09 Feb 2016 - published Delegated Regulation (EU) 2016/161

DELEGATES REGULATION (EU) 2016/161 EU COMMISSION supplementing Directive 2001/83 / EC of the European Parliament and of the Council by establishing detailed rules concerning the safety features on the packaging of human medicinal products

Today is in many respects an important date:

With the release of Delegated Regulation (EU) 2016/161 on the implementation of safety features on the packaging of prescription drugs in the Official Journal of the European Union will begin the three-year deadline for all affected pharmaceutical companies to expire.

Read the legal acts in the original (Web links below)!

As of 09 Feb 2019 only prescription drugs a unique serial number to be assigned may accordingly in Germany are placed on the market, on their packaging (usually folding box) was applied (serialization) and their original package integrity (tamper-evident closure) is clearly visible.

Three years - initially sounds quite comfortable. But our past experience with this subject in the "pioneer" companies shows that more of a minimum period of 18 months to 22 months -from the initial concept to final manufacturing release- is required for such an implementation.

The company argus sensorsysteme GmbH will gladly support you in the preparation and implementation of this task!