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Ireland's HPRA: Guide to Labels and Leaflets of Human Medicines

Last Friday (09 February 2024) the Health Products Regulatory Authority (HPRA) of Ireland updated its guidance on "Labels and Leaflets of Human Medicines" which 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.


Labels and Leaflets: Information provided with a medicine that includes essential details about its safe and effective use, typically found on the packaging and in the accompanying informational leaflet.


This guidance provides detailed instructions and standards for the preparation and presentation of labeling and leaflets to ensure patient safety and compliance with regulatory requirements. The guide is based on European Union (EU) and Irish legislation, which mandates specific requirements for the labeling and packaging of medicinal products. This ensures consistency and compliance across all member states.


The product information texts (SmPC, label and leaflet texts) are agreed in the national procedure or MR/DC procedure for new applications. The registered product information comprises the text versions of the SmPC, package leaflet and package labelling approved by the HPRA at the end of a new application procedure.


It is not necessary to submit product information at the end of the renewal procedure unless changes to product information are being introduced during the renewal. If the changes are a consequence of changes to the SmPC, the revised labels and/or leaflet should be provided with the variation application to update the SmPC. A mock-up of the leaflet is not required, except where significant design changes are proposed that require appropriate user testing and thus submission of a variation application.


To confirm that there are no readability issues with labelling, the HPRA needs to see label mockups, If the product is to be marketed in Ireland a national text version of the agreed package leaflet is required. A mock-up of the package leaflet is not required as the layout and design of the leaflet has been evaluated during the user testing assessment in the new application.


The label must contain all elements required by Article 54 of Directive 2001/83/EC. By adhering to these guidelines, companies can help ensure that patients receive clear and accurate information about their medications. For further details, you can access the full guide here.



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