Exemption from the requirements for labelling, implementation deadlines, package leaflets etc. for medicinal products

Updated 23 June 2025

Please note that as of 23 June 2025, applications for exemption must be submitted via our new digital application form. See the link below.

An exemption is a temporary authorisation granted by the Danish Medicines Agency allowing the sale of an authorised medicinal product in Denmark, even when the product does not fully comply with the statutory requirements for labelling, package leaflet, or related elements.

Pharmaceutical companies must apply for an exemption if, for a limited period, they wish to place on the market medicinal product packages that do not meet these requirements.

Such exemptions may apply in situations where the packages:

  • contain errors in the labelling or package leaflet
  • are presented in a foreign language
  • include an outdated version of the labelling or package leaflet 

When are exemptions granted?

The Danish Medicines Agency assesses each application on a case-by-case basis, taking into account the specific circumstances involved.

Exemptions are granted only in exceptional situations and are subject to conditions determined in each individual case.

An exemption is granted for a limited period of time only.

For example, an exemption permitting the sale of foreign packages or medicinal products that do not meet the requirements for labelling, package leaflet, etc., may be granted if the product would otherwise go out of stock, no suitable alternatives exist, and patients would be unable to continue their treatment.

As a general rule, exemptions are not granted for the sale of foreign packaging if the medicinal product has not previously been marketed in Denmark..

How to apply

Please complete the digital application form via the link below:

Application form for exemption

If you experience any issues with the form or do not receive a confirmation of submission, please send an email.

We aim to review the application within 10 business days.

When assessing an application, the Danish Medicines Agency takes particular account of the following criteria

  • whether the exemption poses any risks to patient safety
  • whether alternative medicinal products are available on the Danish market
  • whether the medicinal product is considered critical to the Danish market
  • whether the medicinal product is prescription-only, over-the-counter, or restricted to hospital use
  • whether the medicinal product is administered by the patient or by healthcare professional

Foreign packages

If the application concerns the temporary sale of a foreign package, the applicant should be aware that, as a condition for granting an exemption, the outer packaging must be relabelled to include the Danish product number (varenummer/Vnr) and the Danish marketing authorisation number (MA number).

In some cases, additional relabelling requirements may also apply.

Extension of implementation deadline

In the case of an exemption application to extend the implementation deadline of a variation, the application must be submitted in sufficient time to allow the Danish Medicines Agency to assess the request before the expiry of the deadline set by the Agency.

Notification duty in the event of medicines supply shortage

With reference to the guidelines available on the Danish Medicines Agency’s website Notification duty in the event of medicines supply shortages please assess whether the supply issue should be reported to the Danish Medicines Agency. If so, please report the shortage via the link provided on the webpage.

Repackaging

In the case of additional labelling etc. a minor repackaging may be required.

See our guidance Temporary repackaging of medicines with a marketing authorisation.