Tasmania: Pharmacy Control Act 2001 (Tas)

Pharmacy Control Act 2001 An Act to provide for the regulation of pharmacy business ownership, the registration of pharmacy business premises, to repeal the Pharmacy Act 1908 and for related purposes [Royal Assent 17 December 2001] Be it enacted by His Excellency the Governor of Tasmania, by and with the advice and consent of the Legislative Council and House of Assembly, in Parliament assembled, as follows: PART 1 - Preliminary 1. Short title This Act may be cited as the Pharmacy Control Act 2001 . 2. Commencement This Act commences on a day to be proclaimed. 3. Interpretation In this Act, unless the contrary intention appears – applicant means a person who submits an application to the Authority; approved means approved by the Authority; Authority means the Tasmanian Pharmacy Authority established under section 6 ; certificate of registration means a certificate given by the Authority under section 71F ; chairperson means chairperson of the Authority; committee means a committee established by the Authority under section 13 ; eligible person means a person who holds an eligibility certificate; eligibility certificate means a certificate issued by the Authority under section 61B ; exempt person means a person who is exempt, under section 61D , from the requirement to apply for an eligibility certificate; financial year means the 12 month period ending on 30 June in any year; Friendly Society means a body that was registered under the Friendly Societies (Tasmania) Code as a society immediately before the repeal of the Friendly Societies (Tasmania) Act 1997 ; functions includes duties; guidelines means guidelines issued by the Authority; Health Complaints Commissioner means the person appointed as Health Complaints Commissioner under the Health Complaints Act 1995 ; inspection means an inspection under section 59 ; interest in a pharmacy business – see section 3B ; lapsing date, for a provision of this Act, means – (a) 30 June or, if another date is prescribed for the provision, that other date; or (b) if the Authority determines in respect of a particular person, pharmacy business or pharmacy business premises that a date other than the date specified or prescribed under paragraph (a) of this definition should be the lapsing date for the provision, the other date so determined by the Authority for that person or business or those premises; member means member of the Authority and includes the chairperson; notice means notice in writing; owner, of a pharmacy business, means the person or persons for the time being holding an eligibility certificate and named in the certificate of registration for the relevant pharmacy business premises; pharmacist means a person who holds general registration under the Health Practitioner Regulation National Law (Tasmania) in the pharmacy profession; pharmacy business – see section 3A ; pharmacy business premises means a shop or other premises where a pharmacy business is carried on; register means the Pharmacy Business Premises Register kept under section 71L ; registered means registered under this Act; registration board means a board established under section 31 of the Health Practitioner Regulation National Law (Tasmania); relevant pharmacy business, in relation to any pharmacy business premises, means the pharmacy business carried on in or from those premises; relevant pharmacy business premises in relation to a pharmacy business, means the premises in or from which the business is carried on; report includes publish; responsible tribunal means the Tasmanian Civil and Administrative Tribunal; Secretary means Secretary of the Department; specified means specified in writing by the Authority. 3A. Meaning of "pharmacy business" (1) In this section – dispensing, of narcotic substances or restricted substances, means preparing the narcotic substances or restricted substances for sale or supply to members of the public; preparing includes packaging, labelling and recording. (2) In this section, the following expressions have the same meaning as they have in the Poisons Act 1971 – (a) medicinal poison; (b) narcotic substance; (c) potent substance; (d) restricted substance. (3) For the purposes of this Act, a business is a pharmacy business if it involves any or any combination of the following activities: (a) the compounding or dispensing, by a pharmacist, of narcotic substances and restricted substances on the prescription or lawful request of a medical practitioner or other health professional; (b) the sale or supply, by a pharmacist, of potent substances; (c) the sale or supply, by a pharmacist or by an employee of that pharmacist under his or her supervision, of medicinal poisons that are in the possession, custody or control of that or another pharmacist. (4) To avoid doubt, a business that is carried on by a person to whom section 27 of the Poisons Act 1971 applies is not a pharmacy business for this Act. 3B. Meaning of "interest in a pharmacy business" (1) For the purposes of this Act, the expression interest in a pharmacy business means any legal or beneficial interest in the business, including an interest as – (a) a sole proprietor; or (b) a partner; or (c) a director, member or shareholder of a company as defined in the Corporations Act; or (d) a trustee or beneficiary of, or unit holder in, a trust. (2) Without limiting the generality of subsection (1) , a person will be taken to have an interest in a pharmacy business for the purposes of this Act if the person is party to an arrangement of a kind prescribed by the regulations. 4. Act binds Crown This Act, other than Parts 4 , 5A and 6A , binds the Crown in right of Tasmania and, so far as the legislative power of Parliament permits, in all its other capacities. 5. Application of Act Nothing in this Act extends to or affects – (a) the business of a licensed manufacturing chemist or licensed wholesale chemist, within the meaning of the Poisons Act 1971 ; or (b) a person who is authorised under the Poisons Act 1971 to sell or supply a scheduled substance, within the meaning of that Act, other than a pharmacist. 5A. Inconsistency between Act and Health Practitioner Regulation National Law (Tasmania) In the event of an inconsistency between a provision of this Act and the Health Practitioner Regulation National Law (Tasmania), the provisions of the Health Practitioner Regulation National Law (Tasmania) prevail. PART 2 - Tasmanian Pharmacy Authority Division 1 - The Authority 6. Establishment of Authority (1) The Tasmanian Pharmacy Authority is established. (2) The Authority – (a) is a body corporate with perpetual succession; and (b) may acquire, hold, dispose of and otherwise deal with property; and (c) may sue and be sued in its corporate name. 7. Membership of Authority (1) The Authority consists of – (a) two pharmacists nominated by the Secretary; and (b) one person, who is not a pharmacist, nominated by the Secretary to represent the interests of consumers. (2) The members are appointed by the Minister. (3) The Secretary, on the recommendation of the members, must appoint a member as chairperson. (4) For the purpose of making nominations under subsection (1)(a) , the Secretary may – (a) request any body that purports to represent the professional interests of pharmacists to provide the Secretary within 28 days of the date of the request with a list of names; and (b) accept a recommendation from any body that purports to represent the professional interests of pharmacists or from any pharmacist; and (c) accept an expression of interest from any pharmacist. (5) Schedule 1 has effect with respect to membership of the Authority. (6) Schedule 2 has effect with respect to meetings of the Authority. Division 2 - Functions, powers and objectives 8. Functions of Authority The Authority has the following functions: (a) to administer a scheme of registration of pharmacy business premises; (b) to approve the ownership of and interests in pharmacy businesses; (c) to ensure that the services that pharmacy businesses provide from pharmacy business premises to the public are of the highest possible standard; (d) to prosecute offences against this Act; (e) to advise the Minister on matters relating to this Act; (f) such other functions as are imposed on the Authority by this or any other Act or as may be prescribed. 9. Powers of Authority The Authority has power to do all things necessary or convenient to be done in connection with the performance of its functions and, in particular, has power to – (a) share information with pharmacists registration authorities and other relevant bodies; and (b) publish and distribute information about this Act to pharmacists and other interested persons; and (c) do anything incidental to any of its powers. 10. Delegation The Authority may delegate any of its functions or powers, other than this power of delegation, to a member of the Authority, the Registrar or a committee. 11. Guidelines (1) The Authority may issue guidelines from time to time to provide practical guidance and direction to persons on the registration and renewal of registration of pharmacy business premises and other matters under this Act. (2) The guidelines – (a) are to be written in plain language, follow a consistent style and format, and be as brief as possible consistent with their intended application; and (b) may be made so as to apply differently according to such matters, limitations or restrictions, whether as to time, location, circumstance or otherwise, as are specified in them; and (c) may confer responsibilities and discretionary responsibilities on the Authority; and (d) may not purport to impose sanctions for any failure to comply with them; and (e) may not contain provisions that are repugnant to the provisions of this or any other Act. (3) In the event that the provisions of any guideline are inconsistent with the provisions of any Act, the provisions of the Act always prevail. (4) The Authority may publish guidelines as it thinks fit having regard to their intended application. (5) No fee is chargeable or payable for issuing, supplying, obtaining or accessing a copy of any guidelines. (6) Guidelines are not – (a) statutory rules for the purposes of the Rules Publication Act 1953 ; or (b) instruments of a legislative character for the purposes of the Subordinate Legislation Act 1992 . (7) Guidelines are taken to be instruments to which section 22 of the Acts Interpretation Act 1931 applies. 12. Compliance with Treasurer's Instructions Treasurer's Instructions issued under the Financial Management Act 2016 in relation to procurement and disposal apply to the Authority as if the Authority were an Agency within the meaning of that Act. Division 3 - Miscellaneous 13. Committees (1) The Authority may establish such committees as it considers necessary for the purpose of assisting it in the performance of any of its functions or the exercise of any of its powers or advising it on any matter relating to this Act. (2) Except as otherwise provided in this Act – (a) a committee comprises such persons as the Authority appoints; and (b) a member of the Authority may be a member of a committee. (3) A member of a committee is entitled to be paid such remuneration, including travelling and subsistence allowances, as the Authority may from time to time determine and any such remuneration is to be paid by the Authority. (4) The Authority may give written directions to a committee and the committee must comply with any such directions. (5) A committee must keep accurate minutes of its proceedings. (6) Except as otherwise provided in this Act, a committee may regulate its own proceedings. 14. Registrar (1) The Authority must appoint a Registrar. (2) The Registrar may be – (a) an independent contractor to the Authority; or (b) a person whose services are made available to the Authority pursuant to an arrangement under section 15 . (3) The Registrar is to act as secretary to the Authority. 14A. . . . . . . . . 15. Use by Authority of services of persons (1) The Authority may arrange with the Head of an Agency, within the meaning of the State Service Act 2000 , for the services of persons employed in that Agency to be made available to the Authority. (2) The Authority may arrange with any other person for the services of persons employed by that person to be made available to the Authority. (3) The cost of making a person's services available to the Authority in accordance with this section is to be met by the Authority. 16. Protection from liability (1) A person engaged in the administration of this Act does not incur any personal liability for an act done or purported or omitted to be done by the person in good faith for that purpose. (2) A person who makes a complaint in good faith does not incur any personal liability in respect of any loss, damage or injury suffered by another person as a result of the making of the complaint. Division 4 - Finance and reports 17. Funds of Authority (1) The Authority is to keep such authorised deposit-taking institution accounts as it considers necessary. (2) The funds of the Authority are to be paid to the credit of such of the accounts referred to in subsection (1) as the Authority determines and are to consist of – (a) money received by way of fees, fines, penalties and charges paid to or recovered by the Authority; and (b) any money borrowed by the Authority; and (c) any money received by the Authority from other sources. (3) The funds of the Authority are to be applied – (a) in payment or discharge of the expenses, charges and obligations incurred or undertaken by the Authority in the performance of its functions and the exercise of its powers; and (b) in the payment of any remuneration payable by the Authority. (4) The Authority may invest any money that it is holding in any manner in which a trustee is authorised by law to invest trust funds. 18. Audit (1) The accounts and records of the Authority are subject to the Audit Act 2008 . (2) The Authority must pay into the Public Account such amounts as the Treasurer may require towards the reasonable costs and expenses of audits conducted pursuant to this section. 19. Accounts The Authority must keep proper accounts and records of its financial affairs and, not later than 15 August after the end of each financial year, prepare a statement of accounts in a form approved by the Auditor-General exhibiting a true and correct view of the financial position and transactions of the Authority for that financial year. 20. Annual report (1) The Authority must, not later than 31 August after the end of each financial year, give the Minister a report on its operations for that financial year. (2) The report is to incorporate the audited statement of accounts prepared for the relevant financial year under section 19 . (3) The Minister may, in writing, direct the Authority to prepare the report in a particular way or to include particular information in the report. (4) The report may be appended to an annual report of the Department. (5) Subsection (4) has effect notwithstanding section 36(3) of the State Service Act 2000 . (6) If the Authority's report is not appended to an annual report of the Department, the Minister must cause the Authority's report to be laid before each House of Parliament by not later than 31 October after the end of the financial year to which it relates. PART 3 - . . . . . . . . 21. . . . . . . . . 22. . . . . . . . . 23. . . . . . . . . 24. . . . . . . . . 25. . . . . . . . . 26. . . . . . . . . 27. . . . . . . . . 28. . . . . . . . . 29. . . . . . . . . 30. . . . . . . . . 31. . . . . . . . . 32. . . . . . . . . 33. . . . . . . . . 34. . . . . . . . . 35. . . . . . . . . 36. . . . . . . . . 37. . . . . . . . . 38. . . . . . . . . 39. . . . . . . . . 40. . . . . . . . . 41. . . . . . . . . PART 4 - Inspections Division 1 - . . . . . . . . 42. . . . . . . . . 43. . . . . . . . . 44. . . . . . . . . Division 2 - . . . . . . . . Subdivision 1 - . . . . . . . . 45. . . . . . . . . Subdivision 2 - . . . . . . . . 46. . . . . . . . . 47. . . . . . . . . 48. . . . . . . . . Subdivision 3 - . . . . . . . . 49. . . . . . . . . 50. . . . . . . . . Subdivision 4 - . . . . . . . . 51. . . . . . . . . 52. . . . . . . . . 53. . . . . . . . . 54. . . . . . . . . 55. . . . . . . . . Division 3 - . . . . . . . . 56. . . . . . . . . 57. . . . . . . . . 58. Interpretation In this Division – relevant party means – (a) in the case of registered pharmacy business premises, the owner of the relevant pharmacy business; and (b) in the case of premises sought to be registered as pharmacy business premises, the applicant for registration; and (c) in the case of all other premises, the person apparently in charge of those premises. 59. Authorisation and powers of inspectors (1) If – (a) the Authority reasonably suspects that a person may be operating a pharmacy business in breach of this Act; or (b) the Authority reasonably suspects that a person may be operating a pharmacy business from premises that may not be suitable for registration having regard to the matters set out in section 71E ; or (c) the Authority receives a referral of a complaint from the Health Complaints Commissioner; or (d) the Authority receives a request from a registration Board to inspect any premises; or (e) premises sought to be registered are being made ready to be used or have been made ready to use for the purposes of a pharmacy business; or (f) premises registered as pharmacy business premises have been, or are being, renovated or altered; or (g) the Authority wishes to carry out a random inspection on registered pharmacy business premises for the purposes of auditing those premises against the matters set out in section 71E – the Authority may, in writing, authorise a person to act as an inspector. (2) On production of the authorisation, the inspector may at any reasonable time enter the relevant premises and do all or any of the following: (a) inspect the premises generally; (b) require the person apparently in charge of the premises to produce for inspection any document held at the premises; (c) inspect and take notes of or extracts from any such document; (d) make a copy of any such document; (e) ask questions of and require answers from persons on the premises; (f) take photographs; (g) open and inspect containers or packages that the inspector reasonably suspects are used for the purpose of, or in connection with, the practice of pharmacy; (h) examine or test any equipment held on the premises; (i) require a person claiming to be a pharmacist to produce evidence of his or her registration as a pharmacist; (j) if the inspector reasonably suspects that an offence has been committed against this Act, seize and, on furnishing a receipt, remove anything that in the reasonable opinion of the inspector is evidence of the offence or contravention; (k) remove, on furnishing a receipt, any document found on the premises to the custody and control of the Authority for as long as the Authority considers necessary or expedient. (3) If the Authority is satisfied that for legitimate reasons a person needs access to a document that has been removed from the person's pharmacy business premises to the custody and control of the Authority under subsection (2)(k) , the Authority in its discretion may – (a) grant the person reasonable access to the document or to a copy of the document; or (b) provide the person with a copy or certified copy of the document; or (c) retain a copy of the document and return the original to the person. (4) A person must not give, agree to give or offer to an inspector a gift, reward or other inducement to do or abstain from doing anything in relation to an inspection. Penalty: Fine not exceeding 25 penalty units. (5) Following an inspection, an inspector is to furnish the Authority with a report – (a) detailing the nature of the inspection; and (b) containing copies of any photographs or documents and particulars of any test, examination or items seized during the course of the inspection; and (c) advising any recommendations of the inspector. 59A. Powers of Authority following inspection (1) Following receipt of a report from an inspector under section 59 , the Authority may make a decision – (a) that no further action be taken; or (b) that action is required by the relevant party to ensure that the premises are suitable for use as pharmacy business premises; or (c) that the premises are being unlawfully used as pharmacy business premises. (2) If the Authority determines that action is required by the relevant party pursuant to subsection (1)(b) , the Authority may direct the relevant party to carry out specified works or actions in relation to the pharmacy business premises and, if it considers it appropriate to do so in the circumstances, further direct the relevant party to close, and not trade from, the pharmacy business premises until those works or actions have been carried out. (3) If the Authority determines that the premises are being unlawfully used as pharmacy business premises pursuant to subsection (1)(c) , the Authority may take appropriate action in accordance with this Act to prevent the further unlawful use of the premises as pharmacy business premises. (4) The Authority is to serve a notice of its decision made under subsection (1) on the relevant party. (5) The written decision of the Authority is to contain the following information: (a) the reason for the decision; (b) in the case of a decision referred to in subsection (1)(b) – (i) a general description of the work to be carried out at the premises; and (ii) whether the decision includes a direction under subsection (2)(b) that the pharmacy business premises be closed until the work or actions have been carried out; and (iii) the day on which the decision is to take effect; and (iv) the relevant party's right to appeal against the decision to the responsible tribunal under section 60 ; (c) in the case of a decision referred to in subsection (1)(c) – (i) a statement to the effect that the premises are being unlawfully used as pharmacy business premises; and (ii) a statement to the effect that the premises must not continue to be used as pharmacy business premises; and (iii) the date upon which the notice was served; and (iv) the relevant party's right to appeal against the decision to the responsible tribunal under section 60 . (6) A decision of the Authority referred to in subsection (1)(b) or (c) takes effect notwithstanding the relevant party's right of appeal. (7) Nothing in subsection (6) is intended to restrict – (a) a relevant party's right to appeal the decision of the Authority; or (b) the responsible tribunal's power to order a stay of the decision; or (c) the Authority's power to prosecute for an offence committed under this Act. (8) If the Authority's decision under subsection (1)(b) or (c) takes effect, the Authority may do any or all of the following: (a) give notice of its decision to a registration board and such other bodies as it considers appropriate; (b) give notice of its decision to the Secretary; (c) cause notice of its decision to be published in the Gazette, in any newspaper or in any professional publication related to the practice of pharmacy; (d) cause notice of its decision to be published in any other way it considers appropriate. (9) The Authority may not do any of the things specified in subsection (8) until – (a) the expiration of the period within which the relevant party may lodge an appeal against the decision; or (b) if the relevant party lodges an appeal against the decision, the decision is affirmed or varied by the responsible tribunal or the appeal is withdrawn. (10) The Authority, as an alternative to taking action under subsection (2)(a) or (b) , may accept an undertaking from the relevant party to take or refrain from taking specified action either generally or within a specified period of time. (11) If the Authority has appointed an inspector following the referral of a complaint from the Health Complaints Commissioner, the Authority must, within a reasonable period, notify the Health Complaints Commissioner of the outcome of the inspection, including details of any notice served under subsection (4) . (12) If the Authority has appointed an inspector following a request from a registration board, the Authority must, within a reasonable period, notify the relevant registration board of the outcome of the inspection, including details of any notice served under subsection (4) . 59B. Failure to comply with Authority's direction (1) If the Authority – (a) takes action under section 59A(2)(a) or (b) ; or (b) accepts an undertaking under section 59A(10) – and the relevant party fails to comply with the direction or undertaking, the Authority may take action under section 71H . (2) The Authority may not take action under section 71H until – (a) the expiration of the period within which the relevant party may lodge an appeal against the decision; or (b) if the relevant party lodges an appeal against the decision, the decision is affirmed or varied by the responsible tribunal or the appeal is withdrawn. PART 5 - Appeals 60. Right of appeal (1) A person may appeal to the responsible tribunal if the person is aggrieved by a decision of the Authority that is made for the purposes of this Act. (a) . . . . . . . . (b) . . . . . . . . (c) . . . . . . . . (d) . . . . . . . . (e) . . . . . . . . (f) . . . . . . . . (g) . . . . . . . . (h) . . . . . . . . (i) . . . . . . . . (j) . . . . . . . . (k) . . . . . . . . (2) The appeal is to be instituted within 28 days after notice of the Authority's decision is given to the person. 61. . . . . . . . . PART 5A - Interests in Pharmacy Businesses 61A. Application of Part (1) This Part does not bind the Crown. (2) This Part does not apply to a pharmacy business located wholly within a hospital operated by an agency or instrumentality of the Crown in right of Tasmania or the Commonwealth. (3) In this Part – close relative, of a pharmacist, means – (a) the spouse of the pharmacist; or (b) the son, daughter, grandson or granddaughter of the pharmacist; or (c) any child of the spouse of the pharmacist, of whom the pharmacist is not the natural parent; or (d) the father, stepfather, mother or stepmother of the pharmacist; or (e) the brother, step-brother, sister or step-sister of the pharmacist; spouse, in relation to a pharmacist, includes a person who is in a significant relationship with the pharmacist within the meaning of the Relationships Act 2003 . 61B. Applying to hold an interest in pharmacy business (1) A person, including a body corporate, that intends to hold an interest in a pharmacy business must apply to the Authority for a certificate deeming the person to be eligible to hold an interest in a pharmacy business (an eligibility certificate), unless the person is an exempt person. (2) An application is to be – (a) in an approved form; and (b) lodged with the Authority; and (c) accompanied by the prescribed application fee, if any; and (d) accompanied by such information or evidence as the Authority requires. (3) The Authority may require the applicant to provide such further information or evidence as it considers necessary in order to consider the application. (4) The Authority may waive all or part of the application fee. (5) The Authority, after considering an application for an eligibility certificate may – (a) issue an eligibility certificate; or (b) refuse to issue an eligibility certificate. (6) The Authority must issue an eligibility certificate to an applicant if – (a) the applicant is an eligible person within the meaning of section 61C ; and (b) the applicant is a fit and proper person, and in the case of a body corporate each of its members is a fit and proper person, to hold an interest in a pharmacy business; and (c) the applicant complies with subsections (2) and (3) . (7) An eligibility certificate remains in force until the earlier of the following: (a) the lapsing date following its date of issue; (b) the end of the period of 14 days commencing on the day a change occurs in the matters relied upon in support of the application for the certificate. (8) If the Authority refuses to issue an eligibility certificate, the Authority is to give the applicant notice of – (a) the refusal; and (b) the reasons for the refusal; and (c) the right to appeal the refusal. 61C. Eligibility (1) A person is eligible to hold an interest in a pharmacy business if, and only if – (a) in the case of a natural person, he or she is a pharmacist, whether or not that pharmacist has had his or her registration suspended within the meaning of the Health Practitioner Regulation National Law (Tasmania); or (b) in the case of a partnership, each member of the partnership is a pharmacist whether or not one or more of those pharmacists have had their registrations suspended within the meaning of the National Practitioner Regulation National Law (Tasmania); or (c) in the case of a body corporate, each director of the body corporate is a pharmacist and each other member of the body corporate is a pharmacist or a close relative of a pharmacist and – (i) the controlling interest in the body corporate is held by a pharmacist or by persons who are pharmacists; and (ii) all the shares and the beneficial interest in those shares are held by pharmacists or close relatives of a pharmacist; and (iii) control and supervision of any pharmacy services carried on by the pharmacy business are vested in a person who is a pharmacist or in persons who are pharmacists; or (d) the person is a body corporate lawfully permitted to call itself a Friendly Society and – (i) control and supervision of the pharmacy business is, or will be, vested in a pharmacist; and (ii) that body corporate held an interest in a pharmacy business in this State before the commencement of the Pharmacists Registration Amendment Act 2010 . (2) Nothing in this section prevents a person who is eligible under subsection (1) from holding the eligible person's interest on trust for a beneficiary if each beneficiary is – (a) a pharmacist; or (b) a close relative of a pharmacist; or (c) a trustee of another trust, each beneficiary or, if applicable, each unit holder of which is – (i) a pharmacist; or (ii) a close relative of a pharmacist. 61D. Exemptions A person is exempt from the requirement to apply for an eligibility certificate if – (a) the person is a member of a body corporate that has applied for, or holds, an eligibility certificate; or (b) the person is a beneficiary of or unit holder in a trust referred to in section 61C(2) and the trustee of that trust has applied for, or holds, an eligibility certificate; or (c) the person is the executor, administrator or trustee of the estate of a pharmacist who has died or become bankrupt while holding an interest in a pharmacy business, and – (i) the executor, administrator or trustee notifies the Authority that it has assumed the interest within 14 days of so assuming; and (ii) control and supervision of any pharmacy services carried on by that pharmacy business are vested in a pharmacist; and (iii) a period not exceeding the duration of the eligibility certificate held by the pharmacist prior to his or her death or bankruptcy, or such longer time as the Authority determines, has not elapsed; or (d) the person is an administrator or liquidator of a body corporate that has become insolvent while holding an interest in a pharmacy business and – (i) the administrator or liquidator notifies the Authority that it has assumed the interest within 14 days of so assuming; and (ii) control and supervision of any pharmacy services carried on by that pharmacy business are vested in a pharmacist; and (iii) a period not exceeding the duration of the eligibility certificate held by the body corporate prior to its insolvency, or such longer time as the Authority determines, has not elapsed; or (e) the person assumes the administration of the property of a pharmacist under a mortgage, bill of sale or security interest and – (i) the person notifies the Authority within 14 days of so assuming; and (ii) control and supervision of any pharmacy services carried on on the property are vested in a pharmacist; and (iii) a period not exceeding the duration of the eligibility certificate held by the pharmacist prior to the assumption of the pharmacist's property, or such longer time as the Authority determines, has not elapsed. 61E. Annual renewal of eligibility certificate (1) On or before the lapsing date each year, the holder of an eligibility certificate may apply for the renewal of the eligibility certificate. (2) An application for renewal of an eligibility certificate is to be – (a) in an approved form; and (b) lodged with the Authority; and (c) accompanied by the prescribed renewal fee, if any; and (d) accompanied by such information or evidence as the Authority requires. (3) The Authority may, upon receipt of an application for renewal of an eligibility certificate, require the applicant to provide such further information or evidence as it considers necessary in order to consider the application. (4) The Authority may waive all or part of the fee. (5) The Authority, after considering an application for renewal of an eligibility certificate may – (a) renew an eligibility certificate; or (b) refuse to renew an eligibility certificate. (6) The Authority may refuse to renew an eligibility certificate if – (a) the applicant fails to comply with subsection (2) or (3) ; or (b) the Authority reasonably believes that the applicant no longer meets the criteria for eligibility set out in section 61B(6) ; or (c) the Authority is satisfied that the facts or matters relied upon in support of the original application, including, in the case of a body corporate, details of its membership, have changed; or (d) the application is made more than 30 days after the lapsing date. (7) If the Authority refuses to renew an eligibility certificate, the Authority is to give the applicant notice of – (a) the refusal; and (b) the reasons for the refusal; and (c) the right to appeal the refusal. (8) A person who applies after the lapsing date but within 30 days after the due date is liable to pay the prescribed late fee. (9) If a person applies for a renewal of an eligibility certificate on or before the lapsing date in accordance with subsection (1) or within 30 days after the lapsing date in accordance with subsection (8) , the eligibility certificate is taken to continue until the earlier of the following: (a) the date upon which the Authority renews the eligibility certificate; (b) the date upon which the Authority gives a notice under subsection (7) . (10) Nothing in this section prevents a person from applying for a new eligibility certificate where the facts and matters relied upon in support of the original application, including, in the case of a body corporate, details of its membership, have changed. 61F. Persons are not required to hold more than one eligibility certificate (1) Subject to section 65 , an eligibility certificate has effect for multiple pharmacy businesses and, accordingly, a person who holds an interest in more than one pharmacy business is not required to hold more than the one eligibility certificate in respect of those interests. (2) However, subsection (1) applies only if, and only to the extent that, the person holds the various interests in the same legal capacity. PART 6 - Public and professional safeguards Division 1 - Public and professional safeguards 62. Offence for certain persons to hold interest in pharmacy business &c. (1) A person must not hold an interest in a pharmacy business unless – (a) the person holds an eligibility certificate; or (b) the person is an exempt person. Penalty: Fine not exceeding 200 penalty units and, in the case of a continuing offence, a further fine not exceeding 20 penalty units for each day during which the offence continues. (2) A person who holds an eligibility certificate must not hold an interest in a pharmacy business if the person knows or ought to know that the facts relied upon in support of the application for an eligibility certificate have changed and the person has not, within 14 days since the change, applied for a new eligibility certificate. Penalty: Fine not exceeding 200 penalty units and, in the case of a continuing offence, a further fine not exceeding 20 penalty units for each day during which the offence continues. 63. . . . . . . . . 64. . . . . . . . . 65. Limitation on number of pharmacies in which person may have interest (1) A person, including a body corporate, must not, at any one time, either alone or in partnership with another person or as a member of a body corporate or as a trustee, beneficiary or unit holder of a trust, hold an interest in more than 4 pharmacy businesses. Penalty: Fine not exceeding 100 penalty units and, in the case of a continuing offence, a further fine not exceeding 10 penalty units for each day during which the offence continues. (2) In this section – pharmacy business means a pharmacy business that is carried on in or from the one premises; premises does not include individual premises that are the subject of an exemption under section 71J that has been granted for a period not exceeding 3 months. 66. Protection of title A person must not, in the course of carrying on business, use the word "pharmacy" to describe the business or the premises unless the business premises are registered under this Act. Penalty: Fine not exceeding 100 penalty units. Division 2 - General offences 67. Time limit for prosecuting offences Proceedings for an offence against this Act may be commenced not later than 24 months after the date on which the offence is alleged to have been committed. 68. Offences of dishonesty (1) A person must not make or produce, or cause to be made or produced, a false or misleading statement, either orally or in writing, in connection with – (a) an application; or (b) . . . . . . . . (c) an inspection. Penalty: Fine not exceeding 100 penalty units. (2) . . . . . . . . (3) . . . . . . . . 69. Obstruction &c. A person must not obstruct, hinder, threaten or intimidate another person – (a) in the exercise by the other person of a power conferred by this Act; or (b) in the performance of a duty imposed on the other person by this Act. Penalty: Fine not exceeding 100 penalty units. 70. Offences relating to inspections &c. (1) A person must not, without reasonable excuse – (a) fail to attend an inspection; or (b) . . . . . . . . (c) fail to produce a document when required to do so by a person conducting an inspection; or (d) fail to answer a question when required to do so by a person conducting an inspection. Penalty: Fine not exceeding 50 penalty units and, in the case of a continuing offence, a further fine not exceeding 5 penalty units for each day during which the offence continues. (2) A person may be required by a person conducting an inspection to answer a question or produce a document notwithstanding that the answer to the question or the contents of the document may tend to incriminate the person. (3) If a person objects to answering a question or producing a document on the grounds that to do so may tend to incriminate the person, the answer to the question or the contents of the document are not admissible in evidence in any other proceedings in relation to the person, other than proceedings in relation to an offence under section 68 or in relation to an appeal under Part 5 . 70A. Failure to notify Authority (1) In this section – relevant event, in relation to a person, means – (a) for an individual – (i) his or her registration as a pharmacist under the Health Practitioner Regulation National Law (Tasmania) is suspended or cancelled or made subject to a condition or another restriction; or (ii) he or she is charged, whether in this State or elsewhere, with an offence punishable by imprisonment for a term of 12 months or longer; or (iii) he or she is convicted of, or is the subject of a finding of guilt for, an offence, whether in this State or elsewhere, punishable by imprisonment; and (b) for a body corporate, there is a change to the membership or particulars of the body corporate; and (c) for any person – (i) the person's authority under a law of a State or Territory to obtain, possess, sell or supply a scheduled medicine or a class of scheduled medicines is cancelled or restricted; or (ii) there is a change of trustees, beneficiaries or, if applicable, unit holders of a trust in which the person has any legal or equitable interest, being a trust that holds an interest in a pharmacy business in this State; scheduled medicine means a substance included for the time being in Schedule 2, 3, 4 or 8 to the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP) produced by the Australian Committee for Chemicals Scheduling (AACS), being a committee of the regulatory body known as the Therapeutic Goods Administration (TGA), which is a part of the Commonwealth Government Department responsible for the administration of the Therapeutic Goods Act 1989 ; (2) A person who holds an eligibility certificate must, within 14 days after becoming aware that a relevant event has occurred in relation to that person, give the Authority written notice of the event. Penalty: Fine not exceeding 100 penalty units and, in the case of a continuing offence, a further fine not exceeding 10 penalty units for each day during which the offence continues. 70B. Improper directions and inducements (1) In this section – induce means induce by making a threat or offering approval, encouragement or a reward. (2) A person must not direct, induce, assist or allow a person to engage in any conduct that the person knows, or ought to know, constitutes or is reasonably likely to constitute a breach of this Act. Penalty: Fine not exceeding 100 penalty units. 71. Failure to comply with orders A person must not – (a) report or otherwise disclose any proceedings of a meeting of the Authority contrary to an order of the Authority; or (b) report or otherwise disclose any information in relation to a meeting of the Authority contrary to an order of the Authority; or (c) fail to comply with any other order or direction of the Authority. Penalty: Fine not exceeding 100 penalty units. PART 6A - Registration of pharmacy business premises Division 1 - Preliminary 71A. . . . . . . . . 71B. Application of Part (1) This Part does not bind the Crown. (2) This Part does not apply to – (a) pharmacy business premises that are located wholly within a hospital operated by an agency or instrumentality of the Crown in right of Tasmania or the Commonwealth; or (b) prescribed premises, prescribed persons or prescribed pharmacy practices or services. Division 2 - Registration 71C. Pharmacy business premises to be registered A person must not use any premises for the purposes of a pharmacy business unless those premises are – (a) registered as pharmacy business premises; or (b) exempt, under section 71J , from the requirement to be registered as pharmacy business premises. Penalty: Fine not exceeding 100 penalty units and, in the case of a continuing offence, a further fine not exceeding 10 penalty units for each day during which the offence continues. 71D. Applications for registration of pharmacy business premises (1) A person may apply to the Authority to have premises registered as pharmacy business premises. (2) The application is to be – (a) in an approved form; and (b) lodged with the Authority; and (c) accompanied by the prescribed application fee, if any; and (d) accompanied by such information or evidence as the Authority requires. (3) The Authority may require the applicant to provide such further information or evidence as it considers necessary in order to consider the application. (4) The Authority may waive all or part of the fee. 71E. Consideration of applications for registration of pharmacy business premises (1) The Authority, after considering an application to have premises registered as pharmacy business premises, may – (a) approve the application subject to any conditions that the Authority thinks appropriate; or (b) refuse the application. (2) However, the Authority must not approve the application unless it is satisfied that – (a) the applicant – (i) is an eligible person; or (ii) has, by virtue of some other status, reasonable grounds for making the application; and (b) . . . . . . . . (c) the premises – (i) are not located wholly or partly within a supermarket; or (ii) are not capable of being entered from within a supermarket; or (iii) are not capable of being used to gain entry to a supermarket; and (d) the premises sought to be registered are suitable, or are being made suitable, to be used for the purposes of a pharmacy business. (3) The matters that the Authority may have regard to for the purposes of subsection (2)(d) include, but are not limited to – (a) the standard or proposed standard of presentation of the premises, including the external appearance and internal fittings; and (b) the physical condition of the premises, and the condition of associated amenities such as lighting, ventilation and sanitation; and (c) the security of the premises and, in particular, the security of dispensing and storage areas; and (d) key professional requirements such as the need for – (i) professional supervision of the sale and supply of medicines and drugs; and (ii) customer privacy and counselling; and (iii) sufficient storage for medicines and drugs; and (e) whether there is or will be reasonable public access to the premises and, in particular, access for disabled persons; and (f) if there is or will be direct access to or from adjoining premises, the nature of the activities carried out on those adjoining premises; and (g) any issues of compliance regarding State or council legislative requirements on matters such as fire safety and occupational health and safety; and (h) in the case of leased premises, the terms of the lease. (4) For the purposes of subsection (2)(c) – (a) a supermarket is taken to be any large enclosed shop that primarily sells fresh and processed foods (including beverages) and where the selection of goods is organised on a self-serve basis, even though – (i) customer advice may always or sometimes be available in the shop; and (ii) customer service and assistance may always or sometimes be available in a part of the shop; and (iii) other goods (including household goods like cleaning and kitchen products and personal care products like toiletries) may also be offered for sale in the shop; and (b) a large enclosed shop that sells general merchandise (commonly known as a department store) is not taken to be a supermarket even though it may – (i) contain a restaurant or café; or (ii) sell specialty foods such as biscuits, confectionery and condiments. (5) If the Authority is unsure, in respect of an application under this Part, whether or not any premises are a supermarket, it may apply to the Secretary for a ruling. (6) If subsection (5) applies – (a) the Secretary, after making such inquiries as he or she considers necessary, may, in writing, make the ruling; and (b) the Authority is bound by that ruling. 71F. Approval or refusal of applications (1) If an application to have premises registered as pharmacy business premises is approved – (a) the Authority is to register the premises by making an appropriate entry in the register; and (b) the registration takes effect as soon as the Authority has complied with paragraph (a) . (2) The Authority, as soon as practicable after registering the premises, must give the applicant a certificate of registration, in an approved form, in evidence of the registration. (3) If an application to have premises registered as pharmacy business premises is refused, the Authority is to give the applicant notice of – (a) the refusal; and (b) the reasons for the refusal; and (c) the right to appeal the refusal. 71G. Nature of registration of pharmacy business premises (1) The registration of pharmacy business premises remains in force, subject to any period of suspension, until the lapsing date following the date on which it takes effect. (2) However, the period of registration of pharmacy business premises is not to exceed 12 months. (3) For the avoidance of doubt, the registration of pharmacy business premises is not affected by a transfer in the ownership of the premises. 71H. Registration of pharmacy business premises may be cancelled or suspended (1) The Authority may cancel or suspend the registration of premises as pharmacy business premises if it is satisfied that – (a) the premises have temporarily ceased to be used for the purposes of a pharmacy business; or (b) having regard to the matters set out in section 71E(3) , the premises are no longer suitable to be used for the purposes of a pharmacy business; or (c) there has been, in respect of the premises, a failure to comply with a decision of the Authority made pursuant to section 59A(1)(b) within the time specified in a notice under section 59A(1) or, if no time is specified, within a time that the Authority considers reasonable. (2) The Authority is to cancel the registration of premises as pharmacy business premises if it is satisfied that – (a) the premises have been, or are about to be, demolished; or (b) the premises have ceased permanently to be, or are incapable of ever again being, used for the purposes of a pharmacy business. (3) If the Authority decides to cancel or suspend the registration of any premises as pharmacy business premises, it is to make an appropriate entry to that effect in the register and give the owner of the relevant pharmacy business notice of – (a) the cancellation or suspension; and (b) the reasons for the cancellation or suspension; and (c) in the case of a suspension on the ground referred to in subsection (1)(b) or (c) , the actions that need to be taken to have the suspension revoked; and (d) the right to appeal the cancellation or suspension. (4) The cancellation takes effect when the notice under subsection (3) is given to the owner of the relevant pharmacy business premises or on such later date as is specified in the notice. (4A) Where the relevant pharmacy business is jointly owned, the Authority is to give each of the owners notice under subsection (3) but if, after making a reasonable attempt, it is unable to do so, subsection (4) still applies provided at least one of the owners has been given the notice. (5) The Authority, for any reason it considers sufficient, may revoke the suspension of the registration of premises as pharmacy business premises at any time. (6) If the Authority decides to suspend the registration of premises as pharmacy business premises it may afford the owner of the relevant pharmacy business an opportunity to be heard but it is not required to do so. (7) . . . . . . . . 71I. Registration of pharmacy business premises may be relinquished (1) The registration of pharmacy business premises may be relinquished at any time. (1A) To effect the relinquishment, the owner of the relevant pharmacy business or, if it is jointly owned, each of the owners jointly or severally is to give an appropriate notice to the Authority. (2) On receiving notice in accordance with subsection (1A) the Authority is to cancel the registration of the premises by making an appropriate entry to that effect in the register. (3) No entitlement to a refund of registration or other fees arises by reason of the relinquishment of registration. 71J. Premises exempt from registration requirements (1) The Authority, by instrument in writing, may exempt any premises used for the purposes of a pharmacy business from the requirement to be registered as pharmacy business premises. (2) An exemption may be granted on the Authority's own initiative, at the written request of the Director of Public Health or on an application by or on behalf of a pharmacist. (3) An application under subsection (2) is to be – (a) in an approved form; and (b) lodged with the Authority; and (c) accompanied by the prescribed application fee, if any; and (d) supported by such information or evidence as the Authority requires. (3A) The Authority may require an applicant for an exemption to provide such further information or evidence as it considers necessary in order to consider the application. (4) The Authority may waive all or part of the fee. (5) An exemption may be granted – (a) for individual premises or a class of premises; and (b) unconditionally or on conditions. (6) Without limiting subsection (5)(b) , the conditions of an exemption may restrict its operation according to matters or limitations, whether as to time, circumstance or otherwise, specified in the instrument of exemption. (7) A person must not engage in the practice of pharmacy contrary to a condition of an exemption under this section. Penalty: Fine not exceeding 25 penalty units. (8) The Authority may revoke an exemption if it is satisfied on reasonable grounds that the exemption is no longer justified or required. (9) In determining whether to grant or revoke an exemption the Authority is to have regard to the prescribed criteria, if any. (10) The Authority may publicise exemptions and their revocation in the Gazette and in such other ways as the Authority thinks fit having regard to the nature of the exemptions. 71K. Annual renewal of registration (1) The registration of pharmacy business premises is from time to time renewable. (2) To effect the renewal, the owner of the relevant pharmacy business is to lodge an application with the Authority on or before the lapsing date. (3) The application is to be – (a) in an approved form; and (b) lodged with the Authority; and (c) accompanied by the prescribed renewal fee, if any; and (d) supported by such information or evidence as the Authority requires. (4) The Authority may require the applicant to provide such further information or evidence as it considers necessary in order to consider the application. (5) The Authority may waive all or part of the renewal fee. (6) If for any reason the application is not lodged on or before the lapsing date, the Authority may still consider the application if it is – (a) lodged no later than 30 days after the lapsing date; and (b) accompanied by, in addition to the renewal fee, the prescribed late fee. (7) The Authority, after considering the application may – (a) renew the registration; or (b) refuse to renew the registration. (8) The Authority may refuse to renew the registration if – (a) the applicant fails to comply with subsection (3) or (4) ; or (b) the Authority reasonably believes that the pharmacy business premises no longer meet the criteria for eligibility having regard to the matters set out in section 71E(3) ; or (c) the Authority is satisfied that material facts or matters relied upon in support of the original application, including, in the case of a body corporate, details of its membership, have changed; or (d) the application is made more than 30 days after the lapsing date. (9) If the Authority refuses to renew the registration, it is to give the applicant notice of – (a) the refusal; and (b) the reason for the refusal; and (c) the right to appeal the refusal. (10) If the application is made on or before the lapsing date or within 30 days after the lapsing date, the registration of the pharmacy business premises is taken to continue until the earlier of the following: (a) the date upon which the Authority renews the registration; (b) the date upon which the Authority gives a notice under subsection (9) . Division 3 - Alterations 71KA. Interpretation of Division In this Division – alteration, to pharmacy business premises, means any alteration, whether permanent or temporary, that is likely to affect or interfere with – (a) the dispensing of medicines or drugs on the premises; or (b) the storage of medicines or drugs on the premises; or (c) access to the premises; or (d) the security arrangements for the premises or any part thereof; or (e) the professional activities of the pharmacist. 71KB. Alterations to pharmacy business premises require approval (1) The owner of a pharmacy business must not cause or allow an alteration to be made to the relevant pharmacy business premises unless the alteration has been approved by the Authority. Penalty: Fine not exceeding 20 penalty units. (2) If a pharmacy business is owned by 2 or more persons jointly, the obligation of those persons under subsection (1) is joint and several but the discharge of that obligation by one owner also discharges the corresponding obligation of each other owner. 71KC. Applications for approval of alterations to pharmacy business premises (1) An application for an approval under section 71KB is to be – (a) in an approved form; and (b) signed by the owner of the relevant pharmacy business or, if it is jointly owned, at least one of the owners; and (c) lodged with the Authority; and (d) accompanied by the prescribed fee, if any; and (e) accompanied by such information or evidence as the Authority requires. (2) The Authority may require the applicant to provide such further information or evidence as it considers necessary in order to consider the application. (3) The authority may waive all or part of the fee. 71KD. Consideration of application for approval of alteration to pharmacy business premises (1) The Authority, after considering an application for an approval under section 71KB , may – (a) grant the application subject to any conditions that the Authority thinks fit to impose; or (b) refuse the application. (2) However, the Authority must not grant the application unless it is satisfied that, the pharmacy business premises, as proposed to be altered – (a) will be suitable to be used for the purposes of a pharmacy busi