Serious medicine supply difficulties
Serious medicine supply difficulties mean a short supply situation, which will affect the treatment of patients. For example, in case no authorised alternatives are available in the market or if such alternatives cannot be used for a certain group of patients.
Serious medicine supply difficulties can occur if the marketing authorisation holder is having delivery problems or if there are any problems relating to the quality, safety or efficacy of a medicinal product. Moreover, serious medicine supply difficulties can occur if the marketing authorisation holder, for other reasons, decides to interrupt the marketing of a medicinal product, either temporarily or permanently.
We receive reports about risks of or expected serious medicine supply difficulties from pharmaceutical companies and authorities in other countries.
When we receive information about a serious medicine supply problem, we examine how this will affect the population. Together with pharmaceutical companies and other European authorities, we will examine whether alternative medicines can be provided to meet market demand for a period.
It may also be relevant to send direct information to healthcare professionals with advice on how to deal with the short supply situation. Likewise, we may also provide information about the situation on our website.
Obligation to report serious medicine supply difficulties
In case of a medicine supply problem, the company must assess whether it will affect the treatment of patients in Denmark. If so, the company must report the serious medicine supply problem to the Danish Medicines Agency by email to firstname.lastname@example.org.
Unless it concerns acute problems, the report must be submitted no later than 2 months before the supply difficulties are expected to start, and the report must contain information about the reason why the medicinal product cannot be placed on the market.