Icelandic Medicines Agency
Text processing
This page brings together various information on the requirements for the preparation of product information texts, including information on standard layout, Icelandic translations of standard statements, Icelandic and European rules on the presentation of texts, glossaries, etc. When processing texts for all medicinal products, the templates and rules issued by the European Medicines Agency must be followed, whether or not the medicinal products are centrally authorised.
See also the information on package labelling and package leaflets.
Information on excipients and Icelandic translation
Information on excipients and the Icelandic translation can be found on the European Medicines Agency's website.
Templates and standard texts
The European Medicines Agency's website contains an Icelandic translation of the product information templates. There is also an annotated template with explanations and guidance, but it is available in English only.
The site also contains various documents with Icelandic translations of standard texts for:
Standard terms
The standard terms for pharmaceutical forms, containers and routes of administration and their translations are published by the EDQM (European Directorate for the Quality of Medicines & HealthCare).
To view the lists, you need to register on the site (the "register" link on the site) and then select "Standard Terms Online" under "Free access". All instructions are on the site. After the first registration, the database is always accessible by entering your email address and password.
Preparation of texts
The European Medicines Agency publishes guidance on the preparation of texts.
Bear the following in mind when preparing texts:
The names of proprietary medicinal products shall not be inflected
If a submitted text proposal is not acceptable in IMA's assessment, it will be returned.
The Icelandic Medicines Agency (IMA) reviews texts to ensure that they are correct in substance and comments on translation errors or anything else that may cause misunderstanding. IMA generally does not correct typographical errors and generally makes no changes to texts other than substantive ones.
Glossaries
IMA's terminology list is available in the term bank of Íslensk málstöð under the name "Lyfjafræði - Lyfjastofnun".