Law Summary
Late Renewal and Surcharge
- Applications submitted within three (3) months after the CPR expiration will incur a surcharge equal to 50% of the renewal registration fee.
Renewal Application After 3 Months of Expiry
- Any application for renewal filed after three (3) months from the CPR expiration date is treated as an initial registration, implying stricter scrutiny and procedures.
Correction of Deficiencies Listed in Letter of Abeyance
- Applicants must correct all deficiencies enumerated in the Letter of Abeyance within three (3) months from receipt, unless a longer period is specifically allowed.
- Failure to correct deficiencies within the three-month window results in the application being dropped from the active pool.
- Within another three (3) months after being dropped, applicants may reactivate their application by submitting proof of correction, not later than six (6) months after receipt of the Letter.
Permanent Cancellation of Application
- If deficiencies remain uncorrected after six (6) months from the Letter of Abeyance issuance, the application is permanently cancelled and cannot be reinstated.
Memorandum of Extension (MOE) for CPR Effectivity
- Applicants may avail of a one (1) year extension of the CPR's validity via a Memorandum of Extension (MOE) while awaiting the BFAD's final action on the renewal application.
- This allows continued manufacture, distribution, and sale of the product without interruption.
- MOE applications should ideally be filed simultaneously with or within three (3) months following the renewal application.
Computation of Receipt Date for Deficiency Period
- The date used to determine the deadline for correcting deficiencies is the date the company's name appears on the BFAD Bulletin Board accompanied by the Product Application Routing Slip Number (RSN).
Application of Clarifications
- These clarified policies apply to all new and pending applications to ensure uniform compliance and administration by the BFAD.
This memorandum provides clear guidance on deadlines, fees, compliance procedures, and remedies related to renewal registration of pharmaceutical products, ensuring regulatory clarity and administrative efficiency.