Once received in the EU, a Wholesale Distribution Authorisation (WDA) is required before product can be distributed. The WDA lists the types of medicines the holder is authorised to handle.
Facilities and systems audit will be undertaken to ensure the warehousing and/or distribution centre to be used meet acceptable criteria for the type of medicinal product listed (e.g. sterile, non-sterile, biological, herbal, homeopathic, APIs, finished products).
The facility will need to have sufficient systems in place usually outlined in a Site Master File (SMF) and the QMS. These will cover areas such as temperature and humidity control, cleanliness, storage areas for products, personnel involved in the process, and procedures to cover issues such as complaints, recalls, deviations etc.