Purpose and Objective
- To set general policies and guidelines on brand names for BFAD product registrations.
- To promote generic/unbranded pharmaceutical products while recognizing the jurisdiction of BFAD, IPO, and courts.
- BFAD’s role limited to ensuring product safety, efficacy, and quality, not marketing or promotion of brand names.
Scope and Coverage
- Applies to all foods, cosmetics, drugs, devices, and household hazardous substances applying for:
- Initial registration,
- Brand name changes,
- Inclusion of brand names in registered generic/unbranded pharmaceutical products with BFAD.
Definitions
- Brand Name: Name given by manufacturers/traders/importers to distinguish products.
- Certificate of Product Registration (CPR): License issued post-evaluation for marketing/distribution.
- Certificate of Product Listing (CPL): Certificate for cosmetics qualified for listing without pre-market approval.
- Generic Name: Scientifically recognized active ingredient names or official generics designated by BFAD.
- Product Classification: Distinct categories such as food, cosmetic, drug, veterinary product, device, diagnostic reagents, and household hazardous substances.
General Guidelines on Brand Names
- Generally, any name may be accepted as brand name for CPR/CPL application.
- Strong encouragement for use of generic/unbranded names for pharmaceutical products per Generics Act.
- Prohibition on brand names that:
- Are identical to existing BFAD-registered names in the same product classification.
- Are offensive, obscene, scandalous, or contrary to public morals and policy.
- Brand name evaluation and acceptance occurs simultaneously with product registration processing.
- Name change or inclusion for registered products must be evaluated within 30 days; absence of action deems acceptance.
- BFAD acceptance does not confer intellectual property rights or endorse the brand name use.
- Applicants must execute an affidavit undertaking to:
- Change the brand name if legally prohibited from use.
- Indemnify BFAD from third-party claims related to the brand name.
Procedures for Disputes
- BFAD to notify complainants that intellectual property disputes fall under IPO or courts’ jurisdiction.
- Notifications of alleged intellectual property claims shall not delay or suspend BFAD’s processing unless restrained by IPO or court orders.
Separability Clause
- Invalid or unenforceable provisions of this Order do not affect the validity or enforceability of the remaining provisions.
Transitory and Repealing Clause
- Applies to previously pending brand name clearance applications.
- Repeals Administrative Order No. 76 (1984), Bureau Circular No. 21 (1999), Bureau Circular No. 08 (2003), and other inconsistent issuances.
Effectivity
- The Order takes effect fifteen (15) days after publication in a newspaper of general circulation.