Commonwealth Numbered Regulations

1990 No. 394 THERAPEUTIC GOODS REGULATIONS - REG 30

30. (1) Where:

   (a)  an official analyst has issued a certificate under subregulation 29
        (1) stating that goods do not conform to a specified standard, or
        requirement, that is applicable to the goods within the meaning of
        regulation 27; and

   (b)  a person to whom the certificate, or a copy of the certificate, was
        issued, sends to the Secretary evidence in writing establishing that
        the goods do conform to that standard or requirement; the person may
        ask for the results of the analysis to be reviewed.

(2) A request for review of the results of the analysis is to be made not
later than 21 days after the person receives the certificate, or the copy of
the certificate, as the case may be.

(3) The Secretary must extend the period of 21 days if it is not reasonable to
expect the person to provide the evidence within the period referred to in
subregulation (2).

(4) A person is not to be regarded as having sent the Secretary evidence
establishing that goods conform to a particular standard unless that person
has sent to the Secretary a certificate of an analyst who has appropriate
qualifications and experience setting out:

   (a)  a statement that the analyst has analysed a part of the same sample,
        or a similar sample from the same batch (if any), of those goods; and

   (b)  the results of that analysis; and

   (c)  details of the tests used in the analysis.

(5) If the certificate referred to in subregulation (4) shows that an analysis
of goods for the purpose of establishing that the goods conform to the
standard was carried out in accordance with the relevant tests in relation to
the goods, subregulation (6) applies to those goods.

(6) Unless the results of the analysis of a sample of goods to which this
subregulation applies, or other information available to the Secretary in
relation to those goods, shows lack of homogeneity in the sample, the
Secretary, at the request of the sponsor of the goods, must direct:

   (a)  if part of the sample remains unimpaired - the official analyst to
        send so much of the sample as remains unimpaired; or

   (b)  if no part of the sample remains unimpaired - that a further sample be
        taken by an authorised person from the same batch as the original
        sample and that that further sample be sent; to an analyst agreed upon
        by the person who requested the review and the official analyst, or,
        in the absence of agreement, to an analyst nominated by the Secretary.

(7) If a sample is forwarded to an analyst referred to in subregulation (6),
the analyst is to:

   (a)  analyse the sample of the goods in accordance with any relevant tests;

   (b)  send to the Secretary a certificate, signed by the analyst, setting
        out the results of the analysis; and

   (c)  send a copy of that certificate, signed by the analyst to the sponsor
        of the goods.

(8) A certificate under regulation 29 setting out the results of the analysis
of a sample of goods ceases to have effect when the Secretary receives the
certificate in relation to those goods under subregulation (7).

(9) If the findings of the official analyst are upheld, the sponsor must pay
any charges payable to the analyst referred to in subregulation (6) in respect
of the analysis of the sample.

(10) In proceedings under the Act or these Regulations, a certificate of an
analyst issued under subregulation (7) or a copy of that certificate is, in
the absence of evidence to the contrary, conclusive proof of the matters
stated in it.

(11) A document purporting to be:

   (a)  a certificate of an analyst issued under subregulation (7); or

   (b)  a copy of that certificate, and purporting to be signed by the
        analyst; is, in the absence of evidence to the contrary, to be
        regarded as the certificate, or a copy of the certificate, and to have
        been issued under that subregulation.