Concerned Member State (CMS)

Decision,decentralised procedure,products,procedures,submission,time,Mutual recognition procedure,company,medicinal product,timelines.

Assessment procedure,period,report,medicine,documents,market,mutual recognition,Centralised procedure,zonal procedure,health,public health,authorisation period,validation period,active substances,assessment reports,draft assessment report.

Agency,Community,issues,notice,Notice to Applicants,package leaflet,Co-ordination Group,major amendments,national marketing authorisation,cover letter,regulatory requirements,cell therapies,positive opinion,Economic Area,centralized procedure,60-day procedure.

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