This regulation establishes the principles, rules, and procedures for the registration of pharmaceutical products to ensure that all pharmaceuticals manufactured domestically, imported, or exported meet the required standards of quality, safety, and efficacy, and comply with applicable regional and international regulatory requirements for distribution in domestic and international markets.

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 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
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