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Food Safety

ASEAN Consultative
Committee on Standards and Quality (ACCSQ)

AFTA (ASEAN Free Trade
Area)

Thai Food and Drug Administration


Food Safety

ACCSQ
2 2547


1.Product Working Group on Traditional Medicines and
Health Supplement (PWG TMHS)
2. Medical Devices and Equipment

Thai Food and Drug Administration


Food Safety

PWG TMHS

Thai Food and Drug Administration


Food Safety

ACCSQ PWG TMHS







Thai Food and Drug Administration


Food Safety

2547- ( TMHS)
6 (
, , ,,

7 2550

Thai Food and Drug Administration


Food Safety

TMHS-PWG
Health Supplement

Thai Food and Drug Administration


Food Safety


1.

31
..2549 (..2006)
2.
31
..2552 (..2009)

Thai Food and Drug Administration


Food Safety

()
3.
ASEAN Model
31 ..2549(..2006)

4.
31 ..2550(..2007)

Thai Food and Drug Administration


Food Safety



Infrastructure

- common set
-

-

- (claims)

Thai Food and Drug Administration
Food Safety


7
1.
2.
( Marketing Authorization including Product Placement
Requirements& licensing system
3.
4.
5.
6.

7.
Thai Food and Drug Administration
Food Safety


1.
Health Supplement
ACCSQ TMHS PWG
Any product that is used to supplement a diet and to maintain,
enhance and improve the healthy function of human body and contains one
or more , or combination of the following ; (a.) vitamins, minerals, amino
acids, fatty acids, enzymes, probiotics and other bioactive substances, (b.)
substances derived from natural source, including animals, minerals and
botanical materials in the forms of extract, isolates, concentrates,
metabolites Synthetic sources of ingredients mentioned in (a) and (b) may
only used when the safety of these have been proven. It is presented in
dosage forms in small unit doses such as capsules, tablets, powder, liquid
and shall not include any sterile preparations. (inject able , eye drops)
Thai Food and Drug Administration
Food Safety

()
2.
( Marketing Authorization including Product Placement Requirements&
licensing system)
2.2.1
(screening of document)
(Notification)
2.2.2
( Pre-
marketing Assessment : Quality & Safety )
(Listing)

Thai Food and Drug Administration


Food Safety

()

2.2.3

( Pre- marketing evaluation : Quality & Safety &
Efficacy )
(registration)

Thai Food and Drug Administration


Food Safety

()
3.
3.1
3.1.1

3.1.2
3.1.3
3.1.4
3.1.5
3.1.6

Thai Food and Drug Administration


Food Safety

()
3. 2
3.2.1
GMP workshop for ASEAN TMHS
2007
3.2.2



ASEAN
Scientific Committee

Thai Food and Drug Administration


Food Safety

()
4.
2
9 HS

9

Thai Food and Drug Administration


Food Safety

()
5.

ASAEN
Scientific Committee scientific risk
assessment

Thai Food and Drug Administration


Food Safety

()
6.






focal point

Thai Food and Drug Administration


Food Safety

()
7.

Thai Food and Drug Administration


Food Safety


ASEAN Harmonization on Healthcare Product


1.

2.
3.
Thai Food and Drug Administration
Food Safety



1.

2.
3.

4.



Thai Food and Drug Administration

http://www.fda.moph.go.th

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