Legalize / Ireland / Act

Pharmacy Act 2007

Type Act

Publication 2007-04-21

Last updated 2026-07-21

State In force

Text Latest available text

Source Irish Statute Book

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articles 85

This is the most recent text the official source publishes. It is not a snapshot of the law as it stood on the date of each change.

31 amending acts · 2026-07-21, HEALTH (PROVISION OF CONTRACEPTION PRESCRIBING SERVICE IN RETAIL PHARMACY BUSINESSES) ACT 2026

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 provide for related matters

Reform history JSON API

(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,

F36[(ea) a failure to comply with Chapter 2 or 3 of Part 2, or Part 3, of the Health (Pricing and Supply of Medical Goods) Act 2013,

(eb) a failure to comply with any duties referred to in section 18(1A) imposed on the pharmacist by regulations made under section 18.]

F37[(ec) a failure to comply, in his or her capacity as a registered pharmacist, with a provision of an Act or statutory instrument referred to in section 7(1)(e)(ii),

(ed) the imposition on the pharmacist of—

(i) a prohibition against him or her providing one or more than one kind of health or social care in the State or another jurisdiction, or

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

(f) a contravention of this Act F38[…], or

(g) a conviction in the State for an offence triable on indictment or a conviction outside the State for an offence consisting of an act or omission that, if done or made in the State, would constitute an offence triable on indictment.

(2) A complaint must be in writing or, if not, in a form acceptable to the Council.

(3) A complaint may be made by or on behalf of any person or by the registrar.

F39[(3B)
(a) The registrar may, in relation to a complaint heard, being heard or to be heard by a committee of inquiry, whenever he or she considers it necessary to do so, request in writing the Garda Síochána to give to him or her information concerning the criminal record of the registered pharmacist the subject of the complaint that the committee may reasonably require for the performance of its functions.

(b) The Garda Síochána shall, subject to section 55 of the Data Protection Act 2018 , comply with a request under paragraph (a) as soon as is practicable after receiving the request.

(c) The registrar may, whenever he or she considers it necessary to do so, request in writing that the registrar or clerk of a court which has convicted a registered pharmacist of an offence in the State to give to him or her a certificate of conviction (or, in the case of the District Court, a certified copy of the order concerned made by the Court), or a certified copy of the judgment, or both, in respect of the offence that the registrar or Council (including any committee thereof), or both, may reasonably require for the performance of his or her or its functions under this Act in relation to that pharmacist.

(d) The registrar or clerk of the court concerned the subject of a request under paragraph (c) shall comply with the request as soon as is practicable after receiving the request.

(e) In this subsection, "criminal record", in relation to a registered pharmacist, means a record of the previous convictions (other than spent convictions within the meaning of section 5 of the Criminal Justice (Spent Convictions and Certain Disclosures) Act 2016 ) of the pharmacist for offences (if any).]

(4) The Council shall inform the registered pharmacist about whom a complaint has been made of that fact and give the registered pharmacist a copy of the complaint.

(5) The Council shall take all reasonable steps to ensure that the complainant and the registered pharmacist are kept informed of the making of all decisions by it in relation to a complaint.

(6) The Council shall take all reasonable steps to ensure that a complaint is processed in a timely manner.

36. Complaints about registered retail pharmacy businesses.

36.— (1) This section applies in relation to a complaint made to the Council about a registered retail pharmacy business on the grounds that—

(a) the pharmacy owner or an employee or partner of the pharmacy owner has been convicted of an offence under this Act, any Act repealed by this Act, or regulations made under this Act or that Act, the Misuse of Drugs Acts 1977 to 2006, the Irish Medicines Board Acts 1995 and 2006, the Poisons Acts 1961 and 1977 or the Animal Remedies Acts 1993 F42[and 2006,]

(b) the pharmacy owner or an employee or a partner of the pharmacy owner has been convicted of any other offence F43[(whether in the State or another jurisdiction) or has committed misconduct (whether in the State or another jurisdiction)] and the nature of that offence or misconduct is such that, were the person applying to the Council for registration as a pharmacist, the Council would be likely to refuse to register the person,

F44[(ba) the pharmacy owner—

(i) has failed to comply, in his or her capacity as a pharmacy owner, with a provision of an Act or statutory instrument referred to in section 7(1)(e)(ii), or]

(ii) ...

(c) in a case where the business has been carried on as mentioned in sections 26 and 29 by a representative, the representative or any person engaged by the representative in connection with the carrying on of the pharmacy (whether or not for the purposes of section 29) has—

(i) been convicted of an offence mentioned in paragraph (a), or

(ii) been convicted of an offence or committed misconduct the nature of which is as mentioned in F42[paragraph (b),]

F45[F46[…]

(d) the pharmacy owner has failed to comply with any of the duties referred to in section 18(1A) imposed on the pharmacy owner by regulations made F43[under section 18, or]

F44[(e) the pharmacy owner or an employee or partner of the pharmacy owner has contravened a provision of this Act not otherwise referred to in this subsection.]]

(2) Subsections (2) to (6) of section 35 shall apply to a complaint about a registered retail pharmacy business as they apply to a complaint about a registered pharmacist but with the substitution for references to the registered pharmacist of references to the pharmacy owner or, as the case may be, the representative of that owner.

(3) In subsection (1), the references to a pharmacy owner include references to a director of a corporate body which owns the retail pharmacy business.

F47[(4) Section 35(3B) shall, with all necessary modifications, apply to a pharmacy owner as that section applies to a registered pharmacist within the meaning of that section.]

37. Mediation of complaints.

37.— (1) The Council may devise guidelines about resolving complaints by mediation.

(2) The guidelines may include provision about—

(a) determining, having regard to the public interest, whether a complaint might be satisfactorily resolved by mediation or warrants the holding of an inquiry,

(b) the persons who may mediate (“mediators”),

(c) the recording of the manner in which the complaint is resolved and of the agreement of the complainant and the registered pharmacist or pharmacy owner to the resolution,

(d) the steps to be taken (including notice to the complainant, the registered pharmacist or pharmacy owner and the preliminary proceedings committee) if the complaint cannot, in the opinion of the mediator, be resolved by mediation,

(e) any other matters that the Council considers necessary or appropriate for facilitating the resolution of a complaint by mediation.

(3) No attempt may be made to resolve a complaint by mediation without the consent of the complainant and the registered pharmacist or pharmacy owner.

(4) Consent given for the purposes of subsection (3) by a registered pharmacist or pharmacy owner shall not be taken as an admission of any allegation made by the complainant.

(5) The mediator shall report the terms of resolution of a complaint by mediation to the Council.

(6) Where the terms of resolution of a complaint consist of or include an outcome corresponding to one or more of the disciplinary sanctions set out in subsection (1)(b) of section 48, the Council may impose that or those sanctions as if under that section.

(7) No answer or statement made by the complainant or by the registered pharmacist or pharmacy owner in the course of mediation may be—

(a) communicated to any person other than those participating in the mediation, or

(b) used in any disciplinary, civil or criminal proceedings.

(8) The Council may revise any guidelines devised under this section.

(9) In this section, “mediation” includes other informal means of resolving complaints.

38. Reference of complaints to preliminary proceedings committee for advice.

38.— (1) As soon as practicable after receiving a complaint, the Council shall refer it to the preliminary proceedings committee for its advice on whether there is sufficient cause to warrant further action being taken.

(2) The committee may—

(a) require the complainant to verify, by affidavit or otherwise, anything contained in the complaint,

(b) require the complainant to give, by statutory declaration or otherwise, more information relating to the matter raised by the complaint,

(c) require the registered pharmacist or pharmacy owner to give such information in relation to the complaint as the committee specifies,

(d) invite the registered pharmacist or pharmacy owner to submit observations.

(3) A requirement under subsection (2)—

(a) must be in writing,

(b) must specify a reasonable time within which it is to be met,

(4) The registered pharmacist or pharmacy owner may give the committee information although not required to do so and submit observations although not invited to do so.

(5) Before arriving at its advice on whether there is sufficient cause to warrant further action, the committee shall consider—

(a) any information given under this section, and

(b) whether the complaint is trivial, vexatious, or made in bad faith.

39. Action by Council on advice for no further action.

39.— (1) On receiving advice pursuant to section 38, the Council shall decide whether to take further action.

(2) If the Council decides to take no further action, it shall inform the registered pharmacist or the pharmacy owner, the preliminary proceedings committee and the complainant accordingly.

40. Procedure following recommendation for, or decision to take, further action.

40.— (1) If the preliminary proceedings committee advises, pursuant to section 38, that there is sufficient cause to warrant further action or the Council decides, under section 39, to take further action, the committee shall either—

(a) refer the complaint for resolution by mediation under section 37, or

(b) refer the complaint to whichever of the following committees (“committees of inquiry”) it considers appropriate—

(i) the professional conduct committee,

(ii) the health committee.

(2) If informed by a mediator that a complaint referred for resolution by mediation—

(a) cannot be so resolved,

(b) can be so resolved but only after taking into account considerations which make the complaint more suitable for a committee of inquiry,

the committee shall refer the complaint to a committee of inquiry as if under subsection (1)(b).

41. Notification of referral of complaint to committee of inquiry and of hearing.

41.— (1) As soon as practicable after a complaint is referred to a committee of inquiry, the committee shall notify the registered pharmacist or pharmacy owner in writing of—

(a) the referral of the complaint and the name of the committee,

(b) the subject matter of the complaint, including the particulars of any evidence provided in support of the complaint, and

(c) the entitlement of the registered pharmacist or pharmacy owner, and his or her representative, to attend the committee and to be heard.

(2) After notifying the registered pharmacist or pharmacy owner under subsection (1) the committee shall arrange a hearing and fix a date, time and place for it.

(3) Not later than 30 days before the date of a hearing, the committee shall notify the registered pharmacist or pharmacy owner and the complainant in writing of the date, time and place of the hearing.

42. Hearings: procedure.

42.— (1) A hearing before the professional conduct committee shall be held in public.

(2) But it shall be held in private if—

(a) the registered pharmacist or pharmacy owner or the complainant so requests, and

(b) the committee is satisfied that it would be appropriate to agree to that request.

(3) A hearing before the health committee shall be held in private.

(4) But it shall be held in public if—

(a) the registered pharmacist or pharmacy owner or the complainant so requests, and

(b) the committee is satisfied that it would be appropriate to agree to that request.

(5) At a hearing before a committee of inquiry—

(a) any person, with leave of the committee, may lead the evidence in support of the complaint,

(b) the testimony of witnesses shall be given on oath or affirmation, and

(6) Any member of a committee of inquiry may administer oaths.

(7) A committee of inquiry may transfer a complaint to the other committee of inquiry before or after hearing any evidence relating to the complaint, but only if both committees are satisfied that—

(a) the nature of the complaint makes it appropriate to do so, and

(b) the registered pharmacist or pharmacy owner will not be prejudiced.

(8) A committee of inquiry to which a complaint is so transferred—

(a) may receive in evidence a transcript of evidence taken before the other committee of inquiry and draw conclusions of fact from the evidence,

(b) if it considers it necessary in the interests of fairness to rehear any evidence taken before the other committee of inquiry, shall do so.

43. Hearings: evidence, powers, immunities, offences, etc.

43.— (1) A committee of inquiry shall have all the powers, rights, privileges and duties of the Court or a judge of the Court that relate to—

(a) enforcing the attendance of witnesses,

(b) examining witnesses on oath or otherwise,

(d) awarding and authorising the recovery of costs.

(2) The chair, or any other member of a committee of inquiry who has been authorised for the purpose by the Council, may issue a summons for the purposes of exercising and performing the powers, rights, privileges and duties referred to in subsections (1)(a) and (c).

(3) Subsection (2) does not limit the generality of subsection (1).

(4) Subject to any rules under section 11 and to the necessity of observing fair procedures, a committee of inquiry may receive evidence given—

(a) orally before the committee,

(b) by statutory declaration,

(5) A witness before a committee of inquiry shall have the same immunities and privileges as a witness before the Court.

(6) An award of costs under subsection (1)(d) may, within 21 days of its having been made, be appealed to the District Court for the time being assigned to the district where the committee awarding the costs sat when doing so.

(7) A person shall be guilty of an offence if he or she—

(a) having been summoned to attend before a committee of inquiry, fails without reasonable excuse to attend,

(b) without reasonable excuse, refuses to—

(i) take an oath or make an affirmation,

(ii) produce or allow inspection of any record or other document or property in his or her possession or control that he or she is required to produce, or allow to be inspected, or

(iii) answer any question that he or she is lawfully required to answer,

(8) On a failure or refusal of a kind mentioned in subsection (7)(a) or (b), the Court, on application by the Council, may—

(a) order the person to attend before the committee,

(b) order the person to do the thing that he or she refused to do,

(d) authorise the award of costs.

(9) An application for the making of an order under subsection (8) does not preclude proceedings for an offence under subsection (7)(a) or (b).

(10) In this section “Court” means the High Court.

44. Procedure following withdrawal of complaint.

44.— If a complaint is withdrawn, the committee considering it may, with the Council’s agreement—

(a) decide that no further action is to be taken, or

(b) proceed as if the complaint had not been withdrawn.

45. Interim suspension of registration.

45.— (1) The High Court, on application by the Council, may by order suspend the registration of a registered pharmacist or registered retail pharmacy business against whom a complaint has been made.

(2) An order under subsection (1) suspending the registration of a retail pharmacy business may also provide for the closure of the premises in which the business has been carried on.

(3) The High Court shall not make an order under subsection (1) unless satisfied that the Council has notified the registered pharmacist or, as the case may be, the pharmacy owner of its intention to apply for an order.

(4) An order under subsection (1) may be made only if the High Court considers that there is a risk to the health and safety of the public which is of such magnitude that the pharmacist’s or pharmacy retail business’ registration should be suspended pending further procedure under this Part and, in the case of an order containing a closure provision under subsection (2), that the premises there referred to should be closed pending that procedure.

(5) An application under this section shall be heard in private, unless the High Court, on a request by the registered pharmacist or the pharmacy owner that it be heard in public, considers that it should be so heard.

F49[(6)
(a) Paragraph (b) applies where—

(i) a registered pharmacist becomes the subject of an order under subsection (1), and

(ii) the Council has reason to believe that—

(I) the pharmacist is registered in another jurisdiction as a pharmacist or has made an application to be registered as a pharmacist in another jurisdiction which has not yet been determined, and

(II) that order may not have come to the attention of the body duly authorised to perform functions in that jurisdiction that correspond to the functions of the Council.

(b) The Council shall give notice in writing to that body of that order and may, notwithstanding any provision of Directive 2005/36/EC or of the Professional Qualifications Regulations, provide that body with a copy of that order and copies of other documents relevant to that order.]

46. Undertaking and consents.

46.— (1) A committee of inquiry may, in dealing with a complaint, request the registered pharmacist or the pharmacy owner to do one or more of the following as appropriate—

(a) to undertake not to repeat the conduct to which the complaint relates,

(b) to undertake to attend specified educational courses, training or other means of improving his or her competence to practise or to carry on a retail pharmacy business,

(d) to consent to being admonished or censured by the Council.

F50[(1A) If a registered pharmacist or pharmacy owner gives an undertaking or consent the subject of a request under subsection (1) by the committee of inquiry, the inquiry into the complaint shall be considered to be completed.]

(2) If a registered pharmacist or pharmacy owner refuses to give an undertaking or consent so requested, the committee of inquiry may proceed as if the request had not been made.

47. Committee’s inquiry report.

47.— (1) On completing an inquiry, a committee of inquiry shall make a written report to the Council.

(2) The report shall specify the subject matter of the complaint, the evidence presented and the committee’s findings.

(3) The report may include such additional matters as the committee considers appropriate.

48. Action by Council on report by disciplinary committee.

48.— (1) Within 30 days after considering the report, the Council shall—

(a) if the committee finds that the complaint is not substantiated, dismiss the complaint, or

(b) if the committee finds that the complaint is substantiated, impose one or more of the following disciplinary sanctions on the registered pharmacist or the pharmacy owner—

(i) an admonishment or a censure,

(ii) the attachment of conditions to the registration of the pharmacist or retail pharmacy business, which may include restrictions on practice or, as the case may be, the carrying on of the business,

(iii) the suspension of the registration for a specified period,

(iv) the cancellation of the registration,

(v) a prohibition for a specified period on applying for restoration to the register.

(2) The Council may not cancel the registration of a pharmacist or retail pharmacy business on the grounds of a conviction for an offence unless in the Council’s opinion, the nature of the offence or the circumstances in which it was committed are such that, were the pharmacist or pharmacy owner applying for registration, the Council would refuse the registration.

F51[(3) If the report referred to in section 47(1) follows an undertaking or consent under section 46(1), then the measures to be taken in respect of the registered pharmacist or the pharmacy owner shall be those contained in the report.]

49. Notification of imposition of disciplinary sanction.

49.— (1) As soon as practicable after deciding to impose a disciplinary sanction, the Council shall notify the registered pharmacist or pharmacy owner and the complainant of the following—

(a) the disciplinary sanction imposed,

(b) the reasons for the imposition of the sanction,

F52[(2) If the Council has imposed a disciplinary sanction other than a disciplinary sanction arising out of measures referred to in section 48(3), the notification under subsection (1) must also specify—

(a) the time within which the registered pharmacist or pharmacy owner may apply to the High Court for cancellation of the decision, and

(b) in the case of a disciplinary sanction other than an admonishment or a censure, the time within which the Council may apply to the High Court for confirmation of the decision.]

50. Disciplinary sanction to be confirmed by High Court.

50.— F53[(1)]A decision under section 48 to impose a disciplinary sanction (F54[not being] an admonishment or a censure) does not take effect unless and until it is confirmed by the High Court on application under section 51 or 52.

F53[(2) A decision under section 48 to impose a disciplinary sanction (being an admonishment or a censure) does not take effect unless—

(a) the decision is confirmed by the High Court on application under section 51, or

(b) the 30 days referred to in section 51(2) within which the registered pharmacist or pharmacy owner concerned may make an application to the High Court for an order cancelling the decision expires without the registered pharmacist or pharmacy owner making such application.]

51. High Court’s power to cancel, etc., disciplinary sanction.

51.— (1) The High Court may, on application by a registered pharmacist or pharmacy owner on whom the Council has imposed a disciplinary sanction (other than F55[a disciplinary sanction arising out of measures referred to in section 48(3)]), order its cancellation.

(2) The application must be made within 30 days after receipt of the notification of the decision from the Council.

(3) The High Court may consider any evidence adduced or argument made to it, whether or not adduced or made to a committee of inquiry.

F55[(4) The High Court may, on an application for an order under subsection (1) —

(a) make any other order it considers just, including an order confirming or modifying the decision, and

(b) give the Council any direction,

and direct how the costs of the application are to be borne.]

52. Confirmation by High Court of disciplinary sanction.

52.— (1) If no application under section 51 is made within the period referred to in subsection (2) of that section, the Council shall apply to the High Court for an order confirming the decision F56[(not being a decision to impose the disciplinary sanction of an admonishment or a censure)].

(2) An application under this section must be made within 60 days of the registered pharmacist’s or pharmacy owner’s receipt of notification of the decision.

(3) The High Court may but need not confirm the Council’s decision.

(4) A suspension of registration confirmed under this section may not begin in the 7 days following the making of the order.

F56[(5) The High Court may direct how the costs of an application under this section are to be borne.]

53. Expert evidence on poor professional performance and professional misconduct.

53.— On an application under section 51 or 52, the High Court may hear evidence from any person of good standing within the profession of pharmacy as to what constitutes poor professional performance or professional misconduct in that profession.

54. Finality of decision of High Court.

54.— The decision of the High Court on an application under section 51 or 52 is final except that, by leave of the High Court or the Supreme Court, the Council or the pharmacist or pharmacy owner may appeal that decision to the Supreme Court on a question of law of public importance.

55. Notification of decision of High Court.

55.— The Council shall notify the pharmacist or pharmacy owner, in writing, of the effect of the decision of the High Court under section 51 or 52.

56. Notification of sanctions, etc., to Minister.

56.— (1) The Council shall notify the F57[Health Service Executive and such other persons as it thinks fit] as soon as practicable of—

(a) the cancellation of a registration,

(b) the restoration of a registration,

(d) the expiry of a suspension,

(e) the attachment of conditions to a registration,

(f) the removal of conditions from a registration,

(g) the prohibition for a specified period of a pharmacist or pharmacy owner from applying for restoration to the register,

(h) the admonishment or censure of a registered pharmacist or pharmacy owner.

(2) If it comes to the Council’s attention that, under the law of a state other than the State, any action corresponding to one referred to in subsection (1) has been taken in relation to a pharmacist, retail pharmacy business or pharmacy owner, the Council shall F57[, if satisfied that it is in the public interest to do so, notify the Health Service Executive] of that fact.

(3) If, in the case of a pharmacist who is an employee—

(a) the Court or the Council has taken any action specified in subsection (1), or

(b) it has come to the Council’s attention that any corresponding action of the kind referred to in subsection (2) has been taken in respect of the pharmacist,

and the Council knows who the employer of the pharmacist is, it shall F58[(if satisfied that, in the case of an action referred to in subsection (2), it is in the public interest to do so)] notify the employer of that fact.

F58[(4)
(a) Paragraph (b) applies where—

(i) it comes to the Council’s attention that any action referred to in subsection (1) has been taken in relation to a registered pharmacist, and

(ii) the Council has reason to believe that—

(I) the pharmacist is registered in another jurisdiction, and

(II) that action may not have come to the attention of the body duly authorised to perform functions in that jurisdiction that correspond to the functions of the Council.

(b) The Council shall give notice in writing to that body of that action and may, notwithstanding any provision of the Professional Qualifications Directive or of the Professional Qualifications Regulations, provide that body with copies of documents relevant to that action (including a copy of the report concerned referred to in section 47).

(5)
(a) Paragraph (b) applies where—

(i) it comes to the Council’s attention that any action referred to in subsection (2) has been taken in relation to a registered pharmacist, and

(ii) the Council has reason to believe that—

(I) the pharmacist is registered in another jurisdiction, and

(II) that action may not have come to the attention of the body duly authorised to perform functions in that jurisdiction that correspond to the functions of the Council.

(b) The Council shall, if satisfied that it is in the public interest to do so, give notice in writing to that body of that action.]

57. Public notice of sanctions, etc.

57.—F59[(1)] The Council shall, F60[(if satisfied that, in the case of an action referred to in paragraph (h) or (i), it is in the public interest to do so)], give public notice of—

(a) the cancellation of registration,

(b) the restoration of a registration,

(d) the expiry of a suspension,

(e) the attachment of conditions to a registration,

(f) the removal of conditions from a registration,

(g) the prohibition for a specified period of a pharmacist or pharmacy owner from applying for restoration to the register,

(h) the admonishment or censure of a registered pharmacist or pharmacy owner,

(i) any action in respect of which the F60[Health Service Executive] is required to be notified under section 56(2).

F59[(2) The Council shall, if it is satisfied that it is in the public interest to do so, publish a transcript of all or any part of the proceedings of a committee of inquiry at an inquiry or publish all or any part of a report referred to in section 47 of a committee of inquiry (and, in either case, whether with or without any information which would enable all, or any one or more than one, of the parties to the proceedings to be identified).

(3) The Council shall not publish anything under this section which is inconsistent with a decision (if any) of the High Court arising from the performance of a function under section 51 or 52.]

58. Absolute privilege for disciplinary proceedings, etc.

58.— In an action for defamation, anything said or done in any of the following shall be absolutely privileged—

(a) proceedings of a preliminary proceedings committee or of a committee of inquiry,

(b) communications by a committee of inquiry,

(d) mediation under section 37,

(e) communications by the Council under this Part,

(f) any other communication by the Council or a committee relating to the disciplinary proceedings.

59. Cancellation of registration on request.

59.— (1) The Council shall cancel a registration if the person to whom or the owner of the retail pharmacy business to which it relates—

(a) applies for its cancellation,

(b) pays the prescribed fee,

(2) For the purposes of subsection (1), the circumstances in which a person or owner of a retail pharmacy business is not subject to a complaint include those in which—

(a) the Council, under section 39(2), has decided to take no further action in relation to the complaint,

(b) the Council, under section 48(1) has dismissed the complaint,

(c) the Court, under section 51(1), has ordered the cancellation of a sanction which has followed on the complaint and given no direction under section 51(4)(b) that might result in another sanction.

60. Cancellation of registration on failure to pay fee.

60.— The Council may cancel a registration if the person to whom or owner of the retail pharmacy business to which it relates—

(a) has failed to pay a retention fee or a fee for recording a change in the register, and

(b) having been notified at least twice by the Council of that failure, continues so to fail.

61. Restoration of registration.

61.— (1) The Council shall restore a registration cancelled—

(a) under section 59, if the person to whom or owner of the pharmacy business to which it related—

(i) applies for its restoration,

(ii) pays the prescribed fee, and

(iii) undertakes to comply with such conditions, if any, as the Council may stipulate,

(b) under section 60, if the person to whom or owner of the retail pharmacy business to which the registration related—

(i) applies for its restoration within six months of the date when the unpaid fee became due,

(ii) pays the prescribed fee and the unpaid fee.

(2) The Council shall, however, refuse to restore a registration cancelled under section 59 or 60 if it is satisfied on the basis of new evidence or evidence of changed circumstances that, were the applicant applying instead under section 14 or, as the case may be, section 17, the Council would refuse registration on one of the grounds specified in section 14(1)(d) or (e) or, as the case may be, section 17(1)(f).

(3) The Council may, with the consent of the Court, restore a registration the cancellation of which has been confirmed under section 51 or 52.

(4) Before arriving at a decision under subsection (3), the Council shall give the pharmacist to whom the registration related an opportunity to make oral or written submissions to it.

(5) The Council may attach conditions to a restoration under subsection (3).

(6) The Council shall notify the person to whom or the owner of the retail pharmacy business to which a cancelled registration related of its decision under this section.

(7) Section 21 applies also to a refusal to restore a registration under this section.

62. Removal of conditions imposed under this Part.

62.— (1) The Council may remove a condition attached to a registration if the pharmacist, or owner of the retail pharmacy business subject to the condition—

(a) applies for its removal, and

(b) pays the prescribed fee.

(2) Before arriving at a decision under subsection (1), the Council must give the pharmacist or owner referred to in that subsection an opportunity of making oral or written submissions to it.

(3) The Council may, instead of removing a condition, amend it or substitute another for it.

(4) The Council must notify the pharmacist or owner referred to in subsection (1) of its decision under this section.

(5) Section 21 applies also to a refusal to remove a condition and to a decision to amend a condition or substitute another for it.

63. Prohibition on certain economic relationships between pharmacists or pharmacies and doctors.

63.— (1) For the purposes of section 35 and so much of this Part as relates to that section, it is professional misconduct by a registered pharmacist if—

(a) he or she, or

(b) to the knowledge of the registered pharmacist, his or her partner or employee,

has a beneficial interest in a medical practice.

(2) For the purposes of section 36 and so much of this Part as relates to that section, it is misconduct of the kind referred to in that section by a pharmacy owner if—

(a) the pharmacy owner, or

(b) to the knowledge of the pharmacy owner, a partner or employee of the pharmacy owner,

has a beneficial interest in a medical practice.

(3) For the purposes of section 45 of the Medical Practitioners Act 1978 and so much of Part V of that Act as relates to that section or any enactments re-enacting those provisions, it is professional misconduct by a registered medical practitioner if—

(a) he or she, or

(b) to the knowledge of the registered medical practitioner, his or her partner or employee,

has a beneficial interest in a registered retail pharmacy business.

(4) For the purposes of this section, an interest consisting of the ownership of a medical practice or registered retail pharmacy business (or part thereof)—

(a) is not to be taken to be a beneficial interest in the practice or business if the benefit deriving from the interest consists of the benefit of ownership alone, but

(b) is to be taken to be a beneficial interest in the practice or business if the benefit so deriving consists of or includes a financial benefit accruing to the registered pharmacist or registered medical practitioner in the exercise of his or her profession as such or, as the case may be, to the owner of the registered retail pharmacy business in his, her or its capacity as such.

(5) In this section—

(a) “beneficial interest” in a medical practice or registered retail pharmacy business includes—

(i) where the practice or business or a part of it is owned by—

(I) a company, the interest of a director of or shareholder in the company,

(II) a corporate body which is not a company, the interest of a member of the body,

(ii) where the practice or business is carried on in leased premises, the interest of the landlord in the rent or other consideration for the tenancy where that rent or other consideration—

(I) does not represent the rental value of the tenancy on the open market and the difference may reasonably be attributed to the existence of a commercial relationship between the parties other than that of landlord and tenant, or

(II) is ascertained by reference to the receipts or profits of a registered retail pharmacy business or a medical practice,

and a person shall be regarded, for the purposes of this section, as having a beneficial interest in such a practice or business if his or her spouse F61[or civil partner within the meaning of the Civil Partnership and Certain Rights and Obligations of Cohabitants Act 2010] or dependent child has such an interest in it;

“dependent child” means, in relation to a person, a child of that person who is under the age of 18 years or, if he or she has attained that age, is a child to whom paragraph (i) or (ii) of the definition of “dependent child of the family” in section 3(a) of the Family Law (Maintenance of Spouses and Children) Act 1976 applies;

“employee” means a person who works under a contract of employment (or has entered such a contract in order to do so) and includes a fixed-term employee and a temporary employee;

F62[…]

“registered medical practitioner” has the meaning given by the Medical Practitioners Act 1978 or any enactment re-enacting that definition;

“shareholder” does not include a shareholder in a company whose holding does not exceed one half of one per cent of the total value of shares issued by the company;

“spouse” does not include a spouse who is a registered pharmacist, a registered pharmaceutical assistant or a registered medical practitioner;

and

(b) references to leased premises, the landlord, the tenancy, the rental value and the tenant include, in a case where premises are made available for use or occupation on licence or similarly, references respectively to the premises so made available, the person who makes them available, the use or occupation, the value of that use or occupation and the person who uses or occupies them.

(6) A—

(a) pharmacist does not commit professional misconduct by virtue of subsection (1)(b),

(b) pharmacy owner does not commit misconduct by virtue of subsection (2)(b),

if he or she, within 21 days of becoming aware that his or her partner has a beneficial interest of the kind respectively referred to in those provisions, notifies the Society (in the case of the pharmacist or the pharmacy owner) or the Medical Council (in the case of the medical practitioner) of the existence and nature of the interest.

64. Prohibitions on carrying on retail pharmacy businesses and medical practices together and on improper recommendations.

64.— (1) A registered retail pharmacy business and a medical practice shall not be carried on—

(a) in the same premises as each other, or

(b) in premises which, although separate—

(i) are such that public access to the one is available only by way of the other, or

(ii) share a common public entrance with each other,

if there is an arrangement of the kind described in subsection (2).

(2) An arrangement is of the kind referred to in subsection (1) if it—

(a) is between the owner of the registered retail pharmacy business referred to in that subsection or the registered pharmacist in whole-time charge of that business and a registered medical practitioner practising in the medical practice referred to in that subsection, and

(b) provides for, acknowledges or regulates a financial benefit to any of them arising from or facilitated by the co-location or juxtaposition described in that subsection.

(3) A registered pharmacist or a pharmacy owner shall not recommend any medical practice or registered medical practitioner to a member of the public otherwise than in the exercise of his or her professional judgment as a pharmacist, or, as the case may be, in the proper carrying on of the business.

(4) In subsection (3), “ proper” means in a way not intended to result in a financial benefit to be derived from the medical practice or registered medical practitioner referred to in that subsection.

(5) A registered medical practitioner shall not recommend any pharmacist or retail pharmacy business to a member of the public otherwise than in the exercise of his or her professional judgment as a registered medical practitioner.

(6) A registered pharmacist or pharmacy owner who is aware of a contravention of this section shall report it to the Society.

(7) A registered medical practitioner who is aware of a contravention of this section shall report it to the Medical Council.

(8) A contravention of this section—

(a) by a registered pharmacist shall for the purposes of section 35 and so much of this Part as relates to that section, constitute professional misconduct by the registered pharmacist,

(b) by the owner of a registered retail pharmacy business shall for the purposes of section 36 and so much of this Part as relates to that section, constitute misconduct of the kind referred to in that provision by the pharmacy owner,

(c) by a registered medical practitioner shall, for the purposes of section 45 of the Medical Practitioners Act 1978 and so much of Part V of that Act as relates to that section, or any enactment re-enacting those provisions, constitute professional misconduct by the registered medical practitioner.

(9) Subsections (1) to (4) and (10) and such much of the remainder of this section as relates to those subsections shall apply in relation to a registered retail pharmacy business or medical practice which was being lawfully carried on immediately before the passing of this Act only with effect on and from such later date as is specified by order made by the Minister.

(10) In this section “registered medical practitioner” has the same meaning as in section 63.

65. Saver for certain property interests.

65.— Nothing in sections 63 and 64—

(a) shall affect—

(i) the title to any property,

(ii) the validity or terms of any lease of or other contract relating to property, or

(iii) the validity or terms of any planning permission, licence, consent or other approval (however described) relating to property,

(b) shall diminish the freedom of any person referred to in those sections to enter into a lease or other contract relating to property other than one that gives rise to a beneficial interest of the kind referred to in section 63 or consists of or includes an arrangement of the kind described in section 64.

PART 7 Powers of Investigation

66. Definitions.

66.— In this Part F63[and Schedule 3]—

“authorised officer” means a person appointed under section 67(1) to be an authorised officer;

F64[…]

“premises” is not restricted to land and buildings;

F64[…]

F63["relevant enactment" means—

(a) this Act, or

(b) any Act or statutory instrument referred to in section 7(1)(e)(ii).]

“relevant thing” means—

(a) any medicinal product,

(b) any article or substance used in the manufacture, preparation, compounding, processing or storage of any medicinal or veterinary medicinal product, and

F64[…]

67. Powers of entry, search, seizure, etc.

67.— (1) The Council—

(a) may appoint such and so many persons as the Council thinks fit to be authorised officers for the purposes of F65[this Act], and

(b) shall furnish each authorised officer so appointed with a warrant of the authorised officer’s appointment.

(2) An authorised officer shall, when performing a function given by or under F65[this Act] to an authorised officer, produce his or her warrant for inspection if requested to do so by a person affected by the performance of that function.

(3) For the purposes of ascertaining whether any F65[offence under a relevant enactment], any breach of a code of conduct or any professional misconduct has been committed or for obtaining information or evidence about these matters, an authorised officer may—

(a) subject to subsection (5), enter (if necessary by the use of reasonable force), at all reasonable times, any premises at which he or she has reasonable grounds for believing that—

(i) any trade, business or activity consisting of or connected with the carrying on of a retail pharmacy business, or

(ii) books, records or other documents (including documents stored in non-legible form) relating to such trade, business or activity are kept,

(b) at such premises inspect and take copies of, any books, records, other such documents or extracts therefrom, which he or she finds in the course of his or her inspection,

(c) remove any such books, records or other documents from such premises and detain them for such period as he or she reasonably considers to be necessary for the purposes of his or her functions under F65[this Act],

(d) carry out, or have carried out, such tests, examinations, analyses, inspections and checks of—

(i) the premises,

(ii) any relevant thing at the premises, or

(iii) any equipment, machinery or plant at the premises,

as he or she reasonably considers to be necessary for the purposes of his or her functions under F65[this Act],

(e) require any person at the premises or the owner or person in charge of the premises and any person employed there to give to him or her such assistance and information and to produce to him or her such books, records or other documents (and in the case of documents or records stored in non-legible form, produce to him or her a legible reproduction thereof) that are in that person’s power or procurement, as he or she may reasonably require for the purposes of his or her functions under F65[this Act],

(f) without payment, take samples of any relevant thing found at the premises for the purposes of any test, examination or analysis,

(g) direct that such relevant thing found at the premises as he or she, upon reasonable grounds, believes provides information about or evidence of a contravention of a provision of F65[a relevant enactment] or of a breach of a code of conduct or of the professional misconduct of a pharmacist not be sold or distributed or moved from the premises, without his or her consent,

(h) secure for later inspection any premises or part of any premises in which a relevant thing is found or ordinarily kept, or books, records or other documents are found or ordinarily kept, for such period as may reasonably be necessary for the purposes of his or her functions under F65[this Act],

(i) without payment, take possession of and remove from the premises for any test, examination or analysis any relevant thing found there, and detain it for such period as he or she considers reasonably necessary for the purposes of his or her functions under F65[this Act],

(j) without payment, take samples of any relevant thing, detained pursuant to paragraph (i), for the purposes of any test, examination, or analysis,

(k) where the taking of samples of any relevant thing pursuant to paragraphs (f) or (j) is, for whatever reason, not practicable, without payment take the relevant thing concerned for the purposes of any test, examination or analysis,

F66[(l) inspect and copy or extract information from any data, including data that constitutes personal data within the meaning of—

(i) the Data Protection Regulation, or

(ii) Part 5 of the Data Protection Act 2018.]

(m) require a person having authority to do so to break open any container or package, or to open any machine, or to permit him or her to do so, as he or she may reasonably require for the purposes of his or her functions under F65[this Act], or

(n) require a person, who makes available facilities such as post office boxes, telecommunications or electronic mail addresses or other like facilities, to give him or her such assistance and information as he or she may reasonably require for the purposes of his or her functions under F65[this Act] in any case where the officer has reasonable grounds for believing that any relevant thing is being supplied by mail or other means of delivery.

F67[(3A) Following an investigation under this section by an authorised officer, the officer shall furnish a written report on the investigation to the Council.]

(4) When performing a function under F65[this Act], an authorised officer may, subject to any warrant under subsection (6), be accompanied by such number of—

(a) other authorised officers,

(b) members of the Garda Síochána, or

as he or she considers appropriate in the circumstances of the case.

(5) An authorised officer shall not enter a dwelling, other than—

(a) with the consent of the occupier, or

(b) in accordance with a warrant issued under subsection (6).

(6) Upon the application of an authorised officer, a judge of the District Court, if satisfied that there are reasonable grounds for believing that—

(a) a relevant thing is to be found in any dwelling, or is being or has been subjected to any process or stored in any dwelling,

(b) a dwelling is occupied in whole or in part by an undertaking engaged in any trade, business or activity referred to in subsection (3)(a)(i), or

(c) books, records or other documents (including documents stored in non-legible form) referred to in subsection (3)(a)(ii) are being stored or kept in any dwelling,

may issue a warrant authorising a named authorised officer accompanied by such other authorised officers, members of the Garda Síochána, or persons with expertise relating to any relevant thing, as may be necessary, at any time or times within one month of the date of issue of the warrant, to enter the dwelling and perform any of the functions of an authorised officer under subsection (3)(b) to (n).

(7) Any person who—

(a) obstructs or interferes with an authorised officer, a member of the Garda Síochána, or a person with expertise relating to any relevant thing, in the course of performing a function conferred on him or her by F65[this Act] or a warrant under subsection (6),

(b) impedes the performance by the officer, member, or person with expertise, as the case may be, of such function or fails or refuses to comply with a request or requirement of, or to answer a question asked by, the officer, member, or person with expertise, as the case may be, pursuant to this paragraph, or

(c) in purported compliance with such request or requirement or in answer to such question gives information to the officer, member, or person with expertise, as the case may be, that he or she knows to be false or misleading in any material respect,

shall be guilty of an offence.

(8) Where an authorised officer, upon reasonable grounds, believes that a person has committed an offence under F65[a relevant enactment], he or she may require that person to provide him or her with his or her name and the address at which he or she ordinarily resides.

(9) A person who, without reasonable excuse, does not comply with a requirement under subsection (8) shall be guilty of an offence.

(10) A statement or admission made by a person pursuant to a requirement under subsection (3)(e) shall not be admissible as evidence in proceedings brought against that person for an offence (other than an offence under subsection (7)).

(11) A person who falsely represents himself or herself to be an authorised officer shall be guilty of an offence.

(12) Nothing in F65[this section] shall be taken to compel the production by any person of a document which he or she would be exempt from producing in proceedings in a court on the ground of legal professional privilege.

F68[(13) In this section, "Data Protection Regulation" means Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016³⁴ on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation).]

68. Samples.

68.— (1) Subject to subsection (3), where an authorised officer takes a sample of a relevant thing pursuant to section 67(3)(f) or (j), he or she shall—

(a) divide the sample into 3 approximately equal parts,

(b) place each part into separate containers, and

(c) forthwith seal and mark each such container in such a manner as to identify it as part of the sample taken by that authorised officer.

(2) Where an authorised officer has complied with subsection (1), he or she shall—

(a) offer one of the sealed containers to the owner or person for the time being in charge or possession of the relevant thing from which the sample concerned was taken,

(b) retain one of the sealed containers, and

(c) forward, or cause to be forwarded, one of the sealed containers for test, examination or analysis of the sample concerned by a person mentioned in section 69(1)(a), (b) or (c).

(3) Where a relevant thing is contained in a container and its division into parts pursuant to subsection (1) is, for whatever reason, not practicable, an authorised officer who wishes to take samples of such relevant things for the purposes of any tests, examination or analysis shall take possession of 3 such containers belonging to the same batch, and each such container shall be deemed to be part of a sample for the purposes of subsection (1), and the provisions of subsections (1) and (2) shall apply thereto accordingly.

(4) Where an authorised officer takes a relevant thing pursuant to section 67(3)(k), he or she shall—

(a) place the relevant thing in a container,

(b) forthwith seal and mark the container in such a manner as to identify it as a relevant thing taken pursuant to that section, and

(c) forward, or cause to be forwarded, the sealed container for test, examination or analysis of the relevant thing by a person mentioned in section 69(1)(a), (b) or (c).

69. Evidence.

69.— (1) In any proceedings for an offence under this Act, a certificate in the form specified in Schedule 3 to this Act signed by—

(a) either—

(i) the State Chemist, or

(ii) another chemist employed or engaged at the State Laboratory and authorised by the State Chemist to sign the certificate,

(b) either—

(i) a public analyst appointed under section 10 of the Sale of Food and Drugs Act 1875, or

(ii) another analyst authorised by such a public analyst to sign the certificate,

stating the result of any test, examination or analysis of a sample of any relevant thing, or of a relevant thing, as the case may be, forwarded under section 68(2)(c or (4)(c) shall, with regard to that sample of the relevant thing, or the relevant thing, as the case may be, be evidence of the matters stated in the certificate unless the contrary is proved.

(2) In proceedings for an offence under this Act, a relevant thing, or a package containing a relevant thing, that bears a trademark shall, unless the contrary is proved, be evidence that the thing was manufactured by the person who at the time of the alleged commission of the offence owned that trademark.

(3) In this paragraph, “trademark” has the same meaning as it has in the Trade Marks Act 1996.

70. Indemnification of authorised officers.

70.— Where the Council is satisfied that an authorised officer appointed by it has discharged his or her functions under this Part in good faith, the Council shall indemnify the authorised officer against all actions or claims arising out of the discharge of those functions.

71. Functions of Council on receipt of report of investigation by authorised officer.

71.— (1) The Council shall consider a written report from an authorised officer following his or her investigation under F69[this Act], as soon as practicable after receipt of it and shall do whatever of the following that it considers appropriate—

(a) take no action,

(b) commence disciplinary proceedings,

(c) if it appears to the Council that any person to whom the written report refers is guilty of an offence, it shall, subject to paragraph (d) and subsection (3), direct the registrar to take specified action and the registrar shall take such action,

(d) take such other action as it considers appropriate in the circumstances.

(2) For the purposes of subsection (1)(c), specified action to be taken by the registrar may include referring the matter to any public body or authority exercising functions which are relevant to the matters considered by the Council when directing the action referred to in that provision and, in such a case, the registrar shall furnish such information, and give such access to and facilities for inspecting and taking any copies of any documents being information or documents in the possession or under the control of the authorised officer, the Council, or the registrar and relating to the matter in question as that body or authority, may require.

(3) The action which the Council may take under subsection (1)(d) includes, in the case of an offence under this Act, the bringing by the Council of summary proceedings for the offence.

72. Penalties for offences.

72.— (1) Subject to subsection (2), a person guilty of an offence under this Act or regulations made thereunder is liable—

(a) on summary conviction, to a fine not exceeding €3,000 or imprisonment for a term not exceeding 6 months, or to both,

(b) on conviction on indictment—

(i) in the case of a first offence, to a fine not exceeding €130,000, or to imprisonment for a term not exceeding 5 years, or to both,

(ii) in the case of a second or subsequent offence under the same provision, to a fine not exceeding €320,000, or to imprisonment for a term not exceeding 10 years, or to both.

(2) Unless it is satisfied that there are special and substantial reasons for not so doing, the court shall, where the person is convicted of an offence, order a person to pay to the prosecution the costs and expenses, measured by the court, incurred by the prosecution in relation to the prosecution of the offence.

(3) Where an offence under this Act is committed by a corporate body and is proved to have been so committed with the consent, connivance or approval of, or to have been attributable to any wilful neglect on the part of, any person being a director, manager, secretary or any other officer of the corporate body or a person who was purporting to act in any such capacity, that person, as well as the corporate body, is guilty of an offence and is liable to be proceeded against and punished as if he or she were guilty of the first-mentioned offence.

(4) In subsection (3), “director” includes a shadow director within the meaning given by section 27 of the Companies Act 1990.

PART 8 Miscellaneous and General

73. Restriction of Apothecaries’ Hall Act 1791.

73.— The powers conferred by the Apothecaries’ Hall Act 1791—

(a) upon the court of directors constituted by that Act, to inspect and direct all chemical and compound preparations and experiments,

(b) to provide for or concerning the composition of medicines, and

(c) to examine apprentices and journeymen for the purposes of their learning and transacting the business of apothecaries and to certify them as qualified for those purposes,

shall cease to be exercisable.

74. Amendment of Poisons Act 1961.

74.— (1) Section 14 of the Poisons Act 1961 is amended by inserting the following after subsection (3)—

“(3A) The Minister may not, however, declare a substance whose sole use is as a medicinal product within the meaning of section 2(1) of the Pharmacy Act 2007 to be a poison for the purposes of the regulations made under subsection (2) or any provision of those regulations.”.

(2) The Poisons Act 1961 is amended by inserting the following after section 18—

“Keeping of open shop for sale of poisons.

18A.— (1) A person who, otherwise than in compliance with subsections (3) or (4), keeps open shop for the sale of poisons commits an offence.

(2) Subsection (1) does not apply in relation to the keeping of open shop by a person of a class specified in regulations under section 14 who is keeping open shop in accordance with those regulations.

(3) This subsection is complied with if—

(a) the person referred to in subsection (1) is—

(i) a registered pharmacist,

(ii) a registered druggist,

(iii) the personal representative of a person who, at the time of his or her death, was lawfully keeping open shop for the sale of poisons,

(iv) the Official Assignee or committee of a person lawfully keeping open shop for the sale of poisons who is adjudicated bankrupt or becomes an arranging debtor within the meaning of section 3 of the Bankruptcy Act 1988 or becomes of unsound mind, or

(v) a corporate body,

and

(b) the shop is personally managed by a registered pharmacist or registered druggist.

(4) The Council of the Pharmaceutical Society of Ireland shall, with the approval of the Minister, make such rules as it considers appropriate for the purpose of facilitating the operation of and compliance with subsections (1) to (4); and those rules may include provision for—

(a) the keeping of records in relation to the premises where open shop is kept for the sale of poisons and in relation to persons employed in such shops, and

(b) the furnishing of statements and returns.

(5) Subsection (4) of section 11 of the Pharmacy Act 2007 shall apply in relation to rules made under subsection (4) of this section as it applies to rules made under subsections (2) or (3) of that section.

(6) A person guilty of an offence under this section shall, on summary conviction, be liable to the same penalty as is provided for, on summary conviction, in section 72(1) of the Pharmacy Act 2007.

(7) Section 72(2) and (3) of the Pharmacy Act 2007 apply in respect of an offence under this section as they apply to an offence under that Act.”.

75. Interpretation of references to pharmaceutical chemists, persons keeping open shop, etc.

75.— (1) Any reference (however expressed) in a prior enactment to a pharmaceutical chemist registered under the Pharmacy Act (Ireland) 1875 or a dispensing chemist and druggist registered under the Pharmacy Act 1951 shall be construed as a reference to a registered pharmacist.

(2) Any reference (however expressed) in a prior enactment to a person who is keeping open shop for the dispensing or compounding of medical prescriptions under the Pharmacy Acts 1875 to 1977—

(a) where that person is, in relation to a pharmacist, a representative within the meaning given by section 25(2), shall be construed as a reference to such a representative, and

(b) in any other case, shall be construed as a reference to a registered retail pharmacy business.

(3) In this section—

“prior enactment” means an enactment passed or made before the coming into operation of this section;

“representative of a registered pharmacist” shall be construed in accordance with sections 25 and 26.

76. Codes, rules and regulations.

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