The 1473 / 22.11.2018 Order of the Ministry of Health was published in Monitorul Oficial on December 5th, 2018 – establishing the framework for the implementation of the Commission’s Delegated Regulation (EU) 2016/161 of October 2nd 2015 stipulations which come as an addition to the European Parliament and Council’s Directive 2001/83/EC by setting detailed rules for the safety elements which appear on the packaging of medicines for human use – click here (Romanian version): extras MOf 1031_05.12.2018 Ordin MS 1473 elemente siguranta ambalaje medicamente