The holder of a pharmacy license holder is obliged to report serious incidents in the operation of a pharmacy to the Icelandic Medicines Agency without delay. A serious incident means an incident that can or could have caused a patient damage or a violation of the provisions of Chapters IX and XII of the Icelandic Medicines Act no. 100/2020. Note that serious incidents that occur in outsourced work, such as in medicine delivery, also fall under the notification obligation.
Delivery
If any, the Agency's comments will be received by the pharmacy within five weeks of receiving this notification. Otherwise, the matter will be closed by the Agency.
Cost
There is no cost to submit a notification.
Service provider
Icelandic Medicines Agency