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Pfizer Supplied Evidence of GMP for manufacturing and testing sites

Catherine Jamieson made this Official Information request to Ministry of Health

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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

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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/  

  

If you have any queries, please feel free to contact the OIA Services Team
on [7][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: [8][email address] or by calling 0800
802 602.

 

Ngā mihi 

 

OIA Services Team 

[9]Ministry of Health information releases 

 

 

------------------- Original Message

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From: OIA Requests


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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 

 

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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/

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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

Link to this

From: OIA Requests


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80K Download


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 

OIA Services Team

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

show quoted sections

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