New criteria for the notification of medicines supply shortages
The Danish Medicines Agency has established new criteria for when companies must notify medicines supply shortages. The new criteria make it easier for the companies to know when and for which medicinal products they must notify supply shortages, and a new form has made notification even easier.
The Danish Medicines Agency keeps a close watch on the medicine supply in Denmark to ensure the Danish population has access to safe medicines.
As part of this work, the agency has developed new criteria for when a company is required to notify medicines supply shortages to the Danish Medicines Agency. As a result, it will be both easier to see when and how to notify supply shortages.
New list of critical medicines
In future, the companies must look up the Danish Medicines Agency’s new list of critical medicines to determine if a supply shortage involving a particular medicinal product must be notified. Supply shortages affecting medicinal products on the Danish Medicines Agency’s list of critical medicines are subject to notification. Companies are also required to always notify supply shortages that are expected to last for more than 60 days as well as supply shortages of medicinal products assessed by the company to be patient critical.
“With the launch of the new list of critical medicines we want to make it easier for the companies to know for which medicines, notification of supply shortages is always requested. The list provides a complete overview, so that you only need to look for information in one place, which makes the process easier for all parties involved,” says Jeanne Majland, Director of Department at the Danish Medicines Agency, and adds:
“We are also proud that the list has come into being in a successful collaboration with external parties that has meant that all expert perspectives are represented. I’d like to thank everyone who provided valuable feedback in the process.”
The new list has been submitted for consultation among the medical societies and Danish Patients. The intention is for the list to be updated regularly.
New form improves the process
Supply shortages must be notified at least two months before the company expects a medicines supply shortage to occur. For this purpose, a new form has been prepared to facilitate notification for the companies and at the same time ensure that the relevant data are reported correctly from the start:
“Before, notification took place by way of a Word file in which everything was free text, which led to many follow-up emails between the companies and the Danish Medicines Agency. With the new form, many of the possible answers are categorised to ensure we get the right input from the start and thus will be able to start the crucial review more quickly, which we know will often mitigate the consequences of a supply shortage,” says Jeanne Majland.
The Danish Medicines Agency considers a supply shortage situation to exist when a marketing authorisation holder is incapable of meeting the wholesalers’ demand for a medicinal product.