FDA License

|FDA License

The Thai Food and Drug Administration (FDA) is responsible for the protection of the consumer’s health and safety, and controls the food, drugs, psychotropic substances, narcotics, medical devices, volatile substances, cosmetics, and hazardous substances on the Thai market.

Anyone intending to import or manufacture such products into Thailand is required to obtain an approval from the Food and Drug Administration of Thailand (FDA) prior to importing or manufacturing these products. The time for filing the application and receiving the registration certificate can take between one week for cosmetics to several months for food products and pharmaceuticals.

Food registration
Companies must apply for a license if:
• They are producing/importing food as a sample for registration or purchase consideration
• The production/import of food is only temporary (e.g. Trade exhibition)
• The intention is to produce/import food for an indefinite period of time

The application for the certification is completed in two steps.
First of all, it has to be placed into the correct category, of which there are three:
1. Specific controlled food, such as: beverages in sealed containers, flavored milk, cultured milk, food containing sodium cyclamate, ice cream, and other milk products, food additives, and weight-control foods
2. Prescribed Food to Have Quality or Standards, such as: coffee, iodized table salt, vitamin fortified rice, cream, tea, chocolate, vinegar, different types of oil, butter, honey, electrolyte drinks, natural mineral water, cheese, and ice
3. Prescribed Food to Have Labels, such as: bread, brine for cooking, husked rice flour, some meat products, flavoring agents, chewing gum and candy, Ready-to-Cook foods, Ready-to-Eat foods, and general food obtained through certain techniques of genetic modification or genetic engineering.

Next, the application form has to be filed with the Food Control Division,  Food and Drug Administration. The amount of time that will pass by before receiving the approval of the FDA depends on the product imported or manufactured. In any case, if the license is approved it will remain valid for 3 years.

Drug registration
Drugs, in the meaning of Drug Act, are any substance intended for use in the diagnosis, treatment, relief, cure, or prevention of human or animal disease or illness.
The Drug Control Division is responsible for handling the application for the certificates.
The process of drug approval by the FDA Thailand starts from asking for permission to import drugs for approval or study. After the company has received license to import drugs for study it can begin the bioequivalence study (generic drug) or the clinical trial study (original drug). Once the study is finished, the drug company will send the results of the study to FDA Thailand. If the drug is registered, this License can also be used to import the drugs for sale. The License is valid for 1 year and must be renewed before its expiration.

Medical Devices registration
In Thailand, medical devices are regulated by the Medical Device Control Division (MDCO), a specialized section in the Thai FDA. According to the category they belong, medical devices must either be registered or licensed.

Medical devices are grouped into 3 categories, as following:
1. Class 1: condoms, examination gloves, surgical gloves, syringes, HIV diagnostic test kits, and contact lenses Manufacturer, importer, and distributor/seller must have their medical devices approved by the FDA before importing/supplying products in Thailand. The manufacturers and importers of HIV Test Kits for Diagnostic use must hold a quality control accreditation.
2. Class 2: rehabilitation devices, blood alcohol level measuring kits, silicone implants, and test kits other that for diagnostic purposes. Manufacturer, importer and distributor/seller must notify the FDA of their device before importing/supplying products in Thailand and obtain a USFDA certificate.
3. Class 3:  lowest-risk devices category. An FDA Import License must be obtained before the device can be imported to or sold in Thailand. The approval process is relatively fast and easy.

The applicant must prepare the required documents and submit them to the Thai FDA service center. If all the submissions are correct and fulfils the required criteria, a letter of approval for importation for general medical devices will be issued.

Cosmetics registration
Under the Cosmetics Act 2015, cosmetics are defined as articles intended to be used by applying, rubbing, massaging, sprinkling, spraying on, dropping, introducing into, perfuming, or by any other means to any part of human body including treatments designed for using with teeth and oral mucosa for cleansing, beautifying, or promoting beauty change to an appearance, deodorize, or protect, including skin-care products and other articles prescribed as cosmetics by the Ministerial Regulation.

Any producer or importer of cosmetics must register with the FDA, prior producing or importing any cosmetic products, in order to obtain a cosmetics license for each particular product.

Cosmetics are classified into two categories based on their ingredients:
1. Controlled Cosmetics: contain controlled ingredients. Before being released on the market, the FDA must be notified as to the product and the process is completed in one day.
2. Specially Controlled Cosmetics: contain specially controlled ingredients.  The cosmetics must be registered at the FDA and the registration process is completed within 30 days.
Cosmetics which do not contain controlled or specially controlled ingredients are classified as general cosmetics.

If a license is granted for a particular product, a maximum government fee of 5,000 Baht must be paid.  The cosmetics license is valid for 3 years and, in order to renew it, the licensee must pay an additional government fee.
If the actual producer or importer is different from the one in the license, the FDA has the power to revoke a product license and impose a fine not exceeding 20,000 Baht.

The holder of a cosmetics license will need to be aware of the various compliance requirements issued by the FDA and others, including, following good manufacturing practice (GMP), creating a database for program information files (PIF), complying with regulations concerning product labels (FDA and OCPB Announcement), complying with advertising regulations (FDA and OCPB Announcement), and complying with regulations on hazardous cosmetic substances (FDA Announcement).

Hazardous Substances registration
Pursuant to the Hazardous Substance Act of Thailand, the Thai FDA classifies hazardous substances into four types according to degree of hazard:
1. Type 1:  products with a low degree of hazard that need to be monitored. In order to import, export, manufacture, or possess of these substances, a person does not have to apply for a license or a registration, but  must comply with certain criteria and procedures.
2. Type 2: products that need to be both monitored and controlled. In order to import, export, manufacture, or possess of these substances, a person must notify and register them with the FDA and must also comply with certain criteria and procedures.
3. Type 3: products with a greater degree of hazard require a stricter control procedure. In order to import, export, manufacture, or possess of these substances, a person must obtain a permit and registration certificate.
4. Type 4: products that may endanger well-being of consumers, animals, plants, property, or the environment. The importation, exportation, and possession of these substances is completely prohibited in Thailand.

The type 2 and 3 products require a lab test of the product, which is performed by the FDA. In order for the FDA to do this test, they need a sample of the product. The sample can only be imported if a sample permit has been applied for.
The type of hazardous substance is considered by the product’s ingredients. In case there are several ingredients and the type for each ingredient is different, the product will be defined as a type of the most hazardous ingredient in the product.

2018-07-27T16:29:42+00:00
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