Quote from VigiServe Admin on November 29, 2020, 7:30 AM

The pharmacovigilance (PV) system in **Serbia** is mature, fully aligned with **EU Good Pharmacovigilance Practices (GVP)** modules and ICH standards, as Serbia is an EU candidate country with strong harmonization efforts. The **Agency for Medicines and Medical Devices of Serbia (ALIMS – Agencija za lekove i medicinska sredstva Srbije)** serves as the primary regulatory authority and national PV center, handling ADR collection, signal detection, risk assessment, inspections, alerts, and contributions to VigiBase (Serbia is a full WHO PIDM member). The system is governed by:

- **Law on Medicines and Medical Devices** (2010, amended).
- **Rulebook on the Method of Reporting, Collecting, and Monitoring Adverse Reactions to Medicines** (2011, still foundational; aligned with EU PV legislation).
- **Rulebook on Clinical Trials** (for trial safety).
- ALIMS guidelines and directives (updated 2023–2025, e.g., ADR reporting forms, medicines under intensive monitoring list per Article 38).

**Organization and Personnel**
- Marketing Authorization Holders (MAHs) must establish and maintain a PV system compliant with EU GVP.
- Appoint a **separate dedicated local Qualified Person for Pharmacovigilance (QPPV)**: Mandatory; must be resident in Serbia, with good PV and quality management knowledge, English proficiency, and serve as the primary ALIMS contact (full-time role).
- **Pharmacovigilance System Master File (PSMF)**: Required (EU GVP Module II-aligned); describes the PV system, must be maintained/updated and available for ALIMS inspections (no mandatory registration/location, but accessibility enforced).

**Individual Case Safety Reports (ICSRs) – Post-Marketing**
- MAHs report all suspected ADRs (serious/non-serious), medication errors, or quality issues to ALIMS (electronic preferred; paper rarely accepted).
- **Timelines** (aligned with EU/ICH):
- **Serious ICSRs** (domestic and unexpected foreign): Within **15 calendar days** of receipt/awareness.
- **Non-serious ICSRs**: Within **90 calendar days** or periodic aggregates.
- Foreign serious unexpected ICSRs: Within **15 calendar days** (except those already in EudraVigilance/UMC).
- HCPs and patients can report; MedDRA coding required.

**Periodic Benefit-Risk Evaluation Reports (PBRER/PSUR)**
- MAHs submit PSURs/PBRERs (ICH E2C(R2) format) to ALIMS.
- Frequency: Typically every **6 months** initially (first 2 years post-authorization), then **annually** or as specified (aligned with EU requirements; evaluated by ALIMS).

**Risk Management Plans (RMP)**
- Mandatory for new substances, high-risk products, biologics, or specific concerns (per EU GVP Module V).
- Submit RMP with pharmacovigilance/risk minimization plans; updates for new risks or changes.
- ALIMS may require Serbia-specific adaptations/annex.

**Signal Management and Emerging Safety Issues**
- MAHs continuously monitor data and notify ALIMS of validated signals or emerging concerns promptly.
- ALIMS leads national signal detection and risk assessment.

**Clinical Trials-Related Safety Requirements**
Clinical trials require ALIMS authorization (via Clinical Trial Application) and ethics committee review (aligned with ICH GCP and EU Regulation 536/2014 principles).
- Sponsors monitor safety and report to ALIMS and ethics committees.
- **Suspected Unexpected Serious Adverse Reactions (SUSARs)**: Expedited reporting (aligned with ICH E2A):
- Fatal/life-threatening SUSARs: **7 calendar days**.
- Other serious unexpected SUSARs: **15 calendar days**.
- **Development Safety Update Reports (DSURs)**: Annual submission required (ICH E2F format), especially for ongoing trials.
- Serious breaches of GCP/protocol must be reported promptly.
- No direct EudraVigilance access (though alignment facilitates); reports via ALIMS channels (electronic/forms). Sponsor responsibility for monitoring, causality assessment, DSMB (if applicable), and communication to ALIMS/ethics committees.

**Additional Monitoring / Other Aspects**
- Medicines under **intensive monitoring** (additional monitoring list per Article 38; includes new substances/biologics).
- Emphasis on electronic reporting, HCP/patient submissions, and inspections (enhanced post-PIC/S membership Jan 2026).
- Reporting volumes moderate; improvements via guidelines/training.

Serbia's PV framework is **EU-harmonized** and robust (mandatory local QPPV, PSMF, 15/90-day ICSR timelines, routine PSUR/RMP, expedited SUSAR/DSUR), one of the strongest in the Balkans/Central Europe. It balances EU alignment with national enforcement.

For precise, product- or trial-specific details (e.g., latest ADR guides from 2025 consultation, forms, or exact timelines), consult **ALIMS** directly via alims.gov.rs (Pharmacovigilance section, downloads, or contacts), as requirements evolve with EU accession and updates. Companies often appoint a local QPPV for compliance in Serbia.

One can send the completed forms to:

E-Mail Address: nezeljene.reakcije@alims.gov.rs

Postal address:

Agencija za lekove i medicinska sredstva Srbije (ALIMS)

Vojvode Stepe 458, 11221 Belgrade, Serbia

FAX:  011 / 3951-130

ONLINE REPORTING