[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR26.60]
[Page 272-273]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 26 MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE
Subpart C_``Framework'' Provisions
Sec. 26.60 Definitions.
(a) The following terms and definitions shall apply to this subpart
only:
(1) Designating Authority means a body with power to designate,
monitor, suspend, remove suspension of, or withdraw conformity
assessment bodies as specified under this part.
(2) Designation means the identification by a designating authority
of a conformity assessment body to perform conformity assessment
procedures under this part.
(3) Regulatory Authority means a government agency or entity that
exercises a legal right to control the use or sale of products within a
party's jurisdiction and may take enforcement action to ensure that
products marketed within its jurisdiction comply with legal
requirements.
(b) Other terms concerning conformity assessment used in this part
shall have the meaning given elsewhere in this part or in the
definitions contained in ``Guide 2: Standardization and Related
Activities--General Vocabulary of the International Organization for
Standardization (ISO) and the International Electrotechnical Commission
(IEC)'' (ISO/IEC Guide 2) (1996 edition), which is incorporated by
reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies
are available from the International Organization for Standardization,
1, rue de Varemb[eacute], Case postale 56, CH-1211 Gen[egrave]ve 20,
Switzerland, or on the Internet at http://www.iso.ch or may be examined
at the Food and Drug Administration's Medical Library, 5600 Fishers
Lane, rm. 11B-40, Rockville, MD 20857, or at the National Archives and
[[Page 273]]
Records Administration (NARA). For information on the availability of
this material at NARA, call 202-741-6030, or go to: http://
www.archives.gov/federal--register/code--of--federal--regulations/ibr--
locations.html. In the event of an inconsistency between the ISO/IEC
Guide 2 and definitions in this part, the definitions in this part shall
prevail.
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