Notification of medicine supply problems
Companies must report supply problems to the Danish Medicines Agency.
The Danish Medicines Agency is following the medicines supply situation closely because the market has been destabilised by the corona crisis. We therefore need to be notified further of potential supply problems. Companies with large market shares are therefore asked to report potential supply difficulties, even though the market is expected to be supplied by substitutable medicines.
When a company experiences a problem with the supply of medicines, it must assess if it is expected to affect the treatment of patients in Denmark. If this is the case, the company must report such supply problems to the Danish Medicines Agency by filling out this form and sending it to the Danish Medicines Agency.
The obligation to notify supply problems applies in
- situations when there is a risk of potential life-threatening or serious consequences for the health of patients because it is not possible to find alternative medicines for the treatment of patients.
- situations when shortage of the medicine can affect the treatment of patients because there is no substitutable product on the market. This implies that the patient must switch to another non-substitutable medicine, e.g. a medicine dispensed according to a compassionate use permit or a new medicine prescribed by a doctor.
Under section 22(2) of the Danish Medicines Act, the marketing authorisation holder of a medicinal product for human use is obliged to notify the Danish Medicines Agency if the marketing ceases temporarily at least two months prior to cessation of marketing, unless special circumstances apply (in the event of permanent cessation of marketing, reference is made to the Danish Medicines Agency’s Guideline on the "sunset clause” – notification about initiation or cessation of marketing of medicinal products). The decision must be justified, particularly if such action is taken on grounds of the medicine’s quality, safety or efficacy. Failure to comply with the notification duty is punishable by a fine.