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FULL SPECTRUM EXTRACT OF CANNABIS: CBD > 65% THC <4% Presentations: 1 Kg, 10 g, Clever leaves Australia c/Dentons Australia Ltd, CON-1188
Product name
FULL SPECTRUM EXTRACT OF CANNABIS: CBD > 65% THC <4% Presentations: 1 Kg, 10 g
Sponsor name
Clever leaves Australia c/Dentons Australia Ltd
Consent start
Consent no.
CON-1188
Duration
The consent is effective from 11 October 2023 until 31 December 2023.
Standard
paragraph 13(3)(f) of Therapeutic Goods (Standard for Medicinal Cannabis) (TGO 93) Order 2017
Non-compliance with standard
The non-compliance arises because the medicinal cannabis products are
manufactured in a country other than those listed in paragraphs 13(3)(a)-(ea) of
TGO 93, at a site that does not currently hold written confirmation from the
Therapeutic Goods Administration (TGA) that the manufacturing site operates in
accordance with the PIC/S Guide to GMP.
Conditions imposed
1. Clever Leaves Australia Pty Ltd shall notify the Therapeutic Goods
Administration, by email at the time the goods are imported into Australia, of
the following information in relation each therapeutic good subject to this
consent:
a. the product name and presentation;
b. batch/lot number;
c. expiry date; and
d. number of units imported into Australia.
Import, Supply, &/or Export
import and supply
Therapeutic product type
Other therapeutic goods non-approved