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

Dokumentet e bashkangjitura

Shkarko –

KMAG 1 – Dossier guidelines

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KMAG 2 – CTD Module 1 Admin Info

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KMAG 3 – CTD Module 2 Summaries

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KMAG 4 – CTD Module 3 ChemPharmBio CAS & BAS

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KMAG 5- CTD Module 4 Non clinical reports

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KMAG 6 – Module 5 Clinical study reports

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KMAG 7 – MP type doc requirements

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KMAG 8 – WEMU guidelines

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KMAG 9 – ESBioABioE guidelines

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KMAG 10 – EU Centralised procedure

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KMAG 11 – EU Decentralised procedure

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KMAG 12 – Kosovo unilateral recognition procedure

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KMAG 13 – Spec Bio

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KMAG 14 – Spec Radio

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KMAG 15 – Spec Ho

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KMAG 16 – Spec He

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KMAG 17 – Spec Adv

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KMAG 19 Readability

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KMAG 20a – SMPC

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KMAG 20b – FIP

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KMAG-18-Phv-and-PSUR

11.12.2024