ຖານຂໍ້ມູນດ້ານລະບຽບການຂໍອະນຸຍາດດຳເນີນທຸລະກິດ

 ສຳລັບຜະລິດຕະພັນນຳເຂົ້າ, ຕ້ອງປະກອບເອກະສານທັງໝົດເປັນພາສາອັງກິດ

Part 1: ADMINISTRATIVE DATA

1. Letter of Application

2. FDD Application Form No. 2

3. Letter of Authorization or Application Nomination Agreement between the manufacturer & trader/distributor/exporter
- Letter of authorization of product owner
- Letter of appointment of a contract manufacturer and/ or  repacked
- Letter of acceptance as a contract manufacturer and/ or  repacked
- Certificate of Pharmaceutical Product (CPP): Original Certificate of Pharmaceutical Product from the country of manufacture (Issued at least 1 years from the date the application for registration was filed)
- Certificate of Product Registration (Valid original Certificate of Product Registration)
 
For countries not issuing CPP, the following may be accepted:
- Government Certificate Licence  of the Manufacturer or GMP Certificate
 - Certificate of Free Sale from the country of origin
For Products not freely sold in the country of origin: 
- Original CPP from a country where the product is freely sold shall be submitted
- Free Sale Certificate (CFS) (From the country of the origin issued by the Health   regulatory authority of the manufacturing country or exporting country)

4. Unit Dose and Batch Formulation

Part 2: TECHNICAL DATA
QUALITY

5. Technical Specification of ALL Raw Materials
- From the supplier of the Active Raw Material (if applicable)
- From the Manufacturer of the finished product
- Certification of Authenticity of Plant Specimen from the authorized government agency in the country of origin

6. Technical Specifications of Finished Product

7. Certificate of Analysis of Finish Product(From the same batch or a lot of the representative sample submitted)

8. Stability Studies
- Accelerated-at least 6 months data, minium of 2 batches at 40°C ± 2°C/75% RH ± 5% RH
- Real time-at least 12 month data, minium of 2 batches at 30°C ± 2°C/75% RH ± 5% RH
- For products intended to be stored in a refrigerator:  1. Accelerated-at least 6-month data, minium of 2 batches, 25°C ± 2°C/60% RH ± 5% RH, and 2. Real time-at least 12-month data, minium of 2 batches 5°C ± 3°C.

SAFETY AND EFFICACY/CLAIM SUBSTANTIATION

9. Evidence of Safety and Efficacy
- Claim: (Referring to the efficacy of  raw and finished product Requirement)
- No-Adverse-Effect Level/Dose and Toxidrome
- Pharmacologic Effects in Animal both in Vivo and in Vitro Studies
- Non-Mutagenicity-including Ames Test and Micronucleus Test
- Subchronic Chronic Toxicity Test
-  Phase I Clinical Trial (for galenical products)
- Phases I, II, III Clinical Trial (For products in pharmaceutical dosage form)

10. Labeling Materials
- Facsimile labels with actual color text(3 copies)
- Package Insert Lao language/English

11. Representative Sample in the market or commercial presentation (at least 1 year before expiry) 

 ເອກະສານທັງໝົດຕ້ອງປະກອບເປັນພາສາອັງກິດ