Therapeutic Goods Act 2001
No. 3 of 2001
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THERAPEUTIC GOODS ACT 2001
Therapeutic Goods Act 2001 Arrangement of Sections
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THERAPEUTIC GOODS ACT 2001
Arrangement of Sections
Section
PART I—PRELIMINARY 5
1 Short title and commencement.........................................................................5
2 Interpretation....................................................................................................6
3 Crown to be bound.........................................................................................10
PART II—THE NATIONAL DRUGS AND 10
MEDICAL SUPPLIES COMMITTEE 10
4 Establishment, functions and constitution of committee ...............................10
PART III—TONGAN REGISTERED LIST OF MEDICINAL
DRUGS 12
5 Establishment of Registered List ...................................................................12
6 Advice as to content of registered list............................................................13
7 Criteria for inclusion in the Registered List...................................................13
8 Application for inclusion in registered list.....................................................13
9 Removal from registered list..........................................................................14
PART IV—IMPORT, EXPORT, MANUFACTURE AND QUALITY
CONTROL OF THERAPEUTIC GOODS 15
10 Import of medicinal drugs..............................................................................15
11 Import licence ................................................................................................16
12 Granting of import licence .............................................................................16
13 Offences .........................................................................................................19
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14 Manufacture of therapeutic goods prohibited except under licence...............20
15 Quality control................................................................................................25
16 Donated medicinal drugs................................................................................25
PART V—SPECIAL IMPORT CONTROLS FOR NARCOTIC
DRUGS AND PSYCHOTROPIC SUBSTANCES 26
17 Authority to import narcotic drugs and psychotropic substances ..................26
PART VI—REGULATION OF SUPPLY OF REGISTERED
DRUGS 26
18 Sale by wholesale prohibited except under licence........................................26
19 Licensing of retailers ......................................................................................27
20 Authority to write prescriptions .....................................................................27
21 Requirements for prescriptions ......................................................................27
22 Dispensing requirements ................................................................................28
23 Labels on Containers......................................................................................29
PART VII—MISCELLANEOUS PROVISIONS 30
24 Authorised officer ..........................................................................................30
25 Powers of entry, search and seizure ...............................................................30
26 Power to obtain information...........................................................................32
27 Continuing offence.........................................................................................33
28 Obstruction .....................................................................................................34
29 Directions may be issued to secure compliance .............................................34
30 Contracts etc. void..........................................................................................35
31 Making false or fraudulent representation......................................................35
32 Offence and penalty .......................................................................................35
33 Offences by corporate bodies .........................................................................35
34 Prosecutions ...................................................................................................36
35 Regulations.....................................................................................................36
PART VIII—TRANSITIONAL ARRANGEMENTS 36
36 Temporary registered list ...............................................................................36
SCHEDULE 37
COUNTRIES OF MANUFACTURE..................................................................37
Therapeutic Goods Act 2001 Section 1
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C
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THERAPEUTIC GOODS ACT 2001
No. 3 of 2001
AN ACT TO ESTABLISH A SYSTEM OF REGULATION OF
THERAPEUTIC GOODS, TO ESTABLISH A NATIONAL DRUGS AND
MEDICAL SUPPLIES COMMITTEE, TO REGULATE THE IMPORT,
QUALITY, AVAILABILITY AND USE OF REGISTERED
THERAPEUTIC GOODS, INCLUDING NARCOTIC DRUGS AND
PSYCHOTROPIC SUBSTANCES 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 Therapeutic Goods Act 2001, and shall come into
force on a date to be proclaimed by His Majesty in Council, and different Parts
may be brought into force on different dates.
Section 2 Therapeutic Goods 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, handbill, 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;
“analysis”, in relation of therapeutic goods, means the carrying out of
tests capable of assessing the composition, strength, potency, sterility,
purity, bioburden, design, construction or performance characteristics of
the goods;
“animal” means any animal (other than a human), whether vertebrate or
invertebrate, and includes the semen, ova or embryo of an animal (other
than a human) or any other substance or thing directly relevant to the
reproduction of an animal (other than a human);
“assistant pharmacist” means a person who is duly registered as such
under the Pharmacy Act 2001;
“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;
“Central Pharmacy and Medical Store” means the Central Pharmacy
and Medical Store of the Ministry of Health;
“Committee” means the National Drugs and Medical Supplies Committee
established under Part II of this Act;
“conduct” means any act or omission;
“container” in relation to therapeutic goods, means a vessel, bottle, tube,
ampoule, syringe, vial, strip pack, blister pack, wrapper, cover or other
similar article that immediately covers the goods or is used in its
administration but does not include an article intended for ingestion;
“counterfeit drug” means a drug which is deliberately and fraudulently
mislabelled with respect to identity or source;
“customs officer” means an officer appointed under the Customs and
Excise Act (Cap. 67);
Therapeutic Goods Act 2001 Section 2
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“dental therapist” means a person who is duly registered as such under
the Medical and Dental Practice Act 2001;
“dentist” means a person who is duly registered as such under the
Medical and Dental Practice Act 2001;
“generic medicinal drug” means any multi-source medicinal drug not
being the originator brand;
“health officer” means a person who is duly registered as such under the
Medical and Dental Practice Act 2001;
“herbal medicine” means a medicine consisting of a substance produced
by subjecting a plant to drying, crushing or other process, or a mixture of
such substances, with or without inert ingredients;
“label” includes any tag, brand, mark or statement in writing on or
attached to or used in connection with any container or package
containing any substance, material, body or thing referred to in this Act;
“licence” means a licence issued and in force for the purposes of this Act
or regulations made hereunder;
“manufacture” includes the process of refining, manipulating or mixing
any medicinal drug (including a medicinal drug in the raw state);
“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;
(b) influencing, modifying or inhibiting of physiological
processes;
(c) testing susceptibility to a disease or ailment;
(d) influencing, controlling or preventing conception;
(e) testing for pregnancy; or
(f) the replacement or modification of parts of the anatomy;
but not a 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” means substances,
whether natural or synthetic, listed in the United Nations Single
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Convention of Narcotic Drugs 1961 and in the United Nations Convention
on Psychotropic Substances, 1971;
“National Health Development Committee” means the National Health
Development Committee of the Ministry of Health;
“new medicinal drug” means a medicinal drug which is not presently
registered in the Kingdom;
“nurse” means a person who is duly registered as such under the Nurses
Act 2001;
“package”, when used in relation to any substance, material, body or
thing referred to in this Act, includes every means by which such
substance, material, body or thing may, for transport or for carriage or for
storage or for supply, be cased, covered, enclosed, contained or packed;
“pharmacist” means a person who is duly registered as such under the
Pharmacy Act 2001;
“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 of 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 operating relates to the
practice of pharmacy; and
(h) supervising the practice of pharmacy;
“premises” includes ships, aircraft and vehicles;
“prescription” means the written order of a dentist, dental officer, health
officer or medical practitioner for the supply of a medicinal drug to any
person or the written order of a veterinary practitioner for the supply of a
medicinal drug to any animal;
“Principal Pharmacist” means the Principal Pharmacist of the Ministry
of Health or person acting for the time being in such position;
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“registered list” means the Tongan Registered List of Medicinal Drugs
under Part III of this Act;
“selling” includes sale by wholesale or retail and barter and exchange, and
also includes dealing in, agreeing to sell, or offering or exposing for sale,
or keeping or having in possession for sale, or sending, forwarding,
delivering or receiving for sale or on sale, or authorising, directing,
causing, suffering, permitting or attempting any such acts or things;
“special prescription” means the written order of a medical practitioner
predominantly practising in a particular recognized special area for the
supply of a medicinal drug for therapeutic use by a person being treated
for a condition under that special area;
“substance” includes preparation or admixture and all salts and
derivatives of any substance;
“supply” with its cognate expressions, includes to sell, or agree to sell, to
offer, advertise, have in possession for any such purposes, expose,
transmit, convey, deliver, make or prepare for sale, or to hire or to
exchange or dispose of for any consideration whatsoever, or to transmit,
convey or deliver in pursuance of sale, hiring, 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 substance or goods in wholesale
quantities for use—
(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;
“therapeutic devices” means therapeutic goods consisting of an
instrument, apparatus, appliance, material or other article (whether for use
alone or in combination), together with any accessories or software
required for its proper functioning, which does not achieve its principal
intended action by pharmacological, chemical, immunological or
metabolic means, though it may be assisted in such function by such
means;
“therapeutic goods” includes—
(a) medicinal drugs and products;
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(b) herbal medicines other than those prepared by traditional
Tongan healers;
(c) therapeutic devices;
(d) goods for use as an ingredient in the manufacturer of
medicinal products and therapeutic devices; and
(e) goods for use as a container or part of a container for goods
referred to in paragraphs (a) (b) and (d);
but not products the principal use of which is cosmetic;
“veterinary practitioner” means a person qualified to practice as a
veterinary practitioner or veterinary surgeon in a jurisdiction outside the
Kingdom who practises as a veterinary practitioner within the Kingdom.
3 Crown to be bound
This Act binds the Crown.
PART II—THE NATIONAL DRUGS AND MEDICAL
SUPPLIES COMMITTEE
4 Establishment, functions and constitution of committee
(1) There shall be established for the purposes of this Act a Committee to be
called the National Drugs and Medical Supplies Committee.
(2) The functions of the Committee shall be—
(a) to establish, maintain and annually revise and amend the list of
medicinal drugs registered for import into the Kingdom;
(b) to determine the class in the registered list to which any medicinal
drug will be allocated;
(c) to maintain, annually revise and amend a List of Essential Drugs for
the Kingdom which shall be the basis for public sector medicinal
drug procurement;
(d) to consider the product range and determine the therapeutic goods
to be purchased by the Ministry of Health based on the list of
essential drugs for the Kingdom;
(e) to confirm or reject decisions of the Principal Pharmacist regarding
the award of tenders for the supply of therapeutic goods;
(f) to control procedures for the procurement, storage, distribution and
administration of therapeutic goods;
Therapeutic Goods Act 2001 Section 4
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(g) to receive from the Central Pharmacy and Medical Store, collate,
review and, if necessary, suggest action, upon reports of adverse
drug reactions within the Kingdom;
(h) to initiate, maintain and supervise a national programme on rational
use of medicinal drugs;
(i) to advise the National Health Development Committee on any
matter relating to the National Drug Policy; and
(j) to propose to the National Health Development Committee any
changes or modifications to this Act, any Schedule hereto, or the
National Drug Policy as may be deemed appropriate.
(3) The Committee shall consist of the following members—
(a) The Director of Health;
(b) The Principal Pharmacist;
(c) The Pharmacist in Charge, Vaiola Hospital;
(d) The Medical Superintendent, Vaiola Hospital;
(e) 1 nominee of the Tonga Medical Association;
(f) 1 nominee of the Tonga Nurses Association;
(g) 2 medical officers employed by the Ministry of Health designated
by the Minister on the nomination of the medical officers of the
Kingdom;
(h) 1 health officer designated by the Minister on the nomination of the
health officers of the Kingdom;
(i) Matron of Vaiola Hospital; and
(j) 1 nominee from the Dental Division of the Ministry of Health
designated by the Minister on the nomination of the Dental
Division.
(4) The members designated by the Minister under subsections (3)(g), (h) and
(i) shall hold office for a period of two years and shall be eligible for
renomination.
(5) The nomination of any member may be cancelled by the body that
nominated such person, and another person may be nominated in place of
such member for the remaining period of office.
(6) Any nominated member may resign by giving notice of such resignation
to the body that made the nomination, and such body may nominate
another person for the remaining period of office.
(7) The Committee may co-opt 1 pharmacist in private practice and 1
medicinal drugs wholesaler to serve on the Committee for such term and
for such purposes as it thinks fit.
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(8) The Director of Health shall be the chairman of the Committee.
(9) The Principal Pharmacist shall be the secretary of the Committee.
(10) The Committee shall determine the procedures and rules governing its
meetings.
(11) The Committee shall meet as required and shall report to the National
Health Development Committee by way of provision of the Minutes of its
meetings.
(12) The Committee shall prepare annually a report of its activities during the
preceding 12 months and this report shall be made to the Minister.
(13) An act in good faith, by the Minister, chairman, secretary or any
Committee member shall not subject that person to any liability.
PART III—TONGAN REGISTERED LIST OF MEDICINAL
DRUGS
5 Establishment of Registered List
(1) The Committee shall maintain a registered list, to be known as the Tongan
Registered List of Medicinal Drugs, specifying those medicinal drugs
which may be imported into the Kingdom.
(2) The registered list shall contain the following classes—
Class 1: Medicinal Drugs available from licensed retail outlets;
Class 2: Medicinal Drugs available from registered pharmacy
premises under the supervision of a registered pharmacist, divided
into—
Class 2A: Where advice of pharmacist at point of sale is not
required;
Class 2B: Where advice of pharmacist at point of sale is required;
Class 3: Medicinal Drugs available on prescription only and
dispensed by a Pharmacist or Assistant Pharmacist;
Class 4: Medicinal Drugs available on special prescription only
and dispensed by a Pharmacist or Assistant Pharmacist;
Class 5: Narcotic Drugs and Psychotropic Substances subject to
Special Import Controls;
Class 6: Medicinal Drugs available from Veterinary Practitioners
for Animal use.
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(3) The Committee shall annually review the content of the registered list and
may amend any of the Classes of the registered list and give notice in the
Gazette.
(4) The registered list may be kept in electronic format.
6 Advice as to content of registered list
The registered list shall record the medicinal drugs both by brand name and
International Non-propriety Name (INN) and chall include the place of
manufacture.
7 Criteria for inclusion in the Registered List
A medicinal drug may be included in the registered list only if the Committee is
satisfied that the medicinal drug—
(a) is of acceptable quality;
(b) meets an acceptable safety profile;
(c) is of demonstrated efficacy;`
(d) is of United States Pharmacopoeia or British Pharmacopoeia
standard or proven equivalent standard;
(e) has been proven by the manufacturer to be registered in one of the
countries listed in the Schedule or following assessment of a
detailed submission by the manufacturer, and payment of the
prescribed fee, is found to meet the requirements of subsections (1)
to (4); and
(f) would be appropriate for use in Tonga.
8 Application for inclusion in registered list
(1) Before any new medicinal drug is imported or offered for sale, the
manufacturer of the medicinal drug or the licensed importer shall make an
application to the Committee for—
(a) inclusion of the medicinal drug in the registered list; and
(b) allocation to the Class of the registered list in which it is to be
included.
(2) Any application for inclusion shall be made in the manner and form
specified by the Committee and shall be accompanied by—
(a) inclusion of the medicinal drug in the registered list; and
(b) allocation to the Class of the registered list in which it is to be
included.
Section 9 Therapeutic Goods Act 2001
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(2) Any application for inclusion shall be made in the manner and form
specified by the Committee and shall be accompanied by—
(a) the specified fee;
(b) a World Health Organization Certificate for a Pharmaceutical
Product Moving in International Commerce, in the prescribed
format and signed by the government regulatory authority in a
country which is a signatory to the World Health Organization
Certification Scheme, the country being that in which the
manufacture has occurred, so long as the medicinal drug has been
registered for sale on the local market in the country of
manufacture; and
(c) any other documentation required under the power contained within
subsection (3).
(3)
(a) The secretary of the Committee may, by notice in writing given to
the applicant, require the applicant to give the Committee, within
such reasonable time as is specified in the notice, such information
specified in the notice concerning the composition, storage,
indications, directions for use or labelling of the medicinal drug,
advertising material relating to the medicinal drug, reports of
adverse drug reactions or concerning treatment of over-dosage;
(b) A notice under paragraph (a) may require the information to be
given—
(i) in writing; or
(ii) in accordance with specified software requirements on a
specified kind of data processing device or by way of a
specified kind of electronic transmission.
(4) Notwithstanding the requirement in subsection (2)(b) the Committee may
define the information required and the format of submission for a
medicinal drug for which inclusion on the registered list is desired and for
which the documentation specified in subsection (2)(b) is not available.
(5) The Committee shall notify the applicant, in writing, of the Committee's
determination and, if necessary, add the new medicinal drug to the
registered list in the appropriate Class.
(6) The decision of the Committee under this section is final.
9 Removal from registered list
The Committee may remove a medicinal drug from the registered list if—
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(a) the importer or manufacturer requests in writing the removal from
the registered list;
(b) the quality, safety or efficacy of the medicinal drug becomes
unacceptable to the Committee;
(c) the importer or manufacturer has failed to comply with a condition
to which the inclusion of the medicinal drug on the registered list is
subject; or
(d) the registration fee is not paid.
PART IV—IMPORT, EXPORT, MANUFACTURE AND
QUALITY CONTROL OF THERAPEUTIC GOODS
10 Import of medicinal drugs
(1) Any person who imports, distributes, prescribes or offers for sale a
medicinal drug which is not included in the registered list commits an
offence.
(2) A person may not import, manufacture, or sell by wholesale or retail any
medicinal drug unless licensed to do so under this Act.
(3) Upon application by a registered medical practitioner or pharmacist, the
Minister may authorise the importation of a medicinal drug not included
in the registered list in order to meet the particular treatment needs of an
individual patient.
(4) The Minister may authorise the importation of a medicinal drug not
included in the registered list in the interest of public health during a
major disaster or period of emergency.
(5) The giving of an authorisation under subsections (3) or (4) shall not render
the Crown, the Minister or the Committee liable to a person in respect of
loss, damage or injury of any kind suffered by the person as a result of, or
arising out of, the use of therapeutic goods by that person or another
person.
(6) Nothing in this section prevents the importation by any person of a
medicinal drug not included in the registered list when that importation is
for personal therapeutic use which is evidenced by a letter or certificate of
that person's medical practitioner registered outside the Kingdom or is for
the purpose of an approved clinical trial.
Section 11 Therapeutic Goods Act 2001
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11 Import licence
(1)
(a) An application for an import licence shall only be made by a
pharmacist, veterinary practitioner, wholesaler or retailer.
(b) The import licence shall be limited to those therapeutic goods in the
Class of the registered list under section 5(2) authorised as able to
be held by the applicant.
(2) The holder of an import licence shall not intentionally or recklessly breach
a condition of the licence.
(3) An application for an import licence shall—
(a) be made in writing in the form prescribed in the regulations;
(b) identify the therapeutic goods that the applicant wishes to import
and the Class of the registered list in which they are included;
(c) be delivered to the Central Pharmacy and Medical Store; and
(d) be accompanied by the specified application fee.
(4) A person shall not, in or in connection with an application for a licence to
import therapeutic goods, make a statement that is, to the person's
knowledge, false or misleading in any material particular.
12 Granting of import licence
(1) The secretary of the Committee may, by notice in writing given to the
applicant for an import licence, require the applicant—
(a) to give the Committee, within such reasonable time as is specified
in the notice, such further information concerning the application as
is specified in the notice; or
(b) to allow an authorised officer, at any reasonable time specified in
the notice, to inspect the premises, equipment and facilities that will
be used for the storage of the therapeutic goods included in the
application for the import licence.
(2)
(a) Where a person has made an application to import therapeutic
goods and the therapeutic goods are within the Class of the
registered list authorised to be held by the applicant; and
(i) the specified application fee has been paid;
(ii) any specified inspection fees have been paid; and
(iii) the person has complied with any requirements made by the
Committee under subsection (1) in relation to the
application—
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the Committee shall grant the person a licence to import therapeutic
goods of the applicable Class of the registered list.
(b) Notwithstanding paragraph (a) if the Committee is satisfied that—
(i) the premises of the applicant, if a pharmacist, do not comply
with the licensing or other requirements of the Pharmacy Act
2001; or
(ii) the premises of the applicant, if a retail outlet, are not
appropriate for the display, storage or sale of therapeutic
goods;
(iii) the applicant has had an import licence granted to him
revoked;
(iv) the applicant has been convicted of an offence against this
Act, the Pharmacy Act 2001 or the Customs and Excise Act
(Cap. 67);
(v) the applicant controls a body corporate (whether directly, or
indirectly through one or more interposed entities) that has
been convicted of an offence against this Act, the Pharmacy
Act 2001 or the Customs and Excise Act (Cap. 67); or
(vi) the applicant controlled a body corporate (whether directly,
or indirectly through one or more interposed entities) when
the body committed an offence against this Act, the
Pharmacy Act 2001 or the Customs and Excise Act (Cap.
67), and the body has been convicted of any such offence or,
where the applicant is a body corporate and is controlled by
another person (whether directly, or indirectly through one or
more interposed entities) and that other person has been
convicted of any such offence—
the Committee shall refuse to grant an import licence.
(3) Where the Committee grants or refuses to grant an import licence, the
Committee shall—
(a) give the applicant written notice of the decision; and
(b) in the case of a refusal, include in the notice reasons for the refusal.
(4) Where the Committee grants an import licence, the secretary to the
Committee shall publish particulars of the decision in the Gazette as soon
as is practicable.
(5) An import licence commences on the day specified in the licence and
remains in force until it is revoked or suspended.
(6) An import licence may be granted subject to—
(i) conditions designed to ensure that the holder of the licence imports
the therapeutic goods in accordance with any required standards for
Section 12 Therapeutic Goods Act 2001
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transport, storage, or display, including temperature standards and
any required standards relating to security of the goods; and
(ii) such other conditions relating to the import of the therapeutic goods
as the Committee deems appropriate.
(7) The Committee may, by notice in writing given to the holder of an import
licence, impose new conditions on the licence or vary or remove existing
conditions.
(8) The imposition or variation of a condition under subsection (7) shall take
effect—
(i) if the notice states that the action is necessary to prevent imminent
risk of death, serious illness or serious injury, on the day on which
the notice is given to the person; or
(ii) in any other case, on a day specified in the notice, being a day not
earlier than 28 days after the notice is given to the person.
(9) In addition to any conditions imposed under subsection (6) or (7), each
import licence is subject to the conditions that the holder of the import
licence shall—
(i) ensure that the goods shall conform to any standard applicable to
the goods; and
(ii) allow an authorised officer or customs officer to enter, at any
reasonable time, the premises to which the goods are imported and,
while on those premises to inspect those premises and any
therapeutic goods stored thereon, and to take samples of such
goods.
(10) Subject to subsection (11), the Committee may, by notice in writing given
to the holder of an import licence, revoke the licence, or suspend the
licence for a period specified in the notice if—
(i) the holder has been convicted of an offence against this Act, the
Pharmacy Act 2001, or the Customs and Excise Act (Cap. 67);
(ii) the holder controls a body corporate (whether directly, or indirectly
through one or more interposed entities) that has been convicted of
an offence against this Act, the Pharmacy Act 2001 or the Customs
and Excise Act (Cap. 67);
(iii) the holder controlled a body corporate (whether directly, or
indirectly through one or more interposed entities) when that body
committed an offence against this Act, the Pharmacy Act 2001 or
the Customs and Excise Act (Cap. 67) and the body has been
convicted of such offence;
(iv) the holder is controlled by another person (whether directly, or
indirectly through one or more interposed entities) and that other
Therapeutic Goods Act 2001 Section 13
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person has been convicted of an offence against this Act, the
Pharmacy Act 2001 or the Customs and Excise Act (Cap. 67);
(v) the holder has breached a condition of the licence;
(vi) the holder requests in writing that the licence be revoked or
suspended, as the case may be;
(vii) the holder ceases to carry on the business or profession to which the
licence relates; or
(viii) the annual licensing charge, or any applicable prescribed inspection
fees, have not been paid within 28 days after they become payable.
(11) Where the Committee proposes to revoke a licence or suspend a licence
otherwise than at the request of the holder of the licence, the Committee
shall, unless the Committee considers that failure to revoke or suspend the
licence immediately would create an imminent risk of death, serious
illness or serious injury—
(i) by notice in writing given to the holder, inform the holder of the
action that the Committee proposes to take and of the reasons for
that proposed action; and
(ii) except where the proposed action is to be taken as a result of a
failure to pay the annual licensing charge or an applicable
prescribed inspection fee, give the holder an opportunity to make,
within such reasonable time as is specified in the notice,
submissions to the Committee in relation to the proposed action.
(12) Where the holder makes submissions in accordance with subsection (11),
the Committee shall take into account the submissions before making a
decision relating to the revocation or suspension of the licence.
(13) A licence may be revoked notwithstanding that the licence is suspended.
(14) Where a licence is suspended, the Committee may, by notice in writing
given to the holder of the licence, cancel the suspension.
(15) Where the Committee revokes or suspends an import licence, the
secretary of the Committee shall publish particulars of the decision in the
Gazette as soon as is practicable.
(16) The Committee may, from time to time and in such manner as the
Committee determines, publish a list of persons who are licensed to
import therapeutic goods under this section, and the Classes of the
registered list to which the licences relate.
13 Offences
(1) A person shall not—
(a) import therapeutic goods into the Kingdom;
Section 14 Therapeutic Goods Act 2001
No. 3 of 2001 Page 20
to
(b) export therapeutic goods from the Kingdom except under an
authority given by the Minister or where the exportation by a
person is for personal therapeutic use which is evidenced by a letter
or certificate of that person's medical practitioner registered in the
Kingdom;
(c) manufacture in the Kingdom therapeutic goods; or
(d) supply therapeutic goods in the Kingdom;
unless the goods are included in the registered list and if imported are
imported under a licence under section 12 or the goods are the subject of
an authorisation by the Minister under section 10.
(2) Where a customs officer seizes medicinal drugs under powers contained
in the Customs and Excise Act (Cap. 67), the Principal Pharmacist shall
be advised of the seizure as soon as practicable thereafter.
14 Manufacture of therapeutic goods prohibited except under licence
(1) A person shall not, at premises in the Kingdom, manufacture or carry out
a set in the manufacture of therapeutic goods for supply for use in humans
unless—
(a) the goods are or the person is exempt by regulations in relation to
the manufacture of the goods; or
(b) the person is the holder of a manufacturing licence that is in force
and authorises the carrying out of that manufacture or step in the
manufacture.
Provided that this subsection shall not apply to or in relation to
therapeutic goods that are manufactured by a dentist, dental
therapist or manufactured by—
(c) a pharmacist or assistant pharmacist on premises in which the
practice of pharmacy is carried on; or
(d) a pharmacist or assistant pharmacist on premises of the Ministry of
Health;
for sale or supply, otherwise than by wholesale, on or from those
premises.
(2) A person who is the holder of a manufacturing licence shall not breach a
condition of the licence.
(3) A person shall not, in or in connection with an application for a
manufacturing licence, knowingly make a statement that is false or
misleading in a material particular.
(4) The Committee may, from time to time, by notice in writing, determine
principles to be observed in relation to—
Therapeutic Goods Act 2001 Section 14
No. 3 of 2001
to
Page 21
(a) the standards to be maintained and the equipment to be used at
premises used for the manufacture of therapeutic goods;
(b) procedures for quality assurance and quality control to be employed
in the manufacture of therapeutic goods;
(c) the qualifications and experience required by persons employed in
the manufacture of therapeutic goods;
(d) the manufacturing practices to be employed in the manufacture of
therapeutic goods; or
(e) other matters relevant to the quality, safety and efficacy of
therapeutic goods that are manufactured in the Kingdom;
and may include codes of good manufacturing practice.
(5) An application for a manufacturing licence shall—
(a) be made in writing in the form prescribed in the regulations;
(b) identify the therapeutic goods or classes of therapeutic goods that
the applicant proposes to manufacture;
(c) identify the premises that will be used in the manufacture of those
goods;
(d) identify the steps in the manufacture of those goods that the
applicant proposes to carry out under the licence;
(e) state the names, qualifications and experience of the persons who
are to have control of the production of the goods and of the quality
control measures that are to be employed;
(f) be delivered to the Central Pharmacy and Medical Store; and
(g) be accompanied by the specified application fee.
(6) The Committee may, by notice in writing, require the applicant—
(a) to give to the Committee, within such reasonable time as is
specified in the notice, such further information concerning the
application as is specified in the notice; or
(b) to allow an authorised officer, at any reasonable time specified in
the application, to inspect the premises, equipment, processes,
goods and facilities that will be used in the manufacture of the
goods.
(7)
(a) Where a person has made an application to carry out steps in the
manufacture of therapeutic goods at particular manufacturing
premises; and
(i) the required prescribed application fee has been paid;
(ii) any applicable inspection fees have been paid; and
Section 14 Therapeutic Goods Act 2001
No. 3 of 2001 Page 22
to
(iii) the person has complied with any requirements made by the
Committee under subsection (6) in relation to the application;
the Committee shall grant the person a licence to carry out those
steps at those premises.
(b) Notwithstanding paragraph (a) if the Committee is satisfied that—
(i) the applicant will be unable to comply with the
manufacturing principles;
(ii) the premises are not satisfactory for the manufacture of the
goods;
(iii) the applicant has had a manufacturing licence granted to him
revoked;
(iv) the applicant has been convicted of an offence against this
Act;
(v) the applicant controls a body corporate (whether directly, or
indirectly through one or more interposed entities) that has
been convicted of an offence against this Act;
(vi) the applicant controlled a body corporate (whether directly,
or indirectly through one or more interposed entities) when
the body committed an offence against this Act, and the body
has been convicted of such offence, or where the applicant is
a body corporate and is controlled by another person
(whether directly, or indirectly through one or more
interposed entities) and that other person has been convicted
of an offence against this Act; or
(vii) the applicant has failed on more than one occasion to observe
the manufacturing principles in connection with the
manufacture of therapeutic goods,
the Committee shall refuse to grant a manufacturing licence.
(8) Where the Committee grants or refuses to grant a manufacturing licence,
the Committee shall—
(a) give the applicant written notice of the decision; and
(b) in the case of a refusal, include in the notice the reasons for the
refusal.
(9) Where the Committee grants a manufacturing licence, the secretary to the
Committee shall publish particulars of the decision in the Gazette as soon
as is practicable.
(10) A manufacturing licence commences on the day specified in the licence
and remains in force until it is revoked or suspended.
(11) A manufacturing licence may be granted subject to—
Therapeutic Goods Act 2001 Section 14
No. 3 of 2001
to
Page 23
(a) conditions designed to ensure that the holder of the licence
manufactures the goods in accordance with the manufacturing
principles, and any standards applicable to the goods; and
(b) such other conditions relating to the manufacture of the goods as
the Committee thinks appropriate.
(12) The Committee may, by notice in writing, impose new conditions in the
manufacturing licence or vary or remove existing conditions.
(13) The imposition or variation of a condition under subsection (12) shall take
effect—
(a) if the notice states that the action is necessary to prevent imminent
risk of death, serious illness or serious injury, on the day on which
the notice is given to the person; or
(b) in any other case, on a day specified in the notice, being a day not
earlier than 28 days after the notice is given to the person.
(14) In addition to any conditions imposed under subsection (11) or (12), every
licence is subject to the conditions that the holder of the licence shall—
(a) ensure that the goods conform to any standard applicable to the
goods;
(b) not manufacture a medicinal drug using any counterfeit starting
materials or without taking reasonable measures to ensure that the
starting materials used or employed in the manufacture of such
medicinal drug are not counterfeit or of suspect quality;
(c) allow an authorised officer—
(i) to enter, at any reasonable time, the manufacturing premises
to which the licence relates;
(ii) while on those premises, to inspect those premises, any
therapeutic good manufactured thereat and any process
relating to that manufacture, and to take samples of such
goods and to take photographs of those premises, goods or
processes; and
(iii) to question the holder or his employees at those premises
about procedures carried out there;
(d) if requested to do so by an authorised officer—
(i) produce to the officer such documents relating to the
manufacture of therapeutic goods at those premises as the
officer requires and allow the officer to copy the documents;
and
(ii) produce to the officer for examination any batch samples
kept by the holder; and
Section 14 Therapeutic Goods Act 2001
No. 3 of 2001 Page 24
to
(e) comply with such other conditions (if any) specified in the
regulations.
(15) Subject to subsection (16), the Committee may, by notice in writing given
to the holder of the licence, revoke the licence, or suspend the licence for
a period specified in the notice, if—
(a) the holder has been convicted of an offence against this Act;
(b) the holder controls a body corporate (whether directly, or indirectly
through one or more interposed entities) that has been convicted of
an offence against this Act;
(c) the holder controlled a body corporate (whether directly, or
indirectly through one or more interposed entities) when that body
committed an offence against this Act and the body has been
convicted of that offence or where the holder is a body corporate
and the holder is controlled by another person (whether directly, or
indirectly through one or more interposed entities) and that other
person has been convicted of an offence against this Act;
(d) the holder has breached a condition of the licence;
(e) the holder has failed to observe the manufacturing principles in
connection with the manufacture of therapeutic goods;
(f) the holder requests in writing that the licence be revoked or
suspended;
(g) the holder ceases to carry on the business of manufacturing the
goods to which the licence relates; or
(h) the annual licensing charge, or any applicable inspection fees, have
not been paid within 28 days after they become payable.
(16) Where the Committee proposes to revoke a licence or suspend a licence
otherwise that at the request of the holder of the licence, the Committee
shall, unless the Committee considers that failure to revoke or suspend the
licence immediately would create an imminent risk of death, serious
illness or serious injury—
(a) by notice in writing given to the holder, inform the holder of the
action that the Committee proposes to take and of the reasons for
that proposed action; and
(b) except where the proposed action is to be taken as a result of a
failure to pay the annual licensing charge or an applicable
inspection fee, give the holder an opportunity to make, within such
reasonable time as is specified in the notice, submissions to the
Committee in relation to the proposed action.
(17) Where the holder makes submissions in accordance with subsection (16),
the Committee shall take into account the submissions before making a
decision relating to the revocation or suspension of the licence.
Therapeutic Goods Act 2001 Section 15
No. 3 of 2001
to
Page 25
(18) A licence may be revoked notwithstanding that the licence is suspended.
(19) Where a licence is suspended, the Committee may, by notice in writing
given to the holder of the licence, cancel the suspension.
(20) Where the Committee revokes or suspends a manufacturing licence, the
secretary of the Committee shall publish particulars of the decision in the
Gazette as soon as is practicable.
(21) The Committee may, from time to time and in such manner as the
Committee determines, publish a list of the persons who are licensed
under this section, the classes of goods to which the licence relates, the
steps of the manufacture that the licence authorises and the address of the
manufacturing premises to which the licence relates.
15 Quality control
(1) No person shall manufacture, import, export, compound, store, sell,
advertise or distribute a medicinal drug that—
(a) is unfit for use in humans or in animals;
(b) is adulterated;
(c) has upon it any natural or added deleterious substance which
renders it injurious to health;
(d) has been manufactured, prepared, preserved, packaged or stored for
sale under insanitary or unfavourable conditions;
(e) has been labelled, packaged or advertised in a manner that is false,
misleading, deceptive or likely to cause an erroneous impression
regarding its source, character, value, quality, composition,
potency, merit or safety;
(f) contains any counterfeit starting materials or is known to be
counterfeit or suspected to be a counterfeit.
(2) Any person who, without reasonable excuse, contravenes subsection (1)
commits an offence.
(3) For the purpose of investigation of any suspected offence under
subsection (1), the Committee may nominate an organisation, body or
person which the Committee considers to be competent and not directly or
indirectly engaged in or connected with the manufacture or sale of
medicinal drugs, to carry out analysis of medicinal drugs.
16 Donated medicinal drugs
Donated medicinal drugs may be imported into the Kingdom only if—
(a) they are in the List of Essential Drugs for the Kingdom;
Section 17 Therapeutic Goods Act 2001
No. 3 of 2001 Page 26
to
(b) they are of known good quality;
(c) they are labelled with the generic international non-proprietary
name (INN);
(d) they, if sent under the same programme or to the same recipient
regularly, are of consistent strength;
(e) they meet the specifications of the Central Pharmacy and Medical
Store;
(f) the prospective donations are fully detailed and approved by the
Principal Pharmacist before dispatch of the donation from the home
port; and
(g) they have a “use by” or “expiry” date provided with sufficient
useful life remaining after estimated arrival date in the Kingdom.
PART V—SPECIAL IMPORT CONTROLS FOR NARCOTIC
DRUGS AND PSYCHOTROPIC SUBSTANCES
17 Authority to import narcotic drugs and psychotropic substances
(1) The Minister is authorised to import all narcotic drugs under international
control listed within the most recent edition of the Annex to the statistical
forms ('Yellow List”) and psychotropic substances under international
control listed within the most recent edition of the Annex to the Annual
Statistical Report (“Green List”), prepared by the International Narcotics
Control Board of the United Nations.
(2) The authorisation of the Minister under subsection (1) may be delegated
to the Principal Pharmacist.
PART VI—REGULATION OF SUPPLY OF REGISTERED
DRUGS
18 Sale by wholesale prohibited except under licence
(1) A person who sells by wholesale therapeutic goods, or a class of
therapeutic goods, to which this section applies commits an offence unless
the sale by wholesale is authorised under a licence.
(2) The Committee, with the approval of the Minister, may by regulations
specify therapeutic goods or classes to which this section applies.
Therapeutic Goods Act 2001 Section 19
No. 3 of 2001
to
Page 27
19 Licensing of retailers
(1) Non-pharmacy, retail outlets may obtain, hold, store and sell medicinal
drugs contained in Class 1 of the registered list, subject to holding a
current retail licence.
(2) The obtaining, holding, storing, selling or offering for sale by a non
pharmacy, retail, outlet, of medicinal drugs other than those contained
within Class 1 of the registered list, or the holding, storing, selling or
offering for sale of medicinal drugs without a retail licence is an offence.
(3) A person who supplies medicinal drugs after the expiry date stated on the
drugs commits an offence.
20 Authority to write prescriptions
(1) Any accredited health officer may write prescriptions for medicinal drugs
included in Classes 1 and 2 of the registered list, and may write
prescriptions for medicinal drugs included in Class 3 of the registered list
on the advice of a medical practitioner.
(2) Any dentist may write prescriptions for medicinal drugs included in
Classes 1, 2 and 3 of the registered list when the particular medicinal drug
is for therapeutic use in the practice of dentistry.
(3) Any medical practitioner may write prescriptions for medicinal drugs
included in Classes 1, 2, 3 and 5 of the registered list.
(4) Any medical practitioner predominantly practising in a particular
recognised special area may write prescriptions for medicinal drugs
included in Class 4 of the registered list, when the particular medicinal
drug is for therapeutic use of a person being treated for a condition under
that special area.
(5) Any veterinary practitioner may write prescriptions for medicinal drugs
included in Class 6 of the registered list.
(6) No person may write a prescription for the supply of narcotic drugs or
psychotropic substances for his own use.
21 Requirements for prescriptions
(1) Except in cases of emergency, a registered pharmacist or assistant
pharmacist shall not dispense any prescription for the supply of medicinal
drugs unless the prescription—
(a) is in writing and dated and signed with the usual signature of the
person authorised to give it, specifies that person's professional
Section 22 Therapeutic Goods Act 2001
No. 3 of 2001 Page 28
to
address and the name and address of the person for whom the
prescription is given;
(b) when given by a registered dentist is endorsed “For dental treatment
only”;
(c) when given by a veterinary practitioner is endorsed “For animal
treatment only”;
(d) is endorsed by a registered medical practitioner issuing it with a
statement as to the number of times the prescription shall be
dispensed;
(e) if containing an unusual or dangerous dose includes a statement by
the person issuing it that the dose is intentionally prescribed;
(f) is written in terms and symbols such as are used in ordinary
professional practice, and states the generic name of the medicinal
drug;
provided that, when the prescription is signed by a medical practitioner,
health officer or dentist, it shall include the practitioner's registration
number given under the Medical and Dental Practice Act 2001.
(2) Where, in any emergency case, a prescription is issued orally to any
registered pharmacist or assistant pharmacist, the prescription shall be
provided in writing to the pharmacist or assistant pharmacist within 24
hours by the person issuing it.
22 Dispensing requirements
(1) Except as provided in subsection (2), no person shall dispense a medicinal
drug upon prescription unless he is a registered pharmacist or assistant
pharmacist or an assistant under the direct personal supervision and
control of a registered pharmacist or a veterinary practitioner.
(2) Nothing in subsection (1) shall prevent a registered medical practitioner,
health officer or nurse from dispensing a starting dose out of hours, or
dispensing a prescription or supplying a medicinal drug within the limit of
his accreditation where no registered pharmacy premises, registered
pharmacist or assistant pharmacist are available within 10 kilometres.
(3) In dispensing a prescription for a medicinal drug—
(a) the medicinal drug shall not be dispensed more than once on the
same prescription, except where the prescription so directs, in
which case the medicinal drug may be dispensed at such interval or
intervals as are stated in the prescription;
(b) the prescription shall be marked with the date on which it is
dispensed, and with the name and professional address of the
person who dispenses it;
Therapeutic Goods Act 2001 Section 23
No. 3 of 2001
to
Page 29
(c) the person who dispenses a prescription for the last occasion shall
endorse the prescription with the word “Cancelled”;
(d) no person shall dispense a prescription endorsed as “Cancelled” or
which has, or appears to have, been written more than 3 months
before its presentation;
(e) no person shall dispense a prescription if he has reason to believe
that the prescription is not genuine;
(f) no person shall dispense a prescription which is illegible or defaced
or which appears to have been altered; and
(g) where a registered pharmacist or assistant pharmacist suspects that
a prescription has been forged or fraudulently issued, or does not
bear the signature of a registered medical practitioner, health officer
or dentist, he shall, notwithstanding that it is not dispensed, retain
the prescription and report his suspicion to the Principal Pharmacist
as soon as practicable.
(4)
(a) Every pharmacist or assistant pharmacist shall record every
prescription dispensed, compounded or made up by him in a
prescription book, or by electronic means.
(b) The prescription book or electronic record shall include:
(i) a number relating to the relevant prescription only and the
prescription number;
(ii) the name and address of the person for whose use the
medicine or drug was dispensed or compounded.
(5) The prescription book or electronic record shall be kept at the place at
which the medicine or drug is dispensed and shall at all reasonable times
be produced when demanded by an authorised officer.
(6) All original prescriptions as they are dispensed shall be marked with the
prescription number, filed in numerical order and retained by the person
dispensing the prescription for 2 years from the date of dispensing.
(7) Any person, who without reasonable excuse, contravenes this section
commits an offence.
23 Labels on Containers
(1) Every registered pharmacist, assistant pharmacist, medical practitioner,
nurse or health officer shall, before delivering or dispatching to any
person, or the agent of that person, a container containing a medicinal
drug dispensed or compounded by him, affix to the container immediately
Section 24 Therapeutic Goods Act 2001
No. 3 of 2001 Page 30
to
containing the medicinal drug a label on which appears clearly in the
Tonga language—
(a) a printed address identifying clearly the pharmacy at which the
medicinal drug was compounded or dispensed;
(b) the name of the person for whom the medicinal drug was
compounded or dispensed;
(c) such identification of the contents as is required by subsection (2);
(d) the directions for use specified in the prescription from which the
medicinal drug was compounded or dispensed; and
(e) an identification mark corresponding to the prescription number as
appearing in the prescription book or electronic record.
(2)
(a) The identification referred to in subsection 1(c) shall be by
reference to the generic name of the medicinal drug in the latest
current edition of the United States Pharmacopoeia or the British
Pharmacopoeia.
(b) the label of the container containing a medicinal drug shall be
marked with such additional precautionary labelling as is
considered relevant by the dispensing pharmacist or assistant
pharmacist.
(3) The contents of this section do not preclude the addition to the label of a
statement in the English language as to all or any of the matters required.
(4) Any person who, without reasonable excuse, contravenes this section
commits and offence.
PART VII—MISCELLANEOUS PROVISIONS
24 Authorised officer
(1) The Minister may, by notice in the Gazette, specify a person or persons as
authorised officers for the purposes of this Act.
(2) An authorised officer shall, upon request, provide proof that he is an
authorised officer.
25 Powers of entry, search and seizure
(1) For the purposes of this Act, an authorised officer may at all reasonable
times—
Therapeutic Goods Act 2001 Section 25
No. 3 of 2001
to
Page 31
(a) enter any premises where medicinal drugs are being kept for retail
trade or for the practice of pharmacy;
(b) enter any place, premises or vehicle in respect of which he knows
or reasonably suspects—
(i) is or are being used for the practice of pharmacy;
(ii) have been or are being or are likely to be used by any person
in contravention of this Act;
(c) 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;
(d) 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 investigation 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;
(iv) question with respect to matters under this Act any person he
finds thereon;
(e) 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
being, or is likely to be used in connection with a contravention of this
Act, may issue a search warrant directing the authorised officer to enter
Section 26 Therapeutic Goods Act 2001
No. 3 of 2001 Page 32
to
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, shall 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;
(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.
26 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;
Therapeutic Goods Act 2001 Section 27
No. 3 of 2001
to
Page 33
(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 thereof 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
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.
27 Continuing offence
If a person commits an offence by failing to furnish information required under
section 26 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
Section 28 Therapeutic Goods Act 2001
No. 3 of 2001 Page 34
to
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 not exceeding $100 for each day during
which the offence continues; and
(d) the person may be prosecuted from time to time in respect of the
offence under subsection (b) above.
28 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 in the
exercise of his powers under this Act 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 deliberately prevents any person from being
questioned by an authorised officer in the exercise of his powers
under this Act; or
(c) in any way obstructs or attempts to obstruct an authorised officer in
the exercise of his powers under this Act.
29 Directions may be issued to secure compliance
(1) If—
(a) any pharmacist, assistant pharmacist, medical practitioner, nurse,
health officer, veterinary practitioner, pharmacy premises,
prescription or other person, place or thing does not comply in
every respect 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.
Therapeutic Goods Act 2001 Section 30
No. 3 of 2001
to
Page 35
(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.
30 Contracts etc. void
(1) A contract, agreement, undertaking or understanding that 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).
31 Making false or fraudulent representation
A person who, in an application for inclusion of a medicinal drug on the
registered list or application for the issue of any licence 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 $2,000 or to imprisonment for a term
not exceeding 12 months or both.
32 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 penalty is provided, be liable to a fine not exceeding $2,000, or
imprisonment for a term not exceeding 12 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.
33 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.
Section 34 Therapeutic Goods Act 2001
No. 3 of 2001 Page 36
to
34 Prosecutions
(1) Prosecutions for an offence under this Act may be brought—
(a) by or on behalf of the Attorney General;
(b) by a member of the police;
(c) by an authorised officer; or
(d) by a customs officer.
(2) A person referred to in subsection (1)(b), (c) or (d), 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.
35 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—
(1) the fees payable under this Act and the regulations;
(2) the manner and form of an application for inclusion of a new drug
on the registered list or an application for any licence under this
Act;
(3) exempting from the operation of any of the provisions of this Act or
the regulations such persons or classes of persons as may be
specified.
PART VIII—TRANSITIONAL ARRANGEMENTS
36 Temporary registered list
(1) The Committee shall create and maintain a temporary registered drug list
to be based upon the List of Essential Drugs for the Kingdom kept by the
Central Pharmacy and Medical Store.
(2) Medicinal drugs utilised, other than those on the List of Essential Drugs
for the Kingdom, may be added to the temporary registered drug list
provided that those medicinal drugs meet the criteria stated in section 7 of
this Act.
(3) The temporary registered list shall cease to exist upon the creation of the
registered list.
Therapeutic Goods Act 2001 SCHEDULE
No. 3 of 2001
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Page 37
SCHEDULE
(Section 7(e))
COUNTRIES OF MANUFACTURE
Australia
Canada
Fiji
Sweden
United Kingdom
United States of America
New Zealand
Passed by the Legislative Assembly this 11 day of July, 2001.
