Commonwealth Consolidated Regulations

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THERAPEUTIC GOODS REGULATIONS 1990 - REG 29

Certificate of responsible analyst

  (1)   The responsible analyst must issue a certificate setting out the results of the examination and analysis.

  (2)   Within a reasonable time of the completion of the analysis, the responsible analyst must send a copy of the certificate to:

  (a)   the sponsor of the goods; and

  (b)   if the sample was taken under paragraph   25(3)(a) and the person from whom the sample was taken is not the sponsor of the goods--the person from whom the sample was taken.

  (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;

a copy of the certificate sent under 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 copy is sent may ask for the results of the analysis referred to in the copy 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 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 issued under subregulation   (1); or

  (b)   a copy of that certificate;

is, in the absence of evidence to the contrary, to be taken to be the certificate or a copy of the certificate.


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