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
- Attachment
- Therapeutic Goods Act_11.07.2001.pdf
- 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
- 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.
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