Guidelines

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Allir classes
Educational materials
Translations and text processing
Marketing authorization withdrawal
Pricing and reimbursement

Guidelines on educational materials

Instructions for submitting educational materials (aRMM) for evaluation and review pdf, 230 kb Educational materials

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Instructions on electronic publication of educational materials at www.serlyfjaskra.is pdf, 147 kb Educational materials

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Guidelines on translations and text processing

Templates for product information for use by applicants and marketing-authorisation holders Translations and text processing

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Additional requirements for the labelling that apply to products via National, Mutual Recognition or Decentralised Procedure only Translations and text processing

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Guidelines on marketing authorization withdrawals

Instructions for marketing authorization withdrawal Marketing authorization withdrawal

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Guidelines on pricing and reimbursement

Price list English Description xlsx, 21 kb Pricing and reimbursement

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Classification of a medicine as a Specialty Care HIgh-Cost Medicine pdf, 223 kb Pricing and reimbursement

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Reimbursement system for Specialty Care High-Cost Medicine pdf, 219 kb Pricing and reimbursement

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Publication of information in the Icelandic Medicinal Product Information Database and the Icelandic Medicine Price Catalogue pdf, 114 kb Pricing and reimbursement

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