Legal basis

Sin­ce Febru­ary 9, 2019, pre­scrip­ti­on medi­ci­nes have car­ri­ed safe­ty fea­tures that are sub­ject to authen­ti­ci­ty checks befo­re being dis­pen­sed to pati­ents. The legal basis for this is:

• the Fal­si­fied Medi­ci­nes Direc­ti­ve 2011/62/EU
• Dele­ga­ted Regu­la­ti­on (EU) 2016/161
• Dele­ga­ted Regu­la­ti­on (EU) 2021/457 (Brexit I)
• Dele­ga­ted Regu­la­ti­on (EU) 2021/1686 (inclu­si­on in the white list)
• Dele­ga­ted Regu­la­ti­on (EU) 2022/315 (Brexit II)

In addi­ti­on, the fol­lo­wing infor­ma­ti­on from the EU Com­mis­si­on appli­es:

• Ques­ti­ons and Ans­wers from the Euro­pean Com­mis­si­on on Dele­ga­ted Regu­la­ti­on 2016/161
• EU mea­su­res to pro­tect pati­ents against fal­si­fied medi­ci­nes in the legal sup­p­ly chain

The Euro­pean regu­la­ti­ons requi­red adjus­t­ments to natio­nal law:

• Fede­ral Law Gazet­te Part I; Year 2018 No. 24 Page 1080
• Fede­ral Law Gazet­te Part I, 2019 No. 30 Page 1202

The fol­lo­wing infor­ma­ti­on also appli­es:

• Announce­ment by the BfArM and PEI on devices to pre­vent tam­pe­ring (BAnz AT 26.04.2017 B3)