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Home > 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.

European Commission. (2016) 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. European Commission. Official Journal of the European Union, L 32/1 27 p.

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The European Commission,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (1), and in particular Article 54a(2) thereof,

Whereas: (1) Directive 2001/83/EC, as amended, provides for measures to prevent the entry into the legal supply chain of falsified medicinal products by requiring the placing of safety features consisting of a unique identifier and an anti-tampering device on the packaging of certain medicinal products for human use for the purposes of allowing their identification and authentication.

Item Type
International research
Publication Type
Guideline
Drug Type
Prescription/Over the counter
Intervention Type
General / Comprehensive
Date
2016
Pages
27 p.
Publisher
European Commission
Corporate Creators
European Commission
Volume
L 32/1
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