Guidance on the Specific Batch Control (SBC) scheme for release of product on to the UK market.
This guidance applies to pharmaceutical veterinary medicines only.
You may apply to release a batch of product that has not been manufactured in accordance with its Marketing Authorisation (MA), including in-process and final batch testing requirements, if the product:
- is nationally authorised
- is authorised under an Animal Test Certificate (ATC)
- is pharmaceutical
The Specific Batch Control scheme does not apply to products that are:
- Mutually recognised or centrally authorised
When applying for SBC, the relevant batch(es) should remain in quarantine until the VMD has issued its decision.
Prior to submission
You should consider whether it is appropriate to apply for SBC taking into account the views of the Qualified Person (QP) as to the suitability of the batch for its intended use.
You should consider whether to vary the authorisation instead as this will apply to all batches of the starting material or finished product.
If a batch of product is already on the market and the QP does not think SBC is suitable and that batch recall is necessary, you should contact the VMD immediately providing details of the nature and extent of the recall.
How to apply
You may submit your application electronically, or in hard-copy.
If the same issue affects a number of batches, you may include all batches on the same. A fee will be charged for each batch.
All applications are checked (validated) upon receipt.
It is up to you to identify and submit all the necessary information in support of your application. If the application is incomplete, it is likely to fail validation.
Once the application has passed validation, it will proceed into the assessment phase.
If the outcome is to approve an application, you will be sent authorisation documentation at the end of the application procedure
If required, the VMD will notify you of any regulatory action that it expects you to take either during or following completion of the application procedure.
Supporting Data - Requirements
You should provide:
all data and relevant material relating to the finding of the batch deviation; complete batch records are not required
copies of the relevant Certificate of Analysis together with the data and / or arguments which justify the suitability of the batch for its intended use
where appropriate, an explanation to address the need for corrective measures to avoid a future reoccurrence of the problem. If relevant, notification of any planned variation applications and the timescale for submitting these.
Validation - validated within 3 days of receipt
Initial Assessment - Approved, refused, or questions asked within 10 days of passing validation
Company Response - If questions asked, you should provide a full company response within the deadline given
Sign-off - Approved or refused within 10 days from receipt of a full company response; the timescales may be suspended once more during this phase if further information is required from you
Issue - Following approval, a certificate will be issued within 3 days
Once an application has passed validation, you will be sent an invoice for the fee.
The fee is £560
If other batches of the same product are affected by the same issue, then a fee of £100 will be charged for each subsequent batch applied for at the same time
The VMD now issues all invoices electronically, so you must provide a valid email address of where to send the invoice; failure to do so will result in your application being rejected.
Requirement for Specific Batch Control include
Examples of situations when it may be appropriate to apply for a SBC :
a batch of the finished product marginally fails to meet the agreed release Finished Product Specification (FPS) for one parameter which will not have a negative impact on the stability of the product nor its safety and efficacy
a batch of the active substance has been subjected to an additional purification step and the rework procedure is not described in the MA dossier. The solvents used and their residual levels do not have an adverse impact on the safety of the product or its physico-chemical characteristics or stability. The batch of active substance may be destined for use in the manufacture of several batches of the finished product
the labelling of the finished product is not in strict accordance with the agreed labelling but the differences are minor and will not have any adverse impact on the safe use of the product
*on-going stability studies for a particular production batch of finished product have identified that a parameter may just fall outside the agreed shelf-life. FPS limits the time the batch reaches the end of its shelf-life but this will not have an adverse impact on safety or efficacy of the product. A justified widening of the shelf-life limits for the relevant parameter is proposed for that specific batch
- a conservative extension to the shelf-life of one batch of the finished VMP beyond the approved shelf-life is required in order to avoid a supply problem in the market place. The batch has been retested against the complete FPS within three months of its expiry date and there is no evidence of any significant degradation
When an SBC is not required
In the following cases, a batch of product may be placed on the UK market without the need for SBC:
the deviation is minor, one-off and unplanned in nature and relates only to the manufacturing process and/or the analytical control methods of either the starting materials or the medicinal product as described in the MA
the active substance and FPS as described in the MA are complied with
an assessment is performed by the manufacturer using the approaches described in ICH Q9, Quality Risk Management, to support a conclusion that the occurrence is a minor quality deviation that does not affect the safety and efficacy of the product
the risk assessment should assess the need for inclusion of the affected batches in the on-going stability programme
the Quality Risk Management Programme is integrated into the manufacturer’s quality assurance system, notably the documentation system established to comply with GMP, and records are available for inspection by the Competent Authorities
all such deviations must be reviewed as part of the annual product quality review. Inspectors will examine the files logging use of this system to ensure that it is not abused and will take a serious view of any abuse