natgillin/translations-raw huggingface dataset:
The national competent authorities and the Agency shall keep training plans and records for documenting, maintaining and developing the competences of personnel and shall make them available for audit.
Pristojni nacionalni organi in Agencija hranijo načrte in evidenco usposabljanj za dokumentiranje, vzdrževanje in razvoj kompetenc osebja in jih dajo na razpolago za presojo.
Appropriate instructions on the processes to be used in case of urgency, including business continuity, shall be provided by the national competent authorities and by the Agency to their personnel.
Pristojni nacionalni organi in Agencija svojemu osebju zagotovijo ustrezna navodila o procesih za ravnanje v nujnih primerih, vključno z neprekinjenim poslovanjem.
The national competent authorities and the Agency shall establish specific procedures and processes in order to achieve all of the following objectives:
Pristojni nacionalni organi in Agencija vzpostavijo posebne postopke in procese za doseganje naslednjih ciljev:
ensuring the evaluation of the quality, including completeness, of pharmacovigilance data submitted;
zagotavljanje ocene kakovosti, vključno s popolnostjo predloženih podatkov o farmakovigilanci;
ensuring the assessment of pharmacovigilance data and its processing within the timelines provided by Directive 2001/83/EC and Regulation (EC) No 726/2004;
zagotavljanje ocene podatkov o farmakovigilanci in njihovi obdelavi v skladu s časovnim potekom iz Direktive 2001/83/ES in Uredbe (ES) št. 726/2004;
ensuring independence in the performance of pharmacovigilance activities;
zagotavljanje neodvisnosti pri izvajanju dejavnosti na področju farmakovigilance;
ensuring effective communication among national competent authorities and between the national competent authorities and the Agency as well as with patients, healthcare professionals, marketing authorisation holders and the general public;
zagotavljanje učinkovite komunikacije med pristojnimi nacionalnimi organi ter med pristojnimi nacionalnimi organi in Agencijo, pa tudi med bolniki, zdravstvenimi delavci, imetniki dovoljenj za promet in širšo javnostjo;
guaranteeing that the national competent authorities and the Agency inform each other and the Commission of their intention to make announcements relating to the safety of a medicinal product authorised in several Member States or an active substance contained in such a medicinal product in accordance with Article 106a of Directive 2001/83/EC;
zagotavljanje, da pristojni nacionalni organi in Agencija obveščajo drug drugega in Komisijo o namerah obveščanja glede varnosti zdravila, odobrenega v več državah članicah, ali zdravilne učinkovine v takem zdravilu v skladu s členom 106a Direktive 2001/83/ES;
conducting inspections, including pre-authorisation inspections.
izvajanje nadzorov, vključno z nadzori pred pridobitvijo dovoljenja za promet.
In addition to the procedures referred to in paragraph 1, national competent authorities shall establish procedures for collecting and recording all suspected adverse reactions that occur in their territory.
Pristojni nacionalni organi poleg postopkov iz odstavka 1 vzpostavijo tudi postopke za zbiranje in evidentiranje vseh domnevnih neželenih učinkov, ki se pojavijo na njihovem ozemlju.
The Agency shall establish procedures for the monitoring of medical literature in accordance with Article 27 of Regulation (EC) No 726/2004.
Agencija vzpostavi postopke za spremljanje medicinske literature v skladu s členom 27 Uredbe (ES) št. 726/2004.
The national competent authorities and the Agency shall record all pharmacovigilance information and ensure that it is handled and stored so as to allow for accurate reporting, interpretation and verification of that information.
Pristojni nacionalni organi in Agencija evidentirajo vse informacije o farmakovigilanci in zagotavljajo, da se obdelujejo in shranjujejo tako, da omogočajo točno poročanje, razlago in preverjanje navedenih informacij.
They shall put in place a record management system for all documents used for pharmacovigilance activities that ensures the retrievability of those documents as well as the traceability of the measures taken to investigate safety concerns, of the timelines for those investigations and of decisions on safety concerns, including their date and the decision-making process.
Vzpostavijo sistem upravljanja dokumentov za vse dokumente, uporabljene za dejavnosti na področju farmakovigilance, ki zagotavljajo dostop do navedenih dokumentov ter sledljivost ukrepov za preiskovanje varnostnih vprašanj, časovnih potekov navedenih preiskav in odločitev o varnostnih vprašanjih, vključno z datumom in procesom odločanja.
The national competent authorities and the Agency shall arrange for the essential documents describing their pharmacovigilance system to be kept for at least five years after the system has been formally terminated.
Pristojni nacionalni organi in Agencija zagotovijo, da se bistveni dokumenti o njihovem sistemu farmakovigilance hranijo vsaj pet let po uradni odpovedi sistema.
Pharmacovigilance data and documents relating to individual authorised medicinal products shall be retained as long as the product is authorised and for at least 10 years after the marketing authorisation has expired.
Podatki o farmakovigilanci in dokumenti, povezani s posameznimi odobrenimi zdravili, se hranijo, dokler je zdravilo odobreno in vsaj 10 let po izteku veljavnosti dovoljenja za promet.
Risk-based audits of the quality system shall be performed at regular intervals according to a common methodology to ensure that the quality system complies with the requirements set out in Articles 8, 14, 15 and 16 and to ensure its effectiveness.
Presoje sistema kakovosti na podlagi analize tveganj se v skladu s skupno metodologijo opravljajo redno, da se zagotovi učinkovitost in skladnost sistema kakovosti z zahtevami iz členov 8, 14, 15 in 16.
Corrective action, including a follow-up audit of deficiencies, shall be taken where necessary.
Popravni ukrep, vključno z naknadno presojo pomanjkljivosti, se sprejme po potrebi.
The dates and results of audits and follow-up audits shall be documented.
Dokumentirajo se datumi in rezultati presoj in naknadnih presoj.
Minimum requirements for the monitoring of data in the Eudravigilance database
Minimalne zahteve za spremljanje podatkov v podatkovni zbirki Eudravigilance
The Agency and national competent authorities shall cooperate in the monitoring of the data available in the Eudravigilance database.
Agencija in pristojni nacionalni organi sodelujejo pri spremljanju podatkov, ki so na voljo v podatkovni zbirki Eudravigilance.
Marketing authorisation holders shall monitor the data available in the Eudravigilance database to the extent that they have access to that database.
Imetniki dovoljenj za promet spremljajo podatke, ki so na voljo v podatkovni zbirki Eudravigilance, v obsegu odobrenega dostopa do podatkov.
Marketing authorisation holders, the national competent authorities and the Agency shall ensure the continuous monitoring of the Eudravigilance database with a frequency proportionate to the identified risk, the potential risks and the need for additional information.
Imetniki dovoljenj za promet, pristojni nacionalni organi in Agencija zagotovijo stalno spremljanje podatkovne zbirke Eudravigilance s pogostostjo, ki je sorazmerna z opredeljenim tveganjem, možnimi tveganji in potrebi po dodatnih informacijah.
The competent authority of each Member State shall be responsible for monitoring the data originating in the territory of that Member State.
Pristojni organi vsake države članice so odgovorni za spremljanje podatkov, ki izvirajo z njenega ozemlja.
Identification of changed risks and new risks
Opredelitev spremenjenih in novih tveganj
The identification of new risks or changed risks shall be based on the detection and analysis of the signals concerning a medicinal product or an active substance.
Opredelitev novih ali spremenjenih tveganj temelji na zaznavanju in analizi signalov, ki zadevajo zdravilo ali zdravilno učinkovino.
For the purposes of this chapter, ‘signal’ means information arising from one or multiple sources, including observations and experiments, which suggests a new potentially causal association, or a new aspect of a known association between an intervention and an event or set of related events, either adverse or beneficial, which is judged to be of sufficient likelihood to justify verificatory action.
Za namene tega poglavja signal pomeni informacijo, ki prihaja od enega ali več virov, vključno z opažanji in poskusi, ki lahko pomenijo novo potencialno vzročno povezavo ali nov vidik znane povezave med posegom in dogodkom ali nizom povezanih dogodkov, neželenih ali koristnih, za katerega se oceni, da je dovolj verjeten, da upraviči preverjanje.
For the purpose of monitoring data in the Eudravigilance database, only signals related to an adverse reaction shall be considered.
Za namene spremljanja podatkov v podatkovni zbirki Eudravigilance se upoštevajo samo signali, povezani z neželenimi učinki.
The detection of a signal shall be based on a multidisciplinary approach.
Zaznavanje signalov temelji na multidisciplinarnem pristopu.
Signal detection within the Eudravigilance database shall be complemented by statistical analysis, where appropriate.
Zaznavanje signalov v podatkovni zbirki Eudravigilance po potrebi dopolnjuje statistična analiza.
After consultation with the Pharmacovigilance Risk Assessment Committee, the Agency may publish a list of medical events that have to be taken into account for the detection of a signal.
Po posvetovanju z odborom za oceno tveganja na področju farmakovigilance lahko Agencija objavi seznam medicinskih dogodkov, ki jih je treba upoštevati za zaznavanje signala.
Methodology for determining the evidentiary value of a signal
Metodologija za določanje dokazne vrednosti signala
National competent authorities, marketing authorisation holders and the Agency shall determine the evidentiary value of a signal by using a recognised methodology taking into account the clinical relevance, quantitative strength of the association, the consistency of the data, the exposure–response relationship, the biological plausibility, experimental findings, possible analogies and the nature and quality of the data.
Pristojni nacionalni organi, imetniki dovoljenj za promet in Agencija določijo dokazno vrednost signala tako, da uporabijo priznano metodologijo, ki upošteva klinično pomembnost, količinsko moč povezave, doslednost podatkov, razmerje med izpostavljenostjo in odzivom, biološko verjetnost, ugotovitve testov, možne analogije ter naravo in kakovost podatkov.
Different types of factors may be taken into account for the prioritisation of signals, in particular whether the association or medicinal product is new, factors related to the strength of the association, factors related to the seriousness of the reaction involved and factors related to the documentation of reports to the Eudravigilance database.
Pri prednostni razvrstitvi signalov se lahko upoštevajo različne vrste dejavnikov, zlasti, ali sta povezava ali zdravilo nova, dejavniki, povezani z jakostjo povezave, dejavniki, povezani z resnostjo zadevnih učinkov ter dejavniki, povezani z dokumentiranjem poročil v podatkovno zbirko Eudravigilance.
The Pharmacovigilance Risk Assessment Committee shall regularly review the methodology(ies) used and publish recommendations, as appropriate.
Odbor za oceno tveganja na področju farmakovigilance redno pregleduje uporabljene metodologije in, če je primerno, objavlja priporočila.
Signal management process
Postopek obravnave signala
The signal management process shall include the following activities: signal detection, signal validation, signal confirmation, signal analysis and prioritisation, signal assessment, and recommendation for action.
Postopek obravnave signala vključuje naslednje dejavnosti: zaznavanje, validiranje, potrjevanje signala, analizo in prednostno razvrstitev, oceno signala in priporočila o ukrepanju.
For the purposes of this Article, ‘signal validation’ means the process of evaluating the data supporting the detected signal in order to verify that the available documentation contains sufficient evidence demonstrating the existence of a new potentially causal association, or a new aspect of a known association, and therefore justifies further analysis of the signal.
Za namene tega člena validacija signala pomeni proces ocenjevanja podatkov, ki podpirajo zaznani signal, s čimer se preveri, ali razpoložljiva dokumentacija vsebuje dovolj dokazov, ki dokazujejo obstoj nove morebitne vzročne povezave ali novega vidika znane povezave in da se tako upraviči nadaljnja analiza signala.
Where a marketing authorisation holder detects a new signal when monitoring the Eudravigilance database, it shall validate it and shall forthwith inform the Agency and national competent authorities.
Kadar imetnik dovoljenja za promet med spremljanjem podatkovne zbirke Eudravigilance zazna nov signal, ga validira in nato o njem obvesti Agencijo in pristojne nacionalne organe.
Where it is considered that a validated signal requires further analysis, it shall be confirmed as soon as possible and no later than 30 days from its receipt as follows:
Kadar se šteje, da validirani signal zahteva dodatno analizo, ga čim prej, najpozneje pa v 30 dneh po njegovem prejemu, potrdi:
where the signal concerns a product authorised in accordance with Directive 2001/83/EC, it shall be confirmed by the competent authority of a Member State in which the medicinal product is marketed or of any lead Member State or co-leader appointed in accordance with Article 22(1);
pristojni nacionalni organ države članice, v kateri je zdravilo v prometu, ali katere koli druge vodilne ali sovodilne države članice, določene v skladu s členom 22(1), kadar signal zadeva zdravilo, odobreno v skladu z Direktivo 2001/83/ES;
where the signal concerns a product authorised in accordance with Regulation (EC) No 726/2004, it shall be confirmed by the Agency in collaboration with the Member States.
Agencija v sodelovanju z državami članicami, kadar signal zadeva zdravilo, odobreno v skladu z Uredbo (ES) št. 726/2004.
When analysing the validated signal, national competent authorities and the Agency may take into account other information available on the medicinal product.
Pri analizi validiranega signala pristojni nacionalni organi in Agencija lahko upoštevajo druge razpoložljive informacije o zdravilu.
Where the validity of the signal is not confirmed, special attention shall be paid to non-confirmed signals concerning a medicinal product where those signals are subsequently followed by new signals concerning the same medicinal product.
Kadar veljavnost signala ni potrjena, je treba biti posebno pozoren na nepotrjene signale, ki zadevajo zdravilo, kadar navedenim signalom sledijo novi signali, ki zadevajo isto zdravilo.
Without prejudice to paragraphs 2 and 3, national competent authorities and the Agency shall validate and confirm any signal that they have detected during their continuous monitoring of the Eudravigilance database.
Pristojni nacionalni organi in Agencija brez poseganja v odstavka 2 in 3 validirajo in potrdijo vsak signal, ki so ga zaznali med stalnim spremljanjem podatkovne zbirke Eudravigilance.
Any confirmed signal shall be entered in the tracking system administered by the Agency and shall be transmitted to the Pharmacovigilance Risk Assessment Committee for the initial analysis and prioritisation of signals in accordance with Article 107h(2) of Directive 2001/83/EC and Article 28a(2) of Regulation (EC) No 726/2004.
Vsak potrjen signal se vnese v sistem sledenja, s katerim upravlja Agencija, in se sporoči odboru za oceno tveganja na področju farmakovigilance, da ta opravi začetno analizo in opredeli prednostne signale v skladu s členom 107h(2) Direktive 2001/83/ES in členom 28a(2) Uredbe (ES) št. 726/2004.
The Agency shall inform forthwith the marketing authorisation holder(s) concerned of the conclusions of the Pharmacovigilance Risk Assessment Committee of the assessment of any confirmed signal.
Agencija zadevnim imetnikom dovoljenj za promet nemudoma sporoči ugotovitve o oceni katerega koli potrjenega signala odbora za oceno tveganja na področju farmakovigilance.
Worksharing for signal management
Delitev dela pri obravnavi signalov
For medicinal products authorised in accordance with Directive 2001/83/EC in more than one Member State and for active substances contained in several medicinal products where at least one marketing authorisation has been granted in accordance with Directive 2001/83/EC, Member States may agree within the coordination group provided for by Article 27 of Directive 2001/83/EC to appoint a lead Member State and, where appropriate, a co-leader.
Za zdravila, ki so v skladu z Direktivo 2001/83/ES odobrena v več kot eni državi članici, in zdravilne učinkovine, ki jih vsebuje več zdravil, pri čemer je bilo vsaj eno dovoljenje za promet izdano v skladu z Direktivo 2001/83/ES, se lahko države članice v okviru skupine za usklajevanje iz člena 27 Direktive 2001/83/ES dogovorijo, da bodo določile vodilno državo članico in, če je potrebno, sovodilno državo članico.
Any such appointment shall be reviewed at least every four years.
Taka imenovanja se pregledajo vsaj vsaka štiri leta.
The lead Member State shall monitor the Eudravigilance database and shall validate and confirm signals in accordance with Article 21(3) and (4) on behalf of the other Member States.
Vodilna država članica spremlja podatkovno zbirko Eudravigilance ter validira in potrjuje signale v skladu s členom 21(3) in (4) v imenu drugih držav članic.
The Member State appointed as co-leader shall assist the lead Member State in the fulfilment of its tasks.
Države članice, določene kot sovodilne države, vodilni državi pomagajo pri izpolnjevanju nalog.
When appointing a lead Member State and as appropriate a co-leader, the coordination group may take into account whether any Member State is acting as reference Member State in accordance with Article 28(1) of Directive 2001/83/EC or as a rapporteur for the assessment of periodic safety update reports in accordance with Article 107e of that Directive.
Skupina za usklajevanje lahko pri imenovanju vodilne države članice in primerne sovodilne države članice upošteva, ali katera država članica deluje kot referenčna država članica v skladu s členom 28(1) Direktive 2001/83/ES ali kot poročevalka za oceno redno posodobljenih poročil o varnosti zdravil v skladu s členom 107e navedene direktive.
The Agency shall publish on the European medicines web-portal a list of the active substances that are subject to worksharing in accordance with this Article and the lead Member State and co-leader appointed for monitoring those substances in the Eudravigilance database.
Agencija na evropskem spletnem portalu o zdravilih objavi seznam zdravilnih učinkovin, za katere velja delitev dela v skladu s tem členom, ter vodilno in sovodilno državo članico, imenovani za spremljanje navedenih učinkovin v podatkovni zbirki Eudravigilance.
Without prejudice to paragraph 1, all Member States shall remain responsible for monitoring the data in the Eudravigilance database in accordance with Article 107h(1)(c) and Article 107h(3) of Directive 2001/83/EC.
Brez poseganja v odstavek 1 so vse države članice še naprej odgovorne za spremljanje podatkov v podatkovni zbirki Eudravigilance v skladu s členom 107h(1)(c) in členom 107h(3) Direktive 2001/83/ES.
For medicinal products authorised in accordance with Regulation (EC) No 726/2004, the Agency shall be assisted in the monitoring of data in the Eudravigilance database by the rapporteur appointed by the Pharmacovigilance Risk Assessment Committee in accordance with Article 62(1) of Regulation (EC) No 726/2004.
Za zdravila, odobrena v skladu z Uredbo (ES) št. 726/2004, Agenciji pri spremljanju podatkov v podatkovni zbirki Eudravigilance pomaga poročevalec, ki ga imenuje odbor za oceno tveganja na področju farmakovigilance v skladu s členom 62(1) Uredbe (ES) št. 726/2004.
Signal detection support
Podpora pri zaznavanju signalov
The Agency shall support the monitoring of the Eudravigilance database by providing national competent authorities with access to the following information:
Agencija podpira spremljanje podatkovne zbirke Eudravigilance tako, da pristojnim nacionalnim organom omogoči dostop do:
data outputs and statistical reports allowing a review of all adverse reactions reported to the Eudravigilance database in relation to an active substance or a medicinal product;
podatkov in statističnih poročil, ki omogočajo pregled vseh neželenih učinkov, sporočenih v podatkovno zbirko Eudravigilance v povezavi z zdravilno učinkovino ali zdravilom;
customised queries supporting the evaluation of individual case safety reports and case series;
prilagojenih poizvedb, ki podpirajo oceno posameznih poročil o neželenih učinkih zdravil in skupin poročil;
customised grouping and stratification of data enabling the identification of patient groups with a higher risk of occurrence of adverse reactions or with a risk of a more severe adverse reaction;
prilagojenega združevanja v skupine in stratifikacijo podatkov, ki omogočata opredelitev skupin bolnikov z večjim tveganjem za pojav neželenih učinkov ali s tveganjem za hude neželene učinke;
statistical signal detection methods.
statističnih metod zaznavanja signalov.
The Agency shall also ensure appropriate support for the monitoring of the Eudravigilance database by marketing authorisation holders.
Agencija imetnikom dovoljenj za promet zagotovi tudi ustrezno podporo pri spremljanju podatkovne zbirke Eudravigilance.
Signal detection audit trail
Evidenca zaznavanja signalov
The national competent authorities and the Agency shall keep an audit trail of their signal detection activities conducted in the Eudravigilance database and of the relevant queries and their results.
Pristojni nacionalni organi in Agencija hranijo evidenco zaznavanja signalov, opravljenega v podatkovni zbirki Eudravigilance, ter zadevnih poizvedb in njihovih rezultatov.
The audit trail shall allow traceability of how signals have been detected and of how validated and confirmed signals have been assessed.
Z evidenco zaznavanja signalov je mogoče slediti, kako so bili signali zaznani ter kako so bili validirani in potrjeni signali ocenjeni.
Use of terminology, formats and standards
Uporaba terminologije, oblik in standardov
Use of internationally agreed terminology
Uporaba mednarodno dogovorjene terminologije
For the classification, retrieval, presentation, risk-benefit evaluation and assessment, electronic exchange and communication of pharmacovigilance and medicinal product information, Member States, marketing authorisation holders and the Agency shall apply the following terminology:
Države članice, imetniki dovoljenj za promet in Agencija za razvrstitev, dostop, predstavitev, oceno razmerja med tveganjem in koristjo, elektronsko izmenjavo in sporočanje podatkov o farmakovigilanci in zdravilih uporabljajo naslednjo terminologijo:
the Medical Dictionary for Regulatory Activities (MedDRA) as developed by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), multidisciplinary topic M1;
Medicinski slovar za regulativne dejavnosti (Medical Dictionary for Regulatory Activities, MedDRA), kot ga je razvila mednarodna konferenca o usklajevanju tehničnih zahtev za registracijo farmacevtskih izdelkov za uporabo v humani medicini (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, ICH), multidisciplinarna tema M1;
the lists of Standard Terms published by the European Pharmacopoeia Commission;
seznam standardnih izrazov, ki ga je objavila Komisija za Evropsko farmakopejo;