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.

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.:

• Guideline on Nordic packages
• Frequently asked Questions - Nordic Packages
• Question to the Nordic package group
• Nordic mock-up assessment cooperation request form

Exemptions from package labelling requirements of marketed medicinal products

The Icelandic Medicines Agency is under certain circumstances authorised to allow for exemptions from package labelling requirements of medicinal products that have an Icelandic market authorisation and are marketed. Generally, such exemptions are granted on a temporary basis, but under extraordinary circumstances, an exemption can be granted permanently.

Temporary exemptions for marketed medicinal products

The Icelandic Medicines Agency can grant exemptions from requirements made to packaging of medicinal products that have an Icelandic marketing authorisation and are marketed with the aim of preventing shortages. Generally, such exemptions are granted with a validity of 12 months. Please note that in cases where another or a similar medicinal product, that is fully compliant with the terms of its marketing authorisation is marketed and can meet market demands for supply, it is less likely that a temporary exemption will be granted.

Application for a temporary exemption

Each instance is assessed on a case-by-case basis, but the following information much accompany an application for a temporary exemption.

1. Reasoning on how the application fulfils the above criteria to prevent shortages and why the terms of the marketing authorisation regarding Icelandic labelling cannot be fulfilled, partially or completely.
2. Information on the number of packs of the medicinal product the application is to cover, or the timeframe of validity of the exemption which is applied for.
3. Mock-ups of the packaging material which is to be used for the time of validity of the exemption.
4. Confirmation from the marketing authorisation holder that the medicinal product applied for is the same medicinal product, in cases the medicinal product is not covered by a central marketing authorisation and/or the packaging does not state the same Nordic article number (Vnr) as the Icelandic packaging articles.

Applications for exemptions from the requirement of an Icelandic package leaflet and/or Icelandic labelling on outer packaging shall be delivered via email at [email protected]. The subject line of the email shall state: „Application for a temporary exemption from Icelandic labelling “

An application will only be taken into consideration at the Icelandic Medicines Agency if it comes directly from the marketing authorisation holder or an authorised local representative. A formal, written Power of Attorney (PoA) document is required.

The Icelandic Medicines Agency reserves the right to request further documentation.

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 when:

• 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. See further on the EMA website. 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 for a permanent exemption

Each instance is assessed on a case-by-case basis, but the following information much accompany an application for a temporary exemption:

1. Reasoning to show how the application meets either of the above criteria for a permanent exemption and why the terms of the marketing authorisation regarding Icelandic labelling cannot be fulfilled, partially or completely.
   
2. Mock-ups of the packaging material which is to be used for under the terms of the exemption.

Applications for permanent exemptions from the requirement of an Icelandic package leaflet and/or Icelandic labelling on outer packaging shall be delivered via email at [email protected]. The subject line of the email shall state: „Application for a permanent exemption from Icelandic labelling “

An application will only be taken into consideration at the Icelandic Medicines Agency if it comes directly from the marketing authorisation holder or an authorised local representative. A formal, written Power of Attorney (PoA) document is required.

The Icelandic Medicines Agency reserves the right to request further documentation.