(1)

This regulation applies if:

(a)

the Agency asks a competitor for a sample under regulation 17; and

(b)

the competitor gives the sample in response to the Agency's request; and

(c)

the result of the relevant test of the sample is positive; and

(d)

the relevant submission period has ended; and

(e)

the Agency has considered any submission that the competitor has given to the Agency under paragraph 45 (2) (a) or 48 (1) (a); and

(f)

the Agency is satisfied that the procedures for collecting and dealing with the sample mentioned in regulation 20 that the relevant orders require the Agency to comply with strictly have been strictly complied with; and

(g)

the Agency has considered any other relevant circumstances; and

(h)

the Agency has decided that the test result is valid and must be entered on the relevant register.

(2)

As soon as practicable, the Agency must enter on the relevant register:

(a)

the name of the competitor; and

(b)

the details of the test result; and

(c)

any information about the competitor that the relevant orders require the Agency to enter in the circumstances.

(3)

The Agency must also enter that information on the relevant register in the circumstances (if any) stated in the relevant orders.

(4)

In this regulation:

"relevant circumstances" includes the following circumstances:

(a)

an investigation conducted by the ASDMAC under subregulation 64 (1), or an analytical investigative body under regulation 25, in relation to the sample, has revealed that the positive test result is not attributable to naturally occurring levels of the substance concerned;

(b)

the competitor had approval from the ASDMAC or a therapeutic approval body for the use of the drug concerned for therapeutic purposes;

(c)

any circumstances stated in the relevant orders for this subregulation.

"relevant submission period" means:

(a)

if only Part A of the competitor's sample has been tested under the relevant scheme — the submission period mentioned in subregulation 45 (2); and

(b)

if both Part A and Part B of the competitor's sample have been tested under the relevant scheme — the submission period mentioned in subregulation 48 (1).

"relevant test "means:

(a)

if only Part A of the competitor's sample has been tested under the relevant scheme — the testing of Part A of the sample; and

(b)

if both Part A and Part B of the competitor's sample have been tested under the relevant scheme and the testing of Part B of the sample confirms the result of the testing of Part A of the sample — the testing of Part A and Part B of the sample.

Note 1
For the meaning of positive test result , see s 14 of the Act.
Note 2
Under r 60, the Agency must give a competitor whose name and details have been entered on the relevant register written notice that the entry has been made.
Note 3
Under r 61, a competitor has a right to apply to the Administrative Appeals Tribunal for a review of a decision of the Agency to enter the competitor's name and details on the relevant register. For other competitors' rights in relation to entries on the register, see Div 2.6.