FOI release

Freedom of Information request about methenamine hippurate legal status (FOI 21/084)

Published 7 May 2021

Thank you for your email, dated 07 February 2021, in which you requested ‘…to access information under the Freedom of Information Act (FOI) to understand the rationale behind the MHRA granting a P-pharmacy only legal status to Hiprex (methenamine hippurate).’

The availability of methenamine hippurate tablets without prescription in the UK pre-dates the Medicines Act 1968. According to our records, the brand leader Hiprex 1 g Tablets (PL 46302/0200; Mylan Products Ltd) was granted a product licence on 18 December 2018, following a series of change of ownership procedures of Hiprex 1 g Tablets (PL 00068/5003R; 3M Health Care Limited). The Pharmacy medicine legal classification of Hiprex 1 g Tablets (PL 00068/5003R; 3M Health Care Limited) was transferred to Hiprex 1 g Tablets (PL 46302/0200; Mylan Products Ltd) at the time of its approval.

Hiprex 1 g Tablets (PL 00068/5003R; 3M Health Care Limited) was granted on 12 October 1989 as a reviewed Product Licence of Right Pharmacy medicine. The original product, Hiprex 1 g Tablets PLR 00068/5003; Minnesota 3M Laboratories Limited), for the Product Licence Hiprex 1 g Tablets (PL 00068/5003R; 3M Health Care Limited) was introduced on to the UK market before the Medicines Act 1968 came into force in1971 and was granted a Product Licence of Right on 22 February 1973. At the time of the review of this Product Licence of Right, Hiprex 1 g Tablets (PLR 00068/5003; Minnesota 3M Laboratories Limited) was a Pharmacy medicine; this legal classification for the product was consistent with the regulations at the time. With the exception of certain categories of medicines, such licences were reviewed in the 1980s to ensure that the products were safe, of suitable quality and had evidence of efficacy. Because of the length of time that such products had been on the market they were considered to have well established use and original clinical data to today’s standards was not necessarily available. We have searched our

records and have not found any information on the MHRA assessment at the time of the review of Hiprex 1 g Tablets (PLR 00068/5003; Minnesota 3M Laboratories Limited). Therefore, having exhausted all the usual avenues in our search to ascertain for this information, we have concluded that, it is no longer on our systems in a retrievable form.

In December 2019 the Commission on Human Medicines (CHM) issued advice to the Licensing Authority that the Pharmacy (P) legal classification of methenamine containing products was not appropriate. CHM’s opinion is that methenamine containing products should not be P medicines as the authorised indication for management without medical supervision is clinically inappropriate. Additionally, there is a risk that the availability of this antibiotic as a P medicine could create the wrong message regarding antimicrobial stewardship.

We have written to all Marketing Authorisation holders of all Pharmacy methenamine products to ask them to reclassify these products from Pharmacy legal status to prescription only. This work is currently in progress.

We now consider this FOI request closed. If you have a query about this letter, please contact the MHRA FOI Licensing mailbox using the email address listed below.

If you are dissatisfied with the handling of your request, you have the right to ask for an internal review. Internal review requests should be submitted within 2 months of the date you receive this response and addressed to: [email protected], quoting reference FOI 21/084.

If you are not content with the outcome of the internal review, you have the right to apply directly to the Information Commissioner for a decision. The Information Commissioner can be contacted at: Information Commissioner’s Office, Wycliffe House, Water Lane, Wilmslow, and Cheshire, SK9 5AF.

Yours sincerely,

The FOI Licensing Team

Email: [email protected]