Procedures for Classifying Product As a Drug, Food, Cosmetic, Medical Device Or Hazardous

Procedures for Classifying Product as a Drug, Food, Cosmetic, Medical Device or Hazardous Substance

When you cannot tell whether a product to be manufactured or imported is a drug, a food, a cosmetic, a medical device or a hazardous substance, you can consult with an officer as described in these steps.

1. Contact an officer

Contact an officer at the Complementary Health Product Group for advice or primary consultation on the category of the product.

1. Submit Health Product Classification Form

In the case that the product needs to be identified by a specialist, the officer will advise you on how to fill the Health Product Classification Form (WorOr. 2). You must fill the form correctly and completely. The form must be submitted with documentation required such as a Thai or English label of the product, process of manufacture etc.

1. Consult

When the officer finishes checking your Health Product Classification Form, and finds that the document is complete, he/she will issue you with a reference number. You can use this reference number to follow up. If the officer finds that your form is not complete, he/she will return the form to you to be corrected and re-submitted.

1. Classify

The officer will examine detail of the product in the form together with documents you have submitted, and then he/ she will classify the product.

1. Bring the case for consultation with a working group

In case that the officer cannot make a decision, he/she will bring the case to a meeting of a working group to make a decision.

1. Asking for more information

The working group will classify the product or ask for more information. In the case that the working group has classified the product, the Thai-FDA will inform you as to the result by letter. In the case that the working group finds that there is not enough information to make a decision, it will ask for more information by sending you a letter asking for additional information.

1. Send information within 30 days

You must send required information to the group within 30 days from the date of issuing the letter. If you cannot do so in the specific time, the group will withdraw your case from process and send a letter, issued by the Thai-FDA to inform you of the rejection of your case.

1. The Thai-FDA sends consultation result

After due consideration by the working group, the Thai-FDA will inform you of the result by letter. It the decision is positive, you may then bring the letter to the division stated therein, and apply for a licence.