Guideline on Labelling and Package Leaflet of Centrally Authorised Medicinal Products Updated

Recommendation

5/6 October 2023

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The Guideline of the EC Commission entitled "Guideline on the packaging information of medicinal products for human use authorised by the Union" is part of EudraLex's "Notice of Applicants; Volume 2C - Regulatory Guidelines" and contains requirements for designing the labelling and package leaflets of centrally authorised medicinal products. The Guideline has been recently released after a radical revision (Revision 14). It now contains many changes and amendments to the previous version 13 from February 2008. The annex with country specific requirements already provides information regarding Croatia, EU's most recent Member State.

Mainly the provisions from the new Regulation (EU) No 1027/2012 on Pharmacovigilance legislation and Directive 2012/26/EU (both dated 25 October 2012) have been integrated into the revised Guideline.

The changes made to the new document can be clearly identified in a comparative document. This comparison is available for ECA members in the ECA members' area.