№ lp_2_3_58688
Official procedural template outlining the required structure and content for applicant submissions to the NCPE Rapid Review process in Ireland, including regulatory, clinical, economic, and budget impact information.
Organization: National Centre for Pharmacoeconomics (NCPE)
Document Type: Submission template
Purpose: Written submission format for Rapid Review
Version: 2.02.1
Version Date: 02/02/2107/04/22
Geographical Scope: Ireland
Subject Area: Health Technology Assessment
Regulatory References: EMA, HPRA, FDA, CHMP
Required Accompanying Documents: NCPE Budget Impact Model Template; Submission Checklist; References; Draft SmPC; EPAR
File Formats Specified: .docx; .pdf; .ris; .xlsm
Sections Included: Intervention Details; Disease and Place in Therapy; Clinical Evidence; Comparative Costs; Budget Impact Analysis; International HTA; References; Appendices
Price: 8 / 10 USD
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