Quote from VigiServe Admin on February 8, 2026, 4:55 AM

In Montenegro, Pharmacovigilance is regulated by the Agency for Medicines and Medical Devices (CALIMS). The system is robust and fully aligned with EU Good Pharmacovigilance Practices (GVP) as part of the country's EU accession process.

1. Clinical Safety (Clinical Trials)

Clinical trials are strictly regulated under the Law on Medicines and aligned with EU Regulation 536/2014 principles.

• Expedited Reporting: Sponsors must report Suspected Unexpected Serious Adverse Reactions (SUSARs) to CALIMS:

  • Fatal or Life-Threatening: Within 7 calendar days.

  • Other Serious Unexpected: Within 15 calendar days.

• Periodic Reporting: Development Safety Update Reports (DSURs) are mandatory annually (ICH E2F format).

• Oversight: Sponsors are responsible for causality assessment and reporting to CALIMS and Ethics Committees.

2. Post-Marketing Pharmacovigilance

Post-approval obligations mirror EU standards, requiring strict compliance and local oversight.

• Personnel:

  • QPPV: A Qualified Person for Pharmacovigilance is mandatory.

  • Local Contact: If the QPPV resides outside Montenegro (e.g., in the EU), a Local Contact Person residing in Montenegro is required for liaison with CALIMS.

• Documentation: A Pharmacovigilance System Master File (PSMF) is mandatory (EU GVP Module II) and must be available for CALIMS inspections.

• Incident Reporting (ICSRs):

  • Serious Cases: Report within 15 calendar days.

  • Non-Serious Cases: Report within 90 calendar days.

  • Submission: Electronic reporting via E2B(R3) is preferred.

• Risk & Periodic Reporting:

  • PSURs: Submitted in ICH E2C(R2) format. Typically every 6 months (first 2 years), then annually.

  • RMPs: Mandatory for new active substances and high-risk products (EU GVP Module V).

  • Additional Monitoring: The Black Triangle (▼) scheme applies to new or high-risk medicines.

Summary of Requirements

Component	Requirement in Montenegro
Regulatory Authority	CALIMS (Agency for Medicines and Medical Devices)
Framework	EU GVP Aligned / Law on Medicines
Local Personnel	QPPV (Mandatory) + Local Contact (if QPPV foreign)
PSMF	Required
SUSAR Reporting	7 days (fatal) / 15 days (other serious)
ICSR Timelines	15 days (serious) / 90 days (non-serious)
RMPs	Mandatory (EU Style)
Special Monitoring	Black Triangle (▼) Scheme applies