13Manufacturing quality

13 Manufacturing quality

(1) This section does not apply to the manufacture of a medicinal cannabis product that is:

(a) plant material; or

(b) oil extracted directly from the cannabis plant;

for use as starting material in the manufacture of another medicinal cannabis product manufactured in accordance with:

(c) subsections (2) and (3); or

(d) a licence under Part 3-3 of the Act.

(2) Each step of manufacture in relation to a medicinal cannabis product that occurs outside Australia must be in accordance with one or more of the following:

(a) the PIC/S Guide to GMP;

(b) Article 47 of EU Directive 2003/94/EC;

(c) Article 47 of EU Directive 2001/83/EC;

(d) the South African Guide to GMP;

(e) Part 211—Current Good Manufacturing Practice for Finished Pharmaceuticals of Subchapter C—Drugs: General, in Chapter I—Food and Drugs Administration of Title 21—Food and Drugs, in the United States Code of Federal Regulations, as in force or existing from time to time;

(f) Division 2 – Good Manufacturing Practices in Part C of the Food and Drug Regulations (Canada), as in force or existing from time to time;

(g) the New Zealand Code of GMP.

(3) A medicinal cannabis product that is manufactured outside Australia must be manufactured at a site that is the subject of one or more of the following:

(a) for a medicinal cannabis product manufactured in the United Kingdom—a valid certificate of good manufacturing practice issued to the manufacturer of the product by the Medicines and Healthcare products Regulatory Agency of the United Kingdom or a licensing authority of an EU Member State;

(b) for a medicinal cannabis product manufactured in an EU Member State—a valid certificate of good manufacturing practice issued to the manufacturer of the product by a licensing authority of an EU Member State;

(c) for a medicinal cannabis product manufactured in Canada—either:

(i) 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:

(A) a valid certificate of good manufacturing practice issued to the manufacturer of the product by a licensing authority of an EU Member State; or

(B) written confirmation from the Therapeutic Goods Administration that the manufacturing site operates in accordance with the PIC/S Guide to GMP; or

(ii) a Drug Establishment Licence issued by Health Canada for the relevant medicinal cannabis product manufactured at the site;