Sec. 102. Definitions
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Section 739 ( 21 U.S.C. 379j–11 ) is amended— by amending paragraph
(1)to read as follows: The term animal drug application means— an application for approval of any new animal drug submitted under section 512(b)(1); or an application for conditional approval of a new animal drug submitted under section 571. Such term does not include either a new animal drug application submitted under section 512(b)(2) or a supplemental animal drug application. ; and in paragraph (8), by adding at the end the following: 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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- 21 USC 379j–11
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Sec. 102
Definitions
Cite21 USC 379j–11
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