Printed from https://fyi.org.nz./request/17027-safety-assessments-by-the-medicine-assessment-advisory-committee on November 16, 2024 06:23

Safety assessments by the Medicine Assessment Advisory Committee

Maxwell made this Official Information request to Ministry of Health

The request was partially successful.

From: Maxwell

Dear Ministry of Health,

I write as a New Zealand citizen.

Under the published Medsafe information: "Guideline on the Regulation of Therapeutic Products in New Zealand" (GRTPNZ source: https://www.medsafe.govt.nz/regulatory/G...) on page 47 it states:

===================
"The following types of medicines will typically be referred to the MAAC irrespective of whether Medsafe has concluded that the application includes sufficient data to attest to the safety, quality and efficacy of the medicine and that the benefits outweigh the risk of harm to the patient:

- novel technologies such as medicines derived from stem cells and nano-tech"
===================

Given the Comirnaty (COVID-19 mRNA vaccine) was been granted Provisional consent (with conditions) from June 2021 until 3 November 2021 (Gazette: https://www.medsafe.govt.nz/COVID-19/Com...) and contains material (lipid nanoparticles) produced via nano-tech (Datasheet: https://www.medsafe.govt.nz/profs/Datash...) can you please provide all safety assessments performed by the Medicine Assessment Advisory Committee (MAAC) and any related correspondence to/from this committee.

Yours faithfully,

Maxwell

Link to this

From: OIA Requests

Attachment image001.png
7K Download

Kia ora Maxwell,

 

Thank you for your request for official information received on 4 October
2021 for:

 

"…Given the Comirnaty (COVID-19 mRNA vaccine) was been granted Provisional
consent (with conditions) from June 2021 until 3 November 2021 (Gazette:
[1]https://www.medsafe.govt.nz/COVID-19/Com...)
and contains material (lipid nanoparticles) produced via nano-tech
(Datasheet:
[2]https://www.medsafe.govt.nz/profs/Datash...) can you
please provide all safety assessments performed by the Medicine Assessment
Advisory Committee (MAAC) and any related correspondence to/from this
committee.”

 

The Ministry's reference number for your request is: H202113568.

 

As required under the Official Information Act 1982, the Ministry will
endeavour to respond to your request no later than 2 November 2021, being
20 working days after the day your request was received.

 

Due to the COVID-19 global pandemic response, the Ministry is experiencing
significantly higher volumes of queries and requests for information. 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.

 

Ngâ mihi

 

OIA Services

Government Services

Office of the Director-General

Ministry of Health

E: [3][email address]

 

show quoted sections

References

Visible links
1. https://www.medsafe.govt.nz/COVID-19/Com...
2. https://www.medsafe.govt.nz/profs/Datash...
3. mailto:[email address]

Link to this

From: OIA Requests

Attachment image.png
20K Download

Attachment H202113568 Appendix.pdf
2.0M Download View as HTML

Attachment H202113568 Maxwell response.pdf
164K Download View as HTML

Kia ora Maxwell,  

 

Please find attached a response to your official information act request. 

 

Ngā mihi  

 

OIA Services 

Government Services 

Office of the Director-General 

Ministry of Health 

E: [1][email address] 

show quoted sections

References

Visible links
1. mailto:[email address]

Link to this

Things to do with this request

Anyone:
Ministry of Health only: