Labelling Review

Product labelling is considered a critical element of the evidence submitted for prequalification assessment. Only clear and comprehensive labelling will effectively communicate the product information to the intended user and ensure the safe use of the prequalified in vitro diagnostic (IVD).

The version of the instructions for use (IFU) of the product which is submitted with the pre-submission form will be considered during the prequalification assessment. The manufacturer must obtain WHO’s written agreement prior to implementing any changes to this version of the instructions for use; otherwise, the application may be cancelled.

The product labelling will be reviewed as part of the pre-submission form, product dossier, performance evaluation and inspection of manufacturing site(s). The IFU is reviewed for clarity, correctness, consistency with the information submitted in the product dossier and in the technical documentation, and with ISO guidance (see below) and requirements, and suitability for the target user group in WHO Member States. The overall feedback on the labelling review will be provided to the manufacturer after all assessment components have been completed. If requested by WHO, the manufacturer must amend the labelling before the product can be prequalified.

The agreed product labelling will be included in the prequalification public report.