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s 8AP

Matters for notice—applications for technical assessments etc

In force
Part 1Preliminary
Division 1.3General provisions about notices

8AP Matters for notice—applications for technical assessments etc

(1)

The APVMA must give a person a notice if:

(a)

the person lodges an application for the APVMA to provide an assessment of a technical nature, and the APVMA decides to provide that assessment (see regulation 8AS); or

(b)

the person lodges an application for the APVMA to:

(i)

make an interchangeable constituent determination (see regulation 19AEB); or

(ii)

make or vary an ingredient determination (see clause 10 of Schedule 3AA).

(2)

The notice must set out the following:

(a)

the date on which the assessment or the determination will commence;

(b)

if an amount of application fee payable for the application under subregulation 70(2) is unpaid:

(i)

the balance of the application fee that is payable; and

(ii)

that the balance must be paid within 28 days of the date of the notice;

(c)

if the applicant must give copies of the application to the APVMA:

(i)

the number of copies that must be given; and

(ii)

the form in which those copies must be given; and

(iii)

that the copies must be given to the APVMA within 28 days of the date of the notice;

(d)

the assessment period for the application and the expected date by which the application will be determined;

(e)

the modules to be completed in relation to the application;

(f)

that the assessment period will be extended if the APVMA or another prescribed authority makes a request under section 159 of the Code;

(g)

that if the APVMA does not determine the application within the assessment period for the application (or the extended application period, if applicable), the applicant may:

(i)

notify the APVMA under subsection 165(3) of the Code that the applicant wishes to treat the application as having been refused; and

(ii)

apply under subsection 167(1) of the Code for review of the decision;

(h)

that the applicant may withdraw the application in accordance with section 8D of the Code.

(3)

The notice must be given to the person within 1 month of the day on which the person lodges the application.

(4)

If a person lodges an application under regulation 8AS for the APVMA to provide an assessment of a technical nature, and the APVMA decides not to provide that assessment, the APVMA must notify the person of that decision within 1 month of the day on which the person lodges the application.

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