I.E. Medica Pharmacovigilance Form
Welcome to I.E. Medica, Inc. (the “Company”, “we”, “us”, and “our”)!
As a pharmaceutical company, we have a legal responsibility to monitor safety of all of our registered products in the Food and Drug Administration (FDA) of the Philippines. This Pharmacovigilance (PV) Privacy Notice illustrates how we collect, process, use and share your personal data to help us fulfil our obligations, specifically stipulated on A.O No. 2011-0009 or the National Policy and Program on Pharmacovigilance, FDA Circular 2020-003 or the Guidelines for Pharmaceutical Industry on Pharmacovigilance, and other PV related guidelines issued by the Philippine FDA.
Our Company is focused on your safety and in order for us to fulfill our PV obligations as a Pharmaceutical Company we may collect personal data through this PV / Adverse Drug Reaction (ADR) Form. An ADR (or side effect) is any undesirable experience associated with the use of a medical product in a patient. If you don’t provide us the information requested in connection with PV, we will also be less likely to identify safety and/or efficacy issues regarding our products and to provide you with the appropriate help needed.
Why do we collect your personal data?
We collect your personal data in relation to PV/ADR to:
1. Investigate the adverse drug reaction or adverse event
2. Contact you, your family, legal representative or health care professional about the reported ADR
3. Analyze the safety and efficacy of our product
4. Comply and provide mandatory reports about the ADR to Philippine FDA and international authorities
We process the information you, your family, legal representative or health care professional provide directly to us in relation to reporting of ADR. We will be collecting personal information of different data subjects namely, the Patient and the Reporter.
If you are the patient who is the subject of the ADR, we will collect the following personal data:
1. Name or your initials
2. Contact details
3. Date of Birth
5. Weight and Height
6. Medical History
7. Data concerning your existing health
8. Race or Ethnic Origin
If you are the patient’s next of kin, legal representative or health care professional, we will collect the following personal data:
1. Full Name
2. Contact Details
3. Relationship to the patient
We respect your rights as data subjects. If you have questions or concerns regarding Data Privacy, you may contact our Data Protection Officer at email@example.com