15 years document protection not automatically granted

What conditions must be fulfilled to receive full document protection for orphan drugs according to TPA2 ?

The document protection for 15 years for an important medication for an orphan drug will only be given when an application is made for such. The extension of the document protection should be applied for with the new application for marketing autorisation (Application form section 6.3) according to the new guidelines of 1.1.2019 and if not then (for applications before 1.1.2019), then at the latest a year following approval of the new marketing authorisation using the variation C.I.104 Typ IB.

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Any questions?
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Dr. Katharina Oehler
Scientific and Managing Director
T +41 44 787 70 20
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