Falsified Medicines Directive (FMD)

EMRAmed packing including the newly prescribed safety features:
2D code with plain text (Unique Identifier) and anti-tampering device (seal).

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 unique 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 comes 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:

  • 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
  • Anti-tampering device: i.e. seals indicate whether a package has already been opened or is still intact

Further information about contents of the directive as well as our measures in detail can be found under the heading ‘Falsified Medicines Directive’ on our MPA Pharma website. Please also visit our ‘Questions and Answers’ section.

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