Falsified Medicines Directive
Requirements according to the Falsified Medicines Directive (Directive 2011/62/EC)
As from 09.02.2019, for medicinal products subject to Directive 2011/62/EC in conjuction with Commission Delegated Regulation (EU) 2016/161 amending Directive 2001/83/EC, a unique identifier (UI) has to be included on the packaging as well as a device allowing verification of whether the packaging has been tampered with (anti-tempering device = ATD).
In accordance with Art. 54a of Directive 2001/83/EC, prescription medicinal products for human use being subject to Directive 2001/83/EC as well as parallel import products may only be placed on the German market, if they comply with the provisions of Section 10 (1c) of the German Drug Law (AMG). According to Article 5(3) of the Delegated Regulation 2016/161(1) manufacturer shall print the barcode on the packaging. A separate label to be put on the box is therefore not possible.
Information on the implementation of the regulatory requirements of the Falsified Medicines Directive
For the inclusion of the unique identifier (UI) and the anti-tempering device (AUT), the provisions and recommendations of the implementation plan of the European Medicines Agency (EMA) are applicable for authorised medicinal products in accordance with the centralised procedure (CP) and, for medicinal products authorised nationally following the mutual recognition or decentralised procedure (MRP/DCP) the CMDh implementation plan and the CMDh clarifications on questions received on the implementation of the Falsified Medicines Directive (Questions & Answers) are applicable, respectively:
For purely nationally authorised medicinal products the provisions and recommendations of the CMDh documents referenced above apply mutatis mutandis. By way of derogation from the above, a national variation pursuant to Section 29(1) AMG of the German Drug Law (AMG) should be submitted, if during the transitional period until 09.02.2019, no use is made of the option to include the safety feature standard statement in the product information by adaptation to the QRD product-information template QRD product-information template in the context of another regulatory procedure affecting the product information.
Voluntary inclusion of the anti-tempering device
For medicinal products, for which,pursuant to Art. 54a (1) of Directive 2001/83/EC, placing an anti-tempering device is not mandatory, such anti-tempering device can be placed on the packaging on a voluntary basis, directly or after the due date of 09.02.2019.
Gemeinsame Bekanntmachung des Bundesinstituts für Arzneimittel und Medizinprodukte (BfArM) und des Paul-Ehrlich-Instituts (PEI) zur Umsetzung des Artikels 54a Absatz 5 Satz 3 der Richtlinie 2001/83/EG zur Vorrichtung gegen Manipulationen (anti-tampering device) (PDF, 119KB, File is accessible)