Batch Specific Request

A batch specific request is intended to ensure that a veterinary medicine can continue to be supplied in exceptional circumstances where the authorised product would otherwise not be available in Ireland and where the absence of the product might pose a threat to animal welfare. It arises when the product is not in full compliance with its marketing authorisation. In this situation, the conditions of approval are temporarily altered to allow a batch of product to be compliant with its registered marketing authorisation dossier. Batch specific requests are limited in duration and are accepted only in respect of authorised medicines.

For further details please refer to the Guide to Batch Specific Requests for Veterinary Medicines which contains additional information about the procedure.

For Batch Specific Request applications please complete the Batch Specific Requests Application Form.

The Irish Medicines Board - www.imb.ie

Batch Specific Request