FOI request EudraCT Number 2019-004475-39
K Glavini made this Freedom of Information request to Medicines and Healthcare Products Regulatory Agency
Dear Medicines and Healthcare products Regulatory Agency,
Under the freedom of information please provide the following information:
Electronic copies of the CTA submission package (e.g. study protocol, investigator brochure) received by the MHRA in relation to the JNJ-73763989/JNJ-56136379 Phase 2 study, with EudraCT Number 2019-004475-39. All appropriately redacted to remove any personal or data protection material.
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Our Ref: FOI 21/192
Dear K. Glavini,
RE: REQUEST UNDER THE FREEDOM OF INFORMATION ACT 2000
Thank you for your enquiry which we received on 18 February 2021.
I confirm that your request is now being handled under the Freedom of Information Act and you should receive a reply within 20 working days from our date of receipt.
If you need to contact us again about this request, please quote the reference number above.
MHRA Customer Service Centre
Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU
Dear MHRA Customer Services,
This is gentle reminder of my previous query, thank you for looking into this.
Dear Mr K. Glavini,
Thank you for your information request, dated 18 February 2021 where you
asked for the following:
1. Electronic copies of the CTA submission package (e.g. study
protocol, investigator brochure) received by the MHRA in relation to the
JNJ-73763989/JNJ-56136379 Phase 2 study, with EudraCT Number
2019-004475-39. All appropriately redacted to remove any personal or
data protection material.
I am pleased to provide you with some of the information requested,
attached to this email.
These documents are provided with any personal information redacted, as
well as any information specific to the structure or molecular formula and
manufacturing process or considered commercially sensitive, under Section
40 (Personal Information), Section 41 (Information Provided in Confidence)
and Section 43 (Commercial Interests) of the Freedom of Information (FOI)
Other application documentation has not been provided as the information
was provided to us in confidence, with the expectation that it will not be
released, and is therefore exempt from disclosure under Section 41 of the
Freedom of Information Act. Disclosure would also likely prejudice
commercial interests and, therefore, exemption under Section 43 also
Section 41 is an absolute exemption and no consideration of the balance of
public interest is required. 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 overriding argument for releasing
the information that outweighs the commercial harm by providing potential
competitors with an insight into the product development and design of
The Freedom of Information Act only entitles you to access to information
– the information supplied is subject to Crown copyright, and there are
some restrictions on its re-use. For information on the reproduction or
re-use of MHRA information, please visit
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