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References

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1. https://www.gov.uk/government/collection...

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.

Kind Regards,

MHRA Customer Service Centre

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

show quoted sections

FOI 21/192
 
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)
Act.
 
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
applies.
 
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
this study.
 
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
[1]https://www.gov.uk/government/publicatio....
 
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: [2][MHRA request email]
 
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 Services
 
[3][email address]
 
Copyright notice
The information supplied in response to your request is the copyright of
MHRA and/or a third party or
parties, and has been supplied for your personal use only. You may not
sell, resell or otherwise use
any information provided without prior agreement from the copyright
holder. For full details on our
copyright policy please visit:
[4]https://www.nationalarchives.gov.uk/info...
sector-information/copyright/crown-copyright/ or e-mail the MHRA
Information Centre. 
 
 

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