Nicovape® Q Product Notice – Interim s14A Consent (TGO 110)

PRODUCT NOTICE

Re: interim s14A Consent granted by TGA for Nicovape® Q50, Q35 & Q20 cartridges

We write to inform you that the Therapeutic Goods Administration (TGA) has granted an interim consent under s14A of the Therapeutic Goods Act 1989 (interim S14A consent) in relation to the continued supply of Nicovape® Q therapeutic vaping cartridges, while it continues the assessment of Liber’s s14A consent application to supply non-compliant goods dated 3 June 2025 (consent application).

A copy of the notifications of the TGA’s interim s14A consent relating to each Nicovape® Q product notification is here.

The interim s14A consent commences on 1 July 2025 and will be in place until 7 July 2025, or earlier, if the Secretary has made a final decision on the consent application.

As a condition of the interim s14A consent, we hereby inform you that, to the extent that you hold any quantity of Nicovape® Q therapeutic vaping cartridges, at any time while this interim s14A consent is effective that Nicovape® Q therapeutic vaping cartridges:

1. Do not conform with an applicable standard, being TGO 110 from 1 July 2025;
2. The TGA is currently assessing an application from Liber Pharmaceuticals to permit supply of these goods, despite that non-compliance;
3. Until that application is assessed, the goods should not be supplied to patients.

Under the interim s14A consent, existing Nicovape® Q products may continue to move within the pharmacy supply chain, but should not be supplied to patients until the TGA has provided a full s14A consent.

Liber will advise all business partners as soon as the TGA has concluded its assessment of the consent application and provide information regarding the conditions, if any, of the full S14A consent.

Should you have any questions or concerns please contact us at medical@liber.com.au, or call us on 1300 642 682 (9am-5pm Mon-Fri AEST).

Sincerely,

Scott Wilson B.Pharm MPS
Chief Operating Officer & Chief Pharmacist
Liber Pharmaceuticals Ltd