Guide
How to Apply for WDA(H) in the UK
Applying for a Wholesale Dealer Authorisation (WDA(H))? This guide covers the official MHRA process, timelines, and requirements based on gov.uk guidance.
If you sell or supply human medicines to anyone other than the patient, you need a wholesale distribution licence, also known as WDA(H). This guide explains the application process based on official MHRA guidance.
What is WDA(H)?
WDA(H) stands for Wholesale Dealer Authorisation (Human). It is required by law for anyone trading in human medicines in the UK, excluding direct supply to patients.
According to UK government guidance, you must hold a WDA(H) if you sell or supply medicines to anyone other than the patient using the medicine, or if you import unlicensed medicinal products from countries inside the EEA.
What Does a WDA(H) Allow?
- Sell, supply, or offer for sale pharmacy, prescription only, traditional herbal and GSL medicines
- Import unlicensed medicinal products from countries inside the EEA
- Export medicinal products to countries of the EEA
The Application Process
Step 1: Prepare Your Documentation
Before applying, ensure you have: Quality Manual, SOPs for all GDP activities, temperature control procedures, training records, and documented processes for deviations and complaints.
Step 2: Submit Your Application
Apply through the MHRA Process Licensing (PCL) Portal. You will need to pay the application fee when you submit.
Step 3: MHRA Assessment
MHRA will check the identities of responsible persons and named staff, and verify company details with Companies House.
Step 4: GDP Inspection
MHRA will conduct a GDP inspection of your premises. Shortly after the inspection, you will receive a report detailing any issues. Once satisfied, MHRA will grant your authorisation.
Key Requirements
To qualify for a WDA(H), you must comply with Good Distribution Practice (GDP) and pass regular GDP inspections. Key requirements include:
- Designated Responsible Person (RP) in place
- Suitable premises and temperature control
- Documented quality management system
- Trained personnel
- Procedures for deviations and complaints
- Supplier qualification processes
- Recall procedures
Processing Times
- New WDA(H) application: Up to 90 working days
- Variations: 30 working days (90 if inspection required)
After You Receive Your WDA(H)
Once granted, you will receive:
- Your licence document
- A GDP certificate for your site
- Your details on the MHRA GMDP database
MHRA operates a risk-based inspection programme. Your site will be re-inspected within 24 months of initial inspection.
Need Help?
Applying for WDA(H) can be complex. If you need support with your application, I can help with:
- WDA(H) application preparation
- QMS development and documentation
- GDP compliance audits
- Responsible Person services