You are using an outdated browser and your browsing experience will not be optimal. Please update to the latest version of Microsoft Edge, Google Chrome or Mozilla Firefox. Install Microsoft Edge

December 28, 2017

Laos: Requirements for Businesses Importing and Exporting Medicines and Medical Products/Devices

Subscribe to Updates

The Ministry of Health in Laos has issued a Decision on the Establishment of Businesses for the Import and Export of Medicine and Medical Products No. 1820/MoH dated August 25, 2017 (the Decision), to provide information on setting up and conducting businesses related to the import and export, distribution, wholesale, and manufacture of medicines and medical products/devices.

The Decision aims to address issues that the Law on Medicine and Medical Products No.07/NA dated December 21, 2011, failed to address, and it also stipulates the requirements necessary to establish a medicine or medical products company, and subsequent requirements needed for the company when it starts to conduct its activities.

Scope of Activities Addressed by the Decision

In Laos, laws alone often do not provide complete information on the criteria necessary to set up or conduct a business. This is also the case for the Law on Medicine and Medical Products, which provides broad principles on the management of medicine and medical products/devices in terms of registration, standard requirements, advertisements of these products, and general prohibitions for operators during their business operations.

Therefore, the Decision perpetuates the long-standing Lao practice of using regulations to complete the law and provide details on the steps and requirements necessary to register and conduct contemplated activities in Laos.

The Decision provides requirements for the establishment and operations of businesses contemplating import and export of medicine and medical products/devices, and distribution and domestic wholesale activities for these products. Provisions in the Decision also cover factories involved in the manufacturing of medicines and medical products/devices, as well as requirements for places to be used to store goods and the minimum maintenance and warehousing standards and requirements for such goods.

Requirements to Establish a Legal Entity

The Decision clarifies that both local and foreign business investors can obtain a license to conduct businesses related to the import and export, distribution, wholesale, and manufacture of medicines and medical products/devices. This clarification, however, still sets out a number of general restrictions on foreign investors.

The Decision sets out that an applicant for business registration should have at least one pharmacist who has received appropriate education in Laos or abroad, and who has been approved by the Ministry of Health to conduct such activity. Pharmacists who are employed by companies that import and export medicine and medical products should have at least five years of experience, while branches or wholesale companies require either a pharmacist, or a pharmacist assistant, who has at least four years of experience.

A company registration applicant should not currently be under investigation or charges, or subjected to sanctions related to the sale of drugs or narcotics. Furthermore, applicants must have good physical and mental health. The Law on Medicine and Medical Products further requires: (1) good ethics for medicine and business; (2) personnel with knowledge and capabilities; (3) measures relating to safety and environmental practices; and (4) appropriate premises, necessary facilities, and standardized warehouses and transport vehicles.

It is important to note that both the Law on Medicine and Medical Products and the Decision do not directly address registered capital, and they leave specific issues or requirements to other laws and regulations to address. Minimum registered capital requirements are thus addressed in the Decision of the Ministry of Industry and Commerce on Wholesale and Retail Businesses No. 1005/MOIC dated May 22, 2015, which states that the Lao regulatory framework allows a foreign investor to wholly own an import-export, distribution, or wholesale-related activity, with the registered capital requirements for the activities dependent on the share ratio that a foreign investor holds in the company, as follows:

  • A company with foreign ownership of 50% or less has registered capital requirements of LAK 4 billion (approximately USD 480,000) to LAK 10 billion (approximately USD 1.2 million).
  • A company with foreign ownership of 70% or less has registered capital requirements of LAK 10 billion to LAK 20 billion (approximately USD 2.4 million).
  • A company with foreign ownership of 100% has registered capital requirements of LAK 20 billion or more.

The Decision also seeks to regulate the organizational structure of a company, as it imposes bodies or departments that are not mandatory for companies per se. Accordingly, a company must have an internal organization chart that includes at least a director and a board of directors (which therefore implies that a director, and second director or a deputy director, may be necessary), along with the following departments: (1) financial accounting; (2) warehouse accounting; (3) pharmacy; (4) technical committee; and (5) other departments, as required.

Registration Process

The Decision provides a list of documents that must be submitted for a new application to be considered by relevant authorities, and also for a renewal application for a granted license.

The registration of businesses related to the import and export, distribution, wholesale, and manufacture of medicines and medical products/devices is divided into two steps. First, approval must be obtained from the Ministry of Industry and Commerce or its related departments, which are in charge of general business registration. Once approval is obtained, the application is passed to the health sector in the vicinity where the business will be established, either at the city, provincial, or Capital Health Office level. The application is then passed to the Department of Food and Drugs for their opinion, before it is submitted to the Minister of Health, who will issue an operating license.

According to the Decision, once the application has reached the health sector stage, consideration of the dossier should take no more than 90 days. In case of a license renewal, the Food and Drug Department will be responsible for approving the renewal. Once issued, an operating license is valid for a period of two years, and subsequent renewals must be undertaken three months before its expiry date.

Post-Establishment Requirements

The Decision also provides other requirements that need to be fulfilled after a legal entity is established, which range from the storage of documents on the company’s premises, to setting up systems to ensure the safety of medicine and medical products/devices which will be handled by the business operators. Accordingly, such operators should retain the following documents on their company premises:

  • Standards for Operation Procedure in relation to tasks which are to be performed by the company, branch, and agent;
  • All relevant laws, regulations, and notifications in respect of drugs and medical products;
  • Guidelines on the utilization of drugs;
  • Monitoring booklets that substantiate the inspections of drugs and medical products performed by government inspectors;
  • Records of the medicine and medical products/devices that have undergone the registration process/notification and that have already been approved by the relevant authorities;
  • A list of the names of suppliers, along with their address, responsible contact person, and contracts detailing the business relationship with the operator;
  • Monitoring list for medicine and products in the company/branch, such as: (1) products purchased; (2) products distributed; (3) actual outstanding stock with expiration date; (4) their lot numbers; and (5) the source of supply;
  • Adverse drug reaction report forms;
  • Copies of bills/invoices related to purchased imported and exported goods of the company/branch. Such bills/invoices must provide information required under laws/regulations on medicine and medical products/devices. These documents must be maintained for at least five years;
  • Copies of the complete documents pertaining to the import, export, and transportation of medicine and medical products. These documents must be maintained at the companies and its branches for at least five years;
  • A report, which must be produced every six months, detailing the activities of the company, and a list that tracks the importation and distribution of products; and
  • A list of drugs that require special management, such as narcotic and psychotropic drugs, and other lists, as required.

In addition to documentation requirements, certain obligations may also be imposed on specific operators, depending on their activities and responsibilities.

Companies that import or export medicine and medical products/devices must have a system to track the quality of their product, monitor the effects of medicine, or provide alerts on the safety of a particular type of medicine (i.e., pharmacovigilance) that falls under the responsibility of the distributor. Moreover, companies have the responsibility to retain or recall products that are the subject of safety and quality concerns that have occurred after their distribution.

Additional requirements may be imposed in accordance with specific activities to be performed by a company. For instance, companies that also modify the bundle or container of medicine or medical products /devices must have a storage place and equipment that are specifically designed, and certified by relevant authorities, for the performance of such actions.

Warehousing and Maintenance

The Decision sets out minimum standards for warehouses where import-export companies store their medicine or medical products/devices.

An import-export warehouse must have the necessary equipment and adequate methods to maintain the storage facility, which must be included in their Good Wholesaling Practice. Likewise, good storage practices may also be required from the facility operator. If narcotic and psychotropic drugs are to be stored, these must be stored in an area that differs from the storage places used for other medicine or medical products/devices. A cold storage facility should have a temperature that ranges from two to eight degrees Celsius, and must have a thermometer or other device to ensure that medicine stays at the appropriate temperature.

If vaccines or biological products are to be stored, the management and distribution standards of these products, the warehouse used to store them, and the vehicles used to transport them must meet requisite regional and international standards.

In the event that regulations require product packaging to be changed, the company must have proper equipment and packaging procedures, which are approved by relevant authorities to ensure they are of good quality.

Distributors and wholesalers will also have specific requirements in regard to warehouses where medicine and medical products are stored, which will differ slightly from storage facilities used by import-export companies in regard to the size of the storage unit, the criteria for determining good storage practice, and the transportation requirements for such products.

Conclusion

The Decision was not only enacted to fill the void and address issues that the Law on Medicine and Medical Products did not address, but it also reiterates the commitment of Lao authorities to implement and impose standards that meet regional and international requirements, which are also reflected in broader legislative changes related to consumer protection being implemented in Laos, including a May 2017 decision on the management of packaged products.

The strong intention of Laos to meet regional standards for the transit of goods, including medicine and medical products, coupled with its geographically strategic location between many ASEAN countries and China, could help the country emerge as a key transportation hub in the region in the near future.

Related Professionals

Industries

Life Sciences

Practices

Corporate/M&A

Regulatory Affairs

Location

RELATED INSIGHTS​ 

September 28, 2026
On September 15, 2026, the Thai Food and Drug Administration (Thai FDA) opened a public consultation period on the principles of a proposed Ministry of Public Health (MOPH) notification establishing specific Good Manufacturing Practice (GMP) requirements for foods derived from cultured animal cells. The proposal would build on Thailand’s existing safety assessment framework by proposing GMP requirements specifically tailored to the production of cultivated meat. As cultivated meat advances toward commercial production, its unique manufacturing processes present food safety challenges involving aseptic conditions, starting cell quality, culture media, and specialized equipment. Thailand’s Food Act B.E. 2522 (1979) provides the legal basis for regulating food manufacturing, but no GMP requirements specifically tailored to cultivated meat have been issued under it. The proposed framework aims to address this gap. The Thai FDA has not yet released a complete draft notification, so the proposed requirements outlined below may change before adoption. However, they indicate the direction the regulator intends to take, and companies preparing to enter the Thai market can use them now to anticipate their compliance obligations. What Is Cultivated Meat? Cultivated meat, also known as cell-based food or cell-cultured meat (and referred to in the proposed notification as food derived from cultured animal cells), is produced by cultivating animal cells rather than raising and slaughtering animals through conventional meat production. The process generally begins with the selection of animal cells or stem cells, which are cultivated in an appropriate culture medium within a bioreactor to promote cell growth and proliferation. Scaffolding materials or other techniques may subsequently be used to develop cells into tissue or other forms suitable for consumption. Unlike conventional meat production, this process introduces specific food safety considerations relating to starting cells, culture media, production substances, contamination controls, and potential residues in the final product. Thailand’s Safety
Read More
September 9, 2026
On August 5, 2026, the Consumer Case Division of Thailand’s Civil Court rendered a judgment in a case involving a beauty clinic that advertised acne scar treatments using claims that the clinic was operated by a specialist physician and that the treatment, allegedly involving stem cell technology, could permanently remove acne scars. The plaintiff brought a claim against both the physician-owner and the clinic company, alleging that the advertisements were false and induced her to purchase the treatment. The court found that the clinic was liable for the false representations and that the physician-owner, as both the authorized director of the company and the medical practitioner who provided treatment, was jointly responsible. Although the plaintiff could not fully prove all damages claimed, the court awarded compensation of THB 20,000, together with interest. While the judgment arose from a consumer protection dispute, it serves as a valuable reminder that medical facility advertisements in Thailand are regulated and may expose clinics and healthcare providers not only to regulatory enforcement but also to civil liability from patients who rely on misleading promotional claims. Regulatory Framework Governing Medical Facility Advertisements Medical facility advertising in Thailand is governed by the Medical Facility Act B.E. 2541 (1998), as amended by the Medical Facility Act (No. 4) B.E. 2559 (2016). The principal secondary legislation is the Department of Health Service Support (DoHSS) Notification Re: Rules, Procedures, Conditions, and Fees for an Advertisement or Publication Concerning a Medical Facility, which came into force on November 25, 2019. Under this notification, “advertising” includes any act, by any means, that causes members of the public to see, hear, or otherwise become aware of a message, sound, or image for the commercial benefit of a medical facility. This broad definition covers not only traditional media but also clinic websites, social
Read More
September 9, 2026
On June 30, 2026, Indonesia’s National Agency of Drug and Food Control (BPOM) issued BPOM Regulation No. 11 of 2026 on Food Packaging, which expands the list of approved food-contact substances and recognizes a broader range of permissible functions for those substances. The new regulation, which revokes BPOM Regulation No. 20 of 2019, reflects developments in packaging technology and materials science. Although the new regulation provides more advantages to business actors by adding more food contact substances to the approved list for use in food packaging, there are more stringent rules and restrictions for testing. One of the most significant changes is a comprehensive migration-testing framework that sets out requirements for packaging materials, testing conditions, food simulants, and specific migration limits. Overall and Specific Migration Under BPOM Regulation No. 20 of 2019, migration requirements were primarily set out within the lists of approved food-contact substances and packaging materials. BPOM Regulation No. 11 of 2026 instead expressly requires packaging materials that come into direct contact with food to meet both overall and specific migration limits. These are defined as follows: Overall migration: The total quantity of all substances that migrate from the packaging, regardless of whether the substances are hazardous or nonhazardous to health. Specific migration: The quantity of a particular identified substance known to be hazardous to health that migrates from the packaging. Stricter Limits on Heavy Metals The overall migration limit for plastic packaging remains unchanged under both regulations at 60 mg/kg or 10 mg/dm². However, the new regulation introduces significant changes to the regulation of heavy metals. Under the 2019 regulation, four heavy metals—lead, cadmium, chromium VI, and mercury—were subject to a single combined limit of 1 mg/kg. The 2026 regulation, however, requires each heavy metal to meet its own individual specific migration limit, adds arsenic as
Read More
September 7, 2026
Indonesia’s Constitutional Court (Mahkamah Konstitusi) has reinstated a key provision limiting pharmaceutical patent protection, signaling a renewed commitment to balancing patent rights with public access to medicines. In its ruling to Case No. 255/PUU-XXIII/2025, the court partially granted a petition for judicial review of Law No. 65 of 2024, which had amended the country’s Patent Law, and ordered the restoration of a provision that had excluded certain pharmaceutical inventions from patentability. The decision took effect immediately upon its pronouncement at the court’s plenary session on August 28, 2026. Background The petition challenged the removal of article 4(f) from Law No. 13 of 2016 concerning Patents (Patent Law), as amended by Law No. 65 of 2024. Article 4(f) had excluded from patentability certain inventions relating to new uses of known substances. The petitioners argued that removing this provision would open the door to patent protection for second medical use inventions and facilitate patent evergreening—practices that can extend exclusivity periods, delay generic market entry, and reduce public access to affordable medicines. The petitioners included several patient advocacy and public-interest organizations: the Indonesian Dialysis Patients Community Association, the Indonesian Association of Drug Abuse Victims (PKNI), the Indonesian Pulmonary Hypertension Foundation (YHPI), the Rekat Peduli Indonesia Foundation, and the Indonesian Positive Women’s Association (IPPI), along with the Indonesia for Global Justice Association and four individual petitioners. The petitioners also challenged the constitutionality of the phrase “interested party” in article 70(1) of the Patent Law, arguing that it should be construed expressly to clarify who has standing to appeal a decision to grant a patent before the Board of Patent Appeal, and to allow a broader range of parties—such as patent holders, licensees, consumer organizations, prosecutors, aggrieved third parties, and others who may suffer direct or indirect harm from the grant of a patent—to
Read More