Licence for a pharmaceutical or medical product business, and product registration in Laos: statutory documents, competent authority and legal basis

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Who can apply

Both Lao citizens and foreigners may apply; the documents differ.

Competent authority: The government administers drugs and medical products centrally through the Ministry of Health (Art. 99) at three levels: the ministry, the capital and provincial health departments (Art. 101) and the district health offices (Art. 102), with a food and drug management committee alongside. For the licence, register the enterprise with the industry and commerce sector first and then apply to the public health sector on the ministry form (Art. 83); product registration goes through the online system to the Food and Drug Department (Agreement, Arts. 10 and 34), and cosmetics import, export and transit go to the capital or provincial health department (Arts. 49 and 50)

At a glance

Statutory document list

Business licence for manufacturing

• The enterprise registration certificate obtained first from the industry and commerce sector under the Enterprise Law (Arts. 83 and 84.1) (required)
• The application on the form the Ministry of Health prescribes, filed with the public health sector (Art. 83) (required)
• The supporting documents that go with the application. The law does not list them: Art. 83 leaves the list to the form the ministry prescribes, so collect the current form from the Food and Drug Department or your provincial health department first (required)
• Proof of a pharmacist or a graduate in a pharmacy or related discipline with knowledge and experience of drugs and medical products (Art. 84.2), who must also meet the five personal conditions in Art. 79 (required)
• Evidence of the area, premises, capital, equipment, tools and facilities, which must be necessary and reasonable (Art. 84.3) (required)
• Assessment against good manufacturing, wholesale, retail, storage and laboratory practice, designed and developed to the ministry handbook (Art. 84.4) (required)
• The safety and environmental protection measures (Art. 84.5) (required)
• Proof of never having been sentenced to imprisonment by a court for an intentional offence involving drugs, narcotics or medical products (Art. 84.6) (required)
• Whatever further conditions attach to the particular kind of business (Art. 84.7); the law stops there and does not enumerate them (optional)

Business licence for compounding

• The enterprise registration certificate obtained first from the industry and commerce sector under the Enterprise Law (Arts. 83 and 84.1) (required)
• The application on the form the Ministry of Health prescribes, filed with the public health sector (Art. 83) (required)
• The supporting documents that go with the application. The law does not list them: Art. 83 leaves the list to the form the ministry prescribes, so collect the current form from the Food and Drug Department or your provincial health department first (required)
• Proof of a pharmacist or a graduate in a pharmacy or related discipline with knowledge and experience of drugs and medical products (Art. 84.2), who must also meet the five personal conditions in Art. 79 (required)
• Evidence of the area, premises, capital, equipment, tools and facilities, which must be necessary and reasonable (Art. 84.3) (required)
• Assessment against good manufacturing, wholesale, retail, storage and laboratory practice, designed and developed to the ministry handbook (Art. 84.4) (required)
• The safety and environmental protection measures (Art. 84.5) (required)
• Proof of never having been sentenced to imprisonment by a court for an intentional offence involving drugs, narcotics or medical products (Art. 84.6) (required)
• Whatever further conditions attach to the particular kind of business (Art. 84.7); the law stops there and does not enumerate them (optional)

Business licence for import and export

• The enterprise registration certificate obtained first from the industry and commerce sector under the Enterprise Law (Arts. 83 and 84.1) (required)
• The application on the form the Ministry of Health prescribes, filed with the public health sector (Art. 83) (required)
• The supporting documents that go with the application. The law does not list them: Art. 83 leaves the list to the form the ministry prescribes, so collect the current form from the Food and Drug Department or your provincial health department first (required)
• Proof of a pharmacist or a graduate in a pharmacy or related discipline with knowledge and experience of drugs and medical products (Art. 84.2), who must also meet the five personal conditions in Art. 79 (required)
• Evidence of the area, premises, capital, equipment, tools and facilities, which must be necessary and reasonable (Art. 84.3) (required)
• Assessment against good manufacturing, wholesale, retail, storage and laboratory practice, designed and developed to the ministry handbook (Art. 84.4) (required)
• The safety and environmental protection measures (Art. 84.5) (required)
• Proof of never having been sentenced to imprisonment by a court for an intentional offence involving drugs, narcotics or medical products (Art. 84.6) (required)
• Whatever further conditions attach to the particular kind of business (Art. 84.7); the law stops there and does not enumerate them (optional)

Business licence for selling, wholesale and retail

• The enterprise registration certificate obtained first from the industry and commerce sector under the Enterprise Law (Arts. 83 and 84.1) (required)
• The application on the form the Ministry of Health prescribes, filed with the public health sector (Art. 83) (required)
• The supporting documents that go with the application. The law does not list them: Art. 83 leaves the list to the form the ministry prescribes, so collect the current form from the Food and Drug Department or your provincial health department first (required)
• Proof of a pharmacist or a graduate in a pharmacy or related discipline with knowledge and experience of drugs and medical products (Art. 84.2), who must also meet the five personal conditions in Art. 79 (required)
• Evidence of the area, premises, capital, equipment, tools and facilities, which must be necessary and reasonable (Art. 84.3) (required)
• Assessment against good manufacturing, wholesale, retail, storage and laboratory practice, designed and developed to the ministry handbook (Art. 84.4) (required)
• The safety and environmental protection measures (Art. 84.5) (required)
• Proof of never having been sentenced to imprisonment by a court for an intentional offence involving drugs, narcotics or medical products (Art. 84.6) (required)
• Whatever further conditions attach to the particular kind of business (Art. 84.7); the law stops there and does not enumerate them (optional)

Business licence for testing and laboratory work

• The enterprise registration certificate obtained first from the industry and commerce sector under the Enterprise Law (Arts. 83 and 84.1) (required)
• The application on the form the Ministry of Health prescribes, filed with the public health sector (Art. 83) (required)
• The supporting documents that go with the application. The law does not list them: Art. 83 leaves the list to the form the ministry prescribes, so collect the current form from the Food and Drug Department or your provincial health department first (required)
• Proof of a pharmacist or a graduate in a pharmacy or related discipline with knowledge and experience of drugs and medical products (Art. 84.2), who must also meet the five personal conditions in Art. 79 (required)
• Evidence of the area, premises, capital, equipment, tools and facilities, which must be necessary and reasonable (Art. 84.3) (required)
• Assessment against good manufacturing, wholesale, retail, storage and laboratory practice, designed and developed to the ministry handbook (Art. 84.4) (required)
• The safety and environmental protection measures (Art. 84.5) (required)
• Proof of never having been sentenced to imprisonment by a court for an intentional offence involving drugs, narcotics or medical products (Art. 84.6) (required)
• Whatever further conditions attach to the particular kind of business (Art. 84.7); the law stops there and does not enumerate them (optional)

Business licence for storage

• The enterprise registration certificate obtained first from the industry and commerce sector under the Enterprise Law (Arts. 83 and 84.1) (required)
• The application on the form the Ministry of Health prescribes, filed with the public health sector (Art. 83) (required)
• The supporting documents that go with the application. The law does not list them: Art. 83 leaves the list to the form the ministry prescribes, so collect the current form from the Food and Drug Department or your provincial health department first (required)
• Proof of a pharmacist or a graduate in a pharmacy or related discipline with knowledge and experience of drugs and medical products (Art. 84.2), who must also meet the five personal conditions in Art. 79 (required)
• Evidence of the area, premises, capital, equipment, tools and facilities, which must be necessary and reasonable (Art. 84.3) (required)
• Assessment against good manufacturing, wholesale, retail, storage and laboratory practice, designed and developed to the ministry handbook (Art. 84.4) (required)
• The safety and environmental protection measures (Art. 84.5) (required)
• Proof of never having been sentenced to imprisonment by a court for an intentional offence involving drugs, narcotics or medical products (Art. 84.6) (required)
• Whatever further conditions attach to the particular kind of business (Art. 84.7); the law stops there and does not enumerate them (optional)

Product registration for a new drug, generic drug or medical device

• For a new drug, the four-part dossier per the guideline; for a generic, the two parts of general information and quality (Agreement on Drug Registration, 2 April 2025, Art. 10.1 and 10.2) (required)
• The Lao-language label and package insert, complete as prescribed (Art. 10.3) (required)
• The patient information leaflet, if there is one (Art. 10.4) (optional)
• Clear colour photographs of the product, inner packaging, outer packaging and carton, showing every face that carries information (Art. 10.5) (required)

Renewing a product registration, five-year validity, ninety working days before expiry

• If nothing about the product has changed since registration, fill in the online system and await the department decision through it (Art. 18.1) (required)
• If the product has changed, fill in the information and submit the supporting documents for the change through the online system (Art. 18.2) (optional)

Transit approval, moving goods through Laos to a third country

• Proof of acting as the representative of a foreign company in Laos (Art. 50.1) (required)
• The export permit from the country of origin (Art. 50.2) (required)
• The import permit of the destination country, or a notice of receipt (Art. 50.3) (required)
• The shipping and packing documents (Art. 50.4) (required)
• Any other related documents (Art. 50.5), which the receiving checkpoint and health authority determine (optional)

Advertising approval for content, form and venue

• The proposed content, form and venue, filed first with the public health sector and then with the other relevant sectors (Art. 59); the law lists no documents and Art. 60 leaves the detail to separate regulations (required)

Statutory requirements

Common issues

• Do not conflate the two gates: the licence is about whether your company may trade, the registration is about whether one particular medicine may be sold in Laos, and Art. 53 requires every medicine and medical product made, imported, exported or distributed to be registered on its own
• Do not follow the 2012 price list — Art. 60 of the 2021 decree No. 002/PPT expressly replaced it, though copies still circulate online and among agents

The full list has 6 items; work through them in the guided form — Open the guided form

Legal basis (Lao Official Gazette texts)

Frequently asked questions

Who can apply for a Licence for a pharmaceutical or medical product business, and product registration in Laos?

Both Lao citizens and foreigners may apply; the documents differ. Competent authority: The government administers drugs and medical products centrally through the Ministry of Health (Art. 99) at three levels: the ministry, the capital and provincial health departments (Art. 101) and the district health offices (Art. 102), with a food and drug management committee alongside. For the licence, register the enterprise with the industry and commerce sector first and then apply to the public health sector on the ministry form (Art. 83); product registration goes through the online system to the Food and Drug Department (Agreement, Arts. 10 and 34), and cosmetics import, export and transit go to the capital or provincial health department (Arts. 49 and 50).

What documents are required for a Licence for a pharmaceutical or medical product business, and product registration in Laos?

17 statutory items: The enterprise registration certificate obtained first from the industry and commerce sector under the Enterprise Law (Arts. 83 and 84.1); The application on the form the Ministry of Health prescribes, filed with the public health sector (Art. 83); The supporting documents that go with the application. The law does not list them: Art. 83 leaves the list to the form the ministry prescribes, so collect the current form from the Food and Drug Department or your provincial health department first; Proof of a pharmacist or a graduate in a pharmacy or related discipline with knowledge and experience of drugs and medical products (Art. 84.2), who must also meet the five personal conditions in Art. 79; Evidence of the area, premises, capital, equipment, tools and facilities, which must be necessary and reasonable (Art. 84.3); Assessment against good manufacturing, wholesale, retail, storage and laboratory practice, designed and developed to the ministry handbook (Art. 84.4); The safety and environmental protection measures (Art. 84.5); Proof of never having been sentenced to imprisonment by a court for an intentional offence involving drugs, narcotics or medical products (Art. 84.6); For a new drug, the four-part dossier per the guideline; for a generic, the two parts of general information and quality (Agreement on Drug Registration, 2 April 2025, Art. 10.1 and 10.2); The Lao-language label and package insert, complete as prescribed (Art. 10.3); Clear colour photographs of the product, inner packaging, outer packaging and carton, showing every face that carries information (Art. 10.5); If nothing about the product has changed since registration, fill in the online system and await the department decision through it (Art. 18.1); Proof of acting as the representative of a foreign company in Laos (Art. 50.1); The export permit from the country of origin (Art. 50.2); The import permit of the destination country, or a notice of receipt (Art. 50.3); The shipping and packing documents (Art. 50.4); The proposed content, form and venue, filed first with the public health sector and then with the other relevant sectors (Art. 59); the law lists no documents and Art. 60 leaves the detail to separate regulations. Competent authority: The government administers drugs and medical products centrally through the Ministry of Health (Art. 99) at three levels: the ministry, the capital and provincial health departments (Art. 101) and the district health offices (Art. 102), with a food and drug management committee alongside. For the licence, register the enterprise with the industry and commerce sector first and then apply to the public health sector on the ministry form (Art. 83); product registration goes through the online system to the Food and Drug Department (Agreement, Arts. 10 and 34), and cosmetics import, export and transit go to the capital or provincial health department (Arts. 49 and 50).

What is the legal basis for a Licence for a pharmaceutical or medical product business, and product registration in Laos?

Based on Law on Drugs and Medical Products (Amended) Article 49; Law on Drugs and Medical Products (Amended) Article 50; Law on Drugs and Medical Products (Amended) Article 51; Law on Drugs and Medical Products (Amended) Article 53; Law on Drugs and Medical Products (Amended) Article 59; Law on Drugs and Medical Products (Amended) Article 60; Law on Drugs and Medical Products (Amended) Article 79; Law on Drugs and Medical Products (Amended) Article 82; Law on Drugs and Medical Products (Amended) Article 83; Law on Drugs and Medical Products (Amended) Article 84; Law on Drugs and Medical Products (Amended) Article 85; Law on Drugs and Medical Products (Amended) Article 86; Law on Drugs and Medical Products (Amended) Article 87; Law on Drugs and Medical Products (Amended) Article 99; Law on Drugs and Medical Products (Amended) Article 101; Law on Drugs and Medical Products (Amended) Article 102; Law on Drugs and Medical Products (Amended) Article 114; Agreement on Drug Registration Article ມາດຕາ 10; Agreement on Drug Registration Article ມາດຕາ 11; Agreement on Drug Registration Article ມາດຕາ 14; Agreement on Drug Registration Article ມາດຕາ 16; Agreement on Drug Registration Article ມາດຕາ 17; Agreement on Drug Registration Article ມາດຕາ 18; Agreement on Drug Registration Article ມາດຕາ 21; Agreement on Drug Registration Article ມາດຕາ 34; Decree of the President of the Lao People's Democratic Republic on Fees and Service Charges (No. 002/PP) Article 35. The full texts are available in the LaoPaniti law library, sourced from the Lao Official Gazette.

Are there time limits or hard requirements for a Licence for a pharmaceutical or medical product business, and product registration in Laos?

The licence and product registration are two different things: the licence says the business may operate, registration says a particular product may be sold. Art. 53 requires every drug and medical product to be registered, with the steps set out in the Agreement on Drug Registration of 2 April 2025. The ministry must decide within fifteen days of receiving a complete and correct application with its attachments, and must give written reasons within the same period if it refuses (Art. 85). The clock starts when the file is complete, so a request for more documents restarts it. There is no single validity period: Art. 85 says it depends on the kind of business and may be renewed under the relevant regulations, so read the expiry date printed on your own licence. Three grounds for suspension (Art. 86): the operator asks for it; the business does not match what was licensed; or a breach causing non-serious harm, where suspension follows only if a warning is not acted on. Two grounds for revocation (Art. 87): ignoring a suspension order, or a breach causing serious harm. The health authority must then notify the industry and commerce sector within five working days, so it reaches your enterprise registration too. For the three classes of specially controlled drugs (Arts. 17 to 20) there are two continuing duties beyond this licence: filing a requirement plan (Art. 21) and reporting quantities produced, imported, exported and sold (Art. 22). Current fees (Presidential Ordinance No. 002 on Fees and Service Charges of 17 June 2021, Art. 35): a manufacturer registration certificate is 1,000,000 kip per two years, an import-export company the same with 600,000 for a branch, wholesale outlets 500,000 and 200,000 by grade, retail outlets 100,000; device registration per five years is 500,000, 1,200,000 or 1,600,000 by risk class; a new drug registration is 8,000,000. Parts of our copy of that table could not be read in full, so confirm at the counter. Do not rely on the 2012 fee schedule: the presidential ordinance of 26 December 2012 was expressly replaced by Art. 60 of the 2021 ordinance, and the item names look alike while the amounts differ. This law is new: No. 85/NA of 25 June 2025, in force from 25 August 2025, replacing the law of 21 December 2011 (Art. 114), so older checklists and article numbers may no longer hold. Three levels administer this (Art. 99): the ministry, the capital and provincial health departments (Art. 101) and the district health offices (Art. 102); product registration sits with the Food and Drug Department (Agreement, Art. 34), and the inspectors are the same food and drug officers (Art. 107). Import and export works on two levels (Art. 49): the enterprise registers or notifies with the ministry, and each consignment, raw materials included, needs its own permit plus inspection at the international checkpoint. Cosmetics go to the capital or provincial health department, and public-health chemicals follow the Law on Chemicals Management instead. Selling, wholesale and retail must take place on premises the ministry has approved (Art. 51); low-risk devices, health products, cosmetics and household hazardous chemicals are licensed by the relevant authorities under their own rules. Ten working days: after the technical review the Food and Drug Department issues the registration certificate, with the number set by the online system within ten working days (Agreement, Art. 14); the certificate is printed from the system (Art. 15), and laboratory results are notified within five working days (Art. 21). Filing is open around the clock through the online registration system (Art. 10); the people who may use it are appointed in writing and approved by the department (Arts. 22 and 23), and an annual per-account system fee applies (Art. 24). Renewal times depend on risk class and whether the product changed (Agreement, Art. 17): five working days for low risk unchanged, fifteen for low risk changed, thirty for medium risk unchanged, forty-five for medium risk changed; a high-risk operator must first send samples for laboratory analysis. The registration lasts five years from signature and the holder must file for renewal within ninety working days before it expires (Agreement, Art. 16) — about four and a half months, not three. Transit is approved by the ministry and inspected by food and drug officers at the international checkpoint (Art. 50), except cosmetics and household hazardous chemicals, which go to the capital or provincial health department.

How much does a Licence for a pharmaceutical or medical product business, and product registration cost in Laos and how long does it take?

Cost: The current schedule is the 2021 fees decree (No. 002/PPT, 17 June 2021), Art. 35. Professional registration certificates (2 years each): pharmaceutical factory 1,000,000 kip; factory making medicines and medical products 600,000; import-export company 1,000,000 and a branch 600,000; first-class wholesaler 500,000, second-class 200,000; first- and second-class retail pharmacies 100,000 each; retail assistant 100,000. Product registration is separate: a new medicine 8,000,000 or 2,000,000 by class; medical devices 500,000 / 1,200,000 / 1,600,000 per item per five years by risk class; a newly developed traditional medicine 2,500,000 and an inherited formula 1,500,000. Do not use the 2012 price list still circulating online — that presidential decree of 26 December 2012 was expressly replaced by Art. 60 of the 2021 decree.. How long: Business licence: fifteen days from a complete and correct filing (Art. 85) — the clock starts on the day the file is complete and correct, not the day you first hand it in. Product registration: the number is set by the online system within 10 working days (Agreement, Art. 14). Renewal runs 5, 15, 30 or 45 working days depending on risk class and whether anything changed (Agreement, Art. 17). There is no single validity period: Art. 85 only says each business type has its own, renewable under the relevant rules — read the expiry printed on your certificate..

Can LaoPaniti obtain the Licence for a pharmaceutical or medical product business, and product registration for me?

LaoPaniti organises the document list, offers online form filling, document upload and pre-check hand-off by staff. It is not a government filing, does not represent acceptance or approval by any authority, and promises neither results nor expedited handling. Formal processing follows the current requirements of the The government administers drugs and medical products centrally through the Ministry of Health (Art. 99) at three levels: the ministry, the capital and provincial health departments (Art. 101) and the district health offices (Art. 102), with a food and drug management committee alongside. For the licence, register the enterprise with the industry and commerce sector first and then apply to the public health sector on the ministry form (Art. 83); product registration goes through the online system to the Food and Drug Department (Agreement, Arts. 10 and 34), and cosmetics import, export and transit go to the capital or provincial health department (Arts. 49 and 50).

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