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  • V3ig Spl R5 Inform 2011may Hl7 Version 3 Implementation Guide: Structured Product Labeling, Release

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V3IG SPL R5 INFORM 2011MAY HL7 Version 3 Implementation Guide: Structured Product Labeling, Release 5 FDA Establishment Registration, Listing, Content of Labeling, and UDI Submission May, 2011 HL7.

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What Is SPL? Structured Product Labeling (SPL) is a Health Level Seven (HL7) International standard for regulatory guidance documents as a method for communicating product and facility information.

Listing process Select the appropriate SPL document type for the product (human Rx drug, human OTC, bulk ingredient, etc.) Fill out all required listing data elements. Create a section within the SPL file for each section of content for labeling (e.g., highlights, warnings, how supplied) and enter the text for each.

Drug listing data elements include information about the product (proprietary and nonproprietary names, ingredients, ingredient strengths, dosage forms, routes of administration, appearance, DEA schedule) and the packaging (package quantity and type).

Listing process Select the appropriate SPL document type for the product (human Rx drug, human OTC, bulk ingredient, etc.) Fill out all required listing data elements. Create a section within the SPL file for each section of content for labeling (e.g., highlights, warnings, how supplied) and enter the text for each.

Structured Product Labeling (SPL) is the FDA's adopted standard for communicating product and quality information. SPL includes very important information like controlled compliant components, ingredients, ingredient strengths, dosage forms, routes of administration and much more.

Structured Product Labeling Resources. Risk Evaluation and Mitigation Strategies (REMS) SPL Resources.

Structured Product Labeling (SPL) is a standard document approved and issued by Health Level Seven (HL7) to exchange information related to product and facility. It is used as a base for Regulatory guidance document in exchange for product labeling content.

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Form Packages
Adoption
Bankruptcy
Contractors
Divorce
Home Sales
Employment
Identity Theft
Incorporation
Landlord Tenant
Living Trust
Name Change
Personal Planning
Small Business
Wills & Estates
Packages A-Z
Form Categories
Affidavits
Bankruptcy
Bill of Sale
Corporate - LLC
Divorce
Employment
Identity Theft
Internet Technology
Landlord Tenant
Living Wills
Name Change
Power of Attorney
Real Estate
Small Estates
Wills
All Forms
Forms A-Z
Form Library
Customer Service
Terms of Service
DMCA Policy
About Us
Blog
Affiliates
Contact Us
Privacy Notice
Delete My Account
Site Map
All Forms
Search all Forms
Industries
Forms in Spanish
Localized Forms
Legal Guides
Real Estate Handbook
All Guides
Prepared for You
Notarize
Incorporation services
Our Customers
For Consumers
For Small Business
For Attorneys
Our Sites
US Legal Forms
USLegal
FormsPass
pdfFiller
signNow
airSlate workflows
DocHub
Instapage
Social Media
Call us now toll free:
1-877-389-0141
As seen in:
  • USA Today logo picture
  • CBC News logo picture
  • LA Times logo picture
  • The Washington Post logo picture
  • AP logo picture
  • Forbes logo picture
© Copyright 1997-2025
airSlate Legal Forms, Inc.
3720 Flowood Dr, Flowood, Mississippi 39232