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食品・医薬品管理局 (FDA)ライセンス(許可)







  • FDAライセンスの申請に当たっての必要文書類、及び情報に関する相談業務

  • FDAライセンスの申請書の記入、及び関係文書類の整理(お客様からの情報・インプットも多く必要とします)

  • FDAへのライセンス申請書の提出(申請代行業務)

  • FDAとの調整・連絡業務

  • FDAとのミーティングへの同伴(必要に応じ)

  • FDAとの積極的なフォローアップ業務

  • 追加情報の必要性の確認、及び提出

  • FDAライセンスの受領

  • FDAライセンスのタイ語→英語訳の作成

  • 上記の遂行に必要なメール交換を含む連絡業務



FDA License

A FDA license is required to import foods, drugs, cosmetics, psychotropic substances, narcotics, medical devices, volatile substances and hazardous substances to Thailand. 


The procedure to obtain a Thailand FDA license requires inspection of the business premises of the importer. The Thailand FDA has very subjective requirements depending on the intended business activities and will not approve all business premises. For example, some business premises may be considered too small for the intended business activities by the Thailand FDA. The Thailand FDA can also demand for a business to install specific types of equipment or fixtures prior to approving a license.


We highly recommend consulting with the Thailand FDA in person prior to obtaining a business premises.


Our FDA license application service includes the following:


  • Advise client on all required information and documents to apply for a FDA license.

  • Prepare a FDA license application with the assistance of the client.

  • Filing the application with the FDA.

  • Assist in communicating with the FDA.

  • Accompanying the representatives of the client in meetings with the FDA if necessary.

  • Follow up the application with the FDA.

  • Submit any additional information or documents required by the FDA with the assistance of the client.

  • Receive the FDA license.

  • Provide an English translation of the FDA license.

  • Correspondence by email, telephone and in person meetings when necessary.

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