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| Procedure of Generic Drugs Registration |
The procedure of generic drugs registration is divided into 2 main steps:
Step 1: Application for the permission to import or manufacture drug sample intended to be registered.
The following documents are required:
1) Application form to be completely filled by authorized licensee
2) Drug formula [ active ingredients(s) only ]
3) Drug literature
4) Drug labeling and packaging
Step 2: Application for the approval of granted credential certificate
The following documents are required:
1) Application form to be completely filled by authorized licensee
2) Permit to manufacture or import drug sample
3) Drug sample
4) Pharmacological and toxicological study (if any)
5) Clinical trials, safety and efficacy study (if any)
6) Complete drug formula
7) Drug literature
8) Labeling and packaging should consist of name of the drug, registration number, quantity of
drug per packaging, formula which shows active ingredient (s) and quantity of strength, lot no.
batch control number, name of manufacturer and address, manufacturing date, the words
" dangerous drug"/ "specially controlled"/ "for external use"/ "for topical use" written in Thai and in
red color if the drug is considered to be of them, the word "household remedy drug" written in Thai if the drug
is considered to be, the word "for veterinary use" written in Thai if the drug
is considered to be, and the expire date
9) Certificate of Free sale (in case of imported drug)
10) Manufacturing method
11) In-process control with the relevant acceptable limits
12) Raw material specifications of active(s) and inert ingredients with the corresponding control
methods in details
13) Finished product specification with the corresponding control methods in details
14) Certificate of analysis of active ingredient (s) (raw material) [ To be required in case of that active
substance dose not conform to official pharmacopoeias (USP, NF, BP,……ect)
15) Drug analytical control method
16) packaging
17) Storage condition
18) Stability studies of finished product
19) Certificate of GMP ( in case of imported drug )
Note: Certificate of Free Sale should be issued/legalized by the competent authorized officer and endorsed by Thai Embassy / Thai consular Office residing in correlation to the country where the documents being issued.
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