Guidelines

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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 www.serlyfjaskra.is 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, 21 kb Pricing and reimbursement

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

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

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