FOI release

Freedom of Information request on Desmopressin sublingual tablets (FOI 21/527)

Published 28 June 2021

28th May 2021 FOI 21/527

Dear

Regarding your letter of 18 May 2021, requesting various information concerning the products Desmopressin 60, 120 & 240 micrograms sublingual tablets, MHRA have published the Summaries of Product Characteristics (SmPCs) and the Patient Information Leaflet for these products. Additionally, MHRA have published a Public Assessment Report (PAR), which consists of the non-confidential parts of the MHRA’s assessment of these products. Links to these documents are provided below: https://mhraproducts4853.blob.core.windows.net/docs/36a1116c3b475c6017c6dbb9dca777a9f7440c37 https://mhraproducts4853.blob.core.windows.net/docs/7b7cd7a66b21f84593b809efa71da5ab45935326 https://mhraproducts4853.blob.core.windows.net/docs/25f63ae4203e6b2082ea6e474088abb6745f7d98 https://mhraproducts4853.blob.core.windows.net/docs/b8f611e91cbe9e7b9b864d98b73995d6c4a199c7 https://mhraproducts4853.blob.core.windows.net/docs/78d2ffa37348ff14a0cd8276ede85d0de082b74b

Regarding the specific documents you have requested, please see below MHRA’s responses in red: • the names of the products indicated in the marketing authorisations for the Kinedexe Products and, if generic products, the name of medicine indicated as Reference Medicinal Product; This information is available in the PAR that is linked above.

• the full composition of the Kinedexe Products and all data regarding the quantity and quality of each compound; The qualitative composition of the products is available in the SmPCs that are linked above. The quantitative composition and any further data regarding the quality/quantity of the active or excipients would be exempt from release under Section 41 (information provided in confidence) and Section 43 (commercial interests) of the Freedom of Information (FOI) Act.

• the SmPC, the labelling and packaging leaflet (parts 1.3.1, 1.3.2 and 1.3.4); The SmPCs and leaflets are published on the MHRA website, please refer to the links above. The labelling is available in the PAR, please refer to the link above.

• any preliminary assessment reports; • any questions raised by the MHRA, whether or not they were communicated to Kinedexe; • any responses to the questions referenced above by the MHRA or Kinedexe; • the final assessment report; • documents relating to bioavailability studies; • documents relating to bioequivalence studies in relation to the Reference Medicinal Product; The MHRA’s assessment of these products, including details of the bioequivalence studies conducted, is available in the PAR, please refer to the link above.

• documents relating to the “dispersion time” and/or “disintegration time” of the Kinedexe Products. This information is exempt from release under Section 41 (information provided in confidence) and Section 43 (commercial interests) of the FOI Act.

• documents relating to the clinical trials supporting the approval of the marketing authorisations for the Kinedexe Products; Details of the bioequivalence studies conducted are available in the PAR, please refer to the link above.

• the following Common Technical Document from Module 3 (or the UK equivalent) from the dossier submitted to support the above applications: o Part 3.2.P.1 regarding the drug product description and composition; o Part 3.2.P.2 regarding the pharmaceutical development; o Part 3.2.P.3 regarding the manufacturing notably 3.2.P.3.3, 3.2.P.3.4 and 3.2.P.3.5; o Part 3.2.P.5 regarding the control of the drug product; and This information is exempt from release under Section 41 (information provided in confidence) and Section 43 (commercial interests) of the FOI Act.

• any scientific advice provided by the MHRA relating to the Kinedexe Products and any communications between the MHRA and Kinedexe and vice versa relating to scientific issues. This information is exempt from release under Section 41 (information provided in confidence) and Section 43 (commercial interests) of the FOI Act.

Regarding the application of Section 41 and Section 43 of the FOI Act, Section 41 is an absolute exemption and no consideration of the public interest is required, except to state that we consider its disclosure to constitute an actionable breach of confidence. Section 43 is a qualified exemption and a consideration of the public interest should be made. We have considered the public interest and cannot see any public interest argument that outweighs the commercial harm in providing data from the quality part (Module 3) of the eCTD dossier that can be used by competitors to gain insight into the development of a current granted medicinal product, and provide know-how in the development of their own product or overcoming regulatory hurdles to get their product onto the market quicker.

If you disagree with how we have interpreted the Freedom of Information Act 2000 with regards to your request, you can ask for the decision to be reviewed. The review will be carried out by a senior member of the Agency who was not involved with the original decision.

If you have a query about the information provided, please reply to this email

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 two months of the date you receive this response and addressed to: info@mhra.gov.uk

Due to the ongoing Covid-19 situation, we are not able to accept delivery of any documents or correspondence by post or courier to any of our offices

Please remember to quote the reference number above in any future communications.

If you were to remain dissatisfied with the outcome of the internal review, you would have the right to apply directly to the Information Commissioner for a decision. Please bear in mind that the Information Commissioner will not normally review our handling of your request unless you have first contacted us to conduct an internal review. The Information Commissioner can be contacted at:

Information Commissioner’s Office Wycliffe House Water Lane Wilmslow Cheshire SK9 5AF

Yours sincerely

MHRA Customer Service Centre

Medicines and Healthcare products Regulatory Agency 10 South Colonnade, Canary Wharf, London E14 4PU