Revocation of S-classification status for certain medicinal products: lists

Revocation of S-classification status for medicinal products used outside hospital environment.

6.7.2018

The Icelandic Medicines Agency (IMA) has decided to revoke the S-classified status of medicinal products that have also been used outside the hospital environment as well as for products which are now not considered to be limited to hospital use. With this change the S-classification will only apply to medicinal products that are exclusively used in the hospital environment, where the right facilities, expertise and equipment is in place which is essential for correct use. This change will take effect on January 1st 2019.

According to Article 8(1) of the Medicinal Products Act No 93/1994 The IMA can limit a marketing authorisation (MA) for a medicinal product to hospital use (S‑classification). This is further specified in newly enacted regulation that took effect in May 2018. 

Review of S-classified medicinal products has been on the IMA‘s agenda for a long time as seen in earlier news reported on this site in December 2012 and May 2013. In 2012 the IMA evaluated all the S-classified medicinal products that had MA in Iceland at that time. MA holders were notified of the review and given time to comment. MA holders were also notified that the cancellation of the S-classification can potentially result in the need for reimbursement application to be submitted to the Icelandic Medicine Pricing and Reimbursement Committee. Since the 2012 review MA holders have been made aware of the upcoming review of S-classified medicinal products when a marketing authorisation is issued.

As mentioned above the aforementioned changes will take effect on January 1st 2019. Until that date all parties involved can prepare for the changes. Possible counter measures include changes in regulations, new reimbursement applications to be submitted, new budget items to account for in the state budget and possibly new reimbursement decisions to be implemented for products which have had S-classification. These changes will also affect medicinal products without MA in Iceland, that are listed by the Icelandic Medicine Pricing and Reimbursement Committee and used on a named-patient basis.

 

The lists are as follows:

  • List of authorised medicinal products for which the S-classification will be revoked on January 1st 2019.

  • List of authorised and marketed medicinal products for which the S-classification will be revoked on January 1st 2019.

  • List of  named-patient basis  use medicinal products for which the S-classification will be revoked on January 1st 2019.

Please note that the lists are still under review.


The lists will be updated at the beginning of each month because temporary S-classification will continue until these changes take effect on January 1st 2019. The lists can be found under Publications -> Lists on our website.

If you have any questions or comments please contact us by email: ima@ima.is. Subject: S-classification – comments.

Please submit comments no later than September 10th 2018.