Regulatory Consulting and Labelling Translation Services
By CoreX Regulatory Consulting GmbH
Within the marketing authorisation application (MAA) process of a medicinal product in the EU, the product labelling is a core element of the information describing the medicinal product.
Its finalisation and approval is the last step of the whole application and review procedure. The product labelling, product information (PI), consists of the summary of product characteristics (SmPC), the package leaflet (PL) or patient information leaflet (PIL) and the packaging labels.
These documents provide the officially approved information on the safety and efficacy of the medicine for healthcare professionals and patients.
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