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Greinasafn

December 17, 2021

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?

December 17, 2021

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

December 17, 2021

11. Are there any rules and restrictions for import?

December 17, 2021

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

December 17, 2021

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

December 17, 2021

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

December 17, 2021

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

December 17, 2021

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

December 17, 2021

05. Who is responsible for making the request?

December 17, 2021

04. Must the product be provided free of charge?

December 17, 2021

03. Are there special requirements regarding labelling?

December 17, 2021

02. Are there any restrictions?

December 17, 2021

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

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