It is a legal requirement for anyone wishing to procure, store, sell or supply human medicines to anyone other than the patient using a medicine, to obtain a Wholesale Distribution Authorisation (WDA).
The WDA is often referred to as a Wholesalers Licence (WL) or Wholesale Dealers Licence (WDL).
Three Steps to Wholesaling Medicines
Each member state of the EU has its own national competent authority responsible for the issue of the Wholesale Distribution Authorisation necessary for wholesaling medicines within their state.
The Medicines and Healthcare Regulatory Agency (MHRA) is the national competent authority in the UK and its principal aim is to safeguard the public’s health.
The three key steps involved in obtaining the Wholesale Distribution Authorisation in the UK include:
How Pharma Experts can help
Pharma Experts offers a complete suite of services to help clients meet the regulatory standards and compliance to the latest GDP guidelines.
Our overarching aim is to provide a truly customised solution for each client which may include a combination or all of the following services:
- Initial WDA licence application required for wholesaling medicines.
- Quality Risk Assessment.
- Developing a Quality System (QS) including Standard Operating Procedures (SOPs).
- Temperature Mapping.
- Contract Responsible Person.
- GDP and RP mandatory training (including Driver Training).
- Pre-inspection Audits.
- External Audits.
The above list is not exhaustive and if you have any specific requirements please contact us for a prompt response.
Already Wholesaling Medicines?
If you already have a Wholesaler Dealers Authorisation, we can assist you:
- Submit variations to your existing authorisation
- Undertake a full compliance evaluation or risk analysis using our proprietary Forensic Audit
- Identify areas of improvement through a Gap Analysis exercise
- Update your Quality System
- Train personnel involved in the dealing of wholesale medicines
Revoked or Suspended Licence?
If you are ready to work with us, or would like to discuss in further detail about how we can help you and your organisation please contact our office and send us your request, or schedule a free initial telephone consultation.