natgillin/translations-raw huggingface dataset:
facilitate patient reporting through the provision of alternative reporting formats in addition to web-based formats;
spodbujajo poročanje bolnikov z zagotovitvijo drugih možnih načinov poročanja poleg spletnih oblik;
take all appropriate measures to obtain accurate and verifiable data for the scientific evaluation of suspected adverse reaction reports;
sprejmejo vse ustrezne ukrepe za pridobitev natančnih in preverljivih podatkov za znanstveno vrednotenje poročil o domnevnih neželenih učinkih;
ensure that the public is given important information on pharmacovigilance concerns relating to the use of a medicinal product in a timely manner through publication on the web-portal and through other means of publicly available information as necessary;
zagotovijo, da javnost dobi pomembne informacije o vprašanjih farmakovigilance glede uporabe zdravila s pravočasno objavo na spletem portalu in v drugih sredstvih obveščanja javnosti, kakor je potrebno;
ensure, through the methods for collecting information and where necessary through the follow-up of suspected adverse reaction reports, that all appropriate measures are taken to identify clearly any biological medicinal product prescribed, dispensed, or sold in their territory which is the subject of a suspected adverse reaction report, with due regard to the name of the medicinal product, in accordance with Article 1(20), and the batch number;
zagotovijo, z načini zbiranja informacij in po potrebi nadaljnjim spremljanjem poročil o domnevnih neželenih učinkih, da so sprejeti vsi ustrezni ukrepi, s katerimi se prepozna vsako biološko zdravilo, ki se predpiše, razdeli ali prodaja na njihovem ozemlju in je predmet poročila o domnevnih neželenih učinkih; ob ustreznem upoštevanju imena zdravila v skladu s členom 1(20) in številke serije;
take the necessary measures to ensure that a marketing authorisation holder who fails to discharge the obligations laid down in this Title is subject to effective, proportionate and dissuasive penalties.
sprejmejo potrebne ukrepe za zagotovitev, da za imetnika dovoljenja za promet z zdravilom, ki ne izpolnjuje obveznosti iz tega naslova, veljajo učinkovite, sorazmerne in odvračalne kazni.
For the purposes of point (a) and (e) of the first paragraph the Member States may impose specific obligations on doctors, pharmacists and other health-care professionals.
Za namene točk (a) in (e) prvega odstavka lahko države članice naložijo zdravnikom, farmacevtom in drugim zdravstvenim delavcem posebne obveznosti.
A Member State may delegate any of the tasks entrusted to it under this Title to another Member State subject to a written agreement of the latter.
Država članica lahko prenese katero koli od nalog, ki so ji zaupane na podlagi tega naslova, na drugo državo članico na podlagi pisnega soglasja slednje.
Each Member State may represent no more than one other Member State.
Vsaka država članica lahko zastopa največ še eno drugo državo članico.
The delegating Member State shall inform the Commission, the Agency and all other Member States of the delegation in writing.
Država članica, ki prenese naloge, o tem pisno obvesti Komisijo, Agencijo in druge države članice.
The delegating Member State and the Agency shall make that information public.
Država članica, ki prenese naloge, in Agencija tako informacijo objavita.
The marketing authorisation holder shall operate a pharmacovigilance system for the fulfilment of his pharmacovigilance tasks equivalent to the relevant Member State’s pharmacovigilance system provided for under Article 101(1).
Imetnik dovoljenja za promet z zdravilom izvaja sistem farmakovigilance za opravljanje nalog farmakovigilance, enakovreden sistemu farmakovigilance zadevne države članice v skladu s členom 101(1).
The marketing authorisation holder shall by means of the pharmacovigilance system referred to in paragraph 1 evaluate all information scientifically, consider options for risk minimisation and prevention and take appropriate measures as necessary.
S sistemom farmakovigilance iz odstavka 1 imetnik dovoljenja za promet z zdravilom znanstveno ovrednoti vse informacije, preuči možnosti za zmanjšanje in preprečevanje tveganj in sprejme primerne ukrepe, kot je potrebno.
The marketing authorisation holder shall perform a regular audit of his pharmacovigilance system.
Imetnik dovoljenja za promet z zdravilom redno presoja svoj sistem farmakovigilance.
He shall place a note concerning the main findings of the audit on the pharmacovigilance system master file and, based on the audit findings, ensure that an appropriate corrective action plan is prepared and implemented.
V glavni dosje o sistemu farmakovigilance vpiše opombo o glavnih ugotovitvah presoje in na podlagi teh ugotovitev zagotovi pripravo in izvedbo ustreznega načrta popravnih ukrepov.
Once the corrective actions have been fully implemented, the note may be removed.
Opomba se lahko umakne po tem, ko so bili v celoti izvedeni popravni ukrepi.
As part of the pharmacovigilance system, the marketing authorisation holder shall:
Kot del sistema farmakovigilance, imetnik dovoljenja za promet z zdravilom:
have permanently and continuously at his disposal an appropriately qualified person responsible for pharmacovigilance;
trajno in stalno razpolaga z ustrezno usposobljeno osebo, ki je odgovorna za farmakovigilanco;
maintain and make available on request a pharmacovigilance system master file;
vodi in na zahtevo daje na voljo glavni dosje o sistemu farmakovigilance;
operate a risk management system for each medicinal product;
izvaja sistem obvladovanja tveganj za vsako zdravilo;
monitor the outcome of risk minimisation measures which are contained in the risk management plan or which are laid down as conditions of the marketing authorisation pursuant to Articles 21a, 22 or 22a;
spremlja izid ukrepov za zmanjšanje tveganj iz načrta za obvladovanje tveganj ali ki so določeni kot pogoji v dovoljenju za promet z zdravilom na podlagi členov 21a, 22 ali 22a;
update the risk management system and monitor pharmacovigilance data to determine whether there are new risks or whether risks have changed or whether there are changes to the benefit-risk balance of medicinal products.
posodablja sistem obvladovanja tveganj in spremlja podatke o farmakovigilanci, da ugotovi, ali je prišlo do novih tveganj ali da so se tveganja spremenila ter ali se je spremenilo razmerje med tveganjem in koristjo zdravil.
The qualified person referred to in point (a) of the first subparagraph shall reside and operate in the Union and shall be responsible for the establishment and maintenance of the pharmacovigilance system.
Usposobljena oseba iz točke (a) prvega pododstavka prebiva in dela v Uniji in je odgovorna za vzpostavitev in vzdrževanje sistema farmakovigilance.
The marketing authorisation holder shall submit the name and contact details of the qualified person to the competent authority and the Agency.
Imetnik dovoljenja za promet pristojnemu organu in Agenciji predloži ime in kontaktne podatke usposobljene osebe.
Notwithstanding the provisions of paragraph 3, national competent authorities may request the nomination of a contact person for pharmacovigilance issues at national level reporting to the qualified person responsible for pharmacovigilance activities.
Ne glede na določbe odstavka 3, lahko pristojni nacionalni organi zahtevajo imenovanje kontaktne osebe za vprašanja farmakovigilance na nacionalni ravni, ki poroča usposobljeni osebi, odgovorni za dejavnosti farmakovigilance.
Article 104a
Člen 104a
Without prejudice to paragraphs 2, 3 and 4 of this Article, holders of marketing authorisations granted before 21 July 2012 shall, by way of derogation from Article 104(3)(c), not be required to operate a risk management system for each medicinal product.
Brez poseganja v odstavke 2, 3 in 4 tega člena in z odstopanjem od točke (c) člena 104(3) imetnikom dovoljenj za promet z zdravili, ki so bila izdana pred 21. julijem 2012, ni treba izvajati sistema obvladovanja tveganj za vsako zdravilo.
The national competent authority may impose an obligation on a marketing authorisation holder to operate a risk management system, as referred to in Article 104(3)(c), if there are concerns about the risks affecting the risk-benefit balance of an authorised medicinal product.
Pristojni nacionalni organ lahko imetniku dovoljenja za promet z zdravilom naloži obveznost izvajanja sistema obvladovanja tveganj iz točke (c) člena 104(3), če ostajajo varnostni zadržki glede zdravila, ki bi lahko vplivali na razmerje med tveganjem in koristjo zdravila, ki je pridobilo dovoljenje za promet.
In that context, the national competent authority shall also oblige the marketing authorisation holder to submit a detailed description of the risk-management system which he intends to introduce for the medicinal product concerned.
V ta namen pristojni nacionalni organ imetniku dovoljenja za promet z zdravilom naloži obveznost predložitve podrobnega opisa sistema obvladovanja tveganj, ki ga namerava uvesti za zadevno zdravilo.
The imposition of such obligations shall be duly justified, notified in writing and shall include the timeframe for submission of the detailed description of the risk-management system.
Naložitev te obveznosti se ustrezno utemelji in se pisno uradno sporoči ter vsebuje časovni okvir za predložitev podrobnega opisa sistema obvladovanja tveganj.
Where the national competent authority confirms the obligation, the marketing authorisation shall be varied accordingly to include the measures to be taken as part of the risk management system as conditions of the marketing authorisation referred to in point (a) of Article 21a.
Kadar pristojni nacionalni organ potrdi obveznosti, se dovoljenje za promet z zdravilom ustrezno spremeni tako, da vključuje ukrepe, ki se bodo sprejeli v okviru sistema obvladovanja tveganj, kot pogoje za dovoljenje za promet z zdravilom v skladu s točko (a) člena 21a.
The management of funds intended for activities connected with pharmacovigilance, the operation of communication networks and market surveillance shall be under the permanent control of the national competent authorities in order to guarantee their independence in the performance of those pharmacovigilance activities.
Upravljanje sredstev, namenjenih za dejavnosti, ki so povezane s farmakovigilanco, delovanje komunikacijskih mrež in tržni nadzor so pod stalnim nadzorom pristojnih nacionalnih organov, da se zagotovi njihova neodvisnost pri opravljanju teh dejavnosti farmakovigilance.
The first paragraph shall not preclude the national competent authorities from charging fees to marketing authorisation holders for performing those activities by the national competent authorities on the condition that their independence in the performance of those pharmacovigilance activities is strictly guaranteed.
Prvi odstavek ne izključuje možnosti pristojnih nacionalnih organov, da imetnikom dovoljenj za promet z zdravili zaračunavajo pristojbine za navedene dejavnosti, ki jih opravljajo pristojni nacionalni organi, pod pogojem, da je njihova neodvisnost pri opravljanju teh dejavnosti farmakovigilance strogo zajamčena.
Transparency and communications
Preglednost in obveščanje
Each Member State shall set up and maintain a national medicines web-portal which shall be linked to the European medicines web-portal established in accordance with Article 26 of Regulation (EC) No 726/2004.
Vsaka država članica vzpostavi in vzdržuje nacionalni spletni portal o zdravilih, ki je povezan z evropskim spletnim portalom o zdravilih, vzpostavljenim v skladu s členom 26 Uredbe (ES) št. 726/2004.
By means of the national medicines web-portals, the Member States shall make publicly available at least the following:
Na nacionalnih spletnih portalih o zdravilih države članice objavijo najmanj naslednje:
public assessment reports, together with a summary thereof;
javna poročila o oceni zdravila, skupaj s povzetkom le-teh;
summaries of product characteristics and package leaflets;
povzetke glavnih značilnosti zdravil in navodila za uporabo za bolnika;
summaries of risk management plans for medicinal products authorised in accordance with this Directive;
povzetke načrtov za obvladovanje tveganj za zdravila, odobrena v skladu s to direktivo;
the list of medicinal products referred to in Article 23 of Regulation (EC) No 726/2004;
seznam zdravil iz člena 23 Uredbe (ES) št. 726/2004;
information on the different ways of reporting suspected adverse reactions to medicinal products to national competent authorities by healthcare professionals and patients, including the web-based structured forms referred to in Article 25 of Regulation (EC) No 726/2004.
informacije o različnih načinih poročanja o domnevnih neželenih učinkih zdravil nacionalnim pristojnim organom s strani zdravstvenih delavcev in bolnikov, vključno s spletnimi strukturiranimi obrazci iz člena 25 Uredbe (ES) št. 726/2004.
As soon as the marketing authorisation holder intends to make a public announcement relating to information on pharmacovigilance concerns in relation to the use of a medicinal product, and in any event at the same time or before the public announcement is made, he shall be required to inform the national competent authorities, the Agency and the Commission.
Takoj ko namerava imetnik dovoljenja za promet z zdravilom objaviti obvestilo v zvezi z informacijami o vprašanjih farmakovigilance glede uporabe zdravila, mora istočasno ali pred javno objavo o tem obvestiti nacionalne pristojne organe, Agencijo in Komisijo.
The marketing authorisation holder shall ensure that information to the public is presented objectively and is not misleading.
Imetnik dovoljenja za promet z zdravilom zagotovi, da so informacije javnosti predstavljene objektivno in da niso zavajajoče.
Unless urgent public announcements are required for the protection of public health, the Member States, the Agency and the Commission shall inform each other not less than 24 hours prior to a public announcement relating to information on pharmacovigilance concerns.
Razen če je zaradi varovanja javnega zdravja potrebno nujno javno obvestilo, se države članice, Agencija in Komisija medsebojno obvestijo najpozneje 24 ur pred javnim obvestilom, ki se nanaša na informacije o vprašanjih farmakovigilance.
For active substances contained in medicinal products authorised in more than one Member State, the Agency shall be responsible for the coordination between national competent authorities of safety announcements and shall provide timetables for the information being made public.
Pri zdravilnih učinkovinah v zdravilih, ki so odobrena v več kot eni državi članici, je Agencija odgovorna za usklajevanje varnostnih sporočil med pristojnimi nacionalnimi organi in zagotovitev časovnega razporeda objave informacij.
Under the coordination of the Agency, the Member States shall make all reasonable efforts to agree on a common message in relation to the safety of the medicinal product concerned and the timetables for their distribution.
Države članice si v usklajevanju, ki ga vodi Agencija, primerno prizadevajo za soglasje o skupnih sporočilih v zvezi z varnostjo in časovnem razporedu razširjanja.
The Pharmacovigilance Risk Assessment Committee shall, at the request of the Agency, provide advice on those safety announcements.
Odbor za ocenjevanje tveganja na področju farmakovigilance na zahtevo Agencije svetuje o navedenih varnostnih sporočilih.
When the Agency or national competent authorities make public information referred to in paragraphs 2 and 3, any information of a personal or commercially confidential nature shall be deleted unless its public disclosure is necessary for the protection of public health.
Ko Agencija ali pristojni nacionalni organi objavijo informacije iz odstavkov 2 in 3, izbrišejo vse osebne ali poslovno zaupne podatke, razen če je javno razkritje potrebno zaradi varovanja javnega zdravja.
Recording, reporting and assessment of pharmacovigilance data
Evidentiranje, poročanje in ocenjevanje podatkov o farmakovigilanci
Recording and reporting of suspected adverse reactions
Evidentiranje in poročanje o domnevnih neželenih učinkih
Marketing authorisation holders shall record all suspected adverse reactions in the Union or in third countries which are brought to their attention, whether reported spontaneously by patients or healthcare professionals, or occurring in the context of a post-authorisation study.
Imetniki dovoljenj za promet z zdravili vodijo dokumentacijo o vseh domnevnih neželenih učinkih v Uniji ali v tretjih državah, na katere jih spontano opozorijo bolniki sami ali zdravstveni delavci ali pa se pojavijo v okviru študije o zdravilu po pridobitvi dovoljenja za promet.
Marketing authorisation holders shall ensure that those reports are accessible at a single point within the Union.
Imetniki dovoljenj za promet z zdravili zagotovi dostopnost navedenih poročil na eni sami točki v Uniji.
By way of derogation from the first subparagraph, suspected adverse reactions occurring in the context of a clinical trial shall be recorded and reported in accordance with Directive 2001/20/EC.
Z odstopanjem od prvega pododstavka se domnevni neželeni učinki, ki se pojavijo v okviru kliničnih preskušanj, evidentirajo in sporočijo v skladu z Direktivo 2001/20/ES.
Marketing authorisation holders shall not refuse to consider reports of suspected adverse reactions received electronically or by any other appropriate means from patients and healthcare professionals.
Imetniki dovoljenj za promet z zdravili ne zavrnejo poročil o domnevnih neželenih učinkih, ki jih od bolnikov in zdravstvenih delavcev prejmejo elektronsko ali na kateri koli drug ustrezen način.
Marketing authorisation holders shall submit electronically to the database and data-processing network referred to in Article 24 of Regulation (EC) No 726/2004 (hereinafter referred to as the “Eudravigilance database”) information on all serious suspected adverse reactions that occur in the Union and in third countries within 15 days following the day on which the marketing authorisation holder concerned gained knowledge of the event.
Imetniki dovoljenj za promet z zdravili elektronsko posredujejo podatke o vseh domnevnih resnih neželenih učinkih, ki se pojavijo v Uniji in v tretjih državah, v podatkovno bazo in omrežje za obdelavo podatkov iz člena 24 Uredbe (ES) št. 726/2004 (v nadaljnjem besedilu: ‚podatkovna baza Eudravigilance‘) v 15 dneh po dnevu, ko je zadevni imetnik dovoljenja za promet z zdravilom izvedel za dogodek.
Marketing authorisation holders shall submit electronically to the Eudravigilance database information on all non-serious suspected adverse reactions that occur in the Union, within 90 days following the day on which the marketing authorisation holder concerned gained knowledge of the event.
Imetniki dovoljenj za promet z zdravili elektronsko posredujejo podatke o vseh domnevnih neželenih učinkih, ki niso resni in se pojavijo v Uniji, v podatkovno bazo Eudravigilance v 90 dneh po dnevu, ko je zadevni imetnik dovoljenja za promet z zdravilom izvedel za dogodek.
For medicinal products containing the active substances referred to in the list of publications monitored by the Agency pursuant to Article 27 of Regulation (EC) No 726/2004, marketing authorisation holders shall not be required to report to the Eudravigilance database the suspected adverse reactions recorded in the listed medical literature, but they shall monitor all other medical literature and report any suspected adverse reactions.
Za zdravila, ki vsebujejo zdravilne učinkovine s seznama publikacij, ki jih spremlja Agencija na podlagi člena 27 Uredbe (ES) št. 726/2004, imetnikom dovoljenja za promet z zdravili v podatkovno bazo Eudravigilance ni treba sporočati domnevnih neželenih učinkov, opisanih v navedeni medicinski literaturi, vendar spremljajo vso ostalo medicinsko literaturo in poročajo o morebitnih domnevnih neželenih učinkih.
Marketing authorisation holders shall establish procedures in order to obtain accurate and verifiable data for the scientific evaluation of suspected adverse reaction reports.
Imetniki dovoljenj za promet z zdravili vzpostavijo postopke za pridobitev natančnih in preverljivih podatkov za znanstveno vrednotenje poročil o domnevnih neželenih učinkih.
They shall also collect follow-up information on these reports and submit the updates to the Eudravigilance database.
Zbirajo tudi nadaljnje informacije o teh poročilih ter posodobljene informacije predložijo v podatkovno bazo Eudravigilance.
Marketing authorisation holders shall collaborate with the Agency and the Member States in the detection of duplicates of suspected adverse reaction reports.
Imetniki dovoljenj za promet z zdravili sodeluje z Agencijo in državami članicami pri odkrivanju dvojnikov poročil o domnevnih neželenih učinkih.
Article 107a
Člen 107a
Each Member State shall record all suspected adverse reactions that occur in its territory which are brought to its attention from healthcare professionals and patients.
Vsaka država članica evidentira vse domnevne neželene učinke, ki se pojavijo na njenem ozemlju, na katere jo opozorijo zdravstveni delavci in bolniki.
Member States shall involve patients and healthcare professionals, as appropriate, in the follow-up of any reports they receive in order to comply with Article 102(c) and (e).
Države članice vključijo bolnike in zdravstvene delavce, kot je primerno, v spremljanje vseh poročil, ki jih prejme, da bi izpolnile točke (c) in (e) iz člena 102.
Member States shall ensure that reports of such reactions may be submitted by means of the national medicines web-portals or by other means.
Države članice zagotovijo, da se poročila o takih učinkih lahko predložijo s pomočjo nacionalnih spletnih portalov o zdravilih ali na drug način.
For reports submitted by a marketing authorisation holder, Member States on whose territory the suspected adverse reaction occurred may involve the marketing authorisation holder in the follow-up of the reports.
Pri poročilih, ki jih predloži imetnik dovoljenja za promet, lahko država članica, na ozemlju katere so se pojavili domnevni neželeni učinki, vključi imetnika dovoljenja za promet z zdravilom v nadaljnje spremljanje teh poročil.
Member States shall collaborate with the Agency and the marketing authorisation holders in the detection of duplicates of suspected adverse reaction reports.
Države članice sodelujejo z Agencijo in imetniki dovoljenj za promet pri odkrivanju dvojnikov poročil o domnevnih neželenih učinkih.
Member States shall, within 15 days following the receipt of the reports of serious suspected adverse reactions referred to in paragraph 1, submit the reports electronically to the Eudravigilance database.
Države članice v 15 dneh od prejema poročil o domnevnih resnih neželenih učinkih iz odstavka 1, poročila elektronsko predložijo v podatkovno bazo Eudravigilance.
They shall, within 90 days from the receipt of reports referred to in paragraph 1, submit reports of non-serious suspected adverse reactions electronically to the Eudravigilance database.
V 90 dneh od prejema poročil iz odstavka 1 elektronsko predložijo v podatkovno bazo Eudravigilance poročila o domnevnih neželenih učinkih zdravil, ki niso resni.
Marketing authorisation holders shall access those reports through the Eudravigilance database.
Imetniki dovoljenj za promet z zdravili imajo dostop do teh poročil preko podatkovne baze Eudravigilance.
Member States shall ensure that reports of suspected adverse reactions arising from an error associated with the use of a medicinal product that are brought to their attention are made available to the Eudravigilance database and to any authorities, bodies, organisations and/or institutions, responsible for patient safety within that Member State.
Države članice zagotovijo, da so poročila o domnevnih neželenih učinkih, ki so posledica napake, povezane z uporabo zdravila, na katera so opozorjene, na voljo podatkovni bazi Eudravigilance in vsem organom, uradom, organizacijam in/ali institucijam, odgovornim za varnost bolnikov v navedeni državi članici.