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

Response 405454257

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Your details

3. Are you providing feedback:

Please select one item
As an individual
Ticked On behalf of an organisation or group

4. Where are you or your organisation based?

Please select one item
New Zealand
Ticked Australia
Other

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

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

Fish and fish products

1. Should labels include a warning statement for fish and fish products?

Please select one item
Ticked Yes
No

2. Do you agree with the inclusions (Cod, Cod liver oil, Halibut, Shark, Tuna)?

Please select one item
Ticked Yes
No

3. Do you agree with the proposed conditions for fish and fish products?

Please select one item
Ticked Yes
No

4. Do you agree with the proposed statement for fish and fish products?

Please select one item
Yes
Ticked No
If no, please suggest an alternative statement
Therapeutic Goods Order No. 91 and 92 permit the use of a shortened statement, ‘contains fish’ or ‘contains fish products’. Since products are often supplied to New Zealand and Australia, sponsors should be permitted to use a shortened statement so that the safety statement and packaging are aligned across the two countries

Lactose

1. Should labels include a warning statement for lactose?

Please select one item
Ticked Yes
No

2. Do you agree with the proposed conditions for lactose?

Please select one item
Ticked Yes
No

3. Do you agree with the proposed statement for lactose?

Please select one item
Yes
Ticked No
If no, please suggest an alternative statement
Therapeutic Goods Order No. 91 and 92 permit the use of a shortened statement, ‘contains lactose’. Since products are often supplied to New Zealand and Australia, sponsors should be permitted to use a shortened statement so that the safety statement and packaging are aligned across the two countries.

Pollen

1. Should labels include a warning statement for pollen?

Please select one item
Ticked Yes
No

2. Do you agree with the proposed conditions for pollen?

Please select one item
Ticked Yes
No

3. Do you agree with the proposed statement for pollen?

Please select one item
Yes
Ticked No
If no, please suggest an alternative statement
Therapeutic Goods Order No. 91 and 92 permit the use of a shortened statement, ‘contains pollen’. Since products are often supplied to New Zealand and Australia, sponsors should be permitted to use a shortened statement so that the safety statement and packaging are aligned across the two countries

Saccharin

1. Should labels include a warning statement for saccharin?

Please select one item
Ticked Yes
No

2. Do you agree with the inclusions (Saccharin calcium, Saccharin sodium)?

Please select one item
Ticked Yes
No

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

Please select one item
Ticked Yes
No

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

Please select one item
Yes
Ticked No
If no, please suggest an alternative statement
Therapeutic Goods Order No. 91 and 92 permit the use of a shortened statement, ‘contains saccharin’. Since products are often supplied to New Zealand and Australia, sponsors should be permitted to use a shorter statement so that the safety statement and packaging are aligned across the two countries.

Sodium salts

1. Should labels include a warning statement for sodium salts?

Please select one item
Ticked Yes
No

2. Do you agree with the inclusions (Sodium bicarbonate, Sodium chloride)?

Please select one item
Ticked Yes
No

3. Do you agree with the proposed conditions for sodium salts?

Please select one item
Ticked Yes
No

4. Do you agree with the proposed statement for sodium salts?

Please select one item
Yes
Ticked No
If no, please suggest an alternative statement
Due to size limitation of the label, it may not be possible to include the full wording Caution: contains [mg quantity of elemental sodium per dosage unit or in a stated weight or volume of the medicine] on the primary pack label (ie. container label) and carton.
Therapeutic Goods Order No. 91 and 92 permit the use of a shortened statement, ‘contains XX mg of sodium per dose’. Since products are often supplied to New Zealand and Australia, sponsors should be permitted to use a shorter statement so that the safety statement and packaging are aligned across the two countries.

Sugar alcohols

1. Should labels include a warning statement for sugar alcohols?

Please select one item
Ticked Yes
No

2. Do you agree with the inclusions (Erythritol, Isomalt, Lactitol, Maltitol, Mannitol, Polydextrose, Sorbitol, Xylitol)?

Please select one item
Ticked Yes
No

3. Do you agree with the proposed conditions for sugar alcohols?

Please select one item
Ticked Yes
No

4. Do you agree with the proposed statement for sugar alcohols?

Please select one item
Yes
Ticked No
If no, please suggest an alternative statement
Due to size limitation of the label, it may not be possible to include the full wording 'Caution: contains [quantity of sugar alcohols present per recommended maximum daily dose]. Products containing [name of sugar alcohol] may have a laxative effect or cause diarrhoea' on the primary pack label (ie container label) and carton. Therapeutic Goods Order No. 91 and 92 permit the use of a shorten statement, eg ‘Products containing [name of sugar alcohol] may have a laxative effect or cause diarrhoea’ if there is also a statement referring the consumer to the consumer medicine information, which is often included on packaging. Since products are often supplied to New Zealand and Australia, sponsors should be permitted to use a shorten statement so that the safety statement and packaging are aligned across the two countries.

Sugars – monosaccharides and disaccharides

1. Should labels include a warning statement for sugars (monosaccharides and disaccharides)?

Please select one item
Ticked Yes
No

2. Do you agree with the inclusions (Fructose, Glucose, Honey, Invert sugar, Lactose, Maltose, Sucrose)?

Please select one item
Ticked Yes
No

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

Please select one item
Ticked Yes
No

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

Please select one item
Yes
Ticked No
If no, please suggest an alternative statement
Therapeutic Goods Order No. 91 and 92 permit the use of a shortened statement, ‘contains sugars’. Since products are often supplied to New Zealand and Australia, sponsors should be permitted to use a shorter statement so that the safety statement and packaging are aligned across the two countries.

Other comments

1. Do you have any other comments about this consultation?

Do you have any other comments?
The New Zealand labelling warning statements should be aligned with TGA’s requirements as many of our products are shared packs across Australia and New Zealand