Notification duty in the event of medicines supply shortages
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.
The notification duty applies to both predictable and unpredictable supply shortages of a temporary nature and the permanent cessation of marketing. Notification must take place no later than two months before a supply shortage is expected to occur.
The marketing authorisation holder is responsible for making the notification but may assign the responsibility to the Danish market representative.
In addition to marketing authorisation holders, including parallel importers, the Danish Medicines Agency would also like parallel distributors to notify supply shortages in line with the below.
Notification duty for medicinal products for human use
According to section 22(2) of the Danish Medicines Act, the marketing authorisation holder of a medicinal product for human use is required to notify the Danish Medicines Agency of any decision about the temporary or permanent cessation of marketing at least two months before the cessation of marketing, unless special circumstances apply. The marketing authorisation holder must provide its reasons for its decision, including, in particular, if the decision results from circumstances relating to the medicine’s quality, safety or efficacy.
In the cases below, medicines supply shortages must always be notified, regardless of the level of generic alternatives.
- Medicinal products on the Danish Medicines Agency’s list of critical medicines with the following exceptions:
- The supply shortage is expected to last for seven business days or less, and no impact on the treatment of patients is expected.
- The company can itself cover the market with a pack size of the same strength and formulation, even if the pack sizes are not substitutable. However, this does not apply if this would imply a switch to a larger pack size, and the supply shortage involves medicinal products that are inappropriate to prescribe in large pack sizes, e.g. section 4 medicinal products and addictive medicines.
- The marketing authorisation holder assesses the supply shortage to be patient critical.
- The supply shortage lasts for more than 60 days.
In addition to this, marketing authorisation holders must always meet their contractual obligations regarding the notification of supply shortages in relation to other actors such as Amgros. This applies whether or not the medicinal product is on the Danish Medicines Agency’s list of critical medicines.
Notification duty for medicinal products for veterinary use
According to article 58(13) of the regulation on veterinary medicinal productsthe marketing authorisation holder shall without delay inform the competent authority which has granted the marketing authorisation or the Commission, as applicable, of any action which the holder intends to take in order to cease the marketing of a veterinary medicinal product prior to taking such action, together with the reasons for such action.
Supply shortages involving veterinary medicinal products must be notified to the Danish Medicines Agency in the following situations:
- When there is a risk of potential life-threatening or serious consequences for the health of animals because it is not possible to find alternative medicines for the treatment.
- When shortage of the medicine can affect the treatment of animals because there is no substitutable product on the market, or if the supply capacity of alternative products is uncertain. This implies that a switch must be made to another non-substitutable medicine, e.g. another medicine prescribed by a doctor or by way of a compassionate use permit.
Further information about the cessation of marketing is available here:
- Guidelines from the Danish Medicines Agency: Deregistration of medicinal products
- Guidelines on the "sunset clause" – notification about initiation or cessation of marketing of medicinal products