Apply or vary Your Wholesale Distribution Authorisation (WDA) with Confidence

What is a WDA
(Wholesale Distribution Authorisation)?

A WDA(H) allows you to legally purchase, hold and distribute human medicinal products within the UK and internationally. It is a legal requirement under the Human Medicines Regulations 2012, and a core part of MHRA oversight into medicine safety and supply chain integrity.

Whether you need a WDA(H) (for human medicines) or a WDA(V) (for veterinary medicines), the process is technical and highly regulated—and even small errors in your application or site setup can lead to delays or rejections.

WDA Application Support Services

We provide fully tailored WDA support for applications or variations to businesses of all sizes covering all business models, including: start-ups, established wholesalers, pharmacies, logistics providers and international suppliers.

Our services include:

• Business & Regulatory Strategy

• Assessment of your business model for GDP and MHRA compatibility

• Product classification guidance (POM, P, GSL, CD, cold chain)

• Assistance selecting appropriate WDA(H) or WDA(V) scope for applications/variations

• Site Readiness & Infrastructure

• Advice and assessment of storage facilities, transport methods, and IT systems

• Advice and assessment of environmental controls, security, pest control, temperature monitoring, HVAC systems and associated SOPs

• QMS & Documentation

• Creation or review of your Quality Management System (QMS)

• Design and development or review of Standard Operating Procedures (SOPs)

• Record keeping and documentation structure tailored to MHRA standards and expectations

• Responsible Person (RP) & Responsible Person for Import (RPi) Provision

• Assistance identifying and onboarding a suitable RP or RPi

• Full or part-time contract RP/RPi services

• RP coaching and training for new appointments

• Pre-Inspection Support

• Mock MHRA inspections by ex-MHRA inspectors

• Inspection coaching and document walkthrough

• Advice on licence conditions/structure, inspection preparation and follow-up

Why Choose GDP Pharma Consulting?

We’re not just consultants—we’re former MHRA GDP Inspectors with over 1500 regulatory inspections completed.

With over 50 years of combined experience, we offer:

• Proven results in WDA application success

• First-hand insight into MHRA inspection standards and expectations

• In-house expertise in QMS, GDP, and RP appointment

• Post-approval support including audits, advice and training

• Full confidentiality and flexible engagement models

Whether you’re applying for your first WDA, managing a complex expansion or looking for assistance in ensuring you are always inspection ready, we offer tailored, regulator-informed support that simplifies the process and protects your business from the start.

Who We Work With

• Start-ups applying for their first WDA licence

• Retail pharmacies launching wholesale operations

• International suppliers

• Courier or logistics providers entering GDP-controlled delivery

• Virtual distributors and global pharmaceutical partners

• Established small, medium and large pharmaceutical wholesalers

We also support businesses under licence review, those looking to remediate post-inspection findings, or who simply need to improve GDP governance before a WDA variation or business model expansion.