35AApplication of this Part

35A Application of this Part

This Part applies to applications for one or more prescribed variations of the relevant particulars of an approval or registration made under section 26B of the Code.

35B Application requirements for prescribed variations

(1) This section specifies, for subsection 8B(1) of the Code, that an application for a prescribed variation of the kind set out in item 2 of the table in the Agricultural and Veterinary Chemicals Code Act (Prescribed Variations) Instrument 2019 must include a statement that the applicant holds:

(a) evidence that each secondary step in the manufacture of the chemical product by the manufacturer at the site of manufacture conforms to a standard that the APVMA has determined is comparable to the manufacturing principles and the Australian GMP Code

(2) This section specifies, for subsection 8B(1) of the Code, that an application for a prescribed variation of the kind set out in item 3 of the table in the Agricultural and Veterinary Chemicals Code Act (Prescribed Variations) Instrument 2019 must include a statement that the applicant holds:

(a) evidence that at the time of the holder’s application, the site of manufacture is entered in the Register as a site for another chemical product of the holder, and the manufacturer conducts the same steps of manufacture in relation to the other chemical product; and

(b) evidence that each primary step in the manufacture of the chemical product by the manufacturer at the site of manufacture conforms to a standard that the APVMA has determined is comparable to the manufacturing principles and the Australian GMP Code

(3) This section specifies, for subsection 8B(1) of the Code, that an application for a prescribed variation of the kind set out in item 4 of the table in the Agricultural and Veterinary Chemicals Code Act (Prescribed Variations) Instrument 2019 must include a statement that the applicant holds:

(a) evidence that the physical properties and storage stability of the product, as varied and relevant to the product’s formulation type or dosage form, are the same as the product’s existing physical properties and storage stability, when measured using the same methodology used for the product before being varied; and

(b) if the application relates to a veterinary chemical product—the following evidence about the product, as varied:

(i) a dissolution profile (if relevant) of at least 2 pilot scale batches that is comparable to the formulation of the product immediately before the application is made;

(ii) at least 3 consecutive months of data on the storage stability of the product.