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.:

PILs and packaging exemptions

In the case of medicinal products indicated for rare diseases, IMA can permit labelling and PILs to be in English or in a Nordic language other than Finnish. IMA can also grant an exemption from generally required information on the labelling or the PIL. Furthermore, exemptions can be granted for the PIL being in Icelandic if the product is not given directly to the patient for self-medication or owner/possessor of an animal in the case of a veterinary medicinal product.

(Source Directive 2001/83/EC art.63 (human medicinal products) and Directive 2001/82/EC, art.61 (veterinary medicinal products).)

Preliminary exemptions for packaging

In exceptional cases IMA can grant provisional exemptions from approved packaging in order to alleviate shortage of specific medicinal products. Each case is individually assessed, but the following information must accompany each application:

  • The number of packages to be exempted must be specified or the time limit intended for the exemption.
  • A mock-up for the intended packaging to be used while the product is not available in approved packaging.
  • If the packaging does not have the same product ID (Nordic Number) as an approved packaging, the MAH must confirm the equivalence of the products.
  • Please send applications for exemptions to [email protected]

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.

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