Document ID: chunk:federal_register_of_legislation:F2024C01255:body:0:p7
Version: federal_register_of_legislation:F2024C01255
Segment Type: other
Provision Reference: 
Character Range: 17247–20386

other than the active ingredient and includes adjuvants;

       expiry date, in relation to a product, means the date (month and year) after which the medicine should not be used;

       expiry date prefix means a prefix which precedes the expiry date which has the following characteristics:
            1.           clearly indicates that the information following the prefix is the expiry date;
            2.           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;
            3.           is not in the following form: 'Best by' or 'Best before' or words to this effect.

       external, in relation to the use of a medicine, means application in the ears, eyes or nose or to a body surface other than in the mouth, rectum, vagina, urethra or other body orifice;

       haemofiltration or haemodiafiltration solution means a replacement/substitution solution used in renal replacement therapy where the movement of solutes is by convection rather than diffusion (haemofiltration) or by a combination of convection and diffusion (haemodiafiltration);

       health professional includes the following:
           (a) a health practitioner of any kind registered under a law of a State or Territory that provides for the registration of health practitioners of that kind; and
           (b) a biomedical engineer, prosthetist or rehabilitation engineer;

       hypertonic, in relation to the tonicity of large volume injections, means an injection with an osmolality of more than 350 milliosmoles per kilogram of solvent, as determined by the osmotic pressure;

       hypotonic, in relation to the tonicity of large volume injections, means an injection with an osmolality of less than 250 milliosmoles per kilogram of solvent, as determined by the osmotic pressure;

       infusion, in relation to injections, means a sterile, pyrogen-free, aqueous solution or emulsion with water as the continuous phase that is intended for slow administration, usually in large volume (>100mL), and does not contain any added antimicrobial preservative;

       intermediate packaging means a level of packaging which, if it exists, encloses one or more containers and is itself enclosed in a primary pack;

       isotonic, in relation to the tonicity of large volume injections, means an injection with an osmolality within the range 250 milliosmoles to 350 milliosmoles per kilogram of solvent, as determined by the osmotic pressure;

       label means a display of printed information upon, or securely affixed to, the container, any intermediate packaging and any primary pack containing the medicine;

       machine readable code means a code that:
            1.           encodes the Global Trade Item Number (GTIN) for the medicine as allocated under the GS1 System; and
            2.           identifies different product variants and differentiates between different strengths, pack sizes and dose forms;
            3.           is formatted as one of the GS1 Bar Codes specified within