Adverse Event and Product Complaint Reporting

1. Purpose

Veltrion takes product safety seriously. This page explains how to report an adverse event, a suspected side effect, a product quality complaint or a special-situation report relating to a product for which Veltrion holds or coordinates a local regulatory or safety role.

2. Our role, stated precisely

Where Veltrion is appointed under a mandate to coordinate a local safety contact function, its role is to receive reports, record them, and transmit them onward to the marketing authorisation holder and, where required, to the relevant national regulatory authority, within the timelines that apply.

Where Veltrion holds no such appointment for the product concerned, we will tell you so and, where we can identify it, direct you to the correct marketing authorisation holder or authority. We will not silently absorb a safety report we are not appointed to handle.

3. What should be reported

• Adverse events. Any untoward medical occurrence in a patient who has been given a medicine, whether or not it is considered related to the medicine.
• Suspected side effects, including those that are not described in the product information.
• Product quality complaints, such as suspected defects in packaging, appearance, labelling or performance.
• Special situations, including use in pregnancy or breastfeeding, medication error, overdose, misuse, off-label use, occupational exposure and lack of expected effect.
• Suspected falsified product.

4. How to report

Send a report to info@veltrionlaboratories.com with the subject line beginning "SAFETY REPORT". Reports sent to this address are routed for safety handling.

Where possible, include the four elements that make a report valid:

1. An identifiable reporter. Your name and a way to contact you.
2. An identifiable patient. Initials, age range or sex is sufficient. Do not send more identifying detail than is needed.
3. A suspect product. Brand or generic name, and batch number if visible.
4. The event. What happened, when it started, and its current outcome.

An incomplete report is still worth sending. Do not delay a report in order to complete it.

5. What happens to your report

1. The report is recorded on receipt, with the date and time.
2. It is assessed for validity and seriousness.
3. It is transmitted to the marketing authorisation holder and, where required, the national regulatory authority, within the applicable reporting timelines.
4. We may contact you for follow-up information.

6. Reporting directly to an authority

You may always report directly to your national regulatory authority instead of, or in addition to, reporting to us. In South Africa this is the South African Health Products Regulatory Authority (SAHPRA). Other national authorities operate their own reporting systems. Reporting to us does not remove your ability to report to an authority, and reporting to an authority does not remove your ability to tell us.

7. Privacy of safety reports

Safety reports usually contain health information. We process it because we are legally obliged to, under section 11(1)(c) of POPIA and, where GDPR applies, Article 6(1)(c) together with Article 9(2)(i) on public health grounds. Access is limited to those handling the report. Safety records are retained for the period required by the applicable authority, which may exceed ten years. See our Privacy Notice.

Contact

Questions about this document should be directed to info@veltrionlaboratories.com, marked for the attention of the Information Officer.