Evaluation documents relating to licensing of certain vaccines
Dear Therapeutic Goods Administration,
I request documents pertaining to the evaluation process of licensing the following vaccines on the Australian market:
M-M-R II
PRIORIX
PROQUAD
PRIORIX TETRA
ENGERIX-B
INFANRIX HEXA
Public Assessment Reports/Clinical Evaluation extracts for these vaccines are not on the TGA website. I request these documents, including clinical trial data in your possession. I do not require duplicates. I do not require personal information.
Yours faithfully,
Karine McKerrell
Dear Therapeutic Goods Administration,
I understand as per email correspondence I have received, that AusPARS had not been introduced at the time these vaccines were licensed. I therefore would like to make acknowledgment of that in relation to this FOI request, and still request any documents that pertain to the evaluation process prior to their introduction on the Australian market, including clinical data. Thank you.
Yours faithfully,
KBurgess
Dear Ms McKerrell
FREEDOM OF INFORMATION REQUEST – NOTIFICATION OF RECEIPT
I am writing to notify you that the Department of Health (Department) has
received your request for access to documents under the Freedom of
Information Act 1982 (FOI Act).
“I request documents pertaining to the evaluation process of licensing the
following vaccines on the Australian market:
M-M-R II
PRIORIX
PROQUAD
PRIORIX TETRA
ENGERIX-B
INFANRIX HEXA
Public Assessment Reports/Clinical Evaluation extracts for these vaccines
are not on the TGA website. I request these documents, including clinical
trial data in your possession. I do not require duplicates. I do not
require personal information.
I understand as per email correspondence I have received, that AusPARS had
not been introduced at the time these vaccines were licensed. I therefore
would like to make acknowledgment of that in relation to this FOI request,
and still request any documents that pertain to the evaluation process
prior to their introduction on the Australian market, including clinical
data.”
Under section 15(5)(b) of the FOI Act, the agency has 30 calendar days
after the date your request was received in which to provide a decision in
response to your request for access. A decision is currently due on or
before 1 January 2019.
However, where there is requirement to undertake consultation with
affected third parties, this timeframe is extended by a further 30 days.
It may also be extended in certain circumstances, including with your
agreement or where the Department applies to the Office of the Australian
Information Commissioner for an extension.
In addition, please note that if the decision maker decides that you are
liable to pay a charge in relation to your request then this timeframe is
extended pending payment of a deposit. You will be notified by the
Department if you are liable to pay a charge and/or if third party
consultation is required.
If you have any queries, please contact the FOI team on (02) 6289 4630, or
via email at [1][email address].
Kind regards
Freedom of Information
[2]cid:image001.png@01D54DDB.C1CF42E0
Therapeutic Goods Administration
Australian Government Department of Health
T: 02 6289 4630 | E: [3][email address]
PO Box 100, Woden ACT 2606, Australia
Web: [4]www.tga.gov.au
[5]cid:image002.png@01D55CBC.5655D390[6]cid:image003.gif@01D55CBC.5655D390[7]cid:image004.png@01D55CBC.5655D390
Important: This transmission is intended only for the use of the addressee
and may contain confidential or legally privileged information. If you are
not the intended recipient, you are notified that any use or dissemination
of this communication is strictly prohibited. If you receive this
transmission in error please notify the author immediately and delete all
copies of this transmission.
The Department of Health acknowledges the Traditional Custodians of
Australia and their continued connection to land, sea and community. We
pay our respects to all Elders past and present.
Dear Ms McKerrell
Please find attached correspondence in relation to your Freedom of
Information request.
As set out in the attached correspondence, we seek your response within 14
days, being 3 January 2020. However, if you are agreeable, due to the
holiday period and our office being shut down from 3pm 24 December 2019 to
2 January 2020, we propose extending the consultation period under section
24AB(5) of the Freedom of Information Act 1982 (FOI Act) to Friday 17
January 2020.
Pursuant to section 24AB(8) of the Freedom of Information Act 1982, the
statutory timeframe for processing your request is set aside during this
consultation process.
If you have any questions, please do not hesitate to contact the FOI Team.
Kind regards
Freedom of Information
[1]cid:image001.png@01D54DDB.C1CF42E0
Therapeutic Goods Administration
Australian Government Department of Health
T: 02 6289 4630 | E: [2][email address]
PO Box 100, Woden ACT 2606, Australia
Web: [3]www.tga.gov.au
[4]cid:image002.png@01D55CBC.5655D390[5]cid:image003.gif@01D55CBC.5655D390[6]cid:image004.png@01D55CBC.5655D390
Important: This transmission is intended only for the use of the addressee
and may contain confidential or legally privileged information. If you are
not the intended recipient, you are notified that any use or dissemination
of this communication is strictly prohibited. If you receive this
transmission in error please notify the author immediately and delete all
copies of this transmission.
The Department of Health acknowledges the Traditional Custodians of
Australia and their continued connection to land, sea and community. We
pay our respects to all Elders past and present.
The Therapeutic Goods Administration (TGA) will commence its close down
for the Christmas / New Year’s period from 3pm Tuesday 24 December 2018
and will return to normal operating hours on Thursday 2 January 2019. The
FOI Inbox will not be monitored during this time, and any correspondence
received will be handled upon return to the office. The TGA FOI Team look
forward to working with you in the new year.
Dear TGA FOI,
Thank you kindly for your response. That is indeed a lot of time and resources. I acknowledge your suggestion to amend the request but I am unsure of exactly which terms to use to narrow it down. If I were to go onto the TGA website and look up e.g. Menveo, I can read an AusPAR with clinical evaluation information. It is basically this information I am looking for. The European Medicines Agency for example, has similar documents e.g. for Infanrix HEXA. Are there any available summary documents which relate to the clinical information that would be included in an AusPAR/Clinical Evaluation Summary if these vaccines were introduced into the Australian market for the first time today? E.g. information relating to clinical efficacy, all adverse events including serious adverse events. It is this type of information I am looking for.
Thank you for your time so far.
Yours sincerely,
KBurgess
Dear Ms McKerrell
Thank you for your response of 5 January 2020, and please accept our
apologies for the delay.
At the outset, I regret that the consultation period for this request
expired on 3 January 2020, in accordance with the [1]FOI Guidelines
(paragraphs 3.134 and 3.135) . However, we have been consulting with the
business area about what documents may suit your requirements as set out
below, for future reference. As such, the following information should be
considered for inclusion in a new FOI request.
The business area have proposed requesting the Delegate’s overviews and/or
the first Product Information or Consumer Medicines Information documents
for a particular vaccine.
Please note that these suggestions do not confirm that the TGA holds these
documents. It is also likely, if the TGA does hold these documents, that
some of the information (in the overviews) may be exempt from release
under the FOI Act.
Should you still require access to these documents, we invite you to
submit a new FOI request.
Thank you
Freedom of Information
[2]cid:image001.png@01D54DDB.C1CF42E0
Therapeutic Goods Administration
Australian Government Department of Health
T: 02 6289 4630 | E: [3][email address]
PO Box 100, Woden ACT 2606, Australia
Web: [4]www.tga.gov.au
[5]cid:image002.png@01D55CBC.5655D390[6]cid:image003.gif@01D55CBC.5655D390[7]cid:image004.png@01D55CBC.5655D390
Important: This transmission is intended only for the use of the addressee
and may contain confidential or legally privileged information. If you are
not the intended recipient, you are notified that any use or dissemination
of this communication is strictly prohibited. If you receive this
transmission in error please notify the author immediately and delete all
copies of this transmission.
The Department of Health acknowledges the Traditional Custodians of
Australia and their continued connection to land, sea and community. We
pay our respects to all Elders past and present.
Dear TGA FOI,
Ah yes, I was hoping the date extension had been applied in the absence of my response but thought it may have been too late. Thank you for your assistance in this matter, it is appreciated. I will follow the suggestions provided.
Yours sincerely,
KBurgess