Published: 16 February 2025

Medicines

Policy statement - Declaring excipient(s) with known effect in data sheets

Purpose

Based on requests from Industry, Medsafe is providing further specific guidance on declaring excipient(s) with known effects in datasheets. This is not a change to requirements relating to the Label Statements Database (LSD).

Background

Medsafe's Data Sheet Template Explanatory Guide (v1.3 January 2025) states that sponsors may refer to the European Medicines Agency's:

Annex to the European Commission guidelines on 'Excipients in the labelling and package leaflet of medicinal products for human use'

(EMA Annex) to declare excipient(s) with known effect in section 2 of the data sheet.

Medsafe also requires sponsors to refer to the LSD on allergen entries (refer to Appendix 1 (PDF 1075KB, 81 pages) of the Consultation outcome for the list of allergens) when declaring excipient(s) with known effect. This requirement ensures that the information on the package labelling is consistent with that in the data sheet.

Policy for declaring excipient(s) with known effects in data sheets

1. Use the EMA Annex and LSD to identify the excipient(s) with known effect that must be declared.
2. Declare excipient(s) with known effect and their quantitative amount in section 2 of the data sheet, under the heading 'Excipient(s) with known effect'.
3. If the EMA Annex and LSD excipient threshold levels do not align, we recommend that you use the document with the lower threshold.
4. For wheat starch and any other gluten-containing ingredient, use the LSD threshold of 3 parts per million (ppm) or more. Declare the excipient in the data sheet if the gluten threshold is met. Identify the source of gluten using the statement 'Contains gluten from [source]'. Additional information on gluten content, such as quantity in ppm, should be included.
5.  Describe the known effects of the excipient in section 4.4 of the data sheet. The sponsor may use the warning/advisory statements provided in the EMA Annex. Where appropriate, the Consumer Medicine Information (CMI) should also be updated with equivalent information.

An example is illustrated in Table 1 for lactose.

Please note that GRTPNZ: New Medicine application (page 29) also outlines requirements for excipients that are unsuitable for particular patient populations.

The above guideline is not a change to requirements relating to the LSD (ie, it does not affect the package labelling requirements).

Medsafe will update the Data Sheet Template Explanatory Guide with the above information in a future update.

Table 1: Data sheet example where lactose is an excipient

New Zealand Data Sheet Section 2 Excipient(s) with known effect Each [medicine tablet] contains [xx] mg lactose. For the full list of excipients, see section 6.1. Section 4.4 Excipient(s) with known effect [Medicine] contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine. Section 6.1 [A list should be given of the excipients, expressed qualitatively only. All excipients, which are present in the product, should be included, even those present in small amounts, such as printing inks. Refer to the Data Sheet Explanatory Guide for further guidance].