Quote from VigiServe Admin on November 29, 2020, 6:02 AM

In Kosovo, the pharmacovigilance system is managed by the Kosovo Medicines Agency (KMA). It aligns with WHO principles and increasingly adopts EU Good Pharmacovigilance Practices due to accession aspirations.

1. Clinical Safety (Clinical Trials)

Clinical trials require KMA authorization and adhere to EU-influenced GCP.

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

   

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

  • Other Serious Unexpected: Within 15 calendar days.

• Periodic Reporting: Development Safety Update Reports (DSURs) or annual updates are required for ongoing trials.

• Submission: Direct submission to the KMA via forms or email.

2. Post-Marketing Pharmacovigilance

• Personnel & Infrastructure:

  • Local QPPV: Mandatory. A dedicated, local Qualified Person for Pharmacovigilance resident in Kosovo must be appointed.

  • PSMF: Docs Locally. No explicit mandatory registration, but pharmacovigilance procedures must be documented and available for inspections.

• Incident Reporting (ICSRs):

  • Timelines:

    • Serious: Within 15 calendar days.

    • Non-Serious: Within 90 calendar days.

       

• Risk & Periodic Reporting:

  • PSURs: Required during renewals, variations, or upon request.

     

  • RMPs: Reactive; implemented for high-risk cases.

Summary of Requirements

Component	Requirement in Kosovo
Regulatory Authority	KMA (Kosovo Medicines Agency)
Framework	Law 03/L-188 / EU-Influenced
Local QPPV / PSMF	Yes (Local QPPV) / Docs Locally
Safety Reporting	15 days (Serious) / 90 days (Non-Serious)
Clinical Reporting	SUSARs (7/15 days)
Submission Language	Albanian / Serbian / English