The granting of an authorization to market medicinal products under the centralized procedure requires that the applicant puts forward a single pan-European tradename. Although it is not mandatory under EU legislation for the name of a medicinal product to be a registered trademark companies submitting marketing authorization applications under Community systems prefer the use of trademarks over International Non-Proprietary Names (INNs).

In evaluating the safety of medicinal products in the authorization procedure the EMEA is obliged to consider whether the proposed trademark of a medicinal product could create a risk to public safety. The possibility of someone mistakenly taking one drug in place of another because the drug names are similar can have very serious consequences. Perhaps nowhere is vigilance more important than when selecting medicinal products. Since many medication errors are caused by look-alike and sound-alike medication names it is evident that even where a registered trademark exists public health considerations must determine whether that trademark may be used for a medicinal product.

In communication CPMP/328/98, Revision 3 dated January 2002 the EMEA Committee for Proprietary Medicinal Products has now published the difficulties which have typically been encountered with product tradenames arising from such public safety concerns. The features of proposed tradenames which give rise to confusion are summarized below:

• The tradename of a medicinal product should not be liable to cause confusion in print, handwriting or speech with the tradename of an existing medicinal product;
• The tradename of a medicinal product should not be liable to cause confusion in print, handwriting or speech with an established Non-Proprietary Name (INN) relating to a different active ingredient.
  Objections to tradenames based on risk of confusion as described above is the most recurrent basis for objection. As a rule of thumb, if there is a minimum of 3 distinguishing letters, it is unlikely that it will be considered that there is a risk of confusion in writing;
• The tradename of a medicinal product should not convey misleading therapeutic or pharmaceutical connotations, e.g. the German trademark CARDIODORON® should only be used for medicinal products for the treatment of cardiovascular diseases;
• The tradename of a medicinal product should not be misleading with respect to the composition of the product;
• The tradename of a product should avoid qualification by letters;
• Qualification of a name by a single detached letter and by numbers is unacceptable;
• The tradename should comply with World Health Organization (WHO) Guidance, e.g. it should not incorporate a "generic stem" which has been adopted and published by the WHO. However, if used, the product should conform to the pharmacological, therapeutic or chemical connotation implicit in the stem.