Pharmaceutical Services Regulations (Northern Ireland) 1997

SCHEDULE 1 PROVISIONS CONFERRING POWERS EXERCISED IN MAKING THESE REGULATIONS

Column 1	Column 2
Provision	Relevant Amendments
The Health and Personal Social Services (Northern Ireland) Order 1972(1)
Article 55(3)	None
Article 63(1), (2) and (2A) to (2D)	The Health and Personal Social Services (Northern Ireland) Order 1978(2), Article 14;
	The Health and Personal Social Services (Amendment) (Northern Ireland) Order 1986(3), Article 5(1);
	The Pharmaceutical Qualifications (EEC Recognition) Regulations (Northern Ireland) 1987(4), regulation 4;
	The Health and Personal Social Services (Northern Ireland) Order 1991, Article 31(1); and
	The Pharmaceutical Services (Northern Ireland) Order 1992(5)
Article 64(1) and (2)	The Health and Personal Social Services (Amendment) (Northern Ireland) Order 1986, Article 5(2); and
	The Health and Personal Social Services (Northern Ireland) Order 1991, Article 31 (2).
Article 95	None
Article 106(b)	None
Article 107(6)	None
Schedule 1, paragraph 8	The Health and Personal Social Services and Public Health (Northern Ireland) Order 1986(6), Article 19 and Schedule
Schedule 3, paragraph 7	None
The Health and Medicines (Northern Ireland) Order 1988(7)
Article 10	None
The Medicines Act 1968(8)
Section 103(3)	The Health and Medicines Act 1988(9), Section 22(4)

Regulations 2(1) and 3(2)

SCHEDULE 2

PART I GENERAL

Incorporation of provisions

1.  Any provisions of the following affecting the rights and obligations of chemists or doctors who provide pharmaceutical services shall be deemed to form part of the terms of service for chemists or, as the case may be, of the terms of service for doctors who provide pharmaceutical services—

(a) these Regulations;

(b) the Drug Tariff in so far as it lists drugs and appliances for the purposes of Article 63 of the Order; and

(c) so much of the Disciplinary Procedures Regulations as relates to—

(i) the investigation of questions arising between chemists and persons receiving pharmaceutical services and other investigations to be made by a pharmaceutical discipline committee or a joint discipline committee and the action which may be taken by a Board as a result of such investigations; and

(ii) appeals to the Department from decisions of a Board.

PART II TERMS OF SERVICE FOR CHEMISTS

Provision of pharmaceutical services

2.—(1) Where any person presents on a prescription form—

(a) an order for drugs, not being Scheduled drugs, or appliances, signed by a doctor; or

(b) an order for drug specified in Schedule 11 to the Medical Regulations, signed by, and endorsed on its face with the reference "S. 11 ", by a doctor in accordance with paragraph 49(2) of Schedule 2 to those Regulations;

(c) an order for listed drugs or medicines, signed by a dentist or his deputy or assistant; or

(d) an order for listed drugs or medicines, or listed appliances, signed by a nurse prescriber,

a chemist shall, with reasonable promptness, supply the drugs or medicines so ordered, and such of the appliances so ordered as he supplies in the normal course of his business.

(2) If the person presenting the prescription form asks the chemist to do so—

(a) he shall give an estimate of the time when the drugs, medicines or appliances will be ready; and

(b) if they are not ready by then, he shall give a revised estimate of the time when they will be ready and so on.

(3) A chemist shall not accept for dispensing any prescription form received at premises other than a pharmacy.

(4) A chemist shall not supply any drugs or appliances ordered on a prescription form other than at a pharmacy.

(5) Any drug which is provided as part of pharmaceutical services and 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, shall comply with the standard or formula specified therein.

(6) Subject to sub-paragraphs (7) to (19) a chemist shall provide pharmaceutical services only in response to and in accordance with an order on a prescription form, signed as specified in sub-paragraph (1).

(7) Where an order, not being an order to which the Poisons Regulations (Northern Ireland) 1983(10) or the Misuse of Drugs Regulations (Northern Ireland) 1986(11) apply, which is issued by a doctor, a dentist or a nurse prescriber on a prescription form for drugs does not prescribe their quantity, strength or dosage, a chemist may supply the drugs in such strength and dosage as in the exercise of his professional skill, knowledge and care he considers to be appropriate and, subject to sub-paragraph (8), in such quantity as he considers to be appropriate for a course of treatment, for the patient to whom the order relates, for a period not exceeding 5 days.

(8) Where an order to which sub-paragraph (7) applies is for—

(a) an oral contraceptive substance;

(b) a drug, which is available for supply as part of pharmaceutical services only together with one or more 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 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 5 days, the chemist may supply that minimum available package.

(9) Where any drug, not being one to which the Misuse of Drugs Regulations (Northern Ireland) 1986 apply, ordered by a doctor, dentist or nurse prescriber on a prescription form, is available for supply by a chemist 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 chemist shall, subject to sub-paragraph (8), supply the drug in the pack whose quantity is nearest to the quantity which has been so ordered.

(10) A chemist shall not supply, pursuant to sub-paragraph (9), a drug in a calendar pack where, in his opinion, it was the intention of the doctor, dentist or nurse prescriber who ordered the drug that it should be provided only in the exact quantity ordered.

(11) 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.

(12) Where, in a case of urgency, a doctor or nurse prescriber personally known to a chemist requests him to supply a drug, the chemist may supply that drug before receiving a prescription form, provided that—

(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(12), other than a drug which is specified in Schedule 1 to the Misuse of Drugs Regulations (Northern Ireland) 1986; and

(c) the doctor or nurse prescriber undertakes to give the chemist such a prescription form within 72 hours.

(13) Except as provided in sub-paragraph (14), a chemist shall not supply a Scheduled drug, by way of pharmaceutical services or otherwise, in response to an order by name, formula or other description on a prescription form.

(14) Where a drug has an appropriate non-proprietary name and it is ordered on a prescription form either by that name or by its formula, a chemist may supply a drug which has the same specification notwithstanding that it is a Scheduled drug, provided that where a Scheduled drug is a pack which consists of a drug in more than one strength, such supply does not involve the supply of part only of the pack.

(15) Where a drug which is ordered as specified in sub-paragraph (14) 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.

(16) A chemist shall supply any drug which he is required to supply under this paragraph in a suitable container.

(17) Subject to sub-paragraph (18), a chemist may, at the request of a doctor licensed under the provision of the Misuse of Drugs (Notification of and Supply to Addicts) Regulations (Northern Ireland) 1973(13), arrange to supply, in accordance with a special prescription form provided for the purpose by the Agency and signed by the licensed doctor, such drugs or appliances as may be so ordered. If the prescription form includes directions that part of the total supply of drugs ordered thereon shall be supplied on a stated day or days the chemist shall comply with such directions.

(18) A chemist shall not be in breach of his terms of service if—

(a) he refuses to enter into an arrangement to supply drugs or appliances under sub-paragraph (17); or

(b) having entered into such an arrangement he gives the licensed doctor seven days notice in writing of his intention to terminate it.

(19) A chemist 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 his presenting an order for drugs or appliances on a prescription form.

Professional standards

3.—(1) A pharmacist whose name is on the pharmaceutical list shall provide 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.

(2) A chemist who employs a pharmacist in connection with the provision of pharmaceutical services shall secure that the pharmacist complies with the requirements set out in sub-paragraph (1).

Premises and hours

4.—(1) Pharmaceutical services shall be provided at each of the premises from which the chemist has undertaken to provide pharmaceutical services at such times as, following an application in writing by the chemist to the Board, shall have been approved in his case by it or, on appeal, the Department, in accordance with the following provisions of this paragraph.

(2) The Board shall not approve any application made by a chemist in relation to the times at which he is to provide pharmaceutical services unless it is satisfied that—

(a) the times proposed are such that a pharmacist will normally be available—

(i) subject to sub-paragraph (4), for no less than 30 hours in any week; and

(ii) on 5 days in any such week; and

(b) the hours when a pharmacist will normally be available in any week are to be allocated between the days on which he will normally be available in that week in such a manner as is likely to meet the needs of persons in the neighbourhood for pharmaceutical services on any working day between the hours of 9.30 a.m. and 5.30 p.m. (1.00 p.m. on an early closing day).

(3) In this paragraph—

(a) “available” means, in relation to a pharmacist, available to provide pharmaceutical services of the kind he has undertaken to provide;

(b) “an early closing day” means any week day when most shops in the neighbourhood are habitually closed after the hour of 1.00 p.m.

(4) The Board may approve an application to provide pharmaceutical services for less than 30 hours in any week provided that it is satisfied that the provision of pharmaceutical services in the neighbourhood is likely to be adequate to meet the need for such services on any working day between the hours of 9.30 a.m. and 5.30 p.m. (or 1.00 p.m. on an early closing day) at times when the pharmacist is not available.

(5) Subject to sub-paragraph (6), in determining any application, the Board shall either—

(a) grant approval;

(b) grant approval subject to any requirements that it considers appropriate for the purpose of ensuring that a chemist is available for the provision of pharmaceutical services at such times as are necessary to meet the need for such services on any working day between the hours of 9.30 a.m. and 5.30 p.m. (or 1.00 p.m. on an early closing day); or

(c) refuse approval.

(6) Where the Board is considering whether to grant approval subject to any requirements, as mentioned in sub-paragraph (5)(b), it shall consult the Local Pharmaceutical Committee before determining the application.

(7) A Board shall notify the chemist in writing of its determination, and, where it refuses an application or grants an application subject to any requirements under sub-paragraph (5)(b), it shall send to the chemist a statement in writing of the reasons for its determination or, as the case may be, for the imposition of the requirements and of the chemist's right of appeal under sub-paragraph (8).

(8) A chemist may, within 30 days of receiving a notification pursuant to sub-paragraph (7), appeal in writing to the Department against any refusal of approval or against any requirement imposed pursuant to sub-paragraph (5)(b).

(9) The Department may, when determining an appeal, either confirm the determination of the Board or substitute its own determination for that of the Board.

(10) The Department shall notify the chemist in writing of its determination and shall in every case include with the notification a written statement of the reasons for the determination.

(11) At each of the premises at which a chemist provides pharmaceutical services he shall exhibit—

(a) a notice specifying the times at which the premises are open for the provision of drugs and appliances; and

(b) at times when the premises are not open, a notice, where practicable legible from outside the premises, specifying the addresses of other chemists in the neighbourhood included in the pharmaceutical list and the times at which pharmaceutical services may be obtained from those addresses.

(12) Where a chemist is prevented by illness or other reasonable cause from complying with his obligations under this paragraph, he shall, where practicable, make arrangements with one or more chemists whose premises are situated in the neighbourhood for the provision of pharmaceutical services during that time.

(13) A chemist may apply to a Board for a variation of the times at which, in accordance with a determination under this paragraph (“the earlier determination”), a pharmacist is required to be normally available, and sub-paragraphs (1) to (10) shall apply to the making and determination (“the subsequent determination”) of an application under this sub-paragraph as if it were the first application by that chemist for the purposes of this paragraph.

(14) Where an application made under sub-paragraph (13) is approved, the earlier determination mentioned in that sub-paragraph shall cease to have effect and the subsequent determination mentioned in that sub-paragraph shall have effect instead—

(a) where the subsequent determination is made by a Board and no appeal is made, from the day falling 8 weeks after the date on which the chemist receives notification of that Board's determination; or

(b) where the subsequent determination is made on appeal, from the day falling 8 weeks after the date on which the chemist receives notification of the Department's determination.

(15) Where it appears to the Board, after consultation with or at the request of the Local Pharmaceutical Committee, that the times at which a pharmacist is available no longer meet the needs of persons in the neighbourhood for pharmaceutical services on any working day between the hours of 9.30 a.m. and 5.30 p.m. (or 1.00 p.m. on an early closing day), it may review the terms of—

(a) any approval granted by the Board under sub-paragraph (5)(a) or (b) or by the Department under sub-paragraph (9); or

(b) any direction given under sub-paragraph (l 7)(a) by the Board or, on appeal, by the Department.

(16) On any review under sub-paragraph (15) the Board shall—

(a) give notice to the chemist of its proposed changes in the times at which the pharmacist is to be available; and

(b) allow the chemist 30 days within which to make representations to the Board about its proposals.

(17) After considering any representations made in accordance with sub-paragraph (16)(b), the Board shall either—

(a) direct the chemist to revise the times at which the pharmacist is to be available in the manner specified in the direction; or

(b) confirm that the existing times at which the pharmacist is to be available continue to meet the need for pharmaceutical services on any working day between the hours of 9.30 a.m. and 5.30 p.m. (or 1.00 p.m. on an early closing day).

(18) The Board shall notify the chemist in writing of its determination under sub-paragraph (17), and where it gives a direction under head (a) of that sub-paragraph it shall include with the notification a statement in writing of the reasons for its determination and of the chemist's right of appeal under sub-paragraph (19).

(19) A chemist may, within 30 days of receiving notification under sub-paragraph (18), appeal in writing to the Department against a direction under sub-paragraph (17)(a).

(20) Sub-paragraphs (9) and (10) shall apply to any appeal made under sub-paragraph (19) but as though in sub-paragraph (10) any reference to a determination were a reference to a decision.

(21) A chemist in respect of whom a direction is given under sub-paragraph (17)(a) shall revise the times of availability of the pharmacist so as to give effect to the direction—

(a) where the direction is given by the Board and no appeal is made, not later than 8 weeks after the date on which he receives notification under sub-paragraph (18); or

(b) where the direction is given or confirmed on appeal, not later than 8 weeks after the date on which he receives notification of the Department's decision.

(22) Where it appears to the Board, after consultation with the Local Pharmaceutical Committee, that the times at which a pharmacist is available—

(a) on any working day before the hour of 9.30 a.m. or after the hour of 5.30 p.m. (or 1.00 p.m. on an early closing day); or

(b) on any Sunday or public holiday,

are not adequate to meet the needs of persons in the neighbourhood for pharmaceutical services at those times or on those days, the Board may (subject to sub-paragraphs (23) to (25)) direct the chemist to revise the times at which the pharmacist is to be available in the manner specified in the direction.

(23) The Board shall not give a direction under sub-paragraph (22) unless a fee, allowance or other remuneration to be paid to the chemist to whom the direction is to be given is included in the Drug Tariff or has been determined by the Board by virtue of regulation 9(2) (as the case may be).

(24) Before giving any direction under sub-paragraph (22) the Board shall—

(a) give notice to the chemist of the revised times at which it proposes the pharmacist to be available; and

(b) allow the chemist 30 days within which to make representations to the Board about its proposals,

and shall take any such representations into account.

(25) The Board shall notify the chemist in writing of a direction under sub-paragraph (22), and shall include with the notification a statement in writing of the reasons for its direction and of the chemist's right of appeal under sub-paragraph (26).

(26) A chemist may, within 30 days of receiving notification under sub-paragraph (25), appeal in writing to the Department against a direction under sub-paragraph (22).

(27) Sub-paragraphs (9) and (10) shall apply to any appeal made under sub-paragraph (26) but as though any reference to a determination—

(a) in sub-paragraph (9) were to a direction; and

(b) in sub-paragraph (10) were to a decision.

(28) A chemist in respect of whom a direction is given under sub-paragraph (22) shall revise the times at which the pharmacist is to be available so as to give effect to the direction—

(a) where the direction is given by the Board and no appeal is made, not later than 8 weeks after the date on which he receives notification under sub-paragraph (25); or

(b) where the direction is given or confirmed on appeal, not later than 8 weeks after the date on which he receives notification of the Department's decision.

Supply of drugs and fitting of appliances

5.—(1) Drugs shall be supplied either by or under the direct supervision of a pharmacist.

(2) Where the pharmacist referred to in sub-paragraph (1) is employed by a chemist, the pharmacist shall not be one—

(a) who, having been disqualified under paragraph 3(b) of Schedule 11 to the Order(14) (or any corresponding provision in force in England and Wales or Scotland) from inclusion in the pharmaceutical list (or, in England and Wales, the pharmaceutical list of a Health Authority or, in Scotland, the pharmaceutical list of a Health Board), is also the subject of a declaration under paragraph 3(c) of Schedule 11 to the Order (or any corresponding provision in force in England and Wales or Scotland) that he is not fit to be engaged in any capacity in the provision of pharmaceutical services; or

(b) who is suspended by direction of the Tribunal, other than in a case falling within paragraph 8B{3) of Schedule 11 to the Order.

(3) Subject to paragraph 2(1), a chemist shall make all necessary arrangements—

(a) for measuring a person who presents on a prescription an order for an appliance of a type requiring measurement and fitting by the chemist; and

(b) for fitting the appliance.

Particulars of pharmacists

6.  A chemist shall give to the Board, if it so requires, the name of any pharmacist employed by him for the supply of drugs for persons from whom he has accepted an order under paragraph 2.

Charges for drugs

7.—(1) Subject to regulations made under Article 98 of, and Schedule 15 to, the Order(15), all drugs, containers and appliances supplied under these terms of service shall be supplied free of charge.

(2) Where a chemist supplies a container in response to an order for drugs signed by a doctor under paragraph 48 of Schedule 2 to the Medical Regulations or by a nurse prescriber or supplies an oxygen container or oxygen equipment, other than equipment specified in the Drug Tariff as not returnable to the chemist, the container and equipment shall remain the property of the chemist.

Inspection of records and premises

8.  A chemist who has undertaken to provide additional professional services shall, on receipt of a request from the Board, make available to the Board all records kept in accordance with regulation 4(2)(c) and shall permit the Board or another person on its behalf at any reasonable time to inspect the premises from which those services are provided for the purpose of satisfying itself that those services are being provided in accordance with the undertaking.

Remuneration of chemists

9.—(1) The Board shall make payments, calculated in the manner provided by the Drug Tariff or in accordance with any determination made by virtue of regulation 9(2) (subject to any deduction required to be made by regulations made under Article 98 of, and Schedule 15 to, the Order) to chemists in respect of drugs and appliances, containers, medicine measures and dispensing or other fees.

(2) The Board shall make such payments, if any, as are provided for by the Drug Tariff or in accordance with any determination made by virtue of regulation 9(2) to chemists who provide additional professional services.

(3) Where a chemist so requests, the Board shall afford him reasonable facilities for examining all or any of the forms on which the drugs or appliances supplied by him were ordered, together with particulars of the amounts calculated to be payable in respect of such drugs and appliances and the Board shall take into consideration any objections made by the chemist in relation to those amounts.

(4) Where so requested by the Local Pharmaceutical Committee or any organisation which is, in the opinion of the Department, representative of the general body of chemists, the Board shall give the Local Pharmaceutical Committee or the organisation in question similar facilities for examining such forms and particulars mentioned in sub-paragraph (3) relating to all or any of the chemists which it represents.

(5) If the Department, after consultation with any organisation mentioned in sub-paragraph (4) and with the Pharmaceutical Committee constituted in accordance with regulation 13 and Schedule 5, is satisfied at any time that the method of payment provided for in this paragraph is such that undue delay in payment may be caused thereby, it may direct that the amounts to be payable to a chemist shall be calculated by such other method, whether by averaging the amounts payable to a chemist or otherwise, as may appear to the Department to be designed to secure that—

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

(b) that payments to a chemist 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.

Withdrawal from pharmaceutical list

10.—(1) Subject to sub-paragraph (2), a chemist may at any time give notice in writing to the Board that he wishes to withdraw his name from the pharmaceutical list and his name shall be removed accordingly on the expiry of the period of—

(a) 3 months from the date of such notice; or

(b) such shorter period as the Board may agree.

(2) Where representations are made to the Tribunal under Schedule 11 to the Order (disqualification of persons providing certain services) that the continued inclusion of a chemist in the pharmaceutical list would be prejudicial to the efficiency of pharmaceutical services, he shall not, except with the consent of the Department, be entitled to have his name removed from such a list pending the determination of the proceedings on those representations.

Complaints

11.—(1) Subject to sub-paragraph (2), a chemist shall establish and operate in accordance with this paragraph, a procedure (in this paragraph and in paragraph 12 referred to as a “ complaints procedure”) to deal with any complaints made by or on behalf of any person to whom he has provided pharmaceutical services.

(2) The complaints procedure to be established by a chemist may be such that it also deals with complaints made in relation to one or more other chemists.

(3) The complaints procedure to be established by a chemist who provides pharmaceutical services from more than one set of premises may be such that it relates to all those premises together.

(4) A complaints procedure shall apply to complaints made in relation to any matter reasonably connected with the chemist's provision of pharmaceutical services and within the responsibility or control of—

(a) the chemist;

(b) where the chemist is a corporate body, any of its directors or former directors;

(c) a partner or former partner of the chemist;

(d) any pharmacist employed by the chemist;

(e) any employee of the chemist other than one falling within head (d);

and in this paragraph and paragraph 12, references to complaints are references to complaints falling within this sub-paragraph.

(5) A complaint may be made on behalf of any person with his consent, or—

(a) where he is a child—

(i) by either parent, or in the absence of both parents, the person having parental responsibility for or care of him; or

(ii) where he is in the care of a Board or HSS trust to whose care he has been committed under the provisions of the Children (Northern Ireland) Order 1995(16) by a person duly authorised by that Board or trust; or

(iii) where he is in the care of a voluntary organisation, by that organisation or a person duly authorised by it; or

(iv) where he is in a training school, by the manager of that training school; or

(b) where he is incapable of making a complaint, by a relative or other adult person who has an interest in his welfare.

(6) A complaint may be made as respects a person who has died by a relative or other adult person who had an interest in his welfare, or when he was a child falling within head (a)(ii), (iii) or (iv) of sub-paragraph (5), by the Board or HSS trust, or voluntary organisation, or the manager of the training school as the case may be.

(7) A complaints procedure shall comply with the following requirements—

(a) the chemist shall specify a person (who need not be connected with the chemist and whom in the case of an individual, may be specified by his job title) to be responsible for receiving and investigating all complaints;

(b) all complaints shall be—

(i) recorded in writing;

(ii) acknowledged, either orally or in writing, within the period of 3 working days beginning with and including the day on which the complaint was received by the person specified under head (a) or, where that is not possible, as soon as reasonably practicable; and

(iii) properly investigated;

(c) within the period of 10 working days beginning with and including the day on which the complaint was received by the person specified under head (a) or, where that is not possible, as soon as reasonably practicable, the complainant shall be given a written summary of the investigation and its conclusions;

(d) where the investigation of the complaint requires consideration of any records relating to the person as respects whom the complaint is made, the person specified under head (a) shall inform him or the person acting on his behalf if the investigation will involve disclosure of information contained in those records to a person other than a person falling within sub-paragraph (4)(a) to (e); and

(e) the chemist shall keep a record of all complaints and copies of all correspondence relating to complaints, but such records shall be kept separate from any records relating to the person by whom the complaint was made.

(8) At each of the premises at which the chemist provides pharmaceutical services he shall provide information about the complaints procedure, and give the name (or job title) and address of the person specified under sub-paragraph (7)(a); and where he provides supplemental services he shall provide the same information to any person to whom he has given advice in accordance with regulation 3(3)(a).

12.—(1) A chemist shall co-operate with any investigation of a complaint by the Board in accordance with the procedures which it operates in accordance with directions given under Article 17(1) of the Order, whether the investigation follows one under the complaints procedure or not.

(2) The co-operation required by sub-paragraph (1) includes—

(a) answering questions reasonably put to the chemist 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 of which due notice has been given), if the chemist's presence at the meeting is reasonably required by the Board.

PART III TERMS OF SERVICE FOR DOCTORS WHO PROVIDE PHARMACEUTICAL SERVICES

13.  Subject to paragraph 14, where a doctor is required by a Board under regulation 12 to supply drugs or appliances to a patient—

(a) he shall record an order for the supply of any drugs, or appliances which are needed for the treatment of a patient on a prescription form completed in accordance with paragraph 48(2) of the doctors' terms of service;

(b) he shall supply those drugs or appliances in a suitable container; and

(c) he shall supply to the patient a drug specified in Schedule 11 to the Medical Regulations only where the conditions in paragraph 49(2) of the doctors' terms of service are satisfied.

14.—(1) Paragraph 13 does not apply to drugs, medicines or appliances ordered on a prescription form signed by a nurse prescriber.

(2) Where a patient presents an order on a prescription form for listed drugs, or appliances, signed by a nurse prescriber, to a doctor who is required by regulation 12 to supply drugs or appliances to that patient, the doctor may supply to the patient such of the drugs or appliances so ordered as he supplies in the normal course of his practice.

(3) Listed drugs or appliances supplied under this paragraph shall be supplied in a suitable container.

15.—(1) Subject to sub-paragraph (2), a doctor who is required by a Board under regulation 12 to supply drugs or appliances to a patient shall not supply to a patient any Scheduled drug, except that, where he has ordered a drug which has an appropriate non-proprietary name either by the name or by its formula, he may supply a drug which has the same specification notwithstanding that it is a Scheduled drug (but, in the case of a drug which combines more than one drug, only if the combination has an appropriate non-proprietary name).

(2) Nothing in this paragraph shall prevent a doctor supplying, otherwise than under these terms of service, a Scheduled drug for a patient.

16.—(1) The provisions of paragraphs 43 to 47 of Schedule 2 to the Medical Regulations (Fees) apply in respect of the supply of any drugs or appliances by a doctor as they apply in respect of prescriptions for drugs and appliances.

(2) Where paragraph 44(2) of Schedule 2 to the Medical Regulations applies and the doctor has supplied any drug or appliance for which, in the case of a person on his list of patients, he would have been entitled to payment from the Agency, the Agency shall credit him with the appropriate amount.

17.  A doctor who is required by a Board under regulation 12 to supply drugs or appliances to a patient or who otherwise provides pharmaceutical services shall secure that the practice based complaints procedure he has established and operates in accordance with paragraphs 52 and 53 of Schedule 2 to the Medical Regulations applies in relation to any matter reasonably connected with his provision of pharmaceutical services as they apply as respects his provision of general medical services.

Regulation 6(2) and 6(10)

SCHEDULE 3

PART I

Regulation 6(2)

FORM A

Regulation 6(2)

FORM A(MR)

Regulation 6(2)

FORM B

Regulation 6(10)

FORM C

PART II

Regulation 6(2)

FORM A

Regulation 6(2)

FORM A (MR)

Regulation 6(2)

FORM B

Regulation 6(10)

FORM C

Regulation 6(4), (8) and (9)

SCHEDULE 4

PART I PROCEDURE ON APPLICATIONS

Notification of applications

1.—(1) Where, on receipt of any properly completed application under regulation 6(2), the Board is satisfied that the application is one to which regulation 6(9) applies, it shall, within 5 working days, give written notice of the application to—

(a) the Local Pharmaceutical Committee;

(b) the Local Medical Committee;

(c) any person whose name is included in the pharmaceutical list and who currently provides pharmaceutical services in the Board's area and whose interests may, in the opinion of the Board, be significantly affected if the application were granted;

(d) any Board whose boundary is within one mile of the proposed premises;

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

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

(a) its Local Pharmaceutical Committee;

(b) its Local Medical Committee;

(c) any person whose name is included in the pharmaceutical list and who currently provides pharmaceutical services in the Board's area and whose interests may, in its opinion, be significantly affected if the application were granted;

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

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

Determination of applications

2.—(1) In considering an application to which regulation 6(9) 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 the pharmaceutical list;

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

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

(2) The Board may determine an application in such manner as it thinks fit and may, if it considers that oral representations are unnecessary, determine the application without hearing any oral representations.

(3) In any case in which the Board decides to hear oral representations, it shall 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.

(4) The applicant and any person mentioned in sub-paragraph (3) shall be permitted to be assisted in making representations at any such meeting by some other person, but a person shall not be entitled to be heard in the capacity of counsel or solicitor.

(5) The procedure by which representations are heard shall be such as the Board may determine.

(6) The functions of the Board under this paragraph shall be exercised by the Pharmacy Practices Committee on behalf of the Board.

Notification of decisions

3.—(1) In the case of an application to which regulation 6(4) applies, the Board shall, within 14 days, give to the applicant and the persons mentioned in paragraph 1 notice of its decision on the application, together with its reasons therefor and any right of appeal under paragraph 4.

(2) In the case of an application to which regulation 6(9) applies, the Board shall, within 14 days of having been notified in accordance with paragraph 11(5), give to the applicant and any person who has made representations to the Board in accordance with paragraph 1(1) or (2), notice of its decision on the application, together with the reasons therefor and any right of appeal under paragraph 4.

Appeals

4.—(1) Where the Board has determined an application to which regulation 6(4) applies, the applicant or any person mentioned in paragraph 1(1)(c) or 1(2)(c) may appeal against the decision of the Board on the application, and notice of any such appeal shall be received by the Board within 21 days from the date on which notification of the Board's decision was sent to him.

(2) Where the Board has determined an application to which regulation 6(9) applies, the applicant or any person who was given notice of the application under paragraph 1(1)(c) or 1(2)(c) and who has made representations to the Board in accordance with paragraph 1 (1) or 1 (2) may appeal against the decision of the Board on the application, and notice of any such appeal shall be received by the Board within 21 days from the date on which notification of the Board's decision was sent to him.

(3) Any notice of appeal under this paragraph shall contain a concise statement of the facts and contentions upon which the appellant intends to rely.

(4) The Board shall refer a notice of appeal under this paragraph to the chairman of the National Appeal Panel appointed in accordance with Part IV.

(5) If the chairman of the National Appeal Panel, after considering the notice of appeal, is of the opinion that the notice discloses no reasonable grounds of appeal or that the appeal is otherwise vexatious or frivolous, he may determine the appeal by dismissing it forthwith, in which case he shall notify the Board accordingly.

(6) In any other case the National Appeal Panel shall be convened in accordance with Part IV and shall thereafter determine the appeal.

PART II PHARMACY PRACTICES COMMITTEE

Establishment

5.  The Board shall appoint a committee (“ the Pharmacy Practices Committee”) and the provisions of Part III shall apply to the proceedings of that committee.

Functions

6.  The Pharmacy Practices Committee shall, on behalf of the Board, exercise the function of the Board under regulation 6(9) in accordance with paragraph 2(6).

Membership

7.—(1) The Pharmacy Practices Committee shall consist of 7 members of whom—

(a) 2 shall be the chairman and vice-chairman respectively and be appointed as such by the Board; the chairman shall be a member of the Board, appointed, under paragraph 3(1)(a) or (b) of Schedule 1 to the Order, and neither shall be a doctor, dentist, ophthalmic optician, pharmacist, or a person or the employee of a person whose name is included in the pharmaceutical list;

(b) 3 shall be pharmacists of whom—

(i) one shall be a pharmacist whose name is not included in the pharmaceutical list and who is not the employee of a person whose name is included in that list; and he shall be appointed by the Board from persons nominated by the Pharmaceutical Society of Northern Ireland; and

(ii) 2 shall be pharmacists each of whom is included in the pharmaceutical list or is an employee of a person whose name is included in that list; and each shall be appointed by the Board from persons nominated by such organisation which is, in the opinion of the Board, representative of the general body of chemists; and

(c) 2 shall be appointed by the Board but neither shall be a pharmacist or a person, or employee of a person, whose name is included in the pharmaceutical list, or be a doctor who is required to supply drugs or appliances in terms of regulation 12; and not more than one of the 2 members so appointed shall be a doctor, dentist or ophthalmic optician.

(2) Persons to act as deputies for, and corresponding in number to, each of those categories of person appointed pursuant to sub-paragraph (1)(b)(i), (b)(ii) and (c) shall, provided they satisfy the criteria specified in the relevant 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 his place.

(3) If a nomination sought for the purposes of sub-paragraph (1)(b)(i) or (ii) 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.

8.  The Board shall prepare and maintain lists of the persons who have been appointed, in accordance with paragraph 7(1)(a) or (b)(i) or (b)(ii) or (c) as the case may be, and who currently serve as members of the Pharmacy Practices Committee, and shall provide the Department with a copy of such lists.

PART III PROCEDURE AT MEETINGS OF THE PHARMACY PRACTICES COMMITTEE

Declaration of interest

9.—(1) Before any meeting of the Pharmacy Practices Committee begins the chairman, or vice-chairman if acting as chairman, 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 such interest,

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

(2) Any member who has, pursuant to the provisions of sub-paragraph (1), declared an interest or who, in the opinion expressed to the meeting, of the chairman or vice-chairman if acting as chairman as the case may be, should have declared 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 his place.

Quorum

10.  No business shall be transacted at a meeting of the Pharmacy Practices Committee unless the chairman or vice-chairman acting as chairman, one member appointed under each of paragraph 7(1)(b)(i) and (ii) and 2 other members appointed under paragraph 7(1)(a) or (c) are present.

Voting and notification of decision

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

(2) Any member appointed by virtue of paragraph 7(1)(b)(i) or 7(1)(c) and the vice-chairman, provided he is not acting as chairman, are entitled to vote.

(3) A member appointed by virtue of paragraph 7(1)(b)(ii) is not entitled to vote and shall withdraw immediately before a decision on an application by voting takes place.

(4) The chairman, or vice-chairman if acting as chairman, 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 he shall have a casting vote.

(5) The Pharmacy Practices Committee shall within 5 working days of making its decision give written notification of it to the Board together with reasons therefor.

Standing Orders

12.  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.

Effect of vacancy or defect in appointment

13.  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.

PART IV NATIONAL APPEAL PANEL

Nominees for the National Appeal Panel

14.—(1) The Board shall submit the names of its nominees for the National Appeal Panel to the Department and shall advise of any changes in such nominees.

(2) The Department shall request the Pharmaceutical Society of Northern Ireland and such organisation which is, in the opinion of the Department, representative of the general body of chemists, to submit to the Department their nominees for the National Appeal Panel.

Chairman and Vice-Chairman of National Appeal Panel

15.—(1) After consultation with all Boards, the Pharmaceutical Society of Northern Ireland and such organisation which is, in the opinion of the Department, representative of the general body of chemists, the Department shall appoint persons as chairman and vice-chairman of the National Appeal Panel.

(2) The persons appointed in accordance with sub-paragraph (1) shall not be a doctor, dentist, ophthalmic optician, pharmacist, or a person or employee of a person whose name is included in the pharmaceutical list.

Membership

16.—(1) In any case in which paragraph 4(6) applies, the Department shall arrange to convene in accordance with this paragraph the National Appeal Panel, the members of which shall be drawn from—

(a) the lists maintained in accordance with paragraph 8; and

(b) the nominees mentioned in paragraph 14.

(2) A member of the National Appeal Panel shall not be a member of—

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

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

(3) The National Appeal Panel shall consist of 9 members of whom—

(a) one shall be chairman appointed in accordance with paragraph 15;

(b) one shall be vice-chairman and likewise be appointed as such in accordance with paragraph 15;

(c) 4 shall be pharmacists one of whom has been nominated by the Pharmaceutical Society of Northern Ireland and the other 3 by such organisation which is, in the opinion of the Department, representative of the general body of chemists; and of those 4 members only 2 shall be persons whose names are, or who are employees of persons whose names are, included in the pharmaceutical list; and

(d) 3 shall have been nominated by a Board, but none shall be a pharmacist or a person, or employee of a person, whose name is included in the pharmaceutical list, or be a doctor who is required to supply drugs and appliances under regulation 12; and not more than one of those 3 shall be a doctor, dentist or ophthalmic optician.

Declaration of interest

17.—(1) Before the start of any meeting of the National Appeal Panel the chairman, or vice-chairman if acting as chairman, 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; or

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

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

(2) Any member who has, pursuant to sub-paragraph (1), declared an interest or who, in the opinion, expressed to the meeting, of the chairman or vice-chairman as the case may be, should have declared such an interest, shall not be present at the consideration or discussion of that appeal or the voting on it.

Quorum

18.  No business of the National Appeal Panel shall be transacted unless the chairman, or vice-chairman if acting as chairman, and 2 members who are appointed under paragraph 16(3)(c) and are entitled to vote, and 2 members appointed under paragraph 16(3)(d) are present.

Voting

19.—(1) Subject to sub-paragraphs (2), (3) and (4), every appeal considered by the National Appeal Panel shall be considered by all members present, but be determined only by a majority of votes of the members present who are entitled to vote.

(2) A member appointed in accordance with paragraph 16(3)(c) and whose name is not included in the pharmaceutical list and who is not an employee of a person whose name is included in that list, and the vice-chairman, provided he is not acting as chairman, are entitled to vote.

(3) A member—

(a) who is appointed in accordance with paragraph 16(3)(c) and whose name is included in the pharmaceutical list, or who is an employee of a person whose name is included in that list; or

(b) who is appointed by virtue of paragraph 16(3)(d),

is not entitled to vote and shall withdraw immediately before a decision on an appeal by voting takes place.

(4) The chairman, or vice-chairman if acting as chairman, 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 he shall have a casting vote.

Decisions by the National Appeal Panel

20.—(1) The National Appeal Panel shall determine an appeal in such manner as it thinks fit and may, if it considers that oral representations are unnecessary, determine the appeal without hearing any oral representations, and its decision in respect of that appeal shall be final.

(2) The National Appeal Panel shall, within 5 working days of making its decision, give written notification of that decision together with reasons therefor to the Board to whom the application was made.

(3) The Board shall, within 14 days of receipt of such notification, notify the applicant and all persons mentioned in paragraph 1 of that decision together with the reasons therefor.

Regulation 13 and Schedule 2 paragraph 9(5)

SCHEDULE 5 PHARMACEUTICAL COMMITTEE

1.  The Pharmaceutical Committee constituted by the Agency after consultation with the Boards and such organisation which is, in the opinion of the Agency, representative of the general body of chemists and such other persons as it considers appropriate, shall consist of a chairman and such number of other members as the Agency thinks fit.

2.  The chairman shall be a pharmacist appointed by the Department.

3.  The term of office of members shall be determined by the Agency.

4.  Where the place of a member becomes vacant before the expiration of his term of office whether by death, resignation or otherwise, the vacancy shall be filled by the Agency after consultation in accordance with paragraph 1 and if necessary with the Pharmaceutical Committee and any other person so appointed shall hold office for the remainder of the term of office of the member who died, resigned or otherwise vacated his office as the case may be.

5.  A member of the Pharmaceutical Committee may resign his membership by giving to the Agency notice in writing.

6.  Where any member of the Pharmaceutical Committee—

(a) is absent from the meetings of the Committee for more than 6 months consecutively (except for a reason approved by the Agency);

(b) has become bankrupt or has made a composition with his creditors; or

(c) is convicted of an indictable offence;

the Agency shall forthwith by resolution, declare the office to be vacant and shall notify that fact in such manner as it thinks fit and thereupon the office shall become vacant.

7.  A member of the Pharmaceutical Committee may vote upon any matter which touches the interests of members of his profession (himself included) but shall not vote upon any matters touching only his individual professional interests.

8.  The proceedings of the Pharmaceutical Committee shall not be invalidated by any vacancy in the membership of the Committee or by any defect in the appointment of its members.

9.  A member of the Pharmaceutical Committee who is a member of a Board shall cease to be a member of that Committee if he ceases to be a member of that Board.

(1)

S.I. 1972/1265 (N.I. 14)

(2)

S.I. 1978/1907 (N.I. 26)

(3)

S.I. 1986/2023 (N.I. 20)

(4)

S.R. 1987 No. 457

(5)

S.I. 1992/2671 (N.I. 18)

(6)

S.I. 1986/2229 (N.I. 24)

(7)

S.I. 1988/2249 (N.I. 24)

(8)

1968 c. 67

(9)

1988 c. 49

(10)

S.R. 1983 No. 201; relevant amending Regulations are S.R. 1985 No. 345, S.R. 1987 No. 240 and S.R. 1994 No. 217

(11)

S.R. 1986 No. 52; relevant amending Regulations are S.R. 1987 No. 68, S.R. 1988 No. 206, S.R. 1989 No. 346, S.R. 1991 No. 1, S.R. 1995 No. 305, S.R. 1995 No. 480 and S.R. 1996 No. 353

(12)

1971 c. 38

(13)

S.R. & O. (N.I.) 1973 No. 1 80 as amended by S.R. 1984 No. 17

(14)

Schedule 11 is amended by Article 3 of, paragraph 2 of Schedule 1 to, Article 17 of and Part I of Schedule 6 to S.I. 1984/1158 (N.I. 8) and Articles 3 to 6 of S.I. 1995/2704 (N.I. 14)

(15)

Article 98 is amended by Article 34 of, and Part II of Schedule 5 to, S.l. 1991/194 (N.l. 1)

(16)

S.I. 1995/755 (N.I. 2)