Question & AnswerQ&A (DOH ADMINISTRATIVE ORDER NO. 2005-0030)
The purpose of DOH Administrative Order No. 2005-0030 is to simplify and expedite the renewal of the Certificate of Product Registration (CPR) issued by the Bureau of Food and Drugs (BFAD), establish responsibility in the renewal process, and assist BFAD in strengthening post-market surveillance of products requiring CPR.
A product is eligible for automatic renewal of CPR if: (a) the registrant has a current and valid License to Operate (LTO) with an attached list of products; (b) the product is covered by a current and valid CPR (general or restricted use for pharmaceuticals); and (c) there are no deficiencies needing correction before renewal.
Key components that must remain unchanged include ownership, registrant's address/location, manufacturer, ingredients, pharmaceutical formulation, dosage form, strength, therapeutic indication, manufacturing process (if applicable), labeling or commercial presentation, and packaging.
If there is an unauthorized change, BFAD may automatically suspend the LTO and/or CPR, the registrant must voluntarily recall the product from the market, and indemnify and hold BFAD harmless against any third-party claims or actions.
The registrant must file an Application for Renewal at least 90 days before CPR expiration, may choose the renewal duration (1, 3, or 5 years), execute an affidavit of undertaking regarding no changes in product details, and pay the renewal fee.
If filed within 60 days after expiration, the renewal application will be subject to a 50% surcharge based on the chosen renewal period's fee.
The CPR is deemed automatically renewed upon submission of the accomplished Application for Renewal, affidavit of undertaking, and proof of payment of the renewal fee to BFAD.
BFAD requires the presentation of the CPR, which it will stamp with its seal to revalidate and indicate the renewal.
No. An expired CPR not renewed within the 60-day grace period cannot be renewed automatically and will be considered an initial application for product registration.
The affidavit must be signed by the registrant's President/General Manager or authorized liaison officer, and if the registrant is a pharmaceutical company, by its medical director or pharmacist.