Medicines: permissions and operating records · France / Switzerland
Health-product vigilance: factual reporting dossier
A vigilance dossier records a suspected event without assuming that causation has already been established. Identify the medicine or device, reporter, chronology and product reference before attaching relevant evidence. France and Switzerland have separate reporting routes and role-specific duties. Link later information to the original reference. A suspected-event report is distinct from a product recall, a medical diagnosis or a compensation determination.
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Product-event and reporting chronology
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What suspected event or adverse effect was observed?
France: describe the suspected reaction or incident without asserting causation. Switzerland: HMG Article 59 distinguishes reporting roles; a safety notification records a suspicion or observation rather than proving that the product caused harm.
Read the referencesYour file concerns “Health-product vigilance: factual reporting dossier”. Does it concern France or Switzerland? Share the document for product and identifier and the decision you need to prepare.
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Which medicine or device and identifier are involved?
France: record medicine or device category, presentation and batch or identifier. Switzerland: identify the therapeutic product equally precisely; medicine and medical-device reporting routes should not be treated as interchangeable.
ANSM effet indésirableLPTh / HMG / LATer : 59OMéd / VAM / OM : 65
Product-event and reporting chronology
Synthetic example: fictional records. Product-event and reporting chronology.
Synthetic example: fictional records · Product-event and reporting chronology
- Jurisdiction
- France
- Product and identifier
- Medicine or device P1, batch L1
- Reporter and route
- Role R1, reporting route C1
- Event and dates
- Observation E1, timeline T1
- Evidence and follow-up
- Documents D1, reference S1
A suspected-event report is distinct from a product recall, a medical diagnosis or a compensation determination.
What suspected event or adverse effect was observed?
France: describe the suspected reaction or incident without asserting causation. Switzerland: HMG Article 59 distinguishes reporting roles; a safety notification records a suspicion or observation rather than proving that the product caused harm.
ANSM effet indésirableLPTh / HMG / LATer : 59OMéd / VAM / OM : 65
Which reporter role determines the appropriate route?
France: check the ANSM route for patient, professional or operator and product type. Switzerland: distinguish professional and business duties from the consumer’s right to report; one generic reporting form does not establish every duty.
ANSM effet indésirableLPTh / HMG / LATer : 59OMéd / VAM / OM : 65
Preparation reference: Product-event and reporting chronology
| Preparation question | Point to verify |
|---|---|
| Which medicine or device and identifier are involved? | France: record medicine or device category, presentation and batch or identifier. Switzerland: identify the therapeutic product equally precisely; medicine and medical-device reporting routes should not be treated as interchangeable. |
| What suspected event or adverse effect was observed? | France: describe the suspected reaction or incident without asserting causation. Switzerland: HMG Article 59 distinguishes reporting roles; a safety notification records a suspicion or observation rather than proving that the product caused harm. |
| Which reporter role determines the appropriate route? | France: check the ANSM route for patient, professional or operator and product type. Switzerland: distinguish professional and business duties from the consumer’s right to report; one generic reporting form does not establish every duty. |
| What dates connect use, event and discovery? | France: record use, event, discovery and notification dates separately. Switzerland: retain the same chronology and its uncertainties; neither this register nor an absent timestamp establishes the implementing deadline for a particular reporting branch. |
ANSM effet indésirableLPTh / HMG / LATer : 59OMéd / VAM / OM : 65
What dates connect use, event and discovery?
France: record use, event, discovery and notification dates separately. Switzerland: retain the same chronology and its uncertainties; neither this register nor an absent timestamp establishes the implementing deadline for a particular reporting branch.
ANSM effet indésirableLPTh / HMG / LATer : 59OMéd / VAM / OM : 65
Which seriousness or reporting-category facts require examination?
France: retain concrete consequences and available technical facts for seriousness assessment. Switzerland: likewise keep observed severity distinct from regulatory classification; category-specific rules must be checked before assigning a reporting period.
ANSM effet indésirableLPTh / HMG / LATer : 59OMéd / VAM / OM : 65
Which official provision helps explain this situation?
A vigilance dossier records a suspected event without assuming that causation has already been established. Identify the medicine or device, reporter, chronology and product reference before attaching relevant evidence. France and Switzerland have separate reporting routes and role-specific duties. Link later information to the original reference. A suspected-event report is distinct from a product recall, a medical diagnosis or a compensation determination.
What batch, use or technical records support the report?
France: link packaging, batch and relevant usage or technical documents. Switzerland: connect corresponding medicine-safety records to the responsible function under VAM Article 65 where applicable; avoid unrelated identifiable health records in this preparation tool.
ANSM effet indésirableLPTh / HMG / LATer : 59OMéd / VAM / OM : 65
How should later information link to the original reference?
France: identify the original notification when supplying corrections or later evidence. Switzerland: preserve the initial reference, transmission date and supplement version; a new document should not silently overwrite the first event description.
ANSM effet indésirableLPTh / HMG / LATer : 59OMéd / VAM / OM : 65
Why is reporting separate from recall or compensation?
France: reporting, product recall and compensation serve separate tasks. Switzerland: a notification under the safety framework likewise determines neither a recall decision nor a damages entitlement; prepare the relevant records separately.
ANSM effet indésirableLPTh / HMG / LATer : 59OMéd / VAM / OM : 65
What other questions arise in this file?
What suspected event or adverse effect was observed?
France: describe the suspected reaction or incident without asserting causation. Switzerland: HMG Article 59 distinguishes reporting roles; a safety notification records a suspicion or observation rather than proving that the product caused harm.
ANSM effet indésirableLPTh / HMG / LATer : 59OMéd / VAM / OM : 65
What dates connect use, event and discovery?
France: record use, event, discovery and notification dates separately. Switzerland: retain the same chronology and its uncertainties; neither this register nor an absent timestamp establishes the implementing deadline for a particular reporting branch.
ANSM effet indésirableLPTh / HMG / LATer : 59OMéd / VAM / OM : 65
What batch, use or technical records support the report?
France: link packaging, batch and relevant usage or technical documents. Switzerland: connect corresponding medicine-safety records to the responsible function under VAM Article 65 where applicable; avoid unrelated identifiable health records in this preparation tool.
ANSM effet indésirableLPTh / HMG / LATer : 59OMéd / VAM / OM : 65
Why is reporting separate from recall or compensation?
France: reporting, product recall and compensation serve separate tasks. Switzerland: a notification under the safety framework likewise determines neither a recall decision nor a damages entitlement; prepare the relevant records separately.
ANSM effet indésirableLPTh / HMG / LATer : 59OMéd / VAM / OM : 65
Which official references should you consult?
- ANSM effet indésirableansm.sante.fr
- LPTh / HMG / LATer : 59www.fedlex.admin.ch
- OMéd / VAM / OM : 65www.fedlex.admin.ch
Texts cited last checked: 3 November 2026