Submitting mock-ups for labels and leaflets – updated guidance

News Category: Regulatory news

Date: 15/02/2022

The HPRA updated the Guide to Labels and Leaflets of Human Medicines on 9 February 2022. This update contains a number of important revisions and clarifications.

The guide now states that the registered text for the labels and leaflet is contained in the text versions of those documents. The label mock-ups are reviewed only for design, layout and readability issues. The guide clarifies when to submit text versions and/or mock-ups of the labels and leaflet, and when text or mock-ups may not be required.

In addition, to facilitate the timely issuing of new licences, the HPRA has separated the approval of label mock-ups from the issuing of the licence. The HPRA now requires a separate Article 61 (3) submission with the proposed label mock-ups, which can be submitted in advance of the new licence being issued to expedite the mock-up review and approval.

For more information, please refer to Chapter 4: ‘Procedure for submitting and approving labels and leaflets’ in the Guide to Labels and Leaflets of Human Medicines.

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