Recalls and drug alerts

• Every notice is read within minutes of arriving: product, batches, expiry, class, recall level and required actions are extracted and shown next to the original text.
• Batches are matched exactly against current stock, stock in transit, returns, and every dispatch since the first distribution date in the notice.
• Matched stock is put on hold in the warehouse system straight away, so nothing more is picked or shipped, pending a person's confirmation.
• Affected customers are listed with quantities and delivery dates, and a notice is drafted from an approved template. A person approves it before it goes.
• Replies and returns are tracked, quantities reconciled, and customers who haven't responded are chased automatically.
• A completion pack is assembled as the recall runs: timeline, decisions, who did what, and quantities supplied against quantities accounted for, ready for the manufacturer's report and for inspection.

• MHRAWholesale dealer's licence (WDA(H)), regulation 43(7)
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  The licence holder must keep an emergency plan for recalls and the sale and supply records that support it. Batch-level dispatch history is searchable in seconds, and the emergency plan says how the AI helps and exactly what happens when it's unavailable.

• MHRAGood Distribution Practice and the Responsible Person
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  Recalls are a quality process the Responsible Person owns. The AI reads, matches, drafts and chases; the Responsible Person or a trained delegate confirms quarantine and approves notices, and only quality can release held stock. Recall arrangements are tested with regular mock recalls. Controlled drugs follow the existing Home Office-licensed procedures and records.

• MHRA DMRCA guide to defective medicinal products (updated February 2026)
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  Wholesalers must tell every customer who may have received an affected batch, and not every recall comes with an MHRA notice: some are led by the manufacturer. The intake handles both, and the evidence pack supports the manufacturer's final report, which the DMRC needs before it closes the case.

• MHRA / NHS EnglandNational Patient Safety Alerts and recall classes
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  Class 1 recalls (risk of death or disability) are issued as National Patient Safety Alerts; Class 2 and 3 as medicines recalls; Class 4 as caution-in-use notifications. The class sets the priority, and Class 1 pages a named on-call person immediately.

• MHRAWindsor Framework and the devolved cascades
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  Since 1 January 2025, one UK-wide licence and 'UK Only' packs cover Northern Ireland, so batch matching works the same across the UK. Cascades still differ: Scotland, Wales and Northern Ireland have their own routes, so the intake watches each one that applies to your customers.

• ICOUK GDPR and the Data Protection Act 2018
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  Customer records name pharmacists and contacts. Patient-level follow-up is the pharmacy's job, so the wholesaler needs no patient data. A short DPIA, UK regions, and a contract that stops providers training their models on your data.

On a phone, the table shows the platform you pick. Sovereign / on-prem means open, portable components you can run in your own data centre or with a UK or European provider; IONOS is shown as one example, and others exist. What sovereign cloud means →

• The recall procedure rewritten to include the AI steps, the approvals and the manual fallback, and signed off by the Responsible Person.
• A named on-call person for Class 1 alerts out of hours, paged by the system.
• Regular mock recalls through the new process, including one with the AI switched off.
• A weekly check of the MHRA alerts page against the recalls processed, so nothing is missed quietly.
• A named owner for every prompt, template and data feed, with change control through the quality system.
• Responsible Person delegates trained in checking extracted batch numbers before go-live, not after.

1. 2 weeks

   Discovery

   Map today's recall procedure, time last year's recalls step by step, and check batch capture at goods-in and dispatch.

2. Gate · must be true to passBaseline agreed, batch traceability confirmed, Responsible Person and quality involved, and DPIA screening done.

3. 4–6 weeks

   Pilot

   Shadow mode: every new notice is handled by the AI and by the team in parallel, and last year's recalls are replayed.

4. Gate · must be true to passZero missed batches in the replay, every extraction error caught by review, and the Responsible Person signs off the updated procedure.

5. 3–4 weeks

   Production

   Holds and drafted notices go live, with monitoring, the manual fallback, and a mock recall before go-live.

6. Gate · must be true to passMock recall passed, out-of-hours route tested, delegates trained.

7. Ongoing

   Scale

   Reuse the pattern for returns, complaints and suspected falsified medicines, and for field safety notices on any medical devices you distribute.

8. Gate · must be true to passEach new use passes the same pilot gate.

R ResponsibleA AccountableC ConsultedI Informed· not involved

Where I'd fit

1. 1

   Goes wrong

   A batch number is misread from a PDF, so the wrong stock is held and the affected stock ships.

   How the design avoids it

   Exact matching against the source text, a side-by-side check by a person, and a hold on near-misses until someone has looked.

2. 2

   Goes wrong

   The warehouse records batches at goods-in but not at dispatch, so nobody can say which customer got which batch.

   How the design avoids it

   Check batch traceability in discovery and fix it first. The AI can only match what was recorded.

3. 3

   Goes wrong

   A notice lands in one person's inbox on a Friday evening and waits until Monday.

   How the design avoids it

   A shared, monitored mailbox, a backstop check of the MHRA alerts page, and an on-call page for Class 1.

4. 4

   Goes wrong

   The team trusts the system and forgets how to run a recall by hand.

   How the design avoids it

   The manual procedure stays in the recall procedure, and mock recalls include a test with the AI switched off.

5. 5

   Goes wrong

   The same recall arrives from the MHRA and the manufacturer, and customers get two different notices.

   How the design avoids it

   One recall record per product and batch set, matched across sources, with one approved notice.

1. No date yet
   A medicines verification scheme for Great Britain

   Great Britain has had no working verification system since the start of 2021, and 2D barcodes are no longer compulsory. The government has committed to consult on a future scheme, and the Royal Pharmaceutical Society called for mandatory 2D barcodes in February 2026. Scan batch and expiry wherever packs carry a code, and design the data model so serial numbers can be added later.

2. Late 2026–2027
   DHSC's changes to the medicines information regulations

   Hub-and-spoke dispensing between different businesses has been allowed since 1 October 2025, and DHSC has consulted on giving hubs the same reporting duties as wholesalers. That adds a step between the wholesaler and the patient. Make sure dispatch records show exactly which site each delivery went to.

3. Under way
   More structured reporting to the MHRA

   Since February 2026, licence holders report suspected defects to the MHRA's Defective Medicines Report Centre through an online form. Notices to wholesalers still arrive as emails and documents. Keep the intake modular, so a structured feed could replace email reading without a redesign.