Recommendations for the implementation of the exemptions to the labelling and package-leaflet obligations in the centralised procedure: update

18 juin 2019


Rev.4 Changes since the last revision : Clarifications on which labelling components are covered by Art.63 (update of sections 2.1 and 2.2), moving of information from section 3.3 as well as information on shortage from section 3.1 to section 2.2 and addition of more flexibility with regards to omission of particulars requests under Art.63.3 affecting small Member States where multilingual packs are used.


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