CRED ERP 25

01/07/2025

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 - Gudeline as 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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References/sources

• EMA QRD product Information templates CP/MRP/DCP (https://www.ema.europa.eu/en/human regulatory/marketing-authorisation/product-information/product-information-templates) • Environmental Risk assessment for products for human use: Environmental risk assessment of medicinal products for human use | European Medicines Agency (europa.eu) • European Commission Register of Orphan Drugs: Union Register of medicinal products - Public health - European Commission (europa.eu) • Sponsor’s report on the maintenance of designation criteria at the time of MA or type II variation application for a designated orphan medicinal product: https://www.ema.europa.eu/en/human-regulatory/marketing authorisation/orphan-medicines/applying-marketing-authorisation-orphan-medicines • 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: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:C:2008:242:0012:0016:EN:PDF

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