Batch Specific Variations – are you aware of the opportunities?
Batch Specific Variations (BSVs) are one of my favourite activities to do – they are fast paced, put my regulatory expertise into action and often mitigate against potentially devastating consequences for patients – Commercial and Finance are normally quite pleased with the outcome too!
I wouldn’t normally recommend reading guidance willy nilly, however I believe BSVs should be something every regulatory professional should understand, since they can bring the opportunity for the company to continue supply to patients and avoid writing off stock, which also alleviates pressure on manufacturing.
BSVs effectively change the marketing authorisation for the batches concerned, which could be one batch or a collection of batches. The change must not impact the safety, efficacy or quality of the product and the submission must be made and approval received before QP release.
Depending on the root cause, BSVs can be complex with many moving parts and it may be necessary to engage with the MHRA for an open and honest conversation about your options. The MHRA are usually very pragmatic in these situations, although getting hold of them is much harder than it used to be, so chase often.
Type II timelines apply, unless you have received agreement for an expedited assessment, which will only be agreed if it is a matter of public health. To request agreement, justification is required as well as endorsement from the Department of Health and Social Care (DHSC) and, if agreed, you will be able to contact the assessor directly to facilitate communication, discussions and agree documentation to submit.
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You will need to compile relevant information for the submission, which may include data, clinical assessments and justifications not typically included within a standard variation. This could mean you have to work outside of your normal internal processes in order to compile a bespoke data package to support the application. Communication with all internal and external stakeholders is key to obtaining this information quickly.
Our BSVs have been known to be approved within 1 day – but it is important to note that the reason for this quick turnaround was due to regular open conversations with the assessor, agreeing a strategy and following it up with a formal submission. Some examples of the BSVs that we have led include:
A word of warning… as soon as commercial/supply chain/manufacturing/finance etc. become aware of BSVs, they may ask you to do this time and time again. It is important to understand that while BSVs present an opportunity to the company, they are not a substitute for poor manufacturing or control of the product and should only be used in exceptional circumstances.
Reach out if you need support engaging with the MHRA or preparing your BSV!
Written by Leah Heathman