HPRA may consider a batch-specific request application from a Marketing Authorisation Holder (MAH) in order to ensure the continued availability of a medicine on the Irish market. Such applications may be appropriate when product in full compliance with its registered Marketing Authorisation dossier is temporarily unavailable or where action is proposed to bring a batch into compliance with the registered details.
As part of any such request the MAH must provide assurance that the deviation from the registered MA is minor and non-critical and/or propose appropriate action to address the deficiency (e.g. repackaging with the approved product information).
Marketing authorisation holders are strongly discouraged from applying for a BSR when a batch does not comply with the registered finished product specifications. However, in exceptional cases non-critical deviations may be considered on a case-by-case basis.
Batch specific requests are limited in duration (normally no longer than three months) and can only be submitted for authorised medicines.
MAHs are requested to read the HPRA Guide to Batch-specific Requests for Human Medicines
and ensure that all points have been appropriately considered prior to submitting a batch-specific request using the dedicated application form.