Today, medicinal product distributors are facing increasing pressure from market competitors and the inexorable advance of digitalisation. This pressure is only likely to increase, which could in turn have an impact on the quality of the product and the safety of its consumers. To mitigate these factors, the European Commission has published revised guidance for good distribution practice for human medicinal products. Switzerland has transposed the guidance adopted by the EU for good distribution practice into its national law, with an amendment dated 1 July 2015 that entered into force on 1 January 2016 following a six-month implementation phase.
The guidance for distribution practice for human medicinal products aims to ensure that both the quality and the safety of medicinal products is guaranteed along the entire distribution chain. The aim is to ensure that counterfeit products cannot enter the legitimate supply chain.
To achieve this, the following criteria must be fulfilled:
- Necessity of using a Quality Management system
- The Responsible Person: roles, responsibilities and requirements
- New requirements for transportation and storage
- Computer system validation
- Equipment qualification
- Vendor audits