Proposed warning statements for substances (eg, allergens) in medicines that may cause undesirable reactions

Response 919900672

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Your details

3. Are you providing feedback:

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Ticked As an individual
On behalf of an organisation or group

4. Where are you or your organisation based?

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Ticked New Zealand
Australia
Other
If you selected other, please specify your country
New Zealand

5. Which of the below options best describes you in the context of this consultation?

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Healthcare professional
Ticked Member of the public
Sponsor
Manufacturer
Supplier
Importer
Government organisation
Researcher
Professional body
Industry organisation
Consumer organisation
Institution (eg, university, hospital)
Regulatory affairs consultant
Laboratory professional
Other

Gluten

1. Should labels include a warning statement for gluten?

Please select one item
Ticked Yes
No

2. Do you agree with the inclusions (Ingredient derived from gluten-containing grain, Wheat starch)?

Please select one item
Yes
Ticked No
If no, please suggest alternative inclusions
Please also include the names of the other gluten containing grains; Barley, Rye, Spelt and Oats. This then aligns with NZ food labelling around gluten. Overseas oats are not considered to contain gluten, I would like to be sure that in New Zealand we have access to genuinely gluten free medications.

3. Do you agree with the proposed conditions for gluten?

Please select one item
Yes
Ticked No
If no, please suggest alternative conditions
20ppm is too high. It should be anything greater than 3ppm or more; this would bring it in line with the NZ gluten food labelling criteria.

4. Do you agree with the proposed statement for gluten?

Please select one item
Ticked Yes
No

Implementation date

1. Do you agree with the proposed implementation date of 1 September 2020 (1/09/2020)?

Please select one item
Ticked Yes
No