natgillin/translations-raw huggingface dataset:
Please note that the document contains links to sections of the EMA website, some of which are only available in English.
Opozarjamo vas, da dokument vsebuje povezave do razdelkov spletišča EMA, med katerimi so nekateri na voljo samo v angleščini.
Facilitate development and access to medicines
Omogočanje razvoja in dostopa do zdravil
If a company wishes to request marketing authorisation in several EU Member States for a medicine that is outside the scope of the centralised procedure, it may use one of the following routes:
Če družba želi v več državah članicah EU zaprositi za dovoljenje za promet z zdravilom, ki ne spada na področje uporabe centraliziranega postopka, lahko uporabi eno od naslednjih poti:
It is consulted on the rules of procedure and the membership of the Agency's committees.
Z njim se posvetujejo o poslovniku in članstvu odborov agencije.
The aim is to mobilise the best expertise for medicines evaluation, regardless of where experts are based.
Cilj je zbrati najboljše strokovno znanje za vrednotenje zdravil ne glede na to, kje se nahajajo strokovnjaki.
The representatives of the Member States, European Commission and European Parliament are appointed directly by the Member State and institution concerned.
Predstavnike držav članic, Evropske komisije in Evropskega parlamenta neposredno imenujejo države članice in zadevne institucije.
It bases these decisions on:
Te odločitve temeljijo na:
They are selected to guarantee the highest levels of specialist qualifications, a broad spectrum of relevant expertise and the broadest possible geographical spread within the EU.
Člani so izbrani tako, da zagotavljajo najvišje ravni specialističnih kvalifikacij, najrazličnejšo ustrezno strokovnost in najširšo možno geografsko razpršenost v EU.
The majority of medicines available in the EU were authorised at national level, either because they were authorised before EMA's creation or they were not in the scope of the centralised procedure.
Za večino zdravil, ki so na voljo v EU, je bilo dovoljenje izdano na nacionalni ravni, ker so bila odobrena pred ustanovitvijo agencije EMA ali ker niso spadala na področje uporabe centraliziranega postopka.
All medicines must be authorised before they can be marketed and made available to patients.
Za vsa zdravila je treba pridobiti dovoljenje, preden jih je mogoče dati v promet in na voljo bolnikom.
It is optional for other medicines:
Neobvezen je za druga zdravila:
• informing the public on the safety of medicines and cooperating with external parties, in particular representatives of patients and healthcare professionals.
• javnost obvešča o varnosti zdravil in sodeluje z zunanjimi strankami, zlasti predstavniki bolnikov in zdravstvenih delavcev.
As of 2015, EMA reviews all of its policies on independence and rules for handling competing interests and their implementation on an annual basis and publishes an annual report.
Od leta 2015 agencija EMA vsako leto pregleda vse svoje politike o neodvisnosti in pravila o obravnavanju navzkrižja interesov ter njihovo izvajanje in objavi letno poročilo.
In addition to the members, the Management Board also has one observer each from Iceland, Liechtenstein and Norway.
Poleg članov ima tudi po enega opazovalca z Islandije, iz Lihtenštajna in Norveške.
EMA does not:
Agencija EMA ne:
The Agency also seeks to publish clear and up-to-date information on how it operates, including planning and reporting documents and information on funding, financial management and budgetary reporting.
Agencija si tudi prizadeva, da bi objavila jasne in posodobljene informacije o svojem delovanju, vključno z dokumenti o načrtovanju in poročanju ter informacijami o financiranju, finančnem poslovodenju in poročanju o proračunu.
Not all aspects of medicine regulation in the EU fall under the remit of the Agency.
Vsi vidiki pravne ureditve zdravil v EU niso v pristojnosti agencije.
The revised rules are similar to the principles adopted for committee members and experts.
Spremenjena pravila so podobna načelom, ki so bila sprejeta za člane odborov in strokovnjake.
Some of the data are supplied by the Member States and centrally managed by EMA.
Nekatere podatke zagotovijo države članice, centralno pa jih upravlja agencija EMA.
• that are a significant therapeutic, scientific or technical innovation;
• ki pomenijo pomembno terapevtsko, znanstveno ali tehnično inovacijo;
Benefits of the network for EU citizens
Prednosti mreže za državljane EU
The Agency also implements policies and procedures to ensure its works independently, openly and transparently and upholds the highest standards in its scientific recommendations.
Izvaja tudi politike in postopke za zagotavljanje neodvisnosti, odprtosti in preglednosti svojega dela ter pri svojih znanstvenih priporočilih upošteva najvišje standarde.
The European medicines regulatory network is the cornerstone of EMA's work and success.
Evropska regulativna mreža za zdravila je steber delovanja in uspeha agencije EMA.
• containing new active substances for indications other than those stated above;
• ki vsebujejo nove učinkovine za indikacije, ki niso navedene zgoraj;
EMA is involved in the assessment of certain categories of medical devices.
EMA sodeluje pri ocenjevanju nekaterih kategorij medicinskih pripomočkov.
All Management Board members must submit a DoI every year.
Vsi člani upravnega odbora morajo vsako leto predložiti izjavo o interesih.
• Transparency
• Preglednost;
This document provides an overview of the main responsibilities of the European Medicines Agency (EMA).
Dokument vsebuje pregled glavnih pristojnosti Evropske agencije za zdravila (EMA).
The four ‘civil society' Board members (patients', doctors' and veterinarians' representatives) are appointed by the Council of the European Union, after consultation of the European Parliament.
Štiri člane upravnega odbora, ki zastopajo „civilno družbo“ (predstavnike bolnikov, zdravnikov in veterinarjev), imenuje Svet Evropske unije po posvetovanju z Evropskim parlamentom.
EMA/338312/2016 Rev. 2 European Medicines Agency
EMA/338312/2016, izd.
They can be nominated by Member States or by the Agency itself and are made available by the national competent authorities.
Imenujejo jih lahko države članice ali agencija, na voljo pa jih dajo pristojni nacionalni organi.
It is responsible for adopting the implementing provisions for the practical application of the rules and regulations applicable to officials and other EU staff.
Odgovoren je za sprejetje izvedbenih določb za praktično izvajanje pravil in predpisov, ki se uporabljajo za uradnike in druge uslužbence EU.
This helps to reduce duplication and supports efficient and effective regulation of medicines across the EU.
S tem se zmanjša podvajanje ter podpira učinkovita in uspešna zakonska ureditev zdravil v EU.
The European Commission also develops EU policies in the field of human or veterinary medicines and public health.
Evropska komisija oblikuje tudi politiko EU na področju zdravil za uporabo v humani ali veterinarski medicini ter javnega zdravja.
The regulatory network also includes the European Commission , whose principal role in the European system is to take binding decisions based on the scientific recommendations delivered by EMA.
V regulativno mrežo je vključena tudi Evropska komisija , katere glavna naloga v evropskem sistemu je sprejemanje zavezujočih odločitev, ki temeljijo na znanstvenih priporočilih agencije EMA.
How we work
Kako delujemo
What we don't do
Česa ne delamo
• paediatric procedures;
• pediatrični postopki;
This includes public versions of scientific assessment reports and summaries written in lay language.
To vključuje javne različice poročil o znanstvenih ocenah in poljudno napisane povzetke.
From April 2017, multinational teams can also evaluate certain post-authorisation applications to extend existing marketing authorisations.
Od aprila leta 2017 lahko mednarodne skupine ocenjujejo tudi nekatere vloge po pridobitvi dovoljenja za promet za razširitev obstoječih dovoljenj za promet.
It includes a number of measures which take into account the nature of the declared interest before determining the length of time any restrictions may apply:
Politika vključuje več ukrepov, ki upoštevajo naravo prijavljenih interesov, preden se določi trajanje veljavnosti omejitev:
It has legally enforceable rule-making authority for implementation of certain parts of the fee regulation.
Ima pravno izvršljivo pristojnost za pripravo pravil o izvajanju nekaterih delov uredbe o pristojbinah.
• Enables Member States to pool resources and coordinate work to regulate medicines efficiently and effectively;
• Državam članicam omogoča združitev virov in usklajevanje dela za učinkovito in uspešno zakonsko ureditev zdravil.
• medicines derived from biotechnology processes, such as genetic engineering;
• zdravila, pridobljena v biotehnoloških postopkih, kot je genski inženiring;
In addition, the Agency has a number of working parties and related groups, which the committees can consult on scientific issues relating to their particular field of expertise.
Ima tudi številne delovne skupine in povezane skupine, s katerimi se lahko odbori posvetujejo glede znanstvenih vprašanj, ki se nanašajo na njihovo posebno strokovno področje.
This restriction is reflected in the guidance document.
Ta omejitev je upoštevana v smernicah;
This policy entered into force on 1 May 2016 and was subsequently updated in October 2016 to clarify restrictions for positions in a governing body of a professional organisation and to align the rules on grants or other funding with those for committee members and experts.
Ta politika je začela veljati 1. maja 2016, nato pa je bila posodobljena oktobra 2016, da bi pojasnili omejitve glede položajev v upravnem organu strokovne organizacije in uskladili pravila glede donacij ali drugih sredstev s pravili za člane odborov in strokovnjake.
• coordinating the monitoring of pharmaceutical companies' compliance with their pharmacovigilance obligations;
• usklajuje spremljanje skladnosti farmacevtskih družb z obveznostmi v zvezi s farmakovigilanco;
• contributing to international pharmacovigilance activities with authorities outside the EU;
• pri mednarodnih dejavnostih farmakovigilance sodeluje z organi zunaj EU;
• scientific advice and protocol assistance;
• znanstveno svetovanje in pomoč pri pripravi protokola;
In the EU, there are two main routes for authorising medicines: a centralised route and a national route.
V EU sta na voljo dva glavna načina za izdajo dovoljenja za zdravila: centralizirani postopek in nacionalni postopek.
• inspections to check compliance with good practice in the clinical development, manufacturing and distribution, and safety monitoring of medicines.
• inšpekcijskimi pregledi za preveritev skladnosti z dobro prakso pri kliničnem razvoju, proizvodnji in distribuciji zdravil ter spremljanju njihove varnosti.
This forms part of the package of controls and reports that lead to Executive Director receiving discharge for the Agency's budget.
To je sestavni del sklopa nadzorov in poročil, na podlagi katerih izvršni direktor prejme razrešnico za izvrševanje proračuna agencije.
The Board's operational tasks range from adopting legally binding implementing rules, to setting strategic directions for scientific networks, to reporting on the use of European Union (EU) contributions for the Agency's activities:
Njegove operativne naloge vključujejo sprejetje pravno zavezujočih izvedbenih pravil, določitev strateških usmeritev za znanstvene mreže in poročanje o porabi prispevkov Evropske unije (EU) za dejavnosti agencije.
Requirements for experts who are members of scientific committees are stricter than for those participating in advisory bodies and ad-hoc expert groups.
Zahteve za strokovnjake, ki so člani znanstvenih odborov, so strožje kot za sodelujoče v svetovalnih organih in priložnostnih strokovnih skupinah.
It has a supervisory role with general responsibility for budgetary and planning matters, the appointment of the Executive Director and the monitoring of the Agency's performance.
Ima nadzorno vlogo s splošno odgovornostjo za proračunske zadeve in zadeve v zvezi z načrtovanjem, za imenovanje izvršnega direktorja in spremljanje uspešnosti delovanja agencije.
As part of this process, the Board conducts an analysis and assessment of the Executive Director's annual activity report.
Upravni odbor v okviru tega postopka opravi analizo in oceno letnega poročila o dejavnostih, ki ga pripravi izvršni direktor.
The Board sets the Agency's budget, approves the annual work programme and is responsible for ensuring that the Agency works effectively and co-operates successfully with partner organisations across the EU and beyond.
Upravni odbor določi proračun agencije, odobri letni delovni program ter je odgovoren za učinkovito delovanje agencije in njeno uspešno sodelovanje s partnerskimi organizacijami v EU in zunaj nje.
By working closely together, this network ensures that safe, effective and high-quality medicines are authorised throughout the European Union (EU), and that patients, healthcare professionals and citizens are provided with adequate and consistent information about medicines.
Ta mreža s tesnim sodelovanjem zagotavlja, da se v vsej Evropski uniji (EU) odobrijo varna, učinkovita in visokokakovostna zdravila ter da se bolnikom, zdravstvenim delavcem in državljanom zagotovijo ustrezne in dosledne informacije o njih.
The tasks and responsibilities of the Management Board are set out in the Agency's legal background.
Naloge in odgovornosti upravnega odbora so določene v pravni podlagi agencije.
• Single evaluation by European experts.
• eno vrednotenje, ki ga opravijo evropski strokovnjaki;
The Agency's Executive Director is the legal representative of the Agency.
Izvršni direktor je pravni zastopnik agencije.
It has a key role to play in the 'discharge' (sign-off) process of the Agency's accounts by the European Union's budgetary authority.
Ima ključno vlogo v postopku „razrešnice“ (potrditve) zaključnega računa agencije, za katerega je pristojen proračunski organ Evropske unije.
This helps to optimise resource use across the regulatory network and encourage cross-border fertilisation of scientific expertise.
To pripomore k boljši rabi virov v celotni regulativni mreži in spodbuja čezmejno oplajanje strokovnega znanja in izkušenj.
The representatives of the Member States and of the Commission may have alternates.
Predstavniki držav članic in Komisije lahko imajo namestnike.
It adopts the Agency's financial regulation and its implementing rules, which are binding texts for the Agency, the Board and the Executive Director.
Sprejme finančno uredbo agencije in njena izvedbena pravila, ki so zavezujoča besedila za agencijo, upravni odbor in izvršnega direktorja.
The revised policy takes into account input from stakeholders at the Agency's September 2013 public workshop Best expertise vs conflicts of interests: striking the right balance.
V spremenjeni politiki so upoštevani prispevki, ki so jih deležniki zagotovili na javni delavnici agencije septembra 2013 z naslovom Najboljše strokovno znanje proti navzkrižju interesov: zagotovitev pravega ravnotežja.
For more information on the authorisation routes of medicines in the EU, see Chapter 2 of this document on the Authorisation of medicines;
Več informacij o načinih izdaje dovoljenja za promet z zdravili v EU je na voljo v poglavju 2 tega dokumenta z naslovom Izdajanje dovoljenj za zdravila;
• Creates certainty for patients, healthcare professionals, industry and governments by ensuring consistent standards and use of best available expertise;
• Bolnikom, zdravstvenim delavcem, industriji in vladam zagotavlja zanesljivost na podlagi doslednih standardov in uporabe najboljšega razpoložljivega strokovnega znanja.
− human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS);
− virusa humane imunske pomanjkljivosti (HIV) ali sindroma pridobljene imunske pomanjkljivosti
Monitor the safety of medicines across their lifecycle
Spremljanje varnosti zdravil v njihovem življenjskem ciklu
Pooling information
Združevanje informacij
They explain the allowable and non-allowable interests for staff, and include controls on the appointment of individuals as responsible for managing the evaluation of medicines.
Pravila pojasnjujejo dovoljene in nedovoljene interese zaposlenih ter vključujejo preverjanja za imenovanje posameznikov, odgovornih za vodenje vrednotenja zdravil.
EMA is committed to enabling timely patient access to new medicines, and plays a vital role in supporting medicine development for the benefit of patients.
Agencija EMA si prizadeva, da se bolnikom omogoči čimprejšnji dostop do novih zdravil, in ima ključno vlogo pri zagotavljanju podpore pri razvoju zdravil v korist bolnikov.
After assigning an interest level, the Agency uses the information provided to determine if an expert's involvement should be restricted or excluded in specific activities of the Agency, such as the evaluation of a particular medicine.
Agencija po določitvi ravni interesa uporabi predložene informacije za določitev, ali bi bilo treba vključitev strokovnjaka omejiti ali izključiti iz posebnih dejavnostih agencije, kot je vrednotenje določenega zdravila.
The diversity of the experts involved in the regulation of medicines in the EU encourages the exchange of knowledge, ideas and best practices between scientists striving for the highest standards for medicines regulation.
Z najrazličnejšimi strokovnjaki, vključenimi v zakonsko ureditev zdravil v EU, se spodbuja izmenjava znanja, zamisli in dobrih praks med znanstveniki v prizadevanju, da bi dosegli najvišje standarde za zakonsko ureditev zdravil.
The Board also gives its opinion on the Agency's annual accounts.
Upravni odbor izda tudi mnenje o zaključnih računih agencije.
EMA also plays a role in supporting research and innovation in the pharmaceutical sector, and promotes innovation and development of new medicines by European micro-, small- and mediumsized-enterprises.
Agencija EMA ima pomembno vlogo tudi pri zagotavljanju podpore raziskavam in inovacijam na farmacevtskem področju ter spodbuja inovacije in razvoj novih zdravil v evropskih mikro, malih in srednjih podjetjih.
The members of the Management Board are appointed on the basis of their expertise in management and, if appropriate, experience in the field of human or veterinary medicines.
Člani upravnega odbora so imenovani na podlagi svoje strokovnosti pri vodenju in, če je ustrezno, izkušenj na področju zdravil za uporabo v humani ali veterinarski medicini.
Benefits for EU citizens
Prednosti za državljane EU:
The Agency operates at the heart of the network, coordinating and supporting interactions between over fifty national competent authorities for both human and veterinary medicines.
Agencija deluje v središču mreže ter usklajuje in podpira sodelovanje več kot 50 pristojnih nacionalnih organov na področju zdravil za uporabo v humani in veterinarski medicini.
EMA coordinates inspections in connection with the assessment of marketing-authorisation applications or matters referred to its committees.
Agencija EMA usklajuje inšpekcijske preglede v zvezi z oceno vlog za izdajo dovoljenja za promet ali zadevami, ki se predložijo njenim odborom.
National governments or the health authorities of individual EU Member States develop guidelines for decisions regarding diagnosis, management, and treatment in specific areas of healthcare (sometimes known as clinical guidelines);
• razvija smernic za zdravljenje: nacionalne vlade ali zdravstveni organi posameznih držav članic EU oblikujejo smernice za odločitve v zvezi z diagnozo, upravljanjem in zdravljenjem na posebnih področjih zdravstvenega varstva (za katere se včasih uporablja izraz klinične smernice);
• scientific guidelines on requirements for the quality, safety and efficacy testing of medicines;
• znanstvene smernice o zahtevah za presojo kakovosti, varnosti in učinkovitosti zdravil;
The Agency updated the procedure in April 2015 to align it with the current version of the policy on handling competing interests and to take into account experience gained since it was first endorsed by EMA's Management Board in 2012.
Agencija je politiko posodobila aprila 2015, da bi jo uskladila s trenutno različico politike o obravnavanju navzkrižja interesov in upoštevala izkušnje, ki jih je pridobila od takrat, ko je upravni odbor agencije EMA potrdil prvo izdajo leta 2012.
EMA continuously monitors and supervises the safety of medicines that have been authorised in the EU, to ensure that their benefits outweigh their risks.
Agencija EMA stalno spremlja in nadzoruje varnost zdravil, za katera so bila izdana dovoljenja za promet v EU, s čimer zagotavlja, da njihove koristi prevladajo nad tveganji.
The Agency's staff support the Executive Director in carrying out his responsibilities, including administrative and procedural aspects of EU law related to the evaluation and safety-monitoring of medicines in the EU.
Zaposleni v agenciji pomagajo izvršnemu direktorju pri opravljanju nalog, vključno z upravnimi in postopkovnimi vidiki zakonodaje EU, ki se nanašajo na vrednotenje in spremljanje varnosti zdravil v EU.
• Reduces the administrative burden through the centralised authorisation procedure, helping medicines to reach patients faster;
• S centraliziranim postopkom izdaje dovoljenj zmanjšuje upravno breme in pripomore k temu, da zdravila hitreje dosežejo bolnike.
EMA and the national authorities depend on standards, processes and Information Technology (IT) systems that allow important information on medicines to be shared between European countries and analysed together.
Agencija EMA in nacionalni organi so odvisni od standardov, postopkov in sistemov informacijske tehnologije (IT), ki omogočajo izmenjavo pomembnih informacij o zdravilih med evropskimi državami in njihovo skupno analizo.
The Agency's code of conduct extends the requirements for impartiality and the submission of annual DoIs to all staff members working at the Agency.
Kodeks dobrega upravnega ravnanja agencije razširja zahteve za nepristranskost in predložitev letnih izjav o interesih na vse zaposlene v agenciji.
• one representative of each of the EU Member States;
• po enega predstavnika vsake države članice EU;
EMA has seven scientific committees that evaluate medicines along their lifecycle from early stages of development, through marketing authorisation to safety monitoring once they are on the market.
Agencija EMA ima sedem znanstvenih odborov, ki vrednotijo zdravila v njihovem življenjskem ciklu, od zgodnjih stopenj razvoja in izdaje dovoljenja za promet do spremljanja varnosti po tem, ko so bila dana na trg.
The scheme began with co-rapporteur assessment teams for human medicines (CHMP and CAT), then expanded to rapporteur assessment teams, veterinary medicines (CVMP) and scientific advice procedures.
Program se je začel s skupinami soporočevalcev za ocenjevanje zdravil za uporabo v humani medicini (odbora CHMP in CAT), nato pa se je razširil na skupine poročevalcev za ocenjevanje, zdravila za uporabo v veterinarski medicini (odbor CVMP) in postopke znanstvenega svetovanja.
4. Who we are
Kdo smo
EMA is governed by an independent Management Board.
Vodi jo neodvisni upravni odbor.
EMA's scientific committees provide independent recommendations on medicines for human and veterinary use, based on a comprehensive scientific evaluation of data.
Znanstveni odbori agencije EMA pripravljajo neodvisna priporočila o zdravilih za uporabo v humani in veterinarski medicini, ki temeljijo na celoviti znanstveni oceni podatkov.
For more information see European Commission: Medicinal products for human use;
Več informacij je na voljo na spletišču Evropske komisije: Zdravila za uporabo v humani medicini ;