Last year, the Health Products Regulatory Authority (HPRA) issued a revised version of the Guide (AUT-G0035-23).
The scope of this guidance applies to the labels and package leaflets of medicinal products for human use, authorised nationally, through mutual-recognition (MR) or through the decentralised (DC) procedure.
The main updates to the guidance are contained in Section 4-Procedure for submitting and Approving labels and leaflets, the bullet points below summarise the main changes:
- Section 4.1 – label mock-ups are no longer reviewed as part of new applications and must be submitted either during or after the procedure as part of an article 61(3) notification to register the label design. All new applications are approved on the basis of the product information texts, regardless of the marketing status.
- National text registration is only required where a product has national safety warnings when authorised through MR/DC procedures.
- A mock-up of the leaflet is no longer required to be registered once the layout and design have been supported by user testing during the application. The exception to this is where the leaflet is part of a combined label-leaflet presentation.
- Section 4.2 – it is no longer necessary to submit product information at the end of the renewal procedure unless changes to product information are being introduced during the renewal. Information on submission requirements has been updated.
- Section 4.3 – the list of amendments where prior notification is not required, via Variation or Article 61(3), has been clarified in section 4.3.1.
- For products authorised through MR/DC procedures, changes that impact the common label or leaflet text must be submitted through the RMS via an MR Article 61(3) notification.
- A mock up of the leaflet is only required to be submitted where significant design changes are proposed that require appropriate user testing and submission of a variation.
- There is no longer a requirement to include a date on the clean national text version of the leaflet that will be published on the HPRA website.
- Clarification has been provided on Mock-up preparation and submission in section 4.3.3.
- Section 10 – submission of an article 61(3) including mock-ups is required if the implementation of the safety features results in changes to the label not covered by section 4.3.1.
For further information please contact info@acornregulatory.com or call 00 353 52 6176706
