A variety of information about requirements, associated with product information, including standard templates, Icelandic translations of standard phrases, Icelandic and European rules of presentation. All the product information should be processed according to EMA templates and rules, whether the product is centrally authorised or not.
Templates and translations of standard sentences
The European Medicines Agency develops, reviews and updates templates for product information for use by applicants and marketing authorisation holders for human and veterinary medicines.
Standard terms for pharmaceutical dose forms, routes and methods of administration, containers, closures, administration devices and units of presentation are included in the Standard Terms database, which is maintained by European Directorate for the Quality of Medicines & Healthcare (EDQM).
In order to access Standard Terms, users will need to register an account with EDQM Publications registration website. Once connected a user has to select Standard Terms Online under the item 'Free access'in the menu. Further instructions are available on the site.
The IMA's volcabulary has been moved to the Icelandic Word Bank and is available online.
Please note that an asterisk (*) must be used to look for a word in a phrase. The search results will be displayed as "Lyfjafræði - Lyfjastofnun".
Guidelines on Icelandic translations in MRPs/DCPs
The IMA postpones review of Icelandic translations of PI (SmPC, PL and labelling) for medicinal products in Mutual recognition (MR)/Decentralised (DC) procedures that are not marketed in Iceland, unless the marketing authorisation holder (MAH) specifically requests review because of planned marketing of the medicinal product.
For medicinal products already marketed in Iceland, Icelandic translations are still required when maintaining the marketing authorisation.
Icelandic translations of approved PI should be sent to the IMA via [email protected] within 7 days of the end of procedure if the product is to be marketed in Iceland. If the IMA does not receive information on intended marketing in Iceland within 7 days, the IMA will assume that the product will not be marketed in Iceland at that time. The MA will then be issued without Icelandic PI.
Marketing in Iceland will then not be possible unless the IMA has received and approved the Icelandic PI. This is explained in more detail in bullet 3 below. Product names nevertheless have to be finalised before MAs can be issued. For products not intended to be marketed, an Rx status is given, even in the the case of an OTC status application. The OTC status application will be assessed when marketing is intended.
Applicants are not required to submit PI in Icelandic when applying for MA renewals or variations for medicinal products which are not marketed in Iceland. This is also applicable for MAs of products that are not marketed but have until now maintained Icelandic translations of PI.
Before a medicinal product can be marketed in Iceland, approved Icelandic PI needs to be in place. The PI shall be based on approved common texts and should be sent to the IMA which will then assess the translations. The MAH is responsible for including all changes approved since the MA grant in the Icelandic PI. In addition, the IMA requests that MAHs submit the approved PI (common texts) that the Icelandic translations are based on, along with the procedure number, e.g. DE / H / XXXX / 001-003 / 047.
The Icelandic PI and corresponding English version are to be sent to the IMA via [email protected]. The subject of the email should be: „Icelandic translations for [name of medicinal product] – [procedure number] for marketing“. The texts should be in Word format. The assessment time is 60 days from submission date. The IMA does not charge an extra fee for the assessment. A request for publication in the Icelandic medicinal price list and marketing cannot take place until the IMA has approved the Icelandic PI.
The applicant shall state via e-mail when marketing is planned. It is generally assumed that medicinal products intended for marketing will be on the Icelandic market within 12 months.
For medicinal products intended for tender participation or similar, applicants should act as is marketing is planned. If it‘s foreseen that the timeframe from the results of tender to delivery of the medicinal product is shorter than 60 days, the Icelandic PI needs to be reviewed before the results are announced, since the review of Icelandic PI can take up to 60 days from IMA‘s receival. A fast-track for the review procedure is not available.
The IMA continues to review Icelandic translations of medicinal products that share packs with the Nordic countries. If a medicinal product that shares packs with other countries is not marketed in Icelandic, a review of the Icelandic PI needs to be clearly requested in a cover letter. If such a request is not included in a cover letter, the translations will not be reviewed.
For medicinal products where some of the product strengths are marketed (but not all) and the PL is common for the different strenghts, the IMA will also review the SmPCs belonging to the strengths not marketed. Such a request shall nevertheless be stated in a cover letter with an application.