Document ID: chunk:federal_register_of_legislation:F2017L01577:front:0:p7
Version: federal_register_of_legislation:F2017L01577
Segment Type: other
Provision Reference: 
Character Range: 16134–19060

demonstrating that the package as specified by the sponsor has been established previously as complying with a relevant Standard.

    (3) In addition to the requirements mentioned in subsections 9(1) and 9(2), if a medicine to which this Order applies is in a reclosable package, the sponsor must hold evidence demonstrating that the requirements of subsections 8(2) and 8(3) are met.
    (4) If a change in specifications for a reclosable package occurs, the sponsor must hold additional evidence demonstrating that the child‑resistant properties of the package and operation of the closure have not been adversely affected.
    (5) In addition to the requirements mentioned in subsections 9(1), 9(2), 9(3), and 9(4), if a medicine to which this Order applies is in a reclosable package, the sponsor must hold information on:
       (a)          the types and sizes of container of immediate relevance to the sponsor's range of medicines to which a specified closure may be applied;
       (b)          the suitability of the package for the type of medicine;
       (c)          the correct application of the closure to the container after filling and engagement of the child‑resistant mechanism, as appropriate to the particular packaging system; and
       (d)          the quality control tests applied to demonstrate that production lots of the package components are of consistent and satisfactory quality and appropriate for use.
    (6) If a medicine to which this Order applies is in a reclosable package, adequate directions for opening and effectively reclosing the package must be:
       (a)          conspicuously marked or written on the package or on a label securely affixed or attached to the package; and
       (b)          written in English or clearly demonstrated in graphics.
    (7) If a medicine to which this Order applies is packaged together with a separate dropper or applicator that is reasonably expected to replace the original closure on the medicine once the product is in use, then that configuration also must comply with the requirements of this Order.

10 Non‑reclosable packages
    (1) Subject to subsection 10(2), if a medicine to which this Order applies is in a non‑reclosable package, the package must be in the form of a blister or other sealed unit formed from paper, film, plastic material, metal foil or other sheet or strip material, or a combination of these materials in which a single dosage unit is enclosed, whether as part of a continuous series comprising a strip or sheet of the same material or not.
    (2) A non‑reclosable package referred to in subsection 10(1) must not be formed from cellulose film or unlaminated paper.

Schedule 1 Medicines to which this Order applies
(section 6)

Part 1 Classes of substance
Note 1   Class names reflect the Anatomical Therapeutic Chemical (ATC) classification system of the World Health Organization Collaborating Centre