EU Directive 2001/62/EU: Transition Period until February 2019

Standards for Tamper-Proof Packaging of Medicines

There is hardly another product that reaches the end consumer or patient for which the regulations are as varied as they are for pharmaceutical products. As early as in 1970, the “Poisons Prevention Packaging Act” (PPPA) for child-resistant packaging of potentially harmful substances was enacted in the United States. Since then, the number of reported deaths of children caused by the ingestion of toxic household products including medicines has significantly decreased. In the EU, the EN ISO 8317 and EN 14375 standards establish the requirements to be met by child-resistant packaging. All the more surprising is the fact that currently hardly any medicine pack is provided with tamper-proof sealing. 

EU Directive 2011/62/EU: Falsified Medicine Directive (FMD)

By means of EU Directive 2011/62/EU, the so-called Falsified Medicine Directive (FMD), legislators and pharmaceutical manufacturers intend to safeguard the supply chain in Europe. Since February 9, 2016, a three-year transition period for implementing EU Regulation 2016/161 on the protection of medicines against counterfeiting has been in effect. The delegated act from Brussels supplements the 2011/62/ EU Falsified Medicines Directive by technical and organizational details pertaining to the required security features. Starting on February 9, 2019, every prescription medicine has to be provided with an individual serial number in the form of a 2D code (DataMatrix) and a device protecting the pack against tampering. In addition, ready-to-use medicines being repackaged by another manufacturer have to be equipped with equivalent security and sealing features, allowing the external enclosure to be checked for authenticity and integrity in a similar manner as the original pack.