INOPP Forum
Pharmacovigilance Requirements in Macedonia
Quote from VigiServe Admin on November 29, 2020, 7:12 AMIn North Macedonia, the pharmacovigilance system is fully integrated into the European Union framework as part of its accession process and is enforced by the Agency for Medicines and Medical Devices (MALMED). The framework closely follows EU Good Pharmacovigilance Practices and international standards.
1. Clinical Safety (Clinical Trials)
Clinical trials require MALMED approval and align with international standards.
Expedited Reporting: Sponsors must report Suspected Unexpected Serious Adverse Reactions (SUSARs) to MALMED.
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: Direct submission to MALMED and relevant ethics committees.
2. Post-Marketing Pharmacovigilance
Marketing Authorization Holders must maintain a system compliant with EU guidelines.
Personnel & Infrastructure:
Qualified Person for Pharmacovigilance: Mandatory. A registered professional with a pharmacy or medical degree is required (typically local or EU-based).
Pharmacovigilance System Master File: Mandatory. The file must be maintained and available for MALMED inspections.
Incident Reporting (ICSRs):
Timelines:
Serious: Within 15 calendar days.
Non-Serious: Within 90 calendar days or in periodic aggregates.
Risk & Periodic Reporting:
Periodic Reports: Required every 6 months for the first two years, then annually or as specified.
Risk Management Plans: Mandatory for new active substances, biologics, and high-risk products.
Summary of Requirements
Component Requirement in North Macedonia Regulatory Authority MALMED (Agency for Medicines and Medical Devices) Framework EU Harmonized / GVP Aligned Local Qualified Person for Pharmacovigilance Yes (Local or EU-based) Pharmacovigilance System Master File Yes Safety Reporting 15 days (Serious) / 90 days (Non-Serious) Clinical Reporting SUSARs (7/15 days) Submission Language Macedonian / English
In North Macedonia, the pharmacovigilance system is fully integrated into the European Union framework as part of its accession process and is enforced by the Agency for Medicines and Medical Devices (MALMED). The framework closely follows EU Good Pharmacovigilance Practices and international standards.
1. Clinical Safety (Clinical Trials)
Clinical trials require MALMED approval and align with international standards.
-
Expedited Reporting: Sponsors must report Suspected Unexpected Serious Adverse Reactions (SUSARs) to MALMED.
-
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: Direct submission to MALMED and relevant ethics committees.
2. Post-Marketing Pharmacovigilance
Marketing Authorization Holders must maintain a system compliant with EU guidelines.
-
Personnel & Infrastructure:
-
Qualified Person for Pharmacovigilance: Mandatory. A registered professional with a pharmacy or medical degree is required (typically local or EU-based).
-
Pharmacovigilance System Master File: Mandatory. The file must be maintained and available for MALMED inspections.
-
-
Incident Reporting (ICSRs):
-
Timelines:
-
Serious: Within 15 calendar days.
-
Non-Serious: Within 90 calendar days or in periodic aggregates.
-
-
-
Risk & Periodic Reporting:
-
Periodic Reports: Required every 6 months for the first two years, then annually or as specified.
-
Risk Management Plans: Mandatory for new active substances, biologics, and high-risk products.
-
Summary of Requirements
| Component | Requirement in North Macedonia |
| Regulatory Authority | MALMED (Agency for Medicines and Medical Devices) |
| Framework | EU Harmonized / GVP Aligned |
| Local Qualified Person for Pharmacovigilance | Yes (Local or EU-based) |
| Pharmacovigilance System Master File | Yes |
| Safety Reporting | 15 days (Serious) / 90 days (Non-Serious) |
| Clinical Reporting | SUSARs (7/15 days) |
| Submission Language | Macedonian / English |
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