Sec. 102. DEFINITIONS
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/statute-compilations/comps-15549/sec-102A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
## SEC. 102 DEFINITIONS Section 739 (21 U.S.C. 379j-11) is amended— ####
(1)by amending paragraph
(1)to read as follows: > > #### “(1) > > > #####
(A)> > The term ‘**animal drug application**’ means— > > > ###### “(i) > > an application for approval of any new animal drug submitted under section 512(b)(1); or > > > ###### “(ii) > > an application for conditional approval of a new animal drug submitted under section 571. > > > ##### “(B) > > Such term does not include either a new animal drug application submitted under section 512(b)(2) or a supplemental animal drug application.” > ; and ####
(2)in paragraph (8), by adding at the end the following: > > ###### “(I) > > The activities necessary for implementation of the United States and European Union Good Manufacturing Practice Mutual Inspection Agreement with respect to animal drug products subject to review, including implementation activities prior to and following product approval.” > .
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