Pharmacy (Northern Ireland) Order 1976

PART IN.I.INTRODUCTORY

Title and commencementN.I.

1.  This Order may be cited as the Pharmacy (Northern Ireland) Order 1976 … Commencement …

InterpretationN.I.

2.—(1) The Interpretation Act (Northern Ireland) 1954 [1954 c.33] shall apply to Article 1 and the following provisions of this Order as it applies to a Measure of the Northern Ireland Assembly.

(2) In this Order—

• “the Act of 1925” means the Pharmacy and Poisons Act (Northern Ireland) 1925 [1925 c.8] ;

• “the Act of 1945” means the Medicines, Pharmacy and Poisons Act (Northern Ireland) 1945 [1945 c.9] ;

• “approved bye-laws” means bye-laws—

  (a)

  submitted by the Council to a meeting of the Society called, after at least fourteen days' notice of the meeting has been served on every person appearing to be a member of the Society, for the purpose of approving bye-laws so submitted (whether or not the meeting has been called for any other purposes in addition), being a meeting at which at least thirty members of the Society are present; and

  (b)

  approved by a majority of the members present and voting at such a meeting;

• “associate” has the meaning assigned to it by paragraph 3(1) of Part I of Schedule 1;

• “certificate of registration” has the meaning assigned to it by Article 12(3);

• [F1 “ competent authorities ” means any authority or body of a relevant European State designated by that State for the purposes of the Directive as competent to—

  (a)

  receive or issue evidence of qualification or other information or documents,

  (b)

  receive applications and take decisions referred to in the Directive in connection with the practice of pharmacy;]

• “the Council” means the Council of the Society;

• “the Department” means the Department of Health and Social Services;

• [F2 “ the Directive ” means Directive 2005/36/ EC of the European Parliament and of the Council of 7th September 2005 on the recognition of professional qualifications and references in this Order to the Directive, or to any provision of the Directive, are references to the Directive, or to that provision of the Directive, as amended from time to time; ]

• [F3“electronic communication” has the meaning given in section 15(1) of the Electronic Communications Act (Northern Ireland) 2001 (general interpretation);]

• “enactment” has the meaning assigned to it by section 1( b) of the Interpretation Act (Northern Ireland) 1954;

• [F4 “ exempt person ” means

  (a)

  a national of a relevant European State other than the United Kingdom;

  (b)

  a national of the United Kingdom who is seeking access to, or is pursuing, the profession of pharmacy by virtue of an enforceable Community right; or

  (c)

  a person who is not a national of a relevant European State but who is, by virtue of an enforceable Community right, entitled to be treated, for the purposes of access to, and pursuit of, the profession of pharmacy, no less favourably than a national of a relevant European State;

• “ General Systems Regulations ” means the European Communities (Recognition of Professional Qualification) Regulations 2007;” ]

• [F5“lay member” means a person who–

  (a)

  is not and has never been a registered person: and

  (b)

  does not hold qualifications which would entitle him to apply for registration under this Order.]

• “the Medicines Act” means the Medicines Act 1968 [1968 c.67] ;

• “member” has the meaning assigned to it by paragraph 2 of Part I of Schedule 1;

• [F6 “national”, in relation to a [F7 relevant European State ] , means the same as in the Community Treaties, but does not include a person who by virtue of Article 2 of Protocol No. 3 (Channel Islands and Isle of Man) to the Treaty of Accession is not to benefit from Community provisions relating to the free movement of persons and services; ]

• “the Pharmacy Inspector” means the inspector appointed under Article 24(1);

• “prescribed” means prescribed by regulations under Article 5;

• “registered” means in relation to a pharmaceutical chemist, [F8visiting pharmaceutical chemist from a relevant European State] druggist or student, registered in the appropriate register under Article 6;

• “registered person” means a person registered as a pharmaceutical chemist [F9,visiting pharmaceutical chemist from a relevant European State] or druggist;

• “registered pharmacy” has the meaning assigned to it by section 74 of the Medicines Act;

• “the registrar” means the registrar appointed under Article 9(1);

• [F10 “ reference date ” in relation to a relevant European State, means the date specified in relation to that State in the column entitled “Reference date” in Annex V, point 5.6.2. of the Directive;

• [F11“regulatory body” means a regulatory body which has the function of authorising persons to practise as a member of a health or social care profession;]

• “ relevant European State ” means an EEA State or Switzerland;” ]

• “retail pharmacy business” has the meaning assigned to it by [F12regulation 8(1) of the Human Medicines Regulations 2012];

• [F13“Scrutiny Committee” means the committee established under paragraph 2(4) of Schedule 2;]

• “the Society” means the Pharmaceutical Society of Northern Ireland;

• “the Statutory Committee” means the Committee continued under Article 19(1);

• “student” means a registered student.

PART IIN.I.THE PHARMACEUTICAL SOCIETY OF NORTHERN IRELAND

The SocietyN.I.

3.—(1) There shall continue to be a Pharmaceutical Society of Northern Ireland ( “the Society”).

(2) The constitution of the Society shall be as provided in that behalf in Part I of Schedule 1; and the supplementary provisions contained in Part II of that Schedule shall have effect with respect to the Society.

(3) The objects of the Society shall be—

(a)to advance chemistry and pharmacy;

(b)to promote pharmaceutical education and the application of pharmaceutical knowledge;

(c)to maintain the honour and safeguard and promote the interests of the members of the Society in their exercise of the profession of pharmacy;

(d)to execute all such functions as may be entrusted to the Society under any enactment;

(e)to provide relief for distressed persons, being—

(i)members of the Society;

(ii)persons who at any time have been members of the Society or have been registered as either pharmaceutical chemists, or chemists and druggists, or druggists or apprentices to pharmaceutical chemists, or as students of the Society; or

(iii)[F14surviving spouses, surviving civil partners,] orphans or dependants of deceased persons who were at any time members of the Society or registered as aforesaid.

(4) Without prejudice to any other provision of this Order, the Society may—

(a)acquire and hold land for the purposes for which the Society is constituted, and either dispose of or charge any such land;

(b)approve bye-laws made under Article 4;

(c)undertake and execute any lawful trust for the furtherance of any of the objects of the Society;

(d)accept gifts and donations and support, or aid in the support of, charitable or benevolent associations or institutions, or any cause which appears to the Society to be deserving of its support or aid;

(e)invest any funds of the Society not required for immediate use or to meet the usual accruing liabilities of the Society in any investment authorised by law for the investment of trust property;

(f)apply funds under the Society's control towards providing scholarships for the furtherance of education and research in pharmacy, in accordance with regulations under Article 5;

(g)do all such other matters and things as are reasonably necessary for, or incidental to the furtherance of, the objects of the Society or any of them, or the exercise of the powers of the Society or any of them.

(5) Any money received by the Society on the disposal of any land under paragraph (4)( a) shall be applied by the Society to some purpose of its functions to which capital moneys are properly applicable.

The CouncilN.I.

4.—(1) There shall continue to be a Council of the Society ( “the Council”) with a President and a Vice-President.

[F15(2) The provisions of Schedule 2 shall have effect with respect to the Council.]

(3) The Council may on behalf, and for the benefit, of the Society—

(a)direct and manage the business and affairs of the Society, and exercise all such powers of the Society as are not by this Order required to be exercised by the Society in general meeting, in accordance with and subject to approved bye-laws made by the Council;

(b)control and manage the property and funds of the Society and invest and apply the same in such manner as the Council may determine, subject to such general or special directions (if any) as may be contained in approved bye-laws made by the Council with respect to the control and management of such property and funds;

(c)regulate the functions of the secretary, treasurer, clerks and other subordinate officers and their terms and conditions of service;

(d)employ and pay such auditors, accountants and other advisers as the Council may think fit.

[F16Continuing professional developmentN.I.

4A.—(1) The Council shall—

(a)set the standards of proficiency for the safe and effective practise of pharmacy which it is necessary for a registered person to maintain in order for their name to be retained in the register; and

(b)set the standards of continuing professional development which it is necessary for a registered person to maintain in order to continue to meet the standards of proficiency referred to in sub-paragraph (a);

(2) The Council shall keep the standards set under this Article under review and may vary or withdraw those standards whenever it considers it appropriate to do so.

(3) The Council must publish the standards set under this Article, as they exist from time to time, in such manner as it considers appropriate.

(4) Before varying or withdrawing the standards referred to in paragraph (1), the Council shall consult such persons as it considers appropriate.

(5) The Council shall—

(a)consult such persons as it considers appropriate about the development of criteria by reference to which compliance with the standards set under paragraph (1)(b) is to be monitored, and

(b)publish those criteria as they exist from time to time in such manner as it considers appropriate.

(6) The Council shall—

(a)adopt and maintain a framework relating to the requirements and conditions to be met by registered persons in respect of their continuing professional development; and

(b)require registered persons—

(i)to complete an annual declaration regarding their compliance with such requirements and conditions in respect of their continuing professional development as they are obliged to meet by that framework, and

(ii)to submit records about any continuing professional development undertaken by them to the registrar for review.

(7) The framework adopted by the Council under paragraph (6)(a)—

(a)must include provision relating to—

(i)the amount and type of continuing professional development that a registered person is required to undertake,

(ii)the information to be provided by a registered person about the continuing professional development that the registered person has undertaken and the form and manner in which that information is to be provided,

(iii)the times at which information about the continuing professional development that a registered person has undertaken is to be provided (including any continuing professional development that relates to an annotation in respect of a particular specialist area of practice that is to be recorded against the registered person’s name in the register),

(iv)the keeping of records about the continuing professional development undertaken by registered persons; and

(b)must require that any continuing professional development that is undertaken by a registered person in accordance with it is relevant to—

(i)the safe and effective practice of pharmacy, and

(ii)a learning need for the individual registered person that is relevant to the current scope of the practice of pharmacy including any specialist area of practice of that individual registered person and the environment in which they practise;

(c)in so far as it relates to a person (“P”) who is a registered person only as a result of being registered in the register mentioned in Article 6(1)(d)—

(i)may not impose requirements on P if P is required to undertake, in P’s home State, continuing professional development in relation to the profession of pharmacy; and

(ii)where they impose requirements on P—

(aa)must take account of the fact that P is fully qualified to pursue the profession in P’s home State, and

(bb)must specify that continuing professional development which P is required to undertake by the requirements may be undertaken outside Northern Ireland.

(8) The Council must publish the framework adopted by it under paragraph (6)(a), as it exists from time to time, in such manner as it considers appropriate.

(9) The Council must make such provision in regulations as it considers appropriate with respect to registered persons who fail to comply with any requirements of the framework adopted by the Council under paragraph (6)(a).

(10) Regulations under paragraph (9) must—

(a)make provision about the circumstances in which the registrar may remove the name of the registered person from the register, or impose such other remedial measures as may be specified in the regulations, where the registered person—

(i)has failed to comply with the requirements or conditions of the framework adopted by the Council under paragraph (6)(a) relating to the continual professional development of registered persons; or

(ii)has made a false declaration about compliance with those requirements or conditions;

(b)where the framework adopted by the Council under paragraph (6)(a) makes provision in respect of a person (“P”) who is a registered person only as a result of being registered in the register mentioned in Article 6(1)(d), secure that any sanction imposed in relation to P by reference to that provision is appropriate and proportionate in view of P’s continued lawful establishment in P’s home State as a pharmacist;

(c)make provision for the registrar to send a statement in writing to the registered person concerned giving the registered person notice of the removal and the reasons for it and of right of appeal to the Statutory Committee under paragraph (13);

(d)make provision for the suspension of a registered person’s entry in the register pending the outcome of any appeal against a decision to remove the name of the registered person from the register;

(e)make provision about the circumstances in which the registrar, upon an application being made by a person whose name has been removed from the register, may restore the name to the register and whether, and if so what, continuing professional development is required after restoration, and the regulations may make provision—

(i)for these issues to be determined in individual cases by the registrar,

(ii)enabling the registrar to determine that the application for restoration is to be granted subject to the applicant agreeing to comply with such undertakings with regard to continuing professional development as the registrar considers appropriate, and

(iii)refusal of applications.

(11) Where a person who has agreed to comply with an undertaking pursuant to regulations made under paragraph (10)(e) breaches that undertaking, that breach may be treated as misconduct for the purposes of paragraph (4)(1)(a) of Schedule 3 and the registrar must consider, in accordance with paragraph (5)(1) of Schedule 3, whether or not to refer the matter to the Scrutiny Committee or (where regulations under paragraph (5)(1) of Schedule 3 so provide) to the Statutory Committee.

(12) Where the registrar refuses an application for restoration of a person’s name to the register, the registrar must send to the applicant a statement in writing giving the applicant notice of decision and the reasons for it and the right of appeal to the Statutory Committee under paragraph (13).

(13) In accordance with regulations made under paragraph (10), a person in respect of whom a decision has been made by the registrar to—

(a)remove their name from the register;

(b)impose such remedial measure as may be specified; or

(c)refuse an application for restoration of their name to the register,

may appeal from that decision to the Statutory Committee which may decide the appeal.

(14) In this Article “home State” in relation to a pharmaceutical chemist registered in the register mentioned in Article 6(1)(d), means the relevant European State in which the registered person is lawfully established as a pharmacist.

The Council’s duties in respect of publicationsN.I.

4B.—(1) The Council shall from time to time publish or provide in such manner as it sees fit information about the regulation of pharmaceutical chemists and registered pharmacies.

(2) The Council may from time to time publish or provide in such manner as it sees fit guidance to registered persons, employers and such other persons it considers appropriate in respect of the standards for the education, training, supervision and performance of persons who are not registered persons but who provide services in connection with those provided by registered persons.

AccountsN.I.

4C.—(1) The Council shall be responsible for ensuring that the Society—

(a)keeps accounts, which shall be in such form as the Department may determine; and

(b)prepares annual accounts in respect of each year, which shall be in such form and shall be prepared by such date as the Department may determine.

(2) Those annual accounts shall be audited by auditors appointed by the Council, but no person may be appointed as an auditor under this paragraph unless that person is eligible for appointment as a statutory auditor under Part 42 of the Companies Act 2006 (statutory auditors).

(3) As soon as is reasonably practicable after those accounts have been prepared, the Council shall—

(a)cause them to be published together with any report on them made by the auditors appointed under paragraph (2); and

(b)send a copy of those annual accounts and of any such report to the Department,

and the Department shall lay before the Assembly a copy of those annual accounts and any report on the accounts made by the auditors appointed under paragraph (2).

Reports and statistical informationN.I.

4D.  The Council shall publish in such manner as it sees fit, at least once in each year, by such date as the Department shall determine—

(a)a statistical report in respect of, and which includes a description of, the procedures which the Society has in place to protect members of the public from registered persons whose fitness to practise is impaired, together with the Council’s observations on the report; and

(b)a report, submitted to the Department, on the Society’s exercise of its functions, and the Department shall lay before the Assembly a copy of the report submitted by the Council under this sub-paragraph.]

[F17Regulations made by the Council: general]N.I.

5.—(1) The Council may, subject to the provisions of this Order, make regulations with respect to all or any of the following matters—

(a)the meetings and other proceedings of the Council and the Society (including meetings for the reading of papers and discussions of scientific subjects);

(b)the examination (including the subjects of examination) or the qualifications of persons desirous of being registered as pharmaceutical chemists under this Order;

[F18(bb)the conditions as to character, physical and mental health and other matters to be satisfied by persons desirous of being registered as pharmaceutical chemists under this Order;]

(c)the qualifications of persons desirous of being registered as students under this Order;

(d)the conditions on which persons who are members of pharmaceutical societies outside Northern Ireland may be registered as pharmaceutical chemists under this Order, and the societies whose members may be so registered;

(e)the fees (being of a reasonable amount) for examination and registration,[F19 for retention of registration and for annotation of the register,] which are to be paid to the Society under this Order;

(f)the conditions on which persons may be required to undergo a course of practical training for the purpose of qualifying for registration as pharmaceutical chemists;

[F20(fff)the recording in the register of fitness to practise matters, including any warnings or advice given by, or undertakings agreed with, the Statutory Committee or the Scrutiny Committee;

(ffg)the recording in the register of continuing professional development matters.]

[F19(ff)annotation of the register of pharmaceutical chemists to indicate particular qualifications, specialist areas of practice and status;]

(g)the making of special provision with respect to the examinations to be passed by ex-servicemen;

(h)generally, any matters with respect to which the Council thinks that provision should be made for the purpose of carrying this Order into effect.

[F21(1A) Regulations made by the Council under this Article may not make provision for the payment of fees in connection with registration as a visiting pharmaceutical chemist from a relevant European State.]

F22(2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(3) Before approving any regulations with respect to—

(a)the matters mentioned in paragraph (1)( b), ( c) and ( g); or

(b)the prescribing of any body for the purposes of Article 7(5) or (6); or

(c)the provision of scholarships under Article 3(4)( f);

the Department shall consult the Department of Education.

F23(4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(5) For the purposes of paragraph (1)( g), the expression “ex-servicemen” includes—

(a)men who have served whole time in the armed forces of the Crown or in the Merchant Navy or the mercantile marine;F24. . .

PART IIIN.I.REGISTRATION OF PHARMACEUTICAL CHEMISTS, DRUGGISTS AND STUDENTS

The registersN.I.

6.—[F25(1) In relation to the registers mentioned in sub-paragraphs (a), (b) and (c) there shall continue to be kept, and in relation to the register mentioned in sub-paragraph (d) there shall be kept, in accordance with the succeeding provisions of this Order,—

(a)a register of pharmaceutical chemists;

(b)a register of druggists;

(c)a register of students; and

(d)a register of visiting pharmaceutical chemists from a relevant European State.]

(2) Registration under this Order shall not entitle any person so registered to practice medicine or surgery or any branch of medicine or surgery.

ExaminationsN.I.

7.—(1) For the purpose of ascertaining the proficiency in any subjects of persons desirous of being registered under this Order as pharmaceutical chemists, the Council may cause examinations to be held at such times and in such manner as may be prescribed, and shall appoint examiners to conduct any such examinations.

(2) A person shall not conduct any such examination until his appointment has been approved by the Head of the Department, and such appointment shall not continue in force for more than five years except with the consent of the Head of the Department on application being made by the Council.

(3) The Society shall allow the Pharmacy Inspector or any other officer appointed by the Department for that purpose to be present during the progress of any examination held for the purposes of this Order.

(4) Examiners appointed to conduct any examination under this Article may, after such examination, grant or refuse to the persons taking part in the examination, as the examiners in their discretion may consider fit, recognition of the proficiency of such persons in the subjects of the examination, or any of them.

(5) The Council may make arrangements for the holding of examinations for the purposes of this Order with—

(a)any university in Northern Ireland;

(b)any institution of further education or other body in Northern Ireland which may be prescribed for the holding of such examinations.

(6) For the purpose of ascertaining the proficiency of candidates in any subject, the Council may recognise—

(a)the examinations of, or any examinations accepted by—

(i)any university in Northern Ireland; or

(ii)any institution or body such as is referred to in paragraph (5)( b) which is prescribed for the purposes of this paragraph;

(b)the examinations of—

(i)any other university in the United Kingdom;

(ii)any body in the United Kingdom which is recognised by the Council as a body of comparable academic status to a university and is prescribed for the purposes of this paragraph.

Qualifications for registrationN.I.

8.—(1) Every person who possesses the prescribed qualifications and gives to the registrar such reasonable proof of such qualifications as may be prescribed shall, upon payment to the Society of the proper fees (if any), be entitled to be registered as a student under this Order.

(2) [F26Subject to paragraph (2A),] The following persons shall, upon payment to the Society of the proper fees (if any), be entitled to be registered under this Order as pharmaceutical chemists—

(a)every person who, immediately before the commencement of this Order, was entitled to be registered as a pharmaceutical chemist under the Act of 1925;

(b)every person who—

(i)is registered as a student;

(ii)has been duly examined in such subjects as may be prescribed and has obtained from the examiners recognition of his proficiency therein; or possesses such qualifications as may be prescribed and, having been duly examined in any additional subject which may be prescribed for a person of those qualifications, has obtained from the examiners recognition of his proficiency in that subject;

(iii)has undergone such a course of practical training as may be prescribed; and

(iv)has attained the age of twenty-one years;

and who gives to the registrar such reasonable proof of those facts as may be prescribed.

[F27(c)every exempt person—

(i)who holds an appropriate European diploma; or

(ii)(aa) whose case falls within regulation 3(9)(a) or (e) of the General Systems Regulations,

(bb)to whom regulations 20 to 26 of those regulations apply by reason of the operation of regulation 3(4) of those regulations, and

(cc)who is permitted to pursue the profession of pharmacy in the United Kingdom by virtue of Part 3 of those regulations (having, in particular, successfully completed any adaptation period, or passed any aptitude test, that he may be required to undertake pursuant to that Part of those regulations).]

[F26(2A) A person shall not be entitled to be registered under this Order as a pharmaceutical chemist by virtue of paragraph (2)(b) or (c) unless he satisfies such conditions (if any) as to character, physical or mental health or other matters as may be prescribed.]

(3) Every person who, immediately before the commencement of this Order, was entitled to be registered as a druggist under the Act of 1925 shall, upon payment of the proper fees (if any), be entitled to be registered as a druggist under this Order.

(4) Notwithstanding anything in paragraph (2), the Council may, if it thinks fit, cause to be registered under this Order as a pharmaceutical chemist any person (other than a person such as is described in paragraph (2)( a)[F28 or (c)] who is a member of a prescribed pharmaceutical society outside Northern Ireland and who—

(a)satisfies the Council as to his competence to practise as a pharmaceutical chemist;

(b)pays to the Society the proper fees (if any) for registration; and

(c)complies with such other conditions as may be prescribed.

[F29(5) Where a person—

(a)gives to the registrar such reasonable proof as may be prescribed that he satisfies the prescribed requirements for a particular annotation to be recorded against his name in the register of pharmaceutical chemists in accordance with regulations under Article 5(1)(ff); and

(b)pays the prescribed fee to the Society,

he shall be entitled to have that annotation recorded against his name in that register.]

[F30Registration by virtue of appropriate European diplomaN.I.

8A.—(1) Where a person is registered by virtue of Article 8(2)(c) an indication that he has been registered in respect of an appropriate European diploma shall be entered in the register against his name.

[F31(1A) F32. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .]

[F33(2) Subject to paragraph (8) the following diplomas are appropriate European diplomas for the purposes of article 8(2)(c)(i), namely—

(a)a diploma listed in Annex V, point 5.6.2 of the Directive which has been granted in a relevant European State after its reference date and which is evidence of training commenced after that date, provided that the diploma is accompanied, where appropriate, by the certificate listed in relation to that State in the column of Annex V, point 5.6.2 of the Directive entitled “Certificate accompanying the diploma”; or

(b)any diploma which—

(i)subject to paragraph (3), has been granted in a relevant European State before its reference date or which is evidence of training commenced before that date but completed on or after that date,

(ii)subject to paragraph (4), was awarded by the competent authorities of, or which is evidence of training started in, the territory specified in column (b) of the table in Schedule 2A before the date specified in the corresponding entry in column (a) of that table,

(iii) subject to paragraph (5), is evidence of training commenced before 3 ^rd October 1990 and undertaken in the territory of the former German Democratic Republic, or

(iv)subject to paragraph (6), does not fall within heads (i) to (iii) and is not listed in Annex V, point 5.6.2 of the Directive but which is a diploma in pharmacy granted in a relevant European State on or after its reference date.

(3) A diploma to which paragraph (2)(b)(i) applies is only an appropriate European diploma if—

(a)in the case of a diploma which is listed in Annex V, point 5.6.2 of the Directive—

(i)the registrar is satisfied (by means of a certificate from the relevant competent authorities or otherwise) that the diploma guarantees that the holder's training satisfies the requirements of Article 44 of the Directive (requirements for pharmacists' training), and

(ii)the diploma is accompanied, where appropriate, by the certificate listed in relation to the relevant European State in which the diploma was awarded in the column of Annex V, point 5.6.2 of the Directive entitled “Certificate accompanying the diploma”;

(b)in the case of a diploma which is not listed in Annex V, point 5.6.2 of the Directive, the diploma is accompanied by a certificate from the competent authorities of the relevant European State in which the diploma was awarded which attests that the diploma—

(i)is evidence of training which satisfies the requirements of Article 44 of the Directive, and

(ii)is treated by the competent authorities of the relevant European State in which it was awarded as equivalent to a diploma listed in relation to that State in Annex V, point 5.6.2 of the Directive, and the certificate is made available to the registrar: or

(c)whether or not the diploma is listed in Annex V, point 5.6.2 of the Directive, the competent authorities of a relevant European State have certified that the holder has, in a relevant European State, been effectively and lawfully engaged in the practice of an activity open to pharmacists in that State for at least three consecutive years during the five years preceding the date of the certificate, and the certificate is made available to the registrar.

(4) A diploma to which paragraph (2)(b)(ii) applies is only an appropriate European diploma if—

(a)the competent authorities of the relevant European State specified in the appropriate row of column (c) of the table in Schedule 2A have certified that the diploma has, in its territory, the same legal validity as regards access to the practice of pharmacy as the diploma listed in Annex V, point 5.6.2 of the Directive in respect of their State;

(b)those competent authorities have also certified that the holder of the diploma has, in the relevant European State specified in the appropriate row of column (c) of the table in Schedule 2A, been effectively and lawfully engaged in the practice of an activity open to pharmacists in that State for at least three consecutive years during the five years preceding the date of that certificate; and

(c)the certificates are made available to the registrar.

(5) A diploma to which paragraph (2)(b)(iii) applies is only an appropriate European diploma if —

(a)the diploma entitles its holder to practice pharmacy throughout the territory of Germany on the same conditions as those that apply to the holder of the diploma listed in Annex V, point 5.6.2 of the Directive in respect of Germany; and

(b)the competent authorities in Germany have certified that the holder of the diploma has been effectively and lawfully engaged in Germany in the practice of an activity open to pharmacists in Germany for at least three consecutive years during the five years preceding the date of that certificate; and

(c)the certificate is made available to the registrar.

(6) A diploma to which (2)(b)(iv) applies is only an appropriate European diploma if—

(a)the competent authorities of the European State that awarded it have certified that the diploma—

(i)is evidence of training which satisfies the requirements of Article 44 of the Directive, and

(ii)is treated by them as equivalent to a diploma listed in Annex V, point 5.6.2 of the Directive in respect of their State; and

(b)the certificates are made available to the registrar.

(7) A diploma is only an appropriate European diploma if—

(a)in a case where the registrar or the Council has justified doubts about the authenticity of the diploma made available to the registrar and has required of the relevant competent authorities confirmation of the authenticity of the evidence, the relevant competent authorities have confirmed the authenticity of the evidence;

(b)in a case where the registrar or the Council has justified doubts about whether the holder of the diploma has completed training which satisfies the requirements of Article 44 of the Directive, and has required of the relevant competent authorities confirmation of completion of such training, the relevant competent authorities have confirmed completion of such training;

(c)in a case where the registrar or the Council has justified doubts concerning training received in a relevant European State other than that in which the diploma was awarded, and has required confirmation of the relevant competent authorities in accordance with Article 50(3) of the Directive, the relevant competent authorities have provided confirmation in accordance with that Article.]]

[F34Visiting pharmaceutical chemist from a relevant European StateN.I.

8B.  Schedule 2B (visiting pharmaceutical chemist from a relevant European State) shall have effect.]

The registrarN.I.

9.—(1) The Department may appoint a fit and proper person as a registrar for the purposes of this Order.

(2) The registrar shall make out and maintain the registers mentioned in Article 6(1)( a ), ( b ) and[F35,(c) and (d)] as complete and separate registers of all persons registered respectively in respect of the several qualifications for registration prescribed by this Order.

(3) Each register shall be divided into such separate parts as may be required for the purposes of this Order, and in each register or separate part thereof the names shall be in alphabetical order according to the surnames, with the respective residences entered opposite to such names.

(4) The registrar shall also keep proper indexes of the registers and all such other lists as may be required and as may be necessary for giving effect to this Order and to the regulations made thereunder.

(5) The registrar shall keep each such register correctly and strike off the names of all registered persons as and when they die or are removed from any such register, and shall make any necessary alterations in the addresses of the persons registered under this Order.

Power of registrar to require informationN.I.

10.—(1) The registrar may—

(a)serve notice in writing on any registered person requiring him, within two months from the service of the notice, to state in writing whether he has ceased to carry on business or has changed his residence, and, where that person fails to comply with that notice, serve a second such notice;

(b)where, within four months from the service of the first notice under sub-paragraph ( a), a registered person has failed to comply with either of the notices mentioned in that sub-paragraph, strike the name of that person off the register, but subject to the restoration of that name by the direction of the Council if it thinks fit to make an order to that effect.

(2) The registrar may at any time serve notice in writing on the occupier of any premises where a retail pharmacy business is carried on requiring the occupier, within seventeen days from the service of the notice to furnish in writing to the registrar a statement of the name and address of the bona fide proprietor of the business, and, if such proprietor does not personally manage and conduct the business, the name of the duly qualified manager or assistant managing or conducting the business and the description of his qualification.

(3) Where a person on whom a notice has been served under paragraph (2), fails to comply with the notice, he shall be guilty of an offence and shall be liable on summary conviction to a fine not exceeding[F36 level 2 on the standard scale].

(4) Where a person is convicted under paragraph (3) in respect of a failure to comply with a notice and the failure continues after conviction he shall be guilty of a further offence under paragraph (3) and shall be liable on summary conviction, in addition to the fine specified in that paragraph, to a fine not exceeding[F36 level 1 on the standard scale] for every day subsequent to the day on which he is first convicted of an offence under that paragraph on which the failure continues.

(5) Where a person on whom a notice has been served under paragraph (2), fails to comply with the notice, a retail pharmacy business shall not be carried on the premises and any person carrying on such a business in contravention of this paragraph shall be guilty of an offence and shall be liable on summary conviction to a fine not exceeding[F36 level 2 on the standard scale], unless he proves to the satisfaction of the court that he did not know of the failure to comply with the notice.

Evidence of qualification to be registeredN.I.

11.—(1) A name shall not be entered in any register kept under this Order unless the registrar is satisfied by the proper evidence that the person applying for the registration is entitled by virtue of this Order to be registered; and the registrar shall notify the secretary of the Society before entering a name in any of those registers.

[F37(1A) The registrar shall enter the name of a person whom the Society has directed him to register in the appropriate register kept under this Order for the purposes of the General Systems Regulations.]

(2) The secretary of the Society or a person aggrieved by any decision of the registrar may appeal from that decision to the Council which may decide the appeal; and any entry which is proved to the satisfaction of the Council to have been fraudulently or incorrectly made may be struck off, or amended in, the register [F38under this Article] under an order made by the Council in writing.

[F39Indemnity arrangementsN.I.

11A.—(1) A registered person who practises as a pharmaceutical chemist must have in operation an indemnity arrangement which provides appropriate cover in relation to that registered person in respect of liabilities which may be incurred in practising as a pharmaceutical chemist.

(2) For the purposes of this Article, an “indemnity arrangement” may comprise—

(a)a policy of insurance;

(b)an arrangement made for the purposes of indemnifying a person; or

(c)a combination of the two.

(3) For the purposes of this Article, “appropriate cover”, in relation to practice as a pharmaceutical chemist, means cover against liabilities that may be incurred in practising as such which is appropriate, having regard to the nature and extent of the risks of practising as such.

(4) The Council may make such provision in regulations in connection with the information to be provided to the registrar—

(a)by or in respect of any person seeking to be registered (including on an application for restoration) for the purposes of determining whether if that person is so registered, there will be in operation in relation to that person by the time that person begins to practise an indemnity arrangement which provides appropriate cover; and

(b)by or in respect of a registered person who practises as a pharmaceutical chemist for the purposes of determining whether, at any time, there is in operation an indemnity arrangement which provides appropriate cover in relation to that registered person.

(5) Regulations under paragraph (4)(b) may require information to be provided—

(a)at the request of the registrar; or

(b)on such dates or at such intervals as the registrar may determine, either generally or in relation to a registered person or registered persons of a particular description.

(6) The Council may also make regulations requiring a registered person who practises as a pharmaceutical chemist to inform the registrar if there ceases to be in operation in relation to that registered person an indemnity arrangement which provides appropriate cover.

(7) The Council may also make regulations requiring a registered person who practises as a pharmaceutical chemist to inform the registrar if there is in operation in relation to that registered person appropriate cover provided under an indemnity arrangement by an employer.

(8) Where there is a failure to comply with the regulations under paragraph (4) by or in respect of a registered person who practises as a pharmaceutical chemist or a person who is seeking to be registered, the registrar may refuse to enter or retain the person’s name in, or to restore their name to, the register.

(9) If a registered person who practises as a pharmaceutical chemist is in breach of paragraph (1), or fails to comply with regulations under paragraph (4)(b), (6) or (7), or there is a failure to comply with regulations under paragraph (4)(b) in respect of that registered person—

(a)the registrar may remove that person’s name from the register; or

(b)the breach or failure may be treated as misconduct for the purposes of paragraph 4(1)(a) of Schedule 3 and the registrar must consider, in accordance with paragraph 5(1) of that Schedule, whether or not to refer the matter to the Scrutiny Committee or (where regulations under paragraph 5(1) of that Schedule so provide) to the Statutory Committee.

(10) Where the registrar—

(a)refuses to enter or retain a person’s name in, or restore their name to, the register pursuant to paragraph (8); or

(b)removes a person’s name from the register, pursuant to paragraph (9)(a),

the registrar must send to the person a statement in writing giving the person notice of the decision and the reasons for it and the right of appeal to the Statutory Committee under paragraph (11).

(11) A person in respect of whom a decision has been made by the registrar to—

(a)refuse to enter or retain a person’s name in, or restore their name to, the register pursuant to paragraph (8); or

(b)remove a person’s name from the register, pursuant to paragraph (9)(a),

may appeal from that decision to the Statutory Committee which may decide the appeal.

(12) This Article does not apply to a person who is registered as a visiting pharmaceutical chemist from a relevant European State.]

Annual publication of registersN.I.

12.—(1) The registrar shall, each year, publish copies of the various registers authorised by this Order, in alphabetical order according to the surnames.

(2) Copies of the registers published under paragraph (1), or any extract therefrom or from the original registers certified under the hand of the registrar and countersigned by the President or two members of the Council, shall be evidence in all courts and proceedings that the persons specified therein are registered according to the provisions of this Order, and the absence of the name of any person from any such copy of any register shall be evidence, until the contrary is made to appear, that such person is not registered in the appropriate register according to the provisions of this Order.

(3) An extract from a register or from a copy of a register certified and countersigned as provided by paragraph (2) is in this Order referred to as a “certificate of registration”.

Copies of registers to be sent to Pharmacy Inspector, etc.N.I.

13.  Each year the registrar shall send copies of the registers kept under this Order to the Pharmacy Inspector, the Poisons Inspector appointed under Article 16(1) of the Poisons (Northern Ireland) Order 1976 [1976 NI 23] and the Society, and also to the divisional commander of each police division, and each such commander shall report to the Pharmacy Inspector any offence against the provisions of this Order committed within his division.

Issue of certificates of registration and penalties for failure to surrender, or abuse of, certificatesN.I.

14.—(1) Subject to paragraph (2), the Council shall, on the demand of a registered pharmaceutical chemist, druggist or student, cause a certificate of registration in the appropriate register under Article 6 to be issued to such a person without any fee.

(2) Where a certificate of registration has already been issued to the person making the demand, there shall not be any obligation upon the Council to cause a further certificate to be issued to him unless he satisfies the secretary of the Society that the original certificate has been lost or destroyed and pays such fee (if any) in respect of the issue of the further certificate as may be prescribed.

[F40(2A) Any certificate of registration issued to any person under this Article shall reproduce any indication entered in the register against that person's name in pursuance of Article 8A(1) F41. . . .]

[F42(2B) Any certificate of registration issued to any person under this Article shall reproduce any annotation entered in the register against that person's name in pursuance of Article 8(5).]

(3) If a person to whom a certificate of registration has been issued ceases to be registered as a pharmaceutical chemist, druggist or student, he shall, within fourteen days after so ceasing, transmit the certificate to the secretary of the Society for cancellation by the registrar, and, if such a person fails to do so, he shall be guilty of an offence and shall be liable on summary conviction to a fine not exceeding[F43 level 3 on the standard scale].

(4) Where a person is convicted under paragraph (3) in respect of a failure to transmit a certificate and the failure continues after the conviction he shall be guilty of a further offence under paragraph (3) and shall be liable on summary conviction, in addition to the fine specified in that paragraph, to a fine not exceeding[F43 level 1 on the standard scale] for every day subsequent to the day on which he is first convicted of the offence under that paragraph on which the failure continues.

(5) If, with intent to deceive, a person—

(a)F44. . . uses, or lends to or allows to be used by any other person, a certificate of registration issued under this Article; or

(b)makes or has in his possession a document so closely resembling any such certificate as to be calculated to deceive;

he shall be guilty of an offence and shall be liable on summary conviction to a fine not exceeding[F43 level 3 on the standard scale] and where this paragraph is again contravened within one year after the conviction to a further fine not exceeding £10 for every day subsequent to the day on which he is first convicted of an offence under this paragraph on which it is so contravened.

Retention feesN.I.

15.—(1) Subject to paragraph (2), every member, associate or student of the Society shall, in addition to the fees payable on his registration in the appropriate register, pay to the Society in respect of each year such fee (a “retention fee”) as may be prescribed, in respect of the retention of his name in the appropriate register in that year.

(2) A retention fee shall not be payable by any person in respect of the year in which he first becomes a member or, as the case may be, an associate or student of the Society.

(3) If a person on whom a demand has been made in the prescribed manner for payment of a retention fee payable by him under this Article fails to pay the fee within two months after the date on which the demand therefor was made, the Council may direct the removal of his name from the appropriate register; but, if, either within the year in respect of which the fee is payable or within such longer period as the Council may allow, the person whose name has been removed from the register pays to the Society the retention fee, together with such additional sum (if any) by way of penalty for the default as may be prescribed, his name shall be restored to the appropriate register and, if the Council so directs, the restoration shall have effect as from the date on which his name was removed from that register.

(4) In this Article, “year” means a period of twelve months beginning on such date as the Council may determine or, where the Council varies that date, such period (whether greater or less than twelve months) immediately following the variation as the Council may determine.

(5) Nothing in this Article shall apply to honorary members of the Society.

Penalty for falsification of registersN.I.

16.  If the registrar wilfully makes or causes to be made any falsification in any matter relating to any register under this Order, he shall be guilty of an offence and shall be liable—

(a)on summary conviction, to a fine not exceeding[F45 level 3 on the standard scale];

(b)on conviction on indictment, to imprisonment for any term not exceeding twelve months or to a fine, or to both.

Duty of registrar of deaths to give notice of deaths of registered personsN.I.

17.  Every registrar of deaths, on registering the death of any person registered under this Order as a pharmaceutical chemist or druggist, shall forthwith transmit by post to the registrar a copy, certified under his hand, of the entry of such death; and, on receipt of such certified copy, the registrar shall strike the name of such deceased person off the appropriate register, and shall pay to the registrar of deaths the fee chargeable by law for such certified copy, together with the cost of its transmission, and may charge those payments as an expense of his office.

Disqualification of persons suffering from disabilityN.I.

F4618.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

PART IVN.I.DISCIPLINARY PROCEEDINGS

The Statutory CommitteeN.I.

19.—(1) For the purposes of this Order, the Statutory Committee constituted under section 12 of the Act of 1945 shall continue in being and the provisions of this Article shall have effect with respect to the Statutory Committee and other matters relating to that Committee and their members.

[F47(2) The Statutory Committee shall consist of—

(a)a lay member who is the chair;

(b)2 lay members who are deputy chairs;

(c)3 other lay members; and

(d)6 members who are registered persons

all of whom shall be appointed by the Council.

(3) A member of the Statutory Committee shall hold office for a period of 4 years from the date of appointment, but shall be eligible for re-appointment at the expiration of that period.

(4) No member of the Statutory Committee may hold office for more than an aggregate of 8 years in any 20 year period.

(5) There shall be paid to the members of the Statutory Committee such remuneration and such travelling, subsistence or other expenses as the Council may determine.

(6) The expenses of the Statutory Committee (including any such fees payable to any of the members thereof as may be fixed by the Council) shall be defrayed by the Society.

(7) The quorum of the Statutory Committee shall be 3 which must include—

(a)the chair or a deputy chair;

(b)a lay member; and

(c)a member who is a registered person.

(8) The Council may by regulations make provision as to—

(a)the procedure of the Statutory Committee (including the validation of proceedings in the event of vacancies or defects in appointment);

(b)the grounds on which persons are to be disqualified from appointment as members of the Statutory Committee; and

(c)the circumstances in which members cease to hold office or may be removed or suspended from office.]

Fitness to practiceN.I.

[F4820.  The provisions of Schedule 3 shall have effect with respect to fitness to practise functions and proceedings of the Statutory Committee and the Scrutiny Committee.]

Conditions as to the giving of directions by Statutory Committee in case of conviction, etc., of employeeN.I.

F4921.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Provisions as to directions given by Statutory Committee and as to appealsN.I.

F5022.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

PART VN.I.MISCELLANEOUS

Dispensing, etc., in public institutionsN.I.

23.  A person shall not be appointed to, or hold, the office of chemist, compounder or dispenser in any institution maintained at the cost of, or in receipt of aid from, public funds in Northern Ireland unless he is a registered pharmaceutical chemist or a fully registered person within the meaning of[F51 section 55 of the Medical Act 1983].

Pharmacy InspectorsN.I.

24.—(1) The Department may appoint one (or, subject to the approval of the Department of Finance, more than one) fit and proper person (being a registered pharmaceutical chemist) as a Pharmacy Inspector for the purposes of this Order ( “the Pharmacy Inspector”).

(2) The Pharmacy Inspector shall discharge such duties as may be assigned to him by the Department, and the duties so assigned may include the duty of taking all reasonable steps to enforce the provisions of this Order.

(3) The Pharmacy Inspector, on producing his authority (if requested to do so), may, for the purposes of enforcing the provisions of this Order, at all reasonable times enter any registered pharmacy and make such examination and inquiry and do such other things as may be necessary for ascertaining whether the provisions of this Order are being complied with.

(4) If any person wilfully delays or obstructs the Pharmacy Inspector in the exercise of any powers under this Article, or fails without reasonable excuse to give any information which he is duly required under this Article to give, such person shall be guilty of an offence and shall be liable on summary conviction to a fine not exceeding[F52 level 3 on the standard scale].

FeesN.I.

25.—(1) The fees paid to the registrar under section 75(1) of the Medicines Act on the entry of premises in the register required to be kept under that section, and the retention or other fees, or any other sums, paid to him under section 76 of that Act, shall be paid by him to the Department.

(2) Of the fees so paid to the Department, such portion, not less than one half, as may be determined by the Department, with the consent of the Department of Finance, shall be paid to the Society.

[F53Regulations: procedureN.I.

25A.—(1) Regulations made under this Order shall be subject to negative resolution.

(2) Regulations made by the Council under this Order shall not come into operation unless and until they are approved by the Department.]

Transitional provisions, amendments and repealsN.I.

26.  Without prejudice to the operation of sections 28 and 29 of the Interpretation Act (Northern Ireland) 1954 [1954 c.33] (effect of repeal and substituting provisions)—

(a)the transitional provisions contained in Schedule 4 shall have effect;