A batch-specific variation is an application to request agreement for a single or small number of batches of product to be released outside of the usual conditions of the marketing authorisation. This procedure is intended to be used seldom i.e. where an unexpected or unavoidable situation has arisen (for example a production problem) and approval is needed to maintain stock on the market. Consequently, such variations should only be submitted in exceptional circumstances. In each case, the applicant should provide evidence that the quality, safety and efficacy of the product are unaffected by the deviation in the batch concerned.
The MAH has to ensure that the deviation cannot be taken care of by the responsible QP, before considering to apply for a batch-specific variation (see GMP Annex 16, Chapter 3).
With a batch-specific variation the MAH has to ensure in each separate case that:
- the divergences from the requirements in the MA do not have impact on the quality, safety and efficacy or
- the divergences related to the quality of the medicinal product do not have negative impact on the safety and efficacy
Batch-specific variations related to the product Information include among other things:
- divergences from the approved packaging material including safety features
- delayed implementation of the product information. Use the following form (processed consecutively):
The applicant should present risk assessment based on relevant competent evaluation for the sake of supporting the application. Suggestions for action to avoid recurrence shall be available.
Batch-specific variations are national matter cases and they 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 fee requirement as for Type II variations. There is an opportunity to apply for an accelerated assessment of the batch-specific variation, if the application is specifically justified.
If the batch of the medicinal product that diverges from the conditions in the MA is already QP released for sale, it cannot be applied for as a 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-mailing to email@example.com with a clearly presented subject title as either "Batch-specific variation" or "Batch-specific variation related to Product Information".