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Governmental authority, approvals

Portable fire extinguishers purchased in the United States should be listed by Underwriters Laboratories (UL). Extinguishers for marine use should bear the label of the U.S. Coast Guard or other Authority Having Jurisdiction (AHJ). Extinguishers and agents purchased outside the United States should be approved by the AHJ, such as the governmental authority. [Pg.227]

Sterility knows no frontiers. Sterile products are manufactured in all countries they are used within national boundaries, they are imported, and they are exported. However. nxKt governments will not permit the marketing of sterile [diarmaceutical products or medical devices unless the products have been noti> fied to them, acntinized for safety and efficacy, and approved. It is not the intention of this chapter to describe in detail the activities of governmental authorities throughout the world in relation to sterile products but to draw attention to some of the issues that are peculiar to sterile products and sterilization. [Pg.259]

CTs with prospective new medicines must be authorized by the competent MRA before started. In addition to the scientific evaluation, another prerequisite for the authorization is an approval of the protocol and the trial site by the competent Ethics Committee. The GCP must be obeyed and its compliance monitored by governmental inspectors. Maximal processing time of CT applications is 60 days, a period within which there is not more than 42 days for the ethical approval. [Pg.188]


See other pages where Governmental authority, approvals is mentioned: [Pg.771]    [Pg.660]    [Pg.42]    [Pg.819]    [Pg.183]    [Pg.819]    [Pg.65]    [Pg.635]    [Pg.3]    [Pg.189]    [Pg.463]    [Pg.611]    [Pg.63]    [Pg.907]    [Pg.106]    [Pg.909]    [Pg.238]    [Pg.17]    [Pg.254]    [Pg.11]    [Pg.1]    [Pg.6]    [Pg.221]   
See also in sourсe #XX -- [ Pg.907 ]




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