Without prejudice to the law on the protection of industrial and commercial property, medicinal products for human use which have been authorised in accordance with the provisions of this Regulation shall benefit from an eight-year period of data protection and a ten-year period of marketing protection, in which connection the latter period shall be extended to a maximum of 11 years if, during the first eight years of those ten years, the marketing authorisation holder obtains an authorisation for one or more new therapeutic indications which, during the scientific evaluation prior to their authorisation, are held to bring a significant clinical benefit in comparison with existing therapies.
Brez poseganja v pravo o varstvu industrijske in trgovske lastnine imajo zdravila za humano uporabo, ki so pridobila dovoljenje za promet v skladu z določbami te uredbe, osemletno varstvo podatkov in desetletno obdobje tržne zaščite, v povezavi s katerim se zadnje obdobje podaljša na največ 11 let, če v obdobju prvih osmih let od desetih imetnik dovoljenja za promet pridobi dovoljenje za promet za eno ali več novih terapevtskih indikacij, za katere je med znanstvenim vrednotenjem pred pridobitvijo dovoljenja veljalo, da prinašajo pomembno klinično korist v primerjavi z obstoječimi terapijami.