Our Ref: FOI 23/613

Dear Gavin Roberts,

RE: REQUEST UNDER THE FREEDOM OF INFORMATION ACT 2000

Thank you for your enquiry which we received on 16 August.

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 Experience Centre
Communications and engagement team
Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf,
London E14 4PU

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Dear Gavin Roberts,

In relation to your request it is likely that clarifications are required
from you. To assist you I would first like to provide some details in
relation to the licensing of Fluad.

According to our records, Fluad was first registered in Italy in 1997 for
the prophylaxis of influenza in elderly people (65 years of age and over).
Since then, it has been approved in 12 European countries through a
procedure (IT/H/0104/001) that was concluded on April 23rd 2000. In the
UK, a full application for this product was granted on 9 August 2017 and
this application followed the decentralised procedure (IT/H/525/001/DC),
because Italy coordinated this procedure their regulatory authority was
responsible for producing the public assessment report. However, we have
located this report and provide it for your information; note the
equivalent product name is Innoflu in Italy. In the attached report
sections on Clinical safety and Clinical efficacy describe the trials used
to support licensing of this product in the UK. In my opinion, it would be
best to approach the reference member state for these procedures (Italy),
in medicines regulation the harmonised language is English and so there
should not be any issues with translations. If you would like me to
contact Italy on your behalf please let me know, or if you want to contact
them directly please do so via: [1][email address].

In terms of the data related to specific trial participants this would
likely be exempt under Section 40(2) of FOIA, as it relates to personal
data.

I note that your request mentions dosage levels, in technical terms it may
be the dose escalation and dose finding studies you are seeking, such
studies are carried out for some medicines and use a range of doses to
help to establish the most suitable dose. If the information you are
seeking does relate to such studies, please mention these terms, ‘dose
escalation and dose finding’, to AIFA (Italy’s regulatory authority for
medicines).

Please note any clarified request received to MHRA will be logged as a new
request as per the ICO’s guidance. When requesting clinical information,
 the aggregated numbers of trial participants can be released and a
deidentification process can be undertaken to redact personal information
of individual trial participant details. However,  depending on the volume
of material requested such a request may be refused under Section 14 of
the FOI Act in terms of the burden placed on our organisation due to the
need to complete a thorough and carefully considered redaction /
de-identification process.

I trust that this information will be of use,

Many thanks,

HQA FOI Team.

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