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Guidelines

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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

Access to Medicines Before Market Authorisation or Marketing pdf, 205 kb Pricing and reimbursement

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Price list English Description xlsx, 25 kb Pricing and reimbursement

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Determining the maximum wholesale price of medicines pdf, 106 kb Pricing and reimbursement

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Classification of a medicine as a Specialty Care HIgh-Cost Medicine pdf, 189 kb Pricing and reimbursement

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Reimbursement system for Specialty Care High-Cost Medicine pdf, 259 kb Pricing and reimbursement

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Publication of information in the Icelandic Medicinal Product Information Database and the Icelandic Medicine Price Catalogue docx, 240 kb Pricing and reimbursement

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Classification in reference price categories pdf, 130 kb Pricing and reimbursement

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Work procedure for issuing a Medicine Price Catalogue pdf, 164 kb Pricing and reimbursement

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Description as to how the currency rate for the Icelandic Medicine Price Catalogue (IMPC) is calculated. pdf, 101 kb Pricing and reimbursement

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Last updated: June 11, 2025
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