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

Response 831331621

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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
Ticked New Zealand
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
Ticked Sponsor
Manufacturer
Supplier
Importer
Government organisation
Researcher
Professional body
Industry organisation
Consumer organisation
Institution (eg, university, hospital)
Regulatory affairs consultant
Laboratory professional
Other

Antibiotics

1. Should labels include a warning statement for antibiotics?

Please select one item
Ticked Yes
No

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

Please select one item
Ticked Yes
No

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

Please select one item
Yes
Ticked No
If no, please suggest an alternative statement
Current TGO92 does not have a requirement to include the word "Caution" before "contains". Therefore it is recommended that we align with TGO 92 and just state “Contains [Name]”. Some flexibility with wording would be required, considering that NZ often shares Australian or other International packs. If very specific wording of statements is required, it will potentially make implementation more challenging.

Aspartame

1. Should labels include a warning statement for aspartame?

Please select one item
Ticked Yes
No

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

Please select one item
Ticked Yes
No

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

Please select one item
Yes
Ticked No
If no, please suggest an alternative statement
Current TGO92 does not have a requirement to include the word "Caution" before "contains". Therefore it is recommended that we align with TGO 92 and just state “Contains [Name]”. Some flexibility with wording would be required, considering that NZ often shares Australian or other International packs. If very specific wording of statements is required, it will potentially make implementation more challenging.

Benzoates

1. Should labels include a warning statement for benzoates?

Please select one item
Ticked Yes
No

2. Do you agree with the inclusions (Benzoic acid, Sodium benzoate)?

Please select one item
Ticked Yes
No

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

Please select one item
Ticked Yes
No

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

Please select one item
Yes
Ticked No
If no, please suggest an alternative statement
Current TGO92 does not have a requirement to include the word "Caution" before "contains". Therefore it is recommended that we align with TGO 92 and just state “Contains [Name]”. Some flexibility with wording would be required, considering that NZ often shares Australian or other International packs. If very specific wording of statements is required, it will potentially make implementation more challenging.

Crustacea and crustacean products

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

Please select one item
Ticked Yes
No

2. Do you agree with the inclusions (Crab, Crayfish, Lobster, Prawn, Shrimp)?

Please select one item
Ticked Yes
No

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

Please select one item
Ticked Yes
No

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

Please select one item
Yes
Ticked No
If no, please suggest an alternative statement
Current TGO92 does not have a requirement to include the word "Caution" before "contains". Therefore it is recommended that we align with TGO 92 and just state “Contains [Name]”. Some flexibility with wording would be required, considering that NZ often shares Australian or other International packs. If very specific wording of statements is required, it will potentially make implementation more challenging.

Egg products

1. Should labels include a warning statement for egg products?

Please select one item
Ticked Yes
No

2. Do you agree with the inclusions (Dried egg yolk, Egg, Egg lecithin, Influenza vaccine, Products manufactured in eggs)?

Please select one item
Ticked Yes
No

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

Please select one item
Ticked Yes
No

4. Do you agree with the proposed statement?

Please select one item
Yes
Ticked No
If no, please suggest an alternative statement
Current TGO92 does not have a requirement to include the word "Caution" before "contains". Therefore it is recommended that we align with TGO 92 and just state “Contains [Name]”. Some flexibility with wording would be required, considering that NZ often shares Australian or other International packs. If very specific wording of statements is required, it will potentially make implementation more challenging.

Ethanol

1. Do you agree with the proposed conditions for ethanol?

Please select one item
Ticked Yes
No

2. Do you agree with the proposed warning statement for ethanol?

Please select one item
Yes
Ticked No
If no, please suggest an alternative statement
Current TGO92 does not have a requirement to include the word "Caution" before "contains". Therefore it is recommended that we align with TGO 92 and just state “Contains [Name]”. Some flexibility with wording would be required, considering that NZ often shares Australian or other International packs. If very specific wording of statements is required, it will potentially make implementation more challenging.

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
Current TGO92 does not have a requirement to include the word "Caution" before "contains". Therefore it is recommended that we align with TGO 92 and just state “Contains [Name]”. Some flexibility with wording would be required, considering that NZ often shares Australian or other International packs. If very specific wording of statements is required, it will potentially make implementation more challenging.

Galactose

1. Should labels include a warning statement for galactose?

Please select one item
Ticked Yes
No

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

Please select one item
Ticked Yes
No

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

Please select one item
Yes
Ticked No
If no, please suggest an alternative statement
Current TGO92 does not have a requirement to include the word "Caution" before "contains". Therefore it is recommended that we align with TGO 92 and just state “Contains [Name]”. Some flexibility with wording would be required, considering that NZ often shares Australian or other International packs. If very specific wording of statements is required, it will potentially make implementation more challenging.

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
Ticked Yes
No

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

Please select one item
Ticked Yes
No

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

Please select one item
Yes
Ticked No
If no, please suggest an alternative statement
Current TGO92 does not have a requirement to include the word "Caution" before "contains". Therefore it is recommended that we align with TGO 92 and just state “Contains [Name]”. Some flexibility with wording would be required, considering that NZ often shares Australian or other International packs. If very specific wording of statements is required, it will potentially make implementation more challenging.

Hydroxybenzoic acid esters

1. Should labels include a warning statement for hydroxybenzoic acid esters?

Please select one item
Ticked Yes
No

2. Do you agree with the inclusions (Ethyl hydroxybenzoate, Methyl hydroxybenzoate, Propyl hydroxybenzoate, Sodium ethyl hydroxybenzoate, Sodium methyl hydroxybenzoate, Sodium propyl hydroxybenzoate)?

Please select one item
Ticked Yes
No

3. Do you agree with the proposed conditions for hydroxybenzoic acid esters?

Please select one item
Ticked Yes
No

4. Do you agree with the proposed statement for hydroxybenzoic acid esters?

If no, please suggest an alternative statement
Current TGO92 does not have a requirement to include the word "Caution" before "contains". Therefore it is recommended that we align with TGO 92 and just state “Contains [Name]”. Some flexibility with wording would be required, considering that NZ often shares Australian or other International packs. If very specific wording of statements is required, it will potentially make implementation more challenging.

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
Current TGO92 does not have a requirement to include the word "Caution" before "contains". Therefore it is recommended that we align with TGO 92 and just state “Contains [Name]”. Some flexibility with wording would be required, considering that NZ often shares Australian or other International packs. If very specific wording of statements is required, it will potentially make implementation more challenging.

Milk and milk products

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

Please select one item
Ticked Yes
No

2. Do you agree with the inclusions (Casein, Hydrolysed milk protein, Non-fat dry milk, Whey powder, Whole dry milk)?

Please select one item
Ticked Yes
No

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

Please select one item
Ticked Yes
No

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

Please select one item
Yes
Ticked No
If no, please suggest an alternative statement
Current TGO92 does not have a requirement to include the word "Caution" before "contains". Therefore it is recommended that we align with TGO 92 and just state “Contains [Name]”. Some flexibility with wording would be required, considering that NZ often shares Australian or other International packs. If very specific wording of statements is required, it will potentially make implementation more challenging.

Peanuts and peanut products

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

Please select one item
Ticked Yes
No

2. Do you agree with the inclusions (Arachis hypogaea, Arachis (peanut) oil)?

Please select one item
Ticked Yes
No

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

Please select one item
Ticked Yes
No

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

Please select one item
Yes
Ticked No
If no, please suggest an alternative statement
Current TGO92 does not have a requirement to include the word "Caution" before "contains". Therefore it is recommended that we align with TGO 92 and just state “Contains [Name]”. Some flexibility with wording would be required, considering that NZ often shares Australian or other International packs. If very specific wording of statements is required, it will potentially make implementation more challenging.

Phenylalanine

1. Should labels include a warning statement for phenylalanine?

Please select one item
Ticked Yes
No

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

Please select one item
Ticked Yes
No

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

Please select one item
Yes
Ticked No
If no, please suggest an alternative statement
Current TGO92 does not have a requirement to include the word "Caution" before "contains". Therefore it is recommended that we align with TGO 92 and just state “Contains [Name]”. Some flexibility with wording would be required, considering that NZ often shares Australian or other International packs. If very specific wording of statements is required, it will potentially make implementation more challenging.

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
Current TGO92 does not have a requirement to include the word "Caution" before "contains". Therefore it is recommended that we align with TGO 92 and just state “Contains [Name]”. Some flexibility with wording would be required, considering that NZ often shares Australian or other International packs. If very specific wording of statements is required, it will potentially make implementation more challenging.

Potassium salts

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

Please select one item
Ticked Yes
No

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

Please select one item
Ticked Yes
No

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

Please select one item
Ticked Yes
No

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

Please select one item
Yes
Ticked No
If no, please suggest an alternative statement
Current TGO92 does not have a requirement to include the word "Caution" before "contains". Therefore it is recommended that we align with TGO 92 and just state “Contains [Name]”. Some flexibility with wording would be required, considering that NZ often shares Australian or other International packs. If very specific wording of statements is required, it will potentially make implementation more challenging.

Propolis

1. Should labels include a warning statement for propolis?

Please select one item
Ticked Yes
No

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

Please select one item
Ticked Yes
No

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

Please select one item
Yes
Ticked No
If no, please suggest an alternative statement
Current TGO92 does not have a requirement to include the word "Caution" before "contains". Therefore it is recommended that we align with TGO 92 and just state “Contains [Name]”. Some flexibility with wording would be required, considering that NZ often shares Australian or other International packs. If very specific wording of statements is required, it will potentially make implementation more challenging.

Royal jelly

1. Should labels include a warning statement for royal jelly?

Please select one item
Ticked Yes
No

2. Do you agree with the proposed conditions for royal jelly?

Please select one item
Ticked Yes
No

3. Do you agree with the proposed statement for royal jelly?

Please select one item
Yes
Ticked No
If no, please suggest an alternative statement
Current TGO92 does not have a requirement to include the word "Caution" before "contains". Therefore it is recommended that we align with TGO 92 and just state “Contains [Name]”. Some flexibility with wording would be required, considering that NZ often shares Australian or other International packs. If very specific wording of statements is required, it will potentially make implementation more challenging.

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
Current TGO92 does not have a requirement to include the word "Caution" before "contains". Therefore it is recommended that we align with TGO 92 and just state “Contains [Name]”. Some flexibility with wording would be required, considering that NZ often shares Australian or other International packs. If very specific wording of statements is required, it will potentially make implementation more challenging.

Sesame and sesame seed products

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

Please select one item
Ticked Yes
No

2. Do you agree with the inclusions (Sesame seed, Sesame oil, Sesamum indicum)?

Please select one item
Ticked Yes
No

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

Please select one item
Ticked Yes
No

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

Please select one item
Yes
Ticked No
If no, please suggest an alternative statement
Current TGO92 does not have a requirement to include the word "Caution" before "contains". Therefore it is recommended that we align with TGO 92 and just state “Contains [Name]”. Some flexibility with wording would be required, considering that NZ often shares Australian or other International packs. If very specific wording of statements is required, it will potentially make implementation more challenging.

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
Current TGO92 does not have a requirement to include the word "Caution" before "contains". Therefore it is recommended that we align with TGO 92 and just state “Contains [Name]”. Some flexibility with wording would be required, considering that NZ often shares Australian or other International packs. If very specific wording of statements is required, it will potentially make implementation more challenging.

Sorbic acid and sorbic acid salts

1. Should labels include a warning statement for sorbic acid and sorbic acid salts?

Please select one item
Ticked Yes
No

2. Do you agree with the inclusion (Potassium sorbate)?

Please select one item
Ticked Yes
No

3. Do you agree with the proposed conditions for sorbic acid and sorbic acid salts?

Please select one item
Ticked Yes
No

4. Do you agree with the proposed statement for sorbic acid and sorbic acid salts?

Please select one item
Yes
Ticked No
If no, please suggest an alternative statement
Current TGO92 does not have a requirement to include the word "Caution" before "contains". Therefore it is recommended that we align with TGO 92 and just state “Contains [Name]”. Some flexibility with wording would be required, considering that NZ often shares Australian or other International packs. If very specific wording of statements is required, it will potentially make implementation more challenging.

Soya beans and soya bean products

1. Should labels include a warning statement for soya beans and soya bean products?

Please select one item
Ticked Yes
No

2. Do you agree with the inclusions (Glycine max, Soya bean, Soya oil)?

Please select one item
Ticked Yes
No

3. Do you agree with the proposed conditions for soya beans and soya bean products?

Please select one item
Ticked Yes
No

4. Do you agree with the proposed statement for soya beans and soya bean products?

Please select one item
Yes
Ticked No
If no, please suggest an alternative statement
Current TGO92 does not have a requirement to include the word "Caution" before "contains". Therefore it is recommended that we align with TGO 92 and just state “Contains [Name]”. Some flexibility with wording would be required, considering that NZ often shares Australian or other International packs. If very specific wording of statements is required, it will potentially make implementation more challenging.

Sucralose

1. Should labels include a warning statement for sucralose?

Please select one item
Ticked Yes
No

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

Please select one item
Ticked Yes
No

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

Please select one item
Yes
Ticked No
If no, please suggest an alternative statement
Current TGO92 does not have a requirement to include the word "Caution" before "contains". Therefore it is recommended that we align with TGO 92 and just state “Contains [Name]”. Some flexibility with wording would be required, considering that NZ often shares Australian or other International packs. If very specific wording of statements is required, it will potentially make implementation more challenging.

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
Current TGO92 does not have a requirement to include the word "Caution" before "contains". Therefore it is recommended that we align with TGO 92 and just state “Contains [Name]”. Some flexibility with wording would be required, considering that NZ often shares Australian or other International packs. If very specific wording of statements is required, it will potentially make implementation more challenging.

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
Current TGO92 does not have a requirement to include the word "Caution" before "contains". Therefore it is recommended that we align with TGO 92 and just state “Contains [Name]”. Some flexibility with wording would be required, considering that NZ often shares Australian or other International packs. If very specific wording of statements is required, it will potentially make implementation more challenging.

Sulfites

1. Should labels include a warning statement for sulfites?

Please select one item
Ticked Yes
No

2. Do you agree with the inclusions (Potassium metabisulfite, Sodium bisulfite, Sodium metabisulfite, Sodium sulphite, Sulfur dioxide (including residues))?

Please select one item
Ticked Yes
No

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

Please select one item
Ticked Yes
No

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

Please select one item
Yes
Ticked No
If no, please suggest an alternative statement
Current TGO92 does not have a requirement to include the word "Caution" before "contains". Therefore it is recommended that we align with TGO 92 and just state “Contains [Name]”. Some flexibility with wording would be required, considering that NZ often shares Australian or other International packs. If very specific wording of statements is required, it will potentially make implementation more challenging.

Tartrazine

1. Do you agree with the proposed conditions for tartrazine?

Please select one item
Ticked Yes
No

Tree nuts and tree nut products

1. Should labels include a warning statement for tree nuts and tree nut products?

Please select one item
Ticked Yes
No

2. Do you agree with the inclusions (Almond oil, Brazil nut, Cashew, Chestnut, Juglans nigra, Macadamia nut oil, Macadamia ternifolia, Prunus dulcis, Walnut)?

Please select one item
Ticked Yes
No

3. Do you agree with the proposed conditions for tree nuts and tree nut products?

Please select one item
Ticked Yes
No

4. Do you agree with the proposed statement for tree nuts and tree nut products?

Please select one item
Yes
Ticked No
If no, please suggest an alternative statement
Current TGO92 does not have a requirement to include the word "Caution" before "contains". Therefore it is recommended that we align with TGO 92 and just state “Contains [Name]”. Some flexibility with wording would be required, considering that NZ often shares Australian or other International packs. If very specific wording of statements is required, it will potentially make implementation more challenging.

Implementation date

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

Please select one item
Yes
Ticked No
If no, please suggest an alternative date
Whilst an implementation date of 1 September 2020 may be possible for some packs shared with Australia, due to the current Australian implementation timeline, an implementation timeframe of one year is insufficient in other cases. The lead times required for the different activities need to be taken into account, including the process to obtain the necessary information from suppliers, artwork preparation, regulatory submission approval and subsequent manufacture of the medicine. Therefore, an implementation period of 3-4 years, which is aligned with the TGAs TGO91/92 4 year implementation timeline is requested. Clarity on the implementation date is also sought ie no further stock would be released using the existing label, however stock already released for sale to market will continue to be sold through.

Other comments

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

Do you have any other comments?
The labelling statements database states that it:
"lists the warning and advisory statements that are required on medicine and related product labels under regulations 13(1)(i) and 14(1)(f) of the Medicines Regulations 1984. Words of a similar meaning to the statements in the database may be used and individual statements may be combined provided the intent is not changed."

This consultation does not make any mention that words of a similar meaning can be used. It proposes statements e.g. "Caution: contains xxxxx". It is unclear whether this exact statement is to be required, or if words of a similar meaning can be used as per other statements in the labelling statements database, or if it would be acceptable to not include ‘Caution’ on the pack . We recommend that some flexibility is provided considering Australia/International share packs are supplied to NZ. If NZ-specific wording of statements is required, this will make them more challenging to implement.
For instance, the TGA does not require "Caution:" to be used. Therefore, it would be preferable to remove ‘Caution’ from the proposed warning and advisory labelling statements