You may have been supplied with medicines in the past by suppliers or organisations who sell or donate the medicines to you, however, if you are to ensure the supply chain is compliant and legal you must obtain a WDA. Where do you start?
The first thing you need to do is to employ either directly or via contract a Responsible Person, RP, they do not need to be a pharmacist however, they should have experience in your business model. If you export outside of the EEA then they should know about export.
The RP will help you with the application process and they will help you to create a Quality Management System to help you maintain compliance with the Human Medicine Regulations 2012 and Good Distribution Practice and help you to prepare for your MHRA inspection.
If you consolidate stock in a UK warehouse, it needs to hold a WDA if they store your medicines for more than 36 hours. In addition, the warehouse must also comply with the above regulations and if it is in the UK, it must be cited on your application for your WDA and will be listed as a holding site on your WDA.
