Automatic Renewal of Product Registration CPR

Simplify and expedite the renewal of CPR for products regulated by BFAD.
Establish clear accountability and responsibility in the renewal process of CPR.
Strengthen BFAD’s ability to conduct post-market surveillance of products requiring CPR.

Registrant must have a valid License to Operate (LTO) with an attached list of products, traders, and covered activities.
For dangerous drugs, a valid License to Handle controlled substances is also required.
The product must have a current and valid CPR.
Pharmaceutical products eligible are limited to those registered for general or restricted use.
No correctable deficiencies should exist before renewal is granted.

Application for Renewal must be filed at least 90 days prior to CPR expiration.
Applications filed within 60 days after CPR expiration incur a 50% surcharge on the renewal fee.
Renewal durations available are 1, 3, or 5 years, as chosen by the registrant.
An affidavit of undertaking must be executed and submitted with the renewal application, signed by authorized company officers.
The affidavit must certify no changes in ownership, address, manufacturer, ingredients, formulation, dosage form, strength, indications, manufacturing process, labeling, packaging, or commercial presentation.
The affidavit must contain agreement that any unauthorized changes may result in suspension of LTO and/or CPR, product recall, and indemnification of BFAD against claims.
Renewal fee payment is required.

CPR is deemed automatically renewed upon submission of a properly accomplished Application for Renewal, affidavit, and proof of payment.
BFAD will stamp the CPR with a seal to indicate revalidation and renewal.

CPR not renewed within the 60-day grace period post-expiration cannot be renewed automatically.
Such expired CPR applications will be treated as initial registrations.

BFAD is authorized to charge appropriate renewal fees.
Fees may be revised periodically upon recommendation by the BFAD Director and approval of the Secretary of Health.

Invalid or unenforceable parts of the Order do not affect the validity or enforceability of the remaining provisions.

All inconsistent administrative issuances, circulars, and memoranda are withdrawn, repealed, or revoked.

The Order takes effect fifteen (15) days after publication in a newspaper of general circulation.