Legal Prin­ci­ples

The work of secur­Ph­arm must be view­ed in con­text with a series of mea­su­res requi­red by the Euro­pean Uni­on to pro­tect pati­ents from fal­si­fied phar­maceu­ti­cals in the legal sup­p­ly chain.

Euro­pean Regu­la­ti­ons

Sin­ce 9th Febru­ary 2019, pre­scrip­ti­on drugs have to bear save­ty fea­tures that are authen­ti­ca­ted befo­re being dis­pen­sed to the pati­ent. The legal bases are:

• Fal­si­fied Medi­ci­nes Direc­ti­ve 2011/62/EU
• Dele­ga­ted Regu­la­ti­on (EU) 2016/161
• Dele­ga­ted Regu­la­ti­on (EU) 2021/457
• Dele­ga­ted Regu­la­ti­on (EU) 2021/1686
• Dele­ga­ted Regu­la­ti­on (EU) 2022/315

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

• Ques­ti­ons and Ans­wers Docu­ment of the EU-Com­­mis­­si­on
• Mea­su­res for pati­ents pro­tec­tion against fal­si­fied medi­ci­nes

Natio­nal legis­la­ti­on

The Euro­pean regu­la­ti­ons requi­red adjus­t­ments in natio­nal law:

• Bun­des­ge­setz­blatt Teil 1, Jahr­gang 2018 Nr.24 Sei­te 1080 (Fede­ral Law Gazet­te)
• Bun­des­ge­setz­blatt Teil I, Jahr­gang 2019, Nr. 30 Sei­te 1202 (Fede­ral Law Gazet­te)

• Announce­ment of the Fede­ral Insti­tut for Drugs and Medi­cal Devices (BfArM) and the Paul-Ehr­­lich-Ins­ti­­tut (PEI) regar­ding the anti-tam­­pe­ring device