Document ID: chunk:federal_register_of_legislation:F2022C01204:body:0:p7
Version: federal_register_of_legislation:F2022C01204
Segment Type: other
Provision Reference: 
Character Range: 17439–20645

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;
              (d) for a medicinal cannabis product manufactured in South Africa—written confirmation from the South African Health Products Regulatory Authority that the manufacturing site operates in accordance with the South African Guide to GMP;
              (e)  for a medicinal cannabis product manufactured in Israel—a valid certificate of good manufacturing practice issued to the manufacturer of the product by the Israel Ministry of Health;
              (ea) for a medicinal cannabis product manufactured in New Zealand—one of the following:
                   (i)                  a valid Licence to Manufacture Medicines issued under the Medicines Act 1981 (NZ), as in force or existing from time to time;
                   (ii)               a valid certificate of good manufacturing practice issued to the manufacturer