Guidelines on Icelandic Translations in MRPs/DCPs

A new protocol came into force on 4 January concerning icelandic translations of medicinal products in Mutual recognition (MR)/Decentralised (DC) procedures. Included in the new protocol is that the IMA will not review  Icelandic translations of PI (SmPC, PL and labelling) for medicinal products in MR/DC procedures that are not marketed in Iceland, unless the marketing authorisation holder specifically requests review because of planned marketing of the medicinal product.

For products currently marketed in Iceland, maintenance of the icelandic PI is still needed.

The new protocol was announced in December 2020 and now guidelines have been published on the IMA's website.

Last updated: March 2, 2021
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