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Certificate of Registration to Import Traditional Medicine Product
进口传统药品注册证明
ໃບຢັ້ງຢືນການຂຶ້ນທະບຽນຜະລິດຕະພັນຢາພື້ນເມືອງນຳເຂົ້າ
Applicants that are eligible to register the traditional medicine are factories, import-export companies that operate the business in traditional medicine, which are properly licensed by the health sector. Apply at Food and Drugs Department.
Who needs this
Applicants that are eligible to register the traditional medicine are factories, import-export companies that operate the business in traditional medicine, which are properly licensed by the health sector.
Requirements
- All procedures must in accordance with the regulations of the Ministry of Health
Documents — first application
| Document | Note |
|---|---|
| Checklist of Requirements for the Registration of Import Traditional Medicine Product in Lao PDR (Form 1) | For Imported Products, all official document must be in English 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) |
| Application for Traditional Medicine Registration (Form 2) |
Documents — renewal
| Document | Note |
|---|---|
| Checklist of Requirements for the Re-Registration of Import Traditional Medicine Product (Form 3) | all official documents must be submitted in English Part 1: ADMINISTATIVE DATA 1 Letter of Application 2 FDD Application Form No. 3 3 Letter of Authorization or Application Nomination Agreement between the manufacturer & trader/distributor/exporter - Letter of authorization of product owner - Letter of appointment of contract manufacturer and/ or repacked - Letter of acceptance as 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) 4 Unit Dose and Batch Formulation Part II TECHNICAL DATA QUALITY 5 Technical Specification of ALL Raw Materials a/ From the supplier of the Active Raw Material (if applicable) b/ From the Manufacturer of the finished product c/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 Analaysis of Finish Product (From the same batch or lot of the representative sample submitted) 8 Stability Studies b/ Real time-at least 12 month data, minium of 2 batches at 30°C ± 2°C/75% RH ± 5% RH c/ For products intended to be stored in a refrigerator - Real time-at leaset 12 month data, minium of 2 batches 5°C ± 3°C 9 Labeling Materials a/ Facsimile labels with actual color text (3 copies) b/ Package Insert Lao language/English (3 copies) 10 Representative Sample in market or commercial presentation (at least 1 year before expiry) |
Legal framework
- Law on Drugs and Medical Products (Amended)
- Presidential Ordinance on Fees and Service Fees
How to submit
- Means of presentation
- At the Authority Offices
- Address of authority
- Food and Drugs Department, Ministry of Public Health
- Processing time
- 180 Each time the applicant has to submit Form 1 first, which will take 3 months to consider. After Form 1 has been considered, the applicant then will be able to submit Form 2 which will take 6 months to consider.
Validity and renewal
- Has an expiry date
- YES
- Validity
- 36 months
- Renewal process
- Certificate of registration for Traditional Medicine is valid for 3 years; 3 months prior to the expiry date, the applicant must apply for the renewal in accordance with the documents required by Food and Drug Department.
Additional comment
Authorized individuals and organizations must comply with the obligations of the licensing agency to contribute to the maintenance and restoration of the ecosystem.