CHECKLIST OF DOCUMENT NEW REGISTRATION

TRADITIONAL MEDICINE AND HEALTH SUPPLEMENT

No. ADMINISTRATION OF DOCUMENTATION INFORMATION

1. Certificate of Free Sale Legalized Embassy Issued by the government or an

agency approved by the
government

2. GMP ( Good manufacturing Practise ) Issued by the government or an

agency approved by the
government

3. Letter Of Appoinment from Manufacturer to Importir There is infomartion Exp .Date

5 years after issued

TEHNICAL OF DOCUMENTATION

4. Data of complete formula with the function of each raw Units are in the form of mg / gr
material

5. Data of complete formula perbatch

6. Method Of Manufacture With Flow chart and batch

record

7. Product code / Batch Accompanied with the meaning of the

code

8. Packaging Specification

9. COA Raw Materials From supplier

10. COA Finished Product Equipped with the test method

11. Protocol Stability 2 batch room temperature 30°C

Methods And Results of Stability Test / 75% RH and Accelerated 40°C /
75% RH

12. Origin Acquisition Of Capsules, Gelatin CoA, BSE Free

Certificate, Halal Certificate And A Statement From The
Company's Stamp