Pharmacy Act 2001
No. 6 of 2001
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PHARMACY ACT 2001
Pharmacy Act 2001 Arrangement of Sections
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PHARMACY ACT 2001
Arrangement of Sections
Section
PART I - PRELIMINARY 7
1 Short title and commencement.........................................................................7
2 Interpretation....................................................................................................8
PART II - THE PHARMACY BOARD 11
3 Pharmacy Board.............................................................................................11
PART III - REGISTRATION OF PHARMACISTS AND
ASSISTANT PHARMACISTS 12
4 Registers.........................................................................................................12
5 Application for registration............................................................................13
6 Registration....................................................................................................13
7 Effect of Registration.....................................................................................13
8 Provisional registration ..................................................................................13
9 Temporary registration...................................................................................14
10 Minister's power to exempt............................................................................14
11 Holding out ....................................................................................................14
12 Content of the Registers.................................................................................14
13 Roll Fee..........................................................................................................15
14 Removal from the register of pharmacists or assistant pharmacists ..............15
PART IV - COMPLAINTS AND DISCIPLINARY PROCEEDINGS 16
15 Making of complaints ....................................................................................16
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16 Procedure on receipt of a complaint...............................................................16
17 Dealing with complaints.................................................................................17
18 Conduct of inquiry .........................................................................................17
19 Power to summon witnesses to inquiry..........................................................17
20 Power to obtain documents at inquiry............................................................17
21 Evidence of other proceedings .......................................................................18
22 Additional complaints ....................................................................................18
23 Release of information concerning inquiry ....................................................18
24 Authentication of documents .........................................................................19
25 Representative complainant ...........................................................................19
26 Expedition of inquiries ...................................................................................19
27 Evidentiary certificate ....................................................................................19
28 Certain complaints not to be heard.................................................................20
29 Consequences of misconduct .........................................................................20
30 Unfitness ........................................................................................................21
31 Removal from registry outside the Kingdom.................................................22
32 Effect of Board's order ...................................................................................22
33 Copy of decision.............................................................................................22
34 Review of orders of the Board .......................................................................23
35 Effect of removal from register or suspension ...............................................23
36 Surrender of certificates of registration..........................................................23
37 Restoration of name .......................................................................................24
PART V - LICENSING OF PHARMACY PREMISES 24
38 Register of Pharmacy Premises......................................................................24
39 Pharmacies to be approved and owners registered.........................................25
40 Standards of Pharmacy Premises ...................................................................25
41 Publications to be kept ...................................................................................26
42 Certificate of registration ...............................................................................26
43 Cancellation or suspension of pharmacy registration.....................................26
PART VI - POWERS OF INSPECTION 27
44 Authorised officers .........................................................................................27
45 Powers of entry, search & seizure ..................................................................27
46 Power to obtain information...........................................................................29
47 Continuing offence.........................................................................................30
48 Obstruction .....................................................................................................30
49 Directions may be issued to secure compliance .............................................31
PART VII - MISCELLANEOUS 31
50 Contracts etc. void..........................................................................................31
51 Wholesale dealing ..........................................................................................31
52 Supervised practice ........................................................................................31
53 Automatic vending machines prohibited........................................................32
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54 Making false or fraudulent representation .....................................................32
55 Offence and penalty .......................................................................................32
56 Offences by corporate bodies.........................................................................32
57 Prosecution.....................................................................................................33
58 Crown to be bound.........................................................................................33
59 Regulations ....................................................................................................33
60 Repeal and savings.........................................................................................33
SCHEDULE 35
CERTIFICATE OF REGISTRATION................................................................35
CERTIFICATE OF PROVISIONAL REGISTRATION.......................................36
LICENCE OF PHARMACY PREMISES...........................................................37
Pharmacy Act 2001 Section 1
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C
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PHARMACY ACT 2001
No. 6 of 2001
AN ACT TO REQUIRE THE REGISTRATION BEFORE PRACTICE
OF PHARMACISTS AND ASSISTANT PHARMACISTS, TO
ESTABLISH THE PHARMACY BOARD, TO PROVIDE FOR THE
MAKING OF COMPLAINTS AND DISCIPLINARY PROCEEDINGS,
TO REQUIRE THE LICENSING OF PHARMACY PREMISES AND
FOR ANCILLARY PURPOSES
I assent,
TAUFA'AHAU TUPOU IV,
21st September, 2002.
[11th July, 2001]
BE IT ENACTED by the King and Legislative Assembly of Tonga in the Legislature
of the Kingdom as follows:
PART I—PRELIMINARY
1 Short title and commencement
This Act may be cited as the Pharmacy Act 2001, and shall come into force on a
date to be proclaimed by His Majesty in Council.
Section 2 Pharmacy Act 2001
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2 Interpretation
In this Act, unless the context otherwise requires—
“advertisement” means an advertisement—
(a) published in a newspaper, magazine or other publication:
(b) placed in a circular, hand bill, poster or other notice;
(c) made orally or by any means of producing light or sound;
(d) made using a form of electronic communication or utilising
an application of information technology, including an
advertisement placed on the internet; or
(e) made in any other manner;
“assistant pharmacist”, means a person who is duly registered as such
under this Act;
“automatic machine” means any machine or mechanical device used or
capable of being used for the purpose of selling or supplying goods
without the personal manipulation or attention of the seller or supplier, or
his employee, or other agent at the time of sale or supply;
“board” means the Pharmacy Board established under section 3(1);
“conduct” means any act or omission;
“Council” means the Health Practitioners Review Council established
under the Health Practitioners Review Act 2001;
“dentist” means a person who is duly registered as such under the
Medical and Dental Practice Act 2001;
“dispensing” in relation to a drug, means supplying that drug in
accordance with a prescription given by a registered medical practitioner,
a registered dentist, a veterinary practitioner or such other health
practitioner as it duly [??] by law to prescribe drugs;
“drug” includes any product defined as a medicinal drug in the
Therapeutic Goods Act 2001;
“health officer” means a person who is duly registered as such under the
Medical and Dental Practice Act 2001;
“medical practitioner” means a person who is duly registered as such
under the Medical and Dental Practice Act 2001;
“medicinal drug” means any substance whether of animal, plant or
synthetic origin (not being a therapeutic device) which is used internally
or externally in humans or animals for—
(a) preventing, diagnosing, curing or alleviating disease, ailment,
defect or injury;
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(b) influencing, modifying or inhibiting a physiological process;
(c) testing susceptibility to a disease or ailment;
(d) influencing, controlling or preventing conception;
(e) testing for pregnancy;
(f) the replacement or modification of parts of the anatomy, but
not any product the principal use of which is cosmetic;
“midwife” means a person who is duly registered as such under the
Nurses Act 2001;
“Minister” means the Minister of Health;
“narcotic drugs and psychotropic substances” are as defined in the
Therapeutic Goods Act 2001;
“nurse” means a person who is duly registered as such under the Nurses
Act 2001;
“pharmacist” means a person who is duly registered as such under this
Act;
“pharmacy” means the physical facility used for the practice of pharmacy
and which is licensed under this Act;
“Pharmacy Board” means the Board established under section 3(1);
“practice of pharmacy” means—
(a) responsibility for preparing, storing, distributing and
controlling medicinal drugs in a pharmacy;
(b) compounding a medicinal drug;
(c) dispensing a medicinal drug;
(d) selling a medicinal drug;
(e) disseminating information on health education and health
promotion, in general, and on the rational use of medicinal
drugs, in particular;
(f) subdividing or breaking up a manufacturer's original package
of a medicinal drug for the purpose of re-packaging the drug
in larger or smaller quantities for re-distribution or sale by
retail;
(g) operating a pharmacy insofar as the operation relates to the
practice of pharmacy; and
(h) supervising the practice of pharmacy;
“prescription” means the written order of a dentist, dental officer, health
officer or medical practitioner for the supply of a drug or poison to any
person or of a veterinary practitioner for the supply of a drug or poison to
Section 2 Pharmacy Act 2001
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any animal which complies with the requirements of Part VI of the
Therapeutic Goods Act 2001;
“Principal Pharmacist” means the Principal Pharmacist of the Ministry
of Health or person acting for the time being in such position;
“professional misconduct”, in relation to a pharmacist or assistant
pharmacist, includes—
(a) any conduct that demonstrates a lack of adequate—
(i) knowledge;
(ii) skill;
(iii) judgment; or
(iv) care;
(b) by the pharmacist or assistant pharmacist in the practice of
pharmacy as the case may be, whether by act or omission:
(i) contravening a provision of this Act or the regulations;
(ii) contravening a registration condition imposed by the
Board;
(iii) contravening an order made or a direction given by the
Board;
(iv) being an habitual drunkard or being addicted to any
deleterious drug; and
(c) any other improper or unethical conduct relating to the
practice of pharmacy;
“register” means the register of pharmacists or the register of assistant
pharmacists or the register of licensed pharmacies, as appropriate,
maintained by the Board in pursuance of Parts III and V of this Act;
“Registrar” means the person designated under section 3(9) of this Act;
“supply” with its cognate expressions includes to sell, or to agree to sell,
to offer, advertise, have in possession for any such purposes, expose,
transmit, convey, deliver, make or prepare for sale, or hire or to exchange
or dispose of for any consideration whatsoever, or to transmit, convey or
deliver in pursuance of a sale, exchange or disposal as aforesaid;
“supply by wholesale”, in relation to a substance or goods, means—
(a) supply of the substance or goods for the purposes of re-
supply; or
(b) supply of an ingredient for the purposes of incorporation in
the substance or goods;
and includes supply of the substances or goods in wholesale quantities for
use—
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(c) in a public institution; or
(d) in connection with the carrying on by persons, in
circumstances required by this Act or the regulations, of any
activity so required.
PART II - THE PHARMACY BOARD
3 Pharmacy Board
There shall be established for the purposes of this Act a Board to be called the
Pharmacy Board.
(2) The functions of the Board shall be —
(a) to register pharmacists, assistant pharmacists and to licence
pharmacies;
(b) to deal with matters relating to disciplinary inquiries and the
cancellation, suspension, withdrawal and restoration of registration
of pharmacists and assistant pharmacists and the licensing of
pharmacies;
(c) to set standards for the education and training of pharmacists and
assistant pharmacists;
(d) to ensure maintenance of the required standards of practice and
conduct among pharmacists and assistant pharmacists and to
promote the development of guidelines and codes of conduct;
(e) to advise the Minister on any matter relating to pharmacists and
assistant pharmacists; and
(f) to review the implementation of the Act, the regulations, guidelines
and codes of conduct and to propose any changes or modifications,
as may be deemed necessary.
(3) The Board shall consist of the following members —
(a) the Principal Pharmacist;
(b) the Registrar;
(c) a pharmacist in private practice nominated by the Minister;
(d) a pharmacist employed by the Ministry of Health designated by the
Minister;
(e) an assistant pharmacist nominated by the Minister
(f) a lay member nominated by the Minister.
(4) When holding an inquiry under PART IV, the Board shall co-opt a senior
law practitioner to sit on the Board for the purpose of hearing the inquiry.
Section 4 Pharmacy Act 2001
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(5) The members nominated or designated by the Minister under subsections
(3)(c), (d), (e) and (f) shall hold office for a period of two years and shall
be eligible for re-appointment.
(6) The nomination of any member may be cancelled by the Minister, and
another person may be nominated in place of such member for the
remaining period of office.
(7) Any nominated member may resign by giving notice of such resignation
to the Minister, and he may nominate another person for the remaining
period of office.
(8) The Principal Pharmacist shall be the chairman of the Board.
(9) The Minister shall designate, from the staff of Ministry of Health, a
Registrar who shall also perform the duties of the Secretary of the Board,
and such officers as are necessary for the implementation of the Act.
(10) The seal of the Board shall be kept in the custody of the Registrar and
shall be affixed by the Registrar or any other officer duly by the Board to
documents to be sealed by the Board.
(11) The Board shall determine the procedures and rules governing its
meetings.
(12) The Board shall meet as required and shall report to the Council by way of
provision of the Minutes of the Board Meetings.
(13) The Board shall prepare annually a report of its activities during the
preceding twelve months and this report shall be made to the Minister.
(14) The Board has the authority to summon and compel the attendance of any
person while conducting complaints and disciplinary proceeding under
PART IV.
(15) An act in good faith, by the Minister, Registrar, chairman or any Board
member shall not subject that person to any liability.
PART III - REGISTRATION OF PHARMACISTS AND
ASSISTANT PHARMACISTS
4 Registers
(1) For the purposes of and Act, the Board shall maintain a register of
pharmacists and a register of assistant pharmacists.
(2) The registers may be kept by electronic means.
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5 Application for registration
The Board shall determine the form in which applications for registration as a
pharmacist or assistant pharmacist shall be made.
6 Registration
(1) A person shall be entitled to be registered as a pharmacist or assistant
pharmacist if he holds the qualification for registration prescribed by
regulation.
(2) Where a person applies to be registered as a pharmacist or assistant
pharmacist and the Board decides that he is entitled to be so registered, the
Board shall grant him a certificate of registration in Form 1 prescribed in
the Schedule.
(3) Where a person has ceased to be registered as a pharmacist or assistant
pharmacist for a consecutive period of 5 years, whether within or outside
the Kingdom, the Board may refuse to register him unless he has passed
such oral or written examination or carried out such training, at a standard
considered satisfactory to the Board, as the Board considers appropriate.
7 Effect of Registration
A person duly registered under this Act shall be entitled to engage in the practice
for which he is so registered pursuant to this Act.
8 Provisional registration
(1) Where a person has applied for registration as a pharmacist or assistant
pharmacist, the chairman of the Board may, if satisfied that person has the
requisite qualification and experience, and on payment of the prescribed
fee, grant to that person a certificate of provisional registration in Form 2
prescribed in the Schedule.
(2) Where a person has obtained a certificate of provisional registration the
person shall be deemed to be registered under the Act until —
(a) the date stated in the certificate, or
(b) such later date as may be fixed by the Board,
which date shall, in either case, be not later than three months after the
granting of the certificate.
(3) The Board may, at any time before the date so stated or fixed, cancel a
certificate of provisional registration.
Section 9 Pharmacy Act 2001
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(4) Upon the cancellation of a certificate of provisional registration, the
holder of the certificate shall no longer be deemed to be registered.
(5) If a person to whom a certificate of provisional registration has been
granted becomes registered before the date stated or fixed pursuant to
subsection (2), the registration shall, unless otherwise decided by the
Board, date from the granting of the provisional certificate.
9 Temporary registration
The Registrar, subject to the approval of the chairman of the Board, may register
pharmacists and assistant pharmacists who are registered as such in another
jurisdiction, for up to 3 months. The Board shall prescribe the fee payable for
such temporary registration.
10 Minister's power to exempt
The Minister may, subject to such conditions as he thinks fit, exempt in writing
members of short-term visiting specialist health teams or individual short-term
visiting pharmacists or assistant pharmacists, from the requirements of this Act.
11 Holding out
(1) No person, except a pharmacist or assistant pharmacist, shall —
(a) represent or hold out, express or by implication, that he is entitled
to engage in the practice of pharmacy;
(b) use any sign, emblem, title or advertisement implying that the
person is a pharmacist or assistant pharmacist; or
(c) use the title pharmacist or assistant pharmacist or any similar
designation or abbreviation implying that he is registered as a
pharmacist or assistant pharmacist.
(2) Any person who contravenes this section commits an offence and upon
conviction shall be liable to a fine not exceeding $10,000 or 5 years
imprisonment or both.
12 Content of the Registers
A person shall be registered by entering in the appropriate register —
(a) the name of the person;
(b) the date of birth of the person;
(c) the person's professional address in the Kingdom or, if the person
has no professional address the person's place of residence;
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(d) particulars of the qualifications entitling the person to be registered;
(e) the registration number allocated to the person;
(f) the date of registration;
(g) any condition to which the person's registration is subject; and
(h) such other particulars, if any, as are prescribed.
13 Roll Fee
(1) Every pharmacist or assistant pharmacist shall, on or before the to the on
or before the thirty-first day of October in each year (which day is this
section referred to as the “prescribed day”) pay to the Registrar a roll fee
fixed by the Board for the year commencing on the first day of January
next following the prescribed day.
(2) The pharmacist or assistant pharmacist shall furnish particulars of his
address for entry in the register and such other particulars as may be
prescribed.
(3) If the person does not pay the roll fee referred to in subsection (1) on or
before the prescribed day in any year, the Board shall forthwith notify the
person by letter addressed to him at the address appearing in the
appropriate register that if the fee be not paid before the end of the first
working day of the next calendar year the person's name shall be removed
from the register as from the next day.
(4) If the name of a pharmacist or assistant pharmacist has been removed
from the register under this section, the Board shall, upon application in
writing and upon being satisfied that the person is of good character,
restore the person's name to the register upon payment of the outstanding
roll fee and a reinstatement fee fixed by the Board.
14 Removal from the register of pharmacists or assistant pharmacists
(1) After due inquiry, as laid down in PART IV, the Board may direct that the
name and other particulars of a pharmacist or assistant pharmacist be
removed from the appropriate register if:
(a) the person is convicted of an offence under this Act or under any
other legislation relating to drugs;
(b) the person has obtained registration by fraud or misrepresentation;
(c) the qualification on the basis of which registration was awarded is
withdrawn or cancelled by the authority which awarded it;
(d) the person is guilty of unsatisfactory professional conduct or
professional misconduct which, after due inquiry by the Board,
Section 15 Pharmacy Act 2001
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renders the person unfit to be a pharmacist or assistant pharmacist;
or
(e) the person's name has been removed from a register of pharmacists
or assistant pharmacists in another jurisdiction having been found
guilty of unsatisfactory professional conduct or professional
misconduct.
(2) The Board may suspend the registration of a pharmacist or assistant
pharmacist pending investigations and disciplinary inquiry.
PART IV - COMPLAINTS AND DISCIPLINARY
PROCEEDINGS
15 Making of complaints
Any person may make a complaint in writing to the Registrar that a pharmacist
or assistant pharmacist —
(a) has been convicted in the Kingdom or elsewhere of an offence
involving fraud, drugs or dishonesty;
(b) has been guilty of unsatisfactory professional conduct or
professional misconduct;
(c) does not have sufficient physical or mental capacity to carry on
practice as a pharmacist or assistant pharmacist; or
(d) is not of good character.
16 Procedure on receipt of a complaint
(1) The Registrar shall refer any complaint to the Board.
(2) The Board may require the complainant to provide further particulars of
the complaint and may make such preliminary inquiries concerning the
complaint as it thinks fit.
(3) The Board shall inform the pharmacist or assistant pharmacist against
whom the complaint is made of the particulars of the complaint and invite
that person to make, within such time as the Board specifies in the notice,
such representations to the Board with respect to the complaint as he
thinks fit.
(4) The Board is required to consider any representations made to it within
the time specified in its notice.
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17 Dealing with complaints
The Board may decide at any time in relation to a complaint that it will —
(a) deal with the complaint at a meeting of the Board;
(b) conduct an inquiry into the complaint; or
(c) decline to deal with or dismiss the complaint.
18 Conduct of inquiry
If the Board decides to conduct an inquiry into a complaint —
(a) the Board, in conducting the inquiry, shall sit as in open court
unless it determines to do otherwise;
(b) the person against whom the complaint was made is to be afforded
an opportunity of defence either in person or by a law practitioner
or another adviser;
(c) the Board is not bound to observe the rules of evidence, but may
inform itself of any matter in such manner as it thinks fit; and
(d) the chairman of the Board is to preside at the inquiry.
19 Power to summon witnesses to inquiry
(1) The chairman of the Board may summon a person to appear at any inquiry
conducted by the Board, to give evidence and to produce such documents
as are referred to in the summons.
(2) The Board may take evidence on oath and require a person appearing at
the inquiry to give evidence on oath.
(3) A person served with a summons shall in the absence of any reasonable
excuse attend as required by the summons.
(4) A person appearing at an inquiry to give evidence shall not, without
reasonable excuse, fail to answer a question or to produce statement that
he is required to produce.
(5) Any person who fails to comply with this section commits an offence.
20 Power to obtain documents at inquiry
(1) The chairman of the Board may, by written notice, require any person to
attend before a member of the Board, at a time and place specified in the
notice and to produce any document specified in the notice.
(2) Any person who fails to comply with this section commits an offence.
Section 21 Pharmacy Act 2001
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21 Evidence of other proceedings
The Board may receive and admit, as evidence at any inquiry —
(a) the judgment and findings of any court (whether civil or criminal)
or tribunal made within or outside the Kingdom;
(b) the verdict or findings of a jury of any such court;
(c) a certificate of the conviction of any person; or
(d) a transcript, duly certified by the registrar or clerk of the court or
tribunal as correct, of the evidence of witnesses taken in any such
court or tribunal;
where the Board is of the opinion that the judgment, findings, verdict, certificate
or evidence is or are relevant to the proceedings.
22 Additional complaints
(1) The Board may at an inquiry deal with one or more complaints about a
pharmacist or assistant pharmacist.
(2) If, during any such inquiry, it appears to the Board that, having regard to
any matters that have arisen, another complaint could have been made
against the pharmacist or assistant pharmacist concerned —
(a) whether instead of or in addition to the complaint which was made;
and
(b) whether or not by the same complainant,
the Board may take that other complaint as having been referred to it and
may deal with it at the same inquiry.
(3) If another complaint is taken to have been referred to the Board under
subsection (2) the complaint may be dealt with after such an adjournment
(if any) as is, in the opinion of the Board, just and equitable in the
circumstances.
23 Release of information concerning inquiry
(1) The chairman at any inquiry conducted by the Board may, on the request
of a complainant, the pharmacist or assistant pharmacist concerned, or any
other person, if he thinks it appropriate in the particular circumstances of
the case direct the..... all or any of the following matters —
(a) the name and address of any witness;
(b) the name and address of a complainant;
(c) the name and address of a pharmacist;
(d) the name and address of assistant pharmacist;
Pharmacy Act 2001 Section 24
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(e) any specified evidence;
(f) the subject matter of a complaint;
shall not be published, except in a publication intended primarily for the
use of members of the pharmacy, medical or legal professions.
(2) A direction may be amended or revoked at any time by the chairman.
(3) A direction under subsection (1) may be given before or during an
inquiry, but is not to be given before the inquiry unless notice is given
to —
(a) the complainant who requested the direction;
(b) the complainant, the pharmacist or assistant pharmacist concerned,
as appropriate; and
(c) such other persons as the chairman thinks fit;
of the time and place appointed by the chairman for consideration of the
request.
(4) A person who contravenes a direction given under this section, without
reasonable excuse, commits an offence.
24 Authentication of documents
Every document requiring authentication by the Board may be sufficiently
authenticated if signed by the chairman of the Board or by a member of the
Board authorised to do so by the chairman without the seal of the Board.
25 Representative complainant
At any inquiry, an officer of the Ministry of Health appointed by the Director of
Health may, with the consent of the complainant, act for the complainant.
26 Expedition of inquiries
(1) It is the duty of the Board to conduct inquiries under this Act and to
determine those inquiries as soon as is reasonably practicable.
(2) Without affecting the generality of subsection (1), the Board may
postpone or adjourn an inquiry being conducted by it as it thinks fit.
27 Evidentiary certificate
A certificate signed by the Registrar, that —
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(a) a person was or was not a pharmacist or assistant pharmacist as
appropriate;
(b) the name of a person was removed from the register;
(c) a person was suspended from practising pharmacy; or
(d) a condition, particulars of which are set out in the certificate,
was —
(i) imposed on the registration of a person so specified; or
(ii) revoked or not in force;
shall be received by the Board, the Council and all courts as prima
facie evidence of its contents.
28 Certain complaints not to be heard
(1) The Board may decide not to conduct an inquiry, or at any time to
terminate an inquiry if —
(a) a complainant fails to comply with a requirement made by the
Board; or
(b) the person about whom the complaint is made ceases to be a
pharmacist or assistant pharmacist.
(2) The Board or Council shall not to conduct or continue any inquiry or any
appeal if the pharmacist or assistant pharmacist has died.
29 Consequences of misconduct
(1) The Board may, if it is satisfied that the subject matter of a complaint
against a pharmacist or assistant pharmacist is proved, do any one or more
of the following —
(a) caution or reprimand the person;
(b) order that the person seek medical or psychiatric treatment or
counselling;
(c) order that such conditions, relating to the person's practice
pharmacy, as it considers appropriate, be imposed on the person's
registration;
(d) order that any authority of that person to prescribe or administer
narcotic drugs and psychotropic substances be withdrawn;
(e) order that the person complete such educational courses as are
specified by the Board;
(f) order that the person report on the person's pharmacy practice at the
times, in the manner and to the persons specified by the Board;
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(g) impose a fine not exceeding $1,000;
(h) order that the person's registration be suspended for such period not
exceeding 12 months as the Board thinks fit;
(i) order that the person's name be removed from the register.
(2) If the registration of a pharmacist or assistant pharmacist is suspended
under this section, the Registrar shall note in the register the suspension
and its date and cause.
(3) The Board shall not suspend a person's registration or remove a person's
name from the register for having committed an offence if, having regard
to the nature of the offence or the circumstances under which it was
committed, the Board is of the opinion that it does not render the person
unfit in the public interest to be registered as a pharmacist or assistant
pharmacist.
30 Unfitness
(1) Notwithstanding any other provision of this Act, where the Board is
satisfied that any applicant for registration under this Act or any
pharmacist or assistant pharmacist is, by reason of infirmity, injury,
illness, whether mental or physical, unfit to carry on the practice of
pharmacy, the Board shall —
(a) refuse to register the applicant's name in the register;
(b) order that the name of the person be removed from the appropriate
register; or
(c) order that the person be suspended from practice as a pharmacist or
assistant pharmacist for such period as may be specified.
(2) For the purposes of subsection (1) the Board may —
(a) require an applicant for registration, a pharmacist or assistant
pharmacist to be examined by any medical practitioner as may be
specified by the Board; and
(b) hold such inquiry as the Board thinks fit.
(3) A failure or refusal by any person required by the Board to be examined in
accordance with a requirement of the Board made under subsection (2)(a)
may be regarded by the Board as evidence that the person is, by reason of
infirmity, injury or illness, whether mental or physical, unfit to carry on
the practice of pharmacy.
(4) Nothing in subsection (1) affects the powers of the Board under any other
provision of this Act to refuse an application for registration under this
Act or to remove the name of a pharmacist or assistant pharmacist from
Section 31 Pharmacy Act 2001
No. 6 of 2001 Page 22
to
the register or to suspend a pharmacist or assistant pharmacist from
practice.
31 Removal from registry outside the Kingdom
Where a pharmacist or assistant pharmacist has, while registered under this Act,
been —
(a) removed from the register, or
(b) suspended from practice,
as a pharmacist or assistant pharmacist for professional misconduct, in some
place outside the Kingdom, the Board may order that the pharmacist's or
assistant pharmacist's name be removed from the register or that the pharmacist
or assistant pharmacist be suspended from the practice of pharmacy for such
period not exceeding 12 months, as the Board determines.
32 Effect of Board's order
(1) An order made by the Board under section 29 or 31 shall take effect one
month from the date the order is served personally on the pharmacist or
assistant pharmacist, or is sent by registered post by the Registrar to the
pharmacist or assistant pharmacist at the address appearing in the register.
(2) If within such period the pharmacist or assistant pharmacist applies in
writing to the Council, for a review of the Board's decision under section
34, the order shall not be effective until the review proceedings have been
completed.
33 Copy of decision
(1) If, under section 29, the Board decides to make an order in respect of a
person or decides to caution or reprimand a person, the Board shall, within
one month of making its order, provide the person and any person who
made a complaint which resulted in the order or decision and such other
persons as it considers appropriate, with a copy statement of its decision.
(2) If the Board makes a decision in relation to a person under any provision
of this Act, other than section 29, the person may request in writing that
the Board provide the person with a copy of the decision.
(3) Any such request shall be made within 60 days after the decision to which
it relates.
(4) The Board shall provide a copy of the decision within one month of
receipt of such a request.
(5) A copy of a decision shall —
Pharmacy Act 2001 Section 34
No. 6 of 2001
to
Page 23
(a) set out any findings on material questions of fact;
(b) refer to any evidence or other material on which the findings were
based; and
(c) give the reasons for the decision.
34 Review of orders of the Board
(1) Any person aggrieved —
(a) by an order made under sections 29 or 31; or
(b) by any refusal or failure to register the person as a pharmacist or
assistant pharmacist;
may, not later than one month after being served or sent notice of the
order in accordance with section 32, or not later than three months after
the application for registration was lodged, apply to the Council for
review.
(2) Any such review will be in the nature of a new hearing at which new
evidence may be given.
(3) The Council may make such order as it thinks fit.
(4) The provisions of this section do not apply to enable an applicant for
provisional registration or the holder of a certificate of provisional
registration that has been cancelled to apply for a review of the refusal or
cancellation of the certificate of provisional registration.
35 Effect of removal from register or suspension
(1) Where the name of a pharmacist or assistant pharmacist has been removed
from the register under this Act, and until the person's name is restored
thereto, the pharmacist or assistant pharmacist shall be deemed not to be
registered under this Act.
(2) Where a pharmacist or assistant pharmacist has been suspended from
practice as a pharmacist or assistant pharmacist under this Act, the
Registrar shall make and entry in the register of that fact and of the date
and cause thereof.
36 Surrender of certificates of registration
(1) Any person whose name is removed from the register, or who has been
suspended from practice as a pharmacist or assistant pharmacist or whose
certificate of provisional registration has been cancelled, pursuant to the
provisions of this Act, shall within 14 days from receipt of the notification
Section 37 Pharmacy Act 2001
No. 6 of 2001 Page 24
to
of such removal or suspension or cancellation surrender to the Board any
certificate of registration or provisional registration issued to the person
under this Act.
(2) Any person who, without reasonable excuse, contravenes this section
commits an offence against this Act and is liable to a fine not exceeding
$200.
37 Restoration of name
(1) Where the name of any person has been removed from the register
(otherwise than under section 13 (3)), or any person has been suspended
from the practice of pharmacy, the person's name shall not be terminated
before the period for which the suspension was imposed, except by
direction of the Board or by order of the Council or by order of a court of
competent jurisdiction.
(2) The Board may, if it thinks fit in any case, direct the Registrar, without
fee, or on payment of such fee, not exceeding the current registration fee
as the Board may direct, to restore to the register any name removed
therefrom and the Registrar shall restore the name accordingly.
PART V - LICENSING OF PHARMACY PREMISES
38 Register of Pharmacy Premises
(1) For the purposes of this Act, the Board shall maintain a register of
licensed pharmacy premises which shall contain particulars of approved
premises and registered owners thereof which may be inspected at the
office of the Board at any reasonable time.
(2) The register may be kept by electronic means.
(3) An application for licensing of a pharmacy is to be made in a form
approved by the Board and shall be accompanied by the fees prescribed in
the regulations.
(4) The Board may require any such application to be supported by an
affidavit.
(5) The Board may —
(a) reject the application
(b) by order, approve the premises and direct that the owner thereof be
registered.
Pharmacy Act 2001 Section 39
No. 6 of 2001
to
Page 25
(6) Premises shall not be approved if they fail to comply with the standards
prescribed by section 40 and any other standards prescribed for them by
regulation. The Board may, by its order, revoke an approval under
subsection (5) if the premises concerned are found not to comply with any
such standard.
39 Pharmacies to be approved and owners registered
(1) A person shall not carry on the practice of pharmacy at any premises
unless the premises are approved and licensed under section 38(5)(b).
(2) Any person who, without reasonable excuse, carries on the practice of
pharmacy in premises which are not licensed or the owner of which is not
registered as owner commits an offence.
40 Standards of Pharmacy Premises
(1) The following standards for premises are prescribed —
(a) at least one doorway allowing direct public access to the premises is
to be provided;
(b) secure doors, windows and roof are to be provided;
(c) the premises are to be equipped with a dispensing area of at least 8
square meters or such lesser area as the Board may approve in a
particular case;
(d) a refrigerator suitable for the storage of medicinal drugs at
appropriate temperatures is to be provided.
(2) The dispensing area referred to in subsection (1) (c) shall —
(a) have adequate lighting and ventilation;
(b) have adequate heating facilities for dispensing and compounding
medicinal drugs;
(c) be equipped with a stainless steel or similarly impervious sink,
being a sink that has an impervious surround and is supplied with
hot and cold running water;
(d) have a dispensing bench that is at least 40 centimetres wide, and of
sufficient length to provide not less than 1 square metre of free
working space, and that has an impervious covering; and
(e) have a safe or vault for secure storage if narcotic drugs or
psychotropic substances are kept on the premises.
Section 41 Pharmacy Act 2001
No. 6 of 2001 Page 26
to
41 Publications to be kept
(1) A person carrying on the practice of pharmacy shall keep at all times a
copy this Act, together with a copy of the Therapeutic Goods Act 2001,
and a recent edition of Martindale -The Extra Pharmacopoeia, and all
published amendments and supplements thereto on the premises.
(2) Any person who, without reasonable excuse, fails to keep the publications
required under this section commits an offence.
42 Certificate of registration
(1) No person shall display on any premises the title “pharmacy” or any
similar title, sign or designation to describe a retail business in medicinal
drugs, unless the premises have been licensed as a pharmacy.
(2) Where premises are licensed under this Act as a pharmacy, the Board
shall issue to the owner a licence in Form 3 prescribed in the Schedule.
(3) In premises registered under this Act as a pharmacy, the licence shall be
displayed, at all times, in a conspicuous place in the pharmacy.
(4) Any person who, without reasonable excuse, contravenes this section
commits an offence.
43 Cancellation or suspension of pharmacy registration
(1) The Board may cancel or suspend the licence in respect of a pharmacy
if —
(a) a pharmacy is no longer opened on the premises to which the
licence relates; or
(b) the pharmacy practices at the pharmacy contravene the provisions
of this Act or the regulations.
(2) Before cancelling or suspending the licence, the Board shall cause a notice
to be served on the owner of the pharmacy, or in his absence on the person
who is in occupation of the pharmacy, to show cause, within such time as
is specified in the notice, as to why the registration should not be
cancelled or suspended.
(3) If no cause is shown within the time stipulated in the notice referred to in
subsection (2), or if cause is shown but the Board is not satisfied with it,
the Board may cancel or suspend the licence.
(4) The order of the Board under subsection (3) take effect from such date as
is specified in the order.
Pharmacy Act 2001 Section 44
No. 6 of 2001
to
Page 27
PART VI - POWERS OF INSPECTION
44 Authorised officers
(1) The Minister may, by notice in the Gazette, prescribe any person or
persons of a specified class or description as authorised officers for the
purposes of this Act.
(2) An authorised officer shall, upon request, provide proof that he is an
authorised officer.
45 Powers of entry, search & seizure
(1) For the purposes of this Act, an authorised officer may at all reasonable
times —
(a) enter any pharmacy or premises in respect of which an application
for a licence has been made;
(b) enter any premises where medicinal drugs are being kept for retail
trade;
(c) enter any place, premises or vehicle in respect of which he know or
reasonably suspects —
(i) is or are being used for the practice of pharmacy; or
(ii) have been or are being or are likely to be used by any person
in connection with a contravention of this Act;
(d) enter any premises where he knows or reasonably suspects that
records are kept relating to the practice of pharmacy or relating to a
contravention of this Act;
(e) in any premises entered by him
(i) search for or examine medicinal drugs, articles, equipment or
documents and may take possession of any medicinal drugs,
articles, equipment or documents, or samples thereof, or
make copies of or extracts from records relating to the
practice of pharmacy or relating to any matter the subject of
an inquiry under this Act;
(ii) seize any medicinal drugs, articles, equipment, documents, or
samples thereof, or container or package which he reasonably
suspects to contain any medicinal drugs, articles or
equipment;
(iii) open any room, place, container or package that he knows or
reasonably suspects contains any medicinal drugs, articles or
equipment;
Section 45 Pharmacy Act 2001
No. 6 of 2001 Page 28
to
(iv) question with respect to matters under this Act any person he
finds thereon; and
(f) make such inquiry and examination as he believes to be necessary
or desirable to assist the discharge or exercise of any function or
power under this Act or to ascertain whether any contravention of
this Act has been, is being or is likely to be committed.
(2) Subsection (1) does not authorise forcible entry by an authorised officer to
any premises except under the authority of a warrant obtained pursuant to
subsection (4).
(3) Unless he has the permission of the occupier of a part of the premises if
that part is used as a dwelling, an authorised officer shall not enter that
part without a search warrant issued by a Magistrate.
(4) A Magistrate, if satisfied upon the information of an authorised officer
that there is reasonable cause to suspect that any place has been, or is
likely to be used in connection with a contravention of this Act, or for the
keeping of records relating to a contravention of this Act, may issue a
search warrant directing the authorised officer to enter the place specified
in the search warrant for the purpose of exercising the powers conferred
on an authorised officer by this Act.
(5) A search warrant issued under this section is, for a period of 1 month from
its issue, sufficient authority —
(a) to the authorised officer to whom it is directed and to all persons
acting in aid of the officer to enter the place specified in the search
warrant; and
(b) to the authorised officer to whom it is directed to exercise in respect
of the place specified in the search warrant all the powers conferred
on an authorised officer by this Act.
(6) For the purpose of gaining entry to any place an authorised officer may
call in aid such persons as he considers necessary and such persons, while
acting in aid of an authorised officer in the lawful exercise of a power of
entry, have a like power of entry.
(7) If an authorised officer has taken possession of records or of other
property for the purposes of this Act he may —
(a) in the case of records, retain them for as long as necessary for those
purposes, but the person otherwise entitled to possession of the
records if he so requests, is entitled to be furnished as soon as
practicable with a copy certified by the authorised officer to be a
true copy and such a certified copy must be received in all courts
and elsewhere as evidence of the matters contained in it as if it were
the original;
Pharmacy Act 2001 Section 46
No. 6 of 2001
to
Page 29
(b) in the case of other property, subject to this Act, retain the property
for as long as is necessary for those purposes, and thereafter dispose
of it as the court directs.
46 Power to obtain information
(1) In relation to any matter relevant to the operation or enforcement of this
Act, an authorised officer may require a person (either by oral or written
requisition) to furnish —
(a) any information;
(b) any records or a copy thereof,
in the person's possession.
(2) For the purpose of subsection (1), a person is to be taken to be in
possession of —
(a) information, if the person has the information or is entitled to have
access to the information;
(b) records, if the person has them in his possession or under his
control in any place, whether for his own use or benefit or for
another's use or benefit and although another person has the actual
possession or custody of the records.
(3) A requisition made under subsection (1) may require that the information
or records or copy therefore be furnished —
(a) to the authorised officer or another authorised officer or to an
officer of a specified department of the Government;
(b) at the place the requisition is made or at another place;
(c) forthwith or at, by or within a time specified;
(d) in person, or by registered mail or in another manner specified;
(e) by means of, or accompanied by, verification in the form of an
affidavit;
(f) in the case of information, orally or in writing.
(4) A person must not without reasonable cause —
(a) refuse or fail to furnish any information, records or copy as required
under this section;
(b) in response to a requisition made under this section furnish
information records or copies that is or are false or misleading in a
material particular.
(5) If a person records or stores any matter by means of a mechanical,
electronic or other device, the duty imposed by this section to produce any
Section 47 Pharmacy Act 2001
No. 6 of 2001 Page 30
to
records containing those matters is to be construed as including a duty to
produce the matters in written form if that is demanded.
(6) The duty imposed by this section to produce a copy of any records is to be
construed as a duty to produce a clear reproduction.
(7) An authorised officer may take notes or copies of or extracts from records
or a copy of any records produced under this section.
(8) Any person who fails to furnish information required under this section
commits an offence.
47 Continuing offence
If a person commits an offence by failing to furnish information required under
section 46 or to produce any records or a copy of any records —
(a) the obligation to furnish the information or to produce the records
or a copy of them, as the case may be, continues until the person
complies with the requirement notwithstanding that in a particular
case a time was specified at, by or within which compliance was
required and that time has passed;
(b) the person commits a continuing offence in respect of each day
after the day of conviction during which the failure to comply with
the requisition continues;
(c) the person is liable to a fine of $100 for each day during which the
offence continues; and
(d) the person may be prosecuted from time to time in respect of any
continuing offence under subsection (2) above.
48 Obstruction
(1) A person shall not obstruct an authorised officer in the exercise of his
powers under this Act.
(2) For the purposes of this Act, a person obstructs an authorised officer if
he —
(a) assaults, abuses, intimidates or insults the authorised officer or any
other person assisting the authorised officer in the exercise of his
powers under this Act;
(b) directly or indirectly prevents any person from being questioned by
an authorised officer in the exercise of his powers under this Act;
(c) in any way obstructs or attempts to obstruct an authorised officer in
the exercise of his powers under this Act.
Pharmacy Act 2001 Section 49
No. 6 of 2001
to
Page 31
49 Directions may be issued to secure compliance
(1) If —
(a) any pharmacist, assistant pharmacist, medical practitioner, nurse,
health officer, pharmacy premises, prescription or other person,
place or thing does not comply with the provisions of this Act; or
(b) any provision of this Act has not been complied with,
an authorised officer may, in writing, direct any person who has
contravened the provision by such non-compliance to take within a
specified time, not exceeding 14 days, such steps as may be specified to
prevent any further contravention and to remedy the matters in respect of
which the non-compliance has occurred.
(2) The issue of a direction under this section does not affect any proceeding
under this Act which has been or may be taken for the non-compliance
which gave rise to the direction.
(3) A person to whom a direction is issued under this section and who does
not comply with the direction commits an offence.
PART VII - MISCELLANEOUS
50 Contracts etc. void
(1) A contract, agreement, undertaking or understanding which is in effect
when this Act comes into force is void to the extent to which it is
inconsistent with this Act.
(2) Neither the Crown nor any person is liable to pay any damages or other
compensation to any other person in consequence of subsection (1).
51 Wholesale dealing
Nothing in this Act applies to a wholesale dealer who supplies medicinal drugs
in the course of supply by wholesale.
52 Supervised practice
Nothing in this Act prevents a person from engaging in the practice of
pharmacy, provided such person functions —
(a) under the direct supervision of a pharmacist or assistant pharmacist;
(b) in the presence of the pharmacist or assistant pharmacist; and
Section 53 Pharmacy Act 2001
No. 6 of 2001 Page 32
to
(c) in accordance with any other conditions that may be prescribed in
the regulations.
53 Automatic vending machines prohibited
Any person who
(a) installs any automatic machine for the sale or supply of any
medicinal drug or allows, permits or suffers any such automatic
machine to be so installed;
(b) sells or supplies to any person or purchases or is supplied with or
otherwise obtains any medicinal drug by any automatic machine; or
(c) allows or permits any person to purchase or be supplied with or
otherwise obtain any medicinal drug by any automatic machine;
commits an offence.
54 Making false or fraudulent representation
Any person who, in an application for registration under this Act, makes or
produces or causes to be made or produced any false or fraudulent
representation, certificate or affidavit, either verbally or in writing, and any
person who knowingly aids or assists therein commits an offence and shall be
liable on conviction to a fine not exceeding $1000 or to imprisonment for a term
not exceeding 6 months or both.
55 Offence and penalty
Any person who contravenes or fails to comply with any provision of this Act or
any regulation made under this Act commits an offence, and on conviction shall,
where no other penalty is provided, be liable to a fine not exceeding $1000, or
imprisonment for a term not exceeding 6 months, or both; and in the case of a
continuing offence, to a fine not exceeding $100 for every day or part of a day
during which the offence has continued.
56 Offences by corporate bodies
If a body corporate commits an offence against this Act or any regulation made
under this Act, each director or other person concerned in the management of the
body corporate is also guilty of, and liable to the penalty provided for, that
offence unless the director or other person proves that he exercised reasonable
diligence to prevent the commission of the offence.
Pharmacy Act 2001 Section 57
No. 6 of 2001
to
Page 33
57 Prosecution
(1) Prosecutions for an offence under this Act may be brought —
(a) by or on behalf of the Attorney General;
(b) by an authorised officer; or
(c) by a member of the police.
(2) A person referred to in subsections (b) or (c), whether or not a law
practitioner, may lay, institute or conduct any charge, information,
complaint or other proceedings arising under this Act, subject to any
directions issued by the Attorney General.
58 Crown to be bound
This Act binds the Crown.
59 Regulations
The Minister may, with the consent of the Cabinet, make regulations prescribing
matters necessary or convenient to be made for carrying out or giving effect to
this Act and, in particular, for the following purposes —
(a) prescribing the duties of the Registrar;
(b) prescribing the fees payable under the Act and the regulations;
(c) exempting from the operation of any of the provisions of this Act or
the regulations made thereunder such persons or classes of persons
as may be specified;
(d) providing a code of conduct for pharmacists and assistant
pharmacists;
(e) prescribing the qualifications for registration as a pharmacist or
assistant pharmacist;
(f) prescribing the format of any examination to be conducted by the
Board in connection with the registration of pharmacists or assistant
pharmacists;
(g) prescribing the grounds on which registration may be suspended;
and
(h) prescribing the procedures to be followed in conducting
disciplinary inquiries.
60 Repeal and savings
(1) All persons who, at the commencement of this Act, are registered in the
pharmaceutical section of the Register of Health Practitioners maintained
Section 60 Pharmacy Act 2001
No. 6 of 2001 Page 34
to
under the Health Practitioners Registration Act 1991 shall be deemed to
be registered under this Act.
(2) A reference in any other Act or instrument to a registered pharmacist or
assistant pharmacist or a pharmacist or assistant pharmacist registered
under the Health Practitioners Registration Act 1991, shall be read and
construed as a reference to a pharmacist or assistant pharmacist registered
under this Act.
Pharmacy Act 2001 SCHEDULE
No. 6 of 2001
to
Page 35
SCHEDULE
Form 1
CERTIFICATE OF REGISTRATION
(Pharmacy Act 2001)
(Section 6(2))
Pharmacy Board of the Kingdom of Tonga
This is to certify that the name of ...............................................................................
was entered in the Register of Pharmacists or Assistant Pharmacists for the Kingdom
of Tonga as a ......................................................... under the Pharmacy Act 2001 on the
...................... day of ....................................... 20..........
Registration No.:...............................................
.......................................
Registrar
This Certificate must be retained as evidence that you have been registered in the
Kingdom of Tonga.
SCHEDULE Pharmacy Act 2001
No. 6 of 2001 Page 36
to
Form 2
CERTIFICATE OF PROVISIONAL REGISTRATION
(Pharmacy Act 2001)
(Section 8(1))
Pharmacy Board of the Kingdom of Tonga
This is to certify that the name of ............................................................................... is
provisionally registered as a ........................................................ until the ......................
day of ....................................... 20..........
Registration No.:...............................................
.......................................
Chairman
This certificate of provisional registration covers practice until the expiry date
shown.
This Certificate must be retained following the expiry date as evidence that you
have been provisionally registered in the Kingdom of Tonga.
Pharmacy Act 2001 SCHEDULE
No. 6 of 2001
to
Page 37
Form 3
LICENCE OF PHARMACY PREMISES
(Pharmacy Act 2001)
(Section 42(2))
Pharmacy Board of the Kingdom of Tonga
This is to certify that the premises operated as a Pharmacy located at
...................................................................................................................... and owned
by ......................................................... who is the registered owner was entered in the
Register of Licensed Pharmacy Premises on the ...................... day of
....................................... 20..........
Registration No.:...............................................
......................................
Chairman
This Licence must be retained and displayed upon the pharmacy premises.
Passed by the Legislative Assembly this 11 day of July, 2001.
