01. Centrally Authorised Products – Does the Icelandic Medicines Agency issue approval letters?

The Icelandic Medicines Agency (IMA) issues a letter of approval in regards to new marketing authorisations, renewals, line extensions, withdrawals, suspensions and lifting of suspensions. In general, variations are considered automatically approved in Iceland at the same time as in the EU Member States. Consequently IMA does not issue letters of approval regarding for example for new indications and new presentations. However, IMA issues a letter of approval when a variation leads to new conditions or restrictions with regard to the safe and effective use of the medicinal product to be fulfilled before marketing in a Member State or when those conditions are changed from the ones previously fulfilled by the marketing authorisation holder. IMA also issues a letter informing the marketing authorisation holder if a variation effects the prescription status of the medicinal product in Iceland. (21.9.2015)