4. Supply of Ingredients

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4. Supply of Ingredients

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Ingredients Regulation Overview for Ingredient Manufacturers
Thailand

This section provides information on any notification, registration, or importation requirements for the ingredient categories in scope.

4.1 As Drug Substances for Drug Manufacture (B2B)

4.1.1 Registration

4.1.1.1 Registration Requirements

Ingredients must be notified to the FDA as pharmaceutical chemicals and receive a notification number before they can be supplied in Thailand. A foreign ingredient supplier must appoint a Thai agent with the appropriate license to submit the notification.

Active substance premixes also need to be notified. If the formulation has not previously been notified, it must be added for approval by the FDA.

The notification process does not include a full assessment of API quality. A full evaluation is performed if the API is used in a drug product that goes through the registration process.

4.1.1.2 Registration Procedure

Notification is submitted by the Thai applicant.
Ingredient is an active substance that has been approved previously by the Thai FDA:
1. The notification first requires registration of the production location to obtain production location reference number, which takes five working days.
2. Once the production location is approved, the applicant requests a notification number and pays a fee of 100 baht. For substances already approved, this number is issued automatically.
For active substances not approved by the Thai FDA (e.g. new formulation of API premix):
1. The applicant submits a request to add the substance with submission of evidence. The approval process takes one month.
2. The applicant then completes registration of the production location as above.
3. The applicant requests a notification number and pays the 100 baht fee. Issuance of the notification number requires approval from the Thai FDA, following provision information on pharmaceutical use and license holder details. Approval takes five days.
The ingredient is not an active substance (i.e. excipients)
1. Registration of the production location is not required.
2. If the ingredient is in the system, the applicant reports use and is issued with a notification number. If it is not in the system, approval from the Thai FDA is required as per the active ingredient process.

4.1.1.3 Documents required from ingredient supplier

For registration of production location:
- GMP certificate covering production of the pharmaceutical chemical to be notified; or
- Other production quality certificates such as ISO and HACCP if the substance is not regulated as a pharmaceutical chemical in its country of production.
For approval of substance by the Thai FDA (new substances/formulations only):
- CoAs demonstrating compliance with pharmacopeial standards or with the manufacturer’s specification if no monograph is available.

4.1.1.4 Cost and Timelines

Notification of active substances incurs a fee of 100 baht (approx. 2.50 EUR/USD), with timelines as indicated above. There is no fee for notification of excipients.

4.1.1.5 Renewal Frequency and Cost

The length of validity of the active ingredient notification number is based on the evidence demonstrating manufacturer quality compliance. If a GMP certificate is provided, the notification is valid for the duration of the certificate plus 6 months. After this time, the notification process must be repeated. Excipient notification numbers do not expire.

4.1.2 Importation

4.1.2.1 Overview of Process

APIs must have a notification number (see above) from the FDA before applying for import permission. Application for import is made by a Thai entity with an appropriate license for import.

The importer obtains a License per Invoice for each import and then files a customs declaration with the Thai Customs authority.

4.1.2.2 Documents Required from the Ingredient Supplier

Certificate of Analysis - Thai translation is required
Certificate of Free Sale may be requested

4.1.3 Change Notification

The trade name of the API is included in the notification. Therefore, a change to the trade name would require resubmitting the notification to obtain a new notification number as described in Section 4.1.1.2, incurring a fee of 100 baht.

4.2 In Pharmaceutical Products Produced by Thai Manufacturers (B2C)

4.2.1 Registration of Drug Product

4.2.1.1 Registration Requirements

Drugs require a certificate of formula registration from the FDA. The applicant (drug manufacturer or their appointed agent) must hold an appropriate license from the FDA. Full evaluation of the API is performed as part of the drug registration process.

4.2.1.2 Registration Procedure

Pre-submission planning form submitted by the applicant.
Registration is submitted by the applicant via the online submission system. The dossier format is in line with Thai-specific, international (ICH, EU, WHO) and ASEAN guidelines.

4.2.1.3 Documents to be Provided by Ingredient Supplier

For APIs

Administrative documents

Letter of Access to DMF/CEP
GMP Certificate covering the manufacture of drug substance

Quality Documents

Process for provision of data on Drug Substance	Documents required from Ingredient Supplier
Drug substance is fully described in Module 3.2.S	Full details on API provided to the drug product manufacturer
Submission of DMF	Full DMF from the supplier. Letter of Access supplied for inclusion in Module 1. In addition, the following are required in Section 3.2.S: Full specification of the drug substance by the drug product manufacturer Batch analysis data from both the ingredient supplier and the drug product manufacturer for typical batches of drug substance
Submission of CEP	CEP is submitted in Module 1 of the ACTD Additional information for nonsterile drug substances: Letter of Access from the drug substance manufacturer Written assurance that no significant changes have been made to the manufacturing method since the CEP was issued Written assurance that the drug substance complies with all conditions and additional tests attached to CEP by the EDQM CoAs for at least 3 production scale batches demonstrating compliance with monograph
Add-on information if full details of manufacture and control have been previously approved by the Thai FDA	Details and scientific justifications must be provided of any additional tests and requirements (e.g. for particle size distribution, polymorphic form) applied to the bulk drug substance before use in the manufacture of the drug product(s) covered by the current application. Detailed validation data must be provided for these additional tests. Representative batch analytical data must be provided. These can be submitted as add-on information.

For Excipients

Certificate of Analysis demonstrating compliance with monograph.

4.2.1.4 Cost and Timelines

Drug category	Application/Dossier screening fee	Technical Document Evaluation Fee	Certificate of Registration Fee
Generic drug	1,000	49,000	2,000
New Drug	2,500	182,500 (New chemical entity)	2,000
New Drug	2,500	155,000 (Not new chemical entity)	2,000

Fees indicated in Thai baht (1 THB = approx. 0.025 EUR/USD)

4.2.1.5 Renewal Frequency and Cost

A registration certificate is valid for seven years.

4.2.2 Importation

Not applicable to locally manufactured products.

4.2.3 Change Notification Relating to API Trade Name Change

A change to the API trade name would have no regulatory impact provided no change occurred to the DMF/CEP.

4.3 As Active Substances for Health Supplements (B2B)

4.3.1 Registration

4.3.1.1 Registration Requirements

Health supplement active ingredients are classified as Category 4 - General Food. Therefore, there is no registration requirement unless the ingredient is considered novel and is not approved by the Thai FDA for use in health supplements. Vitamins are approved for use and, therefore, no registration is required.

Excipients for health supplements are classified as Category 1 food and are required to be registered as food additives.

4.3.1.2 Registration Procedure (Excipients Only)

The applicant must be Thai with a relevant license from the Thai FDA. The application is submitted online.

4.3.1.3 Documents Required from Ingredient Supplier

Document or Certificate Assuring Food Production Standards issued by:
1. A responsible government agency of the producing country
2. An agency recognized by that government agency (e.g. an organization that follows the Codex Guidelines for the Design, Operation, Assessment, and Accreditation of Food Import and Export Inspection and Certification Systems (CAC/GL 26-1997))
3. Certification Body that is membered and accredited by the International Accreditation Forum
Certificate of Analysis demonstrating compliance with the standard (e.g. USP/BP).

NOTE: A Certificate of Free Sale is not accepted by the Thai FDA for this purpose as it does not include both the product and the premises registration details required. An example of a certificate approved by the Thai FDA is provided by the New Zealand Ministry for Primary Industries: https://www.mpi.govt.nz/dmsdocument/12363-CERT9-GMP-Certificate-for-Food-Products-to-Thailand-Form

Examples of acceptable standards of manufacturing practice are listed below but a full list including country-specific standards is published:
Good Hygiene Practices
HACCP
ISO 22000

4.3.1.4 Cost and Timelines

Processing time is 55 days. The fee for registration submission is 3,000 baht and the certificate fee once approved is 5,000 baht.

4.3.2 Importation

4.3.2.1 Overview of Process

The ingredient supplier must appoint an importer, who must be a person or entity with a commercial registration certificate and a place of business in Thailand. The importer must hold a food import license.

The importer prepares evidence regarding the details of product quality and standards of manufacture.

Where the imported product has undergone registration, it will have a product serial number. This is quoted and the required documents are provided.
For imported products that do not require registration (i.e. general food classification- includes raw materials for manufacture of food products), a Virtual Number must be obtained by submitting detailed product information via the Virtual Number System.
Product/Virtual certificate number provided to the Import and Export Inspection Information System of the FDA.
License per Invoice obtained for each import via the National Single Window of the Customs Department.
Import declaration filed with the Thai customs.

4.3.2.2 Documents Required from the Ingredient Supplier

Power of attorney for import
Certificate of Analysis demonstrating compliance with standard
Original Document or Certificate Assuring Food Production Standards as per Section 4.3.1.3. NOTE: A Certificate of Free Sale is not accepted by the Thai FDA for this purpose.

4.3.3 Change Notification

A change to the trade name of an active substance may impact the Certificate Assuring Food Production Standards if the name is listed therein. For the example of the New Zealand certificate provided in Section 4.3.1.3, a change to the name would require the certificate to be re-issued with the revised name.

In the registration of food additives, the trade name is listed in the registration, therefore a change to the name would require a modification to the registration.

4.4 In Health Supplements Produced by Thai Manufacturers (B2C)

4.4.1 Registration of Health Supplement

4.4.1.1 Registration Requirements

A food registration certificate is required to supply health supplements in Thailand. The applicant must be a Thai entity with an appropriate license from the FDA.

4.4.1.2 Registration Procedure

An application for registration is submitted via the electronic submission system along with relevant documentation.
Assessment of compliance by the assessment team.

4.4.1.3 Registration Documents to be Provided by Ingredient Supplier

The applicant must provide quality specifications or reference standards for all active substances used (e.g. USP, BP) and their shelf life. For ingredient premixes, each component must be listed separately.

4.4.1.4 Cost and Timelines

The entire registration process takes 2–4 months, with the product registration component taking 35 days according to the Thai FDA public manual.

The fee for a food registration form submission is 2,000 baht.

4.4.1.5 Renewal Frequency and Cost

The food registration certificate is valid for 3 years. Renewal is 2,000 baht.

4.4.2 Importation

Not applicable to local manufacturers.

4.4.3 Change Notification

A change to the active substance trade name would have no regulatory impact on the registered health supplement.

4.5 As Ingredients for Veterinary Products (B2B)

4.5.1 Registration

Active substances and excipients used for the manufacture of veterinary products must be approved and notified to the Thai FDA as described in Section 4.1.1.

4.5.2 Importation

The import process is the same as described in Section 4.1.2.

4.5.3 Change Notification

A change to the API trade name would require re-notification to the Thai FDA.

4.6 In Veterinary Product Produced by Thai Manufacturers (B2C)

4.6.1 Registration

4.6.1.1 Overview of Process

For new drugs, a full dossier submission by the Thai licensed applicant is required as per the human drug process. For generic drugs, the registration dossier is abridged and a full evaluation of the drug substance is not required.

In both cases, the dossier undergoes a pre-screening for completeness before the full evaluation is performed.