PRODUCT NOTICE

s14/14A Consent granted by TGA for Nicovape® Q50, Q35 & Q20 cartridges

We write to inform you that the Therapeutic Goods Administration (TGA) has granted a consent until 10 October 2025 under s14/14A of the Therapeutic Goods Act 1989 (Consent) in relation to the supply of Nicovape® Q therapeutic vaping cartridges – TGA reference number E25-296715.

The TGA has advised that the Consents relating to each Nicovape® Q product will be published on the TGA website in due course.

Conditions of supply – All Nicovape® Q therapeutic vaping cartridges

As a condition of the Consent, we hereby inform you that, to the extent that you supply any quantity of Nicovape® Q therapeutic vaping cartridges, at any time while this Consent is effective that Liber Pharmaceuticals Ltd (Liber) must take every reasonable effort to inform each participant engaged in the supply of Nicovape® Q therapeutic vaping cartridges (including patients) that:

a) The goods do not conform with an applicable standard, being TGO 110, from 1 July 2025, in relation to labelling requirements;

b) Liber has been granted a consent to supply the Goods for a period of 3 months, subject to conditions; and

c) The goods should not be supplied to patients without a hardcopy Patient Information Leaflet (PIL) approved for distribution by the TGA (see below).

Conditions of supply – Nicovape® Q ‘Coolmint’ therapeutic vaping cartridges

Following a review of the product specifications and toxicological assessment of the Nicovape® Q ‘Coolmint’ products, the TGA established that these goods do not present an unacceptable level of risk to patients or the broader public.

In addition to the above conditions, applicable to all Nicovape® Q therapeutic vaping cartridges, the TGA has imposed a further condition upon the supply of Nicovape® Q ‘Coolmint’ therapeutic vaping cartridges.

d) The goods do not conform with an applicable standard, being TGO 110, from 1 July 2025, in relation to labelling requirements and the concentration of menthol in the products exceeds of the permitted limit.

Providing PILs to patients

The TGA has approved PILs to be provided to patients on supply of (i) Nicovape® Q Coolmint variants and (ii) Nicovape® Q Classic Tobacco and Freshmint variants.

Liber has arranged for printed copies of the PILs to be delivered under separate cover to all pharmacies that have supplied Nicovape® Q cartridges.

If you wish to supply Nicovape® Q cartridges immediately, you may download and print copies of each PIL here (formatted as two (2) A5 copies per A4 page – to be separated):