TONGA

Therapeutic Goods (Amendment) Act 2004
No. 7 of 2004.

I assent,
TAUFA'AHAU TUPOU IV,
23rd August, 2004.

AN ACT
TO AMEND THE THERAPEUTIC GOODS ACT

[27th July, 2004.]

BE IT ENACTED by the King and the Legislative Assembly of Tonga in the Legislature of the Kingdom as follows:

1. (1) This Act may be cited as the Therapeutic Goods (Amendment) Act 2004.

(2) The Therapeutic Goods Act 2001 is in this Act referred to as the Principal Act.

2. Section 7(a) of the Principal Act, in the Tongan version only, is amended by deleting "lelei ko e" and substituting it with " 'oku 'i ha tu'unga lelei ke tali".

3. Section 7(b) of the Principal Act, in the English version only, is amended by deleting "and" and substituting it with "an".

4. Section 8(2) of the Principal Act, in the English version only, is amended by deleting the first appearances of the subsection –

"(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."

5. Section 9 of the Principal Act, in the English version only, is amended by deleting "thee" and substituting it with "the".

6. Section 13(1) of the Principal Act, in the English version only, is amended by deleting the indentation of the final paragraph.

7. Section 14(1) of the Principal Act, in the English version only, is amended by deleting "set" and substituting it with "step".

8. Section 14(16) of the Principal Act, in the English version only, is amended by deleting the first appearance of "that" and substituting it with "than".

9. Section 15(1)(e) of the Principal Act, in the English version only, is amended by deleting "and" and substituting it with "an".

10. Section 16 of the Principal Act, in the Tongan version only, is amended by deleting the section and marginal note and substituting it as follows -

"Ngaahi faito'o fakaesino me'a'ofa

16. 'E ngofua ke hu mai ki he Pule'anga ni ha ngaahi koloa faito'o fakaesino kuo foaki ko ha me'a'ofa kapau-

(a) 'oku 'asi 'i he lisi 'o e Ngaahi Faito'o 'aonga ma'ae Pule'anga;

(b) 'oku 'i ai 'a e 'ilo 'oku 'i he tu'unga 'oku 'iloa 'oku 'i ha tu'unga telei;

(c) 'oku leipolo 'aki 'a e Hingoa Tau'ataina Fakavaha'apule'anga (INN) kehekehe;

(d) ko e faito'o ko 'eni, kapau 'oku 'omai 'i ha polokalama tatau pe toutou 'omai ki ha taha anga maheni, 'oku 'i he malohi tatau;

(e) 'oku nau a'usia 'a e ngaahi fietna'u 'a e Fale Hu'i Vai mo Tauhi'anga Faito'o Tefito;

(f) 'oku hanga 'e he Pule Hu'i Vai 'o fakaikAki kakato mo fakangofua 'a e ngaahi me'a'ofa fakaangaanga kimu'a hono fakafolau 'a e me'a'ofa mei he taulanga 'oku 'omai mei ai; pea

(g) 'oku ha ai ha 'aho "ngata hono ngaue'aki" pe " 'osi hono 'aonga" pea 'oku 'i ai ha 'aonga fe'unga ke kei ngaue'aki hili 'a e 'aho 'oku 'amanaki 'e tau mai ai ki he Pule'anga ni."

11. The Principal Act, in the Tongan version only, is amended by deleting "PART V - SPECIAL IMPORT CONTROLS FOR NARCOTIC DRUGS AND PSYCHOTROPIC SUBSTANCES" and substituting it as follows -

"KONGA V - KO HONO PULE'I MAKEHE 'O E HU MAI 'O E NGAAHI FAITO'O KONA MO E NGAAHI ME'A KONA FAKA'ATAMAI".

12. Section 17 of the Principal Act, in the Tongan version only, is amended by deleting the section and marginal note and substituting it as follows -

"Mafai ke hu mai 'a e mgaahi faito'o kona mo e ngaahi me'a kona faka 'atamai

17. (1) 'E ngofua ki he Minista kehe hu mai 'a e ngaahi faito'o kona kotoa pe, 'oku ha 'i he lisi pule'i fakavaha'a pule'anga 'a ia 'oku ha 'i he tatau fakamuimuitaha 'o e "Fakalahi ki he ngaahi foomu sitetisitika ("Lisi Engeenga") (Annex to the statistical forms ("Yellow List")) pea mo e ngaahi me'a kona fakae'atamai 'a ia 'oku ha 'i he tatau fakamuimuitaha 'o e "Fakalahi 'oku ha 'i he lipooti sitetisitika ("List Lanumata") (Annex to the Annual statistical Report ("Green List")) 'oku teuteu 'i 'e he Poate Fakavaha'ule'anga ki hono Pule'i 'o e Ngaahi Faito'o Kona 'o e Ngaahi Pule'anga Fakatahataha.

(2) Ko e mafai 'o e Minisita 'i he kupu si'i (1) 'oku malava ke 'oatu ki he Pule Hu'i Vai."

13. Section 21(1) of the Principal Act, in the English version only, is amended by deleting the indentation of the final paragraph.

14. Section 21(1)(a) of the Principal Act, in the English version only, is amended by deleting "singed" and substituting it with "signed".

15. Section 23(1) of the Principal Act, in the English version only, is amended by deleting "Tonga" and substituting it with "Tongan".

16. Section 23(4) of the Principal Act, in the English version only, is amended by deleting "and" and substituting it with "an".

17. Section 25(2) of the Principal Act, in the English version only, is amended by deleting "warrnt" and substituting it with "warrant".

18. Section 25(4) of the Principal Act, in the English version only, is amended by deleting "their" and substituting it with "there".

19. Section 29(3) of the Principal Act, in the English version only, is amended by deleting the second appearance of "and" and substituting it with "an".

20. Section 31 of the Principal Act, in the English version only, is amended by deleting the second appearance of "and" and substituting it with "an".

21. Section 32 of the Principal Act, in the English version only, is amended by deleting "fro" and substituting it with "for".

Passed by the Legislative Assembly this 27th day of July, 2004.

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