SIAM TRADE DEVELOPMENT

Dietary Supplements Registration in Thailand

Thai FDA registration for dietary supplement products with or without License holding
No need a local unit!

Dietary supplements registration

Register Dietary Supplement Products in Thailand and let us hold your license!
You only have to care your sales!

Thanks to its internal Regulatory Department, Siam Trade Development provides your Dietary Supplements registration in Thai FDA, with the added value of being your license holder, your importer and stocking your products if you don’t have your Thai Company registered yet or if this is not in your plan.
Dietary supplement products registration in Thai FDA is not an easy task. A mere “file composition” and delivery to the Authority is most of time not enough and brings to a product rejection. We know how to do it and we redesign your product with you to make it fully compliant.
We guarantee a fast resolution of registration in all the sectors under Thai FDA: Medical Devices, Dietary Supplements, Hazardous Substances, Cosmetics, Food and Drugs.

Siam Trade Development services

Your “cheap consultant” failed many times your registration? We’re here for you. We like complicated cases!

Import License

First step for the Dietary Supplement Registration in Thai FDA is the so-called “warehouse registration”, known also as “import license”. This is the first step that only a Thai Company with defined requirements can do (first of all having a warehouse compliant to the law!). The warehouse may be subject to verifications and controls by the post-market Department of Thai FDA.

Business License

Manufacturer Accreditation

After the Thai license holder has been authorized for the import, Dietary supplement registration process starts. First step is the Manufacturer’s accreditation in Thai FDA system. The factory must provide a valid certificate of quality standard (ISO 22000, HACCP, GMP) issued by an accredited certified body and duly notarized and apostilled by local Authotrity and by the Thai embassy or consulate at the origin.

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Product Registration

Once the manufacturer has been approved, it’s the time to register the Dietary Supplement Products. Procedure varies according to product’s nature: liquid, powder, capsule or compress.In all cases a detailed formula with TDS of all the ingredients must be provided. Standards must respect the Thai FDA requirements, and laboratory analysis of finished product as well. Not an easy task, isn’t it?

OUR STANDARD PROPOSAL FOR REGISTRATION OF COSMETIC PRODUCTS

Siam Trade Development register your Dietary Supplement Products in Thailand under its own license. Your company shall be indicated as Manufacturer (see list of relevant certifications that are accepted), Siam Trade shall be indicated as Importer and will use its venue to be recorder as registered business place in Thai FDA for the Import License issuance.
After warehouse accreditation has been concluded, products shall be registered and label created and sent electronically to the manufacturer; They’ll be applied to the external packaging before shipment.
After import procedure has been terminated the product shall be stored and delivered to end user (in case of e-commerce) or passed to the distributor (in case of B2B) or handled directly by STD in case of Multi level Marketing project.
A full process of Dietary Supplements Registration takes from 2 to 4 months. The sole registration of Dietary Supplement takes 3 to 4 weeks.

GENERAL GUIDELINES FOR DIETARY SUPPLEMENT PRODUCTS REGISTRATION IN THAILAND

Before starting the registration process of a food supplement, the Thai FDA must first approve all ingredients of the product. It is common that an ingredient registered and normally used in other countries may not be into the authorized ingrediants in Thai FDA. For new ingredients, the FDA will request additional supporting documents and an external procedure that makes the process longer and more expensive (Novel Ingredient). Before making any decision and before negotiating the cost with the consultant, the Company need to make strategic decisions about whether to retain the new food ingredient in a formula. The new ingredient can be helpful in giving a commercial advantage for the product from competitors, but on the other hand the project will have extra costs.

The Applicant must provide (1) the ingredient list for its products; (2) the source of the ingredients; (3) the manufacturing process; (4) the objectives of use; and (5) the targeted consumer group.

Thai FDA requires the following data and information for food supplement registration:

  • Details of the exact composition by percentage of each ingredient
  • TDS of each ingredient
  • Laboratory analysis of finished product if liquid
  • NO SAMPLES are needed

The product label must show the following information for consumers:

  • Name and brand of the product (both generic and trade)
  • Registration number
  • Name and address of the manufacturer
  • Name and address of the importer
  • Manufacturing and expiry dates
  • Net weight and volume
  • Any additives used
  • Health and nutritional claims (not in all cases)

Thai FDA requirements for Dietary Supplements

A food supplement can contain common herbal ingredients and other bioactive ingredients at a daily intake level recognized by the Thai FDA. For common vitamin and mineral supplements, the levels of the nutrients must be kept between 15–100% of the Thai Recommended Daily Intake (RDI) in order to be classified as a food supplements.

Food supplements can bear exclusively claims that are in line with the Codex Alimentarius nutrition labelling guidelines. For claims pertaining to functions of nutrients there’s a list of claim that Thai FDA authorizes. They follow such list extremely strictly and a single word not compliant may bring to a rejection.

Thai FDA is in the process of reviewing its regulatory framework for evaluating the substantiation of health claims in harmony with the new ASEAN directives. Food supplements can’t bear any medicinal claim, unless the product is a traditional medicine or drug. This is another bottleneck where many consultants hamper.

Health supplements containing ingredients not approved as food ingredients and/or containing vitamins and minerals that exceed the Thai RDI value, must be registered as traditional medicines, drugs or any other related sub-categories, such as modern herbal drugs, generic drugs or new drugs.

The full process of Dietary Supplement Registration in Siam Trade Development takes 1 to 4 months according to the accuracy of your documentation. The license to import Food supplements shall be valid 3 years.

To Register a Dietary Supplement in Thai FDA the applicant shall provide

  • the ingredient list for its products
  • the source of the ingredients (with specific standards)
  • the manufacturing process (including factory certifications)
  • the objectives of use; and the targeted consumer group.

Following data and information are required for food supplement registration in Thai FDA:

  • Details of the exact composition by percentage of each ingredient
  • TDS of each ingredient
  • Laboratory analysis of finished product if liquid
  • NO SAMPLES are needed

A proper label responding to Thai FDA requirements must be attached to the product.

Full process is described at http://www.siamdevelopment.com/company-registration-regulatory-services-thai-fda-registration/thai-fda-registration-3/dietary-supplements-registration-thai-fda/

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DIETARY SUPPLEMENTS REGISTRATION THAILAND

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