natgillin/translations-raw huggingface dataset:
Ameriški urad za hrano in zdravila te podatke že javno objavlja – tako v teoriji kot v praksi.
The USA Food and Drugs Association does make this information public - both in theory and in practice.
Spletni portal mora vključevati tudi povezavo na podatkovno bazo Evropske agencije za vrednotenje zdravil Evropskih javnih poročil o oceni zdravila, ki je bila ustanovljena s členom 13(3) uredbe: http://www.ema.europa.eu/htms/human/epar/eparintro.htm.
The web portal should also include a link to EMEA's European Public Assessment Report (EPAR) database, set up by article 13(3) of the Regulation: http://www.ema.europa.eu/htms/human/epar/eparintro.htm.
Povzetki Evropskih javnih poročil o oceni zdravila so enostranske informativne kartice o vseh centralno odobrenih zdravilih.
The EPAR summaries are one-page information sheets about every centrally-authorised medicinal product.
Določajo, kaj zdravilo je, za kaj se uporablja, kakšna so tveganja in koristi, zakaj je bilo odobreno, znanstvene razprave v zvezi z njim ter postopkovne korake pred in po njegovi odobritvi.
They set out what the medicine is, what it's for, what are the risks and benefits, why it was approved, the scientific discussions surrounding it, and the procedural steps involved before and after its authorisation.
Treba je spodbujati spletno stran Evropske agencije za vrednotenje zdravil in EudraPharm, da bi dvignili ozaveščenost med bolniki o teh uporabnih virih neodvisnih informacij o zdravilih.
Both the EPAR and the EudraPharm websites should be promoted, in order to raise awareness amongst patients of these useful sources of independent information about medicinal products.
Ta sporazumni predlog je treba brati v povezavi s sporazumnim predlogom 6 direktive, saj člen 106 direktive določa, da so države članice odgovorne za objavljanje na svojih nacionalnih spletnih portalih, člen 26 uredbe pa določa, da je Agencija odgovorna za objavljanje na (povezanem) evropskem spletnem portalu.
This compromise amendment should be read in conjunction with compromise amendment 6 on the Directive - as article 106 of the Directive sets out what Member States are responsible for publishing on their national web portal, and article 26 of the Regulation sets out what the Agency is responsible for publishing on the (linked) European web portal.
Opomba: člen 217 direktive je tudi bil vključen v ta sporazum, čeprav bo treba o njem glasovati ločeno na seznamu za glasovanje za direktivo.
N.B. Amendment 217 of the Directive has also been included in this compromise, although will have to be voted separately in the voting list for the Directive.
Člen 26 – odstavek 1 – točka 2
Article 26 - paragraph 1 - point 2
(2) povzetek vsakega sestanka odborov iz točk (a) in (aa) člena 56(1) te uredbe ter koordinacijske skupine v zvezi z dejavnostmi farmakovigilance;
(2) a summary of each meeting of the committees referred to in points (a) and (aa) of Article 56(1) of this Regulation and the coordination group as regards pharmacovigilance activities;
(2) podrobnosti vsakega sestanka odborov iz točk (a) in (aa) člena 56(1) te uredbe ter koordinacijske skupine v zvezi z dejavnostmi farmakovigilance , tudi dnevne rede in zapisnike vsakega sestanka, skupaj s sprejetimi sklepi ;
(2) details of each meeting of the committees referred to in points (a) and (aa) of Article 56(1) of this Regulation and the coordination group as regards pharmacovigilance activities, including agendas for , and records of , each meeting, accompanied by decisions taken;
glej obrazložitev k točki 1 člena 26.
see justification to Article 26 - point 1
Člen 26 – odstavek 1 – točka 3
Article 26 - paragraph 1 - point 3
(3) sisteme obvladovanja tveganja za zdravila, odobrena v skladu s to uredbo;
(3) risk management systems for medicinal products authorised in accordance with this Regulation;
(3) povzetek sistemov obvladovanja tveganja in uporabniku prijazen povzetek teh sistemov za zdravila, odobrena v skladu s to uredbo;
(3) risk management systems, and a user-friendly summary of these systems, for medicinal products authorised in accordance with this Regulation;
Glej obrazložitev k točki 1 člena 26.
see justification to Article 26 - point 1
Člen 26 – odstavek 1 – točka 3 a (novo)
Article 26 - paragraph 1 - point 3 a (new)
(3a) povezava na podatkovno bazo Agencije EudraPharm mora vključevati najsodobnejšo elektronsko različico navodil za uporabo in povzetka glavnih značilnosti zdravila za vsa obstoječa in nova zdravila, odobrena v skladu s to uredbo in Direktivo 2001/83/ES, pa tudi povezavo na bazo podatkov Agencije povzetkov Evropskih poročil o oceni zdravila, ki objavlja informativne kartice o centralno odobrenih proizvodih.
(3a) the link to the Agency's EudraPharm database which must include the most up-to-date electronic version of the package leaflet and summary of product characteristics for all existing and new medicinal products authorised in accordance with this Regulation and with Directive 2001/83/EC, as well as a link to the Agency's European Public Assessment Report summary database which publishes information sheets on centrally authorised products.
Ta dva vira morajo Agencija ali pristojni organi oglaševati pri širši javnosti.
These two resources shall be publicised to the general public by the Agency or the competent authorities .
Člen 26 – odstavek 1 – točka 4
Article 26 - paragraph 1 - point 4
(4) seznam zdravil , za katera se izvaja intenzivno spremljanje iz člena 23 te uredbe;
(4) the list of medicinal products under intensive monitoring referred to in Article 23 of this Regulation;
(4) seznam zdravil iz člena 23 te uredbe;
(4) the list of medicinal products referred to in Article 23 of this Regulation;
Člen 26 – odstavek 1 – točka 6
Article 26 - paragraph 1 - point 6
(6) informacije o tem, kako prijaviti domnevne neželene učinke zdravil, ter standardne obrazce za spletne prijave bolnikov in zdravstvenih delavcev;
(6) information about how to report suspected adverse reactions to medicinal products and standard forms for their web-based reporting by patients and health-care professionals;
(6) informacije o tem, kako prijaviti domnevne neželene učinke zdravil, ter standardne obrazce za prijave bolnikov in zdravstvenih delavcev;
(6) information about how to report suspected adverse reactions to medicinal products and standard forms for reporting by patients and health-care professionals;
Člen 26 – odstavek 1 a (novo)
Article 26 - paragraph 1 a (new)
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).
Before the launch of the portal, and during subsequent reviews, the Agency shall consult relevant stakeholders (including patient and consumer groups, healthcare professionals and industry representatives).
Agencija spremlja izbrano medicinsko literaturo glede poročil o domnevnih neželenih učinkih zdravil za humano uporabo, ki vsebujejo nekatere zdravilne učinkovine.
The Agency shall monitor selected medical literature for reports of suspected adverse reactions to medicinal products for human use containing certain active substances.
Objavi seznam zdravilnih učinkovin, ki se spremljajo, in publikacij v zvezi s tem spremljanjem.
It shall publish the list of active substances being monitored and the publications subject to this monitoring.
Agencija spremlja vso medicinsko literaturo glede poročil o domnevnih neželenih učinkih zdravil za humano uporabo, ki vsebujejo dobro uveljavljene zdravilne učinkovine.
The Agency shall monitor all medical literature for reports of suspected adverse reactions to medicinal products for human use containing well established active substances.
Predlog v sedanji obliki zahteva, da imetnik dovoljenja za promet preverja podatkovno bazo Eudravigilance, da ugotovi, kaj je Evropska agencija za zdravila že zajela, in spremlja drugo neizbrano medicinsko literaturo in neobravnavana zdravila.
The proposal requires the marketing authorisation holder to monitor the EudraVigilance to see what the EMA has covered and to monitor other non-selected medical literature and non-covered medicines.
Za dobro uveljavljene zdravilne učinkovine to nalogo lahko opravlja Evropska agencija za zdravila, saj so iskane podatkovne baze iste kot tiste, v katerih iščejo imetniki dovoljenj za promet s skupnimi dobro uveljavljenimi zdravilnimi učinkovinami.
For well established active substances, the European Medicines Agency can carry out this task since the databases searched are the same searched by all marketing authorisation holders who have well established ingredients in common.
Zahteva, da Evropska agencija za zdravila opravlja to nalogo za vse dobro uveljavljene učinkovine, je torej smiselna in učinkovita (le enkrat).
Consequently, requiring the European Medicines Agency to do this task for all well established substances makes sense and is efficient (once only).
Člen 28 – odstavek 3 – pododstavek 4 a (novo)
Article 28 - paragraph 3 - subparagraph 4 a (new)
Na podlagi ocenjevalnega poročila oblikuje priporočilo za Odbor za zdravila za uporabo v humani medicini.
It shall formulate a recommendation for the Committee for Medicinal Products for Human Use on the basis of the assessment report.
Mnenje Odbora za oceno tveganja na področju farmakovigilance moralo imeti več veljave pri Odboru za zdravila za uporabo v humani medicini, ki bi lahko zavrnil njegovo priporočilo samo, če bi odločitev utemeljil z ugotovitvami znanosti in razlogi javnega zdravja.
The opinion of the PRAC should carry more weight with the CHMP, who should only be able to overturn the recommendation of the PRAC if they justify their decision on the grounds of science and public health.
Člen 28 – odstavek 4
Article 28 - paragraph 4
Odbor za zdravila za uporabo v humani medicini v 30 dneh po prejemu poročila Svetovalnega odbora za oceno tveganja na področju farmakovigilance preuči poročilo in sprejme mnenje o ohranitvi, spremembi, začasni ukinitvi ali razveljavitvi zadevnega dovoljenja za promet.
Within 30 days of receipt of the report by the Pharmacovigilance Risk Assessment Advisory Committee, the Committee for Medicinal Products for Human Use shall consider the report and adopt an opinion on the maintenance, variation, suspension or revocation of the marketing authorisation concerned.
Odbor za zdravila za uporabo v humani medicini v 30 dneh po prejemu priporočila odbora za oceno tveganja na področju farmakovigilance sprejme mnenje o ohranitvi, spremembi, začasni ukinitvi ali razveljavitvi zadevnega dovoljenja za promet.
Within 30 days of receipt of the recommendation by the Pharmacovigilance Risk Assessment Committee, the Committee for Medicinal Products for Human Use shall adopt an opinion on the maintenance, variation, suspension or revocation of the marketing authorisation concerned.
Odbor za zdravila za uporabo v humani medicini sprejme mnenje, ki se razlikuje od priporočila Odbora za oceno tveganja na področju farmakovigilance, samo če obstajajo trdni znanstveni dokazi in razlogi javnega zdravja.
The CHMP shall adopt an opinion which differs from the recommendation of the Pharmacovigilance Risk Assessment Committee, only where there exist strong scientific and public health grounds for do ing so.
Take dokaze razloži v obrazložitvi, ki se priloži njegovemu mnenju.
The CHMP shall explain such grounds in a justification to be annex ed to its opinion.
Kadar je v mnenju določeno, da je potreben regulativni ukrep, Komisija sprejme odločbo o spremembi, začasni ukinitvi ali razveljavitvi dovoljenja za promet.
Where the opinion states that regulatory action is necessary, the Commission shall adopt a decision to vary, suspend or revoke the marketing authorisation.
Člen 10 te uredbe se uporablja za sprejetje navedene odločbe.
Article 10 of this Regulation shall apply to the adoption of that decision.
Kadar Komisija sprejme tako odločbo, lahko v skladu s členom 127a Direktive 2001/83/ES sprejme tudi odločbo, naslovljeno na države članice.
Where the Commission adopts such decision, it may also adopt a decision addressed to the Member States pursuant to Article 127a of Directive 2001/83/EC.
Mnenje Odbora za oceno tveganja na področju farmakovigilance bi moralo imeti več veljave pri Odboru za zdravila za uporabo v humani medicini, ki bi lahko zavrnil njegovo priporočilo samo, če bi odločitev utemeljil z ugotovitvami znanosti in razlogi javnega zdravja.
The opinion of the PRAC should carry more weight with the CHMP, who should only be able to overturn the recommendation of the PRAC if they justify their decision on the grounds of science and public health.
Člen 28 – odstavek 6
Article 28 – paragraph 6
Mnenja in odločbe iz odstavkov od 3 do 5 tega člena se objavijo prek evropskega spletnega portala za varnost zdravil iz člena 26.
The opinions and decisions referred to in paragraphs 3 to 5 of this Article shall be made public by means of the European medicines safety web-portal referred to in Article 26.
Končna mnenja in končne odločbe iz odstavkov od 3 do 5 tega člena se objavijo prek evropskega spletnega portala za varnost zdravil iz člena 26.
The final opinions and final decisions referred to in paragraphs 3 to 5 of this Article shall be made public by means of the European medicines safety web-portal referred to in Article 26.
Informacije, ki naj bi se objavile na tem spletnem portalu, morajo biti popolne, vendar preproste.
Information for publication on this web-portal should be complete but not complex.
Člen 28a – odstavek 2 a (novo)
Article 28a - paragraph 2 a (new)
2(a) Za namene navedene ocene lahko Odbor za ocenjevanje tveganja farmakovigilance izvede javno obravnavo.
2(a) For the purposes of that assessment, the Pharmacovigilance Risk Assessment Committee may hold a public hearing.
Javne obravnave se objavijo na evropskem spletnem portalu o varnosti zdravil.
Public hearings shall be announced by means of the European medicines safety web-portal.
Objava vsebuje informacije o možnih načinih sodelovanja imetnikov dovoljenja za promet in javnosti.
The announcement shall include information on how marketing authorisation holders and the public can participate.
Agencija omogoči vsem, ki to zahtevajo, da osebno ali s pomočjo internetne tehnologije sodelujejo v obravnavi.
The Agency shall provide the opportunity, to all those who request it, to participate in the hearing either in person or through the use of web-based technology.
Kadar ima imetnik dovoljenja za promet ali druga oseba, ki namerava predložiti informacije, zaupne poslovne podatke, pomembne za vprašanje v postopku, lahko zahteva, da te podatke predstavi Odboru za ocenjevanje tveganja farmakovigilance na obravnavi, ki ni javna.
Where a marketing authorisation holder or another person intending to submit information has commercially confidential data relevant to the issue of the procedure, he may request that he be allowed to present those data to the Pharmacovigilance Risk Assessment Committee in a non-public hearing.
Ta predlog spremembe je enak kot pri direktivi.
This is an identical amendment to the Directive.
Odboru za oceno tveganja na področju farmakovigilance omogoča organizacijo javnih obravnav, če to pri vrednotenju zdravil oceni za potrebno, ne glede, ali so bila zdravila odobrena po centraliziranem ali decentraliziranem postopku.
It allows the Pharmacovigilance Risk Assessment Committee to draw on public hearings if it sees fit, in its assessment of medicines authorised both through the centralised and decentralised procedures.
Člen 28d
Article 28d
Na zahtevo Komisije Agencija v sodelovanju z državami članicami sodeluje pri mednarodnem usklajevanju in standardizaciji tehničnih ukrepov v zvezi s farmakovigilanco.
Upon request of the Commission, the Agency shall participate in collaboration with the Member States in international harmonization and standardization of technical measures in pharmacovigilance.
Na zahtevo Komisije Agencija v sodelovanju z državami članicami in vsemi interesnimi skupinami sodeluje pri mednarodnem usklajevanju in standardizaciji tehničnih ukrepov v zvezi s farmakovigilanco.
Upon request of the Commission, the Agency shall participate , in collaboration with the Member States and all interested parties, in international harmonisation and standardisation of technical measures in pharmacovigilance.
Takšno delo temelji na potrebah bolnikov in se izvaja na znanstveni podlagi.
Such work shall be based on patient needs and be carried out from a scientific perspective.
Predlog spremembe, ki zagotavlja skladnost s predlogi sprememb člena 108 Direktive 2001/83/ES.
Amendment to ensure consistency with the proposals for changes to Article 108 of Directive 2001/83/EC.
Člen 28f
Article 28f
Agencija izvaja redne preglede svojih nalog v zvezi s farmakovigilanco in o rezultatih vsaki dve leti poroča upravi.
The Agency shall perform regular audit of its pharmacovigilance tasks and report the results to its Management Board on a two-yearly basis.
Agencija izvaja redne neodvisne preglede svojih nalog v zvezi s farmakovigilanco in o rezultatih vsaki dve leti poroča upravi.
The Agency shall perform regular independent audit of its pharmacovigilance tasks and report the results to its Management Board on a two-yearly basis.
Besedilo predloga direktive vsebuje predlog glede neodvisnih pregledov za države članice (predlog spremembe 13).
The text of the draft directive proposes independent audit for the Member States (Amendment 13).
Da bi zagotovili doslednost, je treba ustrezno prilagoditi tudi podobno določbo iz člena 28f predloga uredbe, ki zadeva Agencijo.
Article 28f of the draft regulation, concerning the Agency, contains a similar provision which should be adapted accordingly to ensure consistency.
Komisija sprejme vse spremembe, ki so morda potrebne za posodobitev določb tega poglavja, da se tako upošteva znanstveni in tehnični napredek.
The Commission shall adopt any amendments which may be necessary to update the provisions of this Chapter to take account of scientific and technical progress.
Ukrepi, namenjeni spremembi nebistvenih elementov te uredbe, se sprejmejo v skladu z regulativnim postopkom na podlagi pregleda iz člena 87(2a).
Those measures, designed to amend non-essential elements of this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 87(2a).
Člen 1 – točka 12 – točka (a)
Article 1 - point 12 - point a
Člen 56 – odstavek 1 – točka (a a)
Article 56 - paragraph 1 - point aa
(aa) Svetovalni odbor za oceno tveganja na področju farmakovigilance, odgovoren za svetovanje Odboru za zdravila za uporabo v humani medicini in koordinacijski skupini o vseh vprašanjih v zvezi s farmakovigilanco zdravil za humano uporabo;
(aa) the Pharmacovigilance Risk Assessment Advisory Committee, which shall be responsible for providing advice to the Committee for Medicinal Products for Human Use and the coordination group on any question relating to the pharmacovigilance of medicinal products for human use;
(aa) Odbor za oceno tveganja na področju farmakovigilance, odgovoren za dajanje priporočil Odboru za zdravila za uporabo v humani medicini in koordinacijski skupini o vseh vprašanjih v zvezi s farmakovigilanco zdravil za humano uporabo;
(aa) the Pharmacovigilance Risk Assessment Committee, which shall be responsible for making a recommendation to the Committee for Medicinal Products for Human Use and the coordination group on any question relating to the pharmacovigilance of medicinal products for human use;
Sprememba je v skladu s predlogoma spremembe 3 in 4.
This change is in line with amendments 3 and 4.
Člen 1 – točka 12 – točka (b a) (novo)
Article 1 – point 12 – point b a (new)
Člen 56 – odstavek 1 – točka (g)
Article 56 – paragraph 1 – point g
(ba) točka (g) se nadomesti z naslednjim:
(ba) point (g) is replaced by the following:
"(g) izvršni generalni direktor, ki izvaja pristojnosti iz člena 64;"
"(g) an Executive Director General, who shall exercise the responsibilities set out in Article 64 ;"
Pojasnilo odraža strukturo, velikost in odgovornosti Agencije.
The clarification reflects the structure, size and responsibilities of the Agency.
V zadnjih letih se je raznolikost novih nalog znatno povečala.
During the last years the variety of new tasks increased considerably.
Danes je Agencija s 600 uslužbenci druga največja agencija v EU.
Today, the Agency is the second largest agency in the EU with 600 members of staff.
Zato je treba izraz izvršni direktor nadomestiti z izrazom generalni izvršni direktor v celotnem besedilu uredbe.
Therefore, the term Executive Director shall be replaced by Executive Director General and shall be changed throughout the Regulation.
Člen 61a – odstavek 1
Article 61a – paragraph 1
Svetovalni odbor za oceno tveganja na področju farmakovigilance sestavlja:
The Pharmacovigilance Risk Assessment Advisory Committee shall be composed of the following:
Odbor za oceno tveganja na področju farmakovigilance sestavlja:
The Pharmacovigilance Risk Assessment Committee shall be composed of the following:
(a) deset članov in deset namestnikov, ki jih imenuje uprava na podlagi predlogov pristojnih nacionalnih organov ;
(a) ten members and ten alternates appointed by the Management Board, on the basis of proposals by the national competent authorities;
(a) deset članov in deset namestnikov, ki jih imenuje uprava po posvetovanju s pristojnimi nacionalnimi organi in na podlagi njihovega ustreznega strokovnega znanja na področju farmakovigilance ter ocene tveganja zdravil za uporabo v humani medicini, kot je določeno v odstavku 2 ;
(a) ten members and ten alternates appointed by the Management Board, following consultation with the national competent authorities and on the basis of their relevant expertise in pharmacovigilance and the risk assessment of medicinal products for human use, as laid down in paragraph 2 ;
(b) pet članov in pet namestnikov, ki jih imenuje Komisija na podlagi javnega razpisa ter po posvetovanju z Evropskim parlamentom.
(b) five members and five alternates appointed by the Commission, on the basis of a public call for expressions of interest, after consulting the European Parliament.
(b) sedem dodatnih članov in pet namestnikov, ki jih imenuje Komisija na podlagi javnega razpisa ter po posvetovanju z Evropskim parlamentom, med njimi pa je vsaj en zdravstveni delavec in vsaj en predstavnik bolnikov .
(b) seven additional members and five alternates appointed by the Commission, including at least one healthcare professional representative, and at least one patient representative, on the basis of a public call for expressions of interest, after consulting the European Parliament.
Država članica lahko zaprosi drugo državo članico, da jo zastopa v odboru.
A Member State may request another Member State to represent it in the committee.
Namestniki predstavljajo člane, kadar so ti odsotni, in glasujejo v njihovem imenu.
The alternates shall represent and vote for the members in their absence.
Komisija lahko glede na tehnične in znanstvene potrebe prilagodi število članov in namestnikov.
The Commission may adapt the number of members and alternates in the light of technical and scientific needs.
Imenovanje članov Odbora za oceno tveganja na področju farmakovigilance, ki ga opravi uprava, temelji zlasti na njihovem strokovnem znanju in izkušnjah.
The appointment of members to the PRAC by the Management Board shall foremost be based on their scientific expertise.
Poleg desetih imenovanih članov, morajo imeti države članice možnost, da pošljejo dodatne predstavnike nacionalnih pristojnih organov, da se udeležijo sestanka Odbora za oceno tveganja na področju farmakovigilance in na njem sodelujejo.
Apart from the ten appointed members, Member States should have the opportunity to send additional representatives from the national competent authorities to attend and participate in the PRAC meetings.
Nadalje morajo biti med člani, ki jih imenuje Komisija, vsaj dva člana predstavnika zdravstvenih delavcev in bolnikov.
Furthermore, the additional members appointed by the Commission should include at least two members from patient and health care representatives.