6Information in the application

6 Information in the application

(1) An application for approval of an active constituent for a proposed or existing chemical product, or to vary the particulars or conditions of an approved active constituent, must contain the following information: (a) the following names of the constituent: (i) the common name; (ii) the IUPAC name (if applicable); (iii) the chemical abstracts name (if applicable); (b) the CAS number of the constituent (if applicable); (c) the minimum purity or constituent standard of the constituent; (d) whether the application relates to a not previously endorsed active constituent or a new manufacturer or site of manufacture for an active constituent, or is to vary the particulars or conditions of an approved active constituent; (e) whether the active constituent is for use in: (i) agricultural chemical products only; or (ii) veterinary chemical products only; or (iii) agricultural and veterinary chemical products; (f) if the application is a timeshift application (which may include an international joint review or workshare arrangement);

Note: A timeshift application must include a project plan: see regulation 8AG of the Regulations.

(g) whether the active constituent contains any ingredients intentionally engineered to be less than 100 nanometres in one or more dimensions;
(h) whether the constituent is a genetically modified organism or is manufactured using genetically modified materials;
(i) the following information about the manufacturer of the constituent:
(i) the manufacturer’s name;
(ii) if the manufacturer has an ACN – the ACN;
(iii) if the manufacturer is an overseas company and has a number equivalent to an ACN – that number;
(iv) the name and street address of the site at which the active constituent is manufactured;
(v) the country in which the active constituent is manufactured;
(j) the applicant details;
(k) the applicant declaration;
(l) whether the applicant considers that there is information, the use of which is limited by the Code, that can be used by the APVMA in determining the application, and if so, the nature of that information;
(m) whether that information can be used by the APVMA pursuant to consent or agreement (for example, the consent of the relevant authorising party).

(2) If there is consent or agreement for the purposes of paragraph (1)(m), the application must be accompanied by the written consent or agreement for the use of the information by the APVMA.