Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Acceptability of brand names for human medicinal products. With focus on German non-generic OTC umbrella brand discussion

Berit Fasse (Abschlußjahr: 2013)

Summary

Language: English

Consumers are accustomed of umbrella brands as umbrella brands are extensive used in Europe in different industrial sectors e.g. automobiles, clothes, cosmetics and food as well as for pharmaceutical products especially within the German overthe-counter (OTC) medicinal products. But for medicinal products special international as well as national laws and guidelines apply.

The common understanding of the different laws and guidelines is, that the most important information of a medicinal product, which are the name of the medicinal product, the strength and route of administration, are critical for a safe use and should therefore be brought together and should be prominently displayed on the outer packaging not interfering with additional information such as company logos, pictograms or symbols.

Of these important characteristics of a medicinal product the name of the medicinal product is the most important fact for consumers to distinguish different medicinal products and therefore, has to ensure a safe use and should not cause confusion e.g. due to similarity in print, handwriting or speech with another already approved name of a medicinal product or due to a misleading therapeutic and/or pharmaceutical connotation. This is ensured by the whole name of a medicinal product consisting of the main-name, which could be an INN or an umbrella brand, together with distinguishable supplements (e.g. prefix, suffix, numbers).

However, European laws and guidelines are not very specific and the respective implementations into national legislations are very variable.

The overview will give an insight in some selected EU countries implementations. Especially German legislation with regard to naming conventions and changing conditions are delineated.

Pages: 66, Annexes: 7, pages: 24