A number of important revisions and clarifications were made in the HPRA's Guide to Labels and Leaflets of Human Medicines on 9 February 2022.
In the new guide, the registered text is found in the text versions of the labels and leaflets, and the mock-ups are only reviewed for design issues, layout issues, and readability issues.
In the guide, it is explained when text versions and/or mock-ups of the labels and leaflet are required, as well as when they might not be required. Additionally, the HPRA has separated the approval of label mock-ups from the issuing of licenses to facilitate the timely issuance of licenses.
In order to expedite the label mock-up review and approval process, the HPRA now requires a separate Article 61(3) submission with the proposed label mock-ups. This can even be done in advance of the new licence being issued.
The guidelines for submitting and approving labels and leaflets are in Chapter 4: 'Procedure for submitting and approving labels and leaflets' in the Guide to Labels and Leaflets of Human Medicines.