The Human Medicines (Amendment) Regulations 2019

Statutory instruments 62 2019

Format:

Corporate Author:

Great Britain

Publisher:

TSO (The Stationery Office)

Enabling power: European Communities Act 1972, ss. 2 (2) (5). Issued: 24.01.2019. Sifted: -. Made: 14.01.2019. Laid: 18.01.2019. Coming into force: 09.02.2019. Effect: S.I. 2012/1916 amended. Territorial extent and classification: E/W/S/NI. General. EC note: These Regulations amend the Human Medicines Regulations 2012 in order to implement: points 8, 9, 11 and 12 of Article 1 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 into the legal supply chain of falsified medicinal products (Directive 2011/62/EU); Commission Delegated 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 the safety features appearing on the packaging of medicinal products for human use (the Delegated Regulation)..