When to Obtain FDA License in Thailand?

Are you planning to trade consumable products in Thailand! The Food and Drug Administration in Thailand is responsible for the protection of the health and safety of the consumer. Therefore, this department is the issuing authority of the FDA License in Thailand. The department controls the following list of products on the market in Thailand:

1. Drug
2. Food
3. Medical Devices
4. Cosmetics
5. Hazardous objects
6. Addictive substance

Food Control

The Food Act of Thailand ensures the quality and safety of the food by –

• Establishing and regulating food standards and specifications including hygienic and labeling requirements;
• Approval for packaging materials and advertisement;
• Controlling food products importation and manufacturing;
• Conducting epidemiological studies while FDA issuing the below mentioned certificated;
• Sanitary Certification;
• HACCP Certification;
• Certification of Free Sale;
• GMP Certification;

Firstly, the application for FDA certification in Thailand completes in two simple steps. Secondly, the premises must get approval prior to manufacturing or importation of the product. And finally, for the approval of the premises, a distinction should be there between manufacturing and importing of the food. Therefore, your process of applying for an FDA License in Thailand must comply with these 3 stages.

Drug Control

Note that, when it comes to approval for an FDA license for drug importation, it needs a lot of details. So that you don’t skip any, following are the details of necessary documents:

• Duly filled application form
• Drug sample
•  Complete drug formula
• Drug literature
• Permit to manufacture or import drug sample
• Manufacturing method
• Drug analytical control method
• Pharmacological and toxicological study (if any)
• GMP certificate (in case of imported drugs)
• In-process control with acceptable limits
• Clinical trials, safety, and efficacy study (if any)
• Certificate of analysis of active ingredient(s)
• Final labeling and packaging including the registration number. Secondly, quantity of drug per packaging. Importantly, name of manufacturer and address, manufacturing date, the expiry date
• Must be Legalized by the authorized officer and by the Thai Embassy. Additionally, it needs certificate of free sale (in case of imported drug).
• Raw material specifications of active(s) and inert ingredients with the corresponding control methods in details
• Final product specification with the corresponding control methods in details
• Packaging (Must be according to the Thai regulations)
• Storage conditions. Note that the conditions must be favorable for the respective type of good.
• Finally, the stability studies of the final product

Therefore, if your business needs you to acquire a Thai FDA license, you must get in touch with a professional for legal assistance.  Moreover, you can mail us at [email protected] for assistance in the issuance of FDA license in Thailand.