The Icelandic Medicines Agency (IMA) is under certain circumstances authorised to allow for exemptions from package labelling requirements of medicinal products that have an Icelandic market authorisation and are marketed.
Generally, such exemptions are granted on a temporary basis, but under extraordinary circumstances, an exemption can be granted permanently.
Guidelines on applications for exemptions have been updated
The IMA has updated guidelines on applications for exemptions from package labelling requirement, including new information on when a permanent exemption can be granted, and clearer requirements for acting on behalf of market authorisation holders. The new and updated guidelines also provide clearer instructions on how to make an application.
Marketing authorisation holders, their representatives, and others involved in the production and distribution of medicines, are encouraged to familiarise themselves with the updated guidelines.