Medicinal product information / Authorisation renewals

To increase transparency for healthcare professionals and patients, all active substances and excipients will have to be declared on packs in a "full declaration" process. Following the same aim, and in order to enhance safety in the use of medicines, the "Black Triangle" will be introduced to identify new medicinal products subject to additional monitoring of safety, and the "Black Box Warning" to highlight special warnings in the medicinal product information. 

The product information for veterinary medicinal products will be thoroughly revised and largely adopt the structure and content of product information texts in the EU. For the sake of simplification and to minimise administrative work – and following a once-only extension of the authorisation of medicinal products five years after first authorisation – further periodic extension of a time-limited authorisation will no longer be needed. Medicinal products will remain authorised for an unlimited period after this first extension.

Last modification 03.05.2018

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