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Adaptation of the Guidance document Orphan Drug HMV4

09.04.2019

ZL100_00_002e_WL Guidance document Orphan Drug (PDF, 258 kB, 01.03.2021)

Correction, supplement an explanation in chapter 5 (Fees), 6.4 (ODS and indication extensions) and 6.8 (Transfer of status)

The new version of the affected document enter into force as of 09.04.2019.

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