Services

We provide FDA License services for these kinds of products;

  1. Food
  2. Drug
  3. Narcotic
  4. Cosmetic
  5. Hazardous substance
  6. Medical Device

1.FDA Food

Services

Under FDA food categories, we provide three kinds of services as below

 

  1. Apply manufacturing license
  2. Apply import license
  3. Apply product license

Importing Food to Kingdom of Thailand

For importing food, there are four categories under the food and the step of preparing the documents is different as the required documents will be differ such as the finished products or the semi-finished products. We are going to show the example of one food category and the procedure to apply for the import license.

 

Request FDA License of food to sell in local (food category: weight control food)

Provision Cost

Government Fee                               20,030

Procedure and Timeline

I.Request place license

Step 1: Prepare the required documents and fill the form

Ordinary person

  1. Copy of ID card /passport, work permit and house registration (1 set)
  2. Copy of commercial Certificate (1 set)

Juristic person

  1. Copy of company affidavit (1 set)
  2. Copy of certified shareholders list (1 set)
  3. Power of attorney and appoint letter to conduct business(1 set)

Documents requirement

  1. Application Form Orr.6
  2. Copy of house registration of operator, import place and storage place(1 set)
  3. Accurate map scale with following details (1 set)
    • Map of location and surrounding place
    • Map of building around 100Meter
    • Plan of inside location with details below
      1. Plan of storage floor which shows the details of rooms and benefits of each
      2. Plan of showing separation each food store, air and light balance system of room, equipment that use to maintain the quality of food
  1. Consent letter of using a location or Lease contract (if any)
  2. Power of attorney (1 set)
  3. Photo of billboard ( 1 set of each)
    1. Billboard of import place
    2. Billboard of storage place
    3. Billboard of product name

Step 2: Submit to Thai FDA.

            It will take around 30 working days for checking the accurate of the request and wait the approval process for 9 days if there are no additional requirements or no accurate of evidence documents occurred which the total is 39 working days. The officer will contact within 7 days after they approved to inform about the result of registration.

Step 3: Receive the approval license Orr.7.

 

II. Request the product license

Step 1: Prepare the required documents and fill the form

Document Requirement

  1. Application Form Orr. 17 and Sor Bor. 3
  2. Approval license of import (Orr.7)
  3. Original of product formula and details from manufacturer ( 1 set)
  4. Original of manufacturing process (1 set)
  5. Original of product specification (1 set)
  6. Original of food product analysis (1 set)
  7. Copy of safety ingredients evidence (1 set)
  8. Copy of active raw materials specification (1 set)
  9. Copy of label food in Thai and English version ( 4 sets)
  10. Sample food (1)
  11. Original of certificate of free sale ( 1 set)

Step 2: Submit to Thai FDA.

It will take around 90 working days for checking the accurate of the request and wait the approval process for 35days if there are no additional requirements or no accurate of evidence documents occurred , then the officer will contact within 7 days after approved. 

Remark: In case of novel food, it has to pass the evaluation process from the expert.

Step 3: Receive the approval of product license.

The approved license will be valid for three years.

 

III.Request the license per invoice (LPI)

Step 1: Prepare the document

For authorized juristic person

  • Copy of certified company affidavit not more than 6 months (1 set)
  • Power of attorney with copy of ID card (1 set)

For delegated juristic person

  • Power of attorney not more than 1 year with 30 Baht stamps together with a set of copy
  • Copy of certified company affidavit not more than 6 months (1 set)
  • Copy of ID card of authorized person (1 set)
  • Cop y of ID card/passport and work permit of delegated person (1 set)

Required document

  • The approval of product license
  • The detail information that was filled in application form
  • Invoice packing list
  • Certificate of place of manufacture

Step 2: Apply for the LPI

Submit the documents through E-Form or at FDA and this can be done within 1 day.

Step 3: Receive the license

It requires renewing every time of importing.

Remark: Must have export and import license or shipping provider in order to import to Thailand.

Applying FDA License for other kind of services or other kind of food category can be discussed case by case.

 

 

For more information, please feel free to contact us:

Phone Nos.: +66 2933 6121, +66 2933 6122, +66 2933 5601

(for call inside Thailand use 0 instead of +66)

Fax: +66 2933 6120

Email: mgr@panwa.co.th

Please CC: to our alternate email: panwagroup@gmail.com