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NMVO Fee Models Overview for 2022
EMVO informs MAHs and OBPs about the national fees for year 2022. Therefore the NMVO Fee Models Overview has been published on the EMVO...
Regulatory House
8. 9. 2021Minut čtení: 1
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EMA has published for public consultation a Guideline on core SmPC, Labelling and PIL for ATMPs
All SMEs and Stakeholders are invited to provide their comments to this guideline on texts for advanced therapy medicinals products...
Regulatory House
18. 8. 2021Minut čtení: 1
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Six-month countdown to go-live for the Clinical Trials Information System (CTIS)
EMA and SÚKL has informed on their website that the entry into application of the Clinical Trials Regulation and hence the go-live date...
Regulatory House
16. 8. 2021Minut čtení: 1
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