Title
Renewal and compliance rules for drug registration
Law
Bfad Memorandum Circular No. 7, S. 1991
Decision Date
Mar 27, 1991
BFAD Memorandum Circular No. 7, S. 1991 clarifies the renewal registration process for drug products, imposing a 50% surcharge for late applications and outlining strict timelines for correcting deficiencies in compliance with Letters of Abeyance.

Q&A (ICT Memorandum Circular No. 2015-002)

The application for renewal registration must be filed within three (3) months BEFORE the expiration date of the Certificate of Product Registration (CPR).

A surcharge of 50% of the renewal registration fees is imposed for applications filed within three (3) months AFTER the expiration date of the CPR.

Such application shall be considered as an initial registration.

Corrections must be made not later than three (3) months from receipt of the Letter of Abeyance, unless a longer period is specified in the letter.

The application will be considered dropped from the active pool of applications but may still be reactivated within three (3) months after its classification by submitting proof of corrections not later than six (6) months after the Letter of Abeyance.

The application will be permanently cancelled.

The MOE extends the CPR's effectivity for one (1) year to allow continuous manufacturing, distribution, and sale of the product while awaiting the final BFAD action on its renewal registration application.

Preferably together with or within three (3) months from the date of the renewal registration application.

The date of posting the company's name on the BFAD Bulletin Board with the Product Application Routing Slip Number (RSN) is counted as the date of receipt.

These clarifications apply to all new and pending product registration applications.


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