Document ID: chunk:federal_register_of_legislation:F2022C01204:body:0:p2
Version: federal_register_of_legislation:F2022C01204
Segment Type: other
Provision Reference: 
Character Range: 3037–6267

the following:
              (a) batch;
              (b) British Pharmacopoeia;
              (c) container;
              (d) European Pharmacopoeia;
              (e) export only medicine;
              (f) label;
              (g) manufacture;
              (h) Register;
              (i) sponsor;
              (j) standard;
              (k) therapeutic goods;
              (l) United States Pharmacopeia–National Formulary.
         (1) In this order:

         acceptance criteria, in relation to microbiological quality, are interpreted as:
         (a) 101 CFU: maximum acceptable count is 20;
         (b) 102 CFU: maximum acceptable count is 200;
         (c) 103 CFU: maximum acceptable count is 2000, and so forth.

         Act means the Therapeutic Goods Act 1989.

         active ingredient has the same meaning as in the Regulations.

         batch number means a number, or a combination of numerals, symbols or letters, which is given by a manufacturer to a batch of a medicinal cannabis product, to uniquely identify that batch and from which it is possible to trace that batch through all stages of manufacture and distribution.

         batch number prefix means the prefix which precedes the batch number and has the following characteristics:
              (a) clearly indicates that the information following the prefix is the batch number; and
              (b) is in the following form: 'BATCH NUMBER', 'BATCH NO.', 'BATCH', 'B', '(B)', 'B/N', 'LOT NUMBER', 'LOT NO.', or 'LOT', or words or symbols to this effect, including a mixture of lower and upper case letters.

         cannabis plant means any plant, or part of a plant, of the genus Cannabis, including, but not limited to, the flowers, fruiting tops, seeds, stems and leaves of the plant.

              Note: Subspecies of the cannabis plant, Cannabis sativa, include Cannabis sativa subsp. sativa, Cannabis sativa subsp ruderalis and Cannabis sativa subsp. indica.

         EU Member State means a member state of the European Union.

         EU Directive 2001/83/EC means Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use, as in force or existing from time to time.

         EU Directive 2003/94/EC means Commission Directive 2003/94/EC of 8 October 2003 laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use, as in force or existing at 28 March 2022.

         excipient, for a medicinal cannabis product, means an ingredient that is not an active ingredient.

         expiry date has the same meaning as in the Regulations.

         expiry date prefix means a prefix which precedes the expiry date and has the following characteristics:
              (a) clearly indicates that the information following the prefix is the expiry date;
              (b) is in the following form: 'EXPIRY DATE', 'EXPIRY', 'EXPIRES', 'EXP. DATE', 'EXP', 'Use by' or 'Use before' or words to this effect, including a mixture of lower and upper case letters;
              (c) is not in the following form: 'Best by' or 'Best