Scope and Applicability
- Applies to drug manufacturers and subclasses (packer, repacker, trader).
- Covers initial licensing, renewal, variations, and other regulatory processes.
License to Operate (LTO) Application Requirements
- Completed and notarized application form signed by the pharmacist and owner or authorized representative.
- Proof of business name registration appropriate to the business structure (DTI for sole proprietorships, SEC for corporations, Cooperative Development Authority for cooperatives, or relevant government law for government corporations).
- Credentials of the pharmacist-in-charge, including valid PRC ID, FDA licensing seminar attendance certificate, and resignation letter if applicable; listing of other qualified personnel without submission of credentials at application.
- Submission of a Risk Management Plan detailing risk identification, characterization, and pharmacovigilance activities.
- Location plan sketch with GPS coordinates to assist inspections.
- Site Master File compliant with the newest PIC/s Good Manufacturing Practice guidelines.
- Proof of payment of applicable fees.
- Self-Assessment Toolkit to facilitate evaluation.
Evaluation Procedures
- Desktop evaluation by FDA regional offices to ensure compliance; may require additional documents.
- Pre-opening inspection verifying compliance with PIC/s-GMP and documentary proofs such as quality management systems, contracts, validation records, master and batch production documents, personnel credentials, ownership or lease agreements, and standard references.
- Post-licensing inspections as routine checks or following major variations or regulatory triggers such as violations or safety concerns.
Variations to LTO
- Major Variations include change of ownership, adding production lines, transfer of location, and change of activity.
- Minor Variations Prior Approval include expansion of establishment, change of business name, and zonal address changes.
- Minor Variations Notification include changes of pharmacist or other qualified personnel, deletion of activity, and warehouse changes.
- All changes must be reported to FDA, whether classified as variations or not.
- Each type of variation requires specific documentary compliance and fee payment, except location transfer which demands a new initial payment.
- Minor variations allow continued operations after filing.
Electronic Accessibility
- All application forms are available electronically on the FDA website to promote efficient access and submission.
Exemption for Pharmacist Handling Additional Activities
- Exemption granted for drug manufacturer-repacker and manufacturer-trader pharmacists handling multiple non-retail, non-manufacturing activities within the same establishment.
- Conditions include activities confined to one business entity and location, with clear documentation of duties, responsibilities, supervision schedule, and signed declarations by pharmacist and owner.
Roles and Responsibilities of Implementing Offices
- FDA and its regional offices may solicit help from other government agencies for implementation.
- Local Government Units (LGUs) are encouraged to monitor compliance and report violations to FDA.
Transitory Provisions
- Existing licensed establishments must submit Risk Management Plan and GPS coordinates upon renewing LTO.
Repealing and Separability Clauses
- Previous conflicting FDA circulars/memoranda are repealed.
- If any provision is declared unlawful or unconstitutional, unaffected provisions remain valid.
Effectivity
- The Circular takes effect upon approval and signature by the FDA Director General.