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. The legal foundation for this are the Falsified Medicines Directive 2011/62/EU as well as the Delegated Regulation (EU) 2016/161. With the publication of the Delegated Regulation in the Official Journal of the European Journal on 9 February 2016, the implementation period for building a system for authentication began in Germany and will end on 9 February 2019. From 9 February 2019 onward, pharmaceutical companies may only release pharmaceuticals subject to verification that bear two safety features. Pharmacies may only dispense these pharmaceuticals to patients after successful authentication.
The EU-Commission points out expressly the legal obligations of all stakeholders regarding the implementation of savety features under the Falsified Medicines Directive 2011/62/EU in the letter of 18 October 2018.
For more information of the EU-Commission see:
- Falsified Medicines Directive 2011/62/EU
- Delegated Regulation (EU) 2016/161
- Questions and Answers Document of the EU-Commission
- Measures for patients protection against falsified medicines
Products in scope
Pursuant to Article 43 of the Delegated Regulation, the higher federal authorities must provide information as to what pharmaceuticals must bear the safety features according to Article 54 lit. o of Directive 2001/83/EC and the Delegated Regulation (EU) 2016/161. The classifications have been made and can be viewed via the public part of the AMIS database. Furthermore, the prescription drugs that were exempt from the obligation were also classified in the AMIS database. Pharmaceutical companies can check the classification and contact Department 1 at the German Federal Institute for Drugs and Medical Devices (BfArM) via email if there are discrepancies. The contact is Michael Horn (1(at)bfarm.de).
Additional national legislation
In July 2018, amendments were made to the German Pharmaceutical Trading Directive (AM-HandelsV). The amendments published in the Bundesgesetzblatt No. 24 of 12 July 2018 refer to the verification of safety features through pharmaceutical wholesalers. Im Juli 2018 gab es Änderungen in der Arzneimittelhandelsverordnung (AM-HandelsV).
For further information by the German government, please visit: