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The License to Operate (LTO) is a mandatory regulatory authorization required for any local manufacturer, importer, or distributor of medicinal products operating in Thailand. Issued by the Thai Food and Drug Administration, the LTO ensures that pharmaceutical activities within the country meet Thailand’s legal, safety, and quality standards.

Without a valid LTO, companies are not permitted to manufacture, import, store, or distribute drugs in Thailand, regardless of whether the product itself has been approved.

Purpose of the LTO

The LTO is designed to ensure that organizations involved in the pharmaceutical supply chain:

  • Operate from approved and compliant premises
  • Follow Good Manufacturing Practice (GMP) or Good Distribution Practice (GDP) standards
  • Maintain proper quality management systems
  • Protect patient safety and product integrity

It is a prerequisite for drug registration and ongoing market authorization in Thailand.

Who Needs an LTO?

An LTO is required for:

  • Local drug manufacturers
  • Importers of finished pharmaceutical products
  • Distributors and wholesalers
  • Companies acting as local legal entities for foreign manufacturers

Foreign companies typically rely on a locally licensed partner holding a valid LTO to conduct regulatory and commercial activities in Thailand.

LTO Application & Compliance Requirements

To obtain an LTO, applicants must submit documentation related to:

  • Company registration and legal status
  • Facility layout and storage conditions
  • GMP/GDP compliance evidence
  • Quality systems and personnel qualifications

The Thai FDA may conduct facility inspections prior to approval. LTOs must be maintained, renewed, and updated to reflect any operational changes.

How Freyr Solutions Supports LTO Compliance

At Freyr Solutions, we support sponsors and local partners with LTO strategy, application support, and ongoing compliance management in Thailand.

Planning to operate or expand in Thailand?

Partner with Freyr Solutions to secure and maintain your LTO efficiently—ensuring uninterrupted market access and regulatory compliance.