Regulation Text
The provisions of this subpart govern the exchange between the parties and normal endorsement by the receiving regulatory authority of official good manufacturing practices (GMP's) inspection reports after a transitional period aimed at determination of the equivalence of the regulatory systems of the parties, which is the cornerstone of this subpart.
Authority
5 U.S.C. 552;15 U.S.C. 1453,1454,1455;18 U.S.C. 1905;21 U.S.C. 321,331,351,352,355,360,360b,360c,360d,360e,360f,360g,360h,360i,360j,360l,360m,371,374,381,382,383,393;42 U.S.C. 216,241,242l,262,264,265.