Commonwealth Consolidated Regulations Commonwealth Consolidated Regulations(1) In this Part, unless the contrary intention appears:
relevant test :
(a) in relation to the analysis of therapeutic goods (other than medical devices), means a test that, under subregulation 28 (1), is a relevant test for the purpose of determining whether goods of a class in which the first‑mentioned goods are included are goods that conform with a standard applicable to the goods; and
(b) in relation to the analysis of a medical device, means a test that, under subregulation 28 (2), is a relevant test for the purpose of determining whether a medical device of that kind complies with the applicable provisions of the essential principles.
"responsible analyst" , in relation to the analysis of a sample of therapeutic goods, means an official analyst who is nominated as a responsible analyst for the sample under paragraph 25 (3) (c).
"samples officer" means an officer of the Department performing duties under the direction of an official analyst.
(2) For this Part, a sample of therapeutic goods is appropriately fastened and sealed if the sample is fastened and sealed:
(a) in a vessel or package that is marked with the name and address of:
(i) the person from whom the sample was taken; or
(ii) for a sample delivered under subsection 28 (5A) or 41FN (2) of the Act -- the sponsor of the goods; and
(b) so as to prevent the opening of the vessel or package, and the removal of the name and address, without breaking the seal.