KMAG - Lista e Udhërrëfyesve për autorizim të Marketingut

List of MA Guidelines

KMAG 1 – Dossier guidelines KMAG 2 – CTD Module 1 Admin Info KMAG 3 – CTD Module 2 Summaries KMAG 4 – CTD Module 3 ChemPharmBio CAS & BAS KMAG 5 – CTD Module 4 Non clinical reports KMAG 6 – Module 5 Clinical study reports KMAG 7 – MP type doc requirements KMAG 8 – WEMU guidelines KMAG 9 – ESBioABioE guidelines KMAG 10 – EU Centralised procedure KMAG 11 – EU Decentralised procedure KMAG 12 – Kosovo-unilateral-recognition-procedure KMAG 13 – Spec Bio KMAG 14 – Spec Radio KMAG 15 – Spec Ho KMAG 16 – Spec He KMAG 17 – Spec Adv KMAG 18 – Phv and PSUR KMAG 19 – Variations

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