A batch-specific variation (BSV) or request is a variation application seeking approval to release one batch (or a small number of batches) of product which does not fully comply with its marketing authorisation. Often such applications are made in situations where continued product supply may be at risk, so an expedited assessment is requested.
The MHRA says “every year we receive more than 200 batch specific variations”. It is therefore worth ensuring that any BSV application is correctly written and submitted.
It is important to demonstrate that the quality, safety and efficacy of the product are unaffected by the deviation in the batch concerned. If this is not the case, the company should not be considering releasing the batch as patient safety may be put at risk.
Even though the most near-matched change code should be selected in the variation application form, it should be noted that all BSVs follow normal Type II timelines and fees unless a request for expedited assessment is made and accepted.
The MHRA blog reminds companies to include batch numbers and sizes in a BSV and goes onto lay out the requirements for expedited review which include:
- An explanation of the public health impact of a break in supply
- Information on the supply and demand situation
- Information on alternative products.
It is worth remembering that with potential or actual interruption to supply of a product, MAHs are required obliged to contact the UK Department of Health (DoH) to alert them to the situation. In addition, because the MHRA usually discuss such a situation with DoH, this may also help to get an expedited assessment.
Regulis has helped many companies deal with potential out-of-stock situations and gained rapid approval for batch specific variations, so it you are facing such a challenge and require some assistance, please do contact us.
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