Call to industry to Apply for Marketing Authorization for Selected Medicines

The Danish Medicines Agency has introduced a new initiative to reduce the risk of shortages of critical medicines. In cases where there are no other marketed alternatives and where the Agency is aware that a particular medicine is  no longer planned to be on the Danish Market, we now  encourage other companies to apply for marketing authorization for a medicine with the same active substance, pharmaceutical form, and strength. Additionally, this may also apply to medicines with high clinical demand where no marketed medicines cover the therapeutic need.

 The list of the medicines will be available on  the Danish Medicines Agency's website, detailing  which medicines the Agency particularly encourages applications for. This list is made based on an assessment of ongoing or previous supply cases, announced withdrawals of marketing authorization, or a lack of marketed medicines where the clinical need cannot be met by other marketed alternatives.

The list includes both human and veterinary medicines, and it will specify the active substances, pharmaceutical forms, strengths, and, if applicable, pack sizes that are needed. The list will be updated continuously.

Initially, two medicines have been added to the list:

- Morphine oral Prolonged-release tablets 5 mg in small pack sizes
- Metronidazole 40mg/ml oral solution

The Danish Medicines Agency urges companies to apply for marketing authorization for these medicines with the aim of approval and subsequent marketing in Denmark.

To encourage applications, the Danish Medicines Agency may utilize various regulatory options that could make it particularly attractive to seek marketing authorization for the medicine in Denmark. The specific regulatory options that may be applied will be assessed on a case-by-case basis.

Send an email. Write "Marketing Authorization for Selected Medicines" in the subject line.

List of Critical Medicines with Supply Issues

The list will be updated continuously.