When you procure, supply, store or export medicinal products, you need a wholesale distribution authorisation (WDA). You also need a WDA when you sell medicinal products although you are not storing them, and if you store medicinal products that you do not sell, you also need a WDA.
According to the EU Good Distribution Practice guideline it is required to have a Responsible Person for wholesale (RP). The RP has the overall responsibility for all wholesale activitities and ensures compliance with all applicable regulations and guidelines. This person must have sufficient skills and qualifications.
We provide consultats that can act as your RP, who is performing all the responsibilities that comes with it such as
– setting up quality systems for GDP
– handle complaints
– handle recalls with 24/7 coverage
– self-inspections and audits
We can help you applying for wholesale distribution authorisation and provide guidance and support according to GDP and local Nordic requirements, all depending on your needs. If you prefer, we can just handle the complaints for you.
RegFile AB
Eklundshovsvägen 1G,
752 37 Uppsala, Sweden
info@regfile.se
