Therapeutic Goods Act

Notifying member
Tonga
Title
Therapeutic Goods Act
First published
11/07/2001
First EIF
01/07/2010
Latest published
In force to
Latest notification
G/LIC/N/3/TON/2
Product categories
List of products subject to licensing
Nature of licensing

Non-automatic

Administrative purpose/measure being implemented
  • Protect human, animal or plant life and health; protect environment
Administrative body(ies) for submission of applications
Ministry of Health and Pharmaceutical Department
Drug Regulatory Authority, Pharmaceutical Department, Baron Road, Vaiola Motu'a, Nuku'alofa
http://www.health.gov.to/
(+676) 24553/7400200

tongadrugregulatory@gmail.com

Contact point for information on eligibility

Same as the "Administrative bodies"

Expected duration of licensing procedure
Ongoing
Found by secretariat
No
Related document symbols
  • G/LIC/N/2/TON/7
Source
Notes
  • Therapeutic Goods Act 2020 revised edition


    Section 10, 11 and 12 - importation;

    Part III, Section 5(2) - products;

    Part IV, Section 11(1)(3) - application, eligibility;

    Part IV, Section 12(3) - granting approval, admin organ;

    Part VII, Section 35 - making or regulations


  • G/LIC/N/2/TON/7

    Therapeutic Goods Act Cap 12.16

    Registered List:


    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.


    This Act is to establish a system of regulation of therapeutic goods, to establish a national drugs and medical supplies committee, to regulate the import of quality, safety, efficacy, affordability, availability and use of registered therapeutic goods, including narcotic drugs and psychotropic substances and for ancillary purposes.