1. Regulations
  2. title 21
  3. chapter I
  4. part 26
  5. subpart A
  6. § 26.13

View all text of Subpart A [§ 26.1 - § 26.21]

§ 26.13 - Transmission of postapproval inspection reports.

Postapproval good manufacturing practice (GMP) inspection reports concerning products covered by this subpart will be transmitted to the authority of the importing country within 60-calendar days of the request. Should a new inspection be needed, the inspection report will be transmitted within 90-calendar days of the request.

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.

SOURCE: 63 FR 60141, Nov. 6, 1998, unless otherwise noted.

CITE AS: 21 CFR 26.13