CRED 8 Presentations

01/07/2024

References/sources

• Notice to Applicants: https://ec.europa.eu/health/sites/health/files/files/eudralex/vol 2/b/update_200805/ctd_05-2008_en.pdf • Pre authorisation guidance on EMA website: https://www.ema.europa.eu/en/human-regulatory/marketing authorisation/pre-authorisation-guidance) • Harmonised Technical Guidance for eCTD Submissions in the EU: http://esubmission.ema.europa.eu/tiges/docs/eCTD%20Guidance%20v5.0_adopted%20version.pdf • EU Module 1 eCTD Specification: http://esubmission.ema.europa.eu/eumodule1/EU%20M1%20eCTD%20Spec%20v3.0.4.pdf • Validation issues frequently seen with initial MAAs: http://www.ema.europa.eu/docs/en_GB/document_library/Other/2017/12/WC500239942.pdf • Dossier administration validation check list: https://www.ema.europa.eu/en/human-regulatory/marketing authorisation/marketing-authorisation-guidance-documents • Cover letter table template (MRP/DCP): http://www.hma.eu/219.html

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References/sources

• Heads of Agency website for specific MAA requirements: http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/procedural_guidance/eSubmissions/CMDh_085_2008_clean. pdf • Guidance on completing MAA application form (CP): Module 1 - Administrative information application form (europa.eu) • MAA user guide on completing MAA application from (MRP and DCP): Heads of Medicines Agencies: eSubmission (hma.eu) • Digital Application Dataset Integration (DADI): (http://esubmission.ema.europa.eu/cessp/cessp.htm) • Heads of Agencies website MAA User Guide for MRP/DCP and Best Practice Guide: https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/procedural_guidance/Application_for_MA/CMDh_332_2017_ Rev2_2018_07_Updated_e-AF_user_guide_for_MA_-_CLEAN.pdf • Heads of Agencies website MAA Best Practice Guide for MRP/DCP: https://www.hma.eu/91.html • Common grounds for invalidation/delaying validation: http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/procedural_guidance/Application_for_MA/CMDh_075_2007_ Rev03_2016_04_clean.pdf • List of national NCA contacts for MRP/DCP: https://www.hma.eu/nationalcontacts.html • European Commission Guideline on Assessing Similarity of Medicinal Products versus authorised orphan medicinal products benefiting from market exclusivity and applying derogations from that market exclusivity List of orphan drugs approved per indication: Microsoft Word - Gudelineas adopted on 19 September 09 - copy from e-Greffe.doc (europa.eu) • EMA QRD product Information templates CP/MRP/DCP: (https://www.ema.europa.eu/en/human-regulatory/marketing authorisation/product-information/product-information-templates)

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