Serialization of pharmaceutical products: EU delegated act 2016/161 now published

Time is ticking

  • Manufacturers and vendors of pharmaceutical products have only three years left to  prepare for serialization
  • Since there was no clear definition until now, companies, especially smaller and medium-sized  ones, have not started acting yet
  • A serialization software should be able to cover all ISA95 levels from single machinery to the entire enterprise to assure proper repository and forwarding of data to the hubs

The realization of the European directive 2011/62/EU („Falsified Medicines Directive“) is now heating up: Today the delegated act was officially published in its final release (EU) 2016/161 in the Journal of the European Union. Starting now, pharmaceutical companies and vendors that sell their products within the European Union have only 3 years to render their processes and workflows fully compliant and to provide products with the required safety features.

„The ones who have not yet started to intensively get involved into the topic might run into shortness of time”, emphasizes CEO from Atlantic Zeiser, Manfred Minich. “From our experience from past projects the majority of big international pharma companies know what needs to be done but they still haven’t implemented all relevant serialization workflows, especially on the enterprise level. However a multitude of smaller and medium-sized manufacturers and CMOs have been procrastinating on this issue for a long time.” The main reason, among others, for that was according to Minich the fact that the directive was more than 30 pages long containing partly complex requirements whereas the technical implications were not always obvious. “Although the technologies that are necessary to generate, print and verify codes are usually common, the reliable interchange with a database solution that can administrate workflows and guarantee the uniqueness of the codes and safety features seems to be undiscovered territory for most players.”

Prepared for each level

Many projects that were initiated in the early stages were mainly focused on machinery and hardware. Printing and verifying codes on secondary packaging was, in most cases, limited to one single pilot line and data that was stored locally (so-called ISA95 Level 1 and 2). “Most companies will need to distribute and recollect serialization data from a multitude of lines on plant or enterprise level (ISA95 Level 3 and 4). At latest when it comes to data repository and forwarding of the data to national hubs this functionality will be required anyway” explains Minich “If the serialization software is not designed in a way to cope with these needs, a retrofit will for sure involve significant additional costs and delays. Most companies will not be able to afford that as time is short.”

According to Minich the situation is inundated by the fact that the EU is not the only region that will be implementing measures to remove danger to patients posed by counterfeiters. Large markets like China have already implemented a law that requires serialization of each single product including full traceability over the entire logistics chain. Other countries like the USA will be among many others following very soon or have at least started to think about this.

„The work that needs to be done to comply with the EU regulation should ideally also be of benefit for other regions in the world – even for regulations that are not known at the moment”, says Minich.

Not only because of that he recommends to focus on the installation of a central serialization software and database application that is characterized by a modular architecture in order to be able to seamlessly grow with any need. This way it is possible to quickly adapt workflows and coding principles to new emerging regulations without the need of reprogramming and time consuming revalidation. A good example for this is the field-tested software solution MEDTRACKER from Atlantic Zeiser.

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Ute Heiler