Package labelling and leaflets

Labelling requirements

Requirements for labelling of medicinal products are according to IS Regulation No. 545/2018 (in Icelandic only) on marketing authorisations for proprietary medicinal products, their labelling and PILs.

Requirements for labelling of immediate packaging and outer packaging for veterinary medicinal products should also be according to article 13 of the Icelandic law on veterinary medicines no 14/2022 (in Icelandic only).

Mock-ups

Marketing authorisation holders shall send mock-ups of packaging and leaflet to the Icelandic Medicines Agency before the medicinal product is placed on the market. The Marketing Authorisation Holder is reminded of the responsibility that mock-ups fulfil the requirements of the marketing authorisation and conditions set out in the aforementioned Regulation/Law.

Mock-ups shall be submitted to the Icelandic Medicines Agency by an e-mail to [email protected], no later than one month before the medicinal product is placed on the market.

If mock-ups have been reviewed via the Nordic Mock-up Cooperation process, there is no need to re-submit the mock-ups.

a) After changes in labelling document
Updated mock-ups shall be sent to [email protected] as soon as they are available with reference to the relevant case/submission.

b) Changes in leaflet text
Submission of updated artwork is not required.

c) Other changes
Submission of updated mock-ups involving technical updates, for example size or layout, is not required.

Nordic packages

The Nordic Medicines Agencies have prepared guidance documents to facilitate the manufacturing of Nordic packages for both human and veterinary medicinal products. There are three documents, i.e.:

Common Nordic English only packages

To improve the supply and accessibility of important hospital medicines in the Nordic markets, the Nordic Medicines Agencies have agreed on a pilot project concerning certain hospital medicines. It has been decided for these specific hospital medicines to allow English only packages (labelling, package leaflet and mockups) for the Nordic countries.

The Nordic Medicines Agencies have prepared guidance documents to facilitate the manufacturing of English only packages for specific hospital medicines. This project grants an exemption from general Icelandic labeling until January 1, 2030. Applications are submitted simultaneously to all Nordic countries.

If the application is approved, the Icelandic Medicines Agency (Lyfjastofnun) will send an approval to the marketing authorization holder or authorized representative. Therefore, there is no need to additionally submit a normal exemption application form.

The documents related to this process are available on the Swedish Medicines Agency, Läkemedelsverket website:

  1. Guideline on common Nordic EN-EN only packages
  2. List of substances
  3. Application form

Exemptions from package labelling requirements of marketed medicinal products

The Icelandic Medicines Agency is authorised, under certain conditions, to grant exemptions from the labelling requirements for medicines that hold a marketing authorisation and are marketed in Iceland. Generally, such exemptions are granted on a temporary basis, but in specific and limited circumstances, it is permitted to grant these exemptions on a permanent basis.

Temporary exemptions for marketed medicinal products

The Icelandic Medicines Agency (Lyfjastofnun) can grant temporary exemptions from packaging requirements for medicines that hold a marketing authorisation and are marketed in Iceland, for example, to prevent a shortage of medicines. Generally, these temporary exemptions are granted for a maximum of one year at a time.

Small inner packaging – The agency may allow a temporary exemption from labelling requirements for small inner packaging if the labelling is in English or a Scandinavian language, provided that no additional information deemed critical is missing. Requests for this can be made during the national phase of marketing authorisation or after the authorisation has been granted, using an application form. This is based on Articles 27 and 28 of Regulation 545/2018.

H-labelled medicines – Medicines that the marketing authorisation holder confirms are only used in healthcare institutions and are not dispensed directly to patients. For these medicines, it is possible to apply for an exemption from Icelandic labelling on both inner and outer packaging, as long as the labelling is in English or a Scandinavian language and contains no information that must be in Icelandic. This exemption is based on Article 30 of Regulation 545/2018.

Permanent exemptions for marketed medicinal products

The Icelandic Medicines Agency can under extraordinary circumstances grant permanent exemptions from requirements made to packaging of medicinal products that have an Icelandic marketing authorisation and are marketed. Applications for permanent exemptions are only considered:

  • In cases where the medicinal product is authorised to treat a rare disease the Icelandic Medicines Agency can grant a permanent exemption that allows for the language of the packaging labelling and/or packaging leaflet to be in English or Nordic language (excluding Finnish). In assessing whether the medicinal product is indicated to treat a rare disease the Icelandic Medicines Agency relies on the definition put forth in regulation (EC) No. 141/2000 on orphan medicinal products. The package leaflet is always required to be accessible in Icelandic on the Icelandic Product Catalogue Sérlyfjaskrá
  • To protect public health the Icelandic Medicines Agency is authorised under extraordinary circumstances to grant a permanent exemption to the obligation that certain particulars should appear on the labelling and in the package leaflet. With the same aim, the Icelandic Medicines Agency is authorised to grant a permanent exemption to the obligation that the labelling and the package leaflet must be in Icelandic, where the medicinal product is not delivered to the patient for self treatment or owner or holder of an animal in cases of veterinary medicinal products. The package leaflet is always required to be accessible in Icelandic on the Icelandic Product Catalogue Sérlyfjaskrá.

Application and application form

  • Each case is evaluated individually, and the application form can be found under published materials → forms. Applications for exemptions from Icelandic package inserts and/or labelling on packaging must be submitted by email to [email protected]. The subject line should state "Application for exemption from labelling – xxxxx (name of the medicine)."
  • An exemption application will only be processed by the Icelandic Medicines Agency if it is submitted by the marketing authorisation holder or their authorised representative. A formal, written Power of Attorney (PoA) is necessary to demonstrate the authority of the representative to act on behalf of the marketing authorisation holder in communications with the Icelandic Medicines Agency, and the PoA must accompany the application.
  • The Icelandic Medicines Agency may request additional information if necessary. Generally, applications are processed within two weeks, so please ensure timely submission. Indicate if expedited processing is requested, the reason for it, and the desired processing time. When evaluating the request, the Icelandic Medicines Agency will assess the requested timelines and prioritise accordingly, and the applicant will be informed of the possible timelines.

National requirements regarding labelling

Please refer to Volume 2C (Guideline on the packaging information of medicinal products for human use authorised by the Union ).

Please refer to Volume 6C (Guideline on the packaging information of veterinary medicinal products authorised by the Community) and „Blue box” text.

Last updated: February 4, 2025
Var efnið hjálplegt Yes No

Hvað þarf að laga?


LiveChat