This Law establishes the principles, regulations, and measures governing the management, monitoring, and inspection of medicines and medical products to ensure their effective and efficient regulation. It aims to ensure that medicines and medical products meet established standards, are of assured quality, safe, effective, and affordable, thereby protecting public health, improving the well-being of all citizens, supporting regional and international integration, and contributing to national protection and development.

Measures / Standards
# Name Type Agency Description Law Valid To Apply To
1 Requirement to register or Notification Prior drugs and medical products before importation Registration Requirement Ministry of Health The importation of medicines requires registration or prior notification with the Ministry of Health. Information on the product name, ingredients, manufacturer, dosage form, strength, packaging, origin, and other relevant details shall be provided to ensure the quality, efficacy, and safety of the medicines.
  1. Decision on business establishment on medicines and medical equipment (Revised Version) no.1820/MoH, dated 25 August 2017.
  2. Law on Drugs and Medical Products (Amendment) No.07/NA, Dated 10 March 2026
  3. Decision on the Registration of Pharmaceutical Products No. 0622/MOH; dated 02 April 2025
 9999-12-31 ALL
2 Requirement to obtain Import Permit - Drug Licensing Requirement Ministry of Health An import permit from the Ministry of Health is required to import any drugs
  1. Regulation Governing Drug Registration 1441/MOH
  2. Law on Drugs and Medical Products (Amendment) No.07/NA, Dated 10 March 2026
 9999-12-31 ALL
3 Labelling Requirement - Imported Drug TBT Ministry of Health Imported drug shall be labelled in specified contents Imported medicines shall be labeled according to the specified content and must be printed in Lao and/or foreign languages ​​authorized by the Ministry of Health to provide information to consumers and monitoring inspectors.
  1. Law on Drugs and Medical Products (Amendment) No.07/NA, Dated 10 March 2026
  2. Decision on the Registration of Pharmaceutical Products No. 0622/MOH; dated 02 April 2025
 9999-12-31 ALL
4 Inspection requirement for exporting Drug Inspection Requirement Ministry of Health Export drugs must be inspected by the public health officers at checkpoint borders. Law on Drugs and Medical Products (Amendment) No.07/NA, Dated 10 March 2026 9999-12-31 ALL
5 Registration requirement for the import of medical products Registration Requirement Ministry of Health the import of medical products and health supplement products must be registered with the department of food and drug, ministry of health.
  1. Decision on business establishment on medicines and medical equipment (Revised Version) no.1820/MoH, dated 25 August 2017.
  2. Decision on the registration and verification of medical devices, No. 1470/MOH, dated 11 July 2023.
  3. Law on Drugs and Medical Products (Amendment) No.07/NA, Dated 10 March 2026
 9999-12-31 ALL
6 Certificate requirement for the import of medicines TBT Ministry of Health Imported medicines must obtain a quality analysis certificate from the National Food and Drug Administration or from an approved domestic or foreign laboratory recognized by the Ministry of Health.
  1. Notification on the Documents to Request for Import License of Raw Materials, Container Equipment, Drug, and Medical Equipment for Production and Contribution No. 2660/16.FDD, dated 16 June 2016
  2. Law on Drugs and Medical Products (Amendment) No.07/NA, Dated 10 March 2026
 9999-12-31 ALL
7 Import permit for the import of medical products Permit Requirement Ministry of Health the import of medical products must be permitted by the department of food and drug, ministry of health
  1. Notification on the Documents to Request for Import License of Raw Materials, Container Equipment, Drug, and Medical Equipment for Production and Contribution No. 2660/16.FDD, dated 16 June 2016
  2. Law on Drugs and Medical Products (Amendment) No.07/NA, Dated 10 March 2026
 9999-12-31 ALL
8 A quality analysis certificate is required for imported medical products. TBT Ministry of Health Imported medical product must obtain a quality analysis certificate from the National Food and Drug Administration or from an approved domestic or foreign laboratory recognized by the Ministry of Health.
  1. Notification on the Documents to Request for Import License of Raw Materials, Container Equipment, Drug, and Medical Equipment for Production and Contribution No. 2660/16.FDD, dated 16 June 2016
  2. Law on Drugs and Medical Products (Amendment) No.07/NA, Dated 10 March 2026
 9999-12-31 ALL
9 Inspection requirement for imported medical products Inspection Requirement Ministry of Health the import of medical products must be inspected by the health officers at checkpoint borders
  1. Decision on business establishment on medicines and medical equipment (Revised Version) no.1820/MoH, dated 25 August 2017.
  2. Law on Drugs and Medical Products (Amendment) No.07/NA, Dated 10 March 2026
 9999-12-31 ALL
10 A requirement for registered importers of drug Registration Requirement Ministry of Health the importers of drug must be registered with the department of food and drug, MOH
  1. Decision on business establishment on medicines and medical equipment (Revised Version) no.1820/MoH, dated 25 August 2017.
  2. Law on Drugs and Medical Products (Amendment) No.07/NA, Dated 10 March 2026
 9999-12-31 ALL
11 Register requirement for drug exporters Registration Requirement Ministry of Health Drug exporters must be registered with the food and drug department, MOH
  1. Decision on business establishment on medicines and medical equipment (Revised Version) no.1820/MoH, dated 25 August 2017.
  2. Law on Drugs and Medical Products (Amendment) No.07/NA, Dated 10 March 2026
 9999-12-31 ALL
12 Inspection requirement for the export of medical products Inspection Requirement Ministry of Health the export of medical products must be inspected by the health officers at checkpoint borders
  1. Decision on business establishment on medicines and medical equipment (Revised Version) no.1820/MoH, dated 25 August 2017.
  2. Law on Drugs and Medical Products (Amendment) No.07/NA, Dated 10 March 2026
 9999-12-31 ALL
13 Registration Requirement for Importing Companies of Medical Products Registration Requirement Ministry of Health Importing Companies of Medical Products must be registered with the department of food and drug, MOH.
  1. Decision on business establishment on medicines and medical equipment (Revised Version) no.1820/MoH, dated 25 August 2017.
  2. Law on Drugs and Medical Products (Amendment) No.07/NA, Dated 10 March 2026
 9999-12-31 ALL
14 Registration or Notification Requirements for Drug Exports Registration Requirement Ministry of Health Legal entities and organizations exporting medicines must register or notify the relevant authorities by providing product details, including the medicine name, ingredients, dosage form, strength, packaging, source, and other relevant information. This is to ensure proper management, legal compliance, product quality, efficacy, and consumer safety. Law on Drugs and Medical Products (Amendment) No.07/NA, Dated 10 March 2026 (not set) ALL
15 Requirement for Registration of Medical Product Exporters Registration Requirement Ministry of Health Exporters of medical products are required to register with the Ministry of Health for regulatory management, monitoring, and inspection purposes. Law on Drugs and Medical Products (Amendment) No.07/NA, Dated 10 March 2026 (not set) ALL
16 Requirement for Registration or Notification of Medical Product Exports Registration Requirement Ministry of Health Legal entities or organizations exporting medical products are required to register or notify the relevant authorities of the medical products by providing details such as the product name, ingredients or manufacturer’s formula, dosage form, strength, packaging unit, international code, and source of the medical products. This is to ensure that business operations are conducted properly and in compliance with established legislation, as well as regional and international standards, while also ensuring product quality and consumer safety.
  1. Decision on the registration and verification of medical devices, No. 1470/MOH, dated 11 July 2023.
  2. Law on Drugs and Medical Products (Amendment) No.07/NA, Dated 10 March 2026
 (not set) ALL
17 Medicines intended for export must be properly labeled. TBT Ministry of Health Exported medicines must be labeled in Lao and/or other languages approved by the Ministry of Health to provide information for consumers and inspectors. Law on Drugs and Medical Products (Amendment) No.07/NA, Dated 10 March 2026 (not set) ALL
18 Imported medical products must be properly labeled. TBT Ministry of Health Imported medical products must be labeled in Lao and/or other languages approved by the Ministry of Health to provide information for consumers and inspectors. Law on Drugs and Medical Products (Amendment) No.07/NA, Dated 10 March 2026 (not set) ALL
19 Exported medical products must be properly labeled. TBT Ministry of Health Exported medical products must be labeled in Lao and/or other languages approved by the Ministry of Health to provide information for consumers and inspectors. Law on Drugs and Medical Products (Amendment) No.07/NA, Dated 10 March 2026 (not set) ALL
20 An export license is required for medicines. Permit Requirement Ministry of Health Exporting medicines requires approval from the Ministry of Health. Law on Drugs and Medical Products (Amendment) No.07/NA, Dated 10 March 2026 (not set) ALL
21 Export License Requirement for Medical Products Permit Requirement Ministry of Health Exporting Medical Products requires approval from the Ministry of Health. Law on Drugs and Medical Products (Amendment) No.07/NA, Dated 10 March 2026 (not set) ALL
22 Import License Required - Cosmetic Products Permit Requirement Ministry of Health The importation of cosmetic products requires approval from the capital and provincial health departments in accordance with the applicable regulations.
  1. Decision on the Controlling Cosmetic Products (Amendment), No. 1626/MOH, dated 21 July 2023.
  2. Law on Drugs and Medical Products (Amendment) No.07/NA, Dated 10 March 2026
 (not set) ALL
23 Export License Required - Cosmetic Products Permit Requirement Ministry of Health The export of cosmetic products must be approved by the Department of Health of the capital or province in accordance with the applicable regulations
  1. Decision on the Controlling Cosmetic Products (Amendment), No. 1626/MOH, dated 21 July 2023.
  2. Law on Drugs and Medical Products (Amendment) No.07/NA, Dated 10 March 2026
 (not set) ALL
24 Quality Analysis Certificate Requirement for Exported Drugs TBT Ministry of Health Exported medicines must obtain a quality analysis certificate from an approved laboratory recognized by the Ministry of Health. Law on Drugs and Medical Products (Amendment) No.07/NA, Dated 10 March 2026 (not set) ALL
25 Quality Analysis Certificate Requirement for Exported Medical Products TBT Ministry of Health Exported medical products must obtain a quality test certificate from the National Food and Drug Administration or an approved laboratory recognized by the Ministry of Health. Law on Drugs and Medical Products (Amendment) No.07/NA, Dated 10 March 2026 (not set) ALL
26 Storage Requirements for Imported Drugs TBT Ministry of Health Medicines must be stored in suitable facilities with adequate space and equipment in compliance with good storage practices. Law on Drugs and Medical Products (Amendment) No.07/NA, Dated 10 March 2026 (not set) ALL
27 Requires storage - imported medical products TBT Ministry of Health Medical products must be stored in suitable facilities with adequate space and equipment in compliance with good storage practices. Law on Drugs and Medical Products (Amendment) No.07/NA, Dated 10 March 2026 (not set) ALL
28 Require transportation - imported drugs TBT Ministry of Health Medicines must be transported safely and in proper condition, following good transportation practices and accompanied by all required transport and packaging documents. Law on Drugs and Medical Products (Amendment) No.07/NA, Dated 10 March 2026 (not set) ALL
29 Require transportation - imported medical products TBT Ministry of Health medical products must be transported safely and in proper condition, following good transportation practices and accompanied by all required transport and packaging documents. Law on Drugs and Medical Products (Amendment) No.07/NA, Dated 10 March 2026 (not set) ALL
30 Drug pricing. General Ministry of Health Drug pricing must follow regulated market mechanisms supervised by the health sector and relevant government agencies to ensure medicines and medical products are available at reasonable prices for everyone Law on Drugs and Medical Products (Amendment) No.07/NA, Dated 10 March 2026 (not set) ALL
31 Medical Product Pricing General Ministry of Health Medical product pricing must follow regulated market mechanisms supervised by the health sector and relevant government agencies to ensure reasonable prices and public access to medicines and medical products. Law on Drugs and Medical Products (Amendment) No.07/NA, Dated 10 March 2026 (not set) ALL
Have you found this information useful ?
Please share your feedback below and help us improve our content.
You can provide comment/feedback on draft legislation to relevant government agencies for improvement before entering into force.

Business areas
 
Can provide specific information about such legislation that poses obstacles or challenges to your business operations.

Example: Article 8 of the (Draft) Agreement on the Import of Fuel and Lubricants, No.........../OK, Date........... March 2025. (300 words)

What is the impact of this legislation on your business?

Example: I spent at least two months going through the annual import plan (Master List) of government departments that I found to be too complex, costly, or time-consuming. (300 words)

Any suggestions for improving the legislation that could help address your challenges?

Example: The requirements for the time frame for approval/approval of the Master List plan should be summarized. (300 words)

Have you previously presented this recommendation to any government agency?
Contact information
Do you want us to make your comments public?