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When the unexpected happens: Batch Specific Variations

Posted by: , Posted on: - Categories: Variations

A batch-specific variation is a variation 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.

Every year we receive more than 200 batch specific variations, many of which are accompanied by a request for expedited assessment.

Timeframe for submitting a batch specific variation

All products released to the market must comply with the relevant marketing authorisation.  The procedure is intended to be used rarely where an unexpected or unavoidable situation has arisen, like 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 most near-matched change code should be selected from the application form but all batch specific variations follow normal Type II timelines and fees. Batch numbers and batch sizes should be specified.

Expediting batch specific variations

Where it is in the interest of public health, it is possible to expedite the assessment to help maintain supply levels of the product, like where there are no alternative suppliers. Our intention is to avoid an adverse impact on public health which would otherwise arise from interruption to supply if the normal assessment timeframe was applied.  In these cases justification is needed as to why the variation application is considered urgent and requires expedited assessment.

In the request we would expect:

  • information on the  nature of the non-compliance
  • an explanation of the public health impact if there was an interruption to supply including how the product is of major clinical significance
  • information about the supply and demand  situation including:
    • whether this is an actual or potential Out Of Stock situation
    • prescription volumes or sales demand
    • current stock levels, including current stock on the market
    • to know whether the Marketing Authorisation Holder is the only or a major supplier including percentage market share
    • information about the availability of alternative products or presentations
    • number of weeks/months of stock ready to release if the variation is approved

In the case of a potential or actual interruption to supply Marketing Authorization holders are obliged to contact the Department of Health (DH) to advise of that risk.  Before agreeing to expedite a variation MHRA will usually also discuss the situation with DH.

Requests for  expedited assessment should be submitted to the Regulatory Information Service (RIS) mailbox, or alternatively, you can call the RIS on 020 3080 7400.  If the request is agreed you will be told of the name of the relevant assessment team manager.

If you have already submitted  the variation via the MHRA Portal or CESP, please give us the reference number and the date of submission as this helps us to locate the submission. However, if you have not already submitted the batch specific variation, please attach a copy of the agreement to expedite to the cover letter of your submission and advise us when it has been submitted so that we can locate it quickly.

Timeframe for assessing a batch specific variation

We aim to validate and begin assessment of any expedited variation on the day of submission or the following day and to determine as soon as possible.  However it may be that further information is required during the assessment.  Please also remember that our agreement to expedite any variation does not necessarily mean that we will be able to approve it as submitted and it may even be refused  - but public health issues arising from an interruption to supply will always be taken into account.

Do you have any other questions about batch specific variations? Let us know in the comments below and we will do our best to answer them.

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  1. Comment by wlm posted on

    It is not mentioned above, but other guidance says the batch must still have met the release specifications. Is this still the case?

    • Replies to wlm>

      Comment by sarahroseburke posted on

      No, it is not necessary for the product to still meet the approved release specification, indeed this may be the reason to submit a BSV. In assessing the variation MHRA will consider the impact of the product test results.

  2. Comment by MM posted on

    In Annex 16 is stated"The deviation should be thoroughly investigated
    and the root cause corrected. This may require the submission of a variation to the MA for the continued manufacture of the product."
    Is this variation the Batch specific variation mentioned above in the topic? or are there other cases not clearly stated?
    Does this means that the QP discretion is always assessed and approved by MHRA?
    Is it possible to release a batch under QP discretion after having found the root cause, fixed the issue and documented the impact assessment, WITHOUT the requirement of submitting an MA Variation?

    • Replies to MM>

      Comment by sarahroseburke posted on

      Thank you for your comment - as you recognised, this is a complex area and we are working on a full response which we hope to be able to send you shortly.