Batch-specific exemptions

Medicinal products that are marketed must comply with the requirements for quality, safety and efficacy as approved in the marketing authorisation (MA). Upon release for sale, the batch must meet the conditions stated in the MA.

When is an application for batch-specific exemptions relevant?

The procedure for batch-specific exemptions should only be used in exceptional cases to manage minor deviations for individual batches. Batch-specific exemptions should only be requested if unexpected and unavoidable situations have occurred, and approval for a batch or a few batches is necessary to deliver the medicine to the market and thereby avoid medicine shortages.

Applications for batch-specific exemptions are a national matter and apply only to the Norwegian market (also for medicines approved via European procedures). Applications for batch-specific exemptions follow the timelines for and are subject to fees similar to type II variations. It is possible to request expedited processing, but this should be specifically justified.

Types of batch-specific exemption applications

Batch-specific exemption applications are divided into deviations related to quality or deviations in the product information.

• Read more about batch-specific exemption applications related to quality.
• Read more about batch-specific exemption applications related to product information.

Shortage situations

Any potential shortage situation must be reported to DMP.

Deviations in medicines released for sale

If the medicinal product deviates from the conditions stated in the MA and has already been released for sale, batch-specific exemptions cannot be applied for. In such cases, it must be reported as a quality defect to DMP. Reporting of quality defects to DMP must be submitted in writing.

Read more about measures for quality defects in medicines.