Awaiting the entry into force of the directive of serialization

Doses October/November/December 2014 – The Healthcare Packaging Products Magazine

There is no doubt that the professionals in the European pharmaceutical industry will be busy, at least until the first quarter of 2018, with getting ready to meet the European directive which requires them to indicate a unique number on each pharmaceutical pack. And as serialization does not target only Europe, the subject has become a matter of importance for all players worldwide.

With a serialization system imposed for each pharmaceutical pack with a MA (marketing authorization), the European Union is going to hit hard the European pharmaceutical world; the professionals who export to this geographical area will also experience a small revolution. This directive 2011/62/EU, called the “Falsified Medicines Directive” – date of entry into force planned for late 2017, no later than the first quarter of 2018 – states that a unique randomized number generated during the packaging process will be printed on each pack.

This means that each operation must be checked and, therefore, manufacturers must be equipped with a software system able to generate these unique codes, but also with a marking system – since this unique number will be encoded in the Data Matrix code, and inevitably a control system which checks the presence of this code and its readability. All these add-ons will trigger a number of consequences for laboratories and manufacturers.

>>> Read complete article (French/English) <<<

Ute Heiler
Ute Heiler
About Ute Heiler

Manager Marketing Services | Atlantic Zeiser