means the addition of any substance to or subtraction of any constituent from a drug or device so as to affect its quality, composition or potency;

includes any representation by any means whatsoever, for the purpose of promoting directly or indirectly, the manufacture, sale or disposal of any drug or device;

means the store for dangerous drugs designated in the regulations made under this Act;

in relation to a form, procedure or other matter means approved by the Board, Minister or Commission, as applicable;

means the Fiji Medicinal Products Board established under Part 2;

means the civil service employee appointed to or acting in the position of Chief Pharmacist in the Ministry of Health;

means a systematic study on any medicine in human subjects including patients and volunteers in order to—

• (a)discover or verify the effects of, or identify any adverse reaction to the medicine that is being investigated; or
• (b)study the absorption, distribution, metabolism and excretion of the medicine with the objective of ascertaining the safety or efficacy of the medicine;

means a code of conduct issued by the Board;

means the Fijian Competition and Consumer Commission established under section 7 of the Fijian Competition and Consumer Commission Act 2010;

means a committee of the Board;

in relation to a medicine or a poison means a medicine or a poison prepared in accordance with a formula and being a combination of medicines or poisons compounded in such a way that one or more constituents cannot be readily separated from the other substance or substances and to compound and derivative expressions have corresponding meanings;

means the Comptroller of Customs and Excise;

includes limitation or restriction;

means entry in the appropriate register subject to conditions set by the Board;

means a substance listed in the regulations enacted under this Act;

means any international convention relating to the control in the manufacture of and traffic in drugs to which Fiji is or becomes a party;

means ship, motor vehicle, aircraft, train and any other means of transport by which goods may be brought into or taken from Fiji;

means a medicine in respect of which—

• (a)the label or presentation of the medicine;
• (b)any document or record relating to the medicine or its manufacture; or
• (c)any advertisement for the medicine,

  contains a false representation of any one of the following—

  • (i)identity or name of the medicine;
  • (ii)formulation, composition or design specification of the medicine or of any ingredient or component of it;
  • (iii)presence or absence of any ingredient or component of the medicine;
  • (iv)strength or size of the medicines, other than the size of any pack in which the medicine is contained;
  • (v)strength or size of any ingredient or component of the medicine; or
  • (vi)sponsor, source, manufacturer or place of manufacture of the medicine;

means a substance listed in the regulations enacted under this Act;

means a substance listed in the regulations enacted under this Act;

means a person for the time being registered under the Medical and Dental Practitioner Act 2010;

means a product consisting of an instrument, apparatus, appliance, material or other product, 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 although it may be assisted in its function by such means, but does not include a—

• (a)medicinal product; or
• (b)product declared not to be a device by the Minister by regulations enacted under this Act;

means an authorisation issued by a competent authority in a country from which a dangerous drug is exported—

• (a)containing—
  • (i)full particulars of the drug and the quantity authorised to be exported; and
  • (ii)the names and addresses of the exporter and the person to whom it is to be sent; and
• (b)stating the country to which and the period within which it is to be exported;

means the Council referred to in section 4 of the Medical and Dental Practitioner Act 2010;

means the period from 1 April to 31 March of the following year;

means the list in the regulations enacted under this Act;

means a substance or class of substance listed in the regulations enacted under this Act;

means the person for the time being holding the office of the Government Analyst and includes any additional Government Analyst, Deputy Government Analyst, Senior Assistant Government Analyst or Assistant Government Analyst;

means a substance listed in the regulations enacted under this Act;

means—

• (a)medical or dental services;
• (b)physiotherapy, psychology, podiatric, occupational therapy, acupuncture, chiropractic, chiropody or osteopathy services; or
• (c)any other service declared by the Minister, by notice in the Gazette, to be a health service for the purposes of this Act;

means a permit authorising a person to purchase, import or otherwise obtain and use medicines for the provision of health services;

means to bring or cause to be brought into Fiji by sea or air;

means an authorisation issued by a competent authority authorising the importation of a specified quantity of a dangerous drug—

• (a)containing—
  • (i)full particulars of the drug;
  • (ii)the name and address of the person authorised to import the drug; and
  • (iii)the name and address of the person from whom the drug is to be obtained; and
• (b)specifying the time within which the importation must be effected;

means a certificate issued by a competent authority in a country from which it is intended to import a dangerous drug;

means such conditions or circumstances as are likely to contaminate a product;

means taken or sent from any country and brought into Fiji by land, air or water, whether or not landed or trans-shipped in Fiji, for the sole purpose of being carried to another country either by the same conveyance or another conveyance;

includes any tag, brand, mark, pictorial or other descriptive matter, written, printed, stencilled, marked, embossed, impressed on or attached to a container of a drug or device;

includes the label and any written, printed or graphic matter relating to and accompanying the drug or device;

includes the process of refining, manipulating and mixing a medicine or poison, including a medicine or poison in a raw state, but does not include the process that is carried out by a pharmacist in the lawful practice of his or her profession in—

• (a)premises used for supply or sale by retail; or
• (b)a hospital pharmacy department in which the pharmacist manufactures preparations of medicines and poisons for supply or sale or distribution only from those premises or from such other premises as may be owned and operated by that pharmacist selling or supplying by retail;

means a person who manufactures medicine or poison;

means, in relation to a—

• (a)medicine, a licence granted, authorising the carrying out of manufacturing and selling or supplying of medicines, whether by wholesale or retail; or
• (b)poison, a licence granted, authorising the carrying out of manufacturing and selling or supplying of poisons, whether by wholesale or retail;

means a substance or product, not being an instrument, apparatus or appliance that is represented to achieve, or likely to achieve, its principal intended action by pharmacological, chemical, immunological or metabolic means in or on the body of a human or an animal and that is—

• (a)represented in any way to be, or that is, whether because of the way that it is presented or for any other reason, likely to be taken to be for—
  • (i)therapeutic use;
  • (ii)use as an ingredient or component in the manufacture of medicines;
  • (iii)use as a container or part of a container for medicines of a kind referred to in subparagraph (i) or (ii); or
• (b)included in a class of substances or products, the sole or principal use of which is or ordinarily is a—
  • (i)therapeutic use; or
  • (ii)use of a kind referred to in paragraph (a)(ii) or (iii) and includes substances and products declared to be medicinal products under this Act, but does not include—
    • (A)substances or products declared under this Act or regulations—
      • (i)not to be medicinal products; or
      • (ii)not to be medicinal products when used, advertised or presented for supply in a specified way if the substances or products are used, advertised or presented for supply in that way;
    • (B)food;
    • (C)any herbal drug or herbal medicine or a homoeopathic drug or homeopathic medicine; or
    • (D)prohibited substances;

means the Minister responsible for health;

means the Ministry of Health;

includes anything in which any drug or device is wholly or partly contained, placed or packed;

means the permanent secretary in the Ministry;

means a substance listed in the regulations enacted under this Act;

means premises in or from which a registered pharmacist supplies, compounds or dispenses medicines to the public and includes the portion of the premises where the pharmacist sells or offers to sell goods of any kind;

means a substance listed in the regulations enacted under this Act;

includes—

• (a)supplying, compounding or dispensing of medicines; and
• (b)advising and counselling on the effective and safe use of medicines;

means a substance listed in the regulations enacted under this Act;

means prescribed by this Act or by the regulations;

means a substance listed in the regulations enacted under this Act;

in relation to a clinical trial, means the person who is in charge of the conduct of the clinical trial;

in relation to a proprietary medicine, means information relating to the safe and effective use of the proprietary medicine, including information regarding the usefulness and limitations of the proprietary medicine;

includes medicinal products, devices, poisons, substances and preparations covered under a convention;

means a substance listed in the regulations enacted under this Act;

means a permit granted authorising a person to purchase, import or otherwise obtain and to possess and use a prohibited substance for industrial, educational, advisory or research purposes;

means a medicine other than a medicine or a class of medicine that is—

• (a)exempted by the regulations;
• (b)exempted under the Act; or
• (c)extemporaneously dispensed or prepared for a specific and individual case;

means the register established under the Act to register medicinal devices in respect of which a notification has been received on or before the appointed date published in the Gazette for the commencement of the registration of devices;

means the register established under the Act to register medicinal products in respect of which a notification has been received on or before the appointed date published in the Gazette for the commencement of the registration of medicinal products;

means the register established under the Act to register poisons in respect of which a notification has been received on or before the appointed date published in the Gazette for the commencement of the registration of poisons;

means the register established under the Act to register any other products in respect of which a notification has been received on or before the appointed date published in the Gazette for the commencement of the registration of any other products (referred to as a specified product);

means—

• (a)a documentary record;
• (b)a record made by an electronic, electromagnetic, photographic or optical process; or
• (c)any other kind of record;

means the register established under the Act to register devices;

means the register established under the Act to register medicinal products;

means the register established under the Act to register poisons;

means the register established under the Act to register any other product (referred to as a specified product);

means the Chief Pharmacist serving as the head of the Fiji Medicinal Products Board Secretariat;

means the Fiji Medicinal Products Board Secretariat established by Part 4;

means sell whether by—

• (a)wholesale or retail or otherwise, barter, exchange, deal in, agree to sell, offer or expose for sale, keep or have in possession for sale, send forward, deliver or receive for, or for the purpose of sale or in the course of sale; or
• (b)authorising, directing, allowing, causing, suffering, permitting or attempting any of the acts or things mentioned in paragraph (a) and “sale” and the derivatives of “sell” have corresponding meanings;

means—

• (a)a manufacturer, importer, wholesale dealer or other person who, in Fiji, is primarily responsible for placing a proprietary medicine on the market in Fiji; or
• (b)in respect of a proprietary medicine that is placed on the market in Fiji by two or more manufacturers, importers, wholesale dealers or other persons independently, includes each of those importers, wholesale dealers or other persons;

includes material, preparation, extract and admixture;

means—

• (a)supply, provide, give or deliver, whether or not for fee, reward or consideration or in expectation of fee, reward or consideration;
• (b)agree or offer for the purpose of supply as defined in paragraph (a), expose for the purpose of supply as so defined, keep or have in possession for the purpose of supply as so defined, send forward or receive for the purpose of supply as so defined; or
• (c)authorise, direct, cause, allow, suffer, permit or attempt to do any of the acts or things referred to in paragraphs (a) or (b) and derivatives of supply have corresponding meanings;

means use in or in connection with—

• (a)preventing, diagnosing, curing or alleviating a disease, ailment, defect or injury in humans or animals;
• (b)influencing, inhibiting or modifying a physiological process in humans or animals;
• (c)testing the susceptibility of humans or animals to a disease or ailment;
• (d)influencing, controlling or preventing conception in humans;
• (e)testing for pregnancy in humans; or
• (f)the replacement or modification of parts of the anatomy in persons or animals;

means a machine or mechanical device used or capable of being used for the purpose of supplying goods without the personal manipulation or attention of the seller or supplier or an employee or other agent of the seller or supplier at the time of the sale or supply;

means a person for the time being registered under the Veterinary Surgeons Act 1956;

means the certification scheme on the quality of pharmaceutical products moving in international commerce adopted by the World Health Organization and any amendments to that scheme; and

means sale or supply—

• (a)for the purpose of resale;
• (b)to a person for the purposes of supply by that person to another person; or
• (c)for the purposes of use in connection with a trade, business, profession or industry.