Labelling National Requirements
An overview
Requirements for labelling on packaging
Requirements for labelling of medicinal products are according to Regulation No.545/2018 (in Icelandic only) on marketing authorisations for proprietary medicinal products, their labelling and PILs
Mock-ups should be submitted to the Icelandic Medicines Agency one month before the medicinal product is marketed or when publication of information in the Drug Catalogue and the Price List is requested. 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. Submission of updated mock-ups involving safety information is necessary. Submission of updated package leaflets or labelling involving technical updates 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.:
- Guideline on Nordic packages
- Frequently asked Questions - Nordic Packages
- Question to the Nordic package group
See Swedish Medical Products Agency site
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.
National requirements (blue box) regarding labelling of centrally authorised human products
Please refer to Volume 2C (Guideline on the packaging information of medicinal products for human use authorised by the Union ).
National requirements (blue box) regarding labelling/package leaflet of human products authorised via MR, DC or national procedure
National requirements (blue box) regarding labelling of centrally authorised veterinary products
Please refer to Volume 6C (Guideline on the packaging information of veterinary medicinal products authorised by the Community).