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National Competent Authorities in Pharmacovigilance System

Petra Lazarić Bošnjak ; PLIVA Hrvatska d. o. o., Zagreb
Vanesa Ivetić Tkalčević ; PLIVA Hrvatska d. o. o., Zagreb
Mateja Cesarec ; PLIVA Hrvatska d. o. o., Zagreb
Mirna Pogačić ; PLIVA Hrvatska d. o. o., Zagreb
Maja Ilijanić Samošćanec ; PLIVA Hrvatska d. o. o., Zagreb

Puni tekst: hrvatski pdf 233 Kb

str. 87-93

preuzimanja: 1.001


Puni tekst: engleski pdf 233 Kb

str. 87-87

preuzimanja: 262



Following regulatory recommendations from the World Health Organisation, all governments are responsible for the establishment of national medicines regulatory authorities (agencies). In the European Union (EU), national agencies closely collaborate with the European Medicines Agency (EMA). Agencies continue to cooperate with Marketing Authorisation Holders (MAHs) during the clinical research and postmarketing phase of a drug’s life cycle. Information gathered from reported adverse drug reactions are interchanged between them. Periodic safety update reports (PSURs) in the EU are written and submitted by all MAHs according to a timetable brought by EMA. PSUR assessment is therefore comprehensive since it is done on up-to-date safety data collected for the particular drug. European national agencies and EMA, represented by Pharmacovigilance Risk Assessment Committee (PRAC), discuss various drug safety signals and issues in a procedure known as referral in order to make recommendations for a harmonised position across the EU (e.g. change of the product information). Web portals are tools widely used by the national agencies for communication with healthcare professionals. Up-to-date safety information and approved Summaries of Product’s Characteristics (SPCs), Patient’s Information Leaflets (PILs), and risk minimisation measures (such as Dear Healthcare Professional Communication, DHPC) are published there. Pharmacovigilance inspections are mostly focused on fulfilment of the requirements of premises, documentation, archives, Pharmacovigilance System Master File (PSMF) and compliance of the Qualified Person for Pharmacovigilance (QPPV).

Ključne riječi

European Medicines Agency (EMA); Agency for Medicinal Products and Medicinal Devices of Croatia (HALMED); Pharmacovigilance Risk Assessment Committee (PRAC); pharmacovigilance; referral procedure; inspection

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Podaci na drugim jezicima: hrvatski

Posjeta: 2.293 *