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: [email protected]
Forms
| # | 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 | |
| 2 | Checklist of Requirements for Drug Registration | Checklist of Requirements for Drug Registration | Ministry of Health | |
| 3 | Checklist of Requirements for Drug Re-registration | Checklist of Requirements for Drug Re-registration | Ministry of Health |
Measures
| # | 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 |
| 11 | Labelling Requirement - Import Cosmetics | An imported cosmetics need to be labelled in Lao or English language clearly. | TBT | 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 |
| 12 | Labelling Requirement - Imported Drug | Imported drug shall be labelled in specified contents | TBT | Ministry of Health | To provide information to consumer and inspector | Regulation Governing Drug Registration 1441/MOH | 9999-12-31 | Good |
| 13 | Requirement to register for import - Narcotic Drugs, Nerve Affecting Substances and Basic Chemical Substances | Before import Narcotic Drugs, Nerve Affecting Substances and Basic Chemical Substances, trader need to register narcotic drugs with Food and Drug Department, MOH | Registration Requirement | Ministry of Health | To monitor the distribution and the use of such drugs in order for the protection of human's health | Decision on the Management of Narcotic Drugs, Nerve Affecting Substances and Basic Chemical Substances no. 456/MOF, dated 19 April 2006 | 9999-12-31 | Good |
| 14 | Requirement to obtain import permit - Narcotic Drugs, Nerve Affecting Substances and Basic Chemical Substances | To import Narcotic Drugs, Nerve Affecting Substances and Basic Chemical Substances, it is necessary to obtain an import permit from Food and Drug Department, MOH. | Permit Requirement | Ministry of Health | For the protection of human's health | Decision on the Management of Narcotic Drugs, Nerve Affecting Substances and Basic Chemical Substances no. 456/MOF, dated 19 April 2006 | 9999-12-31 | Good |
| 15 | Labelling Requirement - Imported Narcotic Drugs, Nerve Affecting Substances and Basic Chemical Substances | Imported Narcotic Drugs, Nerve Affecting Substances and Basic Chemical Substances need to be labelled as specified by Food and Drug Department, MOH | TBT | Ministry of Health | For the protection of human's health | Decision on the Management of Narcotic Drugs, Nerve Affecting Substances and Basic Chemical Substances no. 456/MOF, dated 19 April 2006 | 9999-12-31 | Good |
| 16 | Storage Requirement - Narcotic Drugs, Nerve Affecting Substances and Basic Chemical Substances | The storage Narcotic Drugs, Nerve Affecting Substances and Basic Chemical Substances shall be complied with the certain condition of Food and Drug Department, MOH | TBT | Ministry of Health | To maintain the Narcotic Drugs, Nerve Affecting Substances and Basic Chemical Substances in good condition. | Decision on the Management of Narcotic Drugs, Nerve Affecting Substances and Basic Chemical Substances no. 456/MOF, dated 19 April 2006 | 9999-12-31 | Good |
| 17 | service fee - export certificate of traditional medicines | service fee charged on issuing export certificate of traditioncal medicines is 200,000 kip/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 |
Step-by-Step Guide
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