What are the naming requirements for drugs and supplements? Which guidelines apply? And who checks whether pharmaceutical naming is approved?
Finding new names for drugs: regulatory requirements and strategic considerations
Naming a pharmaceutical product is a complex process where brand strategy, patient safety, and strict regulatory requirements intersect. Creative freedom is limited, and legal pitfalls are everywhere. Regulatory authorities impose strict guidelines that must be carefully followed when naming medications or dietary supplements.
Avoiding misleading claims and exaggerated promises
In pharmaceutical naming and verbal branding for medications, supplements, and healthcare products, strict regulations apply in the European Union, including the Health Claims Regulation and various competition laws. Neither the product name nor its accompanying claims may suggest effects that are not scientifically proven and officially approved.
This means that words like "fit", "vital", or "cure", as well as superlatives like "max" or "top", and even specific syllables such as "lax" may be deemed misleading advertising.
Associative combinations like "Immufit", "Dolomax", or "Seculax" should also be approached with caution. If they imply an immune system boost, the strongest pain relief, or safe laxative effects without scientific backing, they may be considered misleading.
Key principles for pharmaceutical naming:
- No direct or indirect health claims in the name.
- Careful examination of critical terms such as "safe", "better", "effective", or "healthy".
- Avoidance of exaggerations such as "best", "maximum", or "guaranteed".
- Analysis of probable associations and potential implications of specific syllables.
- Early consultation with legal experts to ensure compliance and avoid confusion.
Minimizing the risk of confusion: patient safety first
To prevent trademark conflicts, potential brand names should undergo a thorough trademark screening. Identical or highly similar registered trademarks can lead to objections, cease-and-desist orders, or even lawsuits.
For pharmaceuticals, regulations are even stricter. Authorities such as the German BfArM, the European EMA, and the U.S. FDA conduct in-depth reviews of drug names. Names that sound too similar to existing medications or pose a risk of confusion in prescribing and dispensing can be rejected.
Name safety tests simulate real-world usage scenarios—such as hospitals or pharmacies—to assess whether a name could be misread or misheard in critical situations.
For example, attempting to register "Asvirin" as a brand would not only risk opposition from Bayer (the manufacturer of Aspirin) but would also likely fail industry-specific safety evaluations to prevent potential dispensing errors.
Pharmaceutical naming requires legal precision
A drug name must strike a delicate balance: it should inspire trust, be unique, and still comply with the most stringent legal standards. Regulations such as the Health Claims Regulation, competition law, and industry guidelines set clear boundaries, especially concerning misleading claims, deceptive wording, and potential confusion.
By integrating these regulations into the naming process from the start, costly setbacks can be avoided—ensuring that the name is not only compelling but also legally sound.
Examples of successful pharmaceutical naming
Looking for expert guidance in pharmaceutical naming? Let’s discuss the best approach for your brand.
Please note that other requirements and regulations may apply to health brand development outside of the EU, specifically in the US.
