EMEA and EU Commission – Topical News
European Commission: Proposal for a Directive amending the Community Code as regards the prevention of entry into the legal supply chain of medicinal products which are falsified in relation to their identity, history or source
Dr. Brigitte Friese
Rechtsanwältin, Wyk-Wrixum auf Föhr (Germany)
The draft of a Directive amending the Community Code in relation to prevention of entry into the legal supply chain of medicinal products which are falsified in relation to their identity, history or source envisages to achieve this aim by proposing the implementation of several means:
• Identification, authenticity and traceability of medicinal products subject to medical prescription shall be guaranteed by introduction of safety features on the outer packaging of such medicinal products.
• Any persons participating in the legal supply chain will have to be subject to supervision and inspection. A manufacturing authorisation will be necessary for all actors who are involved in the packaging of a medicinal product. Even the “trading of medicinal products” shall be addressed by legislation by imposing on traders express obligations of notification of their activity and regarding recording and instalment of quality and emergency systems.
• Supervision and inspection of wholesale as well as manufacturing activities including inspection of manufacturing sites in third countries performed by competent authorities shall be enforced. The responsibility of the manufacturer even with respect to falsifications is enlarged. Certificates shall be issued not only for manufacturers, but also for importers and wholesale distributors. The results of inspections shall be entered into a Community database.