sk

Linky

LEGISLATÍVA: 

Nariadenie Európskeho parlamentu a Rady (ES) č. 726/2004

Nariadenie Európskeho parlamentu a Rady (EÚ) č. 1235/2010

Smernica Európskeho parlamentu a Rady 2001/83/ES

Smernica Európskeho parlamentu a Rady 2010/84/EÚ

Vykonávacie nariadenie Európskej komisie (EÚ) č. 520/2012

Zákon č. 362/2011 Z.z. o liekoch a zdravotníckych pomôckach a o zmene a doplnení niektorých zákonov

https://www.slov-lex.sk/pravne-predpisy/SK/ZZ/2011/362/20220401

Moduly Správnej farmakovigilančnej praxe

https://www.ema.europa.eu/en/human-regulatory/post-authorisation/pharmacovigilance/good-pharmacovigilance-practices

 

WEBOVÉ STRÁNKY:

Európska lieková agentúra: https://www.ema.europa.eu/en 

Rozhodnutia Európskej komisie – Community register: https://ec.europa.eu/health/medicinal-products/union-register_en 

Svetová zdravotnícka organizácia (WHO): https://www.who.int/

Uppsala Monitoring Centre: https://who-umc.org/

MedDRA (The Medical Dictionary for Regulatory Activities) – Slovník medicínskej terminológie pre regulačné činnosti: https://www.meddra.org/

 

FARMAKOVIGILAČNÉ PROCEDÚRY:

Farmakovigilancia:

https://www.ema.europa.eu/en/human-regulatory/post-authorisation/pharmacovigilance-post-authorisation

https://ec.europa.eu/health/medicinal-products/pharmacovigilance_en

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 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

 

  • 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/Decommissioned/Decommissioned.html

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://who-umc.org/media/164200/who-umc-causality-assessment_new-logo.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/medicines/ema_group_types/ema_referral

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

https://www.encepp.eu/encepp/studiesDatabase.jsp 

 

Vytlačiť stránku
eu-flag.png sk-flag.png