The Food and Drug Administration (FDA) of the Philippines has announced an extension to the renewal application filing period for the License to Operate (LTO), as detailed in FDA Advisory No. 2025-0095.
Effective February 17, 2025, stakeholders may submit renewal applications 180 days before their LTO expiration date, replacing the previous 90-day requirement. This interim measure is part of the FDA’s efforts to enhance public service delivery and provide stakeholders with additional time for processing authorization documents.
Key Changes:
- Extended Filing Period:
- Renewal applications can be submitted 180 days prior to expiration (previously 90 days).
- Surcharge Exemption:
- No surcharges for payments made before the expiry date.
- Purpose of the Extension:
- Aims to make the renewal process easier, more efficient, and less stressful for stakeholders.
- Reflects the FDA’s commitment to better service delivery.
Implications for Stakeholders
- Affected Parties:
- All stakeholders with an expiring License to Operate (LTO).
- Unchanged Guidelines:
- The expiration and filing procedures for other authorizations will continue to follow current FDA guidelines.
Effectivity Date
- The extension will take effect on February 17, 2025, and will continue until further notice.
Additional Resources
For further details, refer to the official FDA advisory:
FDA Advisory No. 2025-0095.
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