Law Summary
Prohibited Brand Names
- Deceptive brand names are forbidden.
- Deceptively descriptive names implying superlative qualities (e.g., Best, Outstanding) are disallowed.
- Geographically descriptive names that misleadingly suggest country of origin (e.g., Canadian Food Supplement) are prohibited.
- Any brand name identical or similar to an existing registered or previously cleared brand name is not allowed.
- Brand names likely to confuse or mislead consumers into thinking products with different labels are the same or from the same manufacturer are barred.
Specific Requirements for Pharmaceutical Products
- Only one brand name per manufacturer, trader, or distributor is allowed for a given pharmaceutical formulation based on active ingredient(s).
- Different therapeutic indications using the same active ingredient(s) can have distinct brand names.
- Brand names cannot be reused for new formulations with different or additional active ingredients.
- Brand names must not be confusingly similar in speech, rhyme, or writing to existing registered names.
- Similarity in first syllables is disallowed unless the middle syllables provide distinctive difference.
- Different generic drug classes or indications require distinct brand name prefixes, middles, or suffixes to avoid confusion.
- Brand names cannot be identical or similar to International Non-Proprietary Names (INN), including:
- Modifications of INN by minor changes (e.g., dropping/changing a letter).
- Use of INN stems (specific suffixes designated in Annex A).
- Combining INN elements in names of multi-component products.
Procedure for Approval of Brand Names
- Applicant must check proposed brand names against BFAD's posted registry of approved brand names for similarity before application.
- Applications must comply with existing rules for product registration.
- PSD evaluators assess brand names based on the guidelines before granting approval.
- Applications with unacceptable brand names are denied registration.
Special Condition on Certificates of Product Registration (CPR)
- CPRs include a clause disclaiming BFAD endorsement or representation of the applicant's rights to the brand name.
- Registrants agree to indemnify BFAD against any third-party claims related to intellectual property infringement (patents, trademarks, industrial designs) arising from registered brand names.
Enforcement and Compliance
- The guidelines were adopted to ensure orderly registration processes and protect consumers and intellectual property rights.
- Compliance with guidelines is mandatory for product registration and issuance of CPRs.
These guidelines govern the evaluation and approval of brand names to maintain clarity, legality, and consumer protection in the registration of regulated products.