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Applying for Import License from Thai Food and Drug Administration

向泰國食品藥物管理局申請進口許可證

In order to import food to Thailand, one of the requirements is to obtain an import license from Thai Food and Drug Administration (“FDA”) under Food Act B.E. 2522 (1979). To receive the FDA’s license, an applicant has to receive approval in two steps, which are the approval of the premises and approval of the products respectively.

 

向泰國進口食品的其中一項要求是根據佛曆2522(1979)泰國食品法從泰國食品和藥物管理局(FDA )取得進口許可證。要獲得FDA的許可,申請人必須在兩個階段獲得核准,分別是場所核准和產品核准

 

Step 1: Acquire the Approval of Premises

第一步: 獲得場所核准

 

For the approval of the premises, there is a distinction between Manufacturer and Importer.

場所的核准在製造和進口食品之間有區別。

 

For Manufacturers, the required steps to obtain the Approval of Premises can simply be split into 4 steps:

對於製造而言,獲得場所核准所需的步驟可簡單分為4:

 

  1. File for “premises inspection” with the representative of the FDA.

            FDA 提交“場所檢查” 申請。

  1. File for “establishment of manufacture plant” with the FDA.

               FDA 提交“建立製造工廠”申請。

  1. Wait for the Approval.

      等待核准

            i. After the inspection of both documents and previous steps, the FDA agent will inform the applicant regards to their licenses.

       檢查這兩份文件和之前的步驟後,FDA 代理將通知申請人關於許可證的事情。

  1. Fees of the registration will be adjusted accordingly to the numbers of employees and manufacturing instrument horsepower.

      註冊費用將根據員工人數和製造儀器馬力調整。

         D.File for the FDA approval of Food Product.

            FDA提交食品核准申請。 

 

For Importers, the required steps to obtain the Approval for the importation, is much simpler than the Manufacturer. It can be split into 2 simple steps:

對於進口商而言,獲得進口批准所需的步驟比製造商簡單,可分為兩個簡單的步驟:

  1. File for the Importation License;

     提交進口許可證;

  1. Waiting for the Approval;

      等待核准 ;

  1. File for the FDA approval of Food Product.

     向 FDA 提交食品核准申請。

    

Step 2: Acquire FDA Seal of Approval

第二步: 獲得FDA核准

 

After you have a license for Manufacturing/Importation, the next step is to acquire the FDA Seal of Approval in order to sell products to the market in Thailand! For the approval of the products, the product has to be thoroughly examined by the FDA for the suitable imported or produced category. To obtain the FDA Seal of Approval, the required steps are:

獲得製造/進口許可證後,下一步是獲得FDA核准以便在泰國市場銷售!為了獲得產品核准,產品必須由FDA徹底檢查適合進口或生產的類別。獲得 FDA 核准所需的步驟為:

 

  1. File a “Declaration of Foods” Application (Sor-Bor.5);

            提交 食品聲明申請 (Sor-Bor.5);

  1. Waiting for the FDA Food Numbers;

            等待 FDA食品編號;

  1. Affixed the Label and FDA Food Numbers accordingly to the Announcement of the Ministry of Health.

            根據泰國衛生部公告加貼標籤和 FDA食品編號。

 

The waiting time for each application in every step is highly depending on the complexity of the ingredients that both Importers/Manufacturer wishes to sell on Thai’s Market. Additionally, the import licenses are subject to renewal after 3 years.

申請的等待時間高度取決於進口商想要進口或製造的產品。進口許可證有效期為期三年需更新。


IBC International Business Consultancy is a law, finance and accounting firm located in Bangkok, Thailand with experienced lawyers, accountants, and financial advisers. We provide services including investment, tax and legal advice in Thailand. Should you have any questions, please do not hesitate to contact us via Line: @ibcfirm for further information.

IBC泰國法律金融會計事務所 (International Business Consultancy) 為一間位於曼谷的泰國法律金融會計事務所,由經驗豐富的律師、會計師、及財務顧問組成,可提供泰國投資、泰國稅收及泰國法律諮詢等服務。如果有什麼問題,可以隨時通過Line: @ibcfirm與我們聯繫。

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