Kia ora Mark
  
Thank you for your request for official information. The reference number
for your request is: H2023032182
  
As required under the Official Information Act 1982, Manatū Hauora will
endeavour to respond to your request no later than 20 working days after
the day your request was received. If you'd like to calculate the
timeframe, you can use the Ombudsman's online calculator
here: [1]http://www.ombudsman.parliament.nz/  
  
If you have any queries, please feel free to contact the OIA Services Team
on [2][email address]. If any additional factors come to light which
are relevant to your request, please do not hesitate to contact us so that
these can be taken into account. 

Under section 28(3) of the Act you have the right to ask the Ombudsman to
review any decisions made under this request. The Ombudsman may be
contacted by email at: [3][email address] or by calling 0800
802 602.

 
Ngā mihi
 
OIA Services Team
Manatū Hauora | Ministry of Health
M[4]inistry of Health information releases 
U[5]nite against COVID-19
 
 

------------------- Original Message -------------------
From: Mark Shelly <[FOI #24342 email]>;
Received: Wed Oct 04 2023 16:41:20 GMT+1300 (New Zealand Daylight Time)
To: OIA Requests <[email address]>; OIA <[email address]>;
Subject: Official Information request - Comirnaty - Risk Management Plans
& MARC & Medsafe correspondence

Dear Ministry of Health,
Please direct me to or provide copies of all Risk Management Plans issued
by Medsafe for Comirnaty.
Please provide copies of all correspondence between MARC and Medsafe
regarding provisional approval of Comirnaty.
Please provide me with or direct me to agendas and minutes of MARC and
Medsafe meetings within which Comirnaty was discussed.
Yours faithfully,
Mark Shelly

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Kia ora Mark
Thank you for your request the Official Information Act 1982 (the Act) to
Manatû Hauora (the Ministry of Health) on 4 October 2023. Each part of
your request is responded to below:

“Please direct me to or provide copies of all Risk Management Plans
issued by Medsafe for Comirnaty.

Company Risk Management Plans (RMPs) are published on the Medsafe website
here: www.medsafe.govt.nz/COVID-19/status-of-a...

Please provide copies of all correspondence between MARC and Medsafe
regarding provisional approval of Comirnaty.

The Medicines Adverse Reactions Committee (MARC) is not involved in the
approval of medicines. As such, this part of your request is refused under
section 18(g)(i) of the Act as the information requested is not held by
Medsafe and there are no grounds for believing it is held by another
agency subject to the Act. More information on the approval process is
available here
 [1]www.medsafe.govt.nz/consumers/safety-of-medicines/medsafe-evaluation-process.asp 

Please provide me with or direct me to agendas and minutes of MARC and
Medsafe meetings within which Comirnaty was discussed.

This part of your request is refused under section 18(d) of the Act as the
information requested is publicly available in the link provided here:
[2]www.medsafe.govt.nz/committees/marc.asp 
If you wish to discuss any aspect of your request with us, including this
decision, please feel free to contact the OIA Services Team on:
[3][email address] 
Under section 28(3) of the Act, you have the right to ask the Ombudsman to
review any decisions made under this request. The Ombudsman may be
contacted by email at: [email address] or by calling 0800 802
602.

Ngâ mihi 

  

OIA Services Team

Manatû Hauora | Ministry of Health

M[4]inistry of Health information releases 
U[5]nite against COVID-19 

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Kia ora Mark,

Thank you for your follow up request under the Official Information Act
1982 (the Act) to Manatū Hauora (the Ministry of Health) on 13 October
2023 as a follow up to information previously provided to you (H2023032182
refers). You requested: 

  

“In response to my request to be provided copies of all Risk Management
Plans 

issued by Medsafe for Comirnaty I was directed to this
website: [1]https://www.medsafe.govt.nz/COVID-19/sta...

It appears to only show the most recent RMPs. I want copies of all the
RMPs, not just the most recent ones. 

  

For example, under: 

Comirnaty (COVID-19 mRNA vaccine) (Pfizer-BioNTech): 12 years and
older Concentrate for injection 30 µg/0.3 mL (purple cap, must dilute) 

  

The page provides a link to: 

Updated summary of risk management plan (version 8) for
Comirnaty, Comirnaty Original/Omicron BA.1, and Comirnaty Original/Omicron
BA.4-5 (COVID-19 mRNA vaccine).

It does not provide links to all previous versions. Please provide all
RMPs for all variations of Comirnaty received by Medsafe whether approved
or not. 

Manatū Hauora (the Ministry of Health) stands by its decision and has
nothing further to add. You may wish to refer to older versions of the
Risk Management Plans (RMPs) here [2]web.archive.org. 

If you wish to discuss any aspect of your request with us, including this
decision, please feel free to contact the OIA Services Team
on: [3][email address].  

 

Under section 28(3) of the Act, you have the right to ask the Ombudsman to
review any decisions made under this request. The Ombudsman may be
contacted by email at: [4][email address] or by calling 0800
802 602. 

 

Please note that this response, with your personal details removed, may be
published on the Manatū Hauora website at:
[5]www.health.govt.nz/about-ministry/information-releases/responses-official-information-act-requests.  

 

Ngā mihi 

  

OIA Services Team

Manatū Hauora | Ministry of Health

M[6]inistry of Health information releases 
U[7]nite against COVID-19 

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Statement of confidentiality: This e-mail message and any accompanying
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distribute or copy this message or attachments.
If you have received this message in error, please notify the sender
immediately and delete this message.
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References

Visible links
1. https://www.medsafe.govt.nz/COVID-19/sta...
2. https://web.archive.org/
3. mailto:[email address]
4. mailto:[email address]
5. http://www.health.govt.nz/about-ministry...
6. https://www.health.govt.nz/about-ministr...
7. https://covid19.govt.nz/

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