Application for batch-specific exemptions related to quality documentation

Before the MA holder considers applying for a batch-specific exemption, it should be ensured that the deviation cannot:

• be managed by the responsible QP (GMP Annex 16, Chapter 3)
• be managed by applying for a permanent change

Batch-specific exemptions related to quality can be applied for to manage minor deviations from MA documentation for individual batches if:

• there are deviations from the conditions in the marketing authorisation related to the product's quality.
• unexpected and unavoidable situations have occurred, and
• approval for a batch or a few batches is necessary to be able to supply the product to the market and thereby avoid medicinal product shortages.

Regarding medicinal product shortages in this context, it should first be clarified whether interchangeable products and/or other alternative products are available that can be used instead of the product being applied for.

When applying for batch-specific exemptions, the MA holder should demonstrate in each case:

• that the deviation from the conditions in the marketing authorisation does not affect quality, safety, and efficacy, or
• that the deviation related to the product's quality does not negatively impact safety and efficacy

The applicant must provide a risk assessment based on relevant scientific evaluation to support their application as part of the submission. There should also be proposals for measures to avoid recurrence.

How to Apply

Use the application form for batch-specific exemption:

Application for batch-specific exemption (Word, 39 KB) (downloadable file)

Emails containing the application should be clearly marked with "Batch-specific exemption quality." Completed forms should be sent to post@dmp.no.

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 exemptions cannot be applied for. In such cases, a written report of quality defects must be submitted to DMP. Read more about measures for quality defects in medicinal products.