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:
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"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"
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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
From: OIA Requests
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.
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significantly higher volumes of queries and requests for information. If
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If you have any queries related to this request, please do not hesitate to
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Ngâ mihi
OIA Services
Government Services
Office of the Director-General
Ministry of Health
E: [3][email address]
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References
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1. https://www.medsafe.govt.nz/COVID-19/Com...
2. https://www.medsafe.govt.nz/profs/Datash...
3. mailto:[email address]
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From: OIA Requests
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H202113568 Appendix.pdf
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H202113568 Maxwell response.pdf
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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]
****************************************************************************
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.
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References
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1. mailto:[email address]
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