Mandatory Adverse Event Reporting via the SRP (other than RFR reports)

FDA Adverse Event Reports; Electronic Submissions

0645 IC2 Mandatory DSR Wireframes

Mandatory Adverse Event Reporting via the SRP (other than RFR reports)

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Who Should Submit a Safety Report?
Organizations and people in certain professional roles, such as the following,
may be required by law to submit safety reports under some circumstances.
·Food Manufacturers, Processors, Packers, and Holders
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·Dietary supplement manufacturers, packers, and distributors

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Reports You Can Submit Through this Portal
FDA safety issues involving:
·Human or animal reportable foods
·Animal drugs
·Pet foods
· Tobocca Products
·Dietary Supplements

Others, including concerned citizens, health professionals, and public
health officials, may voluntarily submit reports if they encounter
safety issues with a product andlor unanticipated harmful
effects that they believe are related to a product.

·NIH gene-transfer research

Learn more about mandatory and voluntary reporting

For other issues, find out where to submit your report.

NIH safety issues involving:

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A toed facility or responsible party that manufactures, processes, packs, or holds toed who is submitting a reportable food report.

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A federal, state, or local public health official who is submitting a reportable food report involving human and/or animal toed

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A veterinarian or veterinary staff member v.ho is submitting a product problem and/or adverse event report involving pet food

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A consumer or concerned citizen who is submitting a product problem and/or adverse event report involving pet food

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A marketing authorization holder (manufacturer) tor an animal drug who is submitting a product problem and/or an adverse event.

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A healthcore professional submitting a product problem and/or adverse event report involving a tobacco product
A consumer or concerned citizen who is submitting a product problem and/or adverse event report involving a tobacco product
A clinical trial primary investigator or researcher who needs to report an adverse event involving o gene research study.
A dietary supplement manufacturer, packer, or distributor who is submitting a mandatory serious ad·1erse event report.
A consumer, concerned citizen, or healthcore professional who is submitting a report about an illness or injury associated with dietary supplement(s),

or a dietary supplement manufacturer, packer, cr distributor who is submitting a voluntary adverse event and/or product problem report.

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None of tnese oescrit>e nne.

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Mandatory Dietary Supplement Report

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Mandatory Dietary Supplement Report

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WelcomeD. Manufacturer

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Introduction
Contact Information
Problem Summary
Products
Concomitant Products
Attachments

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Introduction
=Required

You have chosen to use this portal to submit a mandatory serious adverse event report about a dietary supplement to the FDA, as required
under section 761 o f the Federal Food, Drug, and Cosmetic Act (FD&C Act) (Z1 U.S.C. 37qaa·1). Manufacturers, packers, or distributors of
dietary supplements whose names appear on the label of a dietary supplement marketed in the United States are required to submit to FDA
on the MedWatch form (3500A) any report received of a serious adverse event associated with such dietary supplement when used in the
United States, accompanied by a copy of the label on or within the reta~ packaging of such dietary supplement. Serious adverse event
reports received through the address or phone number on the label of a dietary supplement, as well as all follow· up reports of new medicol
information received by the responsible person within one year after the initial report, must be submitted to FDA no later t~an 15 business days
after the report is received by the responsible person.

My Report History
OMS~

NUT!>ec.

oq10·064S

OMS Expfo!Xn
0113112013
Dote:

FDA has made available, for those who choose to use it, this method of electronic submission for mandatory serious adverse event reports
about a dietary sup~lement. FDA will accept reports filed via this portcl to satisfy firms' statutory reporting duty under section 761 of the
FD&C Act and intends to exercise enforcement discretion for firms' faillre to use the paper MedWatch form 3500A required by that section,
provided that the responsible person has completed all required fields in and submitted this electronic form. Use of this electronic form (which
contains some new mandatory questions) is completely voluntary and the paper MedWatch form 3500A will continue to be accepted until FDA
conducts rulemaking to require use of an electronic form for mandatory reports. Instructions for completing the MedWatch 3500A form, on
which this report is based, can be found here link to: httg:l/www.fda.gov/Safety/MedWatch/HowToRegort/DownloadForms/ucm14qz38.htm,
and instructions specific to using the MedWatch 3500A form for mandatory dietary supplement serious adverse event reports can be found
here link to: httg://www.fda.gov/Food/GuidanceCo!!J21ianceRegulatorylnformation/GuidanceDocuments/DietarvSugglementslucm171415.htm
Additionally, FDA has published industry guidance for submitting dietary supplement serious adverse event reports. This document can be found
here link to: httg://www.fda.gov/tood/guidanceco[!lllianceregulatoryjnformation/guidancedocuments/dietarysugglements/ucm171383.htm.

IReport Information

I

Please enter a title to help you identify this report.
Consider using your firm's internal case tracking number for
simplified recordkeeping.

I

I

0

•What type of report are you submitting?

Serious adverse event (a serious adverse health·related event

associated with the product)

0

Serious adverse event and product problem (e.g., defects that may

have caused or contributed to a serious adverse event)

•Enter the date yOl received the initial report:
How did the initial reporter learn of the
serious adverse e'lent or product problem?
(check all that apply)

0
0
0
0
0
0
0

It other, please describe

I Save Draft I

Exit

llij

I"
Consumer
Friend or Relative
Distributor
Health Professional
Lawyer
SOGiol Media

Other

I

I

Submit Report

~

I



'

WelcomeD. Manufacturer

Home

Related Links

FAQs

Contact Us

Feedback

Help

blue text = conditional field

Logout

Introduction
Introduction

• =Required

Contact Information

You have chosen to use this portal to submit a mandatory serious adverse event report about a dietary supplement to the FDA, as required
under section 761 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (Z1 U.S.C. 37qaa·1). Manufacturers, packers, or distributors of
dietary supplements whose names appear on the label of a dietary supplement marketed in the United States are required to submit to FDA
on the MedWatch form (3500A) any report received of a serious adverse event associated with such dietary supplement when used in the
United States, accompanied by a copy of the label on or within the retail packaging of such dietary supplement. Serious adverse event
reports received through the address or phone number on the label of a dietary supplement, as well as all follow· up reports of new medical
information received by the responsible person within one year after the initial report, must be submitted to FDA no later than 15 business days
after the report is received by the responsible person.

Problem Summary
Products
Concomitant Products
Attachments
My Report History

FDA has made available, for those who choose to use it, this method of electronic submission for mandatory serious adverse event reports
about a dietary supplement.. FDA will accept reports filed via this portal to satisfy firms' statutory reporting duty under section 761 of the
FD&C Act and intends to exercise enforcement discretion for firms' failure to use the paper MedWatch form 3500A required by that section,
provided that the responsible person has completed all required fields in and submitted this electronic form. Use of this electronic form (which
contains some new mandatory questions) is completely voluntary and the paper MedWatch form 3500A will continue to be accepted until FDA
conducts rulemaking to require use of an electronic form for mandatory reports. Instructions for completing the IMedWatch 3500A form, on
which this report is bosed, can be found here link to: httg:l/www.fda.gov/Satety/MedWatch/HowToRegort/DownloadForms/ucm14qz38.htm,
and instructions specific to using the MedWatch 3500A form for mandatory dietary supplement serious adverse event reports can be found
here link to: httg://www .fda.gov/Food/GuidanceCo~lianceRegulatorylntormation/GuidanceDocuments/Dietarl§ugglementslucm171415.htm
Additionally, FDA has published industry guidance for submitting dietary supplement serious adverse event reports. This document can be found
here link to: httg:/lwww .fda.govltoodlguidanceco~Iianceregulator)lintormationlguidancedocumentsldietary:sugglementslucm171383.htm.

I

I

Report Information

Please enter a title to help you identify this report.
Consider using your firm's internal case tracking number
for simplified recordkeeping.

.

I

I

0

What type of report are you submitting?

Serious adverse event (a serious adverse health·related event

associated with the product)

0

.

Enter the date you received the initial report:

It other, please describe

Orignal ICSR number

0
0
0
0
0
0
0

Lawyer
Social Media
Other

I

I

Z354363463

Reason for follow·up

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.

Exit

Distributor
Health Professional

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I

Consumer
Friend or Relative

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Initial report date

Save Draft

llij

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How did the initial reporter learn of the
serious adverse event or product problem?
(check all that apply)

I

Serious adverse event and product problem (e.g., defects that may

have caused or contributed to a serious adverse event)

I

Submit Report

~

03/ 01 /Z013

Read·only fields pre-populated with the original SRP
report submission information

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