Clarification on companies’ notification of supply problems to the Danish Medicines Agency
The Danish Medicines Agency would like to clarify when and how companies must notify the Danish Medicines Agency of any supply problems they might experience.
In Denmark, the continued supply of medicines is usually not a problem, but supply failure cannot always be avoided. Most often it makes no practical difference to people in Denmark because the pharmacy is able to dispense an alternative product that corresponds to the medicine prescribed by the doctor. But occasionally it does happen that a supply failure affects the treatment of patients.
When it does, the companies have a statutory commitment to notify the Danish Medicines Agency at least two months before the supply problems become a reality. Should it happen that the company does not become aware of the supply problems until later, the Danish Medicines Agency expects to be notified by the company immediately.
The below is a summary, and companies must use this page to report supply problems.
How to notify the Danish Medicines Agency
The Danish Medicines Agency must be notified in situations
- when there is a risk of potential life-threatening or serious consequences for the health of patients
- when shortage of the medicine can affect the treatment of patients because there is no substitutable product on the market
In such cases, the company must inform the Danish Medicines Agency of
- the reason for the supply failure
- the date – if possible – when the medicine is expected to be back on the market
- a risk assessment of the expected consequences
- a proposed plan to mitigate the consequences
- the measures to be taken by the authorities in the opinion of the company
Special alertness under the COVID-19 pandemic
The Danish Medicines Agency is keeping a watchful eye on the supply conditions under the COVID-19 pandemic and has asked companies to pay extra attention to any COVID-19-related supply problems, no matter which factors are threatening supplies.