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Greinasafn

December 17, 2021

09. Will I receive an approval letter from IMA for national authorisations (pure nationals, MR, DC) included in a worksharing application, with at least one centralised marketing authorisation (EMA is the reference authority) and the changes do not affect the product information?

December 17, 2021

08. Centrally Authorised Products – In which instances does the IMA postpone linguistic review?

December 17, 2021

07. How is the sunset clause used in Iceland?

December 17, 2021

06. When applying for a marketing authorization for a generic product and part of the indications are protected by patent, is it necessary to submit Icelandic translation of the whole English product information as approved in the registration procedure or omit (carve out) the patented indications?

December 17, 2021

05. Does the IMA have different requirements from other countries in Europe?

December 17, 2021

04. Has the IMA published rules/guidelines for product names?

December 16, 2021

03. What rule/guidlines does the IMA use for assessing product names?

January 20, 2021

02. Does the Icelandic Medicines Agency (IMA) check acceptability of new names of medicinal products before an application is submitted?

January 20, 2021

01. Centrally Authorised Products – Does the Icelandic Medicines Agency issue approval letters?

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