Task
According to the German law on the advertising of medicinal products (“HWG”) and the German Pharmaceuticals Act (“AMG”), pharmaceutical companies are allowed to distribute limited drug samples to authorised persons. This often involves field staff or mailings with a reply option. In order to comply with legal requirements, it is important to record the orders, check the authorisation, and package and distribute the samples with complete documentation.
Solution
direkt + online offers a holistic and GDP/GMP-validated solution for the sample request and delivery process including storage, ordering, packaging, documentation and delivery. Our customers receive expert support in connection with regulatory and legal compliance and are able to provide the required proof at all times. The process is closely linked to other sample processes and allows for simple coordination and processing.
Project success
Drug samples are delivered in compliance with all applicable laws, whereas the entire process is fully digitalised and thus can be audited at any time. Changes in the sampling scheme, whether due to external requirements, for example, by EFPIA, or internal amendments can be integrated and practically implemented in a timely and uncomplicated manner. Sample delivery is also possible simultaneously without blocking other delivery channels via direct marketing measures.