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
