The new EU Counterfeiting Directive 2011/62 / EU — a major challenge for pharmaceutical companies
The EU Counterfeiting Directive 2011/62 / EU was adopted in 2016 to minimize the risk of counterfeit prescription drugs in the legal supply chain. The change in the existing directive was prompted by the rapid increase in the number of counterfeit medicines within the European Union, which poses a serious threat to public health, among other things.
What will change with the entry into force of the EU Counterfeiting Directive?
Specifically, after the end of the transitional period in February 2019, this means that prescription medicines (with a few exceptions) within the EU must be equipped with a standardized safety feature and serial number to facilitate their verification in order to act swiftly in case of infringements. The new directive not only aims to reduce the economic damage caused by counterfeit medicines, but also serves to protect patients.
Impact on business
Pharmaceutical companies and contract manufacturers will be well occupied with the serialization project by February 2019. The implementation of the new directive not only entails costs for millions of dollars in hardware and software, but also an immense amount of administrative work and the adaptation of processes along the supply chain. In addition, timely implementation in the enterprise is a major challenge as internal human resources are often unable to handle the increased workload. Especially small and medium-sized companies are affected, as they often have little experience with such major projects and their knowledge in the field of IT is not fully available.
In particular, the following areas of the company are affected by the introduction of the EU Counterfeiting Directive:
– Project Management
– Supply Chain Management
– Production (especially packaging)
How we can support you
K-Recruiting specializes in providing companies with flexible bridging solutions to such challenges when internal human resources become scarce. Our freelance specialists will be happy to help you meet the tight implementation timeline and to ensure in February 2019 that your company’s production does not have to sacrifice efficiency.
Let us talk personally about your individual needs.