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Version 1.0 laLdj.k 1.0 MEDICINES SIDE EFFECT REPORTING FORM (FOR CONSUMERS) vkS "kf/k nq "Hkko lwpuk QeZ miHkkskvksa ds fy, Indian Pharmacopoeia Commission, National Coordination Centre.

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How to fill out the MEDICINES SIDE EFFECT REPORTING FORM (FOR CONSUMERS) online

This guide provides clear and supportive instructions for filling out the Medicines Side Effect Reporting Form online. By following these steps, you will ensure that your reporting process is efficient and thorough.

Follow the steps to complete the form accurately and effectively.

  1. Press the ‘Get Form’ button to access the reporting form and open it in your preferred online editor.
  2. In Section 1, enter patient details. Provide the initials of the patient by writing the first letter of their first name and the first letter of their last name. Indicate the patient's gender and age.
  3. In Section 2, provide health information. Include the reason(s) for taking the medicine, as well as who advised its use (e.g., doctor or pharmacist).
  4. In Section 3, fill in the details of the person reporting the side effect. Include their name (optional), address, telephone number, and email.
  5. In Section 4, provide details of the medicine taken. Include the name, quantity, expiry date, start date, and stop date of the medicine. Specify the dosage form (tablet, capsule, etc.).
  6. In Section 5, state when the side effect started and whether it is still continuing. Include the date when the side effect stopped, if applicable.
  7. In Section 6, evaluate how bad the side effect was by ticking the boxes that apply, indicating whether it affected daily activities, required hospitalization, or resulted in any other significant impact.
  8. In Section 7, describe the side effect and any actions taken to manage it. Provide as much detail as possible to help in the assessment.
  9. After completing the form, save your changes. You may then download, print, or share the form as needed.

Start filling out your report online to contribute to safer medicine use.

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There are two types of MedWatch forms: MedWatch Form 3500 and MedWatch Form 3500A.

Adverse Event Reporting using FDA Form 3500A MedWatch is the FDA reporting system for Adverse Events (AEs), and Form 3500A is used for Adverse Event reporting. The Adverse Event reporting system in Ofni Clinical makes generation of FDA MedWatch 3500A forms quick and easy.

The FDA offers a number of ways to report a complaint. Two of the main reporting systems available to consumers are the Consumer Complaint Reporting system and MedWatch.

Following are the mandatory fields for a valid case report: Suspected Adverse Reaction: Description of the reaction (reaction terms), reaction date. Suspected Medication(s): Name (brand/generic) of the medication. Reporter Details: Name, address, contact details, qualification, and date of the report.

MedWatch Form FDA 3500A (Mandatory Reporting) Form FDA 3500A is used by manufacturers, user facilities, distributers, importers, and other respondents subject to mandatory reporting. Mandatory reporting of adverse events or product experiences is governed by statute and often codified in Agency regulations.

The MedWatch form, also known as Form FDA 3500A, is used for mandatory reporting of medical device adverse events by manufacturers, user facilities and importers. Form FDA 3500, a condensed version of 3500A, is used for voluntary reporting of adverse events by healthcare professionals, consumers and patients.

A user facility is required to report a device-related death or a device-related serious injury to the manufacturer and to report a device-related death to FDA. • Manufacturers must prepare and submit a complete Form FDA 3500A for each suspect device.

Form FDA 3500 may be used by health professionals or consumers for VOLUNTARY reporting of adverse events, product use/medication errors, product quality problems, and therapeutic failures for: Prescription and over-the-counter medicines including those administered in a hospital or outpatient infusion centers.

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