Iceland-specific labelling requirements

Iceland-specific requirements (blue box) for the labelling of centrally authorised medicinal products for human use (CP)

See "Volume 2C" (Guideline on the packaging information of medicinal products for human use authorised by the Union)

Iceland-specific requirements (blue box) for labelling and package leaflet text for MR, DC and nationally authorised medicinal products for human use

"Blue box" text.

Iceland-specific requirements (blue box) for the labelling of centrally authorised veterinary medicinal products (CP)

See "Volume 6C" (Guideline on the packaging information of veterinary medicinal products authorised by the Union) and "Blue box" text (Blue-box requirements and additional information on labelling/package leaflet).

Iceland-specific requirements (blue box) for labelling and package leaflet text for MR, DC and nationally authorised veterinary medicinal products

"Blue box" text (Blue-box requirements and additional information on labelling/package leaflet).

Red warning triangle

The red warning triangle is part of the Iceland-specific requirements (blue box) for additional labelling on the packaging of medicinal products. Medicinal products that may impair the ability to drive and use machines must be labelled with a red warning triangle.

The red warning triangle can be found on the packages of certain medicinal products and is intended to indicate that the medicinal product may cause sedation that affects the ability to drive and to perform tasks requiring full alertness.

Marketing authorisation holders must ensure that packages of medicinal products are labelled in accordance with the product information.

Differing requirements between the Nordic countries have created inconsistencies for Iceland. Medicinal products on the Icelandic market are very often in multilingual packages, and due to the small size of the market, Iceland more often than not shares packages with one of the Nordic countries. There is therefore a risk that not all medicinal products marketed in Iceland that may affect the ability to drive and use machines are labelled with a warning triangle.

The Icelandic Medicines Agency (IMA) reiterates the requirements for special labelling on the packages of medicinal products marketed in Iceland. If a medicinal product is considered to warrant a red warning triangle but the triangle is not present on the multilingual package, the marketing authorisation holder or its agent shall label the packages separately.

As with other labelling, IMA may take the initiative to have the package of a medicinal product labelled with a red warning triangle. In the case of a generic medicine, the marketing authorisation holder is expected to label the medicinal product with a red triangle if the reference medicinal product carries one.

For guidance, IMA has published a list of medicinal products that are to be labelled with a red warning triangle.

The effects of medicinal products vary between individuals, and the list is therefore not exhaustive as regards the medicinal products that should carry special labelling. Medicinal products that are not on the list may nevertheless affect the ability to drive and use machines. Each individual must therefore assess their own ability when using medicinal products.

Mock-ups

Marketing authorisation holders must submit mock-ups of the packaging and package leaflet before the medicinal product is placed on the market. It should be noted that the marketing authorisation holder is responsible for ensuring that mock-ups are in accordance with the approved marketing authorisation.

New medicinal products on the market

Mock-ups shall be sent to the Icelandic Medicines Agency (IMA) no later than one month before the medicinal product is placed on the market, by email to hreinteikningar@lyfjastofnun.is or mockups@ima.is.

Mock-ups that have already been assessed in the cooperation on Nordic medicine packages (Nordic mock-up cooperation) do not need to be resubmitted.

Changes to mock-ups after a medicinal product has been placed on the market

Following IMA's processing of an application that results in changes to the text of the labelling document, updated mock-ups of the packaging shall be submitted when available, with reference to the case concerned.

Mock-ups of package leaflets do not need to be submitted for changes to the package leaflet text.

Mock-ups do not need to be submitted for technical changes, e.g. label size or layout.

Nordic medicine packages

The medicines agencies of the Nordic countries have compiled guidelines intended to facilitate the preparation of common medicine packages for the Nordic countries.

It should be considered that if the medicinal product is required to be labelled with a red warning triangle in Iceland but the triangle is not present on the multilingual packages, the packages must be labelled separately before the medicinal product is placed on the market.

Nordic medicine packages in English

To improve the supply of and access to important hospital medicines in the Nordic markets, the medicines agencies of the Nordic countries have additionally agreed on a pilot project concerning only specific hospital medicines. Under the project, the packages of these medicines on the Nordic market (labelling and package leaflet) may be in English. The project grants an exemption from the general Icelandic labelling rules until 1 January 2035.

Guidelines for Nordic medicine packages

The guidelines apply to both medicinal products for human use and veterinary medicinal products. They consist of three documents and a form, which are available on the website of the Swedish Medical Products Agency (Läkemedelsverket):

• Guideline on Nordic packages

• Q&A – Nordic Packages

• Question to the Nordic package group

• Form for requesting a mock-up assessment in the Nordic cooperation

Guidelines for Nordic medicine packages in English

The medicines agencies have compiled guidelines intended to facilitate the preparation of medicine packages in English. Applications for these Nordic medicine packages in English are made at the same time for all the Nordic countries. If an application is approved, the Icelandic Medicines Agency (IMA) will send a confirmation to the marketing authorisation holder or its agent in Iceland.

A separate joint Nordic procedure applies to these packages, and an application for them also serves as a request for a labelling exemption. It is therefore not necessary to use the standard application form for labelling exemptions in addition.

The joint Nordic procedure involves two documents and a form, which are available on the website of the Swedish Medical Products Agency (Läkemedelsverket):

• Guideline on common Nordic EN-EN only packages

• List of hospital medicines included in the project – list of substances

• Application form for Nordic medicine packages in English