Icelandic Medicines Agency

Package labelling and leaflets

Requirements for the labelling of medicinal products are laid down in the Regulation on Marketing Authorisations for Proprietary Medicinal Products, their Labelling and Package Leaflets, No. 545/2018. Requirements for labelling on the immediate and outer packaging of veterinary medicinal products shall also comply with Article 13 of Lög um dýralyf, No. 14/2022.

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):

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):

Exemptions from packaging labelling requirements for marketed medicines

Subject to certain conditions, the Icelandic Medicines Agency (IMA) may grant exemptions from packaging labelling requirements for medicines that have a marketing authorisation and are marketed in Iceland. Such exemptions are generally temporary, but in specific and limited circumstances they may be granted indefinitely.

Temporary exemptions from Icelandic labelling requirements

IMA may grant temporary exemptions from packaging requirements for medicines that have a marketing authorisation and are marketed in Iceland. Temporary exemptions are generally granted for no more than one year at a time.

Examples of temporary exemptions:

Medicine shortages: If no equivalent medicine meeting the labelling requirements is on the market and there is a shortage, IMA may grant temporary exemptions in certain cases. Each case is assessed individually. This authority is based on Articles 30, 31 and 42 of
Regulation No. 545/2018
.
Small immediate packaging: IMA may grant a temporary exemption from labelling requirements for small immediate packaging if the labelling is in English or a Scandinavian language, provided that the packaging does not contain additional information considered important. This may be requested during the national phase of the marketing authorisation procedure or after the marketing authorisation has been granted, using the application form described below. This authority is based on Articles 27 and 28 of
Regulation No. 545/2018
.
H-labelled medicines that the marketing authorisation holder confirms are used only in healthcare institutions and are not supplied to patients. For these medicines, an exemption from Icelandic labelling requirements for the immediate and outer packaging may be requested, provided that the labelling is in English or a Scandinavian language and the packaging does not contain information considered necessary to provide in Icelandic. This authority is based on Article 30 of
Regulation No. 545/2018
. Please also see the electronic patient information project for H-labelled medicines.

Temporary exemptions from the red warning triangle requirement

The red warning triangle is part of Iceland’s specific requirements (blue box) for additional labelling on medicine packaging. Medicines that may impair the ability to drive and use machines must be labelled with a red warning triangle. If an originator medicine carries this label, the generic medicine must always carry the same label.

IMA maintains a list of medicines that must be labelled with a red warning triangle.

Marketing authorisation holders and representatives must ensure that the packaging of medicines on the list is labelled with a red triangle. If the red warning triangle is not printed on the packaging, it must be added using a sticker.

Medicines on the list that are H-labelled and therefore intended exclusively for use in healthcare institutions are exempt from this rule, although it is recommended that H-labelled medicines also carry a red warning triangle. IMA does not grant exemptions from the red warning triangle requirement on the grounds that a medicine is supplied in a multilingual pack shared with countries where the red warning triangle does not apply.

Temporary exemptions only

IMA grants only temporary exemptions from the red warning triangle requirement, and only in the event of a serious medicine shortage.

In this context, it should be reiterated that if the red triangle is not printed on the packaging, it must be added, for example using a sticker. It is therefore essential that marketing authorisation holders and representatives take this procedure into account and explore all possible ways to minimise the risk of medicine shortages.

Temporary exemptions from the red warning triangle requirement are granted only for very short periods. If IMA grants a temporary exemption, the marketing authorisation holder or representative applying for it must inform all pharmacies of the medicine concerned and the duration of the exemption.

An exemption from the red warning triangle requirement is unlikely to be granted if a comparable medicine that meets the requirement is on the market and can meet demand.

IMA does not grant permanent exemptions from the red warning triangle requirement.

An exemption application will only be processed if it is submitted by the marketing authorisation holder or its authorised representative. A formal, written Power of Attorney (PoA) is required to demonstrate the representative’s authority to act on behalf of the marketing authorisation holder in dealings with IMA and must accompany the application.

IMA only considers requests for exemptions from the red warning triangle requirement for medicines on its list of medicines that must carry a red triangle. IMA does not consider requests for exemptions from the red warning triangle requirement for medicines that are not on this list. Such requests must therefore not be submitted to IMA.

Indefinite exemptions from Icelandic labelling requirements

In exceptional cases, IMA may grant indefinite and permanent exemptions from packaging requirements for medicines that have a marketing authorisation and are marketed in Iceland. Applications for indefinite exemptions will only be considered in the following circumstances:

For medicines used to treat very rare diseases, IMA may grant indefinite permission for the packaging labelling and package leaflet to be in English or a Nordic language other than Finnish. When assessing whether a medicine is used to treat very rare diseases, IMA follows the definition in European Commission
Regulation No. 141/2000
on orphan medicinal products. The package leaflet must always be available in Icelandic in the Medicinal Product Information database.
To safeguard public health and the public interest, IMA may, in specific cases, grant a permanent exemption from the requirement to include certain information on the packaging and in the package leaflet. For the same purpose, IMA may also grant a permanent exemption from the requirement for the package leaflet and/or packaging labelling to be in Icelandic, provided that the medicine is not supplied directly to a patient for self-treatment or, in the case of a veterinary medicine, to the animal’s owner or keeper. The package leaflet must always be available in Icelandic in the Medicinal Product Information database.

Applications for exemptions from Icelandic package leaflet and/or labelling requirements

Each case is assessed individually. The application form is available under Published material, Forms.

Applications for exemptions from the requirement for an Icelandic package leaflet and/or Icelandic packaging labelling must be emailed to lyfjastofnun@lyfjastofnun.is. The subject line must read “Application for a labelling exemption – xxxxx (name of medicine)”.

IMA will only process an exemption application if it is submitted by the marketing authorisation holder or its authorised representative. A formal, written Power of Attorney (PoA) is required to demonstrate the representative’s authority to act on behalf of the marketing authorisation holder in dealings with IMA and must accompany the application.

IMA may request additional information if necessary. Applications are generally processed within two weeks; please submit applications in good time. If faster processing is requested, state the reason and the date by which a decision is needed. When reviewing the request, IMA assesses the requested timeframe and the prioritisation of work. The applicant will be informed of the processing time.

Applications for exemptions to distribute individual batches that deviate from the marketing authorisation