Document ID: chunk:federal_register_of_legislation:F2017L01577:front:0:p6
Version: federal_register_of_legislation:F2017L01577
Segment Type: other
Provision Reference: 
Character Range: 13249–16389

to any other packaging requirements that may be applied to medicines under the Act or Regulations.
       (2)  The packaging for a medicine to which this Order applies must:
       (a)          remain fit for its purpose until the expiry date of the medicine; and
       (b)          retain its child‑resistant properties for the expected number of openings and closings necessary to fully use the contents.
    (3)  Performance of the child‑resistant feature must not be adversely affected by the contents of the package.
    (4) Sight, unusual strength or unusual dexterity must not be required to access the contents of the package or, in the case of a reclosable package, to re‑engage the child‑resistant feature.

9 Reclosable packages
    (1) If a medicine to which this Order applies is in a reclosable package, the package must comply with at least one of the following Standards:
       (a)          The International Standards Organisation Standard ISO 8317:2015 entitled Child‑resistant packaging -- Requirements and testing procedures for reclosable packages;
       (b)          The British Standards Institution Standard BS EN ISO 8317:2015 entitled Child‑resistant packaging. Requirements and testing procedures for reclosable packages;
       (c)          The Canadian Standards Association Standard CSA Z76.1‑16 entitled Reclosable Child‑Resistant Packages;
       (d)          The United States Code of Federal Regulations, Title 16, Part 1700 Section [1700.]15, entitled Poison prevention packaging standards and Title 16, Part 1700, Section [1700.]20, entitled Testing procedure for special packaging, as in effect at the date of this Order;
       (e)          The Australian Standard AS 1928-2007 entitled Child-resistant packaging- Requirements and testing procedures for reclosable packages (ISO 8317:2003, MOD).
    (2) If a medicine to which this Order applies is in a reclosable package that complies with a Standard mentioned in subsection 9(1), the sponsor of the medicine must hold evidence of the compliance.  The evidence may consist of:
       (a)          a certificate (or an appropriately authorised copy of a certificate) from a test agency, attesting that the package complies with a relevant Standard, expressed in a way that makes it beyond doubt that the certification in fact refers to the package specified by the sponsor, together with a statement of the protocol used to demonstrate child‑resistance and, if requested, evidence of the test agency's standing; or
       (b)          if the package is not certified as mentioned in paragraph (a), information proving compliance with a relevant Standard, expressed in a way that makes it beyond doubt that the information in fact refers to the package specified by the sponsor, together with a statement of the protocol used to demonstrate child‑resistance; or
       (c)          information 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