Standardized Extract CBD 10% THC 1% Presentations: 30 mL;, Enimera RegPlus Ltd, CON-1191
Product name
Standardized Extract CBD 10% THC 1% Presentations: 30 mL;
Sponsor name
Enimera RegPlus Ltd
ARTG
Consent start
Consent no.
CON-1191
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. Enimera RegPlus Ltd shall notify the TGA, 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.
Therapeutic product type
Other therapeutic goods non-approved