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REGULATORY NEW | ePI

October 20, 2023
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Did you know that the first ePI has been published in the Product Lifecycle Management Portal of the European Medicines Agency (EMA)?

Check it out here! PRODUCT LIFECYCLE MANAGEMENT PORTAL- ePI

ePI refers to the authorised, statutory product information for medicines (including the summary of product characteristics, package leaflet and labelling) adapted for handling in electronic format and dissemination via the web, e-platforms and in print. It is the result of the ePI pilot project that started in July, 2023, managed by the EMA and a a  group of its European medicines regulatory network partners (Denmark, the Netherlands, Sweden and Spain).

Need help for your regulatory affairs? Contact us! [email protected]

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