Batch-specific Requests

What is a batch-specific request?

A batch-specific request (BSR) is a procedure that is used to ensure the availability of a medicine in Ireland.

When should a BSR be used?

• when a product that is in compliance with its manufacturing authorisation is temporarily unavailable or,
• where a product that is not in compliance with its manufacturing authorisation but can be brought into compliance

For products that are temporarily non-compliant, the MAH must provide assurance that the deviation is minor and non-critical. If not, they must propose an action to address the deficiency. An example of this is repackaging with the approved product information.

When should a BSR not be used?

• A BSR should not be used by the MAH when a batch does not comply with the registered finished product specifications.
• A BSR should not be used for products not registered in Ireland.
• Exceptional cases may be considered on a case-by-case basis.

How long is a BSR valid?

BSRs are intended for temporary and exceptional circumstances. They are limited in duration and normally no longer than three months.

How to apply for a BSR

To ensure that the BSR procedure is appropriate for your circumstances, please refer to the HPRA Guide to batch-specific requests for human medicines.

The Batch-specific requests application form should be completed in full, signed and sent to submissions@hpra.ie.