Falsified Medicines Directive (FMD)

For MPA Pharma, patient protection comes first

In line with the European Falsified Medicines Directive (Directive 2011/62/EC), each prescription-based medicine repacked by MPA Pharma and distributed by EMRAmed will receive a 2D code with plain text, including a uniquely serialisation number and a tamper-evident closure, guaranteeing the integrity of the packaging by means of seals. We actively support patient protection.

European security network for the legal supply chain

On 9 February 2019, a European Directive came into force in Germany to counteract possible counterfeiting of prescription medicines for human use. The legal basis is the Falsified Medicines Directive (Directive 2011/62/EC) and the Delegated Regulation (EU) 2016/161.

securPharm is an initiative to protect the pharmaceutical market in Germany from counterfeit medicines entering into the legal supply chain. The objective of the legislation is to provide package-level counterfeiting protection related to prescription-based human medicines through the establishment of a European security network for the legal supply chain. The focus is on patient protection.

Double security for every prescription-based medicine

For this purpose, a Europe-wide verification system with standardised security features on packaging is used. Each individual medicine package shall have two security features:

2D code (Unique Identifier)

Unique identifier: a 2D code with plain text, including product code, batch, expiry date and serialisation number will be printed on the labels or the folding box.
This unique serialisation number identifies each individual packaging and is also registered in a EU-wide verification system.

The 2D code including plain text (Unique Identifier) informs about the product code, batch, expiry date and serial number. The code is for verification as well as for registration and deregistration of the package at EU HUB or national HUB.

Anti-Tampering Device

The tamper-evident closure/ i.e. seal also indicates whether a package has already been opened or is still intact. The EMRAmed safety seal is made of a material that prevents a trace-free opening of our medicine packaging.

An undamaged seal (Anti-Tampering Device) indicates that the package has not yet been opened.

Each trade level takes important security steps

Manufacturers create individual serialisation numbers (Unique Identifier) in the production process and load them into a database system in conjunction with the package.

Wholesalers will verify the content of the 2D codes on all package returns from pharmacies and other wholesalers, as well as any medicine that is not supplied by the manufacturer or its wholesaler.

Reimporters and parallel traders must inspect the security features (seals and the content of the 2D codes) when importing prescription medicines, and then must book the latter before repackaging from the systems of the respective EU HUB. New security features (seal and a 2D code) are generated. The contents of the 2D code will be registered at the EU HUB.

Pharmacies then check the security features: the content of the 2D code (verification) and the integrity of the seals (tamper-evident closure) are checked. The handover of medicines takes place only after a successful positive verification. With the handover of the medicine to the patient, the pharmacist logs off the packaging from the German HUB.

Changing the processes and making investments

At MPA Pharma, we scan, read and verify each medicine package upon receipt. This requires significant changes in our processes to meet the requirements. In order to be able to make all 2D codes available with plain text, all involved departments must enter all relevant master data on the system side and upload them to the German HUB via EU HUB.

In production, we read and verify every package, reject goods from the national HUB via EU HUB and repackage the goods. We issue new 2D codes, including a unique serialisation number for the country of sale and then electronically upload the information via the EU HUB to the relevant national HUB. As integrity protection, we seal every package, thus further increasing its safety.

All in all, it involves a multitude of modification of processes, additional measures and further investments in new machines.

Source: MPA Pharma 2018

Contact person for inquiries

If you have any further questions, feel free to visit our ‘Questions and Answers’ specifically listed on this topic or contact our EMRAmed service team: Kundenservice-Apotheke@EMRAmed.de or by telephone: 0800/3672 634.