Purpose and Objectives
- Simplify and speed up registration of pharmaceutical products by linking to a Principal CPR based on manufacturer and formulation identity.
- Establish responsibility for manufacturing, distribution, and marketing.
- Assist BFAD in post-market surveillance of products.
Definitions
- Certificate of Product Registration (CPR): Official document allowing marketing after safety, efficacy, and quality evaluation.
- Principal CPR: First valid CPR covering a specific pharmaceutical formulation, allowing licensing to third parties.
- Principal Product and Formulation: Product and its specific pharmaceutical formulation covered by the Principal CPR.
- Identical Drug Product and Formulation: Products identical in manufacturer and formulation to the Principal Product.
- Certificate of Listing of Identical Drug Product (CLIDP): Certificate proving official listing of an identical drug product under the Principal CPR.
- Principal Applicant: Owner/holder applying for a Principal CPR.
- Identical Drug Applicant: Applicant listing an identical drug product.
Guidelines and Procedures: Principal CPR
- Application for Principal CPR can be made by owners with a current CPR who license third parties.
- BFAD processes application; upon issuance, the current CPR is surrendered, and validity matches remaining term.
- Principal CPRs are entitled to automatic renewal with conditions including no changes in product details, valid license to operate, renewal application 90 days prior, affidavit undertaking, and fee payment.
- No CPR renewal without registration as Principal CPR under this Order.
- Initial applications must meet regular CPR requirements.
- Changes in manufacturer or formulation must be reported and assessed by BFAD.
Guidelines and Procedures: Listing Identical Drug Products
- No identical drug product can be marketed without official listing under a Principal CPR.
- Applicants must submit copies of licenses to operate, valid Principal CPR, notarized agreements authorizing distribution, and an affidavit confirming no changes to formulation or manufacturer.
- No need to resubmit technical documents already submitted for the Principal Product.
- Identical drug products receive a DR number with suffix indicating listing under the Principal CPR and order of listing.
- Validity and renewal of listing synchronized with the Principal CPR, with automatic renewal conditional on compliance similar to Principal CPR.
- No listing renewal without renewal of the Principal CPR; failure to renew converts listing to initial application.
- Changes affecting formulation may affect listing; however, changes in color, dosage form, labeling, or packaging do not impact listing.
Miscellaneous Provisions
- BFAD authorized to charge fees for registration and renewals.
- Lists of Principal Products with CPR numbers and owners to be posted online or on bulletin boards.
- BFAD to take action against violations or manufacturing defects, possibly issuing cease-and-desist or recall orders affecting Principal and Identical Drug Products.
- Sanctions imposed on violating parties.
Separability Clause
- Invalidity of any part of the Order does not affect the rest; remaining provisions shall be construed as if invalid part were omitted.
Repealing Clause
- All prior inconsistent administrative issuances, circulars, and memoranda are repealed or revoked.
Effectivity
- The Order takes effect 15 days after publication in a newspaper of general circulation.