Apply for specific batch control of a pharmaceutical veterinary medicine
Guidance on the Specific Batch Control (SBC) scheme for release of product on to the UK market.
This guidance only applies to national authorised pharmaceutical veterinary medicines.
Specific Batch Control suitability
You may apply to specifically release a batch of product that has not been manufactured in accordance with its Marketing Authorisation (MA) or Animal Test Certificate (ATC), including in-process and final batch testing requirements, if the pharmaceutical product is nationally authorised.
When applying for Specific Batch Control (SBC), the relevant batch(es) should remain in quarantine until the VMD has issued its decision.
The SBC scheme does not apply to immunological (biological) products or products authorised via EU procedures, such as Mutual recognition or centrally authorised.
Other options
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.
Examples of suitable Specific Batch Control situations
- 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 Specific Batch Control 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 specification, FPS, formulation and manufacturing process, 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
How to submit your application
You must submit your application online using the Veterinary Medicines Digital Service (VMDS) See Submission of an application for an animal medicine licence for further guidance.
Multiple batches
If the same issue affects a number of batches, you may include all batches on the same application form. A fee will be charged for each batch.
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
- data and arguments which justify the suitability of the batch for its intended use, including copies of Certificate of Analysis or explanation of their absence
- 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
All applications are validated upon receipt to check that everything has been provided in order to begin the assessment.
It is up to you to identify and submit all the necessary information in support of your application. If the application is incomplete, we may not be able to progress your application.
We will contact you if further information is needed.
Fees
Once an application has passed validation, you will be sent an invoice for the fee by email so you must provide a valid email address in your application.
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.
See Fees applied to animal medicine authorisations applications for further guidance.
Assessment timescales
Applications will be complete within 20 days of receipt. Once the application has passed validation, it will proceed into the assessment phase. See Timetables for national applications.
If during the assessment phase we need further information from you, these timescales may be suspended until the information is received.
We will notify you of any regulatory action that we expect you to take either during or following completion of the application procedure. If the assessment outcome is to approve an application we will email your authorisation documentation.
Contact
Email s.response@vmd.gov.uk
Last updated 1 April 2019 + show all updates
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Minor changes and addition of link to new Timetables for national applications
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First published.