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

• We request feedback on whether Medsafe accepts additional explanatory information or “words with similar meaning”, e.g. “contains bee pollen” (instead of pollen), or “contains hydroxybenzoates (preservatives)” (instead of “contains hydroxybenzoates”)

However,
Some statements proposed for the NZLSDB differ to those required by TGO 92. We note discrepancies in the following statements:
• Fish: The TGO 92 statement for fish is accompanied by a requirement (see Note 2) that it includes freshwater fish, diadromous fish and marine fish, including shark. The statement proposed by Medsafe states that it includes cod, cod liver oil, halibut, shark, tuna but does not refer to the classes of fish, i.e. freshwater, marine and diadromous. We recommend clarification of this discrepancy and alignment with TGO 92, which is a more inclusive statement.

Refer Above.

Refer Above.

Refer Above.

However,
• Potassium: The statement for potassium that is proposed by Medsafe does not align with TGO 92.
Firstly, the conditions for inclusion differ, with the Medsafe proposal applying when the total potassium content of the maximum recommended daily dose is greater than 39 mg (1 mmol), whereas the TGO 92 requirement applies when the total potassium content of the dose is greater than 39 mg (1 mmol) elemental potassium.
In addition, the proposed statement refers to the mg quantity of elemental potassium per dosage unit or in a stated weight or volume of the medicine, whereas the TGO 92 requirement is to state the quantity of elemental potassium per dose of the medicine.
We query why Medsafe has taken a different approach, requiring a much lower threshold for disclosure as well as a different disclosure statement. Potassium is not required to be declared in dietary supplements in New Zealand. Potassium is classed as a medicine only when the recommended dose (not daily dose) exceeds 100 mg. Potassium is also found in significant quantities in many foods, (e.g. a small banana contains approximately 361 mg potassium). We query whether there is a necessity for this proposed discrepancy.
We recommend that Medsafe aligns with the TGA’s approach of including the statement per dose of medicine.

Consequences of non-alignment: If Medsafe does not align with TGO 92 for declaration of potassium and sodium, this will have a very significant commercial and production impact. Every sponsor supplying products in New Zealand will need to audit the potassium and sodium content of their products and change the label for every one of these products, to create a unique New Zealand label, for both registered and listed medicines. The commercial impact cannot be underestimated and may affect the viability of products in Australia and New Zealand.
Medsafe has not explained why it is necessary to adopt these unique statements, especially when these salts are not declared on labels of many NZ dietary supplements and are found in greater levels in many common foods. We question what the incremental benefits of these tighter requirements are.

Please refer above.

Please refer above.

Please refer above.

• Sodium: Similarly to the proposed statement for potassium, TGO 92 requires a sodium declaration when the total sodium content of the maximum recommended daily dose of the formulation is greater than 120 mg of elemental sodium per dose. The Medsafe proposal however applies when the total sodium content of the maximum recommended daily dose is greater than 120 mg of elemental sodium.
In addition, the TGO 92 requires a sodium declaration as mg elemental sodium per dose, whereas Medsafe proposes a sodium declaration as mg quantity of elemental sodium per dosage unit or in a stated weight or volume of the medicine.
Again, we query why Medsafe proposes a different approach, as there is no justification, and we recommend that Medsafe aligns with the TGA’s approach of including the statement per dose of medicine.

Consequences of non-alignment: If Medsafe does not align with TGO 92 for declaration of potassium and sodium, this will have a very significant commercial and production impact. Every sponsor supplying products in New Zealand will need to audit the potassium and sodium content of their products and change the label for every one of these products, to create a unique New Zealand label, for both registered and listed medicines. The commercial impact cannot be underestimated and may affect the viability of products in Australia and New Zealand.
Medsafe has not explained why it is necessary to adopt these unique statements, especially when these salts are not declared on labels of many NZ dietary supplements and are found in greater levels in many common foods. We question what the incremental benefits of these tighter requirements are.

Please refer above.

Please refer above.

Please refer above.

TRANSITION

The proposed 1st September 2020 transition date mirrors the TGO 92 transition date, and while this may be acceptable for products in harmonised labelling that must comply in Australia on 1st September, the proposed NZLSDB falls short of complete alignment with TGO 92. Sponsors are at different stages of compliance with TGO 92.
If Medsafe does not align the statements with TGO 92, or if any subsequent amendments are required, a 12 month transition is completely unworkable for all products marketed in New Zealand.
For sponsors of unique New Zealand products, one year is insufficient to obtain detailed allergen information from raw material suppliers (since there are no threshold limits), design labels, obtain the necessary Medsafe (and other) regulatory approvals, update internal documentation, sell through existing stock and implement labelling changes, especially when for many overseas manufacturing sites, production planning typically requires a long lead time.
In Australia, TGO 92 had a 4 year transition. We recommend a 4 year transition time for all products. This is a necessity for New-Zealand only products and products where labels are not harmonised; it will also be necessary if there is no alignment with TGO 92.
A long transition timeframe does not mean that all New Zealand products will face delay in adopting labelling with improved allergen information. The long transition is needed for sponsors of New Zealand only products, but products with harmonised labelling will probably have achieved compliance and be in the market within a much shorter timeframe.

APPLICATION AND INTERPRETATION OF TRANSITION.

TGA requires that products must be released for supply with labelling that is compliant with TGO 92, on or after the 1st September 2020. “Release for supply” is defined as the release for supply step on the ARTG. This ensures that there is industry wide understanding and consistency in interpretation of the specific point in the supply chain at which transition must take place.
The NZ LSDB does not specify the point at which transition applies, and for consistency we recommend that Medsafe aligns with Australia in defining this as the “release for supply” step. This interpretation aids industry compliance in that it is a legal step in the manufacturing process and is the step at which the sponsor/manufacturer must sign off on quality and compliance. Having an aligned interpretation on timing of implementation assists sponsors/manufacturers in achieving compliance across both markets.
We recommend that Medsafe considers extending the transition period to 4 years and aligning on the interpretation on transition applying to the release for supply step. This will especially assist New Zealand only sponsors/manufacturers. Sponsors of harmonised products are likely to achieve compliance much sooner.

GROUPING OF STATEMENTS.
TGO 92 allows sponsors to group allergen and excipient statements on labelling when more than one statement applies. For example, a statement can read “Contains [ingredient A, ingredient B, ingredient C].
We recommend that the NZLSDB should make it clear that grouping of statements is permitted.

CONSEQUENCES OF NON-ALIGNMENT.
If Medsafe does not align with TGO 92 for declaration of potassium and sodium, this will have a very significant commercial and production impact. Every sponsor supplying products in New Zealand will need to audit the potassium and sodium content of their products and change the label for every one of these products, to create a unique New Zealand label, for both registered and listed medicines. The commercial impact cannot be underestimated and may affect the viability of products in Australia and New Zealand.
Medsafe has not explained why it is necessary to adopt these unique statements, especially when these salts are not declared on labels of many NZ dietary supplements and are found in greater levels in many common foods. We question what the incremental benefits of these tighter requirements are.

ISSUES AND UNCERTAINTIES -PROCESS FOR FUTURE UPDATES.

Since Medsafe has signalled an intention to align with TGO 92, we would like to bring to Medsafe’s attention some ongoing issues on TGO 92 that Medsafe should also consider.

• Unlike with foods and some other regulatory jurisdictions, the TGA (and Medsafe) do not include threshold limits for declarations for some substances. This is problematic for substances that may be present in trace amounts. Some raw material specifications refer to detection limits (e.g. sulphites < 20 ppm), rather than a “free from” statement, which leave the sponsor in an uncertain position on whether to declare substances that may be present in trace amounts. The TGA’s guidance on TGO 91 and 92 has provided limited guidance on “Substances that must be declared”, however sponsors are still unclear on how to assess risk when substances are not deliberately added but may be present as “traces”. This issue is still evolving, and TGA may update the guidance in future. Industry requires some assurance that Medsafe will align with the TGA in the way it interprets when a substance should be declared, in the absence of threshold or cut-off limits.

If the TGA makes amendments to any guidance relating to declarable ingredients, we request that Medsafe also align to ensure that harmonisation is possible following any future updates. This ought to also apply if Medsafe makes a change – we assume that the two regulatory bodies will communicate to ensure consistency and clarity for industry.

We request feedback on whether Medsafe accepts additional explanatory information or “words with similar meaning”, e.g. “contains bee pollen” (instead of pollen), or “contains hydroxybenzoates (preservatives)” (instead of “contains hydroxybenzoates”)