EU-Directive on counterfeiting medicines in force!

In order to prevent counterfeit medicinal products from entering the legal supply chain, Europe has made a change to the basic Directive 2001/83/EC on medicinal products for human use. This new directive, better known as the FMD directive or the European Falsified Medicine directive (2011/62/EU) is in force since 9 February this year.

Besides the obligation for online pharmacies to have a common EU mark in order to identify the legal online pharmacies, besides stricter rules for the import of active pharmaceutical ingredients and new requirements for wholesalers with regard to data tracking, there are also a number of obligations relating to the packaging of medicinal products.

This directive, applicable to all prescription-only medicinal products,  obliges the manufacturers of medicines to provide their packaging with safety features allowing to
• Control the authenticity of the medicament, and
• Fix the identity of the individual packaging;

This is in fact the introduction of a unique serial number on the pharmaceutical packaging. These unique serial numbers are recorded in national databases.

In addition, they must also be provided with a means to check whether or not the outer packaging has been tampered with. In other words, this directive requires the affixing and checking of a seal on the packaging.

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