Pfizer Supplied Evidence of GMP for manufacturing and testing sites
Catherine Jamieson made this Official Information request to Ministry of Health
Response to this request is long overdue. By law Ministry of Health should have responded by now (details and exceptions). The requester can complain to the Ombudsman.
From: Catherine Jamieson
Dear Ministry of Health,
In respect of each site within the following categories of site under each Covid-19 vaccine provisional consent, please provide the date that evidence of current GMP was provided as part of Medsafe's evaluation process:-
- finished product manufacturing sites
- active ingredient manufacturing sites
- finished product testing sites.
Yours faithfully,
Catherine Jamieson
From: OIA Requests
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Kia ora Catherine,
Thank you for your request for official information. The reference number
for your request is: H2024046670
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: [6]http://www.ombudsman.parliament.nz/
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review any decisions made under this request. The Ombudsman may be
contacted by email at: [8][email address] or by calling 0800
802 602.
Ngā mihi
[9]Ministry of Health information releases
------------------- Original Message -------------------
From: Catherine Jamieson
<[FOI #27664 email]>;
Received: Wed Jul 17 2024 14:29:14 GMT+1200 (New Zealand Standard Time)
To: OIA Requests <[email address]>; OIA <[email address]>;
Subject: Official Information request - Pfizer Supplied Evidence of GMP
for manufacturing and testing sites
Dear Ministry of Health,
In respect of each site within the following categories of site under each
Covid-19 vaccine provisional consent, please provide the date that
evidence of current GMP was provided as part of Medsafe's evaluation
process:-
- finished product manufacturing sites
- active ingredient manufacturing sites
- finished product testing sites.
Yours faithfully,
Catherine Jamieson
****************************************************************************
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legal privilege.
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7. mailto:[email address]
8. mailto:[email address]
9. https://www.health.govt.nz/about-ministr...
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From: OIA Requests
Kia ora Catherine,
Thank you for your request under the Official Information Act 1982 (the
Act) to the Ministry of Health – Manatû Hauora (the Ministry) on 17 July
2024 for information regarding the Comirnaty (Pfizer) COVID-19 vaccine.
You requested:
“In respect of each site within the following categories of site under
each Covid-19 vaccine provisional consent, please provide the date that
evidence of current GMP was provided as part of Medsafe's evaluation
process:-
- finished product manufacturing sites
- active ingredient manufacturing sites
- finished product testing sites.”
All approved manufacturing sites had current evidence or Good
Manufacturing Practice at the time of approval, please refer to Medsafe’s
product search for the approval date and current manufacturing sites. The
consent date and information on approved manufacturing sites for each
Comirnaty vaccine is publicly available at:
[1]https://www.medsafe.govt.nz/regulatory/d...
Further information is available on Medsafe’s product detail search which
can be found here: [2]https://www.medsafe.govt.nz/regulatory/D...
Ngâ mihi
Manatû Hauora | Ministry of Health
M[3]inistry of Health information releases
U[4]nite against COVID-19
****************************************************************************
Statement of confidentiality: This e-mail message and any accompanying
attachments may contain information that is IN-CONFIDENCE and subject to
legal privilege.
If you are not the intended recipient, do not read, use, disseminate,
distribute or copy this message or attachments.
If you have received this message in error, please notify the sender
immediately and delete this message.
****************************************************************************
References
Visible links
1. https://www.medsafe.govt.nz/regulatory/d...
2. https://www.medsafe.govt.nz/regulatory/D...
3. https://www.health.govt.nz/about-ministr...
4. https://covid19.govt.nz/
hide quoted sections
From: Catherine Jamieson
Dear OIA Requests,
I am familiar with the information on the product search. I don't think it shows the dates that the evidence of GMP was provided to Medsafe. I reiterate my original request below.
In respect of each site within the following categories of site under
each Covid-19 vaccine provisional consent, please provide the date that
evidence of current GMP was provided as part of Medsafe's evaluation
process:-
- finished product manufacturing sites
- active ingredient manufacturing sites
- finished product testing sites.
Yours sincerely,
Catherine Jamieson
From: OIA Requests
Kia ora Catherine,
Thank you for your email. Manatū Hauora (the Ministry of Health) stands by
its decision and has nothing further to add. Under section 28(3) of the
Act, you have the right to ask the Ombudsman to review any decisions made
under your requests. The Ombudsman may be contacted by email at:
[1][email address] or by calling 0800 802 602.
Ngā mihi
Manatū Hauora | Ministry of Health
M[2]inistry of Health information releases
--------------------------------------------------------------------------
From: Catherine Jamieson <[FOI #27664 email]>
Sent: Sunday, 19 January 2025 15:08
To: OIA Requests <[email address]>
Subject: Re: Response to your request for official information, ref:
H2024046670 CRM:0121060
Dear OIA Requests,
I am familiar with the information on the product search. I don't think
it shows the dates that the evidence of GMP was provided to Medsafe. I
reiterate my original request below.
In respect of each site within the following categories of site under
each Covid-19 vaccine provisional consent, please provide the date that
evidence of current GMP was provided as part of Medsafe's evaluation
process:-
- finished product manufacturing sites
- active ingredient manufacturing sites
- finished product testing sites.
Yours sincerely,
Catherine Jamieson
-----Original Message-----
Kia ora Catherine,
Thank you for your request under the Official Information Act 1982 (the
Act) to the Ministry of Health – Manatû Hauora (the Ministry) on 17 July
2024 for information regarding the Comirnaty (Pfizer) COVID-19 vaccine.
You requested:
“In respect of each site within the following categories of site under
each Covid-19 vaccine provisional consent, please provide the date that
evidence of current GMP was provided as part of Medsafe's evaluation
process:-
- finished product manufacturing sites
- active ingredient manufacturing sites
- finished product testing sites.”
All approved manufacturing sites had current evidence or Good
Manufacturing Practice at the time of approval, please refer to Medsafe’s
product search for the approval date and current manufacturing sites. The
consent date and information on approved manufacturing sites for each
Comirnaty vaccine is publicly available at:
[1]https://www.medsafe.govt.nz/regulatory/d...
Further information is available on Medsafe’s product detail search which
can be found here: [2]https://www.medsafe.govt.nz/regulatory/D...
Ngâ mihi
OIA Services Team
Manatû Hauora | Ministry of Health
M[3]inistry of Health information releases
U[4]nite against COVID-19
References
Visible links
1. [3]https://www.medsafe.govt.nz/regulatory/d...
2. [4]https://www.medsafe.govt.nz/regulatory/D...
3. [5]https://www.health.govt.nz/about-ministr...
4.
[6]https://aus01.safelinks.protection.outlo...
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Statement of confidentiality: This e-mail message and any accompanying
attachments may contain information that is IN-CONFIDENCE and subject to
legal privilege.
If you are not the intended recipient, do not read, use, disseminate,
distribute or copy this message or attachments.
If you have received this message in error, please notify the sender
immediately and delete this message.
****************************************************************************
References
Visible links
1. mailto:[email address]
2. https://www.health.govt.nz/about-ministr...
3. https://www.medsafe.govt.nz/regulatory/d...
4. https://www.medsafe.govt.nz/regulatory/D...
5. https://www.health.govt.nz/about-ministr...
6. https://covid19.govt.nz/
7. https://fyi.org.nz/help/officers
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Minutes from the 113th meeting of the Medicines Assessment Advisory Committee (MAAC)
To Ministry of Health by Maxwell
Chris Johnston left an annotation ()
If the MoH never asked at the time then they may have retrospectively checked at a later date.
An OIA that asks for communications with the vaccine suppliers, and/or the manufacturing sites themselves, that ask for GMP certification assurances/certification documentation over the last 5 years may flush this out.
A direct question of "was this checked at the time of purchase or receipt?" may also answer the underlying question.
Link to this