Quote from VigiServe Admin on November 29, 2020, 7:20 AM

In Bosnia and Herzegovina, Pharmacovigilance is regulated by the Agency for Medicines and Medical Devices (ALMBiH). The system is currently aligning with EU Good Pharmacovigilance Practices (GVP) as part of the country's EU accession efforts, though it is not yet fully harmonized.

1. Clinical Safety (Clinical Trials)

Safety monitoring during clinical trials requires ALMBiH approval and compliance with GCP standards.

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

  • 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 or periodically to summarize trial safety data.

• Oversight: Sponsors manage causality assessment and communication with ALMBiH and Ethics Committees.

2. Post-Marketing Pharmacovigilance

Post-approval requirements are structured and rigorous, reflecting heavy EU influence.

• Personnel: A Local Qualified Person for Pharmacovigilance (QPPV) is mandatory. This person must reside in Bosnia and Herzegovina and possess relevant pharmacovigilance expertise.

• Documentation: A Pharmacovigilance System Master File (PSMF) is required and must be available for ALMBiH inspections.

• Incident Reporting (ICSRs):

  • Serious (Domestic/Foreign): Report within 15 calendar days.

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

  • Submission: Electronic reporting is standard (since ~2019), though paper is accepted.

• Risk & Periodic Reporting:

  • PSURs: Submitted in ICH formats. Typical frequency starts at 6 months, moving to annually or every 3 years.

  • Risk Management Plans (RMPs): Obligatory for new substances, biologics, and high-risk products.

Summary of Requirements

Component	Requirement in Bosnia & Herzegovina
Regulatory Authority	ALMBiH (Agency for Medicines and Medical Devices)
Local QPPV	Mandatory (Must reside in country)
PSMF	Required
SUSAR Reporting	7 days (fatal) / 15 days (other serious)
ICSR Timelines	15 days (serious) / 90 days (non-serious)
RMPs & PSURs	Required (aligned with ICH/EU standards)

Deadlines for reporting adverse drug reactions:

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• the marketing authorisation holder shall be required to provide complete information about every serious adverse drug reaction or suspicion which are received from medical staff on the territory of Bosnia and Herzegovina, and to report to the Agency using the report form for adverse drug reaction, within 15 days after being informed of an adverse reaction or a suspicion;

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• the marketing authorisation holder shall be required to provide complete information about every unexpected serious adverse drug reaction or suspicion which is received from medical staff on the territory of Bosnia and Herzegovina, and to report to the Agency using the report form for adverse drug reaction, within 15 days after being informed of an adverse reaction or a suspicion;

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• the marketing authorisation holder shall be required to provide complete written information about every serious adverse and unexpected drug reaction, which is received from outside of the territory of Bosnia and Herzegovina, within 15 days after receipt of the report, using the form in which the information is originally received;

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• the marketing authorisation holder shall be required to inform the Agency in writing about any other adverse drug reaction or events that are connected with consumption of or suspicion on medicinal product, regardless of its geographic origin or source of data in form of periodic reports of medicinal product safety.

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The deadlines for reporting of the adverse reactions related to medical devices are:

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• for serious threat to public health: IMMEDIATELY, no later than two days after the manufacturer has become aware of the threat

• for patient’s death or unexpected serious deterioration of patient’s health condition: IMMEDIATELY, no later than ten days after the manufacturer of the medical device has detected connection between medical device and adverse event;

• for other adverse reactions: IMMEDIATELY, no later than thirty days after manufacturer of the medical device has established connection between medical device and adverse event