Document ID: chunk:federal_register_of_legislation:F2017L01577:front:0:p4
Version: federal_register_of_legislation:F2017L01577
Segment Type: other
Provision Reference: 
Character Range: 8101–10860

known as listed goods.
    medicine has the same meaning as in the Act.
    non‑reclosable package means a package that, having been opened, is not capable of being reclosed to its original state.
    packaging means the components that together immediately contain and protect the dosage form of a medicine.
Note The components that immediately contain and protect the dosage form include containers, closures and closure systems, and closure liners. Packaging may be either reclosable or non-reclosable.
    primary pack has the same meaning as in the Act.
    reclosable package means a package that, once opened, can be reclosed to its original state.
    Register has the same meaning as in the Act.
    registered medicine means a medicine that is included in the part of the Register for goods known as registered goods.
    Regulations means the Therapeutic Goods Regulations 1990, as amended from time to time.
    restricted flow insert means a restriction that:
       (a) is fitted or moulded into the neck of a container;
       (b) cannot readily be removed from the container by manual force; and
       (c) limits the delivery of the contents to drops each of which is not more than 200 microlitres.
    Secretary has the same meaning as in the Act.
    sponsor means the person in relation to whom the medicine is registered or listed in the Register, or in relation to whom a medicine is exempt or the subject of an approval or authority in relation to that requirement.
    Standard means any of the national or international Standards referred to in section 9 of this Order.
    strip means packaging in which:
       (a) one or more dosage units are enclosed individually in a continuous strip made by bonding two layers of material together so that the dosage units are separated and protected; and
    (b) the dosage units can only be extracted from one pocket at a time; and
    (c) each layer of material may be similar or different; and
    (d) the material must be cut or torn in order to access the contents.
    young children means children within the age groups specified in the protocols given in the Standards referred to in section 9 for the testing of child‑resistance.
Note The age range specified in the protocols given in the Standards referred to in section 9 for the testing of child-resistance is 42 to 51 months inclusive.

6 Application
    (1) This Order applies to each medicine for human use that is supplied by a sponsor and that is:
       (a)          a registered medicine that contains a substance, or a salt, ester or other derivative of a substance, that belongs to a class of substance specified in Part 1 of Schedule 1; or
       (b)          a listed or registered medicine that contains a substance, or