Certificate of Registration to Import Traditional Medicine Product

Search formalities Certificate of Registration to Import Traditional Medicine Product

General information
Name of formality	Certificate of Registration to Import Traditional Medicine Product
Type of formality	Other
Date of last modification	08.12.2020
Responsible Authorities	Food and Drugs Department
LSIC	Q - Human health and social work activities
Who should complete this business formality?	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.
Qualifications needed by the business to get the formality	All procedures must in accordance with the regulations of the Ministry of Health
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.

LEGAL FRAMEWORK
Name	Number	Date	Comment
Law on Drugs and Medical Products (Amended)	07/NA	21.12.2011	Article 13, 15
Presidential Ordinance on Fees and Service Fees	003/PO	26.12.2012	Chapter IX, Article 45-47, Pages 89-92

REQUIRED DOCUMENTS FORMALITIES - First time
Name	Type	Comment
Checklist of Requirements for the Registration of Import Traditional Medicine Product in Lao PDR (Form 1)	Confirmative act	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)	Confirmative act

REQUIRED DOCUMENTS FORMALITIES - First time

Name

Comment

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)

REQUIRED DOCUMENTS FORMALITIES - Renew
Name	Type	Comment
Checklist of Requirements for the Re-Registration of Import Traditional Medicine Product (Form 3)	Confirmative act	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)

REQUIRED DOCUMENTS FORMALITIES - Renew

Name

Comment

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)

Mean of presentation
Means of presentation	At the Authority Offices
Address of authority	Food and Drugs Department, Ministry of Public Health
Processing Time (Day(s))	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.

RENEWAL INFORMATION
Does the formality have a validity or an expiration date?	YES
How long will the formality be valid for? (in months)	36
What is the process and conditions to get the formality?
What is the process and conditions to renew the formality?	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.

ISSUING FEES
Has application fees?	Service fees	Certificate fees	Application fees	Total fees
YES	100000.00	600000.00	5000.00	705000.00
Comments	Ordinance on Fees and Service Charges, No. 003/PO, Dated 26.12.2012 (Chapter IX, Article 45-47, Pages 89-92)

RENEWAL FEES
Has renewal fees?	Service fees	Certificate fees	Renewal fees	Total renewal fees
YES	100000.00	600000.00	5000.00	705000.00
Comments	Ordinance on Fees and Service Charges, No. 003/PO, Dated 26.12.2012 (Chapter IX, Article 45-47, Pages 89-92)

REQUIRED DOCUMENTS
Document Name	Comment
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)
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)

STATISTICS (Issue or/and renewed number)
Year	Issued	Renewed
2016	12	35
2017	14	42
2018	12	40
2019	12	38
2020	12	35

LAO VERSION

Inventory of Business Licenses

Certificate of Registration to Import Traditional Medicine Product

Partners