Safety labeling on generic drugs is inconsistent, study says

BMJ 2012; 345 doi: (Published 21 December 2012)
Cite this as: BMJ 2012;345:e8650

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Also in the EU differences between generic medicinal products and their originators exist. Many older products have several originators in various memberstates and often the product informations are not harmonised. These differences naturally extend to their generics.

Another reason is data protection. If the originator gets an additional indication approved, this is protected and the new indication must not be listed in the product information. This is unfortunately also the case for safety-information generated during this so called line-extension. There are situations where this is appropriate, eg. in case of higher doses for particular indications. Often this is legally required nonsense.

Competing interests: None declared

Marcus Müllner, Head of agency

Austrian Medicines and Medical Devices Agency, Traisengasse 5, 1200 Vienna, Austria

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