natgillin/translations-raw huggingface dataset:
In order to ensure close cooperation between the Member States in the area of pharmacovigilance, the mandate of the coordination group set up by Article 27 of Directive 2001/83/EC should be enlarged to include the examination of questions related to the pharmacovigilance of all medicinal products authorised by the Member States.
Da se zagotovi tesno sodelovanje držav članic na področju farmakovigilance, bi bilo treba pooblastilo skupine za usklajevanje, ustanovljene s členom 27 Direktive 2001/83/ES, razširiti tako, da vključuje preučevanje vprašanj v zvezi s farmakovigilanco vseh zdravil, ki so jih odobrile države članice.
In order to fulfil its new tasks, the coordination group should be further strengthened through the adoption of clear rules as regards the expertise required, the procedures for reaching agreements or positions, transparency, independence and professional secrecy of its members, and the need for cooperation between Union and national bodies.
Skupino za usklajevanje bi bilo treba zaradi izpolnjevanja nove naloge okrepiti s sprejetjem jasnih pravil glede zahtevane ravni strokovnega znanja in izkušenj, postopkov za doseganje sporazumov ali stališč, preglednosti, neodvisnosti in varovanja poslovne skrivnosti njenih članov ter potrebe po sodelovanju med Unijo in državnimi organi.
With a view to ensuring the same level of scientific expertise in the area of pharmacovigilance decision-making at both Union and national levels, the coordination group should rely on the recommendations of the Pharmacovigilance Risk Assessment Committee when fulfilling its pharmacovigilance tasks.
Zaradi zagotavljanja enake ravni znanstvenega znanja in izkušenj na področju odločanja o farmakovigilanci na ravni Unije in na nacionalni ravni bi se morala skupina za usklajevanje pri izvajanju nalog farmakovigilance opreti na priporočila Odbora za ocenjevanje tveganja na področju farmakovigilance.
In order to avoid duplication of work, the coordination group should agree on a single position for pharmacovigilance assessments concerning medicinal products authorised in more than one Member State.
Da bi se izognili podvajanju dela, bi se morala skupina za usklajevanje dogovoriti za eno samo stališče glede farmakovigilančne ocene za zdravila, odobrena v več kot eni državi članici.
Agreement within the coordination group should suffice for pharmacovigilance measures to be implemented throughout the Union.
Dogovor v skupini za usklajevanje bi moral zadostovati za ukrepe farmakovigilance, ki se izvajajo po vsej Uniji.
Where no agreement is reached within the coordination group, the Commission should be authorised to adopt a decision concerning the necessary regulatory action in respect of the marketing authorisation, addressed to the Member States.
Kadar v skupini za usklajevanje ni dogovora, bi morala biti Komisija pooblaščena, da v ta namen sprejme odločitev o potrebni regulativni dejavnosti glede dovoljenj za promet naslovljeno na države članice.
A single assessment should also be conducted in the case of pharmacovigilance issues which concern medicinal products authorised by the Member States and medicinal products authorised in accordance with Regulation (EC) No 726/2004.
Enotno oceno bi bilo treba izvesti tudi v primeru vprašanj farmakovigilance, ki zadevajo zdravila, odobrena s strani držav članic, in zdravila, odobrena v skladu z Uredbo (ES) št. 726/2004.
In such cases, the Commission should adopt harmonised measures for all medicinal products concerned on the basis of an assessment at Union level.
V takih primerih bi morala Komisija sprejeti usklajene ukrepe za vsa zadevna zdravila na podlagi ocene na ravni Unije.
Member States should operate a pharmacovigilance system to collect information that is useful for the monitoring of medicinal products, including information on suspected adverse reactions arising from use of a medicinal product within the terms of the marketing authorisation as well as from use outside the terms of the marketing authorisation, including overdose, misuse, abuse and medication errors, and suspected adverse reactions associated with occupational exposure.
Države članice bi morale upravljati sistem farmakovigilance za zbiranje informacij, uporabnih za spremljanje zdravil, vključno z informacijami o domnevnih neželenih učinkih, ki nastanejo pri uporabi zdravila v okviru dovoljenja za promet z zdravilom in tudi zaradi uporabe zunaj okvira pogojev dovoljenja za promet z zdravilom, vključno s prevelikim odmerjanjem, nepravilno uporabo, zlorabo in napakami pri zdravljenju in učinki, ki nastanejo zaradi poklicne izpostavljenosti.
Member States should ensure the quality of the pharmacovigilance system through the follow-up of cases of suspected adverse reactions.
Države članice bi morale zagotoviti kakovost sistema farmakovigilance z nadaljnjim spremljanjem primerov domnevnih neželenih učinkov.
For those tasks, Member States should establish a permanent pharmacovigilance system, supported by the appropriate expertise, so that the obligations under this Directive can be fully met.
Države članice za te naloge vzpostavijo stalen sistem farmakovigilance, podprt z ustreznim strokovnim znanjem in izkušnjami, da bi lahko bile v celoti izpolnjene obveznosti iz te direktive.
In order to further increase the coordination of resources between the Member States, Member State should be authorised to delegate certain pharmacovigilance tasks to another Member State.
Za boljše usklajevanje virov med državami članicami bi morala biti država članica pooblaščena, da nekatere naloge farmakovigilance prenese na drugo državo članico.
In order to simplify the reporting of suspected adverse reactions, the marketing authorisation holders and the Member States should report those reactions only to the Union pharmacovigilance database and data-processing network referred to in Article 57(1)(d) of Regulation (EC) No 726/2004 (the ‘Eudravigilance database’).
Za poenostavitev poročanja o domnevnih neželenih učinkih bi morali imetniki dovoljenj za promet z zdravili in države članice te učinke sporočati samo v farmakovigilančno podatkovno bazo Unije in omrežje za obdelavo podatkov iz točke (d) člena 57(1) Uredbe (ES) št. 726/2004 (v nadaljnjem besedilu: „podatkovna baza Eudravigilance“).
The Eudravigilance database should be equipped to immediately forward reports on suspected adverse reactions received from marketing authorisation holders to the Member States on whose territory the reaction occurred.
Podatkovna baza Eudravigilance bi morala biti opremljena tako, da lahko nemudoma posreduje poročila o domnevnih neželenih učinkih, ki jih prejme od imetnikov dovoljenj za promet, državam članicam, na ozemlju katerih se je učinek pokazal.
In order to increase the level of transparency of the pharmacovigilance processes, the Member States should create and maintain medicines web-portals.
Za večjo raven preglednosti o postopkov farmakovigilance bi morale države članice oblikovati in vzdrževati spletne portale o zdravilih.
To the same end, the marketing authorisation holders should provide the competent authorities with prior or simultaneous warnings about safety announcements and the competent authorities should also provide each other with advance notice of safety announcements.
Iz istega razloga bi morali imetniki dovoljenja za promet z zdravili pristojnim organom predhodno ali istočasno posredovati opozorila o varnostnih sporočilih, pristojni organi pa bi si morali o njih medsebojno predhodno obvestiti o varnostnem sporočilu.
Union rules in relation to pharmacovigilance should continue to rely on the crucial role of healthcare professionals in monitoring the safety of medicinal products, and should take account of the fact that patients are also well placed to report suspected adverse reactions to medicinal products.
Pravila Unije v zvezi s farmakovigilanco bi se morala še naprej opirati na odločilno vlogo zdravstvenih delavcev pri spremljanju varnosti zdravil in bi morala upoštevati dejstvo, da so bolniki tudi zelo primerni za poročanje o domnevnih neželenih učinkih zdravil.
It is therefore appropriate to facilitate the reporting of suspected adverse reactions to medicinal products by both healthcare professionals and patients, and to make methods for such reporting available to them.
Zato je primerno zdravstvenim delavcem in bolnikom olajšati poročanje o domnevnih neželenih učinkih zdravil in jim dati na voljo načine za tako poročanje.
As a result of the submission of all suspected adverse reaction data directly to the Eudravigilance database, it is appropriate to amend the scope of periodic safety update reports so that they present an analysis of the risk-benefit balance of a medicinal product rather than a detailed listing of individual case reports already submitted to the Eudravigilance database.
Zaradi predložitve podatkov o vseh domnevnih neželenih učinkih neposredno v podatkovno bazo Eudravigilance je primerno spremeniti obseg rednih posodobljenih poročil o varnosti zdravila, tako da predstavljajo analizo razmerja med tveganjem in koristjo zdravila in ne podrobne predstavitve poročil o posameznih primerih, ki so bila že posredovana v podatkovno bazo Eudravigilance.
Obligations imposed in respect of periodic safety update reports should be proportionate to the risks posed by medicinal products.
Obveznosti, naložene glede rednih posodobljenih poročil o varnosti zdravila, bi morale biti sorazmerne s tveganji, ki jih predstavljajo zdravila.
Periodic safety update reporting should therefore be linked to the risk management system for newly authorised medicinal products and routine reporting should not be required for generic medicinal products, for medicinal products containing an active substance for which well-established medicinal use has been demonstrated, for homeopathic medicinal products or for traditional-use registered herbal medicinal products.
Zato bi bilo treba redno posodobljeno poročanje o varnosti zdravila povezati s sistemom obvladovanja tveganj za nova zdravila, ki so pridobila dovoljenje za promet, običajno poročanje pa se ne bi smelo zahtevati za generična zdravila, zdravila z zdravilno učinkovino z dobro uveljavljeno uporabo, homeopatska zdravila ali zdravila rastlinskega izvora, registrirana za tradicionalno uporabo.
However, in the interests of public health, the competent authorities should require periodic safety update reports for such medicinal products when concerns arise relating to pharmacovigilance data or as a result of the lack of available safety data when the use of the active substance concerned is concentrated in medicinal products for which periodic safety update reporting is not routinely required.
Vendar pa bi morali pristojni organi v interesu javnega zdravja zahtevati redna posodobljena poročila o varnosti takih zdravil, kadar obstajajo pomisleki zaradi farmakovigilančnih podatkov ali ker je na voljo premalo varnostnih podatkov v primeru, da se uporaba zadevne zdravilne učinkovine osredotoča na zdravila, za katere se ne zahteva redno poročanje o varnosti.
It is necessary to increase the shared use of resources between competent authorities for the assessment of periodic safety update reports.
Povečati je treba skupno uporabo virov med pristojnimi organi za ocenjevanje rednih posodobljenih poročil o varnosti zdravil.
A single assessment of periodic safety update reports for medicinal products authorised in more than one Member State should be provided for.
Treba bi bilo predvideti enotno ocenjevanje rednih poročil o varnosti zdravil, odobrenih v več kot eni državi članici.
Moreover, procedures should be established to set single frequency and submission dates of periodic safety update reports for all medicinal products containing the same active substance or the same combination of active substances.
Poleg tega bi bilo treba vzpostaviti postopke, da se določi enotna pogostost in roki za predložitev rednih posodobljenih poročil o varnosti vseh zdravil, ki vsebujejo isto zdravilno učinkovino ali isto kombinacijo zdravilnih učinkovin.
Following a single assessment of periodic safety update reports, any resulting measures as regards the maintenance, variation, suspension or revocation of the marketing authorisations concerned should be adopted through a Union procedure leading to a harmonised result.
Po enotnem ocenjevanju rednih posodobljenih poročil o varnosti zdravila bi bilo treba vse ukrepe, ki iz tega izhajajo, glede ohranitve, spremembe, začasnega preklica ali razveljavitve zadevnega dovoljenja za promet z zdravilom, sprejeti po postopku Unije, ki vodi k usklajenemu rezultatu.
The Member States should automatically submit certain safety issues related to medicinal products to the Agency thereby triggering a Union-wide assessment of the issue.
Države članice bi morale Agenciji samodejno predložiti določena varnostna vprašanja, ki se nanašajo na zdravila in s tem sprožiti oceno vprašanja na ravni Unije.
Therefore it is appropriate to establish rules for an assessment procedure by the Pharmacovigilance Risk Assessment Committee, and for the subsequent follow-up as regards the marketing authorisations concerned with a view to the adoption of harmonised measures across the Union.
Zato je primerno določiti pravila za oblikovanje postopka Odbora za ocenjevanje tveganja na področju farmakovigilance ter pravila za naknadno nadaljnje spremljanje glede pogojev zadevnih dovoljenj za promet z zdravilom zaradi sprejetja usklajenih ukrepov v vsej Uniji.
In connection with the clarification and strengthening of the provisions relating to pharmacovigilance activities in Directive 2001/83/EC, it is also appropriate to further clarify the procedures for all Union-wide post-authorisation assessments of safety issues concerning medicinal products.
V povezavi s sedanjo pojasnitvijo in krepitvijo določb v zvezi z dejavnostmi farmakovigilance v Direktivi 2001/83/ES je primerno tudi dodatno pojasniti postopke za ocenjevanje v celotni Uniji vseh varnostnih vprašanj o zdravilih po odobritvi.
To that end, the number of procedures for Union-wide assessment should be limited to two, one of which allows for a swift assessment and should be applied when urgent action is considered necessary.
V ta namen bi bilo treba število postopkov za ocenjevanje po vsej Uniji omejilo na dva, od katerih eden omogoča hitro oceno in bi se moral uporabiti v primeru, ko je treba nujno ukrepati.
Regardless of whether the urgent procedure or the normal procedure is applied, and whether the medicinal product was authorised through the centralised or non-centralised procedure, the Pharmacovigilance Risk Assessment Committee should always give its recommendation when the reason for taking action is based on pharmacovigilance data.
Ne glede na to, ali se uporabi nujen ali običajen postopek in ali se je zdravilo odobrilo prek centraliziranih ali necentraliziranih postopkov, bi moral Odbor za ocenjevanje tveganja na področju farmakovigilance vedno podati svoje priporočilo, ko so farmakovigilančni podatki razlog za ukrepanje.
It is appropriate that the coordination group and the Committee for Medicinal Products for Human Use should rely on this recommendation when performing their assessment of the issue.
Primerno je, da se skupina za usklajevanje in Odbor za zdravila za uporabo v humani medicini opreta na to priporočilo pri izvajanju svojega ocenjevanja vprašanja.
It is necessary to introduce harmonised guiding principles for, and regulatory supervision of, post-authorisation safety studies that are requested by competent authorities and that are non-interventional, that are initiated, managed or financed by the marketing authorisation holder, and that involve the collection of data from patients or healthcare professionals and that therefore fall outside of the scope of Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use [7].
Treba je uvesti regulativni nadzor in usklajena vodilna načela za ne-intervencijske študije varnosti po pridobitvi dovoljenja, ki jih zahtevajo pristojni organi in ki jih začne, upravlja ali financira imetnik dovoljenja za promet z zdravilom in ki vključujejo zbiranje podatkov od bolnikov ali zdravstvenih delavcev ter tako ne spadajo na področje uporabe Direktive 2001/20/ES Evropskega parlamenta in Sveta z dne 4. aprila 2001 o približevanju zakonov in drugih predpisov držav članic v zvezi z izvajanjem dobre klinične prakse pri kliničnem preskušanju zdravil za ljudi [7].
The supervision of such studies should be the responsibility of the Pharmacovigilance Risk Assessment Committee.
Za nadzor takih študij bi moral biti odgovoren Odbor za ocenjevanje tveganja na področju farmakovigilance.
Studies requested after the marketing authorisation of a medicinal product by only one competent authority to be conducted in only one Member State should be supervised by the national competent authority of the Member State in which the study is to be conducted.
Študije, ki jih po pridobitvi dovoljenja za promet z zdravilom zahteva samo en pristojni organ in ki se izvajajo v samo eni državi članici, bi moral nadzorovati nacionalni pristojni organ države članice, v kateri se ta študija izvaja.
Provision should also be made for the subsequent follow-up, if appropriate, as regards the marketing authorisations concerned with a view to the adoption of harmonised measures across the Union.
Treba bi bilo določiti tudi naknadno nadaljnje spremljanje, če je to primerno, glede zadevnih dovoljenj za promet z zdravili zaradi sprejetja usklajenih ukrepov v vsej Uniji.
In order to enforce the provisions relating to pharmacovigilance, the Member States should ensure that effective, proportionate and dissuasive penalties are applied to marketing authorisation holders for non-compliance with pharmacovigilance obligations.
Države članice bi morale zaradi uveljavljanja določb v zvezi s farmakovigilanco zagotoviti, da za imetnike dovoljenj za promet z zdravili, ki ne izpolnjuje obveznosti farmakovigilance, veljajo učinkovite, sorazmerne in odvračilne kazni.
If the conditions included in the marketing authorisation are not fulfilled within the given deadline, the national competent authorities should have the power to review the marketing authorisation.
Če pogoji iz dovoljenja za promet z zdravilom niso izpolnjeni v predvidenem roku, bi morali biti nacionalni pristojni organi pooblaščeni, da pregledajo dovoljenje za promet z zdravilom.
In order to protect public health, the pharmacovigilance activities of national competent authorities should be adequately funded.
Pristojnim nacionalnim organom bi moralo biti za varovanje javnega zdravja zagotovljeno ustrezno financiranje dejavnosti v zvezi s farmakovigilanco.
It should be ensured that adequate funding is possible for pharmacovigilance activities by empowering the national competent authorities to charge fees to marketing authorisation holders.
Zagotoviti bi bilo treba možnost ustreznega financiranja dejavnosti farmakovigilance s pooblastilom pristojnim nacionalnim organom za zaračunavanje pristojbin imetnikom dovoljenj za promet z zdravilom.
However, the management of those collected funds should be under the permanent control of the national competent authorities in order to guarantee their independence in the performance of those pharmacovigilance activities.
Upravljanje navedenih zbranih sredstev pa bi moralo biti pod stalnim nadzorom pristojnih nacionalnih organov, da se zagotovi njihova neodvisnost pri izvajanju teh farmakovigilančnih dejavnosti.
It should be possible for Member States to allow the relevant actors, under certain conditions, to deviate from certain provisions of Directive 2001/83/EC related to the requirements for labelling and packaging in order to address severe availability problems related to the potential lack of authorised medicinal products or of medicinal products placed on the market or shortages thereof.
Države članice bi morale imeti možnost, da zadevnim subjektom pod določenimi pogoji dovolijo odstopanja od nekaterih določb Direktive 2001/83/ES v zvezi z zahtevami glede označevanja in pakiranja, da se obravnavajo resne težave v zvezi z dostopnostjo, povezane z morebitnim pomanjkanjem zdravil, ki so pridobila dovoljenje za promet, ali zdravil, ki se dajejo v promet, ali primanjkljajem teh zdravil.
Since the objective of this Directive, namely to improve the safety of medicinal products placed on the market in the Union in a harmonised way across the Member States, cannot be sufficiently achieved by the Member States and can, by reason of the scale of the measures, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union (TEU).
Ker cilja te direktive, in sicer usklajenega izboljšanja varnosti zdravil v vseh državah in ki so v prometu v Uniji, države članice ne morejo zadovoljivo doseči in ker se ta cilj lažje doseže na ravni Unije, lahko Unija sprejme ukrepe v skladu z načelom subsidiarnosti iz člena 5 Pogodbe o Evropski uniji (PEU).
In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary in order to achieve this objective.
V skladu z načelom sorazmernosti iz istega člena ta direktiva ne presega tistega, kar je potrebno za doseganje navedenega cilja.
This Directive shall apply without prejudice to Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data [8] and Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies and on the free movement of such data [9].
Ta direktiva se uporablja brez poseganja v Direktivo 95/46/ES Evropskega parlamenta in Sveta z dne 24. oktobra 1995 o varstvu posameznikov pri obdelavi osebnih podatkov in o prostem pretoku takih podatkov [8] ter Uredbo (ES) št. 45/2001 Evropskega parlamenta in Sveta z dne 18. decembra 2000 o varstvu posameznikov pri obdelavi osebnih podatkov v institucijah in organih Skupnosti in o prostem pretoku takih podatkov [9].
In order to detect, assess, understand and prevent adverse reactions, and to identify and take actions to reduce the risks of, and increase the benefits from, medicinal products for the purpose of safeguarding public health, it should be possible to process personal data within the Eudravigilance system while respecting Union legislation relating to data protection.
Za odkrivanje, oceno, razumevanje in preprečevanje neželenih učinkov ter za prepoznavanje in izvajanje ukrepov za zmanjšanje tveganj in povečanje koristi zdravil z namenom varovanja javnega zdravja, bi morala obstajati možnost obdelave osebnih podatkov v okviru sistema Eudravigilance, ob spoštovanju zakonodaje Unije o varstvu osebnih podatkov.
The purpose of safeguarding public health constitutes a substantial public interest and consequently the processing of personal data can be justified if identifiable health data are processed only when necessary and only when the parties involved assess this necessity at every stage of the pharmacovigilance process.
Ta namen varovanja javnega zdravja je pomemben javni interes, zaradi katerega je lahko obdelava osebnih podatkov upravičena, če se določljivi zdravstveni podatki obdelajo le kadar je to potrebno in le kadar udeležene strani to potrebo ocenijo na vsaki stopnji procesa farmakovigilance.