Pharmacy Act 2007

AN ACT TO MAKE NEW PROVISION FOR THE REGULATION OF PHARMACY, INCLUDING PROVISION FOR THE DISSOLUTION OF THE PHARMACEUTICAL SOCIETY OF IRELAND AND THE SETTING UP OF A NEW PHARMACEUTICAL SOCIETY OF IRELAND, FOR THE ESTABLISHMENT, CONSTITUTION AND FUNCTIONS OF THE NEW SOCIETY’S COUNCIL, FOR A NEW SYSTEM OF REGISTRATION OF QUALIFIED PHARMACISTS, DRUGGISTS AND PHARMACEUTICAL ASSISTANTS AND OF PHARMACIES, FOR THE CREATION OF CERTAIN OFFENCES RELATING TO PHARMACY AND FOR THE SETTING UP OF NEW PROCEDURES TO ENSURE THAT PHARMACISTS ARE AND CONTINUE TO BE FIT TO PRACTISE AND TO PREVENT PHARMACISTS, PHARMACY OWNERS AND MEDICAL PRACTITIONERS FROM ENTERING INTO CERTAIN INAPPROPRIATE RELATIONSHIPS; AND TO PROVIDE FOR RELATED MATTERS. [21st April, 2007]

BE IT ENACTED BY THE OIREACHTAS AS FOLLOWS:

PART 1 Preliminary and General

1. Short title and commencement.

1.— (1) This Act may be cited as the Pharmacy Act 2007.

• (2) This Act shall come into operation on such day or days as the Minister may appoint by order or orders either generally or with reference to any particular purpose or provision and different days may be so appointed for different purposes or provisions.

2. Interpretation.

2.— (1) In this Act—

“Company” means a company within the meaning of the Companies Acts 1963 to 2005;

F1["condition" includes a restriction;]

“Council” means the Council established by section 10;

“Directive” means Directive 2001/83/EC of 6 November 2001 on the Community code relating to medicinal products for human use, as amended;

“Enduring power of attorney” means a power of attorney within the meaning of section 2 of the Powers of Attorney Act 1996, which is an enduring power construed in accordance with section 5 of that Act;

F1["health or social care", in relation to a person (howsoever described), means the health or social care that the person provides or has provided in his or her capacity or former capacity as a member of a relevant profession;

"inspect" includes search;]

“medicinal product” has the same meaning as in the Directive except that until 30 April 2011 it does not include herbal or homeopathic medicinal products;

“Minister” means the Minister for Health and Children;

F1["partner" shall be construed in accordance with the Partnership Act 1890;]

“pharmaceutical assistant” means a person who before the coming into operation of section 4(1) of this Act was competent, under section 19 of the Pharmacy Act, (Ireland) Amendment Act 1890 to transact the business of a pharmacist in his or her temporary absence;

“pharmacy owner” means a person carrying on a retail pharmacy business and, as such, being entitled to the profits and liable to sustain the losses of the business and “pharmacy”, when used with reference to a pharmacy owner, means a retail pharmacy business;

“practice” means the carrying on of practice as a registered pharmacist;

“prescribed” means prescribed by rules made by the Council;

F2[“Professional Qualifications Directive”, has the same meaning as that assigned to “Directive” in the Professional Qualifications Regulations;

“Professional Qualifications Regulations” means the European Union (Recognition of Professional Qualifications) Regulations 2017 (No. 8 of 2017);]

F1["record" includes, in addition to a record in writing—

• (a) a disc, tape, sound-track or other device in which information, sounds or signals are embodied so as to be capable (with or without the aid of some other instrument) of being reproduced in legible or audible form,

• (b) a film, tape or other device in which visual images are embodied so as to be capable (with or without the aid of some other instrument) of being reproduced in visual form, and

• (c) a photograph,

and any reference to a copy of a record includes—

• (i) in the case of a record to which paragraph (a) applies, a transcript of the sounds or signals embodied therein,

• (ii) in the case of a record to which paragraph (b) applies, a still reproduction of the images embodied therein, and

• (iii) in the case of a record to which paragraphs (a) and (b) apply, such a transcript together with such a still reproduction;]

“register” means a register set up and maintained under section 13 and “registered” and connected expressions shall be construed accordingly;

“registered medical practitioner” means a person whose name is entered in the General Register of Medical Practitioners established under the Medical Practitioners Act 1978;

F1["relevant profession" means any of the following professions:

• (a) dentist;

• (b) a designated profession within the meaning of section 3 of the Health and Social Care Professionals Act 2005;

• (c) medical practitioner;

• (d) midwife;

• (e) nurse;

• (f) pharmacist;]

F1["restriction" includes a condition;]

“retail pharmacy business” means a business (not being a professional practice carried on by a registered medical practitioner or a registered dentist) which consists of or includes the sale or supply of medicinal products other than medicinal products on a general sales list (whether or not such products on such a list are also sold or supplied in the course of the business);

“sale” means sale by retail;

“the Society” has the meaning assigned to it by section 5;

“the old Society” has the meaning assigned to it by section 5;

F1["this Act" includes a statutory instrument made under this Act;]

“supply” in relation to a medicinal product, means its supply (other than by way of sale) to a person who receives it for a purpose other than—

• (a) selling or supplying it, or

• (b) administering it or causing it to be administered to another person,

in the course of a business or profession.

• (2) References in this Act to the sale and supply or the sale or supply of a medicinal product include references to the keeping, preparing, compounding or dispensing of the medicinal product.

• (3) For the purposes of this Act, two or more premises which are separate and distinct from each other shall each be regarded as separate premises although they are parts of the same building.

• (4) Subsection (3) shall not apply to sections 63 and 64.

• (5) In the definition of “retail pharmacy business” in subsection (1), “medicinal products on a general sales list” means medicinal products which may be sold under section 32(2)(m)(ii) of the Irish Medicines Board Act 1995.

• F1[(6) Unless otherwise specified in this Act, nothing in this Act shall be construed to prejudice the performance by the Council of its functions under the Professional Qualifications Regulations as the competent authority in respect of the regulated professions (within the meaning of Regulation 3 of those Regulations) concerned.]

3. Expenses.

3.— The expenses incurred by the Minister in the administration of this Act shall, to such extent as may be sanctioned by the Minister for Finance, be paid out of money provided by the Oireachtas.

4. Repeals and revocations.

4.— (1) The enactments specified in Schedule 4 are repealed.

• (2) The European Communities (Recognition of Qualifications in Pharmacy) Regulations 1987 to 2004 are revoked.

PART 2 The Pharmaceutical Society of Ireland

5. Dissolution of old and establishment and membership of new Pharmaceutical Society of Ireland.

5.— (1) The Pharmaceutical Society of Ireland constituted and incorporated by section 4 of the Pharmacy (Ireland) Act 1875 (in this Act referred to as “the old Society”) is hereby dissolved.

• (2) There is hereby established in its place a body to be known as Cumann Cógaiseoirí na hÉireann, or, in the English language, “The Pharmaceutical Society of Ireland” (in this Act referred to as “the Society”).

• (3) Every registered pharmacist is a member of the Society.

• (4) All rights, property and liabilities of the old Society are transferred to the Society.

• (5) The Society becomes the employer of all persons who immediately before the dissolution of the old Society were its employees and shall employ each of them on terms and conditions not less favourable than those then applicable to the employee.

• (6) In—

• (a) any proceedings in a court or tribunal, and

• (b) any contract or other agreement,

to which the old Society is a party, the Society is substituted for the old Society.

• (7) References to the old Society which—

• (a) occur in any enactment passed or made before this Act is passed, and

• (b) relate to anything which becomes the responsibility of the Society by virtue of this Act,

are to be construed as references to the Society.

• (8) Anything done by, on behalf of or in respect of the old Society which relates to anything which becomes the responsibility of the Society by virtue of this Act shall be treated as if done by, on behalf of or in respect of the Society.

• (9) Enactments are to be construed and applied, so far as it is possible to do so, in a way which achieves continuity between the functions of the old Society and, so far as they correspond, those of the Society.

• (10) Stamp duty is not chargeable on an instrument under which any property owned by the old Society is transferred to the Society.

• (11) For the purposes of the Capital Gains Tax Acts (within the meaning of section 1 of the Taxes Consolidation Act 1997), any gain accruing to the old Society on a disposal made by virtue of this section shall not be a chargeable gain.

6. Status of the Society.

6.— (1) The Society is a corporate body with perpetual succession and an official seal.

• (2) The official seal of the Society shall be authenticated by—

• (a) the signature of 2 members of the Council, or

• (b) the signature of a member of the Council and an employee of the Society,

authorised by the Council to sign for that purpose.

• (3) Judicial notice shall be taken of the official seal of the Society and any document purporting to be an instrument made by and sealed by the Society shall, until the contrary is shown, be received in evidence and be deemed to be such instrument without further proof.

• (4) The Society may sue and may be sued in its corporate name.

• (5) The Society may acquire, hold and transfer land and other property.

7. Functions of the Society.

7.— (1) The principal functions of the Society shall be—

• F3[(a) to regulate the profession of pharmacy in the State, including prescribing by pharmacists, having regard to the need to protect, maintain and promote the health and safety of the public,]

• (b) to promote and ensure a high standard of education and training for persons seeking to become pharmacists,

• (c) to ensure that those persons and pharmacists obtain appropriate experience,

• (d) to ensure that pharmacists F4[and pharmaceutical assistants] undertake appropriate continuing professional development, including F5[in relation to prescribing and] the acquisition of specialisation, and

• F6[(e) to—

• (i) supervise compliance with this Act, and

• (ii) supervise compliance by pharmacists, pharmaceutical assistants and pharmacy owners in their respective capacities as such, with—

• (I) the Poisons Acts 1961 and 1977,

• (II) the Misuse of Drugs Acts 1977 to 2017,

• (III) the Animal Remedies Acts 1993 and 2006,

• (IV) the Irish Medicines Boards Acts 1995 and 2006,

• (V) the Health (Pricing and Supply of Medical Goods) Act 2013 ,

• (VI) any statutory instrument made under any of those Acts, and

• (VII) the European Communities (Animal Remedies) (No. 2) Regulations 2007 ( S.I. No. 786 of 2007),

and]

• F7[(f) to establish and maintain, in accordance with regulation 19A (inserted by regulation 7 of the Medicinal Products (Prescription and Control of Supply) (Amendment) Regulations 2015 (S.I. No. 87 of 2015)) of the Medicinal Products (Prescription and Control of Supply) Regulations 2003 (S.I. No. 540 of 2003), the ISS supply list of persons entitled to supply non-prescription medicinal products at a distance to the public by means of information society services.]

• (2) Without prejudice to the generality of subsection(1), but subject to the other provisions of this Act—

• (a) it is the duty of the Society to—

• (i) keep the registers,

• (ii) determine and apply the criteria for registration,

• (iii) draw up codes of conduct for pharmacists,

• (iv) determine, approve and keep under review programmes of education and training suitable to enable persons applying for registration to meet those criteria and pharmacists to comply with those codes,

• (v) give the Minister such information and advice about such matters relating to its functions as the Minister may call for,

• (vi) act as the competent authority for the purposes of the mutual recognition of pharmacy qualifications obtained in or recognised by Member States and for the purposes of the Professional Qualifications Directive, F8[Commission Implementing Regulation (EU) 2015/983 of 24 June 20154 and the Professional Qualifications Regulations,]

• (vii) take suitable action to improve the profession of pharmacy,

• (b) the Society shall have power to—

• (i) conduct inquiries into the qualifications and fitness of persons to practise,

• (ii) impose sanctions on pharmacists whom it finds (whether or not after an inquiry) to be unqualified or unfit to practise,

• (iii) impose sanctions on pharmacy owners whom it finds (whether or not after an inquiry) have failed to comply with regulations under section 18,

• (iv) to conduct or arrange for the conduct of examinations of persons who are applying or might apply for registration,

• (v) give the Minister such advice or information about matters relating to its functions as it thinks fit,

• (vi) facilitate the exchange of information between its members collectively or any sector of them and members of the public who use, or might use, their or its services,

• (vii) make public statements about any aspect of pharmacy to which its functions relate,

• (viii) borrow money,

• (ix) authorise persons to exercise the powers of entry and inspection, etc., of drugs and documents, as set out in section 24 of the Misuse of Drugs Act 1977,

• (x) appoint persons as authorised officers for the purposes of the Irish Medicines Board Act 1995 and furnish them with warrants, all as set out in section 32B of that Act.

• (3) In subsection (2)(a)(ii) and (iv), “registration” includes continued registration.

8. Additional functions.

8.— The Minister may, by order—

• (a) confer on the Society such additional functions, connected with those which it has,

• (b) make such provision ancillary to the exercise of the power under paragraph (a),

as the Minister thinks fit.

9. Ancillary powers.

9.— (1) The Society shall have all such powers as are necessary or expedient for the performance by it of its functions.

• (2) Without prejudice to the generality of subsection (1) or section 7 or 8, the Society may—

• (a) carry out or commission research into and evaluation of—

• (i) education and training (including the formulation and testing of experimental curricula),

• (ii) examination and assessment processes,

• (b) keep and publish statistics,

in relation to pharmacy.

PART 3 The Council of the Society

10. The Council of the Society.

10.— (1) The Society shall have a Council.

• (2) The Council shall consist of 21 persons appointed by the Minister.

• (3) Of those 21—

• (a) one shall be nominated by the Irish Medicines Board as representative of the management of the regulation of medicinal products,

• (b) one shall be nominated by the Health Services Executive as representative of the management of the public health sector,

• (c) one shall be a person appearing to the Minister to be representative of the provision of continuing professional development in relation to pharmacy,

• (d) 3 shall be persons with such qualifications, expertise, interests or experience (or such combination of any of them) as would, in the opinion of the Minister, enable them to make a substantial contribution to the performance of the Society’s functions,

• (e) 11 (including the persons referred to in paragraphs (a) to (d)) shall be persons who are not and never have been—

• (i) registered as pharmacists or (before the coming into operation of Part 4) as pharmaceutical chemists or dispensing chemists and druggists, or

• (ii) registered outside the State or otherwise qualified there as pharmacists,

• (f) 9 shall be members of the Society who have been selected by its members in accordance with rules made under section 11(2)(b), and

• (g) one shall be a member of the Society who has been selected as a representative of third level education establishments carrying out education, training or research in pharmacy, by—

• (i) the deans of the schools of pharmacy of those establishments (including, where there is no such dean, the person whose functions are the same as or most nearly correspond to those which might be carried out by a dean), and

• (ii) the heads of those establishments.

• (4) In—

• (a) making nominations under subsection (3)(a) and (b), the bodies there referred to, and

• (b) making appointments in pursuance of subsection (3)(c), (d) and (e), the Minister,

shall have regard to the desirability of ensuring that the persons nominated or, as the case may be, appointed are also representative of the public interest.

• (5) In relation to the first Council appointed after the establishment of the Society, the 9 persons referred to in subsection (3)(f) shall be members of the Council of the old Society selected for the purposes of this section by the members of the Council of the old Society before its dissolution.

• (6) Schedule 1 shall apply in relation to the Council and its members and the employees of the Society.

• (7) The Minister may not refuse to appoint to the Council a person nominated under paragraph (a) or (b) of subsection (3) or selected under paragraph (f) (as read with subsection (5)) or (g) of subsection (3).

11. Functions of the Council and their delegation.

11.— (1) Subject to this Act, the functions of the Society shall be performed on its behalf by the Council.

• (2) The Council may make rules for the purposes of—

• (a) regulating or prescribing anything that may, in accordance with any provision of this Act, be prescribed,

• (b) making such provision as it thinks fit for facilitating the performance of its functions under this Act.

• F9[(2A) The Council may make rules in relation to the specification of grounds for the purposes of section 16(2)(c) after having regard to—

• (a) the standard of education and training required to obtain recognition as a pharmacist in the State referred to in that section for persons seeking to become pharmacists,

• (b) the practical experience of such persons, and

• (c) the continued professional development for such pharmacists.

• (2B) Subject to subsection (2C), the Council may, for the purposes of section 14(1)(a) (including that section as read with section 14(5)) make rules for the purposes of setting criteria to be complied with by persons who wish to—

• (a) resume practice as a registered pharmacist after not having so practised for a period specified in the rules, or

• (b) commence practice as a registered pharmacist after not having so practised previously where a period specified in the rules has elapsed since such persons have obtained their respective qualifications in pharmacy pursuant to which they wish to so practise.

• (2C) Criteria to be complied with by persons referred to in subsection (2B) may include criteria in relation to—

• (a) the education or training of those persons,

• (b) the manner of verifying that those persons possess the relevant competencies, or

• (c) any other matter where, in the opinion of the Council, the specification in rules of criteria in relation to that matter is necessary or desirable for the protection of the public.]

• (3) The Council shall make rules for the purposes of regulating or prescribing anything relating to education or training that, in accordance with this Act, is to be prescribed.

• F10[(3A) The Council shall make rules specifying the education and training which a registered pharmacist must receive to enable him or her to prescribe medicinal products in accordance with regulations made under section 32 (2)(l)(iv) of the Irish Medicines Board Act 1995.

• (3B) Rules made under subsection (3A) shall include—

• (a) the standard of education and training required to be reached by a registered pharmacist in order to prescribe medicinal products in accordance with regulations made under section 32 (2)(l)(iv) of the Irish Medicines Board Act 1995, taking into account any practical professional experience of prescribing which the registered pharmacist may have, and

• (b) any other relevant continuing professional education.]

• (4) The Council may not make rules under F11[subsection (2), (2A), (2B) or (3)] for any purpose for which the Minister may make regulations under section 18.

• (5) Rules made under F12[subsection (2), (2A), (2B), (3) or (3A)] shall be subject to the consent of the Minister and, when the Council has made them, it shall—

• (a) submit them to the Minister for laying before each House of the Oireachtas, and

• (b) publish them in such a manner as it determines.

• (6) The Council, shall in the prescribed manner, publish—

• (a) a draft of the rules it proposes to make under this section, and

• (b) together with the draft, an invitation to the public to comment on the draft by such date as is specified in the invitation.

• (7) The Council shall have such further functions as are assigned to it by or under this Act.

• (8) The Council may delegate any of its functions to any of its committees or to the registrar or to any other employee of the Society and, where it delegates a function to a committee, the committee’s remit under this Act shall be extended accordingly.

12. Codes of conduct: reference to Competition Authority and Ministerial consent.

12.— (1) In performing the function referred to in section 7(2)(a)(iii), the Council shall—

• (a) before giving effect to a code of conduct, submit a draft of it to the Competition Authority for its opinion as to whether any provision of the draft code would, if given effect, be likely to result in competition being prevented, restricted or distorted, and

• (b) request that the opinion be given in writing to the Council before the date specified in the request.

• (2) If, before that date, the Council receives from the Competition Authority a written opinion that a provision of the draft code would, if given effect, be likely to have the result referred to in subsection (1), the Council shall either—

• (a) taking account of the opinion, change the draft code so as to obviate that result, or

• (b) if they do not so change the draft code, supply to the Minister, when submitting it for consent under subsection (3), a copy of the opinion and a written statement of its reasons for not changing the draft code under paragraph (a).

• (3) A code of conduct shall be subject to the consent of the Minister.

• (4) Subsections (1) to (3) apply also in relation to an amendment to a code of conduct and (with the substitution for the references in those subsections to the draft code or any provision in it of references to a proposal to revoke a code of conduct) to a revocation of a code of conduct.

• (5) As soon as practicable after giving effect to a code of conduct, the Council shall—

• (a) publish it in such manner as it determines, and

• (b) submit it to the Minister for laying before each House of the Oireachtas.

PART 4 Pharmaceutical Registration System

13. Registers.

13.— (1) The Council shall perform the function referred to in section 7(2)(a)(i) by—

• (a) setting up, as soon as practicable after the establishment of the Society, a register for each of the following:

• (i) pharmacists;

• (ii) druggists;

• (iii) pharmaceutical assistants;

• (iv) retail pharmacy businesses,

• (b) entering in each of the registers mentioned in subparagraphs (i) to (iii) of paragraph (a) (the “personal registers”) the name of and other prescribed information concerning every person entitled to be registered there,

• (c) entering in the retail pharmacy businesses’ register—

• (i) the address of the premises in which the business is being or is to be carried on,

• (ii) the name under which it is being or is to be carried on,

• (iii) the name of the pharmacy owner, and

• (iv) where the pharmacy owner is a corporate body, the name of the pharmacist specified under section 28(a),

• (d) otherwise maintaining the registers,

• (e) ensuring that the information in the registers is available, without charge, to the public at all reasonable times.

• (2) Without prejudice to the generality of subsection (1)(e), the Council shall publish each register by means of—

• (a) the Internet, and

• (b) at least one other method of publication,

within 12 months of the setting up of the register and thereafter at intervals of not more than 12 months.

• (3) The duties imposed by subsections (1)(e) and (2) do not extend to the home addresses, telephone numbers and e-mail addresses of individuals and to such other similar information about them as the Council considers should, in the interests of the security and privacy of those individuals, not be disclosed.

14. Procedure and criteria for registration of pharmacists.

14.— (1) The Council shall register a person in the pharmacists’ register if the person—

• (a) makes an application which complies with the prescribed requirements in relation to such an application,

• (b) complies with any requirement which may be imposed by the Council—

• (i) to verify anything contained in the application,

• (ii) to supply further information in relation to the application,

• (iii) to make a statutory declaration supplying that information,

• (c) pays the prescribed fee to the Council,

• (d) satisfies the Council that the person is fit to be a registered pharmacist,

• (e) holds a qualification appropriate for practice in accordance with section 16,

• (f) F13[…]

• (g) not being a national of the State or another Member State, satisfies the Council that he or she has the linguistic competence necessary to be a registered pharmacist in the State,

• F14[(h) being a national of the State or another Member State, satisfies the Council that he or she has the linguistic competence necessary to be a registered pharmacist in the State.]

• (2) In determining whether a person is fit to be a registered pharmacist, the Council shall have regard to whether the person has—

• (a) under the law of another state, been—

• (i) prohibited from carrying on any activity in that state corresponding to the practice of a pharmacist or the carrying on of a retail pharmacy business, or

• (ii) convicted in that state of an offence the nature of which has, in the opinion of the Council, a bearing on the person’s fitness to practise,

• (b) under the law of the State or another state, been prohibited from carrying on any other practice, profession or occupation appearing to the Council to consist or mainly to consist of the provision of health care or services or social care or services.

• (3) F15[…]

• (4) In registering a person whose qualification for practice is one to which section 16(2)(b) applies, the Council may impose a condition that the person’s practice must be supervised by a registered pharmacist specified in the condition for such period as is so specified.

• (5) Subsections (1) to (4) apply also in respect of the continued registration of a person in a personal register.

• (6) This section does not apply in respect of the first registration of a person to whom section 15(1) applies.

• (7) Subsection (1)(d) to (g) does not apply in respect of the first registration of a person who—

• (a) at any time during the period of 6 months immediately before the dissolution of the old Society (in this section referred to as the “dissolution”), became entitled to be registered as mentioned in an enactment referred to in section 15(1)(a) and, immediately before dissolution, was still so entitled but was never so registered, or

• (b) was, immediately before dissolution, a licentiate of Apothecaries Hall to whom a certificate under the Apothecaries Hall Act 1791 to transact the business of an apothecary was granted before 31 December 1975.

• (8) In this section, “another state” means a state other than the State.

15. Registration of persons registered or entitled to be registered under repealed legislation.

15.— (1) Subsections (2) and (3) make provision as respects a person who—

• (a) immediately before the dissolution of the old Society (in this section referred to as the “dissolution”) was registered—

• (i) as a pharmaceutical chemist under the Pharmacy Act (Ireland) 1875 or as a dispensing chemist and druggist under the Pharmacy Act 1951,

• (ii) as a druggist under the Pharmacy Act, (Ireland) Amendment Act 1890,

• (b) before dissolution, was a pharmaceutical assistant.

• (2) As soon as practicable after dissolution the Council shall—

• (a) in the case of a person to whom subsection (1)(a)(i) applies, register the person in the pharmacists’ register,

• (b) in the case of a person to whom subsection (1)(a)(ii) applies, register the person in the druggists’ register,

• (c) in the case of a person to whom subsection (1)(b) applies, register the person in the pharmaceutical assistants’ register.

• (3) A person who is to be registered under subsection (2) shall be regarded, for all purposes except those of that subsection, as having been so registered immediately upon dissolution.

16. Qualifications for practice.

16.— F16[(1) A person holds a qualification appropriate for practice if he or she has been awarded a prescribed qualification in the State in accordance with prescribed training and education.]

• (2) A person applying for registration in the pharmacists’ register who does not hold a qualification appropriate for practice as a pharmacist by virtue of subsection (1) shall be regarded as having a qualification appropriate for practice if—

• F17[(a) he or she is a national of a relevant state and has his or her professional qualifications recognised by the Council under the Professional Qualifications F18[Regulations,]]

• (b) he or she has, in a third country received such training and education, passed such examinations and obtained such qualifications as are, in the opinion of the Council, of a standard not lower than the standard of those necessary for practice in the F18[the State, or]

• F19[(c) he or she has a qualification in pharmacy from a state other than the State which—

• (i) falls within a ground prescribed for the purposes of this paragraph, and

• (ii) in the opinion of the Council, is of a standard not lower than the standard of that necessary for practice in the State.]

• F20[(3) The Council may—

• (a) so as to inform itself for the purposes of F18[subsection (2)(b) or (c)] about the standard of training, education, examinations and qualifications in another state, require a person to whom that provision appears to apply to sit an examination,

• (b) in any case in which it is in any doubt about a matter referred to in that provision, require a person to whom that provision appears to apply to undergo such training as it may specify.

• (4) Schedule 2 makes further provision as to the recognition of professional qualifications in pharmacy.

• (5) In this section—

“national of a relevant state” includes a person who is not a national of a relevant state, but who is an eligible person, as defined in Regulation 3 of the Professional Qualifications Regulations;

“relevant state” means—

• (a) a Member State,

• (b) a state that is a contracting state to the EEA Agreement within the meaning given by the European Communities (Amendment) Act 1993 (other than a Member State or the State),

• (c) Switzerland;

“third country” means a country that is not a relevant state.]

• (6) F21[…]

• (7) F21[…]

• (8) F21[…]

• (9) F21[…]

• (10) F21[…]

17. Procedure and criteria for registration of retail pharmacy businesses.

17.— (1) The Council shall register a retail pharmacy business in the retail pharmacy businesses’ register if the applicant for registration—

• (a) is the pharmacy owner,

• (b) specifies in the application the address of the premises in which the business is being or is to be carried on and the name under which it is being or is to be carried on and otherwise meets the prescribed requirements for the application,

• (c) specifies in the application the name of the registered pharmacist who is or is to be in whole-time charge of the carrying on of the business there,

• (d) complies with any requirement of the Council to—

• (i) verify anything contained in the application,

• (ii) supply further information in relation to the application,

• (iii) make a statutory declaration supplying that information,

• (e) pays the prescribed fee to the Council,

• (f) satisfies the Council that the retail pharmacy business will be conducted in accordance with regulations under section 18.

• (2) Where a pharmacy owner carries on business as such in two or more premises, each of those premises shall, for the purposes of subsection (1), be regarded as separate premises in which a retail pharmacy business is being or is to be carried on.

• (3) Subsections (1) and (2) apply also in respect of the continued registration of a retail pharmacy business.

• (4) A change in the ownership of a retail pharmacy business shall have the effect of cancelling its registration.

• (5) The cancellation of the registration of a retail pharmacy business under subsection (4) shall take effect—

• (a) in the case of a change in ownership brought about by the death of an owner or joint owner, at the end of the period of three months beginning with the date of the death, and

• (b) in any other case, at the end of the period of 28 days beginning with the date of the change in ownership.

• (6) In subsection (4), a “change in the ownership of a pharmacy”—

• (a) in the case of a pharmacy which is owned by two or more persons, includes a change of one of the co-owners,

• (b) in the case of a pharmacy which is not so owned, includes a change which results in its being so owned, and

• (c) in the case of a pharmacy which is owned by a company, includes the acquisition or disposal in one transaction or in a series of transactions of shares amounting in value to more than half of those issued by the company.

18. Regulation of retail pharmacy businesses.

18.— (1) The Minister may, for the purposes of the health, safety and convenience of the public, make regulations about all or any of the following matters in respect of retail pharmacy businesses:

• (a) the manner in which medicinal products are prepared there;

• (b) the supervision of those processes there;

• (c) the physical characteristics of that part of the premises which is to be provided for the conduct of those processes, including the separation of that part from the rest of the premises;

• (d) the facilities to be provided for the conduct of those processes;

• (e) the physical characteristics of the part of the premises which is to be used for the storage of medicinal products;

• (f) the conditions, (including those relating to temperature, humidity, cleanliness and sanitation) in which medicinal products are prepared, stored, sold, supplied and dispensed there;

• (g) the precautions to be taken before medicinal products are F22[prepared, supplied, sold or prescribed] there;

• (h) the disposal of medicinal products;

• (i) the manner in which medicinal products are to be F22[supplied, sold or prescribed] there;

• (j) the physical characteristics of that part of the premises which is to be provided for members of the public F22[to whom medicinal products are being sold, supplied or prescribed] or to whom medical prescriptions are being dispensed, and the facilities within that part;

• (k) the facilities to be provided and arrangements made there to enable the review, if necessary in private, of the medicinal treatment of a person to whom medicinal products are being or might be F22[sold, supplied or prescribed] and the counselling, if necessary in private, of that person in connection with that treatment;

• F22[(l) the keeping of records of and in connection with the preparation, prescribing, sale and supply of medicinal products and the preparation and dispensing of medicinal prescriptions;]

• (m) the retention, custody, transfer and disposal of those records following the cessation or transfer of the retail pharmacy business;

• (n) the use and condition of any apparatus, equipment, utensil or furnishing used for or in connection with the carrying on of the retail pharmacy business;

• (o) the safe keeping of medicinal products there.

• F23[(1A) Regulations made under this section may impose duties on—

• (a) a pharmacy owner,

• (b) a pharmacist acting in the capacity specified in section 27(b), 28(a) or 29(b), and who is in personal control of the management and administration of the sale and supply of medicinal products, either where such control is exercised in respect of a single retail pharmacy business or in respect of a number of such businesses, or

• (c) a pharmacist acting in the capacity specified in section 27(c), 28(b) or 29(c), who is in whole-time charge of the carrying on of the retail pharmacy business concerned,

to supervise, in the retail pharmacy business or retail pharmacy businesses in respect of which he or she is the pharmacy owner or such pharmacist, as the case may be, compliance by pharmacists with Chapters 2 and 3 of Part 2, and Part 3, of the Health (Pricing and Supply of Medical Goods) Act 2013.]

• (2) In subsection (1), “medicinal product” includes veterinary medicinal products within the meaning of Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 as amended by Directive 2004/28/EC of the European Parliament and of the Council of 31 March 2004.

• (3) A person who contravenes a relevant provision shall be guilty of an offence.

• (4) In subsection (3), a “relevant provision” is any provision of regulations made under this section designated as such in the regulations.

19. Inspection of premises of retail pharmacy business for the purposes of section 18.

19.— (1) In any case where the Council considers that it is appropriate, it may cause an authorised officer F24[(within the meaning of section 66)] to inspect the premises of a retail pharmacy business in respect of which an application for registration or continued registration has been made to ascertain if they comply with any regulations made by the Minister under section 18 F24[, and the provisions of Part 7 shall apply accordingly for the purposes of such inspection].

• (2) An authorised officer F24[(within the meaning of section 66)] shall, as soon as practicable after the inspection furnish a written report to the Council, and a copy of the written report to the applicant.

20. Certificate of registration.

20.— (1) As soon as practicable, the Council shall issue a certificate of registration to—

• (a) a pharmacist who has, or

• (b) a pharmacy owner whose retail pharmacy business has,

been registered or restored to a register.

• (2) On continuing the registration of a registered pharmacist or registered retail pharmacy business, the Council shall issue a certificate of continued registration to the registered pharmacist or as the case may be the owner of the registered retail pharmacy business.

• (3) A certificate of registration is current for the period of 12 months from the date of registration or restoration.

• (4) A certificate of continued registration is current for the period of 12 months beginning with the day following the date of expiry of the immediately preceding certificate.

• (5) A person who gives to another person a certificate issued to him or her under this section, with the intention that it be used to induce a third person to accept it as relating to that other person or who, with that intention, permits that other person to use the certificate, commits an offence.

• (6) A person to whom a certificate has been issued under this section and who ceases to be registered within the currency of the certificate shall return it to the registrar within 14 days of the cessation.

21. Refusal to register: notification and appeal.

21.— (1) If the Council refuses an application for registration, it shall notify the applicant in writing of its decision, the reason for it and the date when it was made.

• (2) An applicant whose application for registration under this Act is refused by the Council, may appeal to the High Court against the refusal within a period of 3 months beginning on the date of receipt of notification under subsection (1).

• (3) On an appeal under this section, the High Court may make—

• (a) an order affirming the refusal,

• (b) an order setting it aside and requiring the Council to proceed with the registration,

• (c) an order (with or without directions) remitting the application to the Council for reconsideration and the making of a new decision, or

• (d) any other order that it considers appropriate.

21A. F25[Appeal against failure to make a determination

21A.— F26[…]]

21B. F27[Declarations by registered pharmacists in relation to certain matters in State or other jurisdictions, etc.

21B.— (1) Subject to subsections (2) to (4), a registered pharmacist shall, in each year, give to the Council a declaration in writing in the specified form providing particulars of any relevant proceedings that are pending or in progress.

• (2) If, in any year, subsection (1) does not apply to a registered pharmacist because there are no particulars referred to in that subsection which he or she is required to give to the Council, the pharmacist shall give to the Council a declaration in writing to that effect.

• (3) If, in any year subsequent to a year in which a registered pharmacist gave particulars referred to in subsection (1) to the Council, there has been no material change in the matter to which the particulars relate, the pharmacist may, instead of again giving those particulars to the Council, give to the Council a declaration in writing to the effect that there has been no material change to the matter to which the particulars relate.

• (4) A registered pharmacist shall, in each year, comply with subsection (1), (2) or (3) —

• (a) not earlier than 60 days before he or she is required to pay, in that year, the prescribed fee referred to in section 14(1)(c) that applies in the case of the continued registration referred to in section 14(5), and

• (b) not later than the last day of that 60 days.

• (5) A registered pharmacist shall, not later than 3 months after the final determination of any relevant proceedings, give to the Council—

• (a) a declaration in writing providing particulars of the sanctions (if any) imposed on the pharmacist in consequence of those proceedings, or

• (b) if no such sanctions were so imposed, a declaration in writing to that effect.

• (6) The Council may, by notice in writing given to a registered pharmacist who has made a declaration under this section, require the pharmacist to provide to the Council, within a reasonable period specified in the notice, further information concerning any particulars provided to the Council in the declaration.

• (7)
• (a) A registered pharmacist shall comply with a notice under subsection (6) given to the pharmacist.

• (b) Where the Council considers that a registered pharmacist has contravened paragraph (a), the Council shall forthwith make a complaint under section 35.

• (8) In this section—

"final determination", in relation to any relevant proceedings and a registered pharmacist, means—

• (a) the conclusion of those proceedings without any party to the proceedings making an appeal, against a decision in those proceedings to impose or to not impose a sanction on the pharmacist, within the ordinary time in the State or other jurisdiction concerned, as appropriate, for making such an appeal, or

• (b) if such an appeal is made—

• (i) the abandonment or withdrawal of the appeal, or

• (ii) the determination of the appeal, whichever first occurs;

"relevant proceedings", in relation to a registered pharmacist, means any disciplinary or judicial proceedings (other than any such proceedings under this Act) in respect of which the pharmacist is the subject—

• (a) in the State or another jurisdiction which may directly or indirectly result in the pharmacist—

• (i) being prohibited from providing one or more than one kind of health or social care in the State or that jurisdiction, or

• (ii) having a restriction placed on his or her ability to provide one or more than one kind of health or social care in the State or that jurisdiction,

• (b) in another jurisdiction which may result in the pharmacist being convicted, in that jurisdiction, for an offence consisting of acts or omissions that, if done or made in the State, would constitute an offence triable on indictment, or

• (c) in the State which may result in the pharmacist being convicted, in the State, for an offence triable on indictment;

"sanction" includes any restriction or measure.]

21C. F28[Declarations by pharmacy owner.

21C.— ...]

22. Maintenance and correction of registers.

22.— (1) It is the duty of the Council to ensure that the registers are accurate.

• (2) Without prejudice to the generality of subsection (1) the Council shall—

• (a) make any alteration requiring to be made in the information contained in an entry,

• (b) correct typographical and similar errors.

• (3) The Council shall, as soon as practicable after doing anything under subsections (1) and (2), give notice in writing of that fact to the person to whom the cancellation, correction or other change relates or, as the case may be, that person’s next of kin.

• (4) A person to whom an entry in a register relates shall notify the Council in writing of—

• (a) any error that the person knows of in that entry, or

• (b) any change of circumstances that is likely to have a bearing on the accuracy of the entry,

as soon as may be after the person becomes aware of that error or change in circumstances.

23. Evidence as to the registers.

23.— In any legal proceedings—

• (a) a document signed by the registrar stating—

• (i) what is or is not registered,

• (ii) what was or was not registered and when,

is, in the absence of evidence to the contrary, proof of the matters stated,

• (b) a printed document—

• (i) appearing to be a copy of any part of or an extract from a register, and

• (ii) bearing a signed statement by the registrar that it is such a copy or extract,

is, in the absence of evidence to the contrary, proof of the content of so much of the register that is copied or extracted,

• (c) a signature appearing to be the registrar’s on any such document is, in the absence of evidence to the contrary, to be taken as being the registrar’s.

23A. F29[Council may request certain information concerning registered pharmacists from certain bodies in State or other jurisdictions.

23A.— (1) Where a registered pharmacist provides, or has provided, one or more than one kind of health or social care in the State or another jurisdiction, the Council may make a request in writing, accompanied by the relevant statement, to the body, duly authorised in the State or that jurisdiction, as appropriate, to regulate persons who provide that kind of health or social care in the State or that jurisdiction, to provide the Council with any information relevant to either or both of the following:

• (a) any material matter that has occurred in the State or that jurisdiction in relation to the pharmacist;

• (b) the pharmacist’s qualifications, or registration (or equivalent thereof in that jurisdiction), as a person who provides that kind of health or social care.

• (2) In subsection (1) —

"material matter", in relation to a registered pharmacist, means—

• (a) any of the following taken by any regulatory body (whether in or outside the State), other than the Council, in relation to the provision of one or more than one kind of health or social care by such pharmacist:

• (i) the imposition of conditions on any registration or licence;

• (ii) the suspension, withdrawal or removal of any registration or licence;

• (iii) the refusal to grant registration or a licence, or

• (b) a conviction in the State for an offence triable on indictment (other than a spent conviction within the meaning of section 5 of the Criminal Justice (Spent Convictions and Certain Disclosures) Act 2016 ) or a conviction outside the State for an offence consisting of acts or omissions that, if done or made in the State, would constitute an offence triable on indictment;

"registered pharmacist" includes a person who has made an application under section 14 for registration which has not yet been determined by the Council;

"relevant statement", in relation to a request under subsection (1), means a statement to the effect that any information provided to the Council, pursuant to that request, by the body to which the request is made may be used in any proceedings under this Act concerning the pharmacist the subject of the request.]

24. Roll of pharmacy students.

24.— (1) The Council may set up and maintain a roll of persons who are studying pharmacy in the schools of pharmacy of third level educational establishments in the State (but the fact that a person studying pharmacy there is not or has not been enrolled, shall have no effect on his or her eligibility to be awarded a qualification or to be registered).

• (2) No fee shall be payable in respect of any enrolment under subsection (1).

24A. F30[Visiting European pharmacists

24A.— F31[…]]

24B. F32[Division of Register for visiting European pharmacists

24B.— (1) The Register referred to in section 13(1)(a)(i) of this Act shall have a second part, hereinafter referred to as Part B, which shall be entitled “Visiting Pharmacists from Relevant EEA States”.

• F33[(2) The Council shall enter, in Part B of the Register of Pharmacists, the names of persons providing the services of a registered pharmacist in the State on a temporary and occasional basis pursuant to Part 4 of the Professional Qualifications Regulations.

• (3) Notwithstanding the provisions of Part 6 of this Act, the Council may cancel a registration under Part B of the Register of Pharmacists in any of the circumstances referred to Regulation 12(6) of the Professional Qualifications Regulations within two months of the date on which the information concerned becomes known to the Council.]

• (4) F34[…]

• (5) F34[…]]

PART 5 Offences

25. Interpretation of Part 5.

25.— (1) This section has effect for the purposes of the interpretation of Part 5.

• (2) In Part 5—

“3 year minimum post-registration experience” means experience of at least 3 years of—

• (a) practising whole-time as a registered pharmacist—

• (i) in a retail pharmacy business,

• (ii) before the commencement of this Act, in a shop kept open for the dispensing or compounding of medical prescriptions and the sale of poisons, or

• (iii) in a combination of both,

or

• (b) practising whole-time as a pharmacist outside the State in a business corresponding to a retail pharmacy business on foot of a qualification which was (or could have been) the qualification appropriate for practice by reference to which he or she has registered under this Act, or

• (c) any combination of the types of experience set out in paragraphs (a) and (b);

“representative” means—

• (a) in relation to a pharmacist who has died—

• (i) his or her executor or administrator, or

• (ii) where the pharmacist has died without an executor entitled and willing to carry on the retail pharmacy business and the person beneficially interested in the estate has (or, if there are two or more persons so interested, each has or all have jointly), within a period of 3 months after the death, nominated a representative to carry on the business pending the appointment of an administrator, the representative so nominated,

• (b) in relation to a pharmacist who has been adjudicated bankrupt, the official assignee in bankruptcy,

• (c) in relation to a pharmacist who is a ward of court and in respect of whom a committee has been appointed, the committee,

• (d) in relation to a pharmacist who is under a mental incapacity and in respect of whom an enduring power of attorney has been registered, the attorney.

26. Conduct of retail pharmacy business: offences.

26.— (1) A person carries on a retail pharmacy business in accordance with this section if the retail pharmacy business is registered and—

• (a) where the business is carried on by a natural person or by a partnership, the conditions set out in section 27 are met,

• (b) where the business is carried on by a corporate body, the conditions set out in section 28 are met,

• (c) where the business is carried on by a representative of a registered pharmacist, the conditions set out in section 29 are met.

• (2) A person who carries on a retail pharmacy business otherwise than in accordance with this section commits an offence.

27. Carrying on of retail pharmacy business by natural person or partnership.

27.— The conditions referred to in section 26(1)(a) are—

• (a) that the person referred to in section 26(1)(a) is a registered pharmacist or the partnership there referred to consists only of registered pharmacists,

• (b) that the part of the business that consists of the management and administration of the sale and supply of medicinal products is under the personal control of a registered pharmacist who has a 3 years minimum post-registration experience,

• (c) that, at the premises where the business is carried on, or, if there are two or more of those premises, at each of them, there is a registered pharmacist who has a 3 years minimum post-registration experience in whole-time charge of the carrying on of the business there,

• (d) that the sale and supply of medicinal products in the premises in which the business is carried on is conducted in those premises or, as the case may be, in each of them, by or under the personal supervision of a registered pharmacist,

• (e) that the name and certificate of registration of the registered pharmacist referred to in paragraph (c) and the certificate of registration of the business are conspicuously displayed at the premises in which the business is carried on or, as the case may be, at each of those premises.

28. Carrying on of retail pharmacy business by corporate body.

28.— The conditions referred to in section 26(1(b) are—

• (a) that the part of the business that consists of the management and administration of the sale and supply of medicinal products is under the personal control of a registered pharmacist who has a 3 year minimum post-registration experience and who has provided the registrar with a statement—

• (i) specifying the name of the pharmacist and declaring whether he or she is a director of the corporate body or office holder in the other body referred to in section 26(1)(b), and

• (ii) signed by the pharmacist and on behalf of the corporate body or other body,

• (b) that, at the premises where the business is carried on or, if there are two or more of those premises, at each of them, there is a registered pharmacist who has a 3 years minimum post-registration experience in whole-time charge of the carrying on of the business there,

• (c) the sale and supply of medicinal products in the premises in which the business is carried on is conducted in those premises or, as the case may be, in each of them by or under the personal supervision of a registered pharmacist,

• (d) the name and certificate of registration of the pharmacist referred to in paragraph (b) and the certificate of registration of the business are conspicuously displayed at the premises at which the business is carried on or, as the case may be, at each of them.

29. Carrying on of retail pharmacy business by representative.

29.— The conditions referred to in section 26(1)(c) are—

• (a) that the registrar has been notified of the name and address of the representative and of the pharmacist of whom he or she is a representative,

• (b) that the part of the business that consists of the management and administration of the sale and supply of medicinal products is under the personal control of a registered pharmacist who has a 3 year minimum post-registration experience,

• (c) that, at the premises where the business is carried on or, if there are two or more of those premises, at each of them, there is a registered pharmacist who has a 3 years minimum post-registration experience in whole-time charge of the carrying on of the business there,

• (d) that the sale and supply of medicinal products in the premises in which the business is carried on is conducted in those premises or, as the case may be, in each of them by or under the personal supervision of a registered pharmacist,

• (e) that the name and certificate of registration of the pharmacist referred to in paragraph (c) and the certificate of registration of the business are conspicuously displayed at the premises where the business is carried on or, as the case may be, at each of them,

• (f) that—

• (i) in the case where the event that gave rise to the appointment of the representative was the death of the registered pharmacist referred to in section 26(1)(c), not more than 5 years has elapsed since that death, and

• (ii) in any other case, not more than 3 years has elapsed since that event.

30. Saving for temporary cover by pharmaceutical assistant.

30.— (1) No offence is committed under section 26 where a registered pharmaceutical assistant acts on behalf of a registered pharmacist during the temporary absence of the registered pharmacist.

• (2) Rules made by the Council with the consent of the Minister may, for the purposes of subsection (1), provide further as to—

• (a) what may or may not be done by a registered pharmaceutical assistant when acting on behalf of a registered pharmacist,

• (b) what constitutes the temporary absence of a registered pharmacist.

31. Offence of providing skilled pharmaceutical assistance by unregistered person.

31.— (1) A person, other than—

• (a) a registered pharmacist, or

• (b) a registered pharmaceutical assistant,

who knowingly provides skilled assistance to a registered pharmacist shall be guilty of an offence.

• (2) A registered pharmacist who accepts skilled assistance from a person whom he knows or ought to know is not a registered pharmacist or a registered pharmaceutical assistant shall be guilty of an offence.

• (3) Providing or accepting skilled assistance shall not be an offence under this section if it is done as part of the training or education of a person as a pharmacist or in an activity ancillary to pharmacy.

• (4) In this section, “skilled assistance” is any assistance which consists of or includes or should consist of or include the exercise of the knowledge, ability, judgment and other qualities necessary of a person who is a pharmacist or a pharmaceutical assistant, including the exercise of that knowledge, ability and judgment and those other qualities by way of the supervision of others.

32. Offence of holding oneself out as registered pharmacist or registered druggist.

32.— (1) A person other than a registered pharmacist who holds himself or herself out as a registered pharmacist shall be guilty of an offence.

• (2) A person other than a registered druggist who holds himself or herself out as a registered druggist shall be guilty of an offence.

• (3) A person other than a registered retail pharmacy business who holds himself, herself or itself out as a registered retail pharmacy business shall be guilty of an offence.

• (4) A person, other than a registered pharmacist, who—

• (a) publicly describes himself or herself as a “pharmacist”, a “dispensing chemist”, a “pharmaceutical chemist” (whether or not with the addition of the word “registered”) or a “Member of the Pharmaceutical Society of Ireland” or “MPSI” or, in any public description of himself or herself, uses an expression mentioned in subsection (6),

• (b) uses any emblem or device from which the public might reasonably infer that he or she is a registered pharmacist, or

• (c) causes or permits such a public description or use to occur,

is, without prejudice to the generality of subsection (1), to be regarded as holding himself or herself out as a registered pharmacist.

• (5) A person, other than a registered druggist or registered pharmacist, who—

• (a) publicly describes himself or herself as a “druggist”, a “chemist and druggist” (whether or not with the addition of the word “registered”) or, in any public description of himself or herself uses an expression mentioned in subsection (6),

• (b) uses any emblem or device from which the public might reasonably infer that he or she is a registered druggist, or

• (c) causes or permits such a public description or use to occur,

is, without prejudice to the generality of subsection (2) to be regarded as holding himself or herself out to be a registered druggist.

• (6) The expressions referred to in subsections (4) and (5) are—

• (a) pharmacy,

• (b) medical stores,

• (c) drug stores,

• (d) drug hall,

• (e) medical supply stores,

• (f) medical hall,

• (g) chemist.

• (7) A person does not commit an offence under this section by using, in a public description of a registered retail pharmacy business, an expression mentioned in subsection (6).

PART 6 Complaints, Inquiries and Discipline

33. Interpretation of Part 6.

33.— In this Part—

“committee of inquiry” means a health committee or a professional conduct committee;

“complaint” means a complaint made under section 35 or 36;

“disciplinary committee” means a committee established under section 34(1);

“disciplinary sanction” means a sanction specified in any paragraph of section 48(1);

“health committee” means a committee established under section 34(1)(c);

“poor professional performance” , in relation to a registered pharmacist, means any failure of the registered pharmacist to meet the standards of competence that may be reasonably expected of a registered pharmacist;

“preliminary proceedings committee” means a committee established under section 34(1)(a);

“professional conduct committee” means a committee established under section 34(1)(b);

“professional misconduct”, in relation to a registered pharmacist, means any act, omission or pattern of conduct that—

• (a) is a breach of the code of conduct for registered pharmacists,

• (b) is infamous or disgraceful in a professional respect (notwithstanding that, if the same or like act, omission or pattern of conduct were committed by a member of another profession, it would not be professional misconduct in respect of that profession),

• (c) involves moral turpitude, fraud or dishonesty of a nature or degree which bears on the carrying on of the profession of a pharmacist, or

• (d) if the registered pharmacist has been granted a licence, certificate or registration by a body outside the State relating to the practice of pharmacy is a breach of a standard of conduct, performance or ethics that—

• (i) applies to a person holding that licence, certificate or registration, and

• (ii) corresponds to a standard contained in the code referred to in paragraph (a) or a standard breach of which amounts to conduct of the kind mentioned in paragraphs (b) or (c),

but does not include an act, omission or pattern of conduct that consists of a wrongly but honestly formed professional judgment;

“registered” in relation to a complaint against a pharmacist or retail pharmacy business includes a pharmacist or retail pharmacy business which was registered at the time when the circumstances constituting the grounds of the complaint occurred although not registered when the complaint is made or later.

34. Disciplinary committees.

34.— (1) The Council shall establish the following disciplinary committees:

• (a) a preliminary proceedings committee;

• (b) a professional conduct committee;

• (c) a health committee.

• (2) The President of the Society is not eligible to be appointed to a disciplinary committee.

• (3) A majority of the members of a disciplinary committee shall be persons other than registered pharmacists and at least one of those persons shall be appointed to represent the interest of the public.

• (4) At least one third of its members shall be registered pharmacists.

• (5) At least 2 of its members shall be registered pharmacists who are pharmacy owners.

• (6) The quorum of a disciplinary committee considering a complaint against a pharmacy owner shall include at least one registered pharmacist who is a pharmacy owner.

• (7) A person is not eligible to hold concurrent membership of more than one disciplinary committee.

• (8) The members of a disciplinary committee have, as such, the same protections and immunities as a judge of the High Court.

• (9) The Council shall appoint a registered medical practitioner with relevant expertise to advise the health committee in relation to each complaint referred to it.

• (10) The registered medical practitioner must be present at the meetings of that committee, but may not vote.

• (11) The registered medical practitioner has, when advising that committee, the same protections and immunities as a judge of the High Court.

• F35[(12) In this section, references to a pharmacy owner include references to a registered pharmacist who is a director of, or a shareholder in, a corporate body which carries on a retail pharmacy business.]

35. Complaints about registered pharmacists.

35.— (1) This section applies to a complaint made to the Council about a registered pharmacist on the grounds of—

• (a) professional misconduct within or outside the State,

• (b) poor professional performance within or outside the State,

• (c) impairment of the registered pharmacist’s ability to practise because of a physical or mental ailment, an emotional disturbance or an addiction to alcohol or drugs,

• (d) a failure to comply with a condition of registration,