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Information pertaining to item 8.2.1 in the Minutes of the 63rd meeting of the Medicines Classification Committee held in Wellington on 10 October 2019 at 9:39 am

S Mills made this Official Information request to Medicines Classification Committee

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From: S Mills

Dear Medicines Classification Committee,

I hope you are all doing well.

I am writing to get a bit more information around the recommendation made in item 8.2.1 in the Minutes of the 63rd meeting of the Medicines Classification Committee held in Wellington on 10 October 2019 at 9:39 am. This item refers to reclassifications of Alkyl Nitrites including Amyl Nitrites.

I note that the recommended schedule changes to make Alkyl Nitrite a prescription-only substance, and Amyl Nitrites a pharmacy-only substance (although there is currently no distribution through pharmacies of either of these), is for 'harmonisation' with similar regulations in Australia.

May I please request the following:

- A synthesis of material presented and/or made available to the committee providing evidence to support these schedule changes

- If for some reason this does not exist, instead any communication, correspondence, documentation, or further discussion given for or against the following resolution made in the discussion section of 8.2.1:

The Committee recommended harmonising the group entry for alkyl nitrites a prescription medicine.

- Any follow up communication or correspondence pertaining to the following point in the discussion section of 8.2.1:

The Committee discussed how the indicated population are Men who have Sex with Men (MSM) and it was not clear to the Committee what the risks were around these substances.

- Any follow up communication, correspondence, or planning for future engagement pertaining the following point in the discussion section of 8.2.1:

The Committee was also not sure if the LGBTQI community was aware that these substances were being considered by reclassification and suggested that feedback from them should be sought.

This final point is of specific importance as it seems that feedback from the LGBTQI community was not sought prior to the schedule changes coming into effect in February 2020.

Yours faithfully,

S Mills

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Medicines Classification Committee


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Kia ora

Thank you for your request for official information received on 12 April
2020 for:

 "I am writing to get a bit more information around the recommendation
made in item 8.2.1 in the Minutes of the 63rd meeting of the Medicines
Classification Committee held in Wellington on 10 October 2019 at 9:39 am.
This item refers to reclassifications of Alkyl Nitrites including Amyl
Nitrites.

I note that the recommended schedule changes to make Alkyl Nitrite a
prescription-only substance, and Amyl Nitrites a pharmacy-only substance
(although there is currently no distribution through pharmacies of either
of these), is for 'harmonisation' with similar regulations in Australia.

May I please request the following:

- A synthesis of material presented and/or made available to the committee
providing evidence to support these schedule changes

- If for some reason this does not exist, instead any communication,
correspondence, documentation, or further discussion given for or against
the following resolution made in the discussion section of 8.2.1:

The Committee recommended harmonising the group entry for alkyl nitrites a
prescription medicine.

- Any follow up communication or correspondence pertaining to the
following point in the discussion section of 8.2.1:

The Committee discussed how the indicated population are Men who have Sex
with Men (MSM) and it was not clear to the Committee what the risks were
around these substances.

- Any follow up communication, correspondence, or planning for future
engagement pertaining the following point in the discussion section of
8.2.1:

The Committee was also not sure if the LGBTQI community was aware that
these substances were being considered by reclassification and suggested
that feedback from them should be sought.

This final point is of specific importance as it seems that feedback from
the LGBTQI community was not sought prior to the schedule changes coming
into effect in February 2020."

The Ministry's reference number for your request is: H202002084.

As required under the Act we will endeavour to respond to your request no
later than 12 May 2020, being 20 working days after the day your request
was received.  

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Ngā mihi

OIA Services
Government Services
Office of the Director-General
Ministry of Health
E: [email address]

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Link to this

Medicines Classification Committee


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Attachment Signed OIA S.Mills.pdf
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Attachment Harmonisation document Redactedfinal.pdf
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Attachment Document 2 TGA Final decisions.pdf
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Attachment Document 3 TGA Final decisions.pdf
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Attachment Document 4 Redacted.pdf
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Kia ora S Mills

Please find attached a response to your request for official information
along with the relevant supporting documents.

Nga mihi

OIA Services
Government Services
Office of the Director-General
Ministry of Health
E: [email address]

show quoted sections

Link to this

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