Sedaprem (Indica) Resin Cartridge - THC 700 mg/g 0.5 cartridge, MedReleaf Australia, CON-1208
Product name
Sedaprem (Indica) Resin Cartridge - THC 700 mg/g 0.5 cartridge
Sponsor name
MedReleaf Australia
ARTG
Consent start
Consent no.
CON-1208
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 at a site in Canada that does not currently hold the evidence
listed in paragraph 13(3)(c) of TGO 93, including written confirmation from
Health Canada that the manufacturing site operates in accordance with Part 5:
Good Production Practices of the Cannabis Regulations SOR/2018-144 (Canada), as
in force or existing from time to time, and either a valid certificate of good
manufacturing practice issued to the manufacturer of the product by a licensing
authority of an EU Member State; or written confirmation from the Therapeutic
Goods Administration (TGA) that the manufacturing site operates in accordance
with the PIC/S Guide to GMP.
Conditions imposed
MedReleaf Australia shall notify the Therapeutics Goods Administraton, by email
to GMP@health.gov.au, 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