Duties and responsibilities of the Authorized Marketing Department.
The Marketing Authorization Department (DAM) authorizes medicinal products based on Law No. 03/L-188 on medicinal products and devices and the relevant AIs stemming from this law.
DAM in coordination with the KVPPM determines the procedure and conditions for granting the right to renew, change (variations), suspend and withdraw the marketing authorization of medicinal products.
DAM evaluates industrially prepared medicinal and herbal products for human use.
Marketing Authorization for products is issued only on the basis of valid scientific evidence on the quality, safety and efficacy of the products as well as on the basis of the compliance of the harmonized documentation with the legal provisions.
Marketing Authorization Applications.
Marketing Authorization Applications
List of Marketing Authorization Guides
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 Centralized procedure
KMAG 11 – EU Decentralized 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