Pharmacy Act 2007

Pharmacy Act 2007 Skip to content Disclaimer Feedback Helpdesk Gaeilge Léim go dtí an t-ábhar Séanadh Aiseolas Deasc chabhrach English Gaeilge English Produced by the Office of the Attorney General Táirgthe ag Oifig an Ard-Aighne Home Legislation Acts of the Oireachtas Statutory Instruments Pre-1922 Legislation Constitution External Resources Bills (Houses of the Oireachtas) Iris Oifigiúil / Official Gazette Revised Acts (LRC) Classified List of Legislation (LRC) Translations (acts.ie) Translations (Houses of the Oireachtas) Government Publications for Sale EU Law (EUR-Lex) FAQ Disclaimer Feedback Helpdesk Search Baile Reachtaíocht Achtanna an Oireachtais Ionstraimí Reachtúla Reachtaíocht Réamh-1922 Bunreacht Acmhainní Seachtracha Billí (Tithe an Oireachtais) Iris Oifigiúil Achtanna Athbhreithnithe (CAD) (An Coimisiún um Athchóiriú an Dlí) Liosta Rangaithe Reachtaíochta Aistriúcháin (achtanna.ie) Aistriúcháin (Tithe an Oireachtais) Foilseacháin Rialtais ar Díol Dlí AE (EUR-Lex) CCanna (Ceisteanna Coitianta) Séanadh Aiseolas Deasc chabhrach Cuardach TitleTeideal Year(s) or rangeBliain nó blianta nó raon TypeCineál All Legislation Acts Statutory Instruments Advanced SearchCuardach Casta HomeBaile ActsAchtanna 2007 Pharmacy Act 2007 Pharmacy Act 2007 Permanent Page URL View by SectionAmharc de réir Ailt View Full ActAmharc ar an Acht Iomlán Bill History Stair Bille Commencement, Amendments, SIs made under the Act Tosach Feidhme, Leasuithe, IRí arna ndéanamh faoin Acht Revised Act Acht Athbh… Open PDFOscail PDF Print Full ActPriontáil an tAcht Iomlán Number 20 of 2007 PHARMACY ACT 2007 ARRANGEMENT OF SECTIONS PART 1 Preliminary and General Section 1. Short title and commencement. 2. Interpretation. 3. Expenses. 4. Repeals and revocations. PART 2 The Pharmaceutical Society of Ireland 5. Dissolution of old and establishment and membership of new Pharmaceutical Society of Ireland. 6. Status of the Society. 7. Functions of the Society. 8. Additional functions. 9. Ancillary powers. PART 3 The Council of the Society 10. The Council of the Society. 11. Functions of the Council and their delegation. 12. Codes of conduct: reference to Competition Authority and Ministerial consent. PART 4 Pharmaceutical Registration System 13. Registers. 14. Procedure and criteria for registration of pharmacists. 15. Registration of persons registered or entitled to be registered under repealed legislation. 16. Qualifications for practice. 17. Procedure and criteria for registration of retail pharmacy businesses. 18. Regulation of retail pharmacy businesses. 19. Inspection of premises of retail pharmacy business for the purposes of section 18. 20. Certificate of registration. 21. Refusal to register: notification and appeal. 22. Maintenance and correction of registers. 23. Evidence as to the registers. 24. Roll of pharmacy students. PART 5 Offences 25. Interpretation of Part 5. 26. Conduct of retail pharmacy business: offences. 27. Carrying on of retail pharmacy business by natural person or partnership. 28. Carrying on of retail pharmacy business by corporate body. 29. Carrying on of retail pharmacy business by representative. 30. Saving for temporary cover by pharmaceutical assistant. 31. Offence of providing skilled pharmaceutical assistance by unregistered person. 32. Offence of holding oneself out as registered pharmacist or registered druggist. PART 6 Complaints, Inquiries and Discipline 33. Interpretation of Part 6. 34. Disciplinary committees. 35. Complaints about registered pharmacists. 36. Complaints about registered retail pharmacy businesses. 37. Mediation of complaints. 38. Reference of complaints to preliminary proceedings committee for advice. 39. Action by Council on advice for no further action. 40. Procedure following recommendation for, or decision to take, further action. 41. Notification of referral of complaint to committee of inquiry and of hearing. 42. Hearings: procedure. 43. Hearings: evidence, powers, immunities, offences, etc. 44. Procedure following withdrawal of complaint. 45. Interim suspension of registration. 46. Undertaking and consents. 47. Committee’s inquiry report. 48. Action by Council on report by disciplinary committee. 49. Notification of imposition of disciplinary sanction. 50. Disciplinary sanction to be confirmed by High Court. 51. High Court’s power to cancel, etc. , disciplinary sanction. 52. Confirmation by High Court of disciplinary sanction. 53. Expert evidence on poor professional performance and professional misconduct. 54. Finality of decision of High Court. 55. Notification of decision of High Court. 56. Notification of sanctions, etc. , to Minister. 57. Public notice of sanctions, etc. 58. Absolute privilege for disciplinary proceedings, etc. 59. Cancellation of registration on request. 60. Cancellation of registration on failure to pay fee. 61. Restoration of registration. 62. Removal of conditions imposed under this Part. 63. Prohibition on certain economic relationships between pharmacists or pharmacies and doctors. 64. Prohibitions on carrying on retail pharmacy businesses and medical practices together and on improper recommendations. 65. Saver for certain property interests. PART 7 Powers of Investigation 66. Definitions. 67. Powers of entry, search, seizure, etc. 68. Samples. 69. Evidence. 70. Indemnification of authorised officers. 71. Functions of Council on receipt of report of investigation by authorised officer. 72. Penalties for offences. PART 8 Miscellaneous and General 73. Restriction of Apothecaries’ Hall Act 1791. 74. Amendment of Poisons Act 1961. 75. Interpretation of references to pharmaceutical chemists, persons keeping open shop, etc. 76. Codes, rules and regulations. SCHEDULE 1 The Council and its members and the society’s employees SCHEDULE 2 Recognition of Professional Qualifications in Pharmacy SCHEDULE 3 Certificate stating results of test, examination or analysis SCHEDULE 4 Enactments Repealed Acts Referred to Animal Remedies Acts 1993 and 2006 Apothecaries’ Hall Act 1791 31 Geo. 3., c.34 Bankruptcy Act 1988 1988, No. 27 Companies Act 1990 1990, No. 33 Companies Acts 1963 to 2005 Data Protection Acts 1988 and 2003 Ethics in Public Office Act 1995 1995, No. 22 European Communities (Amendment) Act 1993 1993, No. 25 European Parliament Elections Act 1997 1997, No. 2 Family Law (Maintenance of Spouses and Children) Act 1976 1976, No. 11 Irish Medicines Board Act 1995 1995, No. 29 Irish Medicines Board Acts 1995 and 2006 Medical Practitioners Act 1978 1978, No. 4 Misuse of Drugs Act 1977 1977, No. 12 Misuse of Drugs Acts 1977 to 2006 Partnership Act 1890 53 & 54 Vic., c. 93 Pharmacy Act (Ireland) 1875 38 & 39 Vic., c.57 Pharmacy Act, (Ireland) Amendment Act 1890 53 & 54 Vic., c.48 Pharmacy Act 1951 1951, No. 30 Pharmacy Act 1962 1962, No. 14 Pharmacy Acts 1875 to 1977 Poisons Act 1961 1961, No. 12 Poisons Acts 1961 and 1977 Poisons and Pharmacy Act 1908 8 Edw. 7., c. 55 Powers of Attorney Act 1996 1996, No. 12 Sale of Food and Drugs Act 1875 38 & 39 Vic., c.63 Taxes Consolidation Act 1997 1997, No. 39 Trade Marks Act 1996 1996, No. 6 Number 20 of 2007 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 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. Interpretation. 2.— (1) In this Act— “Company” means a company within the meaning of the Companies Acts 1963 to 2005; “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; “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; “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; “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 ; “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 ; “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 . 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. 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 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. 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. Functions of the Society. 7.— (1) The principal functions of the Society shall be— (a) to regulate the profession of pharmacy in the State 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 undertake appropriate continuing professional development, including the acquisition of specialisation, and (e) otherwise to supervise compliance with this Act and the instruments made under it. (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, (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. 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. 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 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). 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. (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. (4) The Council may not make rules under subsection (2) or (3) for any purpose for which the Minister may make regulations under section 18 . (5) Rules made under subsection (2) or (3) 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. 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 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. 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) is not an undischarged bankrupt, (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, (h) being a national of the State or another Member State and lacking that competence, undertakes to acquire it. (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) In registering a person who gives an undertaking under subsection (1)(h), the Council may impose a condition that the person acquires the linguistic competence referred to in that provision before practising in a way which entails dealing directly with the public. (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. 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. Qualifications for practice. 16.— (1) A person holds a qualification appropriate for practice if he or she has received in the State the prescribed training and education and has the prescribed qualifications. (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— (a) he or she is a national of a relevant state and satisfies the Council as to one of the requirements set out in subsections(3) to (5), or (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 State. (3) The first of the requirements referred to in subsection (2)(a) is that the person holds a diploma, certificate or other evidence of formal qualification in pharmacy awarded after training in accordance with Article 44 of the Professional Qualifications Directive and referred to in Annex V, point 5.6.2 to that Directive. (4) The second of those requirements is that the person holds evidence of the formal qualifications as a pharmacist referred to in Article 23 of the Professional Qualifications Directive and is a person in respect of whom a certificate has been issued by a competent authority stating that he or she has been effectively and lawfully engaged in the activities of a pharmacist for at least 3 consecutive years during the 5 years before the issue of the certificate. (5) The third of those requirements is that the person— (a) holds a diploma, certificate or other evidence of formal qualification as a pharmacist granted by a competent authority of a third country, and the diploma, certificate or other evidence has been recognised by a relevant state for the purpose of being a pharmacist in that state, and (b) has experience, of at least three years, of practising as a pharmacist in that state certified in accordance with Article 3.3 of the Professional Qualifications Directive. (6) The Council may— (a) so as to inform itself for the purposes of subsection (2)(b) 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. (7) Schedule 2 makes further provision as to the recognition of professional qualifications in pharmacy. (8) In this section— “competent authority” means, in relation to a relevant state, the authority designated in accordance with Article 56.3 of the Professional Qualifications Directive; “Professional Qualifications Directive” means Directive 2005/36/EC of 7 September 2005 on the recognition of professional qualifications as amended by Council Directive 2006/100/EC of 20 November 2006 adapting certain Directives in the field of freedom of movement of persons by reason of the accession of Bulgaria and Romania; “relevant state” means— (a) a Member State (other than the 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) the Swiss Confederation; “third country” means a country that is not a relevant state or the State. (9) An expression used in this section and also in the Professional Qualifications Directive has the same meaning in this section as it has in that Directive. 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. 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 sold or supplied there; (h) the disposal of medicinal products; (i) the manner in which medicinal products are to be sold or supplied there; (j) the physical characteristics of that part of the premises which is to be provided for members of the public being sold or supplied with medicinal products 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 sold or supplied and the counselling, if necessary in private, of that person in connection with that treatment; (l) the keeping of records of and in connection with the sale and supply of medicinal products and the dispensing of medical 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. (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. 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 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 . (2) An authorised officer 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. 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. 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. 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. 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. 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). PART 5 Offences 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. 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. 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. 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. 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. 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. 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. 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 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. 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. 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, (e) a failure to comply with an undertaking or to take any action specified in a consent given in response to a request under section 46 , (f) a contravention of this Act or rules made by the Council under this Act, or (g) a conviction in the State for an offence triable on indictment o …