Kia ora Erika,  

  

Thank you for your request for official information. The reference number
for your request is: H2022016442.  

  

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 related to this request, please do not hesitate to
get in touch. 

 

Ngā mihi 

  

OIA Services Team 

M[2]inistry of Health information releases 
U[3]nite against COVID-19 

 
------------------- Original Message -------------------
From: Erika Whittome <[FOI #21071 email]>;
Received: Tue Nov 08 2022 06:51:41 GMT+1300 (New Zealand Daylight Time)
To: OIA Requests <[email address]>; OIA <[email address]>;
Subject: Official Information request - Does Medsafe have to follow the
medical process known as informed consent?

Dear Ministry of Health,

The NZ Medical Council has guidelines on informed consent here
[4]https://scanmail.trustwave.com/?c=15517&...
and these guidelines say that the risks and benefits for a treatment are
to be highlighted by health professionals to the patient.

1. Does Medsafe follow these guidelines on informed consent?
2. Does Medsafe come under this jurisdiction of informed consent from the
NZMC OR from another governing body?
3, Who is the regulatory body for Medsafe in the event that Medsafe do not
follow the informed consent guidelines?

Yours faithfully,

Erika Whittome

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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 #21071 email]

Is [Ministry of Health request email] the wrong address for Official Information requests
to Ministry of Health? If so, please contact us using this form:
[5]https://scanmail.trustwave.com/?c=15517&...

Disclaimer: This message and any reply that you make will be published on
the internet. Our privacy and copyright policies:
[6]https://scanmail.trustwave.com/?c=15517&...

If you find this service useful as an Official Information officer, please
ask your web manager to link to us from your organisation's OIA or LGOIMA
page.

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Tēnā koe Erika, 

 

Thank you for your request under the Official Information Act 1982 (the
Act) to Manatū Hauora (the Ministry of Health) on 8 November 2022. You
requested: 

 

“The NZ Medical Council has guidelines on informed consent
here [1]https://scanmail.trustwave.com/?c=15517&...

and these guidelines say that the risks and benefits for a treatment are
to be highlighted by health professionals to the patient. 
 
1. Does Medsafe follow these guidelines on informed consent? 
2. Does Medsafe come under this jurisdiction of informed consent from the
NZMC OR from another governing body? 
3, Who is the regulatory body for Medsafe in the event that Medsafe do not
follow the informed consent guidelines?” 

 

Medsafe is the New Zealand Medicines and Medical Devices Safety Authority
and is responsible for the regulation of therapeutic products in New
Zealand. Medsafe administers New Zealand legislation in relation to
medicines. It is not a healthcare provider.  

 

As Medsafe is not involved in the provision of healthcare to any
individual patient, it does not perform any informed consent process or
require any oversight by the Medical Council of New Zealand. 

 

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: [2][email address] or by calling 0800
802 602.

 

Ngā mihi 

  

OIA Services Team 

M[3]inistry of Health information releases 
U[4]nite against COVID-19 

 

 

 

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References

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2. mailto:[email address]
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4. https://covid19.govt.nz/

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Kia ora

  

Thank you for your request for official information. The reference number
for your request is: H2023019798

  

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 related to this request, please do not hesitate to
get in touch. 

 

Ngā mihi 

 

OIA Services Team 

M[2]inistry of Health information releases 
U[3]nite against COVID-19 

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legal privilege.
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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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Kia ora Erika
Please find attached a letter regarding your request for information

Ngā mihi 

  

OIA Services Team

Manatū Hauora | Ministry of Health

M[1]inistry of Health information releases 
U[2]nite against COVID-19 

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