeatable prescriptions), and

• (iii) of notes provided under sub-paragraph (c);

• (e) if C provides a drug or appliance under an electronic prescription, provide the patient, if the patient so requests, with a written record of the drugs or appliances ordered on that prescription and, in the case of an electronic repeatable prescription, of the number of occasions on which it can be dispensed; and

• (f) ensure that where a person is refused drugs or appliances pursuant to paragraph 7(1)(b), (2), (3) or (4), the patient is referred back to the prescriber for further advice.

Additional requirements in relation to electronic prescribing

9

• (1) The LPS contractor (C) must, if requested to do so by any person—

• (a) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• (b) where the Electronic Prescription Service is temporarily unavailable through C's scheme premises, provide that person with contact details of at least two pharmacies in the area through which the service is available, if these details are known to C.

• (2) ... C must, if requested to do so by any person, enter in that person's PDS patient details—

• (a) where the person does not have a nominated dispensing contractor, a nominated dispensing contractor; or

• (b) where the person does have a nominated dispensing contractor—

• (i) a replacement dispensing contractor, or

• (ii) a further dispensing contractor,

chosen by that person.

• (3) Sub-paragraph (2)(b)(ii) does not apply if the number of nominated dispensing contractors for that person would thereby exceed the maximum number permitted by the Electronic Prescription Service.

• (4) If C is a nominated dispensing contractor for a person (X) but the nomination was made before C became the person specified in an LPS scheme in relation to the scheme premises nominated in X's PDS patient details, C must within 6 months of C becoming the person so specified—

• (a) explain to X that the ownership of the scheme premises has changed; and

• (b) ask X whether X wishes to maintain the nomination in respect of those scheme premises.

• (5) If C dispenses an electronic prescription or makes an urgent supply without a prescription, C must send the form duly completed by or on behalf of the patient, if one is required under regulation 3(3)(b) or (c), (5C) or (5E) of the Charges Regulations in respect of that prescription (which may be the associated EPS token), to the NHS BSA.

Further activities in connection with repeat dispensing

10

In connection with the services provided under paragraphs 3 to 7, the LPS contractor (C) must—

• (a) provide appropriate advice to patients to whom C provides drugs or appliances in accordance with a repeatable prescription, in particular on the importance of only requesting those items which they actually need;

• (b) undertake appropriate training in respect of repeat dispensing, having regard to any recommendations in respect of such training set out in the Drug Tariff;

• (c) if C takes possession of a non-electronic repeatable prescription or an associated batch issue, securely store that repeatable prescription or associated batch issue;

• (d) maintain records of repeatable prescriptions in such a form as to provide a clear audit trail of supplies under the repeatable prescription (including dates and quantities supplied);

• (e) destroy any surplus batch issues relating to drugs or appliances—

• (i) which are not required, or

• (ii) where a patient is refused the drugs or appliances pursuant to paragraph 7;

• (f) where a patient is provided with drugs or appliances under a repeatable prescription, notify the prescriber of any clinically significant issues arising in connection with the prescription and keep a record of that notification; and

• (g) notify the prescriber of any refusal to provide drugs or appliances pursuant to paragraph 7(4).

Information to be provided for the NHSCB's lists

11

• (1) The LPS contractor (C) must ensure that C provides to NHS England, on request, an up to date record of—

• (a) the services that C provides; and

• (b) the days on which and times at which those services are provided.

• (2) Sub-paragraph (1) is without prejudice to the need for a variation of the LPS scheme if C wishes to change—

• (a) the services that C provides; and

• (b) the days on which and times at which those services are provided.

Clinical governance

12

• (1) The LPS contractor must participate, in the manner reasonably required by NHS England in an acceptable system of clinical governance.

• (2) In this paragraph, “system of clinical governance” means a framework through which an LPS contractor endeavours to improve continuously the quality of the LPS contractor's services and safeguards high standards of care by creating an environment in which clinical excellence can flourish.

Professional Standards

13

The LPS contractor must provide local pharmaceutical services and exercise any professional judgement in connection with the provision of such services in conformity with the standards generally accepted in the pharmaceutical profession.

Inducements etc

14

• (1) The LPS contractor (C) (including C's staff) must 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 C's business or by way of discount or rebate or otherwise) as an inducement to or in consideration of a person (X)—

• (a) presenting an order for drugs or appliances on a non-electronic prescription form or non-electronic repeatable prescription;

• (b) nominating C as X's dispensing contractor (or one of them) in X's PDS patient details; or

• (c) being provided with any LP service by C.

• (2) Promising, offering or providing an auxiliary aid in relation to the supply of drugs or a home delivery service is not a gift or reward for the purposes of sub-paragraph (1).

• (3) C (including C's staff) must not give, promise or offer to any relevant person any gift or reward (including by way of a share of, or dividend on, the profits of C's business, or by way of a discount or rebate) as an inducement to or in consideration of the relevant person recommending to any person that they—

• (a) present to C an order for drugs or appliances on a prescription form or repeatable prescription;

• (b) nominate C as their dispensing contractor (or one of them) on their PDS patient details; or

• (c) are provided with any LP service by C.

• (4) For the purpose of sub-paragraph (3), “relevant person” means any person who performs or provides NHS services, whether on their own behalf or on behalf of another, and includes—

• (a) any NHS body or provider of primary medical services; and

• (b) any person employed or engaged by any of the persons mentioned in paragraph (a).

Duty to provide information about fitness to practise matters as they arise

15

• (1) The LPS contractor (C) must within 7 days of its occurrence supply in writing information to NHS England as to whether a person (P) who is a relevant person in relation to C—

• (a) has been convicted of any criminal offence in the United Kingdom;

• (b) has been convicted elsewhere of an offence which would constitute a criminal offence if committed in England and Wales;

• (c) has been charged with an offence and is currently the subject of any proceedings which might lead to a conviction, which have not yet been notified to NHS England;

• (d) has accepted a police caution in the United Kingdom;

• (e) has become subject to an order under section 246(2) or (3) of the Criminal Procedure (Scotland) Act 1995 (admonition and absolute discharge) discharging R absolutely;

• (f) has accepted a conditional offer under section 302 of the Criminal Procedure (Scotland) Act 1995 (fixed penalty: conditional offer by procurator fiscal);

• (g) has agreed to pay a penalty under section 115A of the Social Security Administration Act 1992 (penalty as alternative to prosecution);

• (h) has, to P's knowledge, become subject to any investigation into P's professional conduct by any licensing body or is notified of the outcome of such an investigation where it is adverse;

• (i) has, to P's knowledge, become subject to an investigation into P's professional conduct in respect of any current or previous employment or is notified of the outcome of such an investigation where it is adverse;

• (j) has, to P's knowledge, become subject to any investigation by the NHS CFA in relation to fraud or is notified of the outcome of such an investigation where it is adverse;

• (k) has, to P's knowledge, become the subject of any investigation by another primary care organisation, which might lead to P's removal from any relevant list; or

• (l) either—

• (i) has been removed or contingently removed from, refused admission to, or conditionally included in, any relevant list of another primary care organisation,

• (ii) has been suspended from such a list, on fitness to practise grounds, and if so, why and the name of that other primary care organisation, or

• (iii) has become the subject of a national disqualification,

and if so, C must give details of any investigation or proceedings which are being or were undertaken or brought, including the nature of that investigation or proceedings, where and approximately when that investigation or those proceedings commenced, and any outcome.

• (2) P is a “relevant person” in relation to C for these purposes, in the case of a contractor that is—

• (a) an individual, if P is C;

• (b) a partnership, if P is a partner in C;

• (c) a body corporate, if P is a director, the chief executive, the company secretary or the superintendent pharmacist of C.

• (3) C or any relevant person must consent to a request being made by NHS England to any employer or former employer or licensing body in the United Kingdom or elsewhere, for information relating to a current investigation, or an investigation where the outcome was adverse.

Co-operation with Health Education England

16

The LPS contractor must co-operate with NHS England in the discharge by NHS England of the duty under section 1F(1) of the 2006 Act (duty as to education and training).

Charges for drugs, appliances and containers, and ownership of containers

17

• (1) Subject to regulations made under Part 9 of the 2006 Act (charging), all drugs, containers and appliances provided under these terms of service must be provided free of charge.

• (2) Where the LPS contractor supplies a container in response to an order for drugs signed by a prescriber, other than equipment specified in the Drug Tariff as not returnable to the contractor, the container and equipment must remain the property of the LPS contractor.

Refunds of prescription charges

18

• (1) Where any person who is entitled to a repayment of any charge paid under the Charges Regulations presents the LPS contractor with a valid claim for the repayment within three months of the date on which the charge was paid, the LPS contractor must make the repayment.

• (2) For the purposes of sub-paragraph (1), a claim for repayment is only valid if duly made—

• (a) in such form and manner as the Secretary of State has determined for an application for such a repayment under regulation 18(2)(b) of the Charges Regulations (repayment of charges); or

• (b) on the equivalent form issued in Scotland, Wales or Northern Ireland.

Remuneration, overpayments etc

19

• (1) NHS England must ensure that the LPS scheme requires it to remunerate the LPS contractor (C) promptly, in accordance with the remuneration arrangements provided for in the scheme, but subject to the arrangements for reductions of and deductions from payments provided for in the scheme.

• (2) NHS England must ensure that the LPS scheme requires that payment of any item of remuneration which would, if it were payable to an NHS pharmacist in connection with providing pharmaceutical services, be pharmaceutical reimbursement, is to be paid in accordance with the Drug Tariff.

• (3) For these purposes, “pharmaceutical reimbursement” means pharmaceutical remuneration of the type which may be payable to NHS chemists in accordance with determinations by (only) the Secretary of State under section 164 of the 2006 Act (remuneration for persons providing pharmaceutical services).

• (4) Where an LPS scheme requires a fee, allowance or other item of remuneration to be made in accordance with the Drug Tariff and the Drug Tariff provides that the fee, allowance or other item of remuneration is to be determined by NHS England, that fee, allowance or other item of remuneration must be determined by NHS England.

• (5) NHS England must ensure that the LPS scheme—

• (a) allows it to recover any payment made to C which should not have been made;

• (b) provides that any such recovery of an overpayment is without prejudice to any investigation of any alleged breach of the scheme; and

• (c) provides that the remuneration arrangements under the scheme, referred to in sub-paragraphs (1) to (4), are subject to any right NHS England may have to set off against any amount payable to C, any amount—

• (i) owed by C to it, or

• (ii) which it is entitled to withhold under the terms of the scheme (including terms of the Drug Tariff applied by the scheme).

Local resolution of disputes

20

In the case of any dispute arising out of, or in connection with, the LPS scheme, the LPS contractor and NHS England must made every reasonable effort to communicate and co-operate with each other with a view to resolving the dispute, before referring the dispute for determination in accordance with the NHS dispute resolution procedure (or, where applicable, before commencing court proceedings).

Dispute resolution: non-NHS contracts

21

• (1) In the case of an LPS scheme that is not an NHS contract, any dispute arising out of or in connection with the scheme, except matters dealt with under the complaints procedure pursuant to paragraph 25, may be referred for consideration and determination to the Secretary of State—

• (a) if it relates to a period when the contractor was treated as a health service body, by the contractor or by NHS England; or

• (b) in any other case, by the contractor or, if the contractor agrees in writing, by NHS England.

• (2) In the case of a dispute referred to the Secretary of State under sub-paragraph (1)—

• (a) the procedure to be followed is the NHS dispute resolution procedure; and

• (b) the parties must agree to be bound by any determination made by the adjudicator.

NHS dispute resolution procedure

22

• (1) The procedure specified in this paragraph and paragraph 23 applies in the case of any dispute arising out of or in connection with an LPS scheme which is referred to the Secretary of State—

• (a) in accordance with section 9(6) of the 2006 Act (NHS contracts), where the scheme is an NHS contract; or

• (b) in accordance with paragraph 21(1), where the scheme is not an NHS contract.

• (2) Any party wishing to refer a dispute as mentioned in sub-paragraph (1) must send to the Secretary of State a written request for dispute resolution which must include or be accompanied by—

• (a) the names and addresses of the parties to the dispute;

• (b) a copy of the LPS scheme; and

• (c) a brief statement describing the nature and circumstances of the dispute.

• (3) Any party wishing to refer a dispute as mentioned in sub-paragraph (1) must send the request under sub-paragraph (2) within a period of 3 years beginning with the date on which the matter giving rise to the dispute happened or should reasonably have come to the attention of the party wishing to refer the dispute.

• (4) Where the dispute relates to an LPS scheme which is not an NHS contract, the Secretary of State may determine the matter himself or, if the Secretary of State considers it appropriate, appoint a person or persons to consider and determine it.

• (5) Before reaching a decision as to who should determine the dispute, either under sub-paragraph (4) or under section 9(8) of the 2006 Act, the Secretary of State must, within the period of 7 days beginning with the date on which a matter was referred to the Secretary of State, send a written request to the parties to make in writing, within a specified period, any representations which they may wish to make about the matter.

• (6) The Secretary of State must give, with the notice given under sub-paragraph (5) to the party other than the one which referred the matter to dispute resolution a copy of any document by which the matter was referred to dispute resolution.

• (7) The Secretary of State must give a copy of any representations received from a party to the other party and must in each case request (in writing) a party to whom a copy of the representations is given to make within a specified period any written observations which it wishes to make on those representations.

• (8) Following receipt of any representations from the parties or, if earlier, at the end of the period for making such representations specified in the request sent under sub-paragraph (5) or (7), the Secretary of State must, if the Secretary of State decides to appoint a person or persons to hear the dispute—

• (a) inform the parties in writing of the name of the person or persons whom the Secretary of State has appointed; and

• (b) pass to the person or persons so appointed any documents received from the parties pursuant to sub-paragraph (2), (5) or (7).

• (9) For the purpose of assisting them in their consideration of the matter, the adjudicator may—

• (a) invite representatives of the parties to appear before the adjudicator to make oral representations either together or, with the agreement of the parties, separately, and may in advance provide the parties with a list of matters or questions to which the adjudicator wishes them to give special consideration; or

• (b) consult other persons whose expertise the adjudicator considers will assist the adjudicator's consideration of the matter.

• (10) Where the adjudicator consults another person under sub-paragraph (9)(b), the adjudicator must notify the parties accordingly and, where the adjudicator considers that the interests of any party might be substantially affected by the result of the consultation, the adjudicator must give to the parties such opportunity as the adjudicator considers reasonable in the circumstances to make observations on those results.

• (11) In considering the matter, the adjudicator must consider—

• (a) any written representations made in response to a request under sub-paragraph (5), but only if they are made within the specified period;

• (b) any written observations made in response to a request under sub-paragraph (7), but only if they are made within a specified period;

• (c) any oral representations made in response to an invitation under sub-paragraph (9)(a);

• (d) the results of any consultation under sub-paragraph (9)(b); and

• (e) any observations made in accordance with an opportunity given under sub-paragraph (10).

• (12) In this paragraph, “specified period” means such period as the Secretary of State must specify in the request, being not less than 2, nor more than 4 weeks beginning with the date on which the notice referred to is given, but the Secretary of State may, if the Secretary of State considers that there is good reason for doing so, extend any such period (even after it has expired) and, where the Secretary of State does so, a reference in this paragraph to the specified period is to the period as so extended.

• (13) Subject to the other provisions of this paragraph and paragraph 23, the adjudicator is to have wide discretion in determining the procedure of the dispute resolution to ensure the just, expeditious, economical and final determination of the dispute.

Determination of dispute

23

• (1) The adjudicator must record the adjudicator's determination, and the reasons for it, in writing and must give notice of the determination (including a record of the reasons) to the parties.

• (2) In the case of a scheme referred for determination in accordance with paragraph 21(1), section 9(11) of the 2006 Act must apply as that subsection applies in the case of an LPS scheme referred for determination in accordance with section 9(6) of that Act.

Disputes: supplemental

24

• (1) In this Schedule, where reference is made to any dispute arising out of, or in connection with, an LPS scheme, that includes any dispute arising out of, or in connection with, the termination of the scheme.

• (2) Any term of the LPS scheme that makes provision in respect of the requirements in paragraphs 20 to 23 must survive even where the scheme has terminated.

Complaints

25

• (1) The LPS contractor must have in place arrangements which comply with the requirements of the Local Authority Social Services and National Health Service Complaints (England) Regulations 2009 , for the handling and consideration of any complaints.

• (2) In this paragraph, “complaint” means a complaint about a matter connected with the provision of local pharmaceutical services by the LPS contractor.

Variation of LPS schemes

26

• (1) Subject to sub-paragraphs (2) to (4), no amendment or variation to the LPS scheme is to have effect unless it is in writing and signed by or on behalf of NHS England and the (relevant) LPS contractor (C).

• (2) NHS England may vary an LPS scheme without C's consent where it—

• (a) is reasonably satisfied that it is necessary to vary the scheme so as to comply with the 2006 Act, any regulations made under that Act, or any direction given by the Secretary of State under that Act; and

• (b) notifies C in writing of the wording of the proposed variation and the date upon which that variation is to take effect,

and, where it is reasonably practicable to do so, the date that the proposed variation is to take effect must be not less than 14 days after the date on which the notice under paragraph (b) is served on C.

• (3) During an emergency requiring the flexible provision of pharmaceutical services, NHS England may, on application from C—

• (a) permit C a temporary change to the days on which or times at which C is obliged to provide local pharmaceutical services at or from the scheme premises, or permit temporary closure of those premises, if—

• (i) C gives at least 24 hours notice of the change or closure, and

• (ii) the reasons given by C for the request are, in the opinion of NHS England adequate reasons; or

• (b) permit C any other temporary variation to C's LPS scheme that, in the opinion of NHS England, will facilitate continuity of the provision of services of a kind that may be provided under section 126, or by virtue of section 127, of the 2006 Act (arrangements for pharmaceutical services and additional pharmaceutical services) during the emergency.

• (4) NHS England need not approve the request referred to in sub-paragraph (3)(a)(ii) in advance of the change or closure, but if it does not do so and decides subsequently that C's reasons are not, in its opinion, adequate reasons, then the days on which or times at which C is obliged to provide local pharmaceutical services at or from the scheme premises are to revert to the overridden days and times, from the day after the date on which that decision is given to C.

Termination by agreement

27

NHS England and the LPS contractor may agree in writing to terminate the LPS scheme (or end the LPS contractor's participation in it, in the case of more than one LPS contractor being party to the scheme), and if the parties so agree, they must agree the date upon which that termination should take effect and any further terms upon which the scheme should be terminated.

Termination by serving notice

28

• (1) Either the LPS contractor or NHS England may terminate the LPS scheme (or end the LPS contractor's participation in it, in the case of more than one LPS contractor being party to the scheme), at any time by serving notice of not less than 6 months in writing to the other party.

• (2) Where a notice is served pursuant to sub-paragraph (1), the LPS scheme must terminate on the expiry of the notice period.

• (3) This paragraph is without prejudice to any other rights to terminate the agreement which the LPS contractor and NHS England may have.

Termination of arrangements by the NHSCB on grounds of suitability etc

29

• (1) NHS England may serve notice in writing on the LPS contractor terminating the LPS scheme (or ending the LPS contractor's participation in it, in the case of more than one LPS contractor being party to the scheme) with immediate effect, or from such date as may be specified in the notice, if, in the case of an LPS scheme (or an agreement that is part of an LPS scheme) entered into—

• (a) with an individual as a party, that individual;

• (b) with more than one individual (whether or not practising in partnership), any of those individuals; or

• (c) with a body corporate—

• (i) the body corporate, or

• (ii) any director, chief executive, superintendent or company secretary of the body corporate,

falls within sub-paragraph (2) during the existence of the scheme (or the agreement).

• (2) A person (X) falls within this sub-paragraph if—

• (a) X is the subject of a national disqualification;

• (b) subject to sub-paragraph (3), X is disqualified or suspended (other than by an interim suspension order or direction pending an investigation) from practising by any licensing body anywhere in the world;

• (c) X is removed from, or refused admission to, a relevant list by reason that amounts to inefficiency, fraud or unsuitability (as understood by reference to the conditions in section 151(2) to (4) of the 2006 Act (disqualification of practitioners)), unless X has subsequently been included in such a list;

• (d) X has been convicted in the United Kingdom of murder or a criminal offence other than murder—

• (i) which was committed on or after 1st April 2006, and

• (ii) for which X has been sentenced to a term of imprisonment of over six months;

• (e) subject to sub-paragraph (4), X has been convicted outside the United Kingdom of an offence which, if committed in England and Wales—

• (i) would constitute murder, or

• (ii) would constitute an offence, and—

• (aa) which was committed on or after 1st April 2006, and

• (bb) for which X has been sentenced to a term of imprisonment of over six months;

• (f) X has been convicted of an offence referred to in—

• (i) Schedule 1 to the Children and Young Persons Act 1933 (offences against children and young persons with respect to which special provisions of this Act apply), or

• (ii) Schedule 1 to the Criminal Procedure (Scotland) Act 1995 (offences against children under the age of 17 years to which special provisions apply),

which was committed on or after 1st April 2006;

• (g) X—

• (i) has been made bankrupt, or sequestration of X's estate has been ordered, unless X has been discharged from the bankruptcy or the order has been annulled,

• (ii) has become a person in relation to whom a moratorium period under a debt relief order (under Part 7A of the Insolvency Act 1986 (debt relief orders)) applies,

• (iii) has been made the subject of a bankruptcy restrictions order, an interim bankruptcy restrictions order, a debt relief restrictions order or an interim debt relief restrictions order under Schedule 4A or 4ZB to the Insolvency Act 1986 or Schedule 2A of the Insolvency (Northern Ireland) Order 1989 (which relate to bankruptcy and debt relief restrictions orders and undertakings), which has not been annulled,

• (iv) if X is a body corporate, has been wound up under Part 4 of the Insolvency Act 1986;

• (v) has made a composition or arrangement with, or granted a trust deed for, X's creditors and X has not been discharged in respect of it;

• (h) in respect of X there is—

• (i) an administrator, administrative receiver or receiver appointed, or

• (ii) an administration order made under Schedule B1 to the Insolvency Act 1986 (administration);

• (i) X has been removed—

• (i) from the office of charity trustee or trustee for a charity by an order made by the Charity Commissioners, the Charity Commission, the Charity Commission for Northern Ireland or the High Court on the grounds of any misconduct or mismanagement in the administration of the charity—

• (aa) for which the person was responsible or to which the person was privy, or

• (bb) which the person by their conduct contributed to or facilitated, or

• (ii) under—

• (aa) section 7 of the Law Reform (Miscellaneous Provisions) (Scotland) Act 1990 (powers of Court of Session to deal with management of charities), or

• (bb) section 34(5)(e) or (ea) of the Charities and Trustee Investment (Scotland) Act 2005 (powers of the Court of Session),

from being concerned with the management or control of any body;

• (j) X has been subject to—

• (i) a disqualification order or disqualification undertaking under the Company Directors Disqualification Act 1986 or the Company Directors Disqualification (Northern Ireland) Order 2002 , or

• (ii) an order made under section 429(2) of the Insolvency Act 1986 (disabilities on revocation of a county court administration order);

• (k) X (in the case of an individual) has refused to comply with a request by NHS England for X to be medically examined on the grounds that it is concerned that X is incapable of adequately providing services under the scheme; or

• (l) it comes to the attention of NHS England that information provided to it pursuant to—

• (i) regulation 12 or 17 of the 2006 Regulations,

• (ii) a term of the scheme required by paragraph 16 of Schedule 2 to the 2006 Regulations,

• (iii) regulation 106, or

• (iv) paragraph 15,

was, when given, untrue or inaccurate in a material respect.

• (3) NHS England is not to terminate the LPS scheme (or end an LPS contractor's participation in it) pursuant to sub-paragraph (2)(b) where it is satisfied that the disqualification or suspension imposed by a licensing body outside the United Kingdom does not make X unsuitable to be—

• (a) an LPS contractor; or

• (b) in the case of an LPS scheme (or agreement) with a body corporate, a director, chief executive, superintendent or company secretary of a contractor.

• (4) NHS England is not to terminate the scheme pursuant to sub-paragraph (2)(e) where it is satisfied that the conviction does not make X unsuitable to be—

• (a) an LPS contractor; or

• (b) in the case of an LPS scheme (or agreement) with a body corporate, a director, chief executive, superintendent or company secretary of an LPS contractor.

Termination by the NHSCB: patient safety and material financial loss

30

NHS England may serve notice in writing on the LPS contractor (C) terminating the LPS scheme (or ending the LPS contractor's participation in it, in the case of more than one LPS contractor being party to the scheme) with immediate effect or with effect from such date as may be specified in the notice if—

• (a) C has breached the scheme and as a result of that breach, the safety of C's patients is at serious risk if the scheme is not terminated (or C's participation in it is not ended, in the case of more than one LPS contractor being party to the scheme); or

• (b) C's financial situation is such that NHS England considers that NHS England is at risk of material financial loss.

Termination and the NHS dispute resolution procedure

31

• (1) Where NHS England is entitled to serve written notice on the LPS contractor (C) terminating the LPS scheme (or ending C's participation in it) pursuant to paragraph 29 or 30, it must, in the notice served on C pursuant to those provisions, specify a date on which the scheme terminates (or C's participation in it is to end) that is not less than 28 days after the date on which NHS England has served that notice on C, unless sub-paragraph (2) applies.

• (2) This sub-paragraph applies if NHS England is satisfied that a period less than 28 days, or termination with immediate effect, is necessary in order to—

• (a) protect the safety of the C's patients; or

• (b) protect itself from material financial loss.

• (3) In a case falling within sub-paragraph (1), where—

• (a) the exceptions in sub-paragraph (2) do not apply;

• (b) C invokes the NHS dispute resolution procedure before the end of the period of notice referred to in sub-paragraph (1); and

• (c) C notifies NHS England in writing that it has done so,

subject to paragraph (5), the LPS scheme (or C's participation in it) is not to terminate at the end of the notice period but instead is only to terminate in the circumstances specified in sub-paragraph (4).

• (4) Subject to paragraph (5), the LPS scheme (or C's participation in it) is only to terminate if and when—

• (a) there has been a determination of the dispute pursuant to paragraph 23 and that determination permits NHS England to terminate the scheme; or

• (b) C ceases to pursue the NHS dispute resolution procedure,

whichever is the sooner.

• (5) If NHS England is satisfied that it is necessary to terminate the scheme before the NHS dispute resolution procedure is concluded in order to—

• (a) protect the safety of the C's patients; or

• (b) protect itself from material financial loss,

sub-paragraphs (3) and (4) shall not apply and NHS England is entitled to confirm, by written notice to be served on C, that the LPS scheme (or C's participation in it) will nevertheless terminate at the end of the period of the notice it served pursuant to paragraph 29(1) or 30.

Third party rights

32

The LPS scheme shall not create any right enforceable by any person not a party to it.

SCHEDULE 8 — Service remuneration determined by NHS England

1

• (1) Any fees and allowances payable to NHS pharmacists for professional services provided as part of the provision of pharmaceutical services.

• (2) Without prejudice to the generality of sub-paragraph (1), those fees and allowances may include—

• (a) fees in connection with the dispensing of drugs and appliances, including any additional fees relating to the dispensing of particular types of drug or appliance;

• (b) payments made to NHS pharmacists in respect of their providing particular types of advice or assistance to patients or in respect of their participation in particular activities or schemes; and

• (c) payments made to NHS pharmacists that are a contribution to the overall cost of professional services provision (which may be calculated by reference to particular levels of activity).

• (3) For the purposes of sub-paragraph (1), “professional services” does not include providing pre-registration training experience for pharmacy graduates or undergraduates.

2

• (1) Any fees and allowances payable to NHS appliance contractors for professional services provided as part of the provision of pharmaceutical services.

• (2) Without prejudice to the generality of sub-paragraph (1), those fees and allowances may include—

• (a) fees in connection with the dispensing of appliances, including any additional fees relating to the dispensing of particular types of appliance;

• (b) payments made to NHS appliance contractors in respect of their providing particular types of advice or assistance to patients or in respect of their participation in particular activities or schemes; and

• (c) payments made to NHS appliance contractors that are a contribution to the overall cost of professional services provision (which may be calculated by reference to particular levels of activity).

SCHEDULE 9 — Transitional provisions

The continuity principles

1

• (1) Where by virtue of this Schedule—

• (a) a matter is to be dealt with in accordance with the 2006 Regulations or the 2012 Regulations; or

• (b) a matter (by virtue of having been dealt with in accordance with Schedule 7 to the 2012 Regulations (transitional provisions)), is to be dealt with in accordance with the 2005 Regulations or the SCAT Regulations,

if that matter under those Regulations would fall to be dealt with by a Primary Care Trust, unless the context requires otherwise, that matter is to be dealt with instead by NHS England.

• (2) Any matter that is ongoing under the 2006 Regulations or the 2012 Regulations (including, by virtue of Schedule 7 of those Regulations, under the 2005 Regulations or the SCAT Regulations) immediately before the appointed day, unless the context requires otherwise—

• (a) is to be treated as ongoing under these Regulations on the appointed day (and where appropriate after that); and

• (b) where that matter becomes the responsibility of NHS England on the appointed day, anything done in relation to that matter by or with regard to a Primary Care Trust before the appointed day is to be treated as having been done (for the purposes of the ongoing treatment of the matter) by or with regard to NHS England.

• (3) Where a period of time specified in a provision of the 2006 Regulations or the 2012 Regulations is current on the appointed day, and a period of time is also specified in a corresponding provision of these Regulations, unless the context requires otherwise, these Regulations have effect as if the corresponding provision of these Regulations had been in force when that period began to run.

• (4) Where—

• (a) consideration of a matter under a provision of these Regulations in respect of a specified period of time requires consideration of a period of time before the appointed day; and

• (b) a corresponding provision of the 2006 Regulations or the 2012 Regulations also required consideration of that matter in respect of a specified period of time,

unless the context requires otherwise, the provision of these Regulations has effect as if it had been in force when the period of time specified in it began to run.

• (5) Subject to sub-paragraphs (6) and (7), where on or after the appointed day—

• (a) a matter is to be dealt with in accordance with the SCAT Regulations, the 2005 Regulations, the 2006 Regulations or the 2012 Regulations; or

• (b) a matter that relates to circumstances that arose, or first arose, before the appointed day is to be dealt with in accordance with these Regulations or the Drug Tariff,

in dealing with that matter NHS England (or where appropriate, on appeal, the Secretary of State or the First-tier Tribunal) is to apply those Regulations, the Drug Tariff and related provisions of the 2006 Act subject to such modifications as it (or where appropriate, on appeal, the Secretary of State or the First-tier Tribunal) considers necessary or expedient.

• (6) Modifications pursuant to paragraph (5) must—

• (a) be for a purpose related to—

• (i) dealing with the matter justly, or

• (ii) effecting an orderly transition from the scheme established by the Regulations mentioned in sub-paragraph (5)(a), read with the 2006 Act as in force before the appointed day, to the scheme established by these Regulations, read with the 2006 Act,

or for purposes related to both; and

• (b) take account, as appropriate, of the manner in which—

• (i) provisions in the 2005 Regulations were carried forward into the 2012 Regulations,

• (ii) provisions in the 2006 Regulations and the 2012 Regulations were carried forward into these Regulations, and

• (iii) the 2006 Act was amended by the Health and Social Care Act 2012 .

• (7) Modifications pursuant to paragraph (5) may—

• (a) be for the purpose of seeking to ensure that a matter is dealt with expeditiously;

• (b) be for the purpose of seeking to ensure that a matter is dealt with proportionately, having regard to (as relevant)—

• (i) the importance of protecting the safety of persons to whom pharmaceutical and local pharmaceutical services are provided,

• (ii) the need for fairness,

• (iii) the complexity of the issues,

• (iv) the importance of protecting NHS England from material financial loss, and

• (v) the importance of saving expense; or

• (c) (without prejudice to the generality of the power to make modifications) have the effect of—

• (i) adding to, modifying or removing functions that would have been performed by a Primary Care Trust under the SCAT Regulations, the 2005 Regulations, the 2006 Regulations, the 2012 Regulations or the 2006 Act as in force before the appointed day, or

• (ii) adding to, modifying or removing functions that are to be performed by NHS England or a HWB under these Regulations or the 2006 Act.

• (8) In this Schedule, “the continuity principles” means the provisions of sub-paragraphs (1) to (7).

Listing applications under the 2005 Regulations: NHS chemists

2

• (1) An application made to a Primary Care Trust under regulation 5(1), 40(1) or 54(2) of the 2005 Regulations (which relate to applications for inclusion in a pharmaceutical list, preliminary consent applications and temporary provision during a period of suspension) which—

• (a) has not been determined before the appointed day; and

• (b) by virtue of Schedule 7 to the 2012 Regulations (transitional provisions), was to be determined in accordance with the 2005 Regulations and if relevant the 2006 Regulations,

is to be dealt with by NHS England in accordance with the 2005 Regulations.

• (2) Where an application made under the 2005 Regulations for preliminary consent has been finally granted under those Regulations—

• (a) an application under regulation 5(1) of the 2005 Regulations that is in accordance with regulation 41(1) of those Regulations (effect of preliminary consent) may be made in relation to that consent (within the 6 months period referred to in regulation 40(4) of the 2005 Regulations); and

• (b) any such application is to be dealt with by NHS England in accordance with the 2005 Regulations.

• (3) Where on or after the appointed day, by virtue of this paragraph, an application is to be determined by NHS England having regard to regulation 13(1)(a) of the 2005 Regulations (exemptions from the necessary or expedient test), for the purposes of that application an area is an approved retail area if on 31st August 2012 it was a retail area that was for the time being approved by the Secretary of State under regulation 15 of those Regulations (approved retail areas).

• (4) Where an application under regulation 5(1), 40(1) or 54(2) of the 2005 Regulations has been determined in accordance with the 2005 Regulations, whether before the appointed day or by virtue of this paragraph—

• (a) the arrangements for bringing an appeal in relation to that application; and

• (b) the determination of any appeal validly brought,

are to be in accordance with the 2005 Regulations.

Listing applications under the 2012 Regulations: NHS chemists

3

• (1) Where a routine application has been made to a Primary Care Trust before the appointed day under the 2012 Regulations, subject to paragraph (2)—

• (a) if that application has not been notified under Part 3 of Schedule 2 to the 2012 Regulations (applications in respect of pharmaceutical lists and the procedures to be followed – notification of certain applications) before the appointed day, it is to be dealt with by NHS England in accordance with these Regulations; and

• (b) if that application has been notified under Part 3 of Schedule 2 to the 2012 Regulations before the appointed day, it is to be dealt by NHS England in accordance with the 2012 Regulations and the 2006 Act as in force immediately before the appointed day.

• (2) Where—

• (a) a routine application has been made to a Primary Care Trust before the appointed day under the 2012 Regulations; and

• (b) determination of that application requires determination of whether granting it, or granting it in respect of some only of the services specified in it, would meet a current or future need for pharmaceutical services, or pharmaceutical services of a specified type, which have been included in a pharmaceutical needs assessment,

it is to be dealt with by NHS England in accordance with the 2012 Regulations and the 2006 Act as in force immediately before the appointed day, whether or not it has been notified under Part 3 of Schedule 2 to the 2012 Regulations before the appointed day.

• (3) Where an excepted application has been made to a Primary Care Trust before the appointed day under the 2012 Regulations—

• (a) if that application—

• (i) is not a notifiable application, and

• (ii) has not been determined by the Primary Care Trust before the appointed day,

it is to be dealt with by NHS England in accordance with these Regulations;

• (b) if that application—

• (i) is a notifiable application, and

• (ii) has not been notified under Part 3 of Schedule 2 to the 2012 Regulations before the appointed day,

it is to be dealt with in accordance with these Regulations; and

• (c) if that application—

• (i) is a notifiable application, and

• (ii) has been notified under Part 3 of Schedule 2 to the 2012 Regulations before the appointed day,

it is to be dealt with in accordance with the 2012 Regulations and the 2006 Act as in force immediately before the appointed day.

• (4) Where an application under the 2012 Regulations is determined in accordance with the 2012 Regulations, whether before the appointed day or by virtue of this paragraph—

• (a) the arrangements for bringing an appeal in relation to that application; and

• (b) the determination of any appeal validly brought,

are to be in accordance with the 2012 Regulations.

• (5) In applying the continuity principles in relation to decisions which are to be made under the 2012 Regulations by virtue of this paragraph, NHS England must ensure that LPS chemists that would, by virtue of paragraph 32(5)(b)(ii) of Schedule 2 to these Regulations, have rights of appeal against particular types of decision under these Regulations, have the same rights of appeal against equivalent decisions under the 2012 Regulations, notwithstanding that those rights of appeal were not provided for in the 2012 Regulations.

Listing applications under the 2005 Regulations: dispensing doctors

4

• (1) An application made to a Primary Care Trust under Part 5 of the 2005 Regulations (provision of pharmaceutical services by doctors) for outline consent or premises approval (including temporary premises approval) which—

• (a) has not been determined before the appointed day; and

• (b) by virtue of Schedule 7 to the 2012 Regulations (transitional provisions) was to be determined in accordance with the 2005 Regulations,

is to be dealt with by NHS England in accordance with the 2005 Regulations.

• (2) Where an application under Part 5 of the 2005 Regulations has been determined in accordance with those Regulations, whether before the appointed day or by virtue of sub-paragraph (1)—

• (a) the arrangements for bringing an appeal in relation to that application; and

• (b) the determination of any appeal validly brought,

are to be in accordance with the 2005 Regulations.

• (3) If, before the appointed day—

• (a) a Primary Care Trust has required a doctor to provide pharmaceutical services under regulation 60(4)(a) of the 2005 Regulations (arrangements for provision of pharmaceutical services by doctors); and

• (b) the doctor has appealed against that decision,

the arrangements for bringing that appeal, and the determination of any appeal validly brought, are to be in accordance with the 2005 Regulations.

Listing applications under the 2012 Regulations: dispensing doctors

5

• (1) Where an application has been made to a Primary Care Trust before the appointed day under Part 8 of the 2012 Regulations (dispensing doctors) for outline consent or premises approval, other than an application for temporary premises approval to which regulation 58 or 61 of those Regulations (which relate to temporary provision in cases where premises approval has not taken effect or during an emergency requiring the flexible provision of pharmaceutical services) applies—

• (a) if that application has not been notified under regulation 52 of the 2012 Regulations (notification of applications for outline consent and premises approval), it is to be dealt with by NHS England in accordance with these Regulations; and

• (b) if that application has been notified under regulation 52 of the 2012 Regulations, it is to be dealt with by NHS England in accordance with the 2012 Regulations.

• (2) Where—

• (a) an application has been made to a Primary Care Trust before the appointed day under regulation 58 or 61 of the 2012 Regulations for temporary premises approval; and

• (b) that application has not been determined before the appointed day,

it is to be dealt with by NHS England in accordance with these Regulations.

• (3) Where an application under that Part 8 of the 2012 Regulations has been determined in accordance with the 2012 Regulations, whether before the appointed day or by virtue of this paragraph—

• (a) the arrangements for bringing an appeal in relation to that application; and

• (b) the determination of any appeal validly brought,

are to be in accordance with the 2012 Regulations.

• (4) If, before the appointed day, a Primary Care Trust has required a doctor to provide pharmaceutical services under regulation 48(5)(b) of the 2012 Regulations (arrangements for provision of pharmaceutical services by doctors: applications by patients), and—

• (a) the doctor has appealed against that decision before the appointed day; or

• (b) the time limit for bringing an appeal against the decision in regulation 63(1) of the 2012 Regulations (appeals against decisions under Part 8) has not elapsed before the appointed day,

the arrangements for bringing an appeal in relation to that decision, and the determination of any appeal validly brought, are to be in accordance with the 2012 Regulations.

Outstanding cases relating to dispensing contractor lists

6

• (1) If, before the appointed day the Primary Care Trust was engaged in a process which could have led to the inclusion or removal of a contractor or premises from a dispensing contractor list, that process and the action to be taken following its outcome (including relating to any appeal) are to be dealt with by NHS England in accordance with paragraph 10 of Schedule 7 to the 2012 Regulations (transitional provisions – dispensing contractor lists).

• (2) Where—

• (a) NHS England grants an application for premises approval by virtue of this paragraph; and

• (b) NHS England is as a consequence required to consider any postponement of the making of arrangements to provide dispensing services, arising out of that grant,

that consideration, NHS England’s decision on any postponement, the arrangements for bringing an appeal against its decision, and the determination of any appeal validly brought, are to be in accordance with paragraph 10 of Schedule 7 to the 2012 Regulations.

• (3) Conditions relating to postponement of the making of arrangements to provide dispensing services which are imposed by virtue of this paragraph, or which continued to have effect by virtue of paragraph 10 of Schedule 7 to the 2012 Regulations, continue to have effect as if imposed under these Regulations in relation to the provision of pharmaceutical services.

Controlled localities

7

• (1) NHS England must—

• (a) in respect of an area which on the appointed day continues to be, or to be part of, a controlled locality by virtue of regulation 36(1), delineate precisely the boundary of the controlled locality on a map (which may be part of a series of maps which relate to HWB areas);

• (b) publish that map; and

• (c) make that map available as soon as is practicable to any HWB that has all or part of that controlled locality in its area.

• (2) Where—

• (a) before the appointed day, a Primary Care Trust was considering whether or not an area is either a controlled locality or part of a controlled locality; or

• (b) NHS England is required, by virtue of paragraphs 2 to 5, to determine an application and in connection with determining that application, it also needs to determine whether or not an area is or is not a controlled locality, or part of a controlled locality,

paragraph (3) applies.

• (3) Where—

• (a) consideration by a Primary Care Trust mentioned in sub-paragraph (2)(a) was, or (by virtue of paragraph 2 or 4) an application referred to in sub-paragraph (2)(b) is, to be dealt with under the 2005 Regulations—

• (i) the consideration of whether or not a locality is either a controlled locality or part of a controlled locality is to be dealt with by NHS England in accordance with the 2005 Regulations, and

• (ii) the arrangements for bringing an appeal in relation to the decision of NHS England, and the determination of any appeal validly brought, are to be in accordance with the 2005 Regulations;

• (b) consideration by a Primary Care Trust mentioned in sub-paragraph (2)(a) was under the 2012 Regulations (unless it was in connection with an application which by virtue of paragraph 3 or 5 is to be determined in accordance with these Regulations)—

• (i) the consideration of whether or not a locality is either a controlled locality or part of a controlled locality is to be dealt with by NHS England in accordance with the 2012 Regulations, and

• (ii) the arrangements for bringing an appeal in relation to the decision of NHS England, and the determination of any appeal validly brought, are to be in accordance with the 2012 Regulations,

but if that consideration was in connection with an application which by virtue of paragraph 3 or 5 is to be determined in accordance with these Regulations, the consideration of whether or not a locality is either a controlled locality or part of a controlled locality is also to be dealt with by NHS England in accordance with these Regulations;

• (c) an application referred to in sub-paragraph (2)(b) is to be dealt with under the 2012 Regulations (by virtue of paragraphs 3 or 5)—

• (i) the related consideration of whether or not a locality is either a controlled locality or part of a controlled locality is to be dealt with by NHS England in accordance with the 2012 Regulations, and

• (ii) the arrangements for bringing an appeal in relation to the decision of NHS England, and the determination of any appeal validly brought, are to be in accordance with the 2012 Regulations;

• (d) an application referred to in sub-paragraph (2)(b) is to be dealt with under these Regulations, the related consideration of whether or not a locality is either a controlled locality or part of a controlled locality is to be dealt with by NHS England in accordance with these Regulations.

• (4) Where, by virtue of sub-paragraph (3), it is determined (whether by NHS England or on appeal by the Secretary of State) that an area is or is not, or is or is not part of, a controlled locality, NHS England must—

• (a) delineate precisely the boundary of any resulting controlled locality on a map;

• (b) publish that map; and

• (c) make that map available as soon as is practicable to any HWB that has all or part of any resulting controlled locality in its area,

and any area that becomes, or becomes part of, a controlled locality as a consequence of that determination is then a controlled locality, or part of a controlled locality, for the purposes of these Regulations (unless or until it is determined under these Regulations that it is no longer, or no longer part of, a controlled locality).

Reserved locations

8

• (1) Where—

• (a) an application has been received which is to be determined under the 2005 Regulations—

• (i) in accordance with paragraph 2, and

• (ii) having regard to regulation 12 or 13 of the 2005 Regulations (which relate to the necessary or expedient test and exemptions from it); and

• (b) the premises or relevant location at or from which the applicant wishes to provide pharmaceutical services is or may be a reserved location,

pending the final determination of that application, the classification of any area in relation to those premises or that relevant location as, or as not, a reserved location is to be determined in accordance with the 2005 Regulations (if a further reserved location determination is required after the application is finally determined, it is to be in accordance with these Regulations).

• (2) Where a determination of whether or not an area is a reserved location is made under the 2005 Regulations by virtue of—

• (a) sub-paragraph (1); or

• (b) before the appointed day, paragraph 6 of Schedule 7 to the 2012 Regulations (transitional provisions – reserved locations),

the arrangements for bringing an appeal against the decision, and the determination of any appeal validly brought, are to be in accordance with the 2005 Regulations.

• (3) Where—

• (a) a routine application was received by a Primary Care Trust which NHS England is required to determine under the 2012 Regulations in accordance with paragraph 3; and

• (b) the premises or relevant location at or from which the applicant wishes to provide pharmaceutical services is or may be a reserved location,

pending the final determination of that application, the classification of any area in relation to those premises or that relevant location as, or as not, a reserved location is to be determined in accordance with the 2012 Regulations (if a further reserved location determination is required after the application is finally determined, it is to be in accordance with these Regulations).

• (4) Where before the appointed day—

• (a) a Primary Care Trust received a request for a determination under regulation 42 of the 2012 Regulations (second and subsequent determinations of reserved location status), but there is no related routine application which is (still) to be finally determined under the 2012 Regulations in accordance with paragraph 2; and

• (b) the request was notified under regulation 42(2)(a) of the 2012 Regulations,

the classification of any area as, or as not, a reserved location pursuant to that request is to be determined in accordance with the 2012 Regulations (if a further reserved location determination is required after that determination, it is to be in accordance with these Regulations).

• (5) Where a determination of whether or not an area is a reserved location is made under the 2012 Regulations by virtue of sub-paragraph (3) or (4), the arrangements for bringing an appeal against the decision, and the determination of any appeal validly brought, are to be in accordance with the 2012 Regulations.

• (6) Where before the appointed day, a request is made to a Primary Care Trust for a reserved location determination, but the determination is not to be made under the 2005 Regulations or the 2012 Regulations by virtue of sub-paragraphs (1) to (5), it is to be made by NHS England (or on appeal the Secretary of State) under these Regulations.

• (7) Where, by virtue of sub-paragraphs (1) to (5), it is determined (whether by NHS England or on appeal by the Secretary of State) that an area is a reserved location, if following the determination a reserved location thereafter takes effect (because the pharmacy premises to which it relates are included in a pharmaceutical list), NHS England must—

• (a) delineate precisely the boundary of the reserved location on a map;

• (b) publish that map; and

• (c) make that map available as soon as is practicable to any HWB that has all or part of that reserved location in its area.

Gradual discontinuation of the provision of pharmaceutical services by doctors

9

• (1) Where, when granting an application which by virtue of paragraph 2 is finally determined in accordance with the 2005 Regulations, NHS England is required to consider under regulation 20(2) of the 2005 Regulations (imposition of conditions)—

• (a) any termination of arrangements with any person on its dispensing doctor list; and

• (b) any postponement of any such termination,

arising out of that grant (but not for a reason set out in regulation 50(1)(a) to (c), (e) or (f) of these Regulations), that consideration and its decision are to be in accordance with the 2005 Regulations.

• (2) Where before the appointed day a Primary Care Trust was considering under the 2005 Regulations, in any case in which it could postpone the termination of arrangements with a dispensing doctor—

• (a) the termination of arrangements with a dispensing doctor; or

• (b) the postponement of the termination of arrangements with a dispensing doctor,

that matter is to be dealt with by NHS England, in accordance with the 2005 Regulations.

• (3) Where, under the 2005 Regulations—

• (a) a decision relating to termination of arrangements, or the postponement of the termination of arrangements, with a dispensing doctor is made by virtue of sub-paragraph (1) or (2); or

• (b) before the appointed day, a decision relating to termination of arrangements, or the postponement of the termination of arrangements, with a dispensing doctor was made by a Primary Care Trust under the 2005 Regulations, and—

• (i) that decision has been appealed before the appointed day, or

• (ii) the time limit for bringing an appeal against that decision has not elapsed before the appointed day,

the arrangements for bringing an appeal in relation to that decision, and the determination of any appeal validly brought, are to be in accordance with the 2005 Regulations.

• (4) Where, when granting an application which by virtue of paragraph 3 is finally determined in accordance with the 2012 Regulations, NHS England is required to consider under regulation 50(1) or (3) of the 2012 Regulations (discontinuation of arrangements for the provision of pharmaceutical services by doctors)—

• (a) any termination of arrangements with any person on its dispensing doctor list; and

• (b) any postponement of any such termination,

arising out of that grant, that consideration and its decision are to be in accordance with the 2012 Regulations.

• (5) Where before the appointed day a Primary Care Trust was considering under regulation 50(1) to (6) of the 2012 Regulations, in any case in which it could postpone the termination of arrangements with a dispensing doctor—

• (a) the termination of arrangements with a dispensing doctor; or

• (b) the postponement of the termination of arrangements with a dispensing doctor,

that matter is to be dealt with by NHS England, in accordance with the 2012 Regulations.

• (6) Where, under the 2012 Regulations—

• (a) a decision relating to termination of arrangements, or the postponement of the termination of arrangements, with a dispensing doctor is made by virtue of sub-paragraph (4) or (5); or

• (b) before the appointed day, a decision relating to termination of arrangements, or the postponement of the termination of arrangements, with a dispensing doctor was made by a Primary Care Trust pursuant to the 2012 Regulations, and—

• (i) that decision has been appealed before the appointed day, or

• (ii) the time limit for bringing an appeal against that decision has not elapsed before the appointed day,

the arrangements for bringing an appeal in relation to that decision, and the determination of any appeal validly brought, are to be in accordance with the 2012 Regulations.

• (7) Regulation 50(1)(f) applies to a determination under the 2005 Regulations or the 2012 Regulations (either before the appointed day or by virtue of paragraph 8) that a location ceases to be or be part of a reserved location as it does to a determination referred to in regulation 42 as D2.

• (8) Conditions imposed by virtue of—

• (a) regulation 20(2) or 35(6)(b) (pharmaceutical services in reserved locations) of the 2005 Regulations; or

• (b) regulation 50(2), (5) or (6) of the 2012 Regulations,

relating to the postponement of termination of arrangements with a dispensing doctor, whether or not imposed by virtue of this paragraph, continue to have effect as if imposed under these Regulations.

Gradual introduction of the provision of pharmaceutical services by doctors

10

• (1) Where, when granting an application which by virtue of paragraph 4 is finally determined in accordance with the 2005 Regulations, NHS England is required to consider under regulation 20(2) of the 2005 Regulations (imposition of conditions) any postponement of the making of arrangements with a dispensing doctor arising out of that grant, that consideration and its decision are to be in accordance with the 2005 Regulations.

• (2) Where before the appointed day a Primary Care Trust is considering under regulation 20(2) of the 2005 Regulations the postponement of the making of arrangements with a dispensing doctor, that matter is to be dealt with by NHS England, in accordance with the 2005 Regulations.

• (3) Where, under the 2005 Regulations—

• (a) a decision relating to postponement of the making of arrangements with a dispensing doctor is made by virtue of sub-paragraph (1) or (2); or

• (b) before the appointed day, a decision relating to postponement of the making of arrangements with a dispensing doctor was made by a Primary Care Trust under the 2005 Regulations, and—

• (i) that decision has been appealed before the appointed day, or

• (ii) the time limit for bringing an appeal against that decision has not elapsed before the appointed day,

the arrangements for bringing an appeal in relation to that decision, and the determination of any appeal validly brought, are to be in accordance with the 2005 Regulations.

• (4) Where, when granting an application which by virtue of paragraph 5 is finally determined in accordance with the 2012 Regulations, NHS England is required to consider under regulation 57(1) of the 2012 Regulations (gradual introduction of premises approval)—

• (a) any postponement of the making of arrangements with a dispensing doctor arising out of that grant; or

• (b) any limitation on the patients to whom a dispensing doctor is able to provide pharmaceutical services,

that consideration and its decision are to be in accordance with the 2012 Regulations.