Registration and Import of Drugs, Cosmetics and Traditional Medicines

Procedure for medication registration and application

Before importing medicines to treat diseases in Lao PDR, importers must first obtain a certificate from the Ministry of Health as states in the Decision on the Management of Narcotic Drugs, Nerve Affecting Substances and Basic Chemical Substances no. 456/MOF, dated 19 April 2006.

Procedure 1

Entrepreneurs can purchase a certificate with the Department of Food and Drug, Ministry of Health. Click for reviewing application forms. Click for checking relevant documents which need to be submitted. Click for requiring documents which need to extend the drug registration.

Procedure 2

The submission of an import plan must be accompanied by some supporting documents. Document details may vary by product type. For further clarification, you can consult with the Department of Food and Drug, Ministry of Health.

Procedure 3

The Ministry of Health will request importers in order to provide a sample of the product for testing. The import sample application can download here for your reference.

Procedure 4

After the import plan is approved by the Ministry of Health, a registration certificate will be issued along with a number of conditions that the importer must comply with each time the importation is made. The certificate of registration is valid for one term. For each import, the importer must apply for an import license from the Ministry of Health.

Procedure 5

Applicant for registration or license. For registrations valid for two years, after two years the register must apply for extended license.

For more information: Department of Food and Drug, Ministry of Health

Thatkhao Village, Simuang Road, Vientiane Capital, Lao PDR

Phone: + (856-21) 214013

Fax: + (856-21) 214015

Website: www.fdd.gov.la

Email: info@fdd.gov.la

Forms

Showing 1 to 3 of 3 entries

#	Title	Description	Issued By	File
1	Request for importation of drug samples for registration in Lao PDR.	Request Request for importation of drug samples for registration in Lao PDR.Drug Sample	Ministry of Health	PDF
2	Checklist of Requirements for Drug Registration	Checklist of Requirements for Drug Registration	Ministry of Health	PDF
3	Checklist of Requirements for Drug Re-registration	Checklist of Requirements for Drug Re-registration	Ministry of Health	PDF

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Measures

Showing 1 to 10 of 17 entries

#	Name	Description	Measure Type	Agency	Comments	Legal Document	Validity To	Measure Class
1	Requirement to register drugs and medical products before importation	The import of modern and traditional medicines must be registered by the department of food and drug, ministry of public health.	Registration Requirement	Ministry of Health	to easy the management and inspection process and be able to control from the production to the distribution process to ensure the safety, efficiency, and quality of the treatment.	Regulation Governing Drug Registration 1441/MOH	9999-12-31	Good
2	Requirement to register cosmetics for import	To import specially controlled cosmetics, it is necessary to register with Department of Food and Drug, Ministry of Health.	Registration Requirement	Ministry of Health	To ensure the quality and safety of product to consumer	Provision on the Quality Control of Cosmetic Products No. 2580/MOH	9999-12-31	Good
3	Requirement to register Importer of Food	The importer of food to be consumed by humans under the responsibility of the ministry of health must be registered with the Department of Food and Drug, Ministry of Health	Registration Requirement	Ministry of Health	To control, monitor,inspect food business, to ensure the safety of consumers and to avoid falsification by others	Decision on Food Inspection No. 297/MOH	9999-12-31	Good
4	Registration Fee for Imported International Medicines	fees charged on the import of international medicines are as followings: + fees: - new medicines 3,000,000 kip/5 years/item - old medicines 2,000,000 kip/5 years/item + service charges: research and consideration oif the registration of medicines is 100,000 kip/item	Duty/Tax Payable	Ministry of Health	For administrative revenue collection of state	The President of Lao PDR’s Decree on Fee and Service Charge, No. 002/POL, date 17 June 2021	9999-12-31	Good
5	Registration Fee for Imported Medical Equipment	registration fees for imported medical equipments are as followings: + fees: - medical equipment A with low risk (voluntary) is 500.000 kip/year/time/item - medical equipmetn B with low to medium risk is 1.200.000 kip/year/time/item - medical equipment C with medium to high risk is 1.600.000 kip/year/time/item - medical equipment D with high risk is 2.000.000 kip/year/time/item + service charges: research and consideration for the registration of medical equipment is 100.000 kip/item	Duty/Tax Payable	Ministry of Health	for state revenue purpose	The President of Lao PDR’s Decree on Fee and Service Charge, No. 002/POL, date 17 June 2021	9999-12-31	Good
6	Registration Fee for Imported Traditional Medicines	registration fees of imported traditional medicines: + charges: - newly developed medicines 2,500,000 kip/5years/time/item - old traditional medicines (ancient heritage recipe) 1,500,000 kip/5year/time/item + service fee: research and consider the registration of traditional medicines is 100,000 kip/item	Duty/Tax Payable	Ministry of Health	For administrative revenue collection of state	The President of Lao PDR’s Decree on Fee and Service Charge, No. 002/POL, date 17 June 2021	9999-12-31	Good
7	charge fee for the import license of traditional medicine	charge fee for the import license of traditional medicine is 20,000/time	Duty/Tax Payable	Ministry of Health	For administrative revenue collection of state	The President of Lao PDR’s Decree on Fee and Service Charge, No. 002/POL, date 17 June 2021	9999-12-31	Good
8	registration fee - imported cosmetics	registration fees of imported cosmetics: - charge fee is 200,000 kip/2 years/item - service fees on the research and consideration is 50,000 kip/item	Duty/Tax Payable	Ministry of Health	For technical management and to support expenditure of state budget	The President of Lao PDR’s Decree on Fee and Service Charge, No. 002/POL, date 17 June 2021	9999-12-31	Good
9	Site Inspection Fee for imported medical products (site inspection)	Fee to inspect imported medical equipment (site inspection) of 50,000/time	Duty/Tax Payable	Ministry of Health	For technical management and to support expenditure of state budget	The President of Lao PDR’s Decree on Fee and Service Charge, No. 002/POL, date 17 June 2021	9999-12-31	Good
10	Inspection Fee for Imported medical equiptments (Documents scrutiny)	- service fee charged on the document inspection for the import of medical equipment at the department of import and export or the provincial department of health is 20,000 kip/invoice/time - service fee charged on the document inspection for the import of medical equipment including attaching import barcode, 1 barcode equals 1 time at the border is 20,000 kip/invoce/time	Duty/Tax Payable	Ministry of Health	For technical management and to support expenditure of state budget	The President of Lao PDR’s Decree on Fee and Service Charge, No. 002/POL, date 17 June 2021	9999-12-31	Good

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Step-by-Step Guide

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#	Process name	Process short name	Activity
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