MHRA MIA & WDA(H) Authorisations – Who Can Manufacture, Import and Distribute Medicines in the UK

This topic is part of the SG Systems Global regulatory & operations glossary.

Updated December 2025 • GMP / cGMP, GDP, Qualified Person (QP), PQS, Traceability, WMS, Mutual Recognition & Reliance • UK MAHs, QPs, Responsible Persons (RP), QA, Supply Chain, Regulatory Affairs

MHRA Manufacturer’s / Importer’s Authorisation (MIA) and Wholesale Dealer Authorisation (Human), WDA(H) are the core licences that control who is allowed to manufacture, import and wholesale human medicines in the UK. Together with GMP/GDP rules and QP/RP roles, they define the legal “nodes” in the UK supply chain that Medicines and Healthcare products Regulatory Agency (MHRA) can inspect, approve or shut down. For companies, MIA and WDA(H) are not just regulatory labels: they determine which entities can hold stock, certify batches, move product between sites and supply pharmacies and hospitals. If the wrong company—or the wrong site—doesn’t have the right authorisation, the whole supply chain is on shaky ground regardless of how good your internal SOPs look.

“In the UK, if you’re touching product at scale and you don’t have the right MIA or WDA(H), you’re not just ‘non-compliant’; you’re operating outside the legal supply system.”

1) What MIA and WDA(H) Authorisations Actually Are

A Manufacturer’s / Importer’s Authorisation (MIA) is the UK licence that allows an organisation to manufacture human medicines and/or import them from outside the UK (including some imports from non-MRA countries). It embeds GMP obligations, requires QP oversight for batch certification and is granted for specific activities and sites. A Wholesale Dealer Authorisation (Human), WDA(H) is the licence to wholesale human medicines: procure, hold, supply or export them to other businesses (not to the public) under GDP. Both are granted and supervised by MHRA and are legal conditions for operating in the regulated UK medicines supply chain. Without them, manufacturing and wholesale activities are effectively illicit, regardless of the technical competence on display.

2) Legal Framework – UK Law and MHRA Guidance

MIA and WDA(H) authorisations sit under UK legislation derived from the Human Medicines Regulations and related statutory instruments, now operating under a post-Brexit domestic regime. MHRA issues guidance on how to apply for, maintain and vary MIAs and WDA(H)s, and references EU-style GMP/GDP guidelines (updated for UK context). The law defines what counts as “manufacture” and “wholesale dealing,” sets obligations for QPs and RPs, and gives MHRA powers to inspect, suspend, vary or revoke licences. For companies, this means that compliance is not just about satisfying inspectors; it’s about meeting explicit legal requirements tied to named authorisation holders and locations.

3) MIA – Scope and Activities Covered

An MIA may cover activities such as:

• Manufacture of finished dose medicinal products.
• Packaging and labelling operations.
• Import of finished medicinal products from third countries.
• Sometimes, certain intermediate or bulk operations as defined in the authorisation.

Each MIA details the sites, dosage forms, activities and sometimes specific products. It also ties to the QP(s) responsible for certification. The scope must be accurate: if you start manufacturing a new dosage form, using a new sterilisation technology, or importing from a new country or site, you may need to vary the MIA. Running operations outside your authorised scope is a straightforward route to non-compliance and regulatory action, especially once MHRA cross-checks authorisations against actual activity in inspections or market intelligence.

4) WDA(H) – Scope and GDP Responsibilities

A WDA(H) licence covers wholesale dealing activities for human medicines, including:

• Purchasing medicinal products from authorised sources.
• Holding and storing stock in compliant facilities.
• Supplying medicinal products to other authorised persons (pharmacies, hospitals, other wholesalers, etc.).
• Exporting medicinal products to other markets.

WDA(H)s embed Good Distribution Practice (GDP) obligations: appropriate storage conditions, stock control, transport, returns handling, recall readiness and record-keeping. Each WDA(H) lists the premises and activities covered and names a Responsible Person (RP) who ensures compliance. As with MIAs, scope drift (e.g. starting to handle new product types, cold-chain products or high-risk medicines without updating the WDA(H) and underlying systems) is a common inspection issue.

5) Roles of the QP and RP in the MIA/WDA(H) Ecosystem

Under MIA, the Qualified Person (QP) certifies batches before release, ensuring they are manufactured and checked according to the MA, GMP and any additional national requirements. Under WDA(H), the Responsible Person (RP) oversees GDP compliance: ensuring that authorised products are sourced and supplied safely, that conditions are maintained, and that the quality system for distribution is effective. These roles are complementary:

• QP: Focus on manufacturing control, batch certification, API controls, process/analytical validation, deviations and CAPA.
• RP: Focus on supply-chain integrity, storage/transport, returns, falsified medicines prevention, recalls and distribution records.

For global supply chains, QPs and RPs must work together, not in sequence. A batch incorrectly certified or released at the MIA stage remains a risk even if GDP is flawless; a GDP failure at the WDA(H) stage can ruin quality achieved in manufacturing. The MIA/WDA(H) structure makes that dual accountability explicit.

6) Relationship to GMP, GDP and the PQS

MIAs and WDA(H)s are the legal wrappers around GMP and GDP compliance for specific entities. They assume the presence of a functioning pharmaceutical quality system (PQS) that:

• Controls manufacturing, packaging, testing and release (for MIAs).
• Controls storage, handling, transport and supply (for WDA(H)s).
• Ensures change control, deviation management, CAPA, audits and PQR/APR span both manufacturing and distribution where appropriate.

In inspections, MHRA will often sample both GMP and GDP elements across the MIA/WDA(H) network, particularly where the same group acts as both manufacturer/importer and wholesaler. Gaps between the PQS and the authorised scope of MIA/WDA(H) (e.g. uninspected warehouses, unverified third-party logistics providers) are a prime source of findings.

7) Applying for MIA or WDA(H) – What MHRA Looks For Up Front

Applications for MIA or WDA(H) must describe:

• The legal entity applying and relevant contact details.
• Sites/premises to be covered and the activities to be performed.
• Types of products (e.g. sterile, non-sterile, biologicals, IMPs, controlled drugs where relevant).
• Key personnel (e.g. QP, RP, senior management, QA leadership).
• Summary of quality systems, facilities, equipment and IT systems.

MHRA reviews applications and usually performs an inspection (especially for new or significantly changed sites) before granting authorisations. Thin applications that under-describe systems, or that omit important activities “to keep scope small,” often backfire later when inspectors find the real picture. A realistic, risk-based, well-documented application makes subsequent inspections and variations smoother because it anchors expectations in reality from day one.

8) Inspections and Enforcement Against MIAs and WDA(H)s

MHRA uses risk-based inspection scheduling for both MIAs and WDA(H)s, with frequency influenced by product types, previous findings, complaint/recall history and intelligence from other regulators. Outcomes can include:

• GMP/GDP certificates or inspection reports with no or minor observations.
• Deficiency reports requiring CAPA.
• Conditions or restrictions on authorisations (e.g. excluding certain activities or products).
• Suspension or revocation of MIA/WDA(H) in severe cases.

Inspections often test whether authorised activities match what is happening, whether QP/RP roles are effective, and whether digital/physical controls support the claimed system. Findings under a MIA or WDA(H) can have knock-on effects in other regions, especially where mutual recognition or reliance frameworks exist (e.g. with EMA, some EU/EEA, and other PIC/S members).

9) Supply Chain Mapping – Who Needs MIA, Who Needs WDA(H)

Practical supply chain design requires clarity on where MIA and WDA(H) licences are needed:

• Manufacturing sites in the UK typically need an MIA.
• UK-based importers of finished product from outside the UK generally need an MIA for import activities and may also need a WDA(H) for onward wholesale.
• Wholesalers and distributors within the UK require WDA(H)s for the premises where they hold stock.
• Third-party logistics providers may require WDA(H)s depending on how they hold and supply product and how contracts are structured.

MAHs must understand which entities in the chain hold which licences—and ensure quality agreements, technical agreements and SOPs reflect those allocations. If everyone assumes “someone else holds the WDA(H),” MHRA will eventually reveal that no-one really does in a defensible way.

10) Digital Systems, WMS and Traceability Under MIA/WDA(H)

Because MIAs and WDA(H)s are about who touches product, your digital systems must align with authorised scopes and GDP/GMP obligations. That means:

• WMS and ERP systems reflecting MIA/WDA(H) sites as inventory locations with appropriate controls (temperature mapping, segregation, quarantine/release states).
• Integrated traceability from manufacturing batch to wholesale deliveries and returns.
• Visible links between QP certification decisions and batch availability for WDA(H) operations.
• Audit trails and user access controls that enforce segregation of duties and data integrity.

MHRA will often ask for walkthroughs that start with a batch on the shop floor (MIA) and follow it into and through wholesale stock (WDA(H)), sampling both digital and physical controls. Systems that cannot map MIA/WDA(H) scope to real inventory movements undermine confidence in both licences.

11) Quality Agreements and Third-Party Oversight

When activities within a MIA or WDA(H) supply chain are outsourced, quality and technical agreements become critical. They should clearly define:

• Which party’s MIA or WDA(H) applies to which activities and sites.
• Responsibility for GMP and GDP compliance, deviations, CAPA and product quality complaints.
• How audits, inspections and regulatory communications are handled and shared.
• Who owns recall decision-making and communication processes.

For MAHs, oversight of CMOs, contract packers, third-party logistics providers and wholesalers must be risk-based and documented. In inspections, MHRA may ask to see how MIA/WDA(H) holders ensure that outsourced steps remain compliant and how they react when partners’ licences are restricted or revoked, or when serious findings emerge from other NRAs.

12) Cross-Border Context – EU, Northern Ireland and Mutual Recognition

Post-Brexit, the regulatory landscape includes UK-wide and Northern Ireland-specific aspects, alongside EU authorisations. While the details are evolving, a few principles hold:

• MHRA issues MIAs and WDA(H)s for Great Britain; EU/EEA authorities issue their own for operations in member states.
• There are arrangements for supply into Northern Ireland that rely on EU frameworks and UK arrangements; MIA/WDA(H) design must respect these realities.
• Mutual recognition and reliance agreements with some regulators (e.g. in GMP inspections) influence how MIA-based GMP certificates are viewed abroad.

For companies, this means supply chain and authorisation design must consider jurisdictional boundaries explicitly. Assuming “we have an EU MIA so we’re fine for GB” (or vice versa) is no longer valid. Clear mapping of which MIA/WDA(H) covers which flows is a compliance necessity, not an academic exercise.

13) Common Pitfalls with MIA and WDA(H)

MHRA and other NRAs repeatedly see similar failure patterns:

• MIA or WDA(H) authorisations that do not reflect actual activities (e.g. unlisted sites, unlisted dosage forms).
• Weak or token QP/RP involvement in critical decisions.
• Poor oversight of contractors whose activities fall under the MIA/WDA(H) but whose performance is not monitored.
• Disconnects between authorised scopes and digital systems (ERP/WMS/MES) managing stock and releases.
• Failure to update authorisations and quality agreements after significant organisational or supply-chain changes.

These issues are avoidable if MIA/WDA(H) governance is integrated into change control, supplier management and business development processes. They are hard to fix retroactively once MHRA has noted them in inspection reports or published outcomes.

14) Integrating MIA/WDA(H) Governance into the PQS

For MIA/WDA(H) holders, the authorisations should be embedded in:

• Change control: Every supply-chain, site or activity change triggers a check of whether MIA/WDA(H) licences and scopes need updating.
• Risk management: MIA/WDA(H) status and inspection history are included in risk registers and supply risk assessments.
• Management review: MIA/WDA(H) performance (inspections, recalls, deviations) is a regular item in quality and business reviews.
• Training: Operational, regulatory and commercial teams understand the consequences of acting outside authorised scopes.

When MIAs and WDA(H)s are treated as living parts of the PQS rather than as static certificates, organisations are far less likely to be caught by “scope creep” or by deals and projects that assume licences can be “sorted out later.”

15) Implementation Roadmap – Building Robust MIA & WDA(H) Control

A practical roadmap for strengthening MIA/WDA(H) governance includes:

• Creating a consolidated register of all MIAs and WDA(H)s, mapping sites, activities, products and key personnel (QP, RP) for each.
• Aligning that register with ERP/WMS/MES master data and physical site lists.
• Embedding MIA/WDA(H) checks into supplier onboarding, CMO/3PL contracting and new-product launch processes.
• Linking inspection planning, internal audits and CAPA to MIA/WDA(H) scopes and performance.
• Using digital tools and dashboards to monitor licence status, scope, inspection outcomes and upcoming renewal/variation deadlines.

The goal is that anyone asking “who is authorised to do what, where?” in your UK medicines supply chain can get a single, accurate answer in minutes—not after a week of reconciling licences, spreadsheets and email trails before an MHRA visit.

16) FAQ

Q1. Do we always need both an MIA and a WDA(H)?
Not necessarily. It depends on the activities performed. A company that only manufactures or imports might only need an MIA; one that only wholesales might only need a WDA(H). Many larger organisations hold both because they manufacture/import and wholesale. The key is to map activities to licence types explicitly.

Q2. Does holding an MIA automatically allow us to wholesale medicines?
No. Manufacturing/import and wholesale are distinct activities with different legal definitions and obligations. An MIA does not substitute for a WDA(H), and vice versa. If you intend to perform both, you generally need both authorisations, with scopes reflecting your operations.

Q3. Can quality or regulatory functions sit outside the MIA/WDA(H) holder’s legal entity?
Yes, but roles, responsibilities and oversight must be clearly defined in the PQS and quality agreements. MHRA will expect the authorisation holder to retain effective control and oversight, even when functions are shared or outsourced across group companies or third parties.

Q4. How often are MIA and WDA(H) inspections performed?
Inspection frequency is risk-based and depends on product types, previous findings, complaint/recall history and other intelligence. Some sites may be inspected every few years; higher-risk or problematic sites may be inspected more frequently. Authorisation holders should assume that inspections can occur whenever risk warrants, not only on a fixed calendar.

Q5. What is a practical first step to improve our MIA/WDA(H) compliance posture?
Start by building a clear map of all UK activities, sites and partners that touch medicinal products and reconcile that map against current MIAs and WDA(H)s. Use the gaps you find to update authorisation scopes, quality agreements, master data and SOPs, and embed licence checks into change control and supplier/partner onboarding.

Related Reading
• Authorisations & Regulators: EMA Centralised Marketing Authorisation Procedure | Health Canada DEL | TGA GMP Clearance
• PQS & Governance: Pharmaceutical Quality System (QMS) | Quality Risk Management (QRM) | PQR/APR | Qualified Person (QP) Release
• Supply Chain & Systems: Traceability | WMS | MES | Mutual Recognition & Reliance in GMP Inspections