Drug Facility Licensing

1.1 “Domestic pharmaceutical manufacturing facility” requires a license from the Food and Drug Administration.

1.2 “Overseas pharmaceutical manufacturing facility” requires a GMP Clearance from the Food and Drug Administration.

1.3 “Import facility” requires the person intending to import or order drugs from another country into the Kingdom (except for drugs brought by passengers traveling into the Kingdom in the amount necessary for personal use for no more than 30 days) to obtain a license from the Food and Drug Administration. Where the facility is in Bangkok, the application shall be submitted at the Food and Drug Administration. Where the facility is in another province, the application shall be submitted at the Provincial Public Health Office of the province where the facility is located.

1.4 “Sales establishment”, whether in the form of retail or wholesale, requires an approval from the Food and Drug Administration. Any person intending to import or order drugs from another country into the Kingdom (except for drugs brought by passengers traveling into the Kingdom in the amount necessary for personal use for no more than 30 days) is required to obtain a license from the Food and Drug Administration. Where the establishment is in Bangkok, the application shall be submitted at the Food and Drug Administration. Where the establishment is in another province, the application shall be submitted at the Provincial Public Health Office of the province where the establishment is located;

Details of Drug Facility Licensing

1.1 Application for facility licensing

Facility license consists of a license for a sales establishment, a license for manufacturing facility, and a license for import facility. The law on drugs prescribes the qualification and characteristic requirements applicable to the applicants for these licenses, for instance, the applicant must be a natural person or a juristic person recognized by Thai law. Where the applicant is an alien, the applicant must obtain a license for the business under List Three (14) and (15) or a certificate under section 11 or section 12 of the Alien Business Operations Act, B.E. 2542 (1999), and must present the license or certificate as evidence. 

A licensee must ensure that a pharmacist is present and on duty at the sales establishment, manufacturing facility, or import facility.

Licenses for all types of drug facilities must be renewed yearly, and different rates of fees will be charged for different types of licenses. 

1.2 Standards, rules and good practices for drug facilities

Once a license is granted, the licensee has the duty to take actions in accordance with the rules and good practices prescribed for their license. In other words, a licensed manufacturer must comply with the Good Manufacturing and Distribution Practice (GMDP), a licensed importer must comply with the Good Distribution Practice (GDP), and a licensed seller must comply with the Good Pharmacy Practice (GPP). Overseas manufacturing facilities must also apply for a GMP Clearance. The rates of fees will vary according to the types of standards.