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Therapeutic Goods Act 2001

TONGA

THERAPEUTIC GOODS ACT 2001

I assent,

TAUFA'AHAU TUPOU IV,
21st September, 2002.

ARRANGEMENT OF PARTS AND SECTIONS

PART I - PRELIMINARY

1. Short Title and Commencement
2. Interpretation
3. Crown to be Bound

PART II - THE NATIONAL DRUGS AND MEDICAL
SUPPLIES COMMITTEE

4. Establishment and functions

PART III - THE TONGAN REGISTERED LIST OF MEDICINAL DRUGS

5. Registered List
6. Content of Registered List
7. Inclusion in Registered List
8. Application for Registered List
9. Removal from Registered List

PART IV - IMPORT, EXPORT, MANUFACTURE AND QUALITY
CONTROL OF THERAPEUTIC GOODS

10. Importation of Drugs
11. Import Licence
12. Granting of Import Licence
13. Offences
14. Manufacture of therapeutic goods
15. Quality Control
16. Donated Drugs

PART V - SPECIAL IMPORT CONTROLS FOR NARCOTIC
DRUGS AND PSYCHOTROPIC SUBSTANCES

17. Authority to Import

PART VI - REGULATION OF SUPPLY OF REGISTERED DRUGS

18. Sale by Wholesale
19. Licensing of Retailers
20. Authority to Write Prescriptions
21. Prescriptions
22. Dispensing
23. Labels on Containers

PART VII - MISCELLANEOUS PROVISIONS

24. Authorised Officers
25. Powers of Entry, Search & Seizure
26. Power to Obtain Information
27. Continuing Offence
28. Obstruction
29. Direction to Comply
30. Void Contracts
31. Making False or Fraudulent Representation
32. Offence and Penalty
33. Offences by Corporate Bodies
34. Prosecutions
35. Regulations

PART VIII - TRANSITIONAL ARRANGEMENTS

36. Temporary Registered List

Schedule

-----------------------------------

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.

[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

Short title and commencement

1. 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.

Interpretation

2. 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;

(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);

"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;

(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 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;

(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;

"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-

(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;

(b) herbal medicines other than those prepared by traditional Tongan healers;

(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.

Crown to be bound

3. This Act binds the Crown.

PART II - THE NATIONAL DRUGS AND
MEDICAL SUPPLIES COMMITTEE

Establishment, functions and constitution of committee

4. (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;

(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;

(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.

(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

Establishment of Registered List

5. (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.

(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.

Advice as to content of registered list

6. The registered list shall record the medicinal drugs both by brand name and International Non-proprietary Name (INN) and shall include the place of manufacture.

Criteria for inclusion in the Registered List

7. 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 and acceptable safety profile;

(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.

Application for inclusion in registered list

8. (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.

(2) [sic] 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

(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.

Removal from registered list

9. The Committee may remove a medicinal drug from thee registered list if-

(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

Import of medicinal drugs

10. (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.

Import licence

11. (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;

(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.

Granting of import licence

12. (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-

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 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 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.

The Therapeutic Goods Act - 3 of 2001.
Lao ki he Ngaahi Koloa Faito 'o- 3 'o e 2001.

(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.

Offences

13. (1) A person shall not-

(a) import therapeutic goods into the Kingdom;

(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;

(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.

Manufacture of therapeutic goods prohibited except under licence

14. (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 -

(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 -

(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;

(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;

(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

(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 -

(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;

(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

(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.

(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.

Quality control

15. (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;

(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 and 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.

Donated medicinal drugs

16. Donated medicinal drugs may be imported into the Kingdom only if-

(a) they are in the List of Essential Drugs for the Kingdom;

(b) they are of known good quality;

(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

Authority to import narcotic drugs and psychotropic substances

17. (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

Sale by wholesale prohibited except under licence

18. (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.

Licensing of retailers

19. (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.

Authority to write prescriptions

20. (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.

Requirements for prescriptions

21. (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 singed with the usual signature of the person authorised to give it, specifies that person's professional 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";

(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.

Dispensing requirements

22. (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;

(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.

Labels on Containers

23. (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 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;

(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

Authorised officer

24. (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.

Powers of entry, search and seizure

25. (1) For the purposes of this Act, an authorised officer may at all reasonable times-

(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 their 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 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.

Power to obtain information

26. (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 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;

(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.

Continuing offence

27. 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 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;

(d) the person may be prosecuted from time to time in respect of the offence under subsection (b) above.

Obstruction

28. (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

Directions may be issued to secure compliance

29. (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.

(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.

Contracts etc. void

30. (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).

Making false or fraudulent representation

31. 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 and 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.

Offence and penalty

32. 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.

Offences by corporate bodies

33. 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.

Prosecutions

34. (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;

(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.

Regulations

35. 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

Temporary registered list

36. (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.

Passed by the Legislative Assembly this 11 day of July, 2001.

SCHEDULE

(Section 7(e))

Countries of Manufacture

Australia

Canada

Fiji

Sweden

United Kingdom

United States of America

New Zealand

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TONGA

'Oku ou loto ki ai,

TAUFA'AHAU TUPOU IV,
21 'o Sepitema, 2002.

LAO NGAAHI KOLOA FAITO'O 2001

KONGA I - TALATEU

1. Hingoa nounou mo e kamata'anga
2. 'Uhinga'i lea
3. Ha'i 'a e Kalauni

KONGA II - KOMITI FAITO'O MO E NGAAHI NAUNAU
FAITO'O FAKAFONUA

4. Fokotu'u ngaue mo e konisitutone 'o e komiti

KONGA III - LISI LESISITA 'O E NGAAHI
FAITO'O FAKAESINO 'A TONGA

5. Fokotu'u 'o e lisi lesisita
6. Fale'i fekau'aki mo e kakano 'o e lisi lesisita
7. Ngaahi tu'unga ke fakakau'aki ki he lisi lesisita
8. Tohi kole ke kau 'i he lisi lesisita
9. To'o mei he lisi kuo lesisita

KONGA IV - HU MAI, HU ATU, NGAAHII MO PULE'I 'O E
LELEI 'O E NGAAHI KOLOA FAITO'O

10. Hu mai 'a e ngaahi faito'o fakaesino
11. Laiseni hu mai
12. Foaki 'o e ngaahi laiseni hu faito'o
13. Ngaahi hia
14. Tapu ke ngaahi ha ngaahi koloa faito'o tukukehe 'i ha laiseni
15. Pule'i 'o e lelei
16. Ngaahi faito'o fakaesino me'a'ofa

KONGA V - PULE'I MAKEHE 'O E HU MAI 'O E NGAAHI FAITO'O KONA
TAPU MO E NGAAHI ME'A KONGA FAKA'ATAMAI

17. Mafai ke hu mai 'a e ngaahi faito'o kona tapu mo e ngaahi me'a faito'o 'atamai

KONGA VI - PULPI 'O E TUKU ATU 'O E NGAAHI FAITO'O LESISITA

18. Tapui fakatau holoseila tukukehe 'i he laiseni
19. Laiseni 'o e kau fakatau fakamovetevete
20. Mafai ke tohi ngaahi tu'utu'uni fakatoketa
21. Ngaahi fiema'u ki he ngaahi tu'utu'uni fakatoketa
22. Ngaahi fiema'u ki he teuteu'i mo tuku atu
23. Ngaahi leipolo 'i he ngaahi 'ai'anga

KONGA VII - NGAAHI ME'A KEHEKEHE

24. 'Ofisa kuo fakamafai'i
25. Ngaahi mafai ke hu, kumi mo puke
26. Mafai ke ma'u ha fakamatala
27. Hia hokohoko
28. Fakafe'atungia
29. Ngofua ke 'oatu ha ngaahi fekau ke fakapapau'i ke talangofua
30. Ngaahi aleapau etc. ta'e'aonga
31. Fefakatau'aki holoseila
32. Fai ha fakamatala loi pe kaka
33. Hia mo e tautea
34. Ngaahi hia 'a e ngaahi sino fakakautaha
35. Ngaahi faka'ilo
36. Ngaahi tu'utu'uni

KONGA VIII -NGAAHI FOKOTU'UTU'U FAKATAIMI

37. Lisi kuo lesisita fakataimi

Tepile

---------------------------------------------

Fika 3 'o e 2001.

KO E LAO
KE FOKOTU'U HA FOUNGA PULE'I 'O E NGAAHI KOLOA FAITO'O, KE FOKOTU'U HA KOMITI FAITO'O MO E NGAAHI NAUNAU FAITO'O FAKAFONUA, KE PULE'I 'A E HU MAI, LELEI, MA'U MO E NGAUE'AKI 'O E NGAAHI KOLOA FAITO'O LESISITA, KAU AI 'A E NGAAHI FAITO'O KONA TAPU MO E NGAAHI ME'A KONA FAKA'ATAMAI PEA MO E NGAAHI TAUMU'A KAU KI AI

[11 'o Siulai, 2002.]

'OKU TU'UTU'UNI 'e he Tu'i mo e Fale Alea 'o Tonga 'i he Fakataha Alea 'o e Pule'anga 'o pehe:

KONGA I-TALATEU

Hingoa nounou mo e kamata'anga

1. 'E ui 'a e Lao ni ko e Lao ki he Ngaahi Koloa Faito'o 2001, pea kuo pau 'e kamata ngaue'aki 'i ha 'aho 'e fanongonongo 'e he 'Ene 'Afio 'i he Fakataha Tokoni, pea 'e ngofua ke fanongonongo ke kamata ngaue'aki ha ngaahi Konga kehekehe 'i ha ngaahi 'aho kehekehe.

'Uhinga'i lea

2. 'I he Lao ni, tukukehe 'o ka ha atu ha toe 'uhinga kehe 'i hono tu'unga-

"tu'uaki" 'oku 'uhinga ki ha tu'uaki-

(a) kuo pulusi 'i ha nusipepa, makasini pe ha pulusi kehe:

(b) kuo tu'u 'i ha tohi 'ave takai, henipila, posita pe ha fanongonongo kehe;

(d) kuo fakahoko 'o ngaue'aki ha fetu'utaki faka'elekitulonika pe 'oku ngaue'aki 'a e tekinolosia ki he fakamatala', kau ai ha tu'uaki 'oku tu'u 'i he 'initaneti; pe

(e) kuo fakahoko 'i ha founga kehe;

"'analaiso" 'i he fekau'aki mo e ngaahi koloa faito'o, 'oku 'uhinga ki hono fakahoko 'o ha ngaahi sivi 'oku ne lava ke fakafuofua'i 'a e fa'unga, malohi, ivi, hao mei he siemu, ma'a, malohinga fakapaio, fotunga, anga hono fa'u pe ngaahi 'ulungaanga 'o e ngaue 'a e ngaahi koloa';

"monumanu" 'oku 'uhinga ki ha monumanu (kehe mei ha tangata), 'o tatau ai pe pe 'oku huitu'a pe ta'ehuitu'a, pea 'oku kau heni 'a e huhu'a fakatupu, fua pe 'uhiki te'eki fanau'i 'o ha monumanu (kehe mei ha tangata) pe ha me'a kehe 'oku fekau'aki fakahangatonu mo e fakatupu 'o ha monumanu (kehe mei he tangata);

"tokoni hu 'ivai" 'oku 'uhinga ki ha taha kuo lesisita totonu pehe 'i he Lao ki he Hu'i Vai 2001;

"misini 'otometiki" 'oku 'uhinga ki ha misini pe ha me'angaue fakamisini 'oku ngaue'aki pe 'oku lava ke ngaue'aki ki he taumu'a 'o hono fakatau atu pe tuku atu 'o e ngaahi koloa ta'e toe pule'ia pe tokanga'i 'e he taha fakatau atu' pe taha 'oku ne tuku atu', pe ko 'ene taha ngaue, pe ha fakafofonga kehe 'i he taimi 'o hono fakatau atu' pe tuku atu';

"Fale Hu 'i Vai mo Tauhi 'anga Faito 'o Tefito" 'oku 'uhinga ki he Fale Hu'i Vai mo Tauhi'anga Faito'o Tefito 'a e Potungaue Mo'ui';

"Komiti" 'oku 'uhinga ki he Komiti Faito'o mo e Ngaahi Naunau Faito'o Fakafonua 'i he KONGA II 'o e Lao ni;

"anga jai" 'oku 'uhinga ki ha me'a 'oku fai pe ta'e fai;

"'ai'anga" fekau'aki mo e ngaahi faito'o, 'oku 'uhinga ki ha fa'o'anga, hina, tiupi, 'emipolo, me'a huhu, vaiolo, kofukofu fo'i'akau hae, kofukofu fo'i'akau lomi, me'a kofukofu, takafi pe ha me'a kehe pehe 'oku ne 'ufi'ufi taupotu 'a e ngaahi koloa' pe 'a is 'oku ngaue'aki ki hono 'ai 'o is ki he sino' ka 'oku 'ikai ke kau heni ha me'a 'oku taumu'a ke folo;

"faito'o loi" 'oku 'uhinga ki ha faito'o 'oku leipolo fakahangatonu mo kaka ke hala fekau'aki mo hono hingoa totonu pe ma'u'anga';

"'ofisa tute" 'oku 'uhinga ki ha 'ofisa kuo fokotu'u 'i he Lao ki he Ngaahi Tute mo e Tute 'Ekisia (Vahe 67);

"taha faito'o nifo" 'oku 'uhinga ki ha taha kuo lesisita totonu pehe 'i he Lao ki he Ngaue Fakafaito 'o mo e Nifo 2001;

"toketa nifo" 'oku 'uhinga ki ha taha kuo lesisita totonu pehe 'i he Lao ki he Ngaue Fakafaito'o mo e Nifo 2001;

"faito 'o fakaesino kehekehe" 'oku 'uhinga ki ha faito'o fakaesino ma'u'anga kehekehe 'oku 'ikai ko e hingoa kamata';

"'ofisa mo'ui" 'oku 'uhinga ki ha taha kuo lesisita totonu pehe 'i he Lao ki he Ngaue Fakafaito'o mo e Nifo 2001;

"faito'o ngaohi mei he 'akau" 'oku 'uhinga ki ha faito'o ko e me'a 'oku ma'u mei hono fakamomoa, momosi pe ha founga ngaohi kehe 'o e 'akau', pe ko ha fio 'o e ngaahi me'a ko ia', 'o kau pe 'ikai kau ai ha ngaahi me'a 'oku 'ikai fio;

"leipolo" 'oku kau heni ha tikite faka'ilonga, hingoa, faka'ilonga pe fakamatala 'oku tohi 'i he pe fakapipiki ki he pe faka'aonga'i 'o fekau'aki mo ha 'ai'anga pe kofukofu 'oku 'i loto ha me'a, sino pe ha me'a 'oku lau ki ai 'i he Lao ni;

"laiseni" 'oku 'uhinga ki ha laiseni kuo foaki pea 'oku 'conga ki he ngaahi taumu'a 'o e Lao ni pe ngaahi tu'utu'uni kuo fa'u 'i ai;

"ngaohi" 'oku kau heni 'a e ngaue ki hono sivi ke ma'a, filio'i pe ko hono fefiohi 'o ha faito'o fakaesino (kau ai ha faito'o fakaesino 'oku te'eki ngaohi);

"toketa" 'oku 'uhinga ki ha taha kuo lesisita totonu pehe 'i he Lao ki he Ngaue Fakafaito'o mo e Nifo 2001;

"faito 'o fakaesino" (medicinal drug) 'oku 'uhinga ki ha me'a 'o tatau ai pe pe mei ha monumanu, 'akau pe me'a ngaohi 'e he tangata ('ikai ko ha me'angaue tokoni faito'o) 'a is 'oku faka'aonga'i fakalotosino pe fakatu'asino 'i he tangata pe monumanu' ki hono-

(a) ta'ofi, fakafuofua'i, faito'o pe fakamalu 'o ha puke, mahaki, mele pe lavea;

(b) uesia, liliu pe ta'ota'ofi ha ngaue fakaesino;

(d) uesia, pule'i pe ta'ofi 'a e feitama;

(e) sivi pe 'oku feitama; pe

(f) fetongi pe liliu ha ngaahi konga 'i he sino;

kae 'ikai ko ha koloa 'oku faka'aonga'i tefito ki he fakamatamatalelei';

"ma 'uli" 'oku 'uhinga ki ha taha kuo lesisita totonu pehe 'i he Lao ki he Kau Neesi 2001;

"Minisita" 'oku 'uhinga ki he Minisita Mo'ui';

"ngaahi faito'o kona mo e ngaahi me'a kona faka'atamai" 'oku 'uhinga ki ha ngaahi me'a, 'o tatau ai pe pe 'oku fakanatula pe fa'u 'e ha tangata, 'a is 'oku lisi 'i he Konivesio 'o e Ngaahi Faito'o Kona Tapu 1961 'o e Ngaahi Pule'anga Fakatahataha mo e Konivesio ki he Ngaahi Me 'a Kona Faka 'atamai, 1971 'o e Ngaahi Pule'anga Fakatahataha.

"Komiti Fakafonua ki he Fakalakalaka 'o e Mo'ui" 'oku 'uhinga ki he Komiti Fakafonua ki he Fakalakalaka 'o e Mo'ui 'o e Potungaue Mo'ui;

"faito 'o fakaesino fo 'ou" 'oku 'uhinga ki ha faito'o fakaesino 'a is 'oku 'ikai ke lolotonga lesisita 'i he Pule'anga ni;

"neesi" 'oku 'uhinga ki ha taha kuo lesisita totonu pehe 'i he Lao ki he Kau Neesi 2001;

"kofukofu" 'i hono ngaue'aki 'o fekau'aki mo ha me'a, kau ai e sino pe me'a matelie 'oku lau ki ai 'i he Lao ni, 'oku kau ai 'a e founga kotoa pe 'oku lava ai 'a e me'a ko ia', sino pe ha me'a, ke 'ave pe ke uta pe ke tauhi pe ke 'oatu, 'o kofukofu'i, 'ufi'ufi'i, takatakai'i, fa'o pe fa'oaki ai;

"taha hu'i vai" 'oku 'uhinga ki ha taha kuo lesisita totonu pehe 'i he Lao ki he Hu'i Vai 2001;

"ngaue hu'i vai" 'oku 'uhinga ko e -

(a) fatongia ki hono teuteu'i, tauhi, tufaki mo pule'i 'o e ngaahi faito'o fakaesino' 'i ha fale hu'i vai;

(b) ngaohi 'o ha faito'o fakaesino; (c) 'oatu ha faito'o fakaesino;

(d) fakatau atu 'o ha faito'o fakaesino;

(e) tukuange atu 'o e fakamatala ki he ako ki he mo'ui lelei' mo e fakalakalaka 'o e mo'ui lelei', 'i hono fakalukufua', pea tautautefito, ki hono ngaue fakapotopoto 'aki 'o e ngaahi faito'o fakaesino';

(f) vahevahe iiki pe veteki 'a e 'uluaki kofukofu mei he taha fo'u koloa' 'o ha faito'o fakaesino 'i he taumu'a ke toe kofukofu fo'ou 'a e faito'o' 'i ha lahi 'oku lalahi ange pe iiki ange ki hono toetufaki pe fakatau fakamovetevete atu;

(g) fakalele 'o ha fale hu'i vai kehe pe ke fekau'aki mo e ngaue hu'i vai' 'a hono fakalele ko ia'; mo e

(h) tokanga'i 'o e ngaue hu'i vai';

"ngaahi fale" 'oku kau ai 'a e ngaahi vaka, ngaahi vakapuna mo e ngaahi saliote misini;

"tu'utu'uni fakatoketa" 'oku 'uhinga ki ha tu'utu'uni tohi 'a ha toketa nifo, 'ofisa nifo, 'ofisa mo'ui pe ha toketa ki hono tuku atu ha faito'o fakaesino ki ha taha pe ha tu'utu'uni tohi 'a ha toketa monumanu ki hono tuku atu 'o ha faito'o ki ha monumanu;

"Pule Hu'i Vai" 'oku 'uhinga ki he Pule Hu'i Vai 'o e Potungaue Mo'ui pe ha taha 'oku lolotonga le'ole'o 'i he lakanga ko ia';

"lisi lesisita" 'oku 'uhinga ki he Lisi 'a Tonga 'o e Ngaahi Faito'o Fakaesino kuo Lesisita 'i he KONGA III 'o e Lao ni;

"'fakatau atu" 'oku kau ai hono fakatau atu holoseila pe fakamovetevete mo e fakafetongi koloa mo e fakafetongi pea 'oku kau ai 'a e fealea'aki, felotoi ke fakatau atu, pe ko e 'oatu pe faka'ali'ali ke fakatau atu, pe ko e puke pe tauhi ke fakatau atu, pe 'ave, 'oatu, tiliva pe ko e ma'u mai ke fakatau atu pe tu'uaki fakatau atu, pe fakamafai'i, fekau, fakatupu, faka'ata, fakangofua pe ko e feinga ke fakahoko ha ngaahi ngaue pe ngaahi me'a pehe;

"tu 'utu 'uni fakatoketa makehe" 'oku 'uhinga ki ha tu'utu'uni tohi 'a ha toketa 'oku ne ngaue taafataha 'i ha 'elia makehe 'oku 'iloa ki hono 'oatu 'o ha faito'o fakaesino ki he faito'o ha mahaki 'a ha taha 'oku lolotonga faito'o 'i ha puke 'i he 'elia makehe ko ia';

"me 'a" 'oku kau ai 'a e me'a kuo teuteu pe fefiohi pea mo e ngaahi masima mo e ngaahi me'a ma'u mei ha me'a;

"tuku atu" mo hono ngaahi fakalea famili taha' 'oku kau ai ke fakatau atu, pe ke felotoi ke fakatau atu, ke fokotu'u atu, tu'uaki, ma'u ki ha ngaahi taumu'a pehe, faka'ali'ali, tukuange atu, 'ave, tiliva, ngaohi pe teuteu'i ke fakatau atu, pe no atu pe ke fakafetongi pe tukuange ki ha fa'ahinga mahu'inga, pe ke tukuange atu, 'ave pe tiliva koe'uhi ko hano fakatau atu, fakafetongi'aki pe tukuange 'o hange ko is 'oku lau ki ai kimu'a';

"tuku atu holoseila" 'oku 'uhinga 'i he fekau'aki mo ha me'a pe ngaahi koloa ki hono -

(a) tuku atu 'a e me'a pe ngaahi koloa 'i he ngaahi taumu'a ke toe tuku atu; pe

(b) tuku atu 'o ha me'a ki he taumu'a ke kau 'i he me'a pe ngaahi koloa';

pea kau ai 'a e tuku atu 'o e me'a pe ngaahi koloa 'i he lahi fakaholoseila ke ngaue'aki -

(d) 'i he'ene fekau'aki mo hono fai 'e ha ni'ihi, 'i he ngaahi 'atakai 'oku fiema'u 'e he Lao ni pe ngaahi tu'utu'uni', 'o ha ngaue 'oku fiema'u pehe.

"ngaahi me'angaue faito'o" 'oku 'uhinga ki ha ngaahi koloa faito'o 'a is ko ha me'angaue, naunau, naunau ngaue, me'a pe ha me'a kehe (ke faka'aonga'i 'iate is pe pe fakataha mo ha me'a kehe), fakataha mo hono ngaahi kongokonga pe polokalama komipiuta 'oku fiema'u ke fakahoko lelei 'ene ngaue', 'a is 'oku 'ikai ke ne fakahoko 'ene tefito'i ngaue kuo fakataumu'a ki ai' 'i ha founga hu'i vai, fakakemikale, fakamalu'i pe fakaesino, neongo 'e lava ke tokoni'i is 'i hono fatongia ko is 'e ha ngaahi founga pehe;

"ngaahi koloa faito 'o" 'oku kau ai heni 'a e -

(a) ngaahi faito'o mo e ngaahi koloa fakaesino;

(b) ngaahi faito'o ngaohi mei he 'akau tukukehe meiate kinautolu 'oku teuteu'i mo tuku atu 'e he kau faito'o faka-Tonga;

(d) ngaahi koloa ke faka'aonga'i ko ha konga 'i hono fa'u 'o e ngaahi koloa faito'o mo e ngaahi me'angaue faito'o;

(e) ngaahi koloa ke faka'aonga'i ko ha 'ai'anga pe konga 'o ha 'ai'anga ki he ngaahi koloa 'oku lau ki ai 'i he palakalafi (a)(b) mo e (d);

kae 'ikai ko ha ngaahi koloa 'oku faka'aonga'i tefito ki he fakamatamatalelei 'o e sino;

"toketa monumanu" 'oku 'uhinga ki ha taha 'oku poto taau ke ne ngaue ko ha toketa monumanu pe toketa tafa monumanu 'i tu'a Pule'anga' 'a is 'oku ne ngaue ko ha toketa monumanu 'i he Pule'anga ni;

Ha'i 'a e Kalauni

3. 'Oku ha'iha'i 'e he Lao ni 'a e Kalauni'.

KONGA II - KO E KOMITI FAITO'O MO E NGAAIH
NAUNAU FAITO'O FAKAFONUA

Fokotu'u, ngaahi ngaue mo e konisitutone 'o e komiti

4. (1) Kuo pau ke fokotu'u koe'uhi ko e ngaahi taumu'a 'o e Lao ni ha Komiti 'e ui ko e Komiti Faito'o mo e Ngaahi Naunau Faito'o Fakafonua.

(2) Ko e ngaahi fatongia 'o e Komiti' kuo pau -

(a) ke fokotu'u, tauhi mo vakai'i fakata'u mo fakatonutonu 'a e lisi 'o e ngaahi faito'o fakaesino kuo lesisita ke hu mai ki he Pule'anga' ni;

(b) ke tu'utu'uni 'a e kalasi 'i he lisi lesisita ke vahe'i ki ai ha faito'o fakaesino;

(c) ke tauhi, vakai'i fakata'u, mo fakatonutonu ha Lisi 'o e Ngaahi Faito'o Taau ma'a e Pule'anga 'a is kuo pau ko e makatu'unga is ki hano fakatau mai 'e ha sekitoa fakapule'anga 'a e faito'o;

(d) ke fakakaukau'i 'a e lahi 'o e ngaahi fa'ahinga 'o e koloa mo tu'utu'uni 'a e ngaahi koloa faito'o ke fakatau mai 'e he Potungaue Mo'ui' 'o makatu'unga 'i he lisi 'o e ngaahi faito'o taau ma'a e Pule'anga';

(e) ke tali pe ta'etali 'a e ngaahi tu'utu'uni 'a e Pule Hu'i Vai 'o fekau'aki mo e tali 'o e talamahu'inga ki hono 'oatu 'o e ngaahi koloa faito'o;

(f) ke pule'i 'a e ngaahi founga ngaue ki hono fakatau mai, tauhi, tufaki mo hono pule'i 'a e ngaahi koloa faito'o';

(g) ke ma'u mei he Fale Hu'i Vai mo e Tauhi'anga Faito'o Tefito, fakama'opo'opo, vakai'i pea, kapau 'oku fiema'u, fokotu'u atu ha ngaue, makatu'unga 'i ha ngaahi lipooti ki he ola kovi 'a e faito'o 'i he loto'i Pule'anga ni;

(h) ke kamata, tauhi mo tokanga'i ha polokalama fakafonua ki hono ngaue'aki fakapotopoto 'o e ngaahi faito'o fakaesino';

(i) ke fale'i 'a e Komiti Fakafonua ki he Fakalakalaka 'o e Mo'ui 'i ha fa'ahinga me'a fekau'aki mo e Palani Fakafonua ki he Faito'o; mo

(j) fokotu'u atu ki he Komiti Fakafonua ki he Fakalakalaka 'o e Mo'ui ha ngaahi liliu pe ngaahi fakalelei ki he Lao ni, ha Tepile ki heni, pe ki he Palani Fakafonua ki he Faito'o 'a is to ne pehe 'e taau'.

(3) Kuo pau ko e Komiti 'a e kau memipa ko 'eni -

(a) Ko e Talekita Mo'ui;

(b) Ko e Pule Hu'i Vai';

(d) Ko e Toketa Pule, Fale Mahaki Vaiola';

(e) Fakafofonga 'e 1 'o e Kautaha Toketa 'a Tonga;

(f) Fakafofonga 'e 1 'o e Kautaha Neesi 'a Tonga;

(g) Toketa 'e 2 'oku fakangaue'i 'e he Potungaue Mo'ui' 'e fokotu'u 'e he Minisita 'i hano fili 'e he kau toketa 'o e Pule'anga ni;

(h) 'ofisa mo'ui 'e 1 'e fokotu'u 'e he Minisita 'i hano fili 'e he kau 'ofisa mo'ui 'o e Pule'anga ni';

(i) Metuloni 'o e Fale Mahaki Vaiola; mo e

(j) Fakafofonga 'e 1 mei he Va'a ki he Nifo 'o e Potungaue Mo'ui' 'e fokotu'u 'e he Minisita 'i hano fili 'e he Va'a ki he Nifo.

(4) Ko e kau memipa kuo fokotu'u 'e he Minisita 'i he kupusi'i (3)(g), (h) mo e (i) kuo pau ke nau ma'u lakanga 'i ha ta'u 'e ua pea kuo pau 'e lava ke toe fili kinautolu.

(5) 'E ngofua ke fakata'e'aonga'i hono fili ha memipa 'e he sino na'a ne fili 'a e taha ko ia', pea 'e ngofua ke fili ha taha kehe ke fetongi 'a e memipa ko ia' ki he toenga taimi 'o e lakanga'.

(6) 'E ngofua ke fakafisi ha memipa kuo fili 'i ha'ane 'oatu ha fanongonongo 'o e fakafisi ko ia' ki he sino na'a ne fili ia', pea 'e ngofua ki he sino ko ia'ke ne fili ha taha kehe ki he toenga taimi 'o e lakanga'.

(7) 'E ngofua ke ui 'e he Komiti ha taha hu'i vai 'e 1 'oku ne ngaue taautaha mo ha taha holoseila faito'o 'e 1 ke kau 'i he Komiti 'i ha va'a taimi mo ha ngaahi taumu'a to ne fakakaukau 'oku taau'.

(8) Kuo pau ke sea 'a e Talekita Mo'ui 'i he Komiti.

(9) Kuo pau ke sekelitali 'a e Pule Hu'i Vai 'i he Komiti.

(10) Kuo pau ke tu'utu'uni 'e he Komiti 'a e ngaahi founga mo e ngaahi tu'utu'uni ke pule'i 'aki 'ene ngaahi fakataha'.

(11) Kuo pau ke fakataha 'a e Komiti' 'oka fiema'u pea kuo pau ke ne lipooti ki he Komiti Fakafonua ki he Fakalakalaka 'o e Mo'ui 'aki 'ene 'oatu ki ai 'a e ngaahi Miniti 'o 'ene ngaahi fakataha'.

(12) Kuo pau ke teuteu'i mo tuku atu fakatau 'e he Komiti ha lipooti 'o 'ene ngaahi ngaue lolotonga 'a e mahina 'e 12 kimu'a' pea kuo pau ke fai 'a e lipooti ko 'eni' ki he Minisita.

(13) Ko ha ngaue na'e fakahoko 'i he loto ma'a, 'e he Minisita, sea, sekelitali pe ha memipa 'o e Komiti' kuo pau 'e 'ikai mo'ua ki ai 'a e taha ko ia'.

KONGA III - LISI LESISITA TONGA 'O E NGAAHI FAITO'O FAKAESINO

Fokotu'u 'o e lisi lesisita

5. (1) Kuo pau ke tauhi 'e he Komiti lisi lesisita, 'e 'iloa ko e Lisi Lesisita Tonga 'o e Ngaahi Faito'o Fakaesino, 'o fakamahino'i ai 'a e ngaahi faito'o 'e ngofua ke hu mai ki he Pule'anga ni.

(2) Kuo pau ke 'i he Lisi Lesisita 'a e ngaahi kalasi ko 'eni'-

Kalasi 1: Ngaahi Faito'o Fakaesino ala ma'u mei he ngaahi hu atu fakamovetevete laiseni;

Kalasi 2: Ngaahi Faito 'o Fakaesino ala ma 'u mei ha ngaahi fale hu 'i vai lesisita 'oku tokanga 'i 'e ha taha hu 'i vai lesisita, vahevahe ki he -

Kalasi 2A: 'A is 'oku 'ikai fiema 'u 'a e fale 'i 'a e taha hu 'i vai 'i he taimi fakatau;

Kalasi 2B: 'A is 'oku fiema 'u 'a e fale 'i 'a e taha hu 'i vai 'i he taimi fakatau;

Kalasi 3: Ngaahi Faito 'o Fakaesino 'oku ala ma 'u pe 'i ha to 'u-tu 'uni fakatoketa pea teuteu 'i mo tukuange 'e ha Taha Hu'i Vai pe Tokoni Hu'i Vai;

Kalasi 4: Ngaahi Faito 'o Fakaesino ala ma 'u pe 'i ha to 'utu 'uni fakatoketa makehe pea teuteu 'i mo tukuange 'e ha taha Hu'i Vai pe Tokoni Hu'i Vai;

Kalasi 5: Ngaahi Faito 'o Kona Tapu mo e Ngaahi Me 'a Kona Faka 'atamai fakatatau ki he Ngaahi Pule 'i Hu Mai Makehe;

Kalasi 6: Ngaahi Faito'o Fakaesino ala ma'u mei he Kau Toketa Monumanu ke ngaue 'aki ki he Monumanu.

(3) Kuo pau ke vakai'i fakatau 'e he Komiti 'a e kakano 'o e lisi lesisita pea 'e ngofua ke ne fakatonutonu ha taha pe 'o e ngaahi kalasi 'o e lisi lesisita pea ke ne fanongonongo 'i he Kasete.

(4) 'E ngofua ke tauhi 'a e lisi lesisita 'i ha founga faka'elekitulonika.

Fale'i fekau'aki 'o e lisi lesisita mo e kakano

6. Kuo pau ke lekooti 'e he lisi lesisita 'a e ngaahi faito'o fakaesino 'aki hono hingoa fefakatau'aki' mo hono Hingoa Tau'ataina a Fakavaha 'apule'anga (INN) pea kuo pau ke ha ai 'a e feitu'u na'e ngaohi ai'.

Ngaahi tu'unga ke fakakau 'aki ki he lisi lesisita

7. 'E toki ngofua pe ke fakakau ha faito'o fakaesino 'i he lisi lesisita' kapau alie 'e fiemalie 'a e Komiti' ko e faito'o fakaesino' -

(a) 'oku lelei ko e

(b) 'oku 'i ha tu'unga malu ke tali;

(d) 'oku 'i he tu'unga Hu'ivai 'a 'Amelika pe Pilitania (United States Pharmacopoeia pe British Pharmacopoeia standard) pe 'i ha toe tu'unga tatau kuo fakamo'oni'i;

(e) kuo fakamo'oni'i 'e he taha na'a ne ngaohi kuo 'osi lesisita 'i ha taha 'o e ngaahi fonua 'oku lisi 'i he Tepile pe hili hano vakai'i ha fakamatala fakaikiiki mei he taha na'a ne ngaohi', mo hano totongi 'a e totongi kuo tu'utu'uni', 'e 'ilo 'oku hoc mo e ngaahi fiema'u 'o e ngaahi kupusi'i (1) ki he (4); pea

(f) 'e fe'unga ke ngaue'aki 'i Tonga.

Kole ke kau 'i he lisi lesisita

8. (1) Kimu'a pea hu mai ha faito'o fakaesino fo'ou pe 'oatu ke fakatau 'atu, kuo pau ki he taha na'a ne ngaohi 'a e faito'o fakaesino ko iape taha hu mai laiseni' ke ne kole ki he Komiti' ke -

(a) fakakau 'a e faito'o fakaesino ko ia' 'i he lisi lesisita; pea

(b) vahe'i ki he kalasi 'o e lisi lesisita' 'e fakakau ki ai'.

(2) Kuo pau ke fai 'a e kole ke fakakau' 'i he founga mo e foomu 'e fakamahino'i 'e he Komiti' pea kuo pau ke 'oatu fakataha is mo e -

(a) totongi kuo fakamahino'i';

(b) Tohi Fakamo'oni Kautaha Mo'ui 'a Mamani ki he Fe'ave'aki Koloa Fakahu'ivai 'i he Fefakatau'aki Fakavaha'apule'anga, 'i he fotunga kuo tu'utu'uni' pea kuo fakamo'oni hingoa ki ai 'a e ma'u mafai fai tu'utu'uni fakapule'anga' 'i ha fonua 'a is ko ha taha fakamo'oni hingoa ki he Founga Fakamo'oni 'a e Kautaha Mo'ui 'a Mamani, ko e fonua is na'e ngaohi ai', kehe pe ke 'osi lesisita 'a e faito'o fakaesino ko ia' ke fakatau atu 'i he maketi fakalotofonua 'i he fonua na'e ngaohi ai'; mo

(3) (a) 'E ngofua ki he sekelitali 'o e Komiti, 'i ha fanongonongo tohi 'e 'oatu ki he taha kole', ke ne fiema'u 'a e taha kole' ke ne 'oange ki he Komiti', 'i loto 'i ha vaha'a taimi fakapotopoto' 'o hange ko is 'e fakamahino'i 'i he fanongonongo' 'a e fakamatala 'a is 'e fakamahino'i 'i he fanongonongo 'o fekau'aki mo e fa'unga, tauhi, ngaahi faka'ilonga, mo e ngaahi me'a 'oku 'conga ki ai, ngaahi fakahinohino ki he anga hono faka'aonga'i pe fakaleipolo 'o e faito'o fakaesino, me'a 'oku ha ai 'a e tu'uaki 'o fekau'aki mo e faito'o fakaesino, ngaahi lipooti 'o e ola kovi 'o e faito'o' pe fekau'aki mo hono faito'o 'o e totu'a hono ngaue'aki';

(b) 'E ngofua ke fiema'u 'i ha fanongonongo' 'i he palakalafi (a) ke 'omai 'a e fakamatala' -

(i) 'i he tohi; pe

(ii) fakatatau ki he ngaahi fiema'u polokalama fakakomipiuta 'i ha fa'ahinga me'angaue faifakamatala 'e fakamahino'i pe 'i ha fa'ahinga fetu'utaki faka'elekitulonika 'e fakamahino'i.

(4) Neongo 'a e fiema'u 'i he kupusi'i (2)(b) 'e ngofua ke fakamahino 'e he Komiti"a e fakamatala 'oku ne fiema'u' mo e fotunga ke 'omai 'aki ha kole koe'uhi ko ha faito'o fakaesino 'oku fiema'u ke fakakau 'i he lisi lesisita' pea 'a is 'oku 'ikai ke 'i ai hano tohi kuo fakamahino'i 'i he kupusi'i (2)(b).

(5) Kuo pau ke fanongonongo 'e he Komiti' ki he taha kole, 'i he tohi, 'a e tu'utu'uni 'a e Komiti'pea, kapau 'e fiema'u, fakakau 'a e faito'o' fakaesino fo'ou' ki he lisi lesisita' 'i he kalasi 'oku kau ai'.

(6) 'Oku aofangatuku 'a e tu'utu'uni 'a e Komiti 'i he kupu ni.

To'o mei he lisi lesisita

9. 'E ngofua ke to'o 'e he Komiti ha faito'o fakaesino mei he lisi lesisita kapau -

(a) kuo kole 'e he taha hu mai pe ko e taha ngaohi 'i he tohi kole ke to'o mei he lisi lesisita';

(b) kuo 'ikai ke kei tali 'e he Komiti' 'a e lelei', malu mo e 'conga 'o e faito'o fakaesino';

(c) kuo ta'efai 'a e taha hu mai pe taha ngaohi ki ha tu'unga 'a is na'e makatu'unga ai hano fakakau 'o ha faito'o fakaesino 'i he lisi lesisita'; pe

(d) 'oku 'ikai ke totongi 'a e totongi lesisita'.

KONGA IV - HU MAI, HU ATU, NGAOHI MO PULE'I 'O E LELEI
'O E NGAAHI KOLOA FAITO'O.

Hu mai 'o e ngaahi faito'o fakaesino

10. (1) Ko ha taha 'oku ne hu mai, tufaki, fai tu'utu'uni fakatoketa pe tu'uaki ke fakakau atu ha faito'o fakaesino 'a is 'oku 'ikai ke kau 'i he lisi lesisita' 'oku ne fai ha hia.

(2) 'E 'ikai ngofua ki ha taha ke ne hu mai, ngaohi, pe fakatau atu holoseila pe fakamovetevete ha faito'o fakaesino kae'oua kuo laiseni ke ne fai pehe 'i he Lao ni.

(3) 'I ha kole 'a ha toketa pe ha taha hu'i vai kuo lesisita, 'e ngofua ki he Minisita ke ne fakamafai'i hono hu mai 'o ha faito'o fakaesino 'oku 'ikai ke kau 'i he lisi lesisita' koe'uhi ke feau 'a e ngaahi fiema'u fakafaito'o 'a ha taha mahaki fakafo'ituitui.

(4) 'E ngofua ke fakamafai'i 'e he Minisita 'a hono hu mai 'o ha faito'o fakaesino 'oku 'ikai ke kau 'i he lisi lesisita' ma'a e lelei 'a e mo'ui 'a e kakai' lolotonga ha fakatu'utamaki lahi pe vaha'a taimi 'o ha me'a fakatu'upake.

(5) Ko e 'oatu ha fakamafai' 'i he kupusi'i (3) pe (4) kuo pau 'e 'ikai ke fakamo'ua'i ai 'a e Kalauni, Minisita pe Komiti' ki ha taha 'oka hoko ha fa'ahinga mole, maumau pe lavea ki he tokotaha ko ia' ko e ola 'o e, pe tupu mei he, ngaue'aki 'o e ngaahi koloa faito'o 'e he tokotaha ko ia' pe ha tokotaha kehe.

(6) Kuo pau 'e 'ikai ha me'a 'i he kupu ni to ne ta'ofi 'a hono hu mai 'e ha taha ha faito'o fakaesino 'oku 'ikai ke kau 'i he lisi lesisita' kapau ko e hu mai koe'uhi ke ngaue'aki fakafaito'o fakafo'ituitui 'a is 'e fakamo'oni'i 'aki ha tohi pe ha tohi fakamo'oni 'a e toketa 'a e taha ko ia'kuo lesisita totonu 'i tu'a Pule'anga' pe koe'uhi ko e taumu'a 'o ha 'ahi'ahi fakakiliniki kuo fakangofua.

Laiseni hu mai

11. (1) (a) Ko ha kole ki ha laiseni hu mai kuo pau ke fakahoko pe is 'e ha taha hu'i vai, toketa monumanu, taha holoseila pe taha faifakatau fakamovetevete.

(b) Kuo pau ke fakangatangata 'a e laiseni hu mai' ki he ngaahi koloa faito'o pe ko is 'i he kalasi 'o e lisi lesisita 'a is 'oku fakamafai'i 'e he kupu 5(2) ke ma'u 'e he taha kole'.

(2) Kuo pau 'e 'ikai ke maumau'i 'i he loto ki ai pe ta'etokanga 'e ha taha ma'u laiseni hu mai 'o ha tu'unga 'o e laiseni'.

(3) Ko ha kole laiseni hu mai kuo pau -

(a) ke 'i he tohi 'i he foomu 'oku tu'utu'uni 'i he ngaahi tu'utu'uni';

(b) ke fakamahino'i ai 'a e ngaahi koloa faito'o 'oku faka'amu 'a e taha kole' ke ne hu mai' mo e Kalasi 'o e lisi lesisita' 'a is 'oku kau ki ai';

(d) ke 'oatu fakataha mo e totongi kole kuo fakamahino'i'.

(4) Kuo pau 'e 'ikai ha taha, 'i ha pe fekau'aki mo ha kole laiseni hu mai ha ngaahi koloa faito'o, to ne fai ha fakamatala 'a ia, 'oku 'ilo 'e he tokotaha ko ia', 'oku loi pe taki hala 'i ha fa'ahinga me'a mahu'inga.

Foaki 'o e laiseni hu mai

12. (1) 'E ngofua ki he sekelitali 'o e Komiti', 'i ha fanongonongo tohi 'e 'oatu ki he taha kole ki ha laiseni hu mai', ke ne fiema'u 'a e taha kole'-

(a) ke ne 'oatu ki he Komiti, 'i loto 'i ha vaha'a taimi fakapotopoto' 'a is 'e fakamahino'i 'i he fanongonongo', ha fakamatala kehe 'o fekau'aki mo e kole' 'a is 'oku fakamahino'i 'i he fanongonongo'; pe

(b) ke ne fakangofua ha 'ofisa fakamafai, 'i loto 'i ha taimi fakapotopoto' 'a is 'e fakamahino'i 'i he fanongonongo', ke sivi 'a e ngaahi fale, me'angaue mo e ngaahi naunau 'e faka'aonga'i ki hono tauhi 'o e ngaahi koloa faito'o 'oku ha 'i he kole ki ha laiseni hu mai'.

(2) (a) Ka fai 'e ha taha ha kole ke hu mai ha ngaahi koloa faito'o pea 'oku kau 'a e ngaahi koloa faito'o ko ia' 'i he Kalasi 'o e lisi lesisita kuo fakamafai'i ke ma'u 'e he taha kole'; pea

(i) kuo totongi 'a e totongi kole kuo fakamahino'i';

(ii) kuo totongi ha ngaahi totongi sivi kuo fakamahino'i; pea

(iii) kuo fakahoko 'e he tokotaha ko is 'a e ngaahi fiema'u 'a e Komiti' 'i he kupusi'i (1) 'o fekau'aki mo e kole'-

kuo pau ke foaki 'e he Komiti ki he tokotaha ko ia' ha laiseni hu koloa faito'o 'o e Kalasi 'oku kau ki ai 'i he lisi lesisita'.

(b) Neongo 'a e palakalafi (a) kapau 'oku fiemalie 'a e Komiti'-

(i) 'oku 'ikai ke muimui 'a e ngaahi fale 'o e taha kole', kapau ko ha taha hu'i vai, ki he ngaahi fiema'u fakalaiseni pe ngaahi fiema'u kehe 'a e Lao ki he Hu'i Vai 2001;

(ii) ko e ngaahi fale 'o e taha kole', kapau ko ha taha fakatau atu fakamovetevete, 'oku 'ikai fe'unga ke faka'ali'ali, tauhi pe fakatau atu ai 'a e ngaahi koloa faito'o';

(iii) na'e foaki ha laiseni hu mai ki he taha kole' ka kuo 'osi fakata'e'aonga'i;

(iv) kuo fakahalaia 'a e taha kole' 'i ha hia 'i he Lao ni, Lao ki he Hu 'i Vai 2001 pe Lao ki he Ngaahi Tute mo e Tute 'Ekisia (Vahe 67);

(v) 'oku pule'i 'e he taha kole' ha sino fakakautaha (fakahangatonu, pe ta'efakahangatonu 'o fou 'i ha ngaahi sino tu'u vaha'a 'e taha pe lahi ange) 'a is kuo fakahalaia'i 'i ha hia 'i he Lao ni, Lao ki he Hu'i Vai 2001 pe Lao ki he Ngaahi Tute mo e Tute 'Ekisia (Vahe 67); pe

(vi) na'e pule'i 'e he taha kole ha sino fakakautaha (fakahangatonu pe ta'e fakahangatonu 'o fou 'i ha ngaahi sino tu'u vaha'a 'e taha pe lahi ange) 'i he taimi na'e fai ai 'e he sino ko is ha hia 'i he Lao ni, Lao ki he Hu'i Vai 2001 pe Lao ki he Ngaahi Tute mo e Tute 'Ekisia (Vahe 67); pea kuo fakahalaia'i 'a e sino ko is 'i he hia ko is pe, kapau ko e taha kole ko ha sino fakakautaha pea 'oku pule'i is 'e ha tokotaha kehe (fakahangatonu pe ta'e fakahangatonu 'o fou 'i ha ngaahi sino tu'u vaha'a 'e taha pe lahi ange) pea na'e fakahalaia'i 'a e tokotaha kehe ko is 'i he hia ko ia-

kuo pau ke fakafisi 'a e Komiti' ke foaki ha laiseni hu mai.

(3) Kapau 'e foaki pe fakafisi 'a e Komiti' ke foaki ha laiseni hu mai, kuo pau ki he Komiti' ke ne-

(a) 'oatu ki he taha kole' ha fanongonongo tohi 'o e tu'utu'uni ko ia'; pea

(b) kapau ko ha fakafisi, fakakau 'i he fanongonongo' 'a e ngaahi 'uhinga 'o e fakafisi'.

(4) Kapau 'oku foaki 'e he Komiti' ha laiseni hu mai, kuo pau ke pulusi 'e he sekelitali 'o e Komiti' 'a e ngaahi fakaikiiki 'o e tu'utu'uni' ko is 'i he Kasete 'i he vave taha 'e ala lava'.

(5) 'Oku kamata ngaue'aki ha laiseni hu mai 'i he 'aho 'oku fakamahino'i 'i he laiseni' pea 'e hokohoko atu kae'oua ke fakata'e'aonga'i pe to'o fakataimi.

(6) 'E ngofua ke foaki ha laiseni hu mai 'o fakatatau ki he-

(i) ngaahi tu'unga kuo fa'u ke fakapapau'i 'e hu mai 'e he taha ma'u laiseni' 'a e ngaahi koloa faito'o ko is 'o fakatatau ki he ngaahi tu'unga 'oku fiema'u ki hono fe'ave'aki, tauhi, pe faka'ali'ali, kau ai 'a e ngaahi tu'unga fua mafana mo ha ngaahi tu'unga 'oku fiema'u felave'i mo e malu 'a e ngaahi koloa'; mo

(ii) ha ngaahi tu'unga kehe felave'i mo hono hu mai 'o e ngaahi koloa faito'o' 'a is 'oku pehe 'e he Komiti' 'oku taau'.

(7) 'E ngofua ki he Komiti, 'i ha fanongonongo tohi 'e 'oatu ki he taha ma'u laiseni hu mai', ke ne hilifaki ha ngaahi tu'unga fo'ou ki he laiseni pe to ne liliu pe to'o 'a e ngaahi tu'unga lolotonga'.

(8) Kuo pau 'e ngaue'aki 'a e hilifaki pe liliu 'o ha tu'unga 'i he kupusi'i (7)-

(i) kapau 'oku fakaha 'i he fanongonongo' 'oku fai is koe'uhi 'oku fiema'u ke ta'ofi ha fakatu'utamaki 'e hoko ai ha mate, puke lahi pe lavea lahi, 'i he 'aho ko is 'oku 'oatu ai 'a e fanongonongo' ki he taha ko ia'; pe

(ii) 'i ha me'a kehe 'e hoko, 'i ha 'aho 'e fakamahino'i 'i he fanongonongo', 'a is ko e 'aho ko ia' 'e 'ikai toe nounou ange 'i he 'aho 'e 28 hili hono 'oatu 'o e fanongonongo'ki he taha ko ia'.

(9) 'O tanaki atu ki he ngaahi tu'unga kuo hilifaki 'i he kupusi'i (6) pe (7), kuo pau ke fakatatau 'a e laiseni hu mai kotoa pe, ki he ngaahi tu'unga 'a is kuo pau ki he taha ma'u laiseni hu mai'-

(i) ke ne fakapapau'i 'oku a'u 'a e ngaahi koloa ki he tu'unga 'oku fiema'u ke a'u ki ai 'a e koloa ko ia'; pea

(ii) ke ne fakangofua ha 'ofisa fakamafai pe ha 'ofisa tute ke ne hu, 'i ha taimi fakapotopoto', ki he ngaahi fale 'oku hu mai ki ai 'a e ngaahi koloa', pea, lolotonga 'ene 'i he ngaahi fale ko ia'ke ne sivi 'a e ngaahi fale'mo ha ngaahi koloa faito'o 'oku tauhi ai, pea ke ne to'o ha ngaahi semipolo mei he ngaahi koloa ko ia'.

(10) Fakatatau ki he kupusi'i (11), 'e ngofua ki he Komiti, 'i ha fanongonongo tohi 'a is 'e 'oatu ki he taha ma'u laiseni hu mai, ke ne fakata'e'aonga'i 'a e laiseni', pe to'o fakataimi 'a e laiseni 'i ha vaha'a taimi 'e fakamahino'i 'i he fanongonongo' kapau-

(a) kuo fakahalaia'i 'a e taha ma'u laiseni 'i ha hia 'i he Lao ni, Lao ki he Hu'i Vai 2001, pe Lao ki he Ngaahi Tute mo e Tute 'Ekisia (Vahe 67);

(b) 'oku pule'i 'e he taha ma'u laiseni ha sino fakakautaha (fakahangatonu, pe ta'e fakahangatonu 'o fou 'i ha ngaahi sino tu'u vaha'a 'e taha pe lahi ange) 'a is kuo fakahalaia'i 'i ha hia 'i he Lao ni, Lao ki he Hu'i Vai 2001 pe Lao ki he Ngaahi Tute mo e Tute 'Ekisia (Vahe 67);

(c) na'e pule'i 'e he taha ma'u laiseni ha sino fakakautaha (fakahangatonu, pe ta'e fakahangatonu 'o fou 'i ha ngaahi sino tu'u vaha'a 'e taha pe lahi ange) 'i he taimi na'e fakahoko ai 'e he sino ko ia' ha hia 'i he Lao ni, Lao ki he Hu 'i Vai 2001 pe Lao ki he Ngaahi Tute mo e Tute 'Ekisia (Vahe 67) pea kuo fakahalaia'i 'a e sino ko ia' 'i he hia ko ia';

(d) 'oku pule'i 'a e taha ma'u laiseni' 'e ha taha kehe (fakahangatonu pe ta'e fakahangatonu 'o fou 'i ha ngaahi sino tu'u vaha'a 'e taha pe lahi ange) pea kuo fakahalaia'i 'a e taha kehe ko ia' 'i ha hia 'i he Lao ni, Lao ki he Hu 'i Vai 2001 pe Lao ki he Ngaahi Tute mo e Tute 'Ekisia (Vahe 67);

(e) kuo maumau'i 'e he taha ma'u laiseni ha tu'unga 'o e laiseni';

(f) 'oku kole 'e he taha ma'u laiseni 'i he tohi ke fakata'e'aonga'i pe to'o fakataimi 'a e laiseni, 'o hange ko is 'e hoko;

(g) 'oku 'ikai ke fakahoko 'e he taha ma'u laiseni 'a e pisinisi pe ngaue 'oku felave'i mo e laiseni; pe

(h) kuo te'eki ai ke totongi 'a e totongi laiseni fakaaa'u, pe ko ha ngaahi totongi sivi kuo tu'utu'uni 'oku kau ki ai, 'i loto 'i he 'aho 'e 28 mei hono taimi totongi totonu'.

(11) Kapau 'e fokotu'u atu 'e he Komiti ke fakata'e'aonga'i pe ke to'o fakataimi ha laiseni 'o 'ikai ko ha kole 'e he taha ma'u laiseni', kuo pau ki he Komiti, tukukehe ka pehe 'e he Komiti' 'oka 'ikai ke fakata'e'aonga'i pe to'o 'i he taimi pe ko ia' 'a e laiseni'te ne fakatupu ha fakatu'utamaki 'e hoko ai ha mate, puke lahi pe lavea lahi-

(a) 'i ha fanongonongo tohi 'e 'oatu ki he taha ma'u laiseni', ke ne fakaha ki he taha ma'u laiseni' 'a e ngaahi ngaue 'oku pehe 'e he Komiti' 'e fai' mo e ngaahi 'uhinga 'e fai ai 'a e ngaue ko ia'; pea

(b) tukukehe kapau ko e ngaue kuo fokotu'u ke fakahoko'ko e tupu mei ha ta'e totongi 'o e totongi laiseni fakata'u pe ko ha totongi sivi kuo tu'utu'uni, ke ne 'oatu ki he taha ma'u laiseni' ha faingamalie ke ne fai, 'i loto 'i ha taimi fakapotopoto' 'a is 'oku fakamahino'i 'i he fanongonongo', ha'ane ngaahi fokotu'u ki he Komiti' 'o fekau'aki mo e ngaue kuo fokotu'u atu'.

(12) Kapau 'e 'oatu 'e he taha ma'u laiseni' ha ngaahi fokotu'u 'o fakatatau ki he kupusi'i (11), kuo pau ki he Komiti' ke ne fakakaukau'i 'a e ngaahi fokotu'u ko ia' kimu'a pea ne fai ha tu'utu'uni 'o kau ki hono fakata'e'aonga'i pe to'o fakataimi 'o e laiseni'.

(13) 'E ngofua ke fakata'e'aonga'i ha laiseni neongo 'oku to'o fakataimi 'a e laiseni ko ia'.

(14) Kapau 'e to'o fakataimi ha laiseni, 'e ngofua ki he Komiti, 'i ha fanongonongo tohi 'e 'oatu ki he taha ma'u laiseni', ke ne kaniseli 'a e to'o fakataimi ko ia'.

(15) Kapau 'e fakata'e'aonga'i pe to'o fakataimi 'e he Komiti'ha laiseni hu mai, kuo pau ki he sekelitali 'o e Komiti'ke ne pulusi 'a e ngaahi fakaikiiki 'o e tu'utu'uni' ko is 'i he Kasete' 'i he vave taha 'e ala lava'.

(16) 'E ngofua ki he Komiti', mei he taimi ki he taimi pea 'i he founga ko is 'e tu'utu'uni 'e he Komiti', ke ne pulusi ha lisi 'o e ni'ihi kuo laiseni ke hu mai 'a e ngaahi koloa faito'o 'i he kupu ni, mo e ngaahi Kalasi 'o e lisi lesisita' 'a is 'oku felave'i mo e ngaahi laiseni ko ia'.

Ngaahi Hia

13. (1) Kuo pau 'e 'ikai ha taha to ne-

(a) hu mai ha ngaahi koloa faito'o ki he Pule'anga ni;

(b) hu atu ha ngaahi koloa faito'o mei he Pule'anga ni tukukehe 'i ha fakamafai'i 'e he Minisita pe kapau ko e hu atuu 'e ha taha ke faka'aonga'i fakafo'ituitui 'a is 'e fakamo'oni'i 'e ha tohi pe ha tohi fakamo'oni 'a e toketa lesisita 'a e taha ko ia' 'i he Pule'anga ni;

(d) tuku atu ha ngaahi koloa faito'o 'i he Pule'anga ni;

tukukehe kapau 'oku kau 'a e ngaahi koloa ko ia' 'i he lisi lesisita pea kapau 'oku hu mai 'oku hu mai 'aki ha laiseni 'i he kupu 12 pe 'oku fakatatau 'a e ngaahi koloa' ki ha fakamafai 'e he Minisita 'i he kupu 10.

(2) Ka puke 'e ha 'ofisa tute ha ngaahi faito'o fakaesino 'i he ngaahi mafai 'oku ha 'i he Lao ki he Ngaahi Tute mo e Tute 'Ekisia (Vahe 67), kuo pau ke fakaha 'a e puke ko is ki he Pule Hu'i Vai 'i he vave taha 'e ala lava' hili ia'.

Tapu ke ngaohi ha ngaohi koloa faito'o tukukehe 'i ha laiseni

14. (1) Kuo pau 'e 'ikai ha taha, 'i ha fale 'i he Pule'anga ni, to ne ngaohi pe fakahoko ha sitepu 'i hono ngaohi 'o e ngaahi koloa faito'o ke loam ke ngaue'aki 'e he tangata tukukehe kapau-

(a) 'oku faka'ata 'a e ngaahi koloa'ko is pe ko e tokotaha ko ia' 'e ha ngaahi tu'utu'uni fekau'aki mo hono ngaohi 'o e ngaahi koloa'; pe

(b) ko e tokotaha ko ia' 'oku ne ma'u ha laiseni ngaohi 'a is 'oku 'conga pea 'oku ne fakamafai'i ke fakahoko 'a e ngaohi ko ia' pe ha sitepu 'i hono ngaohi ko ia'.

Ka kuo pau 'e 'ikai ngaue'aki 'a e kupusi'i ni ki he pe fekau'aki mo e ngaahi koloa 'oku ngaohi 'e ha toketa nifo, taha faito'o nifo pe ngaohi 'e-

(d) ha taha hu'i vai pe ha tokoni hu'i vai 'i ha fale 'o e Potungaue Mo'ui;

ke fakatau atu pe 'oatu, 'o 'ikai ko ha holoseila, 'i he pe mei he ngaahi fale ko ia'.

(2) Kuo pau 'e 'ikai ke maumau'i 'e ha taha ma'u laiseni ngaohi ha tu'unga 'o e laiseni'.

(3) Kuo pau 'e 'ikai ha taha, 'i ha pe fekau'aki mo ha tohi kole laiseni ngaohi, to ne fai ha fakamatala 'oku ne 'ilo 'oku loi pe taki hala 'i ha me'a mahu'inga.

(4) 'E ngofua ki he Komiti', mei he taimi ki he taimi, 'i ha fanongonongo tohi, ke ne tu'utu'uni 'a e ngaahi tefito'i tu'utu'uni ke fai pau ki ai 'o fekau'aki mo e-

(a) ngaahi tu'unga ke tauhi mo e me'angaue ke ngaue'aki 'i he ngaahi fale 'oku ngaue'aki ki hono ngaohi 'o e ngaahi koloa faito'o';

(b) ngaahi founga ke fakapapau'i 'a e lelei mo pule'i 'a e lelei ke fakahoko 'i hono ngaohi 'o e ngaahi koloa faito'o';

(d) ngaahi ngaue ngaohi angamaheni ke fakahoko 'i hono ngaohi 'o e ngaahi koloa faito'o'; pe

(e) ngaahi me'a kehe 'oku kau ki he lelei, malu mo e 'conga 'o e ngaahi koloa faito'o 'oku ngaohi 'i he Pule'anga ni;

pea 'e ngofua ke ne fakakau ai 'a e lao 'o e ngaue ngaohi angamaheni lelei'.

(5) Kuo pau ki ha kole laiseni ngaohi ke-

(a) fai 'i he tohi 'i he foomu kuo tu'utu'uni 'i he ngaahi tu'utu'uni;

(b) fakamahino'i 'a e ngaahi koloa faito'o pe ngaahi kalasi 'o e ngaahi koloa faito'o 'oku fokotu'u atu 'e he taha kole'ke ne ngaohi';

(d) fakamahino'i 'a e ngaahi sitepu 'i hono ngaohi 'o e ngaahi koloa ko is 'oku fokotu'u atu 'e he taha kole' ke ne fakahoko 'i he laiseni';

(e) fakaha 'a e ngaahi hingoa, poto taau mo e taukei 'o e ni'ihi 'a is to nau pule'i 'a hono ngaohi 'o e ngaahi koloa mo e ngaahi founga pule'i lelei 'a is 'e ngaue'aki';

(f) 'oatu is ki he Fale Hu'i Vai mo Tauhi'anga Faito'o Tefito; pea

(g) 'oatu fakataha is mo e totongi kole kuo fakamahino'i'.

(6) 'E ngofua ki he Komiti, 'i ha fanongonongo tohi, ke ne tu'utu'uni ki he taha kole'-

(a) ke ne 'oatu ki he Komiti', 'i loto 'i ha taimi fakapotopoto' 'a is 'e fakamahino'i 'i he fanongonongo, ha fakamatala kehe 'o fekau'aki mo e kole' 'a is 'e fakamahino'i 'i he fanongonongo'; pe

(b) ke ne fakangofua ha 'ofisa fakamafai, 'i ha taimi fakapotopoto' 'a is 'e fakamahino'i 'i he fanongonongo', ke ne sivi 'a e ngaahi fale, me'angaue, ngaahi founga ngaue, ngaahi koloa mo e ngaahi naunau 'e ngaue'aki ki hono ngaohi 'o e ngaahi koloa'.

(7) (a) Kapau kuo kole ha taha ke ne fakahoko ha ngaahi sitepu 'i hono ngaohi 'o e ngaahi koloa faito'o' 'i ha ngaahi fale ngaohi pau; pea

(i) kuo totongi 'a e totongi kole kuo tu'utu'uni;

(ii) kuo totongi ha ngaahi totongi sivi 'oku fiema'u'; pea

(iii) kuo muimui pau 'a e tokotaha ki he ngaahi fiema'u 'a e Komiti' 'i he kupusi'i (6) 'o fekau'aki mo e kole';

kuo pau ke foaki 'e he Komiti ki he taha ko ia' ha laiseni ke ne fakahoko 'a e ngaahi sitepu ko ia' 'i he ngaahi fale ko ia'.

(b) Neongo 'a e palakalafi (a) kapau 'oku fiemalie 'a e Komiti'-

(i) 'e 'ikai ke lava 'e he taha kole' ke ne muimui pau ki he ngaahi tefito'i tu'utu'uni 'o e ngaohi';

(ii) 'oku 'ikai fakafiemalie 'a e ngaahi fale ki hono ngaohi 'o e ngaahi koloa';

(iii) na'e 'osi foaki ki he taha kole' ha laiseni ngaohi faito'o ka kuo 'osi fakata'e'aonga'i;

(iv) kuo fakahalaia'i 'a e taha kole' 'i ha hia 'i he Lao ni;

(v) 'oku pule'i e he taha kole' ha sino fakakautaha (fakahangatonu, pe ta'e fakahangatonu 'o fou 'i ha ngaahi sino tu'u vaha'a 'e taha pe lahi ange) 'a is kuo fakahalaia'i 'i ha hia 'i he Lao ni;

(vi) na'e pule 'i 'e he taha kole' ha sino fakakautaha (fakahangatonu, pe ta'e fakahangatonu 'o fou 'i ha ngaahi sino tu'u vaha'a 'e taha pe lahi ange) 'i he taimi na'e fakahoko ai 'e he sino ko ia' ha hia 'i he Lao ni, pea kuo fakahalaia'i 'a e sino ko ia' 'i he hia ko ia', pe kapau ko e taha kole' ko ha sino fakakautaha pea 'oku pule'i is 'e ha taha kehe (fakahangatonu pe ta'e fakahangatonu 'o fou 'i ha ngaahi sino tu'u vaha'a 'e taha pe lahi ange) pea kuo fakahalaia'i 'a e taha kehe ko ia' 'i ha hia 'i he Lao ni; pe

(vii) kuo laka hake 'i he tu'o taha 'a e 'ikai ke fakahoko 'e he taha kole' 'a e ngaahi tefito'i tu'utu'uni 'o fekau'aki mo hono ngaohi 'o e ngaahi koloa faito'o,

kuo pau ke fakafisi 'a e Komiti ke foaki atu ha laiseni ngaohi.

(8) Kapau 'oku foaki pe fakafisi 'a e Komiti ke foaki atu ha laiseni ngoahi, kuo pau ki he Komiti-

(a) ke ne 'oatu ki he taha kole' ha fanongonongo tohi 'o e tu'utu'uni'; pea

(b) kapau ko ha fakafisi, ke ne fakakau 'i he fanongonongo' 'a e ngaahi 'uhinga ki he fakafisi'.

(9) Kapau 'oku foaki 'e he Komiti ha laiseni ngaohi, kuo pau ke pulusi 'e he sekelitali 'o e Komiti' 'a e ngaahi fakaikiiki 'o e tu'utu'uni' 'i he Kasete' 'i he vave taha 'e ala lava'.

(10) 'Oku kamata ngaue'aki ha laiseni ngaohi 'i he 'aho 'e fakamahino'i 'i he laiseni pea 'e 'conga is kae'oua ke toki fakata'e'aonga'i pe to'o fakataimi.

(11) 'E ngofua ke foaki ha laiseni ngaohi 'o fakatatau ki he-

(a) ngaahi tu'unga kuo fokotu'u ke fakapapau'i 'oku ngaohi 'e he taha ma'u laiseni' 'a e ngaahi koloa' 'o fakatatau ki he ngaahi tefito'i tu'utu'uni ki he ngaohi, mo ha ngaahi tu'unga 'e ala ngaue'aki ki he koloa'; mo ha

(b) ngaahi tu'unga kehe fekau'aki mo hono ngaohi 'o e ngaahi koloa 'a is 'e fakakaukau 'a e Komiti 'e taau'.

(12) 'E ngofua ki he Komiti, 'i ha fanongonongo tohi, ke ne hilifaki ha ngaahi tu'unga fo'ou ki he laiseni ngaohi pe to ne liliu pe to'o 'a e ngaahi tu'unga lolotonga'.

(13) Ko e hilifaki pe liliu 'o ha tu'unga 'i he kupusi'i (12) kuo pau 'e kamata ngaue'aki ia-

(a) kapau 'e fakaha 'i he fanongonongo' 'oku fiema'u 'a e ngaue ko ia'ke ta'ofi ha fakatu'utamaki 'e hoko ai ha mate, puke lahi pe lavea lahi, 'i he 'aho ko is 'oku 'oatu ai 'a e fanongonongo' ki he tokotaha ko ia'; pe

(b) 'i ha me'a kehe, 'i ha 'aho 'e fakamahino'i 'i he fanongonongo', 'a is ko ha 'aho 'e 'ikai nounou ange 'i he 'aho 'e 28 hili hono 'oatu 'o e fanongonongo' ki he taha ko ia'.

(14) 'O tanaki atu ki ha ngaahi tu'unga 'e hilifaki 'i he kupusi'i (11) pe (12), kuo pau ki he laiseni kotoa pe ke fakatatau ki he ngaahi tu'unga 'a is kuo pau ai ki he taha ma'u laiseni-

(a) ke ne fakapapau'i 'oku fakatatau 'a e ngaahi koloa' ki ha fa'ahinga tu'unga 'e ngaue'aki ki he ngaahi koloa ko ia';

(b) ke 'oua to ne ngaohi ha faito'o fakaesino 'o kamata 'aki ha ngaahi me'a loi pe ta'e to ne fakahoko ha me'a fakapotopoto ke fakapapau'i ko e ngaahi me'a ke kamata 'aki hono ngaohi pe ngaue'aki ki he ngaohi 'o ha faito'o fakaesino pehe 'oku 'ikai loi pe faka'alongaua hono lelei;

(i) ke hu, 'i ha taimi 'oku fakapotopoto', ki he ngaahi fale ngaohi 'a is 'oku kau ki ai 'a e laiseni';

(ii) lolotonga 'ene 'i he ngaahi fale ko ia', ke ne sivi 'a e ngaahi fale ko ia', ha koloa faito'o 'oku ngaohi ai mo ha ngaue fekau'aki mo e ngaohi ko ia', pea ke ne 'ave ha ngaahi semipolo 'o ha ngaahi koloa pehe pea ke ne faitaa'i 'a e ngaahi fale, ngaahi koloa pe ngaahi ngaue ko ia'; pea

(iii) ke ne fakafehu'i 'a e taha ma'u laiseni' pe ko 'ene kau ngaue 'i he ngaahi fale ko is' 'o fekau'aki mo e ngaahi founga ngaue 'oku fakahoko ai';

(d) kapau 'e fiema'u 'e ha 'ofisa fakamafai-

(i) ke ne 'oatu ki he 'ofisa' ha ngaahi tohi 'oku fekau'aki mo hono ngaohi 'o e ngaahi koloa 'i he ngaahi fale ko ia' 'a is 'e fiema'u 'e he 'ofisa' pea ke ne faka'ata 'a e 'ofisa' ke ne hiki ha tatau 'o e ngaahi tohi ko ia'; pea

(ii) ke ne 'oatu ki he 'ofisa ke sivi ha ngaahi semipolo 'oku tauhi 'e he taha ma'u laiseni'; pea

(e) ke ne muimui pau ki ha ngaahi tu'unga kehe (kapau 'e 'i ai) 'a is 'e fakamahino'i 'i he ngaahi tu'utu'uni'.

(15) Fakatatau ki he kupusi'i (16), 'e ngofua ki he Komiti', 'i ha fanongonongo tohi 'e 'oatu ki he taha ma'u laiseni', ke ne fakata'e'aonga'i 'a e laiseni', pe to'o fakataimi 'a e laiseni' 'i ha vaha'a taimi 'e fakamahino'i 'i he fanongonongo', kapau-

(a) kuo fakahalaia'i 'a e taha ma'u laiseni' 'i ha hia 'i he Lao ni;

(b) 'oku pule'i 'e he taha ma'u laiseni' ha sino fakakautaha (fakahangatonu, pe ta'e fakahangatonu 'o fou 'i ha ngaahi sino tu'u vaha'a 'e taha pe lahi ange) 'a is kuo fakahalaia'i 'i ha hia 'i he Lao ni;

(c) na'e pule'i 'e he taha ma'u laiseni' ha sino fakakautaha (fakahangatonu, pe ta'e fakahangatonu 'o fou 'i ha ngaahi sino tu'u vaha'a 'e taha pe lahi ange) 'i he taimi na'e fakahoko ai 'e he sino ko ia' ha hia 'i he Lao ni, pea kuo fakahalaia'i 'a e sino ko ia' 'i he hia ko ia'pe, kapau ko e taha ma'u laiseni' ko ha sino fakakautaha 'a is 'oku pule'i 'e ha taha kehe (fakahangatonu pe ta'e fakahangatonu 'o fou 'i ha ngaahi sino tu'u vaha'a 'e taha pe lahi ange) pea kuo fakahalaia'i 'a e taha kehe ko ia' 'i ha hia 'i he Lao ni;

(d) kuo maumau'i 'e he taha ma'u laiseni ha tu'unga 'o e laiseni';

(e) kuo 'ikai fakahoko 'e he taha ma'u laiseni' 'a e ngaahi tefito'i tu'utu'uni ngaohi 'o fekau'aki mo hono ngaohi 'o e ngaahi koloa faito'o;

(f) 'oku kole 'e he taha ma'u laiseni 'i he tohi ke fakata'e'aonga'i pe ke to'o fakataimi 'a e laiseni';

(g) 'oku 'ikai ke toe fakahoko 'a e pisinisi 'a e taha ma'u laiseni' ki hono ngaohi 'o e ngaahi koloa 'oku kau ki ai 'a e laiseni'; pe

(h) kuo te'eki ai ke totongi 'a e totongi laiseni fakata'u, pe ko ha ngaahi totongi sivi, 'i loto 'i he 'aho 'e 28 hili 'a e taimi na'e totonu ke totongi ai'.

(16) Kapau 'e fokotu'u 'e he Komiti ke fakata'e'aonga'i ha laiseni pe ke to'o fakataimi ha laiseni 'o 'ikai 'i ha kole 'a e taha ma'u laiseni', kuo pau ki he Komiti, tukukehe ka pehe 'e he Komiti' 'e fakatupu 'e he 'ikai ke fakata'e'aonga'i pe to'o fakataimi leva 'o e laiseni' ha fakatu'utamaki 'e hoko ai ha mate, puke lahi pe lavea lahi-

(a) 'i ha fanongonongo tohi 'e 'oatu ki he taha ma'u laiseni', ke ne fakaha ki he taha ma'u laiseni''a e ngaue 'oku fokotu'u atu 'e he Komiti' ke fakahoko' pea mo e ngaahi 'uhinga ki he ngaue kuo fokotu'u ko ia'; pea

(b) tukukehe kapau ko e fokotu'u 'o e ngaue ko ia'koe'uhi ko ha ta'etotongi 'o e totongi laiseni fakaaa'u pe ha totongi sivi, ke ne 'oatu ki he taha ma'u laiseni' ha faingamalie ke ne fai, 'i loto 'i ha vaha'a taimi fakapotopoto' 'a is 'oku fakamahino'i 'i he fanongonongo', ha ngaahi fokotu'u ki he Komiti' 'o fekau'aki mo e ngaue kuo fokotu'u atu;

(17) Kapau 'e fai 'e he taha ma'u laiseni ha ngaahi fokotu'u 'o fakatatau ki he kupusi'i (6) kuo pau ke fakakaukau'i 'e he Komiti 'a e ngaahi fokotu'u ko is kimu'a pea ne fakahoko ha tu'utu'uni 'o fekau'aki mo hono fakata'e'aonga'i pe to'o fakataimi 'o e laiseni'.

(18) 'E ngofua ke fakata'e'aonga'i ha laiseni neongo 'oku to'o fakataimi 'a e laiseni ko ia'.

(19) Kapau 'e to'o fakataimi ha laiseni, 'e ngofua ki he Komiti', 'i ha fanongonongo 'i he tohi ki he taha ma'u laiseni', ke ne kaniseli 'a e to'o fakataimi ko ia'.

(20) Kapau 'e fakata'e'aonga'i pe to'o fakataimi 'e he Komiti' ha laiseni ngaohi, kuo pau ke pulusi 'e he sekelitali 'o e Komiti' 'a e ngaahi fakaikiiki 'o e tu'utu'uni' ko is 'i he Kasete 'i he vave taha 'e ala lava'.

(21) 'E ngofua ki he Komiti, mei he taimi ki he taimi pea 'i ha founga 'e tu'utu'uni 'e he Komiti', ke ne pulusi ha lisi 'o e ni'ihi 'oku laiseni 'i he kupu ni, ngaahi kalasi 'o e ngaahi koloa 'oku kau ki ai 'a e ngaahi laiseni', ngaahi sitepu 'o e ngaohi 'a is 'oku fakamafai'i 'e he laiseni mo e tu'asila 'o e ngaahi fale ngaohi 'oku kau ki ai 'a e laiseni'.

Pule'i 'o e lelei

15. (1) Kuo pau 'e 'ikai ke ngaohi, hu mai, hu am, hu'i, tauhi, fakatau atu, tu'uaki pe tufaki 'e ha taha ha faito'o fakaesino 'a ia-

(a) 'oku 'ikai fe'unga ke faka'aonga'i 'e he tangata pe monumanu;

(b) kuo 'uli'i 'o 'ikai taau ke ngaue'aki;

(d) kuo ngaohi, teuteu'i, fakatolonga, kofukofu pe tauhi ke fakatau am 'i he ngaahi tu'unga 'uli pe ta'e fakafiemalie;

(e) kuo leipolo, kofukofu pe tu'uaki 'i ha founga 'oku loi, takihala, kaka pe ngalingali ke ne fakatupu ha ma'u hala 'o fekau'aki mo hono tupu'anga, 'ulungaanga, mahu'inga, lelei, fa'unga, malohi, taau pe malu;

(f) 'oku 'i ai ha ngaahi me'a loi na'e kamata'aki pe kuo 'ilo 'oku loi pe mahalo'i ko ha me'a loi.

(2) Ko ha taha 'a ia, 'i he 'ikai ha 'uhinga lelei, to ne maumau'i 'a e kupusi'i (1) 'oku ne fai ha hia.

[Ed. English version appears here in the original]

Ngaahi faito'o fakaesino me'a'ofa

16. Donated medicinal drugs may be imported into the Kingdom only if-

(a) they are in the List of Essential Drugs for the Kingdom;

(b) they are of known good quality;

(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.

KONGA V - PULE'I MAKEHE 'O E HU MAI 'O E NGAAHI FAITO'O KONA
TAPU MO E NGAAHI ME'A KONGA FAKA'ATAMAI

Mafai ke hu mai 'a e ngaahi faito'o kona tapu mo e ngaahi me'a faito'o 'atamai

(2) The authorisation of the Minister under subsection (1) may be delegated to the Principal Pharmacist.

Tapui fakatau holoseila tukukehe 'i he laiseni

18. (1) Ko ha taha 'oku ne fakatau atu holoseila ha ngaahi koloa faito'o, pe ha kalasi 'o e ngaahi koloa faito'o, 'a is 'oku kau ki ai 'a e kupu ni 'oku ne fai ha hia tukukehe kapau 'oku fakamafai'i 'a e fakatau atu holoseila ko ia' 'i ha laiseni.

(2) 'E ngofua ke fakamahino'i 'e he Komiti, 'i ha fakangofua 'e he Minisita, 'i ha ngaahi tu'utu'uni 'a e ngaahi koloa faito'o pe ngaahi kalasi 'a is 'oku kau ki ai 'a e kupu ni.

Laiseni kau fakatau fakamovetevete

19. (1) 'E ngofua ki he ngaahi hu atu fakamovetevete, 'oku 'ikai ko ha fale hu'i vai ke ne ma'u mai, tuku, tauhi mo fakatau atu ha ngaahi faito'o 'oku 'i he KALASI I 'o e lisi lesisita, 'o fakatatau ki ha laiseni fakamovetevete 'oku lolotonga ngaue'aki.

(2) Ko hono ma'u mai, tuku, tauhi, fakatau atu pe fokotu'u ke fakatau atu 'e ha ngaahi hu atu fakamovetevete, 'oku 'ikai ko ha fale hu'i vai, 'o ha ngaahi faito'o fakaesino kehe meite kinautolu 'oku tu'u 'i he KALASI I 'o e lisi lesisita', pe ko hono tuku, tauhi, fakatau atu pe fokotu'u ke fakatau atu 'o e ngaahi faito'o fakaesino ta'e 'i ai ha laiseni fakamovetevete ko ha hia ia.

(3) Ko ha taha 'oku ne tuku atu ha ngaahi faito'o fakaesino hili 'a e 'aho ta'e'aonga 'oku tu'u 'i he ngaahi faito'o', 'oku ne fai ha hia.

Mafai ke tohi ngaahi tu'utu'uni fakatoketa

20. (1) 'E ngofua ki ha 'ofisa mo'ui kuo fakamafai'ii ke ne tohi ha ngaahi tu'utu'uni fakatoketa ki ha ngaahi faito'o fakaesino 'oku kau 'i he KALASI 1 mo e 2 'o e lisi lesisita', pea 'e ngofua ke ne tohi ha ngaahitu'utu'unifakatoketa ki ha ngaahifaito'o fakaesino 'oku kau 'i he KALASI 3 'o e lisi lesisita 'i ha fale'i 'a ha toketa.

(2) 'E ngofua ki ha toketa nifo ke ne tohi ha ngaahi tu'utu'uni fakatoketa ki ha ngaahi faito'o fakaesino 'oku kau 'i he KALASI 1, 2 mo e 3 'o e lisi lesisita'kapau ko e faito'o fakaesino ko is 'oku ngaue'aki fakafaito'o 'i ha ngaue ngaohi nifo'.

(3) 'E ngofua ki ha toketa ke ne tohi ha ngaahi tu'utu'uni fakatoketa ki ha ngaahi faito'o fakaesino 'oku kau 'i he KALASI 1, 2, 3 mo e 5 'o e lisi lesisita'.

(4) 'E ngofua ki ha toketa 'oku ne mei ngaue tafataha 'i ha 'elia makehe 'oku 'iloa ai, ke ne tohi ha ngaahi tu'utu'uni fakatoketa ki ha ngaahi faito'o fakaesino 'oku kau 'ii he KALASI 4 'o e lisi lesisita', 'i ha taimi 'e fiema'u ai ke ngaue'aki fakafaito'o 'a e faito'o ko ia' ki ha taha 'oku faito'o ki ha puke 'i he 'elia makehe ko ia'.

(5) 'E ngofua ki ha toketa monumanu ke ne tohi ha ngaahi tu'utu'uni fakatoketa ki ha ngaahi faito'o fakaesino 'oku kau 'i he KALASI 6 'o e lisi lesisita.

(6) 'E 'ikai ngofua ke tohi 'e ha taha ha tu'utu'uni fakatoketa ki hono tuku atu 'o ha ngaahi faito'o kona tapu pe ngaahi me'a kona faka'atamai ke ne ngaue'aki pue ma'ana.

Ngaahi fiema'u ki he ngaahi tu'utu'uni fakatoketa

21. (1) Tukukehe 'i ha ngaahi me'a fakatu'upake, kuo pau 'e 'ikai ha taha hu'i vai pe ha tokoni hu'i vai lesisita to ne teuteu'i mo tuku atu ha tu'utu'uni fakatoketa ki hono tuku atu 'o ha ngaahi faito'o fakaesino tukukehe kapau ko e tu'utu'uni fakatoketa ko ia'-

(a) 'oku tohi pea faka'aho mo fakamo'oni hingoa 'aki 'a e fakamo'oni hingoa maheni 'o e taha kuo fakamafai'i ke ne 'oatu ia', fakamahino'i 'a e tu'asila fakangaue 'a e taha ko ia' mo e hingoa mo e tu'asila 'o e taha 'oku fakahoko ki ai 'a e tu'utu'uni fakatoketa;

(b) kapau ko e 'oatu 'e ha toketa nifo lesisita 'oku tohi'i ai 'a e "Ki he faito'o nifo 'ata'ata pe";

(d) 'oku tohi fakamo'oni'i 'e ha toketa lesisita 'oku ne 'oatu ia' mo ha ki'i fakamatala ai ki he tu'o lahi kuo pau ke teuteu'i mo tuku atu 'i he tu'utu'uni fakatoketa ko ia'

(e) kapau 'oku ha ai ha tousi (dose) 'oku 'ikai anga maheni pe fakatu'utamaki 'oku kau ai ha fakamatala 'a e tokotaha 'oku ne 'oatu ia' 'oku tu'utu'uni pehe pe 'a e tousi is ko ia';

(f) 'oku tohi 'i ha ngaahi lea mo e ngaahi faka'ilonga 'a is 'oku faka'aonga'i fakangaue angamaheni, pea ke fakahaa'i ai 'a e hingoa kehekehe 'o e faito'o fakaesino ko ia';

ka kuo pau, 'i he taimi 'e fakamo'oni hingoa ai 'a e toketa, 'ofisa mo'ui pe toketa nifo 'i he tu'utu'uni fakatoketa, kuo pau ke kau ai hono fika lesisita 'oku foaki 'i he Lao ki he Ngaue Fakafaito 'o mo e Nifo 2001.

(2) Kapau, 'i ha me'a fakatu'upake, 'e tala ngutu ha tu'utu'uni fakatoketa ki he taha hu'i vai pe tokoni hu'i vai lesisita, kuo pau ke 'oatu tohi 'a e tu'utu'uni fakatoketa ki he taha hu'i vai pe tokoni hu'i vai ko is 'i loto 'i he houa 'e 24 'e he tokotaha na'a ne tala ngutu ia'.

Ngaahi fiema'u ki he teuteu'i mo tuku atu

22. (1) Tukukehe ka tu'utu'uni 'i he kupusi'i (2) kuo pau 'e 'ikai ha taha to ne teuteu'i mo tuku atu ha faito'o fakaesino 'i ha tu'utu'uni fakatoketa ngata pe kapau ko ha taha hu'i vai pe tokoni hu'i vai lesisita is pe taha tokoni 'oku fakahinohino'i mo pule'i hangatonu is 'e ha taha hu'i vai pe toketa monumanu lesisita.

(2) Kuo pau 'e 'ikai ha me'a 'i he kupusi'i (1) to ne ta'ofi ha toketa lesisita, 'ofisa mo'ui pe ha neesi mei ha'ane teuteu'i mo tuku atu ha tousi kamata 'i tu'a 'i he ngaahi houa ngaue, pe teuteu'i mo tuku atu ha tu'utu'uni fakatoketa pe 'oatu ha faito'o fakaesino 'i loto 'i he fakangatangata 'o hono mafai kapau 'oku 'ikai ke 'i ai ha fale hu'i vai lesisita, taha hu'i vai pe tokoni hu'i vai lesisita 'i loto 'i he kilomita 'e 10 mei he feitu'u ko ia.

(3) 'I hono teuteu'i mo tuku atu ha tu'utu'uni fakatoketa ki ha faito'o fakaesino-

(a) kuo pau 'e 'ikai ke teuteu'i mo tuku atu ha faito'o fakaesino 'o laka hake 'i he tu'o taha 'i ha fo'i tu'utu'uni fakatoketa tatau, tukukehe kapau 'oku fekau'i pehe 'e he tu'utu'uni fakatoketa 'a ia, 'i ha me'a pehe 'e ngofua ke teuteu'i mo tuku atu 'a e faito'o fakaesino' 'i ha vaha'a taimi pe ngaahi vaha'a taimi 'o hange ko is 'oku ha 'i he tu'utu'uni fakatoketa;

(b) kuo pau ke faka'ilonga'i 'a e tu'utu'uni fakatoketa 'aki 'a e 'aho 'oku teuteu'i mo tuku atu ai', mo e hingoa mo e tu'asila fakangaue 'o e tokotaha na'a ne teuteu'i mo tuku atu ia';

(c) ko e tokotaha to ne teuteu'i mo tuku atu fakamuimui taha 'a e tu'utu'uni fakatoketa kuo pau ke ne tohi'i 'i he tu'utu'uni fakatoketa 'a e fo'i lea "Kaniseli";

(d) kuo pau 'e 'ikai ke teuteu'i mo tuku atu 'e ha taha ha tu'utu'uni fakatoketa kuo 'osi tohi'i ai 'a e "Kaniseli" pe 'a is kuo, pe 'oku ngalingali kuo, laka hake 'i he mahina 'e 3 hono fai 'o e tu'utu'uni fakatoketa ko ia';

(e) kuo pau 'e 'ikai ke teuteu'i mo tuku atu 'e ha taha ha tu'utu'uni fakatoketa kapau 'oku 'i ai ha 'uhinga ke ne tui ai 'oku 'ikai ko ha tu'utu'uni fakatoketa mo'oni ia;

(f) kuo pau 'e 'ikai ke teuteu'i mo tuku atu 'e ha taha ha tu'utu'uni fakatoketa 'oku 'ikai lava 'o lau pe 'oku pa'usi'i pe ngalingali na'e liliu; pea

(g) kapau 'e mahalo'i 'e ha taha hu'i vai pe ha tokoni hu'i vai lesisita na'e tohi loi'i pe na'e 'oatu kaka ha tu'utu'uni fakatoketa, pe 'oku 'ikai ke tu'u ai 'a e fakamo'oni hingoa 'o ha toketa, ha 'ofisa mo'ui pe toketa nifo lesisita, kuo pau, neongo 'oku te'eki ai ke teuteu'i mo tuku atu ia, ke ne puke 'a e tu'utu'uni fakatoketa ko is mo lipooti 'ene mahalo 'i he vave taha 'e ala lava' ki he Pule Hu'i Vai'.

(4) (a) Kuo pau ke lekooti 'e he taha hu'i vai pe tokoni hu'i vai kotoa pe 'a e tu'utu'uni fakatoketa kotoa pe kuo ne teuteu'i mo tuku atu, hu'i pe ngaahi 'i ha tohi tu'utu'uni fakatoketa, pe 'i ha founga faka'elekitulonika.

(b) Kuo pau ke kau 'i he tohi tu'utu'uni fakatoketa pe lekooti faka'elekitulonika:

(i) ha fika fekau'aki mo e tu'utu'uni fakatoketa 'oku kau ki ai mo e fika 'o e tu'utu'uni fakatoketa ko ia;

(ii) 'a e hingoa mo e tu'asila 'o e taha 'oku fakataumu'a ke ne faka'aonga'i 'a e faito'o na'e teuteu'i mo tuku atu'pe hu'i'.

(5) Kuo pau ke tauhi 'a e tohi tu'utu'uni fakatoketa pe lekooti faka'elekitulonika' 'i he feitu'u na'e teuteu'i mo tuku atu ai 'a e faito'o' pea kuo pau 'i he ngaahi taimi fakapotopoto kotoa pe ke loam is kapau 'e 'eke 'e ha 'ofia fakamafai.

(6) Ko e ngaahi 'olisinale 'o e ngaahi tu'utu'uni fakatoketa kotoa pe kuo pau ke faka'ilonga'i 'aki 'a e fika tu'utu'uni fakatoketa, faile 'i he hokohoko fakafika' pea ke tauhi 'e he taha 'oku ne teuteu'i mo tuku atu 'a e tu'utu'uni fakatoketa ko ia' 'i ha ta'e 'e 2 mei he 'aho 'o hono teuteu'i mo tuku atu'.

(7) Ko ha taha, ta'e 'i ai ha 'uhinga fakapotopoto, to ne maumau'i 'a e kupu ni 'oku ne fai ha hia.

Ngaahi leipolo 'i he ngaahi 'ai'anga

23. (1) Kuo pau ki he taha hu'i vai, tokoni hu'i vai, toketa, neesi pe ha 'ofisa mo'ui lesisita kotoa pe, kimu'a ke 'oatu pe tukuange atu ki ha taha pe ko ha fakafofonga 'o e taha ko ia' ha 'ai'anga 'oku 'i loto ha faito'o kuo ne teuteu'i mo tuku atu pe hu'i 'e ia, ke ne fakapipiki ki he 'ai'anga ko is 'oku 'i ai 'a e faito'o' ha leipolo 'oku ha mahino ai 'i he lea faka-Tonga'-

(a) ha tu'asila 'oku tohi'i mahino ai 'a e fale hu'i vai na'e hu'i pe teuteu'i mo tuku atu ai 'a e faito'o fakaesino';

(b) 'a e hingoa 'o e taha na'e hu'i pe teuteu'i mo tuku atu ma'ana 'a e faito'o';

(d) 'a e ngaahi fakahinohino ki hono ngaue'aki' 'a is 'oku fakamahino'i 'i he foomu tu'utu'uni fakatoketa na'e hu'i pe na'e teuteu'i mo tuku atu mei ai 'a e faito'o fakaesino'; mo ha

(e) faka'ilonga tatau mo e fika 'o e tu'utu'uni fakatoketa 'i he tohi tu'utu'uni fakatoketa pe lekooti faka'elekitulonika'.

(2) (a) Ko e faka'ilonga 'oku lau ki ai 'i he kupusi'i 1 (c) kuo pau ke fai 'aki 'a e hingoa 'iloa kehekehe 'o e faito'o' 'i he pulusi fakamuimui taha 'o e United States Pharmacopoeia pe ko e British Pharmacopoeia.

(b) kuo pau ke faka'ilonga'i 'i he leipolo 'o e 'ai'anga 'oku 'i ai ha faito'o fakaesino ha leipolo fakatokanga makehe 'a is 'oku pehe 'e he taha hu'i vai pe tokoni hu'i vai 'oku ne teuteu'i mo tuku atu 'oku taau'.

(3) 'Oku 'ikai ke ta'ofi 'e he kupu ni 'a hono tanaki atu ki he leipolo 'o ha fakamatala 'i he lea faka-Pilitania 'o fekau'aki mo e kotoa pe ha ni'ihi 'o e ngaahi me'a 'oku fiema'u'.

(4) Ko ha taha, ta'e 'i ai ha 'uhinga fakapotopoto, to ne maumau'i 'a e kupu ni 'oku ne fai ha hia.

KONGA VII - NGAAHI TU'UTU'UNI KEHEKEHE

'Ofisa fakamafai

24. (1) 'E ngofua ki he Minisita, 'i ha fanongonongo 'i he Kasete, ke ne fakamahino'i 'a e tokotaha pe ha ni'ihi ko ha kau 'ofisa fakamafai ki he ngaahi taumu'a 'o e Lao ni;

(2) Kuo pau ki ha 'ofisa fakamafai, 'i ha kole, ke ne 'oatu ha fakamo'oni ko e 'ofisa fakamafai ia.

Ngaahi mafai ke hu, kumi mo puke

25. (1) Ki he ngaahi taumu'a 'o e Lao ni, 'e ngofua ki ha 'ofisa fakamafai 'i ha ngaahi taimi fakapotopoto kotoa pe ke ne-

(a) hu ki ha ngaahi fale pe 'oku tauhi ai ha ngaahi faito'o fakaesino ke fefakatau'aki fakamovetevete pe ki he ngaue hu'i vai;

(b) hu ki ha feitu'u, fale pe me'alele pe 'a is 'oku ne 'ilo pe 'oku ne mahalo fakapotopoto-

(i) 'oku ngaue'aki ki he ngaue hu'i vai;

(ii) kuo pe 'oku lolotonga pe 'oku ngalingali 'e ngaue'aki 'e ha taha 'i hono maumau'i 'o e Lao ni;

(c) hu ki ha ngaahi fale pe 'a is 'oku ne 'ilo pe 'oku ne mahalo fakapotopoto 'oku tauhi ai ha ngaahi lekooti 'o fekau'aki mo e ngaue hu'i vai pe fekau'aki mo hano maumau'i 'o e Lao ni;

(d) 'i ha ngaahi fale pe to ne hu ki ai-

(i) kumi pe sivi ha ngaahi faito'o fakaesino, ngaahi me'a, me'angaue pe ngaahi tohi pea 'e ngofua ke ne 'ave ha ngaahi tohi, pe ko ha ngaahi semipolo 'o ia, pe hiki ha ngaahi tatau pe to'o ha konga mei ha ngaahi lekooti 'oku fekau'aki mo e ngaue hu'i vai pe fekau'aki mo ha me'a 'oku fakatotolo'i 'i he Lao ni;

(ii) puke ha ngaahi faito'o fakaesino, ngaahi me'a, me'angaue, ngaahi tohi, pe ha ngaahi semipolo 'o ia, pe ha 'ai'anga pe kofukofu 'a is 'oku ne mahalo'i fakapotopoto 'oku 'i loto ha ngaahi faito'o fakaesino, ngaahi me'a pe ha me'angaue;

(iii) fakaava ha loki, feitu'u, 'ai'anga pe ha kofukofu pe 'oku ne 'ilo pe 'oku ne mahalo fakapotopoto 'oku 'i loto ai ha ngaahi faito'o fakaesino, ngaahi me'a pe me'angaue;

(iv) faka'eke'eke ha taha to ne 'ilo 'i ai 'o fekau'aki mo ha ngaahi me'a 'i he Lao ni;

(e) fakahoko ha faka'eke'eke pe ha sivi 'a is 'oku ne tui 'oku taau pe fiema'u ke tokoni ki hono fakakakato pe fakahoko 'o ha fatongia pe ha mafai 'i he Lao ni pe ke ne fakapapau'i kuo, 'oku lolotonga pe 'oku ngalingali 'e fakahoko hano maumau'i 'o e Lao ni.

(2) 'Oku 'ikai ke fakamafai'i 'e he kupusi'i (1) 'a e hu fakamalohi 'a ha 'ofisa fakamafai ki ha fale tukukehe 'i ha mafai 'o ha tohi fakamafai kuo ma'u 'o fakatatau ki he kupusi'i (4).

(3) Tukukehe ka 'oku ne ma'u ha fakangofua mei he taha 'oku ne nofo 'i ha konga 'o e fale kapau 'oku ngaue'aki 'a e konga ko ia' ki he nofo'anga, kuo pau 'e 'ikai ke hu ha 'ofisa fakamafai ki he konga ko ia' ta'e 'i ai ha tohi kumi koloa kuo foaki 'e ha Fakamaau Polisi.

(4) Ko ha Fakamaau Polisi, kapau 'oku ne fiemalie ki he fakamatala 'a ha 'ofisa fakamafai 'oku 'i ai ha 'uhinga fakapotopoto ke mahalo'i 'oku 'i ai ha feitu'u kuo, pe 'oku, pe 'oku ngalingali 'oku ngaue'aki 'o fekau'aki mo hano maumau'i 'o e Lao ni, 'e ngofua ke ne 'oatu ha tohi kumi koloa 'o fekau'i ai 'a e 'ofisa fakamafai' ke ne hu ki he feitu'u 'oku fakamahino'i 'i he tohi kumi koloa' 'i he taumu'a ke fakahoko 'a e ngaahi mafai kuo foaki ki ha 'ofisa fakamafai 'e he Lao ni.

(5) Ko ha tohi kumi koloa 'e 'oatu 'i he kupu ni, ki ha mahina 'e 1 mei hono 'oatu', ko e mafai fe'unga ia-

(a) ki he 'ofisa fakamafai 'oku 'oatu ki ai'pea ki he ni'ihi kotoa pe to nau tokoni ki he 'ofisa' ke hu ki he feitu'u 'oku fakamahino'i 'i he tohi kumi koloa'; pea

(b) ki he 'ofisa fakamafai 'oku 'oatu ki ai' ke ne fakahooko 'o fekau'aki mo e feitu'u 'oku fakamahino'i 'i he tohi kumi koloa' 'a e ngaahi mafai kotoa 'oku foaki ki ha 'ofisa fakamafai 'e he Lao ni.

(6) Koe'uhi ke lava 'o hu ki ha feitu'u 'e ngofua ki ha 'ofisa fakamafai ke ne kole tokoni ki ha ni'ihi to ne pehe 'oku fiema'u pea ko e ni'ihi ko ia', lolotonga 'enau tokoni ki ha 'ofisa fakamafai 'i he fakahoko fakalao 'o ha mafai ke hu, kuo pau ke nau ma'u 'a e mafai tatau ke hu.

(7) Kapau kuo ma'u 'e ha 'ofisa fakamafai ha ngaahi lekooti pe ha koloa kehe ki he ngaahi taumu'a 'o e lao ni 'e ngofua-

(a) kapau ko ha ngaahi lekooti, ke ne tauhi kinautolu 'i he fuoloa 'e fiema'u ki he ngaahi taumu'a ko ia', ka ko e tokotaha 'a is 'oku 'i ai ha'ane totonu ke ne ma'u 'a e ngaahi lekooti ko is', kapau to ne kole, 'oku 'i ai 'ene totonu ke ne ma'u 'i he vave taha 'e ala lava' ha tatau kuo fakamo'oni'i 'e he 'ofisa fakamafai' ko ha tatau mo'oni is pea kuo pau ke tali ha tatau kuo fakamo'oni'i pehe 'i he ngaahi fakamaau'anga kotoa mo ha feitu'u pe ko e fakamo'oni is 'o e ngaahi me'a 'oku ha 'i ai' 'o hange pe ko e 'olisinale ia';

(b) kapau ko ha koloa kehe, fakatatau ki he Lao ni, ke ne tauhi 'a e koloa ko ia' 'i he fuoloa 'e fiema'u ki he ngaahi taumu'a ko ia', pea hili ia' ke ne 'oatu is 'o hange ko e tu'utu'uni 'a e Fakamaau'anga'.

Mafai ke ma'u ha fakamatala

26. (1) 'O fekau'aki mo ha me'a 'oku kau ki hono fakahoko pe fakamalohi'i 'o e Lao ni, 'e ngofua ki ha 'ofisa fakamafai ke ne fiema'u ha taha ('i he fekau lea pe tohi) ke ne 'oange-

(a) ha fakamatala;

(b) ha ngaahi lekooti pe ko ha tatau 'o ia, 'a is 'oku ma'u 'e he taha ko ia'.

(2) Ki he taumu'a 'o e kupusi'i (1), 'e lau 'oku ma'u 'e ha taha ha-

(a) fakamatala, kapau 'oku 'i he taha ko ia' 'a e fakamatala' pe 'oku totonu ke ne ma'u 'a e fakamatala ko ia';

(b) ngaahi lekooti, kapau 'oku tauhi kinautolu 'e he taha ko ia' pe 'oku ne pule'i is 'i ha feitu'u, 'o tatau ai pe ke ne ngaue'aki pe ki ha'ane lelei pe ke ngaue'aki pe ki ha lelei 'a ha taha kehe pea neongo ko e tokotaha kehe 'oku ne ma'u pe tauhi 'a e ngaahi lekooti ko ia'.

(3) 'E ngofua ki ha fekau 'e fai 'i he kupusi'i (1) ke ne fiema'u ke loam 'a e fakamatala' pe ngaahi lekooti' pe ko ha tatau 'o ia-

(a) ki he 'ofisa fakamafai pe ha 'ofisa fakamafai kehe pe ki ha 'ofisa 'o ha potungaue 'a e Pule'anga' kuo fakamahino'i;

(b) 'i he feitu'u 'oku fai ai 'a e fekau' pe 'i ha feitu'u kehe;

(d) 'e ha taha, pe 'i he meili lesisita pe 'i ha founga kehe 'e fakamahino'i;

(e) 'i he founga 'o e, pe 'oatu fakataha mo ha, fakamo'oni 'i he founga 'o e fakamatala fuakava';

(f) kapau ko ha fakamatala, ke tala ngutu pe 'i he tohi.

(4) Kuo pau 'e 'ikai ha taha ta'e 'i ai ha 'uhinga fakapotopoto-

(a) to ne fakafisi pe ta'e 'oatu ha fakamatala, ngaahi lekooti pe ha tatau 'a is 'oku fiema'u 'i he kupu ni;

(b) 'i hano fakahoko ha fiema'u 'i he kupu ni to ne 'oatu ha fakamatala, ngaahi lekooti pe ha ngaahi tatau 'oku loi pe taki hala 'i ha me'a mahu'inga.

(5) Ka 'i ai ha taha to ne lekooti pe tauhi ha me'a 'i ha founga fakamekaniki, 'elekitulonika pe ha me'angaue kehe, ko e fatongia ko is 'i he kupu ni ke 'oatu ha ngaahi lekooti 'oku 'i ai 'a e ngaahi me'a ko ia'kuo pau ke faka'uhinga'i 'oku kau ai ha fatongia ke loam 'a e ngaahi me'a ko ia' 'i he tohi kapau 'oku fiema'u ia.

(6) Ko e fatongia ko is 'oku hilifaki 'e he kupu ni ke 'oatu ha tatau 'o ha ngaahi lekooti 'oku lau ko e fatongia is ke 'oatu hano hiki tatau 'oku mahino.

(7) 'E ngofua ki ha 'ofisa fakamafai ke ne hiki ha ngaahi nouti pe ha ngaahi tatau 'o e pe 'ave ha ngaahi konga mei ha ngaahi lekooti pe ha tatau 'o ha ngaahi lekooti kuo 'oatu 'i he kupu ni.

(8) Ka 'i ai ha taha 'e 'ikai to ne 'oatu ha fakamatala 'oku fiema'u 'i he kupu ni 'oku ne fakahoko ha hia,

Hia hokohoko

27. Ka 'i ai ha taha to ne fai ha hia 'aki 'ene ta'e 'oatu ha fakamatala 'oku fiema'u 'i he kupu 26 pe ta'e 'oatu ha ngaahi lekooti pe ha tatau 'o ha ngaahi lekooti -

(a) ko e fatongia ko is ke 'oatu 'a e fakamatala' pe ke 'oatu 'a e ngaahi lekooti pe ha tatau 'o kinautolu, 'o hange ko is 'e hoko', 'oku hokohoko atu kae'oua ke fai pau 'a e tokotaha ko ia' ki he fiema'u ko ia' neongo ha me'a pau na'e fakamahino'i ha taimi ke fakahoko ai, ngata ki ai pe ke fakahoko 'i loto ai 'a e fai pau na'e fiema'u pea kuo 'osi 'a e taimi ko ia';

(b) 'oku fai 'e he tokotaha ko ia' ha hia hokohoko 'i he 'aho taki taha hili 'a e 'aho 'o hono fakahalaia'i 'a is 'oku hokohoko atu ai 'a e ta'e fai pau ki he fiema'u ko ia';

(c) 'oku ala mo'ua 'a e tokotaha' ko is ki ha tautea pa'anga 'e 'ikai laka hake 'i he $100 ki he 'aho taki taha 'a is 'oku hokohoko atu ai 'a e hia'; pea

(d) 'e ngofua ke faka'ilo 'a e tokotaha ko ia' mei he taimi ki he taimi 'o fekau'aki mo e hia 'i he kupusi'i (b) 'i 'olunga'.

Faka fe'atungia

28. (1) Kuo pau 'e 'ikai ke fakafe'atungia'i 'e ha taha ha 'ofisa fakamafai 'i he'ene fakahoko hono ngaahi mafai 'i he Lao ni;

(2) Koe'uhi ko e ngaahi taumu'a 'o e lao ni, 'oku fakafe'atungia'i 'e ha taha ha 'ofisa fakamafai 'i he'ene fakahoko hono ngaahi mafai 'i he Lao ni kapau to ne -

(a) taa'i, lea kovi'i, fakailifia'i pe faka'ita'i 'a e 'ofisa fakamafai pe ha taha kehe 'oku ne tokoni'i 'a e 'ofisa fakamafai 'i he'ene ngaue'aki hono ngaahi mafai 'i he Lao ni;

(b) ta'ofi 'i he loto ki ai hangatonu pe ta'ehangatonu ha taha mei hano faka'eke'eke ha 'ofisa fakamafai 'i he'ene ngaue'aki hono ngaahi mafai 'i he Lao ni; pe

(c) ta'ofi pe feinga ke ta'ofi 'i ha fa'ahinga founga pe ha 'ofisa fakamafai 'i he'ene ngaue'aki hono ngaahi mafai 'i he Lao ni.

Ngofua ke 'oatu ha ngaahi fiema'u ke fakapapau'i 'a e fai pau

29. (1) Kapau 'e 'i ai -

(a) ha taha hu'i vai, tokoni hu'i vai, toketa, neesi, 'ofisa mo'ui, toketa monumanu, fale hu'i vai, tu'utu'uni fakatoketa pe ha taha kehe, feitu'u pe ha me'a kehe 'e 'ikai ke ne fai pau 'i he me'a kotoa pe ki he ngaahi tu'utu'uni 'o e Lao ni; pe

(b) ha tu'utu'uni 'o e Lao ni 'e 'ikai fai pau ki ai,

'e ngofua ki ha 'ofisa fakamafai, 'i he tohi, ke ne fekau ki ha taha kuo ne maumau'i 'a e tu'utu'uni' 'aki 'a e ta'e-fai pau ko is ke ne fai 'i loto 'i ha taimi kuo fakapapau'i, 'o 'ikai laka hake 'i he 'aho 'e 14, ha ngaahi sitepu 'a is 'e ngofua ke fakamahino'i' ke ta'ofi ha toe maumau lao pea ke fakalelei'i 'a e ngaahi me'a ko is kuo hoko ai 'a e ta'e fai pau'.

(2) Ko hono 'oatu 'o ha fekau 'i he kupu ni 'oku 'ikai ke ne uesia 'e is ha hopo 'i he Lao ni 'a is kuo pe 'e ngofua ke fakahoko ki he ta'e fai pau ko is na'e tupunga ai 'a e fekau'.

[sic] 'ikai ke ne fai pau ki he fekau' 'oku ne fai ha hia.

(3) Ko ha taha 'oku 'oatu ki ai ha fekau 'i he kupu ni pea 'a is 'oku 'ikai ke ne fai pau ki he fekau' 'oku ne fai ha hia.

Ta'e'aonga ngaahi aleapau etc.

30. (1) Ko ha aleapau, felotoi, tukupa pe femahino'aki 'oku lolotonga 'conga 'i he taimi 'oku kamata ngaue'aki ai 'a e Lao ni 'oku ta'e'aonga is 'i he me'a 'e faikehekehe mo e Lao ni.

(2) 'Oku 'ikai ke ala mo'ua 'a e Kalauni pe ha taha ke ne totongi ha ngaahi maumau pe ha totongi huhu'i kehe ki ha taha kehe pe ko e tupunga 'i he kupusi'i (1).

Fai ha fakamatala loi pe kaka

31. Ka 'i ai ha taha, 'i ha'ane kole ke kau ha faito'o fakaesino 'i he lisi isita pe kole ke 'oatu ha laiseni 'i he Lao ni, to ne fai pe 'oatu pe fakatupu ke fai pe 'oatu ha fakamatala, tohi fakamo'oni pe fakamatala fuakava loi pe kaka, 'o tatau ai pe pe 'i he lea pe 'i he tohi, pea ka 'i ai ha taha to ne kaunga pe tokoni ki ai 'i he 'ilo pau 'oku ne fai ha hia pea kuo pau ke ne ala mo'ua 'i ha'ane halaia, ki ha tautea pa'anga 'e 'ikai laka hake 'i he $2000 pe ko e ngaue popula 'i ha vaha'a taimi 'e 'ikai laka hake 'i he mahina 'e 12 pe fakatou'osi.

Hia mo e Tautea

32. Ka 'i ai ha taha to ne maumau'i pe 'ikai ke ne fai pau ki ha tu'utu'uni 'o e Lao ni pe ha tu'utu'uni kuo fa'u 'i he Lao ni 'oku ne fai ha hia, pea 'i ha'ane halaia kuo pau, kapau 'oku 'ikai ke tu'utu'uni ha tautea ki ai, ke ne ala mo'ua ki ha tautea pa'anga 'e 'ikai laka hake 'i he $2000, pe ngaue popula ki ha vaha'a taimi 'e 'ikai laka hake 'i he mahina 'e 12, pe fakatou'osi; pea kapau ko ha hia hokohoko, ki ha tautea pa'anga 'e 'ikai laka hake 'i he $100 ki he 'aho taki taha pe konga 'o ha 'aho 'oku lolotonga hokohoko ai 'a e hia'.

Ngaahi hia 'a e ngaahi sino fakakautaha

33. Ka fai 'e ha sino fakakautaha ha hia 'i he Lao ni pe ha tu'utu'uni kuo fa'u 'i he Lao ni, 'oku halaia ai pe mo e talekita pe taha kehe taki taha 'oku kau 'i hono pule'i 'o e sino fakakautaha' ko ia, pea 'oku ne ala mo'ua ki he tautea 'oku tu'utu'uni, ki he hia ko ia'tukukehe kapau 'e fakamo'oni'i 'e he talekita' pe taha kehe' ko is na'a ne fakahoko 'a e ngaue tokanga fakapotopoto' ke ta'ofi 'a e fai 'o e hia'.

Ngaahi faka'ilo

34. (1) 'E ngofua ke fai ha ngaahi faka'ilo 'o ha hia 'i he Lao ni -

(a) 'e he pe ma'ae 'Ateni Seniale;

(b) 'e ha memipa 'o e kau polisi;

(d) 'e ha 'ofisa tute.

(2) 'E ngofua ki ha taha 'oku lau ki ai 'i he kupusi'i (1)(b), (c) pe (d), 'o tatau ai pe pe ko ha fakafofonga lao ke ne ta, kamata pe fakahoko ha faka'ilo, fakamatala, launga pe ha hopo 'e hoko 'i he Lao ni, 'o fakatatau ki ha ngaahi fekau 'e 'oatu 'e he 'Ateni Seniale'.

Ngaahi Tu'utu'uni

35. 'E ngofua ki he Minisita, 'i he loto ki ai 'a e Kapineti, ke ne fa'u ha ngaahi tu'utu'uni 'o tu'utu'uni ni 'a e ngaahi me'a 'e taau pe 'e faingamalie ke fai'ki hono fakahoko pe ngaue'aki 'o e Lao ni pea, tautau tefito, ki he ngaahi taumu'a ko 'eni' -

(1) ko e ngaahi totongi ke totongi 'i he Lao ni mo e ngaahi tu'utu'uni';

(2) ko e anga mo e fotunga 'o ha kole ke fakakau ha faito'o fo'ou 'i he lisi lesisita' pe ko ha kole ki ha laiseni 'i he Lao ni;

(3) ko hono faka'ata mei he ngaue 'o ha taha 'o he ngaahi tu'utu'uni 'o e Lao ni pe ngaahi tu'utu'uni"o ha ni'ihi pe ha ngaahi kalasi 'o ha ni'ihi 'o hange ko is 'e fakamahino'i'.

KONGA VIII - NGAAIH FOKOTU'UTU'U FAKATAIMI

Lisi lesisita fakataimi

36. (1) Kuo pau ke fa'u mo tauhi 'e he Komiti ha lisi faito'o lesisita fakataimi 'a is 'e makatu'unga 'i he Lisi 'o e Ngaahi Faito'o 'Aonga ma'ae Pule'anga' 'a is 'oku tauhi 'e he Fale Hui Vai mo Tauhi'anga Faito'o Tefito.

(2) 'E ngofua ke tanaki atu 'a e ngaahi faito'o fakaesino kuo ngaue'aki, kehe meiate kinautolu 'i he Lisi 'o e Ngaahi Faito'o 'Aonga ma'ae Pule'anga', ki he lisi lesisita fakataimi' ka kuo pau ke fakatatau 'a e ngaahi faito'o fakaesino ko ia'ki he ngaahi tu'unga 'oku fakaha 'i he kupu 7 'o e Lao ni.

(3) Kuo pau ke ngata 'a e lisi lesisita fakataimi' 'i hono fokotu'u 'o e lisi lesisita'.

TEPILE

(Kupu 7(e))

Ngaahi Fonua Na'e Ngaahi ai

'Aositelelia

Kanata

Fisi

Sueteni

Pilitania

'Amelika

Nu'u Sila

Na'e tali 'i he Fale Alea 'i he 'aho ni 11 'o Siulai, 2001.

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