CRED 8 Presentations

01/07/2024

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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References/sources

• Demonstrating significant benefit of orphan medicines: analysis of 15 years of experience in Europe: https://www.sciencedirect.com/science/article/pii/S1359644617301599 • EMA QRD product template: http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_00 0134.jsp&mid=WC0b01ac0580022c59 • Product Information CMDh annotated template: http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Templates/QRD/CMDh_201_2005_Rev 9_2016_02_clean.pdf • Notice to Applicants Volume 2A, Chpt. 1: https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-2/vol2a_chap1_en.pdf • CHMP Note for Guidance on inclusion of appendices in clinical study reports in MAAs: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003638.p df

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