Thailand: Urgent reminder – Drug product registration license renewal deadline fast approaching

In brief

The deadline for renewing the drug product registration license is approaching. All renewals must be submitted by 12 October 2024.


Contents

In more detail

Manufacturers and importers who obtained drug product registration license approvals from the Food and Drug Administration (FDA) before 1 January 1997 (prior to the enforcement of the ASEAN harmonization requirement) must submit the documents in the ASEAN Common Technical Dossier (ACTD) format to obtain the approvals for the drug product registration license renewals by 12 October 2024. Key actions include ensuring that all necessary documents are updated in line with current regulations, submitting the renewal applications to the FDA by the deadline, and keeping a record of the approval status.

Failure to renew drug product registration licenses by 12 October 2024 may result in penalties and suspension of the drug product registration license.

For more information or assistance, please contact our Healthcare & Life Sciences and Regulatory Affairs Services team.

The following have contributed to this legal update:

  • Praween Chantanakomes, Head of Regulatory Affairs Department
  • Prim Uditananda, Regulatory Affairs Manager
  • Monsicha Boonsiri, Regulatory Affairs Officer

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