Question & AnswerQ&A (DOH ADMINISTRATIVE ORDER NO. 2005-0031)
The main purpose is to simplify and expedite the registration of pharmaceutical products based on the identity of the manufacturer and the same pharmaceutical formulation by linking them to the Principal Certificate of Product Registration (CPR), establishing responsibility in their manufacture and distribution, and assisting BFAD in post-market surveillance.
CPR is the certificate issued by BFAD for the purpose of marketing or free distribution of a product after evaluation of its safety, efficacy, and quality.
A Principal CPR is the first or prior existing and valid CPR of a particular pharmaceutical product with a particular pharmaceutical formulation, issued to the owner/holder who can grant third persons the authority to export, import, distribute, market or sell the same formulation.
Identical Drug Products are pharmaceutical products identical in the manufacturer of the finished product and pharmaceutical formulation to the Principal Product, containing the same active ingredients in the same amounts and manufactured by the same process.
No, the Order mandates that no Identical Drug Product shall be distributed, marketed, sold, or offered for sale unless officially listed under a Principal CPR.
Documents required include photocopies of current and valid Licenses to Operate (LTOs) of both the Identical Drug Applicant and the Principal CPR owner, a photocopy of the valid Principal CPR, an authenticated notarized distributorship or license agreement between parties, and an affidavit of undertaking regarding no changes in manufacturer or formulation.
If the Principal CPR is not renewed, all Identical Drug Products listed under it shall be deemed to have expired and must apply for a regular CPR according to existing laws and regulations.
Both the Principal CPR and the listings of Identical Drug Products have a validity period synchronized for five (5) years starting from the date of expiration of the previous CPR or listing.
Automatic renewal is allowed upon compliance with conditions such as the product being registered for general or restricted use, having a valid License to Operate, timely filing of a renewal application, execution of an affidavit of undertaking confirming no changes in product details, and payment of the renewal fee.
BFAD may suspend the LTO and/or Principal CPR, require voluntary recall of the product from the market, and the registrant must indemnify and hold BFAD free from any third party claims or actions.