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Use of Chinese blood plasma products

Brendon Barnes made this Official Information request to Ministry of Health

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From: Brendon Barnes

Dear Ministry of Health,

Are any blood plasma products manufactured in China authorised for use, or are in use in New Zealand (immunoglobulins etc)?

Yours faithfully,

Brendon

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Ministry of Health


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Dear Brendon

Thank you for your email dated 9 February 2019 requesting the following
information under the Official Information Act 1982:

Are any blood plasma products manufactured in China authorised for use, or
are in use in New Zealand (immunoglobulins etc)?

The Ministry's reference number for your request is: H201900435.

As required under the Act we will endeavour to respond to your request no
later than 8 March 2019, being 20 working days after the day your request
was received.  

If we are unable to respond to your request within this time frame, we
will notify you of an extension of that time frame.

If you have any queries related to this request, please do not hesitate to
get in touch.
 
Yours sincerely,

Jan Torres
Advisor
Ministerial Services (OIA)
[Ministry of Health request email]
Ministerial Services  l  Government Services  l  Office of the Director
General

From:        Brendon Barnes
<[FOI #9554 email]>
To:        OIA/LGOIMA requests at Ministry of Health <[Ministry of Health request email]>,
Date:        09/02/2019 09:53 p.m.
Subject:        Official Information request - Use of Chinese blood plasma
products

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Dear Ministry of Health,

Are any blood plasma products manufactured in China authorised for use, or
are in use in New Zealand (immunoglobulins etc)?

Yours faithfully,

Brendon

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This is an Official Information request made via the FYI website.

Please use this email address for all replies to this request:
[FOI #9554 email]

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Ministry of Health


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Dear Brendon

I refer to your request of 9 February 2019 under the Official Information
Act 1982 (the Act) for:

Are any blood plasma products manufactured in China authorised for use, or
are in use in New Zealand (immunoglobulins etc)?

Therapeutic products are produced by combining a biologically active
ingredient(s) with excipients. Excipients are included for a wide range of
reasons. For example, excipients can be used as bulking agents or to aid
in long-term stability of the active. Manufacture of the active,
excipients and final therapeutic product can (and frequently does) occur
at different sites.

Components derived from human blood plasma can either be used as active
ingredients (eg, blood cells and immunoglobulins) or excipients (eg,
albumin). As previously described, the manufacture of the active blood
component, blood derived excipients and final therapeutic product can
occur at different sites.

Determining the manufacturing location of blood derived excipients (eg,
albumin) that are used in some New Zealand approved therapeutic products
could not be achieved without substantial collation or research – and for
this reason – the request may be refused under section 18(f) of the
Official Information Act 1982.

In order to provide you with the information you are seeking, the Ministry
is requesting for you to clarify if you are requesting information on the
manufacturing sites of active blood components (eg, blood cells and
immunoglobulins) and/or the therapeutic products that contain such actives
(eg, Privigen® and Gamunex®), or if you are requesting information on the
manufacturing sites of active blood components, the therapeutic products
that contain such actives, and the manufacturing sites of blood derived
excipients (eg, albumin).

Please note that even with your request clarified, we may still need to
narrow it further, extend the amount of time necessary to respond, or even
refuse the request (should provide the correspondent a reason for on what
basis we would refuse it, e.g. under section 18(f) of the Act.

We are happy to continue discussing how we might be able to provide you
with the information you seek, and will provide you with further
opportunity to re-scope the request if we feel it necessary.

I look forward to your advice clarifying the OIA request.

Kind regards
Jan
Ministerial Services (OIA)
[Ministry of Health request email]  

Government Services
Office of the Director-General
Ministry of Health
[1]www.health.govt.nz

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