Amended policy relating to patented indications
The Medicines Evaluation Board (MEB) will no longer publish the full product information about the active substance of generic medicinal products on its website if an indication is still subject to a patent. This has been announced recently by the MEB in the news item Change in policy on patient information due to judgement by the European Court of Justice.
The new policy can be found on the page Patented indication. It states how marketing authorisation holders can remove a patented indication from the product information.
After approval of the variation, the indication is no longer part of the marketing authorisation and will no longer be listed in the SmPC and package leaflet. This is also the case when receiving the notification, depending on whether the product has been authorised via the national or decentralised/mutual recognition procedure. The MEB will then remove the patented indication from the Medicines Information Bank.
Within 2 weeks, the MEB will send a letter to the marketing authorisation holders of generic medicinal products for which a patented indication is still included in the Medicines Information Bank. The marketing authorisation holders do not need to wait for this letter. If a marketing authorisation holder wishes to remove a patented indication from the product information, this can be done by submitting a variation or notification in accordance with the requirements included in the new policy.