Educational Information Only
The content on this page is for general educational purposes and does not constitute legal advice. Every legal situation is unique. For matters involving investigation, arrest, litigation, or formal proceedings, consult a qualified legal professional.
Unregistered Medicines in Thailand
Making, selling or importing a medicine that has not been registered with the Thai FDA.
Drug Act B.E. 2510 §72(4), Drug Act B.E. 2510 §122, Drug Act B.E. 2510 §79
Up to 3 years imprisonment or a fine of up to THB 5,000, or both (section 122). Medicines must generally carry a drug-formula registration (section 79), subject to the section 79 bis exceptions (e.g., pharmaceutical chemicals, herbal drugs and samples).
serious
Definition
Making, selling or importing a medicine that has not been registered with the Thai FDA. Under Thai law, this offence is classified as a serious offence within the category of food-drug.
Legal Basis
Drug Act B.E. 2510 §72(4)
Primary legislative provision for unregistered medicines offences.
Drug Act B.E. 2510 §122
Primary legislative provision for unregistered medicines offences.
Drug Act B.E. 2510 §79
Primary legislative provision for unregistered medicines offences.
Elements of the Offence
For a conviction, the prosecution must prove all of the following elements beyond reasonable doubt:
The medicine has no Thai drug-formula registration
The accused produced, sold or imported it
Penalties
Maximum Penalty
Up to 3 years imprisonment or a fine of up to THB 5,000, or both (section 122). Medicines must generally carry a drug-formula registration (section 79), subject to the section 79 bis exceptions (e.g., pharmaceutical chemicals, herbal drugs and samples).
Actual sentences depend on factors including the severity of the conduct, harm caused, prior convictions, and mitigating circumstances. Courts have discretion to impose lesser sentences within the statutory range.
Possible Defences
The following defences may be available depending on the circumstances:
The product is in fact registered
The actor is a government body, the Red Cross or the GPO (the only §72(4) carve-out)
Note: The availability of defences depends on specific facts. Professional legal advice is essential.
For Foreigners
Special Considerations for Foreign Nationals
Ordering medicines or many 'supplements' online from abroad that are not FDA-registered can breach this section, and the goods can be seized at customs.
When Legal Representation Matters
If you are accused of unregistered medicines or facing investigation, immediate legal representation is essential to protect your rights and build an effective defence.
Anglo Siam Legal provides experienced legal services across Thailand for both Thai nationals and foreigners.
feedback.wasThisHelpful