Commonwealth Consolidated Regulations

[Index] [Table] [Search] [Search this Regulation] [Notes] [Noteup] [Previous] [Next] [Download] [Help]

THERAPEUTIC GOODS REGULATIONS 1990 - REG 30

Review of findings of official analyst

         (1)   A person:

                (a)    to whom a certificate, setting out the results of an examination and analysis of goods, is issued under subregulation 29 (1); and

               (b)    who sends to the Secretary evidence in writing establishing that the goods do conform with the specified standard or comply with an applicable requirement, or, for medical devices, do comply with the applicable provisions of the essential principles or an applicable requirement;

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 with a specified standard or comply with an applicable requirement, or, for medical devices, comply with the applicable provisions of the essential principles or an applicable requirement, 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 with a specified standard or comply with an applicable requirement, or, for medical devices, comply with the applicable provisions of the essential principles or an applicable requirement, 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 officer 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.



[Index] [Table] [Search] [Search this Regulation] [Notes] [Noteup] [Previous] [Next] [Download] [Help]