natgillin/translations-raw huggingface dataset:
Za zagotovitev sledljivosti bioloških zdravil, ki so predpisana, razdeljena, ali prodajana v EU, morajo standardni obrazci in postopki vsebovati ime imetnika dovoljenja za promet, mednarodno nelastniško ime (INN), ime zdravila, kot je določeno v členu 20(1) Direktive 2001/83/ES, in številko serije.
To ensure the traceability of biological medicinal products prescribed, dispensed or sold on EU territory, the standard forms and procedures shall include the name of the marketing authorisation holder, the International Non-proprietary Name (INN), the name of the medicinal product as defined in point 20 of Article 1 of Directive 2001/83/EC and the batch number.
Ker se biotehnološka zdravila od konvencionalnih razlikujejo po tem, da so „živa zdravila“, je primerno, da obstajajo ločena pravila glede vrst informacij, o katerih morajo poročati zdravstveni strokovnjaki v primeru neželenih učinkov, da se tako zagotovi sledljivost zdravil in določi vzrok za neželene učinke.
As biotech medicines vary from conventional medicines in so far as they are ‘live products’ it is appropriate to have separate rules for what kind of information health care professionals should report in case of adverse effects so as to ensure the traceability of the medicine and to be able to establish the cause of the adverse effect.
Člen 1 – točka 11
Article 1 — point 11
Člen 26 – točka 2
Article 26 — point 2
(2) dnevne rede za sestanke in zapisnike sestankov, skupaj s sprejetimi sklepi, podrobnostmi glasovanja ter razlago glasovanja, vključno z manjšinskimi mnenji odborov iz točk (a) in (aa) člena 56(1) te uredbe ter koordinacijske skupine v zvezi z dejavnostmi farmakovigilance;
(2) agendas for meetings and records of meetings, accompanied by decisions taken, details of votes and explanations of votes, including minority opinions, 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;
V skladu s členom 126b Direktive 2004/27/ES „države članice zagotovijo, da pristojni organ javno objavi svoj poslovnik in poslovnik svojih odborov, dnevne rede za svoje sestanke in zapisnike sestankov, skupaj s sprejetimi sklepi, podrobnostmi glasovanja in razlage glasovanja, vključno z manjšinskimi mnenji“.
According to Article 126b of Directive 2004/27/EC the 'Member States shall ensure that the competent authority makes publicly accessible its rules of procedure and those of its committees, agendas for its meetings and records of its meetings, accompanied by decisions taken, details of votes and explanations of votes, including minority opinions'.
Ameriški urad za hrano in zdravila že ravna tako, v Evropi pa se to še ne izvaja.
This is also already done by the US Food and Drug Administration, but is not implemented in Europe.
Svetovalni odbor za oceno tveganja na področju farmakovigilance oceni z zadnjimi podatki dopolnjena redna poročila o varnosti .
The Pharmacovigilance Risk Assessment Advisory Committee shall assess the periodic safety update reports.
Odbor za farmakovigilanco znanstveno oceni razmerje med koristmi in tveganji zdravila na podlagi vseh razpoložljivih informacij, kamor sodijo z zadnjimi podatki dopolnjena redna poročila in podatki iz podatkovne zbirke Eudravigilance .
The Pharmacovigilance Committee shall assess scientifically the risk-benefit balance of the medicinal product on the basis of all the information available, including the periodic update reports and the data entered in the Eudravigilance database.
Odbor v 90 dneh od prejema z zadnjimi podatki dopolnjenega rednega poročila o varnosti pripravi poročilo o oceni in ga pošlje imetniku dovoljenja za promet.
It shall prepare an assessment report within 90 days of receipt of the periodic safety update report and send it to the marketing authorisation holder.
Odbor v 90 dneh od prejema z zadnjimi podatki dopolnjenega rednega poročila o varnosti pripravi znanstveno poročilo o razmerju med tveganji in koristmi zdravil in ga pošlje imetniku dovoljenja za promet.
It shall prepare a scientific report on the risk-benefit balance of the medicinal product within 90 days of receipt of the periodic safety update report and send it to the marketing authorisation holder.
Imetnik dovoljenja za promet lahko Agenciji predloži pripombe v 30 dneh od prejema poročila o oceni.
Within 30 days of receipt of the assessment report, the marketing authorisation holder may submit comments to the Agency .
Imetnik dovoljenja za promet lahko odboru za farmakovigilanco predloži pripombe v 30 dneh od prejema poročila o oceni.
Within 30 days of receipt of the assessment report, the marketing authorisation holder may submit comments to the Pharmacovigilance Committee .
Svetovalni odbor za oceno tveganja na področju farmakovigilance na svojem naslednjem sestanku po koncu obdobja, v katerem lahko imetnik dovoljenja za promet predloži pripombe, sprejme poročilo o oceni s spremembami ali brez njih ob upoštevanju vseh predlogov , ki jih predloži imetnik dovoljenja za promet .
At its next meeting following the end of the period for comments by the marketing authorisation holder, the Pharmacovigilance Risk Assessment Advisory Committee shall adopt the assessment report with or without changes, taking into account any comments submitted by the marketing authorisation holder .
Odbor za farmakovigilanco na svojem naslednjem sestanku po koncu obdobja, v katerem lahko imetnik dovoljenja za promet predloži pripombe, sprejme poročilo o oceni s spremembami ali brez njih ob upoštevanju vseh vloženih predlogov.
At its next meeting following the end of the period for comments by the marketing authorisation holder, the Pharmacovigilance Committee shall adopt the assessment report with or without changes, taking into account any comments submitted.
To poročilo o oceni je nemudoma objavljeno na evropskem spletnem portalu za varnost zdravil, in sicer od [navedba natančnega datuma: 18 mesecev po datumu iz člena 3].
With effect from [indicate precise date, namely 18 months after the date referred to in Article 3] the assessment report shall be published immediately on the European medicines safety web-portal.
Znanstveno poročilo o oceni, ki ga pripravi poročevalec, temelji na podatkih, ki jih posredujejo družbe (poročila o varnosti za paciente, podatki o kliničnih preizkusih in študije, opravljene po izdaji dovoljenja za promet z zdravilom), pa tudi na podatkih, ki jih posredujejo sistemi farmakovigilance iz različnih držav članic (zlasti na sporočilih zdravstvenih delavcev in pacientov).
The scientific assessment report drawn up by the rapporteur shall be based on the data supplied by firms (PSURs and data obtained from the clinical trials and studies carried out after marketing authorisation has been granted) and also on the data supplied by the pharmacovigilance systems in the various Member States (including notifications from health professionals and patients).
Člen 28 – odstavek 4 – pododstavek 1
Article 28 – paragraph 4 - subparagraph 1
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 farmakovigilanco v 30 dneh po prejemu poročila sprejme mnenje o ohranitvi, spremembi, začasni ukinitvi ali razveljavitvi zadevnega dovoljenja za promet.
Within 30 days of adoption of the report, the Pharmacovigilance Committee shall adopt an opinion on the maintenance, variation, suspension or revocation of the marketing authorisation concerned.
Člen 28 – odstavek 6
Article 28 - paragraph 6
Poročila o oceni , mnenja in odločbe iz odstavkov od 3 do 5 tega člena se objavijo prek evropskega spletnega portala za varnost zdravil iz člena 26.
The evaluation reports, 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.
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 zainteresiranimi stranmi sodeluje pri mednarodnem usklajevanju in standardizaciji tehničnih ukrepov v zvezi s farmakovigilanco.
At the Commission's request , the Agency shall participate , in collaboration with the Member States and all interested parties, in international harmonisation and standardisation of technical measures in pharmacovigilance.
To delo izhaja iz potreb pacientov in se opravi na znanstveni podlagi.
Such work shall be based on patient needs and be carried out from a scientific perspective.
Namen predloga spremembe je uskladitev s spremembami člena 108 Direktive 2001/83/ES.
Amendment to ensure consistency with the proposals for changes to Article 108 of Directive 2001/83/EC.
Člen 1 – točka 12 – točka (a)
Article 1 – point 12 – point a
Člen 56 – odstavek 1 – točka aa
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 farmakovigilanco , odgovoren za oceno farmakovigilance zdravil, danih v promet po centraliziranem postopku, po pridobitvi dovoljenja za promet ;
(aa) the Pharmacovigilance Committee, which shall be responsible for the pharmacovigilance assessment, after marketing authorisation has been granted, of medicinal products placed on the market in accordance with the centralised procedure ;
Ta odbor mora biti pristojen za priporočila na enaki ravni kot komisija za izdajanje dovoljenj za promet z zdravilom na evropski ravni (odbor za zdravila za humano uporabo).
This committee should have the same power to make recommendations as the European committee responsible for marketing authorisation (Committee for Medicinal Products for Human Use).
Po analizi in razpravah, ki jih opravijo države članice pod njegovim nadzorom (sistem poročevalcev in soporočevalcev), mora imeti ta odbor pristojnost, da Evropski komisiji neposredno predlaga sklep o preklicu ali spremembi dovoljenja za promet z zdravilom, ne da bi ga pri tem nadzorovale komisije za izdajo dovoljenja (odbor za zdravila za humano uporabo ali njegova koordinacijska skupina).
Following analysis and discussion of the assessments carried out by the Member States under the committee's supervision (systems of rapporteurs and co-rapporteurs), it should be able to make a direct proposal to the Commission for a decision to revoke or modify a marketing authorisation, without having to work under the tutelage of the marketing authorisation committees (CMPHU or coordination group).
Svetovalni odbor za oceno tveganja na področju farmakovigilance sestavlja:
1.The Pharmacovigilance Risk Assessment Advisory 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) po en član in en namestnik na državo članico , ki jih imenuje nacionalni pristojni organ po posvetovanju z upravo ;
(a) one member and one alternate per Member State , appointed by the national competent authority in consultation with the Management Board ;
(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) dva dodatna člana in dva namestnika, en predstavnik zdravstvenih strokovnjakov in en predstavnik bolnikov , ki jih imenuje Komisija na podlagi javnega razpisa ter po posvetovanju z Evropskim parlamentom.
(b) two additional members and two alternates , one a representative of healthcare professionals and one a representative of patients, appointed by the Commission, on the basis of a public call for expressions of interest, after consulting the European Parliament.
Država članica lahko prosi drugo državo članico, da prevzame njeno mesto v odboru.
A Member State may request another Member State to take its place in the committee.
Države članice posredujejo Agenciji imena nacionalnih strokovnjakov z dokazanimi izkušnjami pri vrednotenju zdravil, ki bi bili na voljo za delo v delovnih skupinah ali znanstvenih svetovalnih skupinah katerega koli odbora iz člena 56(1), skupaj z navedbo kvalifikacij in posebnih strokovnih področjih.
Member States shall transmit to the Agency the names of national experts with proven experience in the evaluation of medicinal products who would be available to serve on working parties or scientific advisory groups of any of the committees referred to in Article 56(1), together with an indication of their qualifications and specific areas of expertise.
Države članice posredujejo Agenciji imena nacionalnih strokovnjakov z dokazanimi izkušnjami pri vrednotenju zdravil, ki bi bili na voljo za delo v delovnih skupinah ali znanstvenih svetovalnih skupinah katerega koli odbora iz člena 56(1), skupaj z navedbo kvalifikacij in posebnih strokovnih področjih , pa tudi njihovo stopnjo neodvisnosti od farmacevtskih družb .
Member States shall transmit to the Agency the names of national experts with proven experience in the evaluation of medicinal products who would be available to serve on working parties or scientific advisory groups of any of the committees referred to in Article 56(1), together with an indication of their qualifications and specific areas of expertise , and also of their degree of independence from pharmaceutical firms .
Več primerov odločitev, ki so bile spremenjene po ustanovitvi nove skupine strokovnjakov, narekuje previdnost pred povezavami med interesi teh strokovnjakov in farmacevtskimi družbami.
Several instances of decisions which have been changed following the establishment of new groups of experts prompt a cautious approach with regard to the existence of interests linking such experts and pharmaceutical firms.
Izjave o interesih ne zadoščajo za odpravo tega pritiska.
Declarations of such links are not enough to free experts from pressure.
Člen 1 – točka 18 – točka (b)
Article 1 – point 18 – point b
To ne izključuje zbiranja pristojbin, ki jih morajo plačati imetniki dovoljenj za promet za dejavnosti, ki jih izvaja Agencija.
This shall not preclude the collection of fees to be paid by marketing authorisation holders for the carrying out of these activities by the Agency .
Te so ustrezno javno financirane, sorazmerno z dodeljenimi nalogami.
They shall receive adequate public funding commensurate with the tasks conferred .
Pomembno je, da se dejavnosti farmakovigilance še naprej financirajo iz javnih sredstev, da bi se izognili navzkrižjem interesov.
It is important that pharmacovigilance activities remain financed by public funds to avoid conflicts of interest.
Besedilo starega odstavka 4 je treba ohraniti.
The text of the old paragraph 4 should be maintained.
Zdravila pomembno prispevajo k zdravju državljanov EU.
Medicinal products contribute considerably to the health of EU citizens.
Lahko pa povzročijo neželene učinke, zaradi česar je po podatkih Evropske komisije hospitaliziranih okoli 5 % vseh bolnikov (ker so podatki o tem pomanjkljivi, številka ni natančna).
They can however also have adverse effects, leading to about 5% of all hospital admissions according to the European Commission (underreporting does however not allow for accurate estimates).
Škandal z rofekoksibom (Vioxx), protivnetnim zdravilom, ki je bilo leta 2004 umaknjeno s trga zaradi povečanega kardiovaskularnega tveganja (v ZDA je bilo po nekaterih ocenah več kot 30.000 kapi, nekatere s smrtnim izidom), je omogočila ozaveščanje o tem, da je treba okrepiti farmakovigilanco.
The rofecoxib (Vioxx) case, an anti-inflammatory that was withdrawn of the market in 2004 because of increased cardiovascular risks (more than 30.000 estimated strokes in the US, some of which were fatal) permitted to raise awareness about the need to strengthen pharmacovigilance.
Farmakovigilanca je proces in veda o spremljanju varnosti zdravil, kar zajema tudi zbiranje in obdelavo podatkov o varnosti zdravil, vrednotenju teh podatkov za ugotavljanje, ali bi bil lahko v zvezi z varnostjo kak problem, ukrepanje za reševanje morebitnih težav z varnostjo, tudi z obveščanjem, ter ovrednotenje izvedenega postopka in doseženih rezultatov.
Pharmacovigilance is the process and science of monitoring the safety of medicines, including the collection and management of data on the safety of medicines, the assessment of that data to detect whether there is a safety issue, action to address the possible safety issue including informing on this issue, and the evaluation of the procedure followed and results obtained.
Za zdravila, ki se odobrijo po centraliziranem postopku, je postopek farmakovigilance določen v Uredbi št. 726/2004.
As regards centrally authorised medicines the pharmacovigilance procedure is laid down by Regulation 726/2004.
Za zdravila, ki se odobrijo nacionalno, je postopek določen v Direktivi 2001/83.
As regards nationally authorised medicinal products the procedure is laid down by Directive 2001/83.
To mnenje zadeva predloge sprememb k Uredbi št. 726/2004.
This opinion concerns the amendments to Regulation 726/2004.
Komisija želi izboljšati sedanji sistem farmakovigilance z razjasnitvijo vloge različnih udeležencev, poenostavitvijo postopkov, povečano preglednostjo in obveščanjem, večjo udeležbo zainteresiranih strani ter vzpostavitvijo najboljših praks.
The Commission wishes to improve the current system of pharmacovigilance by clarifying the roles of the various actors involved, simplifying procedures, enhanced transparency and communication, better data collection and evaluation procedures, more involvement of stakeholders and the establishment of best practices.
Čeprav pripravljavec mnenja pozdravlja predlog, meni, da ga je mogoče še izboljšati, zlasti pri vprašanjih varstva potrošnikov, preglednosti in varstva podatkov.
Though the rapporteur for opinion welcomes the proposal, he is of the view that there is a room for further improvement, mainly with regard to consumer protection issues, transparency and data protection .
Zato vlaga predloge sprememb v skladu s spodnjimi smernicami:
He therefore proposes amendments along the following lines:
· Osebni podatki uporabnikov zdravil se v procesu farmakovigilance obdelujejo na več stopnjah in bi zanje morala veljati načela varstva podatkov, ki so opredeljena v Direktivi 95/46/ES.
· The processing of personal data of users of medication taking place at several stages of the pharmacovigilance process, should take place in accordance with the data protection principles laid down by Directive 95/46/EC.
· Predlagani povzetek osnovnih informacij o varni in učinkoviti uporabi zdravil bi bilo treba zavrniti, saj je pojem „osnovne informacije“ zavajajoč in bi ga kaj hitro lahko narobe razumeli.
· The proposed summary of essential information about the safe and effective use of medicines should be rejected since the concept of 'essential information' is misleading and might be misunderstood.
· Poročila bolnikov so lahko nov prispevek k razumevanju neželenih učinkov, kar se je zgodilo v primeru paroksetina (Deroxat/Seroxat), antidepresiva, pri katerem so prav zaradi poročil bolnikov odkrili, da povečuje tveganje za samomor in povzroča odtegnitveni sindrom (občutek „elektrike“ v glavi), ko so želeli bolniki prekiniti zdravljenje.
· Patient reports can bring a new contribution to the understanding of adverse drug reactions (ADR) as it was the case for paroxetine (Deroxat/Seroxat), an antidepressant which was found, thanks to patient reports, to increase the risk of suicides and to cause a deprivation syndrome (“electric head”) if the patients wanted to stop their treatment.
· Potrošniki bi morali poročati neposredno nacionalnim organom.
· Consumers should report directly to national authorities.
Decentralizirani sistemi poročanja, pri čemer se sporočanje vseh neželenih učinkov (o katerih poročajo bolniki, zdravstveno osebje in farmacevtska podjetja) v evropsko zbirko podatkov usklajuje na nacionalni ravni, povečuje zanesljivost varstva podatkov in zagotavlja kakovost podatkov, ki se beležijo na evropski ravni.
Decentralised reporting systems whereby communication of all adverse drug reactions (reported whether by patients, health professionals and pharmaceutical companies) to the European database is coordinated at a national level, increase the safety for data protection and guarantees the quality of the data which are registered at the European level.
Bližina nacionalnim zdravstvenim organom tudi omogoča:
Proximity also allows national health authorities to:
– da poročila preučijo in dodajo dragocene informacije, pri čemer uporabijo svoje strokovno znanje,
- investigate the reports to add valuable information whereby they apply their particular expertise,
– da pridobijo jasen vpogled o neželenih učinkih, ki se pojavljajo na njihovem ozemlju,
- to have a clear view of the adverse effects occurring on their territory,
– da dajo te informacije na voljo svojemu prebivalstvu v domačem jeziku (kakor je praksa v Združenem kraljestvu in na Nizozemskem).
- and to make this information accessible to their country’s population in its own language (as the UK and the Netherlands already do).
· Potrošniki in zdravstveno osebje bi morali imeti tudi popoln dostop do osrednje evropske zbirke podatkov Eudravigilance, da bi lahko dali ovrednotene informacije na razpolago javnosti in s tem preprečijo ponovno pojavljanje neželenih učinkov.
· Consumers and Healthcare professionals should also have full access to the central European Eudravigilance database in order to prevent the repetition of preventable adverse drug reactions by making validated information easily available.
To je učinkovit način za odpravo razlik med državami članicami glede informacij o neželenih učinkih.
It is an effective way to tackle inequalities of information on adverse drug reactions among Member States.
Javni dostop do podatkovne zbirke Eudravigilance je potreben za povrnitev zaupanja državljanov, da zdravstveni organi vendarle zmorejo varovati javno zdravje.
This public access to Eudravigilance is needed to restore citizens’ trust in health authorities’ capacity to protect public health.
· Spletno obliko za poročanje bi morali dopolniti z drugimi sredstvi, na primer po pošti, faksu in telefonu, kakor je mogoče v ZDA in Združenem kraljestvu, da ne bi izključili tistih, ki nimajo dostopa do interneta ali ga ne morejo uporabljati, pa tudi da bi izboljšali poročanje bolnikov.
· The use of a web format for reporting should be supplemented by other means, such as mail, fax and phone as it is the case in the US and in the UK, in order to not exclude those who do not have access to or cannot use the internet and to improve patient reporting.
· Vsa ocenjevalna poročila, ki zadevajo zdravila v okviru nacionalnih in evropskega sistema farmakovigilance, bi morali biti na voljo javnosti.
· All assessment reports concerning a medication in the framework of the national and European pharmacovigilance systems should be available to the public.