Improvements to the process of issuing new licences – Article 61(3) submissions

News Category: Regulatory news

Date: 13/04/2022

The HPRA has simplified the procedure for reviewing labelling mock-ups in order to accelerate the issuing of licences for new products and to provide greater predictability for applicants planning product launches. The improvements help to facilitate timely availability of new medicines for patients.

In the new procedure, only the layout, design and readability of the labelling mock-ups are reviewed. This allows the early submission of these mock-ups using an Article 61 (3) notification. As a result of this change, companies can submit the Article 61 (3) notification with the proposed labelling mock-ups at any time during the new application procedure. This facilitates the Article 61 (3) notification being reviewed in advance and approved at the same time as the new licence approval or allows a licence to issue while finalising mock-ups prior to marketing.

It is not required to resubmit amended labelling mock-ups if the labelling text changes during the new application procedure after the submission of the Article 61(3) if there have been no consequential design changes.

In addition, the HPRA reaffirms that it is the responsibility of the applicant to ensure that the final publishable versions of the national SmPC and package leaflet submitted to the HPRA based on the end of procedure texts are correct. The HPRA will not re-check these documents before publication on the HPRA website.

The HPRA will monitor the effectiveness of the changes to the process and will continue engaging with applicants to ensure the intended benefits are delivered.

For detailed information on submitting mock-ups, consult Chapter 4: ‘Procedure for submitting and approving labels and leaflets’ in the HPRA Guide to Labels and Leaflets of Human Medicines.

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