Generally if the medicinal product has been released for sale on the Icelandic market, it is permitted to stay there for up to 12 months. IMA requests updated mock-ups and PILs within a year from the time the MA transfer has been granted. IMA expects updated packages to be available on the market within 12 months. If a situation arises where it is foreseen that one year will not be sufficient to sell old supplies the MA holder can apply to IMA for an extension which will then be assessed on a case-by-case basis.
(24.11.2016)