Anticipated revocation of S-classification

7.12.2012

According to Article 8(1) of the Medicinal Products Act No 93/1994 a product's marketing authorisation can be limited to hospital use (Sclassification). The Icelandic Medicines Agency has now reviewed the so called S-classification of all medicinal products which have an Icelandic marketing authorisation. The Agency intends to revoke the Sclassification of all products which are known to be used outside the hospital environment, as well as for products which are now not considered to be limited to hospital use.

A letter has been sent to those marketing authorisation holders who will be affected by the above mentioned, allowing for time to comment.

The cancellation of the S-classification can potentially result in the need for a reimbursement application to be submitted to the Icelandic Medicine Pricing and Reimbursement Committee. It may take some time for the committee to deal with such applications. The Icelandic Medicines Agency plan is that the cancellation of the S-classification will be implemented in May 2013. The exact implementation date will be published on the Agency´s website in due time. As of same time, S-classification of name patient basis use products will be changed accordingly.