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Ory Agency, the Association of the British Pharmaceutical Industry, the Proprietary Association of Great Britain, the British Association of Research Quality Assurance and the British Generic Manufacturers Association as part of a BROMI initiative February 2011 MedDRA is a registered trademark of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) Crown Copyright 2011 Published by the Medicines and Healthcare products Regulatory Agency Guidance on reprodu.

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Description: The HL7 Individual Case Safety Report (ICSR) captures information needed to support reporting of adverse events, product problems and consumer complaints associated with the use of FDA regulated products.

Individual Case Safety Report in the European Union For reporting purposes, done electronically in EU/EEA, the ICSR should contain the following 4 basic elements: An identifiable patient/subject; An identifiable reporter, A suspect drug or biological product, An adverse event or fatal outcome.

However, for the purpose of regulatory reporting, the minimum data elements for an ADR case are: an identifiable reporter, an identifiable patient, an adverse reaction, and a suspect product.

Serious post marketing cases are reported within 15 calendar days to the NCA (national competent authorities)/HA (health authorities)...to consider it as a valid case; Identifiable patient. Identifiable reporter. The drug suspected of causing reaction/event. Adverse event or fatal outcome.

Must report adverse drug experience that is both serious and unexpected, whether foreign or domestic, as soon as possible but no later than 15 calendar days from initial receipt of the information and must submit follow-up reports within 15 calendar days of receipt of new information by the applicant.

Unexpected fatal or life-threatening suspected adverse reactions represent especially important safety information and must be reported to FDA as soon as possible but no later than 7 calendar days following the sponsor's initial receipt of the information.

Non serious cases: Non serious ICSRs (cases with no serious adverse drug events or reactions) are submitted to regulatory authority within 90-day timeline period.

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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