K jednotlivým farmakovigilančným procedúram zodpovedajúce moduly Správnej farmakovigilančnej praxe, vrátane príloh a špecifických usmernení a ICH (International Conference on Harmonisation) usmernenia https://www.ich.org/page/efficacy-guidelines.

Držiteľ registrácie humánneho lieku je povinný vykonávať činnosti súvisiace s dohľadom nad bezpečnosťou humánnych liekov v súlade s modulmi správnej farmakovigilančnej praxe (podľa § 68 ods. 15 písm. e) Zákona č. 362/2011 Z. z.).

Moduly Správnej farmakovigilančnej praxe:

Module I – Pharmacovigilance systems and their quality systems
Module II – Pharmacovigilance system master file
Module III – Pharmacovigilance inspections
Module IV – Pharmacovigilance audits
Module V – Risk management systems
Module VI – Collection, management and submission of reports of suspected adverse reactions to medicinal products
Module VI Addendum I – Duplicate management of suspected adverse reaction reports
Module VI Addendum II – Masking of personal data in individual case safety reports submitted to EudraVigilance
Module VII – Periodic safety update report
Module VIII – Post-authorisation safety studies
Module VIII Addendum I – Requirements and recommendations for the submission of information on non-interventional post-authorisation safety studies
Module IX – Signal management
Module IX Addendum I – Methodological aspects of signal detection from spontaneous reports of suspected adverse reactions
Module X – Additional monitoring
Module XV – Safety communication
Module XVI – Risk minimisation measures: selection of tools and effectiveness indicators
Module XVI Addendum I – Educational materials
Module XVI Addendum II – Methods for evaluating effectiveness of risk minimisation measures

Product- or Population-Specific Considerations I: Vaccines for prophylaxis against infectious Diseases
Product- or Population-Specific Considerations II: Biological medicinal products
Product- or Population-Specific Considerations IV: Paediatric population

Annex I – Definitions
Annex II:
- Templates: Cover page of Periodic Safety Update Report (PSUR)
- Templates: Direct Healthcare Professional Communication (DHPC)
- Templates: Communication Plan for Direct Healthcare Professional Communication (CP DHPC)
Annex III:
- Guideline on the exposure to medicinal products during pregnancy: need for post-authorisation data
- Note for guidance – EudraVigilance Human – Processing of safety messages and individual case safety reports (ICSRs)
- Overview of comments received on draft note for guidance: EudraVigilance version 7.1 Processing of safety messages and individual case safety reports (ICSRs)
Annex IV - International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guidelines for pharmacovigilance:
- ICH Topic E 2 A - Clinical safety data management: Definitions and standards for expedited reporting
- ICH guideline E2B (R3) on electronic transmission of individual case safety reports (ICSRs) - data elements and message specification - implementation guide
- ICH guideline E2B (R3) - questions and answers
- ICH guideline E2C (R2) on periodic benefit-risk evaluation report (PBRER)
- ICH Topic E 2 D - Post Approval Safety Data Management
- ICH Topic E 2 E - Pharmacovigilance Planning (Pvp)
- ICH guideline E2F on development safety update report
Annex V – Abbreviations

Hlásenia podozrení na nežiaduce účinky liekov

Detailed guide regarding the EudraVigilance data management activities by the EMA

https://www.ema.europa.eu/en/documents/other/detailed-guide-regarding-eudravigilance-data-management-activities-european-medicines-agency_en.pdf

EU Individual Case Safety Report (ICSR) Implementation Guide

https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/european-union-individual-case-safety-report-icsr-implementation-guide_en.pdf

EudraVigilance - Európska databáza hlásení podozrení na nežiaduce účinky liekov

https://eudravigilance.ema.europa.eu/human/restricted/os/organizationselection.asp

https://www.ema.europa.eu/en/human-regulatory/research-development/pharmacovigilance/eudravigilance

https://www.adrreports.eu/

WHO-UMC system for standardised case causality assessment

https://www.who.int/docs/default-source/medicines/pharmacovigilance/whocausality-assessment.pdf

Brighton Collaboration – definície nežiaducich účinkov

https://brightoncollaboration.us/category/pubs-tools/case-definitions/

Periodické hodnotenie bezpečnosti lieku (PSUR)

Periodické hodnotenie bezpečnosti lieku, vrátane EURD listu

https://www.ema.europa.eu/en/human-regulatory/post-authorisation/pharmacovigilance/periodic-safety-update-reports-psurs

Explanatory Note to GVP Module VII

https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-good-pharmacovigilance-practices-gvp-module-vii-periodic-safety-update-report-explanatory_en.pdf

Signály

Výsledky posúdenia signálov:

https://www.ema.europa.eu/en/human-regulatory/post-authorisation/pharmacovigilance/signal-management/prac-recommendations-safety-signals

Plány riadenia rizík (RMP)

Risk management plans - zoznam bezpečnostných problémov (safety concerns)

https://www.hma.eu/human-medicines/cmdh/pharmacovigilance/rmp.html

Risk management plan (RMP): questions and answers

https://www.ema.europa.eu/en/human-regulatory/post-authorisation/pharmacovigilance/risk-management-plan-rmp-questions-answers

CMD(h) Guidance for MAHs on the Pharmacovigilance System and RMP in the MRP and DCP procedures https://www.hma.eu/uploads/media/PhV_system__RMP_in_MRP_DCP.pdf

Guidance on the format of the risk management plan (RMP) in the EU – in integrated format

https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/guidance-format-risk-management-plan-rmp-eu-integrated-format-rev-201_en.pdf

Výbor pre hodnotenie rizík liekov (Pharmacovigilance Risk Assessment Committee – PRAC)

https://www.ema.europa.eu/en/committees/pharmacovigilance-risk-assessment-committee-prac

Závery zo zasadnutia:

https://www.sukl.sk/hlavna-stranka/slovenska-verzia/bezpecnost-liekov/informacie-z-prac?page_id=4834

Výsledky referálov pre jednotlivé lieky

https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/referral-procedures-human-medicines

https://www.ema.europa.eu/en/documents/report/medicines-output-referrals-report_en.xlsx

Štúdia o bezpečnosti lieku po registrácii (PASS)

https://www.ema.europa.eu/en/human-regulatory/post-authorisation/pharmacovigilance/post-authorisation-safety-studies-pass-0

Európsky register PASS