Page 1 of 3

Administrative Documents

1. Does your health authority require documentation from the relevant drug regulatory authority certifying that the manufacturer is in compliance of the Good Manufacturing Practice (GMP) requirements of the country?

2. Does your health authority require the Certificate of Pharmaceutical Product (COPP)?

3. Does your health authority require the Free Sale Certificate (FSC) from the country of origin?

4. Does your health authority require Registration Certificate from other countries in which our products have been registered?

If yes, how many/which countries?

5. Does your health authority require PIC/S Compliance Certificate?

6. Does your health authority require the Manufacturing License?

7. Does your health authority require a Letter of Authorization?

8. Does your health authority require a Power of Attorney (POA)?

9. Does your health authority require an Agency/Manufacturing Agreement?

10. List the documents that will require legalization (authorized by your country’s embassy):

11. List the documents that will require notarization (authorized by our local Commerce Department):

12. Any other documents you require: