Analysis Market access

MHRA's monthly licence terminations list is a supply-chain check market access teams should use

The November 2026 MHRA list of ended UK manufacturing and wholesale licences is routine, but recent shortage notices in France, Slovenia and Czechia show why access teams should read it.

VigiEye editorial · Wed 11 Nov 2026

What happened

On 10 November 2026 the MHRA replaced its October file with a November 2026 version of the list of terminated and cancelled UK manufacturing and wholesale dealer licences. The list names UK companies whose licences to manufacture or wholesale medicines have been terminated, cancelled or revoked.

The agency published a companion file on the same day: the November 2026 CSV of new UK manufacturer and wholesale dealer licences. Together the two files give a month-on-month view of which UK sites have entered and left the licensed supply chain. The records do not say how many entries appear on either list, which companies are named, or why the licences ended. Teams need to open the files themselves to find out whether any partner is affected.

Why it matters for market access

Market access work usually focuses on price, reimbursement and evidence. All of it depends on product actually reaching patients. A contract manufacturer, importer or wholesaler that loses its licence can interrupt that flow, whatever the quality of a dossier or the terms of a tender or managed-entry agreement.

The licence lists are a low-cost early check. A company's appearance on the terminated list is not in itself evidence of a shortage. The records give no reasons for any entry, and a licence can end for different reasons. It is, however, a prompt to confirm whether your own supply arrangements, or those of a competitor or a comparator product, run through that entity.

The new-licence file serves the reverse purpose. It shows which sites have been added, and so which businesses might serve as alternative partners. The MHRA's own description of it is a resource for checking supply-chain partners.

Context: supply fragility elsewhere in Europe

Other regulators' notices published the same day show how local supply problems get managed once they appear. In France, the ANSM refreshed its situation update on contrast agents. It lists the contrast media currently available from Bayer and Bracco and says tensions have persisted since a change in the distribution circuit. The update ties the problem to how products reach the market, not to a manufacturing issue.

In Slovenia, JAZMP has asked wholesalers to temporarily import two strengths of cefaclor oral suspension from other EU states, with bridging quantities set for six months. In Czechia, SÚKL has called for proposals for a Specific Treatment Programme for oral ferrous sulfate heptahydrate for neonates and young children, because no suitable product is marketed there.

These are different problems in different countries, and they have no stated link to the MHRA lists. They do show a common pattern. When a supply gap opens, the response is often a regulatory workaround, such as an import call or a special programme, not a normal commercial solution. Those workarounds create their own pricing, reimbursement and documentation questions.

Who is affected

Any UK-facing company that relies on third-party manufacturing or wholesale partners should look at the terminated list. That includes marketing authorisation holders, parallel importers, and distributors serving the NHS. HTA and pricing teams that make supply-continuity commitments in submissions or contracts have a particular reason to check, because those commitments depend on partners holding valid licences.

The Czech notices are a reminder that a regulatory status change does not always mean product on shelves. SÚKL says Erdostein Zentiva 300 mg capsules can be dispensed without a prescription from 29 October 2026, but the product is not yet marketed in the Czech Republic. SÚKL has also published a draft price and reimbursement list for foods for special medical purposes, dated 10 November 2026. It sets out manufacturer prices, reimbursement levels and co-payments, and is open for comment until the 20th of the month. Teams with products in that category have a short window to respond.

What to watch

Three things are worth tracking. The first is the December editions of both MHRA files. A month-by-month comparison will show whether any partner is leaving or joining the licensed base. The second is whether the ANSM's contrast agent updates show tensions easing or persisting. The third is how the Slovenian cefaclor import call and the Czech ferrous sulfate programme resolve. Neither record gives an outcome yet, so the results are not known.

None of the records describe any link between the MHRA lists and specific shortages. Treat the lists as a due-diligence input to be combined with your own supplier knowledge, not as a signal in themselves.

What to do
  • Open the November 2026 MHRA terminated and cancelled licence list and check every UK manufacturing, importation and wholesale partner against it, including sub-tier contractors.
  • Add the monthly MHRA terminated and new-licence files to your supply-chain review calendar, and record any change in a partner's status alongside your contract and tender commitments.
  • If you have products in the Czech foods for special medical purposes category, review SÚKL's draft price and reimbursement list and submit any comments before the 20 November deadline.
  • For products in markets with active shortage responses, such as French contrast media or Slovenian cefaclor, check whether temporary import or special-programme arrangements affect your pricing, reimbursement or documentation obligations.

Sources this analysis is based on

Written by VigiEye's editorial system with AI assistance (model claude-sonnet-5-5) strictly from the official records listed above. It can contain errors: check the sources before acting. Not legal, medical or investment advice.

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