Íslenska
Search
My pages
Close

Greinasafn

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?

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

07. How is the sunset clause used in Iceland?

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?

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

04. Has the IMA published specific instructions for product names?

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

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

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

How can we help?

LiveChat