License products: opioid medicines

Georgia Richards made this Freedom of Information request to Therapeutic Goods Administration

The request was successful.

From: Georgia Richards

Delivered

Dear Therapeutic Goods Administration,

Could you please supply me with the most up to date list of opioid medicines including opioid-containing products (i.e. combination products) licensed for prescription in Australia?

Yours faithfully,

Georgia Richards

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From: TGA FOI
Therapeutic Goods Administration


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Dear Ms Richards

FREEDOM OF INFORMATION REQUEST – NOTIFICATION OF RECEIPT

I am writing to notify you that the Department of Health (Department) has
received your request for access to documents under the Freedom of
Information Act 1982 (FOI Act).

                “Could you please supply me with the most up to date list
of opioid medicines including opioid-containing products (i.e. combination
products) licensed for prescription in Australia.”

SCOPE CLARIFICATION

 

We wish to advise that the information you are seeking is already publicly
available.

 

Following is a link to the Therapeutic Goods Administration’s closed
consultation paper on ‘Prescription strong (Schedule 8) opioid use and
misuse in Australia – options for a regulatory response’.

 

[1]https://www.tga.gov.au/consultation/cons...

 

As detailed on page 5 of the consultation paper, prescription opioids are,
at present, scheduled as follows:

 

Schedule 4 (S4) – Prescription Only Medicine

Codeine (after February 2018), dihydrocodeine, pholcodeine,
dextromethorphan in moderate doses (except in low-dose cough
preparations), dextropropoxyphene (at low doses), diphenoxylate at
moderate doses, and tramadol.

Schedule 8 (S8) – Controlled Drug

Buprenorphine, fentanyl, hydromorphone, methadone, morphone, oxycodone,
talpentadol and pethidine.

Other opioids in S8 include: acetyldihydrocodeine, acetylmorphines,
benzylmorphine, dextropropoxyphene (at high doses), dihydromorphine,
diphenoxylate (at high doses), dihydrocodeine, hydromorphinol,
levorphanol, methyldihydromorphine, morphine methobromide,
morphine-N-oxide, norcodeine, normethadone and oxymorphone.

 

Further, S4 and S8 medicines that are registered in the Australian
Register of Therapeutic Goods (see [2]https://www.tga.gov.au/artg) can be
lawfully supplied in Australia. A search of the substances above will
provide an entry for any currently registered product(s) that contains
those active ingredients, as well as sponsor (company) name and a number
of other relevant details.

 

In light of this publicly available information, can we kindly seek your
advice as to whether you wish to proceed with your FOI request.

 

We would be grateful for your response by COB Monday 13 May 2019.

 

If you have any questions, please do not hesitate to contact the FOI team.

 

Kind regards

Freedom of Information
(02) 6232 8806

Reporting and Collaboration Services Section

Regulatory Engagement and Planning Branch

Therapeutic Goods Administration
Address: PO Box 100, Woden ACT, 2606
Email: [3][email address]

 

[4]cid:image001.png@01D1D5D9.7DDEADA0

 

 

 

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From: TGA FOI
Therapeutic Goods Administration


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Attachment List of registered prescription only opioids as of 24 May 2019.xlsx
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Dear Ms Richards

 

Thank you for your FOI request of 6 May 2019.

 

We recommend you search the Australian Register of Therapeutic Goods
(ARTG) for the information you are seeking. You can find the ARTG here:
[1]https://www.tga.gov.au/artg

 

Here you will find publicly available information that does not need to be
accessed under the FOI Act. Anyone can find all registered medicines that
are approved for supply in Australia. Noting however, not all registered
medicines are necessarily being supplied regardless of approval.

 

For your convenience, I have searched the ARTG for you. The results of
these searches I have attached to this email. This data is publicly
available and as such, an FOI request is not necessary to obtain this
information.

 

As the information you are seeking is publicly available and has been
provided to you (attached to this email), your FOI has been deemed
withdrawn and no further action will be taken in relation to this FOI
matter.

 

If you are seeking further information that is not publicly available, you
will need to submit a new FOI request.

 

Kind regards

Freedom of Information
(02) 6232 8806

Reporting and Collaboration Services Section

Regulatory Engagement and Planning Branch

Therapeutic Goods Administration
Address: PO Box 100, Woden ACT, 2606
Email: [2][email address]

 

[3]cid:image001.png@01D1D5D9.7DDEADA0

 

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