Wholesale dealer licence
A Wholesale Distribution Authorisation is required for the procurement, storage or supply of authorised medicinal products within the EU to pharmacies or other wholesalers. This licence also allows the holder to export to third countries if the receiving country allows the import of the respective medicinal product.
Several business models are possible to run wholesale with medicinal products, like a “classic” wholesaler maintaining its own storage facilities to a “virtual wholesaler” where only parts of the wholesale activities are carried out by the wholesaler itself whereas most of the activities are outsourced to adequately qualified business partners.
According to Article 79 of Directive 2001/83/EC the organisation applying for a WDA-licence has to appoint a responsible person for wholesale distribution. This person has to be available 24h/7d and will be listed on the WDA licence.
EUDRAC supports its clients with Wholesale Distribution Authorisation applications, preparation of an adequate Quality Management System as well as for the inspection performed by the competent authority in compliance with EU Good Distribution Practice Guideline (GDP) as well as country specific laws and regulations.
QMS & SOP development
Organisations involved in wholesale have to maintain a Quality Management System (QMS) to provide documented evidence that the organisation complies with EU GDP guidelines and local applicable laws and regulations. The level of complexity of the QMS depends on the complexity of the business model and the organisation itself. However several processes are mandatory to maintain a GDP-compliant QMS such as deviations, change control, supplier and customer qualification, recall, complaints, returns and falsified medicines.
Quality Management Systems can be built as stand-alone QMS or integrated systems depending on the complexity of the organisation.
Standard Operating Procedures (SOP) and Work Instructions are, therefore, necessary to establish and implement the best practices that are necessary to meet the strict regulatory requirements of the industry. The QMS will be inspected by the relevant competent authority prior to granting a WDA.