INOPP Forum
Pharmacovigilance Requirements in Finland
Quote from VigiServe Admin on March 15, 2026, 12:09 PMIn Finland, the pharmacovigilance system is fully integrated into the European Union framework and enforced by the Finnish Medicines Agency (Fimea). All EU pharmacovigilance legislation applies directly, including Good Pharmacovigilance Practices, with no significant national deviations.
1. Clinical Safety (Clinical Trials)
Clinical trials are governed by the EU Clinical Trials Regulation (CTR 536/2014) and require approval via the Clinical Trials Information System (CTIS).
Expedited Reporting: Sponsors must report Suspected Unexpected Serious Adverse Reactions (SUSARs) to EudraVigilance.
Fatal or Life-Threatening: Within 7 calendar days.
Other Serious Unexpected: Within 15 calendar days.
Periodic Reporting: Development Safety Update Reports (DSURs) are required annually.
Submission: Electronic submission via CTIS and EudraVigilance.
2. Post-Marketing Pharmacovigilance
Marketing Authorization Holders must maintain a pharmacovigilance system compliant with EU Good Pharmacovigilance Practices.
Personnel & Infrastructure:
Qualified Person for Pharmacovigilance: Mandatory. An EU-resident, qualified professional must be appointed. Fimea may also require a local contact person fluent in Finnish or Swedish to facilitate national communication.
Pharmacovigilance System Master File: Mandatory. The file must be maintained and available for Fimea inspections.
Incident Reporting (ICSRs):
Timelines:
Serious: Within 15 calendar days.
Non-Serious: Within 90 calendar days.
Submission: All reports are submitted electronically to EudraVigilance.
Risk & Periodic Reporting:
Periodic Benefit-Risk Evaluation Reports: Mandatory. Frequency aligns with the EU EURD list (typically every six months initially, then annually).
Risk Management Plans: Mandatory for new active substances, biologics, and high-risk products.
Additional Monitoring: Medicines under intensive monitoring must display the black inverted triangle (▼) in the Summary of Product Characteristics and package leaflet.
Summary of Requirements
Component Requirement in Finland Regulatory Authority Fimea (Finnish Medicines Agency) Framework EU Good Pharmacovigilance Practices / Medicines Act Local Qualified Person for Pharmacovigilance Yes (EU Qualified Person / Local Contact) Pharmacovigilance System Master File Yes Safety Reporting 15 days (Serious) / 90 days (Non-Serious) Clinical Reporting SUSARs (7/15 days - EU CTR) Submission Language Finnish / Swedish / English
In Finland, the pharmacovigilance system is fully integrated into the European Union framework and enforced by the Finnish Medicines Agency (Fimea). All EU pharmacovigilance legislation applies directly, including Good Pharmacovigilance Practices, with no significant national deviations.
1. Clinical Safety (Clinical Trials)
Clinical trials are governed by the EU Clinical Trials Regulation (CTR 536/2014) and require approval via the Clinical Trials Information System (CTIS).
-
Expedited Reporting: Sponsors must report Suspected Unexpected Serious Adverse Reactions (SUSARs) to EudraVigilance.
-
Fatal or Life-Threatening: Within 7 calendar days.
-
Other Serious Unexpected: Within 15 calendar days.
-
-
Periodic Reporting: Development Safety Update Reports (DSURs) are required annually.
-
Submission: Electronic submission via CTIS and EudraVigilance.
2. Post-Marketing Pharmacovigilance
Marketing Authorization Holders must maintain a pharmacovigilance system compliant with EU Good Pharmacovigilance Practices.
-
Personnel & Infrastructure:
-
Qualified Person for Pharmacovigilance: Mandatory. An EU-resident, qualified professional must be appointed. Fimea may also require a local contact person fluent in Finnish or Swedish to facilitate national communication.
-
Pharmacovigilance System Master File: Mandatory. The file must be maintained and available for Fimea inspections.
-
-
Incident Reporting (ICSRs):
-
Timelines:
-
Serious: Within 15 calendar days.
-
Non-Serious: Within 90 calendar days.
-
-
Submission: All reports are submitted electronically to EudraVigilance.
-
-
Risk & Periodic Reporting:
-
Periodic Benefit-Risk Evaluation Reports: Mandatory. Frequency aligns with the EU EURD list (typically every six months initially, then annually).
-
Risk Management Plans: Mandatory for new active substances, biologics, and high-risk products.
-
Additional Monitoring: Medicines under intensive monitoring must display the black inverted triangle (▼) in the Summary of Product Characteristics and package leaflet.
-
Summary of Requirements
| Component | Requirement in Finland |
| Regulatory Authority | Fimea (Finnish Medicines Agency) |
| Framework | EU Good Pharmacovigilance Practices / Medicines Act |
| Local Qualified Person for Pharmacovigilance | Yes (EU Qualified Person / Local Contact) |
| Pharmacovigilance System Master File | Yes |
| Safety Reporting | 15 days (Serious) / 90 days (Non-Serious) |
| Clinical Reporting | SUSARs (7/15 days - EU CTR) |
| Submission Language | Finnish / Swedish / English |