Pharmacovigilance

What a report is

A report — formally an Individual Case Safety Report, or ICSR — is one person's account of one patient who had something unwanted happen while taking or after taking a medicine. It is not an accusation and it is not a legal claim. It does not have to prove that the medicine caused the reaction: causality is assessed afterwards, by us and by the authorities, across many cases. The word that matters is suspected. If you suspect a connection, that is the threshold for reporting, and it is deliberately set low.

The four validity criteria, in plain terms

An identifiable reporter

Someone we can go back to with questions. A name or initials plus one contact route is enough. Patients, parents, carers, doctors, nurses, pharmacists, distributors and our own staff all count as reporters.

An identifiable patient

One single, distinguishable person. They are identifiable if you can give any one of: initials, a patient reference, date of birth, an age or age band, or sex. A full legal name is never required. "A friend of mine" without any of those cannot be counted, because we cannot tell two such reports apart.

A suspect medicinal product

At least one Ergopharm product named as suspected — the product name or the active substance. Strength, LOT and EXP from the carton make the case far more useful, but their absence does not invalidate it.

A suspect reaction

At least one unwanted effect, described in your own words. "Painful lump at the injection site that lasted five days" is a valid reaction description. Medical vocabulary is not expected of you; converting your words into standard terminology is our job.

What happens to your report

1. 01

   1 — Intake

   Every report is logged in our safety database on the day it reaches us and given a unique case number. You receive an acknowledgement with that number, normally within two business days. Reports arriving by email, by post, through a distributor or through our contact form all enter the same queue.

2. 02

   2 — Validity check

   A trained case processor tests the report against the four criteria above. Valid cases proceed to full processing. Cases missing an element are held open as incomplete and enter follow-up rather than being closed. Nothing is deleted.

3. 03

   3 — Coding

   Your words — the verbatim term — are preserved unchanged, and a standardised term is attached alongside them using MedDRA, the ICH medical terminology, currently version 29.0 (March 2026). Coding runs up the hierarchy from Lowest Level Term to Preferred Term to System Organ Class, so that a "lump at the injection site" and an "injection-site nodule" reported in two countries become countable as the same thing. The case is structured to the ICH E2B(R3) data model.

4. 04

   4 — Seriousness and expectedness

   Seriousness is a regulatory classification, not a measure of how bad you felt. A case is serious if it resulted in death, was life-threatening, required or prolonged hospitalisation, caused persistent or significant disability or incapacity, caused a congenital anomaly, or is another medically important condition — the ICH E2A criteria. Separately, the reaction is checked against the reference safety information for the product (the undesirable-effects section of the SmPC and leaflet) to determine whether it is expected or unexpected. Serious and unexpected is the combination that moves fastest.

5. 05

   5 — Follow-up

   For anything serious, unexpected, or unclear, we come back to you with targeted questions: dates of first and last dose, dose and route, what happened when the medicine was stopped and — only if it happened, never as a suggestion — restarted, other medicines taken, relevant history, and how the reaction ended. We make up to three follow-up attempts and then close follow-up, keeping the case on file as it stands. You are free to decline; the original report still counts.

6. 06

   6 — Onward transmission

   Where our product is placed on a market by a local marketing-authorisation holder, the validated case is transmitted to that holder under the safety data exchange agreement, inside the clock agreed there so that they can meet their own submission deadlines to the competent authority.

7. 07

   7 — Aggregate and signal review

   Individual cases are the raw material; the analysis happens across them. Cases are reviewed in a standing periodic aggregate review together with complaints, batch records and literature, using the signal-management approach of EU GVP Module IX and the planning principles of ICH E2E. A confirmed signal can end in a leaflet or SmPC change, a manufacturing or packaging investigation, a change to a specification, or a documented decision that no change is warranted. "No change, and here is why" is a legitimate and recorded outcome.

Reporting to us, reporting to a national scheme

These are two separate channels and they are not connected in the way most people assume. Telling us does not automatically place your report in your national database, and telling your national authority does not automatically bring it to us. Each route does something the other cannot. A report to Ergopharm reaches the people who hold the batch record, the packaging line data and the serialisation history for your exact carton, so it can be tied to a LOT and, if needed, trigger a manufacturing investigation. A report to your national scheme enters an independent public database that pools data across every manufacturer and every product, which is where population-level patterns become visible. You may use either. You may use both, and for anything serious we would rather you did — duplicate cases are routinely identified and merged by the authorities, so there is no harm in reporting twice.

Public reporting schemes

• United Kingdom — the MHRA Yellow Card scheme, at yellowcard.mhra.gov.uk, through the Yellow Card app, or by freephone on 0800 731 6789. Open to patients and to healthcare professionals alike.
• United States — FDA MedWatch. Consumers and patients use Form FDA 3500B; healthcare professionals use Form FDA 3500. Both can be submitted online.
• European Union and EEA — the national reporting system for your own country, listed in EMA QRD Appendix V. The relevant national details are reproduced in the possible-side-effects section of the printed package leaflet of each authorised product.
• India — the Pharmacovigilance Programme of India (PvPI), coordinated by the Indian Pharmacopoeia Commission in Ghaziabad, with a toll-free helpline on 1800-180-3024 and the ADR PvPI mobile app.
• Elsewhere — your national pharmacovigilance centre. Most national centres contribute de-identified data to the WHO global database maintained by the Uppsala Monitoring Centre, so a report made locally still counts internationally.

Situations worth reporting even when nothing obviously went wrong

• Pregnancy and breastfeeding exposure — any exposure during pregnancy, around conception, or while breastfeeding, whether or not anything unwanted has happened. These cases are followed up to outcome, because that is the only way exposure data is ever accumulated. Several of our products are contraindicated in pregnancy; report the exposure regardless.
• Off-label use — the medicine used for an indication, population, dose or duration outside the authorised labelling. Report the use and any reaction. We record it; we do not advise on it and we cannot endorse it.
• Misuse, abuse and overdose — intentional excessive use, use for non-medical effect, or a dose above what was prescribed. Reports of this kind are handled clinically and confidentially; they are not passed to employers, sporting bodies or law enforcement as a matter of routine practice.
• Medication error — a wrong product, wrong strength, wrong route, wrong patient or wrong frequency, including errors caught before they reached the patient. Near-misses are especially informative, because they often point at something about the carton, the label or the leaflet that we can change.
• Lack of effect — the medicine did nothing, or stopped working. Reported alongside the LOT, this is one of the few external signals that can point at a genuine product-quality problem, so it is handled as a quality complaint as well as a safety report.
• Occupational exposure — exposure at work rather than by prescription: a needlestick, a spill, powder handling, or contact during transport and warehousing. Report it through this page even if you have never been our patient or customer.

Who is responsible where

Ergopharm, as manufacturer

We manufacture the product under GMP conditions in Vadodara, Gujarat, and we serialise every saleable carton. Our safety function receives reports from anywhere in the world, processes them, investigates anything that touches a batch, and holds the manufacturing and packaging record behind your specific LOT.

The local marketing-authorisation holder

In each market where our product is placed on the market by a local holder, that holder — not Ergopharm — carries the statutory pharmacovigilance obligations in that territory: submission of cases to the competent authority within the local timeframes, periodic safety reporting, literature monitoring and labelling maintenance. Sending your report to us does not replace that route; we pass the case on to them.

The safety data exchange agreement

A written safety data exchange agreement between us and each local holder fixes the mechanics before anything goes wrong: who receives what, in which format, within how many calendar days, in which language, who owns follow-up, who answers a regulator's question, and how reconciliation is performed so that a case cannot be lost in the gap between two companies.

You, the reporter

Nothing. There is no obligation on a patient or member of the public to report, no consequence for reporting, and no cost. Healthcare professionals may have obligations under their own national rules — those apply independently of anything on this page.

How to reach the safety function

Use the form below; it collects the fields we would otherwise have to obtain from you by follow-up. If you prefer, write to pharmacovigilance@ergopharm.net with as much of the same information as you have, or contact the distributor who supplied the product and ask them to forward it — they are contractually required to pass safety information to us. Quote the case number in any later correspondence. If your report concerns a pack you believe to be falsified rather than a reaction to it, use the pack verification page as well; suspected-falsification cases follow a different internal path.