Commonwealth Consolidated Regulations

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THERAPEUTIC GOODS REGULATIONS 1990 - REG 29

Certificate of official analyst

         (1)   The responsible analyst must send to the sponsor of the goods a certificate signed by the analyst setting out the results of the examination and analysis.

         (2)   The responsible analyst must send a copy of the certificate, signed by the analyst, to:

                (a)    the Secretary; and

               (b)    if the sample was taken under subregulation 25 (3) -- the person from whom the sample was taken, if that person is not the sponsor of the goods.

         (3)   The certificate and copies of the certificate of the official analyst must be sent to the persons referred to in subregulations (1) and (2) within a reasonable time of the completion of the analysis.

         (4)   If the certificate referred to in subregulation (1) states:

                (a)    for relevant goods other than medical devices -- that the goods do not conform with a specified standard or comply with a requirement that is applicable to the goods under regulation 27; or

               (b)    for medical devices -- that the goods do not comply with the applicable provisions of the essential principles or a requirement that is applicable to the goods under regulation 27;

the certificate, and the copy of it referred to in subregulation (2), must be accompanied by a notice that complies with subregulation (4A).

      (4A)   For subregulation (4), the notice must:

                (a)    state that the person to whom the certificate or copy is sent may ask for the results of the analysis referred to in the certificate to be reviewed in accordance with regulation 30; and

               (b)    specify the time within which a request for a review of the results may be made; and

                (c)    state that the person may ask for an extension of that time if it is not reasonable to expect the person to comply with regulation 30 within the specified time.

         (5)   In proceedings under the Act or these Regulations, a certificate of an official analyst issued under subregulation (1), or a copy of that certificate, is, in the absence of evidence to the contrary, conclusive proof of the matters set out or stated in it.

         (6)   A document purporting to be:

                (a)    a certificate of an official analyst issued under subregulation (1); or

               (b)    a copy of that certificate;

and purporting to be signed by an official analyst is, in the absence of evidence to the contrary, to be taken to be the certificate or a copy of the certificate and to have been issued under subregulation (1) or (2), as the case requires.



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