Category
Implementation Guide
Organisation
ID
3_IG_DSRR2_INFORM_R3_2012FEB
Type
Standard
Version
3
Access
Open
Status
Active
Created
Feb 2012
This implementation guide is for the use of the Health Level 7 (HL7) stability standard. The guide describes the basic requirements for using the standard and the requirements for electronically submitting information to the Food and Drug Administration (FDA) using the standard. The Health Level 7 (HL7) stability standard should be used for all regulated products – for example, test kits, drugs, reagents and medicated feeds – but not for foods.
Main sections:
· Introduction to drug stability reporting (eStability)
· Detailed description of eStability elements
· Code lists
Main sections:
· Introduction to drug stability reporting (eStability)
· Detailed description of eStability elements
· Code lists
Access HL7 Version 3 Implementation Guide: Drug Stability Reporting (eStability) R2, Release 3
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