natgillin/translations-raw huggingface dataset:
any biological medicinal product not covered by point (a) that was authorised after 1 January 2011.
katerega koli biološkega zdravila, ki ni zajeto v točki (a) in je bilo odobreno po 1. januarju 2011.
At the request of the Commission, following consultation with the Pharmacovigilance Risk Assessment Committee, medicinal products that are authorised pursuant to this Regulation subject to conditions referred to in points (c), (ca), (cb) and (cc) of Article 9(4), or in Articles 10a, Article 14(7) and (8) and in Article 21(2), may also be included in the list.
Na zahtevo Komisije in po posvetu z Odborom za ocenjevanje tveganja na področju farmakovigilance se lahko na seznam uvrstijo tudi zdravila, ki so odobrena v skladu s to uredbo, pod pogoji iz točk (c), (ca), (cb) in (cc) člena 9(4) ali iz člena 10a, člena 14(7) in (8) ter 21(2).
At the request of a national competent authority, following consultation with the Pharmacovigilance Risk Assessment Committee, medicinal products that are authorised pursuant to Directive 2001/83/EC, subject to the conditions referred to in Articles 21a, 22, 22a and 104a of that Directive, may also be included in the list.
Na zahtevo pristojnega nacionalnega organa in po posvetu z Odborom za ocenjevanje tveganja na področju farmakovigilance se lahko na seznam uvrstijo tudi zdravila, odobrena v skladu z Direktivo 2001/83/ES in pod pogoji iz členov 21a, 22, 22a in 104a navedene direktive.
The list shall include an electronic link to the product information and to the summary of the risk management plan.
Seznam vsebuje elektronsko povezavo do informacij o zdravilu in povzetka načrta za obvladovanje tveganj.
The Agency shall remove a medicinal product from the list 5 years after the Union reference date referred to in Article 107c(5) of Directive 2001/83/EC.
Agencija umakne zdravilo s seznama pet let po referenčnem datumu Unije iz člena 107c(5) Direktive 2001/83/ES.
However, the Commission or the national competent authority, as appropriate, may, following a recommendation of the Pharmacovigilance Risk Assessment Committee, extend that period until such time as they conclude that the conditions referred to in Article 14a and Article 21(2) of this Regulation or referred to in Articles 22b and 104a of Directive 2001/83/EC have been fulfilled.
Vendar lahko Komisija ali pristojni nacionalni organ, če je to potrebno in na priporočilo Odbora za ocenjevanje tveganj na področju farmakovigilance podaljša to obdobje, dokler ne ugotovi, da so izpolnjeni pogoji iz člena 14a in člena 21(2) te uredbe ali člena 22b in 104a Direktive 2001/83/ES.
The Agency shall, in collaboration with the Member States and the Commission, set up and maintain a database and data processing network (hereinafter the “Eudravigilance database”) to collate pharmacovigilance information regarding medicinal products authorised in the Union and to allow competent authorities to access that information simultaneously and to share it.
Agencija v sodelovanju z državami članicami in Komisijo ustanovi in vodi podatkovno bazo in omrežje za obdelavo podatkov (v nadaljnjem besedilu: podatkovna baza Eudravigilance), v katerih se zbirajo informacije o farmakovigilanci zdravil, odobrenih v Uniji, ter ki omogočajo pristojnim organom hkraten dostop do informacij in njihovo skupno uporabo.
The Eudravigilance database shall contain information on suspected adverse reactions in human beings arising from use of the medicinal product within the terms of the marketing authorisation as well as from uses outside the terms of the marketing authorisation, and on those occurring in the course of post-authorisation studies with the medicinal product or associated with occupational exposure.
Podatkovna baza Eudravigilance vsebuje informacije o domnevnih resnih neželenih učinkih pri ljudeh zaradi uporabe zdravila v skladu s pogoji dovoljenja za promet in zaradi uporabe izven okvira pogojev dovoljenja za promet, ter o tistih, ki se pojavijo med študijami po pridobitvi dovoljenja za promet v zvezi z zdravilom ali zaradi poklicne izpostavljenosti.
The Agency shall, in collaboration with the Member States and the Commission, draw up the functional specifications for the Eudravigilance database, together with a timeframe for their implementation.
Agencija v sodelovanju z državami članicami in Komisijo pripravi funkcijske specifikacije za podatkovno bazo Eudravigilance in časovni rok za njihovo izvedbo.
The Agency shall prepare an annual report on the Eudravigilance database and send it to the European Parliament, the Council and the Commission.
Agencija pripravi letno poročilo o podatkovni bazi Eudravigilance ter ga pošlje Evropskemu parlamentu, Svetu in Komisiji.
The first annual report shall be prepared by 2 January 2013.
Prvo letno poročilo se pripravi do 2. januarja 2013.
The Management Board of the Agency shall on the basis of an independent audit report that takes into account the recommendation of the Pharmacovigilance Risk Assessment Committee confirm and announce when the Eudravigilance database has achieved full functionality and the system meets the functional specifications drawn up pursuant to the first subparagraph.
Uprava Agencije na podlagi neodvisnega revizijskega poročila, ki upošteva priporočilo Odbora za ocenjevanje tveganja na področju farmakovigilance, potrdi in napove, kdaj bo podatkovna baza Eudravigilance popolno funkcionalna, sistem pa bo zadostil opredeljenim funkcijskim specifikacijam, pripravljenim v skladu s prvim pododstavkom.
Any substantial change to the Eudravigilance database and the functional specifications shall take into account the recommendations of the Pharmacovigilance Risk Assessment Committee.
Ob vsaki bistveni spremembi podatkovne baze Eudravigilance in funkcijskih specifikacij se vedno upošteva priporočilo Odbora za ocenjevanje tveganja na področju farmakovigilance.
The Eudravigilance database shall be fully accessible to the competent authorities of the Member States and to the Agency and the Commission.
Podatkovna baza Eudravigilance je v celoti dostopna pristojnim organom držav članic, Agenciji in Komisiji.
It shall also be accessible to marketing authorisation holders to the extent necessary for them to comply with their pharmacovigilance obligations.
Imetnikom dovoljenj za promet je dostopna v ustreznem obsegu, da lahko izpolnijo svoje obveznosti v zvezi s farmakovigilanco.
The Agency shall ensure that healthcare professionals and the public have appropriate levels of access to the Eudravigilance database, while guaranteeing personal data protection.
Agencija zagotovi ustrezen dostop do podatkovne baze Eudravigilance tudi zdravstvenim delavcem in javnosti, ob zagotovitvi varstva osebnih podatkov.
The Agency shall work together with all stakeholders, including research institutions, healthcare professionals, and patient and consumer organisations, in order to define the “appropriate level of access” for healthcare professionals and the public to the Eudravigilance database.
Agencija sodeluje z vsemi interesnimi skupinami, vključno z raziskovalnimi ustanovami, zdravstvenimi delavci ter organizacijami bolnikov in potrošnikov, da se opredeli ‚ustrezna raven dostopa‘ do podatkovne baze Eudravigilance za zdravstvene delavce in javnost.
The data held on the Eudravigilance database shall be made publicly accessible in an aggregated format together with an explanation of how to interpret the data.
Podatki, ki se hranijo v podatkovni bazi Eudravigilance, so javno dostopni v združeni obliki skupaj s pojasnilom o razlagi podatkov.
The Agency shall, in collaboration either with the marketing authorisation holder or with the Member State that submitted an individual suspected adverse reaction report to the Eudravigilance database, be responsible for operating procedures that ensure the quality and integrity of the information collected in the Eudravigilance database.
Agencija, v sodelovanju z imetnikom dovoljenja za promet ali državo članico, ki je bazi Eudravigilance posredovala poročilo o posameznem domnevnem neželenem učinku, je odgovorna za operativne postopke, ki zagotavljajo kakovost in celovitost informacij, zbranih v podatkovni bazi Eudravigilance.
Individual suspected adverse reaction reports and follow-ups submitted to the Eudravigilance database by marketing authorisation holders shall be transmitted electronically upon receipt to the competent authority of the Member State where the reaction occurred.
Poročila o posameznem domnevnem resnem neželenem učinku in nadaljnja poročila, ki jih v podatkovno bazo Eudravigilance predložijo imetniki dovoljenja za promet, se po prejemu v elektronski obliki posredujejo pristojnemu nacionalnemu organu države članice, v kateri je do resnega neželenega učinka prišlo.
The Agency shall, in collaboration with the Member States, develop standard web-based structured forms for the reporting of suspected adverse reactions by healthcare professionals and patients in accordance with the provisions referred to in Article 107a of Directive 2001/83/EC.
Agencija v sodelovanju z državami članicami razvije standardne spletne oblike, prek katerih lahko zdravstveni delavci in bolniki poročajo o domnevnih neželenih učinkih v skladu z določbami iz člena 107a Direktive 2001/83/ES.
The Agency shall, in collaboration with the national competent authorities and the Commission, set up and maintain a repository for periodic safety update reports (hereinafter the “repository”) and the corresponding assessment reports so that they are fully and permanently accessible to the Commission, the national competent authorities, the Pharmacovigilance Risk Assessment Committee, the Committee for Medicinal Products for Human Use and the coordination group referred to in Article 27 of Directive 2001/83/EC (hereinafter the “coordination group”).
Agencija v sodelovanju s pristojnimi nacionalnimi organi in Komisijo vzpostavi in vzdržuje arhiv rednih posodobljenih poročil o varnosti zdravila (v nadaljnjem besedilu: arhiv) in ustreznih poročil o oceni, tako da so ta v celoti in stalno dostopna Komisiji, pristojnim nacionalnim organom, Odboru za ocenjevanje tveganja na področju farmakovigilance, Odboru za zdravila za humano uporabo in skupini za usklajevanje iz člena 27 Direktive 2001/83/ES (v nadaljnjem besedilu: skupina za usklajevanje).
The Agency shall, in collaboration with the national competent authorities and the Commission, and after consultation with the Pharmacovigilance Risk Assessment Committee, draw up the functional specifications for the repository.
Agencija v sodelovanju s pristojnimi nacionalnimi organi in Komisijo po posvetovanju z Odborom za ocenjevanje tveganja na področju farmakovigilance pripravi funkcijske specifikacije za arhiv.
The Management Board of the Agency shall, on the basis of an independent audit report that takes into account the recommendations of the Pharmacovigilance Risk Assessment Committee, confirm and announce when the repository has achieved full functionality and meets the functional specifications drawn up pursuant to the second paragraph.
Uprava Agencije na podlagi neodvisnega revizijskega poročila, ki upošteva priporočila Odbora za ocenjevanje tveganja na področju farmakovigilance, potrdi in napove, kdaj bo arhiv popolno funkcionalen in bo zadostil funkcijskim specifikacijam opredeljenim v skladu z drugim odstavkom.
Any substantial change to the repository and the functional specifications shall always take into account the recommendations of the Pharmacovigilance Risk Assessment Committee.
Ob vsaki bistveni spremembi arhiva in funkcijskih specifikacij je treba vedno upoštevati priporočilo Odbora za ocenjevanje tveganja na področju farmakovigilance.
The Agency shall, in collaboration with the Member States and the Commission, set up and maintain a European medicines web-portal for the dissemination of information on medicinal products authorised in the Union.
Agencija v sodelovanju z državami članicami in Komisijo postavi in vodi evropski spletni portal o zdravilih, namenjen širjenju informacij o zdravilih, odobrenih v Uniji.
By means of that portal, the Agency shall make public at least the following:
Agencija prek tega portala objavi vsaj naslednje:
the names of members of the Committees referred to in points (a) and (aa) of Article 56(1) of this Regulation and the members of the coordination group, together with their professional qualifications and with the declarations referred to in Article 63(2) of this Regulation;
imena članov odborov iz točk (a) in (aa) člena 56(1) te uredbe in članov skupine za usklajevanje, skupaj z njihovimi poklicnimi kvalifikacijami in izjavami v skladu s členom 63(2) te uredbe;
agendas and minutes from each meeting of the Committees referred to in points (a) and (aa) of Article 56(1) of this Regulation and of the coordination group as regards pharmacovigilance activities;
dnevne rede in zapisnike vsakega sestanka odborov iz točk (a) in (aa) člena 56(1) te uredbe ter skupine za usklajevanje v zvezi z dejavnostmi farmakovigilance;
a summary of the risk management plans for medicinal products authorised in accordance with this Regulation;
povzetek načrtov obvladovanja tveganj za zdravila, odobrena v skladu s to uredbo;
the list of medicinal products referred to in Article 23 of this Regulation;
seznam zdravil iz člena 23 te uredbe;
a list of the locations in the Union where pharmacovigilance system master files are kept and contact information for pharmacovigilance enquiries, for all medicinal products authorised in the Union;
seznam mest v Uniji, kjer se hrani glavni dosje o sistemu farmakovigilance in naslove za vprašanja o farmakovigilanci za vsa zdravila, odobrena v Uniji;
information about how to report to national competent authorities suspected adverse reactions to medicinal products and the standard structured forms referred to in Article 25 for their web-based reporting by patients and healthcare professionals, including links to national websites;
informacije o tem, kako pristojnim nacionalnim organom prijaviti domnevne neželene učinke zdravil ter standardne obrazce iz člena 25 za spletne prijave bolnikov in zdravstvenih delavcev, vključno s povezavami na nacionalna spletna mesta;
Union reference dates and frequency of submission of periodic safety update reports established in accordance with Article 107c of Directive 2001/83/EC;
referenčne datume Unije in pogostost pošiljanja rednih posodobljenih poročil o varnosti zdravil, določene v skladu s členom 107c Direktive 2001/83/ES;
protocols and public abstracts of results of the post-authorisation safety studies referred to in Articles 107n and 107p of Directive 2001/83/EC;
protokole in javne povzetke rezultatov, kar zadeva študije varnosti po pridobitvi dovoljenj za promet, navedene v členih 107n in 107p Direktive 2001/83/ES;
the initiation of the procedure provided for in Articles 107i to 107k of Directive 2001/83/EC, the active substances or medicinal products concerned and the issue being addressed, any public hearings pursuant to that procedure and information on how to submit information and to participate in public hearings;
začetek postopka v skladu s členi od 107i do 107k Direktive 2001/83/ES, zadevne učinkovine ali zdravila ter obravnavano vprašanje, kakršne koli javne obravnave v skladu z navedenim postopkom in informacije o predložitvi podatkov in sodelovanju v javni obravnavi;
conclusions of assessments, recommendations, opinions, approvals and decisions taken by the Committees referred to in points (a) and (aa) of Article 56(1) of this Regulation and by the coordination group, the national competent authorities and the Commission in the framework of the procedures of Articles 28, 28a and 28b of this Regulation and of sections 2 and 3 of Chapter 3 and Chapter 4 of Title IX of Directive 2001/83/EC.
ocenjevalne sklepe, priporočila, mnenja, odobritve in sklepe, ki jih na podlagi ocene sprejmejo odbori iz točk (a) in (aa) člena 56(1) te uredbe ter skupina za usklajevanje, pristojni nacionalni organi in Komisija v skladu s postopki iz členov 28, 28a in 28b te uredbe ter oddelkov 2 in 3 poglavja 3 ter poglavja 4 naslova IX Direktive 2001/83/ES.
Before the launch of this portal, and during subsequent reviews, the Agency shall consult relevant stakeholders, including patient and consumer groups, healthcare professionals and industry representatives.
Pred ustanovitvijo tega portala in pri poznejših pregledih se Agencija posvetuje z zadevnimi interesnimi skupinami, vključno s skupinami bolnikov in potrošnikov, zdravstvenimi delavci in predstavniki industrije.
The Agency shall monitor selected medical literature for reports of suspected adverse reactions to medicinal products containing certain active substances.
Agencija spremlja izbrano medicinsko literaturo glede poročil o domnevnih neželenih učinkih zdravil, ki vsebujejo določene zdravilne učinkovine.
It shall publish the list of active substances being monitored and the medical literature subject to this monitoring.
Objavi seznam zdravilnih učinkovin, ki se spremljajo in medicinske literature v zvezi s tem spremljanjem.
The Agency shall enter into the Eudravigilance database relevant information from the selected medical literature.
Agencija v podatkovno bazo Eudravigilance vnese zadevne informacije iz izbrane medicinske literature.
The Agency shall, in consultation with the Commission, Member States and interested parties, draw up a detailed guide regarding the monitoring of medical literature and the entry of relevant information into the Eudravigilance database.
Agencija po posvetovanju s Komisijo, državami članicami in interesnimi skupinami pripravi podrobne smernice glede spremljanja medicinske literature in vnašanja zadevnih informacij v podatkovno bazo Eudravigilance.
The obligations of marketing authorisation holders and of Member States laid down in Articles 107 and 107a of Directive 2001/83/EC shall apply to the recording and reporting of suspected adverse reactions for medicinal products for human use authorised in accordance with this Regulation.
Obveznosti imetnikov dovoljenj za promet in držav članic, določene v členu 107 in 107a Direktive 2001/83/ES, se uporabljajo za evidentiranje in poročanje o domnevnih neželenih učinkih zdravil, odobrenih v skladu s to uredbo.
The obligations of marketing authorisation holders laid down in Article 107b of Directive 2001/83/EC and the procedures under Article 107b and Article 107c of that Directive shall apply to the submission of periodic safety update reports, the establishment of Union reference dates and changes to the frequency of submission of periodic safety update reports for medicinal products for human use authorised in accordance with this Regulation.
Obveznosti imetnikov dovoljenj za promet, določene v členu 107b Direktive 2001/83/ES, ter postopki v skladu s členom 107b in 107c navedene direktive se uporabljajo za pošiljanje rednih posodobljenih poročil o varnosti zdravil, določitev referenčnih datumov Unije in spremembe pogostosti pošiljanja rednih posodobljenih poročil o varnosti zdravil za humano uporabo, odobrenih v skladu s to uredbo.
The provisions applicable to the submission of periodic safety update reports laid down in the second subparagraph of Article 107c(2) of that Directive shall apply to holders of marketing authorisations which were granted before 2 July 2012 and for which the frequency and dates of submission of the periodic safety update reports are not laid down as a condition to the marketing authorisation until such time as another frequency or other dates of submission of the reports are laid down in the marketing authorisation or are determined in accordance with Article 107c of that Directive.
Določbe, ki se uporabljajo za pošiljanje rednih posodobljenih poročil o varnosti zdravil iz drugega pododstavka člena 107c(2) navedene direktive se uporabljajo za imetnike dovoljenj za promet, izdanih pred 2. julijem 2012, za katere pogostost in datumi pošiljanja rednih posodobljenih poročil o varnosti zdravil niso določeni kot pogoj za izdajo dovoljenja za promet, dokler se ne določi druga pogostost ali drugi datumi pošiljanja poročil v dovoljenju za promet ali v skladu s členom 107c navedene direktive.
The assessment of the periodic safety update reports shall be conducted by a rapporteur appointed by the Pharmacovigilance Risk Assessment Committee.
Oceno rednih poročil o varnosti zdravila izvede poročevalec, ki ga imenuje Odbor za ocenjevanje tveganja na področju farmakovigilance.
The rapporteur shall closely collaborate with the rapporteur appointed by the Committee for Medicinal Products for Human Use or the Reference Member State for the medicinal products concerned.
Poročevalec tesno sodeluje s poročevalcem, ki ga imenuje Odbor za zdravila za humano uporabo ali referenčna država članica za zadevna zdravila.
The rapporteur shall prepare an assessment report within 60 days of receipt of the periodic safety update report and send it to the Agency and to the members of the Pharmacovigilance Risk Assessment Committee.
Poročevalec v 60 dneh od prejema rednega posodobljenega poročila o varnosti zdravila pripravi poročilo o oceni in ga pošlje Agenciji ter članom Odbora za ocenjevanje tveganja na področju farmakovigilance.
The Agency shall send the report to the marketing authorisation holder.
Agencija posreduje poročilo imetniku dovoljenja za promet.
Within 30 days of receipt of the assessment report, the marketing authorisation holder and the members of the Pharmacovigilance Risk Assessment Committee may submit comments to the Agency and to the rapporteur.
Imetnik dovoljenja za promet in člani Odbora za ocenjevanje tveganja na področju farmakovigilance lahko Agenciji in poročevalcu predložijo pripombe v 30 dneh od prejema poročila o oceni.
Following the receipt of the comments referred to in the third subparagraph, the rapporteur shall within 15 days update the assessment report taking into account any comments submitted, and forward it to the Pharmacovigilance Risk Assessment Committee.
Po prejemu pripomb iz tretjega pododstavka poročevalec v 15 dneh posodobi poročilo o oceni, pri čemer upošteva vse posredovane pripombe, in ga posreduje Odboru za ocenjevanje tveganja na področju farmakovigilance.
The Pharmacovigilance Risk Assessment Committee shall adopt the assessment report with or without further changes at its next meeting and issue a recommendation.
Odbor za ocenjevanje tveganja na področju farmakovigilance na svojem naslednjem sestanku sprejme poročilo o oceni z nadaljnjimi spremembami ali brez njih in izda priporočilo.
The recommendation shall mention the divergent positions with the grounds on which they are based.
V priporočilu se navedejo razlike in razlogi za njih.
The Agency shall include the adopted assessment report and the recommendation in the repository set up under Article 25a, and forward both to the marketing authorisation holder.
Agencija vključi sprejeto poročilo o oceni in priporočilo v arhiv, vzpostavljen v skladu s členom 25a, ter ju posreduje imetniku dovoljenja za promet.
In the case of an assessment report that recommends any action concerning the marketing authorisation, the Committee for Medicinal Products for Human Use shall, within 30 days of receipt of the report by the Pharmacovigilance Risk Assessment Committee, consider the report and adopt an opinion on the maintenance, variation, suspension or revocation of the marketing authorisation concerned, including a timetable for the implementation of the opinion.
Če se v poročilu o oceni priporoči kakršen koli ukrep v zvezi z dovoljenjem za promet, Odbor za zdravila za humano uporabo v 30 dneh po prejemu poročila Odbora za ocenjevanje tveganja na področju farmakovigilance preuči poročilo in sprejme mnenje o ohranitvi, spremembi, začasnem preklicu ali ukinitvi zadevnega dovoljenja za promet, vključno s časovnim razporedom za izvajanje mnenja.