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 8317:2003 entitled Child‑resistant packaging — Requirements and testing procedures for reclosable packages (as amended by Technical corrigendum issued January 2005: ISO 8317:2003/Cor 1:2005 : Child‑resistant packaging — Requirements and testing procedures for reclosable packages — Technical Corrigendum 1);

(b) The British Standards Institution Standard BS EN ISO 8317:2004 entitled Child‑resistant packaging. Requirements and testing procedures for reclosable packages;

(c) The Canadian Standards Association Standard CSA Z76.1‑99 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 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.