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13. What happens when a product becomes commercially available in Iceland? Does all „compassionate“ supply finish immediately or is there any period to allow a patient to move from a compassionate to a commercial supply of the drug?

12. Are there any specific reporting obligations, e.g. pharmacovigilance, adverse event reporting?

11. Are there any rules and restrictions for import?

10. Are pharmacies able to hold stock of these products?

09. Does the product need to be licenced somewhere in the EU?

08. How long does the approval last and can it be renewed?

07. How long does it take to get an approval?

06. Can an application be made for a group of patients?

05. Who is responsible for making the request?

04. Must the product be provided free of charge?

03. Are there special requirements regarding labelling?

02. Are there any restrictions?

01. How are products prescribed for compassionate use handled in Iceland?

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