EMA (European Medicines Agency) rejects brand names resembling existing drugs. "Xanax" vs "Zanax" = too similar (medication error risk). Sound-alike names = patient safety threat = automatic refusal.
Look-Alike Sound-Alike
EMA tests: Visual similarity (written prescription errors), phonetic similarity (verbal miscommunication), semantic similarity (treatment confusion). All three dimensions evaluated before approval.
INN Conflicts
INN (International Nonproprietary Name) = generic drug names. Can't use INN or confusingly similar terms. "Paracetamol Solutions" = prohibited (INN embedded). Protects against confusion with generic alternatives.
The Stem System
Drug name stems indicate class: "-mab" (monoclonal antibodies), "-pril" (ACE inhibitors), "-statin" (cholesterol). Avoid these stems unless drug actually in that class. Misleading = rejected.
Multi-Lingual Testing
EU = 24 official languages. Name acceptable in English tested in German, French, Spanish, etc. "Gift" (English = present, German = poison). Translation meanings = critical.
The Approval Timeline
EMA naming review: 6-12 months. Rejection = restart with new name. Total: 12-24 months from concept to approved name. Budget extra timeline vs consumer products (4-8 months).
Trademark Coordination
EMA approval ≠ trademark clearance. Need both: (1) EMA name approval (safety), (2) EUIPO trademark registration (commercial rights). Sequence: Preliminary trademark search → EMA submission → formal trademark filing post-EMA approval.
Generic Competition
Patent expires. Generic manufacturers use INN, not brand name. But brand equity persists. "Viagra" (sildenafil) = brand worth protecting even after genericization via trademark.
Trademark Lens checks commercial trademark conflicts - EMA pharmaceutical name screening requires separate specialist consultant for safety evaluation.