Regulatory House18. 8. 20211 minEMA 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 House16. 8. 20211 minSix-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 House27. 7. 20211 minCBDs has to be considered novel foodCourt of Justice of the European Union ruled in 19 November 2020 that cannabidiol (CBD) ‘does not appear to have any psychotropic effect...