Impact Of The Anti-Counterfeiting Directive 2011/62/Eu And The Delegated Regulation (Eu) 2016/161 On Tissue Preparations And Blood Products

As of 09.02.2019, in Germany, the human medicinal products covered by Directive 2011/62/EU in conjunction with the Delegated Regulation (EU) 2016/161 supplementing Directive 2001/83/ECmust be supplemented by additional security features and a device for the detection of possible manipulation. According to the current assessment of the Paul-Ehrlich-Institut, the primarily affected tissue preparations with an authorization according to 21, 25 AMG are not classified as falling under the directive 2001/83/EC, as they are not produced by an industrial process. The Anti-Counterfeiting Directive 2011/62/EU and Delegated Regulation (EU) 2016/161 therefore do not apply. In addition to the exceptions set out in Annex I to Delegated Regulation (EU) 2016/161, blood components (whole blood, plasma and blood cells of human origin) are also excluded from the scope of the Directive in accordance with Article 3 (6) of Directive 2001/83/EC. In this respect, only plasma that is manufactured using an industrial process and the plasma derivatives resulting from these plasmas have an obligation to comply with the provisions of the Anti-Counterfeiting Directive and the Delegated Regulation.