Upcoming changes to Icelandic translations of Product Information

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

1. Issuing MAs for medicinal

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
. The assessment time is 60 days from submission date. The IMA does
not charge an extra fee for the assessment.

Last updated: December 29, 2020
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