Product labels and the package leaflet play an essential part in the safe and effective use of the
medicine by both the patients and healthcare professionals. Thus, the approval of the label and
package leaflet is an intrinsic part of the authorisation process for all medicinal products.
The guidance in this document applies to the labels and package leaflets of medicinal products for human use, authorised nationally, through mutual-recognition, or through the decentralised procedure.
The guidance does not apply to medicinal products authorised through the centralised procedure.
Labels and leaflets should be prepared in line with directive requirements and with the advice available in EU guidelines.
Further additional advice is provided in this guidance document.
This guidance was released on 17-June-2021 and you can search all the guidance realted with HPRA in this link