Guidelines on educational materials

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

Instructions on electronic publication of educational materials at pdf, 147 kb Educational materials

Guidelines on translations and text processing

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

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

Guidelines on marketing authorization withdrawals

Instructions for marketing authorization withdrawal Marketing authorization withdrawal

Guidelines on pricing and reimbursement

Price list English Description xlsx, 25 kb Pricing and reimbursement

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

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

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

Publication of information in the Icelandic Medicinal Product Information Database and the Icelandic Medicine Price Catalogue pdf, 103 kb Pricing and reimbursement

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

Work procedure for issuing a Medicine Price Catalogue pdf, 146 kb Pricing and reimbursement

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

Last updated: January 5, 2024
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