Communication from the Ministry of Health No 29 / 2019 Coll.

The Ministry of Health shall, on the basis of Article III of Act No. 70 / 2013 Coll., amending Act No. 378 / 2007 Coll., on Medicines and on Amendments to Certain Related Acts (the Law on Medicines), as amended, that on 9 February 2016, an act of the European Commission was published in the Official Journal of the EU in a delegated act pursuant to Article I (12) of Directive 2011 / 62 / EU of the European Parliament and of the Council of 8 June 2011 amending Directive 2001 / 83 / EC on the Community code relating to medicinal products for human use, as regards the prevention of the entry of falsified medicinal products into the legal supply chain, by the Commission Regulation (EU) 2016 / 161 of 2 October 2015 supplementing Directive 2001 / 83 / EC of the European Parliament and of the Council by laying down detailed rules for protective elements on the packaging of medicinal products for human use.