Site Readiness (MIA/WDA) · 6 min read
From Plan to Licence: Getting Site-Ready for an MIA or WDA
Applying for a manufacturing or wholesale licence? Here is the six-stage journey from gap assessment to a granted MIA/WDA — and where projects usually stall.
By B. Subramanian · 9 June 2026 · Updated 19 June 2026
Securing a Manufacturer's (MIA) or Wholesale Dealer's (WDA) licence is a milestone — and a process that rewards preparation. Most delays are not technical; they come from starting the application before the foundations are in place. Here is the journey we use to get a site genuinely licence-ready, and the traps at each stage.
1. Gap assessment
Start by mapping the distance between where you are and what the licence requires. This single step sets a realistic timeline and stops nasty surprises late on.
2. Build the quality system
A licence assumes a functioning quality management system — procedures, defined roles and the records to prove it runs. This is the foundation everything else sits on.
3. Facilities and validation
Premises, equipment and computerised systems must be qualified and validated for their intended use. Inspectors will want evidence, not intentions.
4. Application and dossier
A complete, internally consistent application moves faster. Gaps, contradictions and missing evidence are the most common cause of delay.
5. Pre-inspection preparation
Before the regulator arrives, a mock inspection and focused subject-matter-expert prep turn an anxious team into a confident one. Our readiness checklist applies directly here.
6. Inspection and grant
Host the MHRA inspection in a calm, organised way, then close any findings with disciplined CAPAs. A clean close-out is the final step to grant.
Where projects stall — and how to avoid it
The two most common stalls are applying with an immature QMS, and underestimating validation. A named QP or RP on the team early prevents both. See how we have guided other sites in our case studies, or get in touch.
Regulatory sources
This guidance reflects current UK and EU GMP/GDP requirements. Primary references:
- MHRA — UK Medicines & Healthcare products Regulatory Agency
- EudraLex Volume 4 — EU GMP Guidelines
- MHRA Inspectorate Blog
Always confirm against the latest published version of each source.
Frequently asked questions
What is the difference between an MIA and a WDA?+
An MIA (Manufacturer's / Importer's Authorisation) covers manufacture or import; a WDA (Wholesale Dealer's Authorisation) covers storage and distribution.
How long does it take to get a licence?+
After applying, expect an MHRA inspection and several months to determination — readiness work before you apply is what keeps that timeline short.
What do we need in place before applying?+
Suitable premises, a working quality system, named responsible people (QP / RP) and a Site Master File — we help you put all of these in place.