definiens: means the current good distribution practice regulatory standards as may be applicable to manufacturers, distributors, repackagers, pharmacists or other retail purveyors of medicinal products or drug products intended for use in the United States, Great Britainor the European Union, and the current principles and guidelines relating to the labeling, product identification, verification, tracking, tracing, inspection, recordkeeping, reporting, data - 12 -management, recall, warehousing, storage, transportation, security, physical distribution or other conditions of distribution, repackaging, relabeling, or sale of medicinal products or drugs as specified in the FDCA, enacted as part of the Drug Supply Chain and Security Act of2013, in implementing regulations or guidance issued by FDA, Articles 76 to 85 of Directive 2001/83 / EC of the European Parliament and of theCouncil of 6 November 2001, the guidelines for good distribution practice as promulgated in ( 2013 / C 343/01 ), all other applicable rules, regulations, orders, guidance, guidelines ( including those issued by the ICH or other Governmental Entities ), as may be amended from time to time