Application for batch-specific exemptions related to product information

The applicant must demonstrate that deviations in packaging materials do not affect quality, safety or efficacy. The applicant should also provide a risk assessment based on relevant professional evaluations, along with proposals for measures to prevent recurrence.

Examples of batch-specific exemption applications related to product information:

• deviations from approved packaging materials (package leaflet and labeling), including safety features
• delayed implementation of product information
• repackaging

How to apply?

Use the application form for batch-specific exemption.

Application for batch-specific exemption

Emails containing batch-specific exemption applications must be clearly marked with "Batch-specific exemption application related to product information" and sent to post@dmp.no.

Application for exemption from Norwegian package leaflet and labelling

In cases where there is a need to temporarily place foreign packaging on the Norwegian market, an application for exemption must be submitted in accordance with article 63(1) or 63(3).

The Norwegian marketing authorisation holder can apply for permission to sell foreign packaging. Applications can be sent via email to pi@noma.no.

Please note that a new item number should not be ordered, as the foreign packaging is placed on the market in accordance with the Norwegian packaging.

Deviations in medicinal products released for sale

If the medicinal product deviating from the conditions stated in the MA has already been released for sale, batch-specific exemption applications cannot be submitted. In such cases, a written report of quality defects must be sent to DMP. Read more about measures for quality defects in medicinal products.