Updated SmPC and PL forms

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We would like to inform all applicants and marketing authorisation holders that the forms for Summary of product characteristics (SmPC) and Package leaflet (PL) have been changed and are available on CInMED portal in the section Human medicines – Placing a medicine on the market . The change refers to new QR code for online reporting of suspected adverse reactions to medicines. Accessing the form by scanning old QR code will be possible until January 2025; after that accessing the form will only be possible by using new QR code. We kindly ask all applicants and marketing authorisation holders to use updated forms.

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