Upcoming changes to Icelandic translations of Product Information

The changes will come into effect on the 4th of January 2021

29.12.2020

Starting with the upcoming year, the IMA will not review or approve Icelandic translations of PI (SmPC, PL and labelling) in Mutual recognition (MR)/Decentralised (DC) procedures unless the marketing authorisation holder (MAH) intends to market the medicinal product in Iceland. This change will come into effect on 4 January 2021.

For medicinal products already marketed in Iceland, Icelandic translations are still required when maintaining the marketing authorisation.

1. Issuing MAs for medicinal products

Icelandic translations of approved PI should be sent to the IMA via [email protected] within 7 days of the end of procedure if the product is to be marketed in Iceland. If the IMA does not receive information on intended marketing in Iceland within 7 days, the IMA will assume that the product will not be marketed in Iceland. The MA will then be issued without Icelandic PI.

Marketing in Iceland will then not be possible unless the IMA has received and approved the Icelandic PI. This is explained in more detail in bullet 3 below. Product names nevertheless have to be finalised before MAs can be issued. For products not intended to be marketed, an Rx status is given, even in the the case of an OTC status application. The OTC status application will be assessed when marketing is intended.

2. Maintenance of MR/DC MAs for medicinal products which are not marketed in Iceland

Applicants are not required to submit PI in Icelandic when applying for MA renewals or variations for medicinal products which are not marketed in Iceland. This is also applicable for MAs of products that are not marketed but have until now maintained Icelandic translations of PI.

3. Marketing of a medicinal product at a later stage

Before a medicinal product can be marketed in Iceland the MAH must provide the IMA with updated Icelandic PI. The PI shall be based on approved common texts and should be sent to the IMA which will then assess the translations. The MAH is responsible for including all approved changes in the Icelandic PI. In addition, the IMA requests that MAHs submit an English version of the PI that the Icelandic translations are based on, along with the procedure number, e.g. DE / H / XXXX / 001-003 / 047. The Icelandic PI and corresponding English version is to be sent to the IMA via [email protected]. The subject of the email should be: „Icelandic translations for [name of medicinal product] – [procedure number]“. The texts should be in Word format. Further information on translations and text processing is available on the IMA‘s website. The assessment time is 60 days from submission date. The IMA does not charge an extra fee for the assessment.

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