Safety reporting for medicines obtained from abroad
What pharmacovigilance is, who reports side effects, and how families can help keep imported medicines safe.
Reviewed by the Reserve Meds clinical operations team on 17 October 2026. Sources accessed 17 October 2026.
The short answer
Pharmacovigilance is the science and activities of detecting, assessing, understanding and preventing side effects and other medicine-related problems. When a medicine is imported for a named patient, the treating hospital reports side effects to the national regulator, and FDA's MedWatch program also accepts reports on FDA-regulated products. Tell the treating team about any new symptom.
- What it is: Detecting and preventing medicine-related harm.
- Who reports: The treating doctor or hospital, and patients where allowed.
- US channel: FDA MedWatch.
- Global role: WHO supports national pharmacovigilance systems.
What pharmacovigilance is
WHO describes pharmacovigilance as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem. WHO supports countries in building national systems and runs a global programme for sharing safety data.[1]
Why it matters more for imported medicines
A medicine supplied for a named patient may be new in your country. Local doctors may have limited experience with it, and the national regulator has not reviewed its full file. Good safety reporting closes that gap.
Under Singapore's special access route, for example, the regulator states plainly that it has not assessed the product, and the requesting doctor is fully responsible for its use. Many regulators take a similar approach to unregistered products.[2]
Who reports, and where
- The treating hospital reports serious or unexpected side effects to the national regulator, following local rules for unregistered medicines.
- FDA's MedWatch program collects safety information and adverse event reports on FDA-regulated products from health professionals and consumers.[3]
- The manufacturer also collects reports through its own safety department; the US label lists how to contact it.
- Families should tell the treating team about any new or worsening symptom, even if it seems unrelated.
What families can do
- Keep the US label and patient leaflet, and read the warnings and side effects sections with the doctor.
- Keep a simple diary of doses, dates and any symptoms, especially in the first weeks.
- Bring all medicines, including supplements, to every appointment so the team can check for interactions.
- Keep the batch number and expiry date from the pack; they are needed for any report.
Labels change, so check for updates
US labels are updated as new safety information appears. DailyMed shows the current version of each label with its effective date, which the treating team can compare with the copy they hold.[4]
We send the current US label with each supply and flag significant label changes we see to the treating team.
What a good adverse event report contains
- Who: the patient's age, sex and relevant conditions (without unnecessary personal details).
- What: the medicine's name, batch number, dose, route, start and stop dates, and other medicines taken.
- What happened: the event, when it started, how serious it was, what treatment was given and the outcome.
- Reporter: the doctor's or hospital's contact details for follow-up questions.
Reports with a batch number and clear dates are far more useful than general descriptions.
Why reports from abroad still matter
WHO's pharmacovigilance work relies on reports collected by national systems and shared internationally, so a well-documented report from one country can inform safety decisions in others.[1]
How Reserve Meds helps
Reserve Meds is a digital health company. Medicines are supplied through a US-licensed pharmaceutical wholesale partner. We help families and treating doctors understand the route, prepare the documents the regulator or hospital asks for, arrange supply from the US once approval is in place, and keep everyone updated. We do not diagnose, prescribe or decide what a regulator approves.
We coordinate access to FDA-approved medicines only. Investigational medicines are only available through a manufacturer's expanded-access program requested by the treating physician; we can explain that route, but we do not supply them. Your coordination fee is quoted in writing for your case before you commit. No hidden charges. We give you a written timeline estimate for your case before you commit.
Ask us about a medicine
Tell us the medicine, your country and a WhatsApp or phone number. We reply within one business day. On WhatsApp we usually reply the same day.
Frequently asked questions
Who reports side effects for a medicine imported for one patient?
Usually the treating doctor or hospital, to the national regulator under local rules. The manufacturer and FDA's MedWatch program also collect reports.
Can patients report to FDA?
FDA's MedWatch program accepts adverse event reports from health professionals and consumers on FDA-regulated products.
What information is needed for a report?
The medicine name, batch number, dose and dates, what happened and when, and any other medicines taken. Keep the pack and a symptom diary.
Does Reserve Meds give medical advice about side effects?
No. Contact the treating doctor straight away. We help by supplying the current US label and passing on label updates we see.
Sources for these answers: [1, 3]
Sources
All sources were opened and checked on 17 October 2026. Rules and labels change, so the treating hospital or regulator confirms the current position before anything is filed.
- World Health Organization: Pharmacovigilance (Regulation and Prequalification) (accessed 17 October 2026)
- Health Sciences Authority Singapore: Import and supply of unregistered therapeutic products for patient's use (accessed 17 October 2026)
- US FDA: MedWatch, the FDA Safety Information and Adverse Event Reporting Program (accessed 17 October 2026)
- DailyMed: Qalsody (tofersen) US prescribing information, version effective 13 November 2024 (accessed 17 October 2026)
Related
- Fake and substandard medicines
- Answers to common access questions
- Named-patient access, explained
- US expanded access (compassionate use)
This page is general information, not medical or legal advice. It does not replace advice from your own doctor or the regulator.