Guidance on exemption from the Danish executive order on labelling pursuant to section 38
Pursuant to section 38 of the Danish executive order on labelling etc. of medicinal products (in Danish: “Mærkningsbekendtgørelsen”), we may, in exceptional circumstances and on conditions established in each individual case, grant exemptions from the provisions of the executive order.
An exemption will always be given for a limited period of time.
When are exemptions granted?
The Danish Medicines Agency reviews each individual application. Exemptions permitting the sale of medicines that do not comply with the rules of the executive order on labelling can be granted in special situations, for example, if medicines would otherwise go into short supply, implying that patients cannot continue their medical treatment.
Generally, permissions are not granted to sell foreign packages if the medicinal product has not previously been marketed in Denmark.
The applicant must justify why an exemption is needed and must clearly describe the difference between the present and the new packaging material (for example in table form).
We will review your application within 10 days.
The application must include information about:
- the reason why exemption is requested
- a description of the precautionary measures the applicant has taken to prevent that a similar situation occurs
- the consequences for patient safety if exemption is granted
- the difference(s) between the new and present packaging material
- duration of exemption
- number of packages
- if relevant, a copy of any decision from the Danish Medicines Agency, which has caused the application for exemption.
In deciding whether to grant exemption, the Danish Medicines Agency considers:
- whether the patients are exposed to unnecessary risks
- whether there are alternative medicinal products on the Danish market
- whether or not the medicinal product is prescription-only
- whether the medicinal product is administered by healthcare professionals
Read more about repackaging: Temporary repackaging of medicines with a marketing authorisation
Please send your request to the Danish Medicines Agency, Workflow, Axel Heides Gade 1, 2300 Copenhagen S, Denmark, or by email to email@example.com