Communications relating to Sun Pharmaceuticals
Dear Therapeutic Goods Administration,
I am requesting documents relating to Sun Pharmaceutical Industries Limited of Mumbai, India ('Sun Pharmaceuticals'), including their manufacturing and production premises, under the Freedom of Information Act 1982.
The Food and Drugs Administration recently issued Sun Pharmaceuticals with warning letter 320-14-08, on the 7th of May this year.
I am writing to you today to request the following documents regarding Sun Pharmaceuticals between 1 November 2013 and 1 November 2014:
- communications between the Food and Drugs Administration and the Therapeutic Goods Administration,
- any communications originating from within the Therapeutic Goods Administration regarding inspections and actions taken by the Food and Drug Administration.
I look forward to your response either way.
Yours faithfully,
Kristof Wing
Attention: Kristof Wing
Please see attached correspondence in relation to your FOI request to the
Department of Health.
Kind regards
FOI Officer
Information Law Section| Legal Services Branch
Department of Health
Phone: (02) 6289 1666
GPO Box 9848, Canberra ACT 2601 | MDP 350
--------------------------------------------------------------------------
"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."
Dear Mr Wing
Please find attached correspondence relating to your Freedom of
Information request 107-1415.
Kind regards
Emily
Freedom of Information
Liz Santolin 02 6232 8664
Karen Bedford 02 6232 8772
Emily May 02 6232 8792
Heather Kerr 02 6232 8163
Group Support Unit
Monitoring and Compliance Group
Therapeutic Goods Administration
Address: PO Box 100, Woden ACT, 2606
Email: [1][email address]
[2]cid:image003.gif@01CFA69C.488B9550
--------------------------------------------------------------------------
"Important: This transmission is intended only for the use of the
addressee and may contain confidential or legally privileged information
and has been sent in accordance with the TGA security policy.
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."
--------------------------------------------------------------------------
References
Visible links
1. mailto:[email address]
Dear Ms. May,
Thank you for the prompt reply and the estimate of charges.
I wish to contend these charges, the reasons for which are outlined below.
Initially, it is worth noting that my request is in keeping with the objects of the Freedom of Information Act 1982 (herein 'The Act'), subsection 3(2)(b). By releasing these documents, the Therapeutic Goods Administration (herein 'TGA') would allow the public, and medical professionals who rely on the TGA, to scrutinise, discuss, and most importantly comment upon and review the decisions made by the TGA with regard to Sun Pharmaceuticals. Furthermore, release of these documents would permit scrutiny and discussion of the TGA's interactions with other regulatory agencies, such as the Food and Drugs Administration (herein 'FDA').
Firstly, I wish to appeal these charges in accordance with subsection 29(5)(a) of The Act. I am a full-time student studying a demanding professional degree, with limited sources of income.
The charges imposed would cause financial hardship, as these charges constitute up to one week's income. I sincerely request that the TGA review these charges in light of this potential hardship.
Secondly, I wish to appeal the charges in accordance with subsection 29(5)(b) of The Act. These communications are of interest to a substantial section of the public, specifically healthcare professionals who prescribe, dispense, and administer Sun Pharmaceutical's generic medications, and consumers who willingly and with great trust take these generic medications.
These two groups constitute a substantial section of the public, and it would be in their interest to know the nature and rigor of communications and compliance actions within the TGA, and between the TGA and international regulatory bodies.
Finally, I wish to contend these charges on the basis that the documents do not require photocopying or postage. These documents are able to be supplied electronically, as on the Department of Health FOI Disclosure Log. Should redaction of these documents be required Adobe Acrobat X, instead of manual redaction is able to be used, as outlined in the following Office of the Information Commissioner document: http://www.oaic.gov.au/freedom-of-inform...
Thank you for taking the time to consider this reasoning, and I look forward to hearing from you either way soon.
Yours sincerely,
Kristof Wing
Dear Mr Wing
Thank you for your email below requesting a waiver of charges in relation
to your FOI application 107-1415.
Under the FOI Act, the decision maker has 30 days in which to make a
decision on a waiver of charges request. With this in mind, you will be
notified of the TGA’s decision on or before 19 December 2014.
As you are aware, in addition to the public interest grounds you have
raised, the decision maker will consider whether the imposition of the
full amount of charges would cause you financial hardship. In coming to
this decision, they will consider the impact on your overall financial
position.
In these circumstances, the decision maker has asked if you are able to
provide evidence that payment of the FOI charges ($321.47) would cause you
financial hardship. It has been noted that you are a full time student
with limited income, however, it may support your claim if you were able
to provide documented evidence of financial hardship, e.g. receipt of
ABSTUDY, Austudy or Youth Allowance payments or other evidence of income,
debts and assets (e.g. statutory declaration).
Further information on the requirements is available in the FOI Guidelines
issued by the Australian Information Commissioner, which state at
paragraph 4.53:
‘4.53 An applicant relying on this ground could ordinarily be expected to
provide some evidence of financial hardship. For example, the applicant
may rely upon (and provide evidence of) receipt of a pension or income
support payment; or provide evidence of income, debts or assets…’
Finally, it appears that any third parties relating to this matter are
able to be consulted by electronic means. Therefore, the TGA does not
propose to charge you the postage itemised in the Estimate of Charges
letter.
Please let me know if you have any queries in relation to the above.
Kind regards
Liz
Freedom of Information
Liz Santolin 02 6232 8664
Karen Bedford 02 6232 8772
Emily May 02 6232 8792
Heather Kerr 02 6232 8163
Group Support Unit
Monitoring and Compliance Group
Therapeutic Goods Administration
Address: PO Box 100, Woden ACT, 2606
Email: [1][email address]
[2]cid:image003.gif@01CFA69C.488B9550
-----Original Message-----
From: Kristof Wing [[3]mailto:[FOI #793 email]]
Sent: Wednesday, 19 November 2014 2:50 PM
To: FOI Mail
Subject: Re: Estimate of Charges - FOI 107-1415 [SEC=UNCLASSIFIED]
Dear Ms. May,
Thank you for the prompt reply and the estimate of charges.
I wish to contend these charges, the reasons for which are outlined below.
Initially, it is worth noting that my request is in keeping with the
objects of the Freedom of Information Act 1982 (herein 'The Act'),
subsection 3(2)(b). By releasing these documents, the Therapeutic Goods
Administration (herein 'TGA') would allow the public, and medical
professionals who rely on the TGA, to scrutinise, discuss, and most
importantly comment upon and review the decisions made by the TGA with
regard to Sun Pharmaceuticals. Furthermore, release of these documents
would permit scrutiny and discussion of the TGA's interactions with other
regulatory agencies, such as the Food and Drugs Administration (herein
'FDA').
Firstly, I wish to appeal these charges in accordance with subsection
29(5)(a) of The Act. I am a full-time student studying a demanding
professional degree, with limited sources of income.
The charges imposed would cause financial hardship, as these charges
constitute up to one week's income. I sincerely request that the TGA
review these charges in light of this potential hardship.
Secondly, I wish to appeal the charges in accordance with subsection
29(5)(b) of The Act. These communications are of interest to a substantial
section of the public, specifically healthcare professionals who
prescribe, dispense, and administer Sun Pharmaceutical's generic
medications, and consumers who willingly and with great trust take these
generic medications.
These two groups constitute a substantial section of the public, and it
would be in their interest to know the nature and rigor of communications
and compliance actions within the TGA, and between the TGA and
international regulatory bodies.
Finally, I wish to contend these charges on the basis that the documents
do not require photocopying or postage. These documents are able to be
supplied electronically, as on the Department of Health FOI Disclosure
Log. Should redaction of these documents be required Adobe Acrobat X,
instead of manual redaction is able to be used, as outlined in the
following Office of the Information Commissioner document:
[4]http://www.oaic.gov.au/freedom-of-inform...
Thank you for taking the time to consider this reasoning, and I look
forward to hearing from you either way soon.
Yours sincerely,
Kristof Wing
-----Original Message-----
Dear Mr Wing
Please find attached correspondence relating to your Freedom of
Information request 107-1415.
Kind regards
Emily
Freedom of Information
Liz Santolin 02 6232 8664
Karen Bedford 02 6232 8772
Emily May 02 6232 8792
Heather Kerr 02 6232 8163
Group Support Unit
Monitoring and Compliance Group
Therapeutic Goods Administration
Address: PO Box 100, Woden ACT, 2606
Email: [1][email address]
[2][5]cid:image003.gif@01CFA69C.488B9550
References
Visible links
1. [6]mailto:[email address]
-------------------------------------------------------------------
Please use this email address for all replies to this request:
[7][FOI #793 email]
Write your response as plain text. Only send PDF documents as a last
resort. Government guidelines make it clear that PDF is not an acceptable
format for you to use in the delivery of government information.
[8]https://www.righttoknow.org.au/help/offi...
This request is being made by an individual using the Right to Know
website. The unique email address provided by the service for this request
satisfies s.15(2)(c) of the Freedom of Information Act.
Disclaimer: This message and any reply that you make will be published on
the internet. Our privacy and copyright policies:
[9]https://www.righttoknow.org.au/help/offi...
If you find this service useful as an FOI officer, please ask your web
manager to link to us from your organisation's FOI page.
-------------------------------------------------------------------
--------------------------------------------------------------------------
"Important: This transmission is intended only for the use of the
addressee and may contain confidential or legally privileged information
and has been sent in accordance with the TGA security policy.
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."
--------------------------------------------------------------------------
References
Visible links
1. mailto:[email address]
3. mailto:[FOI #793 email]
4. http://www.oaic.gov.au/freedom-of-inform...
5. file:///tmp/cid:image003.gif@01CFA69C.488B9550
6. mailto:[email
7. mailto:[FOI #793 email]
8. https://www.righttoknow.org.au/help/offi...
9. https://www.righttoknow.org.au/help/offi...
Dear Mr Wing
I am following up on the below email sent to you on 28 November.
The TGA would be very grateful if you could please provide a response to
the below email by Wednesday 10 December to allow the decision maker
sufficient time to make a decision. Please note that if a response is not
received from you by this time, the TGA decision maker will make a
decision on your request for waiver without the benefit of this
information.
Please don’t hesitate to contact me if you would like to discuss this
further.
Thank you for your assistance.
Kind regards
Liz
Freedom of Information
Liz Santolin 02 6232 8664
Karen Bedford 02 6232 8772
Emily May 02 6232 8792
Heather Kerr 02 6232 8163
Group Support Unit
Monitoring and Compliance Group
Therapeutic Goods Administration
Address: PO Box 100, Woden ACT, 2606
Email: [1][email address]
[2]cid:image003.gif@01CFA69C.488B9550
From: Emily May On Behalf Of FOI Mail
Sent: Friday, 28 November 2014 4:33 PM
To: '[FOI #793 email]'
Cc: FOI Mail
Subject: FW: Estimate of Charges - FOI 107-1415 [SEC=UNCLASSIFIED]
Dear Mr Wing
Thank you for your email below requesting a waiver of charges in relation
to your FOI application 107-1415.
Under the FOI Act, the decision maker has 30 days in which to make a
decision on a waiver of charges request. With this in mind, you will be
notified of the TGA’s decision on or before 19 December 2014.
As you are aware, in addition to the public interest grounds you have
raised, the decision maker will consider whether the imposition of the
full amount of charges would cause you financial hardship. In coming to
this decision, they will consider the impact on your overall financial
position.
In these circumstances, the decision maker has asked if you are able to
provide evidence that payment of the FOI charges ($321.47) would cause you
financial hardship. It has been noted that you are a full time student
with limited income, however, it may support your claim if you were able
to provide documented evidence of financial hardship, e.g. receipt of
ABSTUDY, Austudy or Youth Allowance payments or other evidence of income,
debts and assets (e.g. statutory declaration).
Further information on the requirements is available in the FOI Guidelines
issued by the Australian Information Commissioner, which state at
paragraph 4.53:
‘4.53 An applicant relying on this ground could ordinarily be expected to
provide some evidence of financial hardship. For example, the applicant
may rely upon (and provide evidence of) receipt of a pension or income
support payment; or provide evidence of income, debts or assets…’
Finally, it appears that any third parties relating to this matter are
able to be consulted by electronic means. Therefore, the TGA does not
propose to charge you the postage itemised in the Estimate of Charges
letter.
Please let me know if you have any queries in relation to the above.
Kind regards
Liz
Freedom of Information
Liz Santolin 02 6232 8664
Karen Bedford 02 6232 8772
Emily May 02 6232 8792
Heather Kerr 02 6232 8163
Group Support Unit
Monitoring and Compliance Group
Therapeutic Goods Administration
Address: PO Box 100, Woden ACT, 2606
Email: [3][email address]
[4]cid:image003.gif@01CFA69C.488B9550
-----Original Message-----
From: Kristof Wing [[5]mailto:[FOI #793 email]]
Sent: Wednesday, 19 November 2014 2:50 PM
To: FOI Mail
Subject: Re: Estimate of Charges - FOI 107-1415 [SEC=UNCLASSIFIED]
Dear Ms. May,
Thank you for the prompt reply and the estimate of charges.
I wish to contend these charges, the reasons for which are outlined below.
Initially, it is worth noting that my request is in keeping with the
objects of the Freedom of Information Act 1982 (herein 'The Act'),
subsection 3(2)(b). By releasing these documents, the Therapeutic Goods
Administration (herein 'TGA') would allow the public, and medical
professionals who rely on the TGA, to scrutinise, discuss, and most
importantly comment upon and review the decisions made by the TGA with
regard to Sun Pharmaceuticals. Furthermore, release of these documents
would permit scrutiny and discussion of the TGA's interactions with other
regulatory agencies, such as the Food and Drugs Administration (herein
'FDA').
Firstly, I wish to appeal these charges in accordance with subsection
29(5)(a) of The Act. I am a full-time student studying a demanding
professional degree, with limited sources of income.
The charges imposed would cause financial hardship, as these charges
constitute up to one week's income. I sincerely request that the TGA
review these charges in light of this potential hardship.
Secondly, I wish to appeal the charges in accordance with subsection
29(5)(b) of The Act. These communications are of interest to a substantial
section of the public, specifically healthcare professionals who
prescribe, dispense, and administer Sun Pharmaceutical's generic
medications, and consumers who willingly and with great trust take these
generic medications.
These two groups constitute a substantial section of the public, and it
would be in their interest to know the nature and rigor of communications
and compliance actions within the TGA, and between the TGA and
international regulatory bodies.
Finally, I wish to contend these charges on the basis that the documents
do not require photocopying or postage. These documents are able to be
supplied electronically, as on the Department of Health FOI Disclosure
Log. Should redaction of these documents be required Adobe Acrobat X,
instead of manual redaction is able to be used, as outlined in the
following Office of the Information Commissioner document:
[6]http://www.oaic.gov.au/freedom-of-inform...
Thank you for taking the time to consider this reasoning, and I look
forward to hearing from you either way soon.
Yours sincerely,
Kristof Wing
-----Original Message-----
Dear Mr Wing
Please find attached correspondence relating to your Freedom of
Information request 107-1415.
Kind regards
Emily
Freedom of Information
Liz Santolin 02 6232 8664
Karen Bedford 02 6232 8772
Emily May 02 6232 8792
Heather Kerr 02 6232 8163
Group Support Unit
Monitoring and Compliance Group
Therapeutic Goods Administration
Address: PO Box 100, Woden ACT, 2606
Email: [1][email address]
[2][7]cid:image003.gif@01CFA69C.488B9550
References
Visible links
1. [8]mailto:[email address]
-------------------------------------------------------------------
Please use this email address for all replies to this request:
[9][FOI #793 email]
Write your response as plain text. Only send PDF documents as a last
resort. Government guidelines make it clear that PDF is not an acceptable
format for you to use in the delivery of government information.
[10]https://www.righttoknow.org.au/help/offi...
This request is being made by an individual using the Right to Know
website. The unique email address provided by the service for this request
satisfies s.15(2)(c) of the Freedom of Information Act.
Disclaimer: This message and any reply that you make will be published on
the internet. Our privacy and copyright policies:
[11]https://www.righttoknow.org.au/help/offi...
If you find this service useful as an FOI officer, please ask your web
manager to link to us from your organisation's FOI page.
-------------------------------------------------------------------
--------------------------------------------------------------------------
"Important: This transmission is intended only for the use of the
addressee and may contain confidential or legally privileged information
and has been sent in accordance with the TGA security policy.
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."
--------------------------------------------------------------------------
References
Visible links
1. mailto:[email address]
3. mailto:[email address]
5. mailto:[FOI #793 email]
6. http://www.oaic.gov.au/freedom-of-inform...
7. file:///tmp/cid:image003.gif@01CFA69C.488B9550
8. mailto:[email
9. mailto:[FOI #793 email]
10. https://www.righttoknow.org.au/help/offi...
11. https://www.righttoknow.org.au/help/offi...