Electronic delivery of caution-in-use letters for batch-specific requests

Electronic caution-in-use letters

Caution-in-use (CIU) letters are communications that are used by the Marketing Authorisation Holder (MAH) to inform healthcare professionals e.g., a community pharmacist, of essential information for medicine that the HPRA has agreed can be provided to Irish patients using the BSR procedure. These are usually physical letters supplied with the medicine.

Electronic communication of the CIU letter, for instance by email, may be used by the MAH in exceptional cases, e.g., when the medicine is being used in a hospital.

Requests for electronic delivery of the CIU letter are considered on a case-by-case basis. Full justification should be provided by the MAH with the batch-specific-request (BSR).

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.

Please see Batch-specific Requests for further details.

Information for Patients

If a patient has any concerns about their medicine, the HPRA recommends that they discuss their treatment with their doctor or pharmacist.

Find a CIU letter:

While the HPRA maintains a list of CIU letters, this does not replace the requirement for MAHs to distribute the CIU letter to the healthcare providers.

The MAH is responsible for the distribution of the CIU letter.

CIU letters can be found by searching the below table by product or active ingredient. For further information, contact us at info@hpra.ie.