Various matters must be considered before a medicinal product can be placed on the market.

Icelandic translations of product information texts

Before a medicinal product can be placed on the market, approved Icelandic translations of the product information texts must be available. For nationally authorised medicinal products and medicinal products approved in an MR/DC procedure, Icelandic translations of the SmPC, package leaflet and labelling shall be based on the approved English texts (common texts) and sent to the Icelandic Medicines Agency (IMA), which will assess the translations. The marketing authorisation holder is responsible for ensuring that all approved changes since the marketing authorisation was granted are included.

In addition, IMA requests the approved English product information texts (common texts) on which the Icelandic translations are based, together with a reference to the procedure number, for example: DE / H / XXXX / 001-003 / 047.

Further information on text processing can be found on IMA's website.

Processing time

The processing time for the assessment of Icelandic product information texts before marketing may be up to 60 days from receipt. IMA does not charge a separate fee for the assessment. Nevertheless, publication of a medicinal product in the medicines registers cannot be requested, and the medicinal product cannot be placed on the market, until the Icelandic product information texts have been approved by IMA.

Planned marketing

The applicant shall state in the email when marketing is planned. As a rule, medicinal products intended to be marketed are considered to be placed on the market within 12 months.

Medicinal products in tenders

For medicinal products that are to take part in a tender or similar, applicants shall consider that marketing of the medicinal product is planned. If it is foreseeable that the time from when the results of a tender are available until the medicinal product is to be delivered will be shorter than 60 days, the Icelandic translations must be reviewed before the tender result is available, as the processing time for the assessment of Icelandic product information texts may be up to 60 days from receipt. Fast-track processing cannot be requested for this processing time.

Multilingual Nordic packs

IMA will continue to review the Icelandic translations of medicinal products in multilingual Nordic packs. If a medicinal product in a multilingual pack is not marketed in Iceland, the request for the Icelandic translations to be reviewed must be clearly stated in the application, the cover letter or an annex to the application. If the request is not part of the application, the translations will not be reviewed.

Medicinal products with a common package leaflet for different strengths

In the case of medicinal products where certain strengths are marketed but not all, and the strengths share a common Icelandic package leaflet, IMA will also review the SmPC of the strengths that are not marketed.

However, such a request must be stated in the application.