Please Read before completing this form.
The Substandard/Falsified & Adverse Drug Reaction Form comprises six (6) Sections. Sections 1 to 5 are to be completed by the Health Professionals or Patient Representatives. Section 6 will be completed by The Chemistry Food & Drugs Division of the Ministry of Health.
SECTION 1: Reporter Information
SECTION 2: Medicinal Product Details
SECTION 3: Description of Suspected Substandard or Falsified (SF) Product or Adverse Drug Reaction (ADR)
SECTION 4: Patient Information and Additional Adverse Drug Reaction Details
SECTION 5: Upload Files
SECTION 6: For Official Use
The Health Professionals or Patient Representatives must enter his/her email address to begin completing the form.
Photos of suspected SF product and label (name, manufacturer, batch number, expiry) can be uploaded in Section 5.
Upon completion of the form, it is recommended to select "Send Me A Copy of my Responses" prior to selecting the "SUBMIT" button.
It should be noted that Submission of a report does NOT constitute an admission that the health personnel caused or contributed to the adverse reaction or problem. This information will be sent to our local database, VigiCarib and/or The Global Surveillance Monitoring System for future reference, follow-up and archiving.
This form can be used to report both adverse drug/medicine reactions (ADR/AMR) and substandard and/or falsified (SF) medical products to the Chemistry Food and Drugs Division, Ministry of Health.
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Reports may be of pharmaceuticals, biologics, and natural health products.
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Reports do not need to be completely filled out (however, asterisk sections are the most critically needed information). The Chemistry Food and Drugs Division may request further supporting information if required.
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Information related to SF products should be reported in sections A, B, and D, and C if an ADR is also involved.
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Information related to ADR/AMRs should be reported in all sections: A, B, C and D as far as possible.
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Respondents should retain samples of suspected SF products reported.
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Respondent identities can be kept anonymous if requested.
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Health professionals, regulatory authorities/ministries of health, industry, and the public are encouraged to report.
For further information on ADR/SF reporting, contact us at:
rapidalert-tt@health.gov.tt.
For further information you can contact The Chemistry Food & Division, Ministry of Health 623-2834, 625-5968, 623-5242