INOPP Forum
Pharmacovigilance Requirements in Albania
Quote from VigiServe Admin on January 29, 2026, 1:53 PMIn Albania, the pharmacovigilance system is evolving to align with EU legislation as part of its accession efforts. The National Agency for Medicines and Medical Devices (AKBPM) is the competent authority. The system operates under Law No. 105/2014 (amended in 2022).
1. Clinical Safety (Clinical Trials)
Clinical trial safety is aligning with EU standards, though specific national guidelines are less detailed.
Expedited Reporting: Sponsors must report Suspected Unexpected Serious Adverse Reactions (SUSARs) to AKBPM.
Fatal or Life-Threatening: Often 7 calendar days (aligned with EU norms).
Other Serious Unexpected: 15 calendar days.
Unexpected Adverse Effects: The 2022 amendments mention a 24-hour reporting requirement for unexpected adverse effects.
Periodic Reporting: Development Safety Update Reports (DSURs) may be required annually or upon request.
Submission: Reports go to AKBPM via email or forms.
2. Post-Marketing Pharmacovigilance
Post-approval obligations are becoming stricter with recent legislative updates.
Personnel: A Qualified Person for Pharmacovigilance (QPPV) is mandatory. This person must reside in Albania and have relevant medical/pharmacy qualifications.
Documentation: A PV System Master File (PSMF) is not explicitly mandatory for registration, but PV procedures must be documented and available for inspection.
Incident Reporting (ICSRs):
Unexpected Adverse Effects: Report within 24 hours.
Serious Cases: Report within 15 calendar days.
Non-Serious Cases: Report within 90 calendar days.
Risk & Periodic Reporting:
PSURs: No mandatory routine frequency codified; submitted upon request or during renewals.
RMPs: Not routinely mandatory; may be requested for high-risk products.
Summary of Requirements
Component Requirement in Albania Regulatory Authority AKBPM (Nat. Agency for Medicines) Framework Law 105/2014 (EU Alignment) Local Personnel Mandatory QPPV (Resident) PSMF Not explicitly mandatory (Docs required) Serious ICSR Timeline 15 Days (24h for unexpected) Clinical Reporting SUSARs (7/15 days) / 24h unexpected Submission Language Albanian
In Albania, the pharmacovigilance system is evolving to align with EU legislation as part of its accession efforts. The National Agency for Medicines and Medical Devices (AKBPM) is the competent authority. The system operates under Law No. 105/2014 (amended in 2022).
1. Clinical Safety (Clinical Trials)
Clinical trial safety is aligning with EU standards, though specific national guidelines are less detailed.
-
Expedited Reporting: Sponsors must report Suspected Unexpected Serious Adverse Reactions (SUSARs) to AKBPM.
-
Fatal or Life-Threatening: Often 7 calendar days (aligned with EU norms).
-
Other Serious Unexpected: 15 calendar days.
-
Unexpected Adverse Effects: The 2022 amendments mention a 24-hour reporting requirement for unexpected adverse effects.
-
-
Periodic Reporting: Development Safety Update Reports (DSURs) may be required annually or upon request.
-
Submission: Reports go to AKBPM via email or forms.
2. Post-Marketing Pharmacovigilance
Post-approval obligations are becoming stricter with recent legislative updates.
-
Personnel: A Qualified Person for Pharmacovigilance (QPPV) is mandatory. This person must reside in Albania and have relevant medical/pharmacy qualifications.
-
Documentation: A PV System Master File (PSMF) is not explicitly mandatory for registration, but PV procedures must be documented and available for inspection.
-
Incident Reporting (ICSRs):
-
Unexpected Adverse Effects: Report within 24 hours.
-
Serious Cases: Report within 15 calendar days.
-
Non-Serious Cases: Report within 90 calendar days.
-
-
Risk & Periodic Reporting:
-
PSURs: No mandatory routine frequency codified; submitted upon request or during renewals.
-
RMPs: Not routinely mandatory; may be requested for high-risk products.
-
Summary of Requirements
| Component | Requirement in Albania |
| Regulatory Authority | AKBPM (Nat. Agency for Medicines) |
| Framework | Law 105/2014 (EU Alignment) |
| Local Personnel | Mandatory QPPV (Resident) |
| PSMF | Not explicitly mandatory (Docs required) |
| Serious ICSR Timeline | 15 Days (24h for unexpected) |
| Clinical Reporting | SUSARs (7/15 days) / 24h unexpected |
| Submission Language | Albanian |