Batch-specific variation applications
All medicinal products QP released to the market must comply with the requirements for quality, safety and efficacy approved with the relevant marketing authorisation (MA).
A batch-specific variation is an application to request agreement for a single batches of product to be released outside of the conditions of the MA. This procedure is intended to be used when an unexpected or unavoidable situation has arisen and approval is needed to maintain stock on the market. Consequently, such variations should only be submitted in exceptional circumstances. The MAH should ensure that the deviation cannot be handled by the responsible QP (see GMP Annex 16, Chapter 3), before considering to apply for a batch-specific variation.
With a batch-specific variation the marketing authorisation holder (MAH) has to ensure in each separate case that:
- the deviation from the requirements in the MA do not affect quality, safety and efficacy or
- the deviation related to the quality of the medicinal product do not have negative impact on the safety and efficacy
Batch-specific variations can include among other things:
- deviation from the requirements in the MA (e.g. quality documentation)
- deviations from the approved packaging material including safety features
- deviations from the approved labelling
- delayed implementation of the product information.
The applicant should present risk assessment based on relevant competent evaluation for the sake of supporting the application. Suggestions for action to avoid recurrence should be provided.
Batch-specific variations are national matter, and refer only to the Norwegian market for medicinal products. This includes medicinal products approved in EU procedures. Batch-specific variations follow the timeline and the fees as for Type II variations. There is an opportunity to ask for an accelerated assessment of the batch-specific variation, but this should be specifically justified.
If the batch of the medicinal product which deviates from the conditions in the MA is already QP released for sale, this cannot be resolved by batch-specific variation. In these cases, the MAH shall report a quality defect for the medicinal product to NoMA. The report on the defect shall be sent in writing. Read more here: Tiltak ved kvalitetssvikt på legemidler (Norwegian).
Batch-specific variations shall be applied for by e-mail to email@example.com with a clearly presented subject title as either "Batch-specific variation" or "Batch-specific variation related to Product Information".