FOI release
Request for MHRA Rx-to-OTC application receipt dates and current legal-status register extract
This request was refused in part, so we didn't provide some of the information the requester asked for. This may include information where we can neither confirm nor deny that we hold it.
Case reference FOI2026/01012
Received 8 September 2026
Published 15 October 2026
Request
Thank you for your response of 19 May 2026 (ref FOI2026/00435), and in particular for the advice under section 16 that a request restricted to Questions 1 and 2 would fall below the section 12 cost limit. I am acting on that advice. This is a new, narrowed request. Question 3 — the pre-submission and scientific-advice counts — is withdrawn in full. That question was the sole stated cause of the cost estimate, since it would have required opening every meeting record. Nothing below requires that work. I would also like to address the section 21 exemptions you raised, because I think the position has changed since your letter. Request 1 — Rx-to-OTC reclassifications, 1 January 2015 to date I have obtained and am using the published register (Reclassifications_Approved_1991_-_01-3-2026.xlsx). It is genuinely useful and I am grateful it exists. For approved reclassifications I therefore withdraw the request entirely — section 21 plainly applies. What that register does not carry is the date the application was received alongside the grant date. I request only that single additional field for the entries already published in it, if it is held. I am not requesting information on refused or withdrawn applications, so the section 41 and section 43 concerns in your letter fall away. Request 2 — one machine-readable extract of the legal-status register This is the substance of my request, and it is one query against one table: PL number · product name · active substance(s) · ATC code · legal status (POM / P / GSL) · MA holder · date of first authorisation for all currently authorised human medicines, as a single CSV or Excel file. Your letter cited section 21 for this, pointing to the Marketing authorisations: lists of granted licences collection. Having worked with that collection, I would ask you to reconsider whether it makes this information reasonably accessible for the purpose stated: It is published as PDF, in fortnightly instalments. It is a notice of what was granted, not an extract of the register, and it cannot be read as a dataset without re-keying thousands of entries by hand. It runs substantially in arrears. As at 8 September 2026 the most recent instalment on the 2026 page covers 15–31 March 2026, and the page records that the 1–14 March list was added on 3 September 2026 — a lag of approximately five months. It is incremental, not cumulative. It shows what was granted in a fortnight. It does not give the current legal status of the authorised portfolio, which is what I have asked for and what Products.MHRA.gov.uk presents one record at a time with no download. I do not say this to be difficult. I say it because a single export of a table the Agency already maintains is, I believe, far less work for you than the alternative, and it is the only form in which the information is usable for the stated purpose. Why this matters, briefly I am building a consumer-healthcare intelligence platform covering the national medicines registers of Europe. Twenty-three EU member states publish exactly this data as a downloadable extract — the Netherlands, Spain, France, Belgium, Ireland and others — and it is incorporated. The United Kingdom is the significant omission, not because MHRA withholds it, but because the published form cannot be processed. The practical consequence is that UK legal-status data in my platform currently ends in April 2026 while comparable EU markets are current to within days. I would much rather represent the UK accurately. Format and cost CSV or Excel preferred; any machine-readable format is welcome. I am content to receive a point-in-time snapshot rather than anything ongoing, and I make no request for commercially sensitive or unpublished information — only regulatory-decision metadata of the kind routinely published by other European national registers. If any part of this still approaches the cost limit, I would ask that Request 2 be treated as the priority and Request 1 set aside. I am grateful for the Agency's time, and for the section 16 advice that made this narrower request possible.
Response
See attached
Documents
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