natgillin/translations-raw huggingface dataset:
The Agency's work with its international partners will intensify, particularly in the context of the continued implementation of confidentiality arrangements with the US Food and Drug Administration (FDA), and implementation of the recently signed arrangements with the Japanese and Canadian health authorities.
Sodelovanje Agencije z mednarodnimi partnerji se bo še okrepilo, zlasti v okviru nadaljnjega izvajanja dogovorov o zaupnosti z ameriškim Uradom za zdravila in živila (FDA) in izvajanja nedavno podpisanega dogovora z japonskimi in kanadskimi zdravstvenimi organi.
In addition, the Agency plans to provide public access to information on paediatric clinical trials by the end of 2008, to create further transparency in this area (EU telematics project).
Hkrati namerava Agencija do konca leta 2008 omogočiti javni dostop do informacij o pediatričnih kliničnih preskušanjih (telematski projekt EU) za nadaljnje ustvarjanje preglednosti na področju pediatričnih kliničnih preskušanj.
Annex 2 EMEA establishment plan 2006-2008
Priloga 2 Načrt delovnih mest agencije EMEA za obdobje 2006-2008
As for human medicinal products, the Agency will carry out preparatory work to provide access to EudraVigilance Veterinary data by the professional community and the general public.
Kot v primeru zdravil za uporabo v humani medicini bo Agencija opravljala pripravljalno delo za omogočanje dostopa do podatkov veterinarskega sistema EudraVigilance za strokovne kroge in splošno javnost.
The Agency will support the European Commission in any necessary follow-up to the report.
Agencija bo Komisijo podprla, če bo potrebna kakršna koli dopolnitev.
GCP and pharmacovigilance inspections are expected to rise relative to previous years, taking into account the GCP policy on increasing numbers of routine inspections and increasing pharmacovigilance activity, as well as the need for greater supervision of the conduct and ethical standards of clinical trials performed outside the EU.
Pričakuje se, da bodo inšpekcijski pregledi dobre klinične prakse (GCP) in farmakovigilance številčnejši kot v prejšnjih letih, kar temelji na politiki dobre klinične prakse glede povečanja števila rutinskih inšpekcijskih pregledov in povečane dejavnosti na področju farmakovigilance ter tudi na potrebi po večjem nadzoru etičnih standardov in načina izvajanja kliničnih preskušanj zunaj EU.
The primary responsibility for implementation lies with the Agency, under the auspices of the telematics management structure.
Agencija ima glavno vlogo pri izvajanju pod okriljem telematske upravljalne sheme.
EMEA IN THE EUROPEAN MEDICINES NETWORK
EMEA v Evropski mreži zdravil
This will continue to be done as part of the review process for initial marketing authorisations and will be reflected in the European public assessment reports (EPARs).
To se bo še naprej izvajalo kot del postopka pregleda za izdajo začetnega dovoljenja za promet z zdravilom in bo razvidno v evropskih javnih poročilih o oceni zdravil (EPAR).
PDCO Paediatric Committee
PDCO Odbor za pediatrijo
The EMEA PMF/VAMF-certification process is an assessment of the PMF/VAMF-application dossier.
Certifikacijski postopek agencije EMEA za PMF/VAMF je ocena dokumentacije za vlogo za PMF/VAMF.
The Agency's interaction and engagement with patients and healthcare professionals will continue.
Agencija bo še naprej vzdrževala stike z bolniki in zdravstvenimi delavci.
For enquiries concerning VAMF certificates
Za vprašanja v zvezi s potrdili VAMF
However, the Agency expects that the number of referrals due to differences in opinion at Member State level in the framework of mutual-recognition procedures will be similar to that of 2007.
Agencija kljub temu pričakuje, da bo zaradi razlik v mnenjih med državami članicami glede postopkov vzajemnega priznavanja število napotitev primerljivo s številom v letu 2007.
Review and further strengthen collaboration with the FDA in the context of the EU/US FDA confidentiality arrangements; implement the EU/Japanese Health Authorities and EU/Health Canada confidentiality arrangements.
Preučiti in nadalje okrepiti sodelovanje z Uradom za zdravila in živila (FDA) v okviru dogovorov o zaupnosti med EU in ameriškim uradom FDA; izvajati dogovore o zaupnosti med EU in japonskimi zdravstvenimi organi ter EU in Ministrstvom za zdravje iz Kanade;
Improve the methodology for determining benefit-risk balance of both human and veterinary medicinal products in order to improve predictability and consistency of the Agency's scientific opinions; place more emphasis on benefit-risk issues in the post-authorisation phase.
Izboljšava metodologije za določanje ravnovesja med koristmi in tveganji pri zdravilih za uporabo v humani in veterinarski medicini, da bi se izboljšala predvidljivost in skladnost znanstvenih mnenj Agencije; večji poudarek na vidike koristi in tveganj pri zdravilih v fazi po pridobitvi dovoljenja za promet;
transparency, communication, paediatric medicines and the benchmarking of European medicines agencies (BEMA).
razvijanja sposobnosti, mreže zdravstvenih informacij, preglednosti, komunikacije, zdravil za uporabo v pediatriji ter primerjalno analizo evropskih agencij za zdravila (BEMA);
The Agency also plans to work with the US FDA to implement the process for parallel designation of orphan medicinal products.
Hkrati namerava Agencija sodelovati z Uradom za živila in zdravila (FDA) iz ZDA pri izvajanju postopka vzporednega določanja zdravil sirot.
In the area of initial evaluation of medicines, the Agency will work to improve the content and presentation of information in the assessment report of the Committee for Medicinal Products for Human Use and in the EPARs.
Na področju začetne ocene zdravil se bo Agencija trudila izboljšati vsebino in predstavitev informacij v poročilu o oceni, ki ga izda Odbor za zdravila za uporabo v humani medicini, in javnih poročilih (EPAR).
These certify the marketing-authorisation and good-manufacturing status of medicinal products in the EU and are intended for use in support of marketing-authorisation applications in, and export to, non-EU countries.
Ta potrjujejo izdajo dovoljenja za promet in dober proizvodni status zdravil v EU, uporabljajo pa se kot spremni dokumenti k vlogam za izdajo dovoljenj za promet v državah, ki niso članice EU, in za izvoz v te države.
Foster transparency, communication and provision of information
Pospeševati preglednost, obveščanje in zagotavljanje informacij
This takes into account the increasing number of authorised products requiring reinspection, increasing numbers of variations, the impact of generic applications, and new requirements for GMP for active substances.
To pričakovanje temelji na večjem številu izdelkov z dovoljenjem za promet, za katere je potreben ponovni pregled, na večjem številu sprememb, vplivu generičnih vlog in novih zahtevah za dobro proizvodno prakso pri zdravilnih učinkovinah.
Continue to apply a proactive approach to safety of medicines throughout their lifecycle, through initiatives undertaken in the context of the European Risk-Management Strategy (ERMS), in particular by implementing the ENCePP (European Network of Centres of Pharmacovigilance and Pharmacoepidemiology) project, by further developing EudraVigilance as a cornerstone of the EU Pharmacovigilance System, and by further improving the concept of risk-management plans for medicines for human use.
Nadaljnji proaktivni pristop k varnosti zdravil skozi njihov življenjski cikel, s pobudami v okviru Evropske strategije obvladovanja tveganja (ERMS), zlasti z izvajanjem projekta Evropske mreže centrov za farmakovigilanco in farmakoepidemiologijo, z nadaljnjim razvojem sistema EudraVigilance kot temelja sistema farmakovigilance EU in z nadaljnjo izboljšavo koncepta načrtov za obvladovanje tveganja pri uporabi zdravil v humani medicini;
This trend, coupled with the requirements of legislation that aims to improve the availability of medicines for children, increases the need for the Agency to ensure that due care is given to ethical standards in clinical trials performed in non-EU countries.
Ta trend, skupaj z zakonodajnimi zahtevami, katerih namen je izboljšati dostopnost zdravil za otroke, še povečujejo potrebo, da Agencija zagotovi upoštevanje etičnih načel pri kliničnih preskušanjih zunaj EU.
The focus of additional activities in the area of evaluation of veterinary medicines will include further improvement of the quality-assurance system in respect of the procedures of the Committee for Medicinal Products for Veterinary Use (CVMP) and establishing systems for peer review of the quality and consistency of scientific assessments.
Na področju vrednotenja veterinarskih zdravil bo poudarek na dodatnih dejavnostih za nadaljnje izboljšave sistema zagotavljanja kakovosti glede na postopke Odbora za zdravila v veterinarski medicini (CVMP) in uvedbo sistema za stanovski strokovni pregled kakovosti in skladnosti znanstvenih vrednotenj.
In 2008, the scope of the mandatory centralised procedure will extend to products for autoimmune diseases and other immune dysfunctions and viral diseases.
V letu 2008 bo obvezen centralizirani postopek veljal tudi za zdravila za avtoimune bolezni in druge motnje
In addition, the Agency plans to upgrade the functionality of the EudraCT database as specified by the Clinical Trials Facilitation Group (EU telematics project).
Poleg tega namerava Agencija nadgraditi funkcionalnost podatkovne baze EudraCT, kot jo je opredelila Skupina za omogočanje kliničnih preskušanj (telematski projekt EU).
The effective conduct of the Agency's core responsibilities, in cooperation with all members of the European medicines network, in the areas of scientific advice, evaluation and supervision of medicinal products to the highest quality standards will continue to constitute the Agency's overall priority.
Splošna prednostna naloga Agencije bo še naprej ostalo učinkovito opravljanje njenih glavnih nalog, v sodelovanju z vsemi člani Evropske mreže zdravil, na področju znanstvenega svetovanja ter vrednotenja in nadzora zdravil za dosego najvišjih standardov kakovosti.
The certificates confirm the marketing-authorisation status of products authorised through the centralised procedure.
Potrdila potrjujejo, da so zdravila pridobila dovoljenje za promet po centraliziranem postopku.
In order to strengthen active pharmacovigilance, the Agency, together with its partners in the European medicines network, is implementing the European Risk-Management Strategy.
Da bi Agencija okrepila aktivno farmakovigilanco, izvaja s svojimi partnerji v Evropski mreži zdravil evropsko strategijo o obvladovanju tveganj (ERMS).
Medical information
Zdravstvene informacije
SPECIFIC MEDICINAL PRODUCT AREAS
Specifična področja zdravil
Work will continue on improving the website to enable easy access to information currently contained in various EMEA databases and other sources by stakeholders, in particular patients and healthcare professionals.
Delo bo usmerjeno v izboljšavo spletne strani, da se zainteresiranim stranem, zlasti bolnikom in zdravstvenim delavcem, omogoči preprost dostop do informacij, ki so trenutno zajete v različnih podatkovnih bazah EMEA in drugih virih.
Integrated quality management - Internal audit
Celovito obvladovanje kakovosti - notranja revizija Svetovalka za celovito obvladovanje kakovosti
In the field of human medicinal products, the Agency, in addition to the actions mentioned above, will focus on the implementation of the initiatives that the EMEA/CHMP Think-Tank on innovative drug development has elaborated.
Poleg zgoraj omenjenih dejavnosti se bo Agencija na področju zdravil za uporabo v humani medicini osredotočila na izvajanje pobud, ki jih je razvila ustvarjalna enota EMEA/CHMP za razvoj inovativnih zdravil.
Legal sector
Sektor za pravne zadve
The Agency will also progress the validation of the EudraVigilance data-analysis system (EU telematics project).
Agencija bo tudi nadaljevala validacijo sistema obdelave podatkov EudraVigilance (telematski projekt EU).
Additional functionalities will be added to the database and known defects resolved in the course of 2008 (EU telematics project).
V letu 2008 bodo podatkovni bazi dodane dodatne funkcionalnosti, in odpravljene bodo ugotovljene pomanjkljivosti (telematski projekt EU).
Taking this into account, and also considering the EU legislation aimed at improving the availability of medicinal products in children, the Agency will increase its supervision of the conduct and ethical standards of clinical trials performed outside the EU.
Ob upoštevanju tega dejstva ter glede na zakonodajo EU, ki želi izboljšati dostopnost zdravil za otroke, bo Agencija povečala nadzor izvajanja ter etičnih standardov pri kliničnih preskušanjih zunaj EU.
Continue the contribution to pan-European efforts to facilitate innovation and research, and thus to increase availability of medicines, in particular through participation in the work of the Innovative Medicines Initiative for human medicines, the European Technology Platform for Global Animal Health for veterinary medicines, and the continued implementation of recommendations of the EMEA/CHMP Think-Tank Group on innovative drug development.
Nadalje prispevati k vseevropskemu prizadevanju za spodbujanje inovacij in raziskav ter tako povečati dostopnost zdravil, zlasti s sodelovanjem pri delu pobude za inovativna zdravila za uporabo v humani medicini (Innovative Medicines Initiative), evropske tehnološke platforme za globalno zdravje živali (European Technology Platform for Global Animal Health) za zdravila za uporabo v veterinarski medicini ter z nadaljnjim izvajanjem priporočil ustvarjalne enote EMEA/CHMP za razvoj inovativnih zdravil;
The Agency provides financial incentives because such medicines might, for economic reasons, not otherwise be developed.
Takih zdravil iz gospodarskih razlogov morda ne bi razvijali, zato Agencija prispeva finančne spodbude.
For matters relating to pharmacovigilance for
Za zadeve v zvezi s farmakovigilanco za
Pharmacovigilance and post-authorisation safety and efficacy of medicines
Farmakovigilanca ter varnost in učinkovitost zdravil po izdaji dovoljenja za promet
Contribute to earlier availability of medicines for human and veterinary use
Prispevati k zgodnejši dostopnosti zdravil za uporabo v humani in veterinarski medicini
Promote the supervision of veterinary medicines once authorised, through effective and targeted pharmacovigilance, including further development and use of the EudraVigilance veterinary database for continuous surveillance, and establishment of the concept of risk-management plans as it applies to the veterinary context.
Spodbujanje nadzora zdravil za uporabo v veterinarski medicini po izdaji dovoljenja za promet z učinkovito in ciljno farmakovigilanco, kar vključuje nadaljnji razvoj in uporabo veterinarske baze podatkov EudraVigilance za stalni nadzor, in uvedbo koncepta načrtov za obvladovanje tveganja v okviru veterinarske medicine.
The Agency plans to make further progress on parallel review of the development of paediatric medicines with this international partner.
Agencija želi s svojim mednarodnim partnerjem doseči nadaljnji razvoj pri vzporednem ocenjevanju razvoja pediatričnih zdravil.
European public- and animal-health activities
1.4 Evropske dejavnosti na področju javnega zdravja in zdravja živali
For product quality defects and recalls see www.emea.europa.eu/inspections/defectinstruction.html for instructions and contact points
Za pomanjkljivosti izdelkov in druge preklice pojdite na naslov www.emea.europa.eu/inspections/defectinstruction.html, ki vsebuje navodila in kontaktne osebe E-pošta: qdefect@emea.europa.eu
Pharmacovigilance and maintenance activities
2.6 Farmakovigilanca in vzdrževalne dejavnosti
The Agency plans to streamline the implementation of legislative requirements regarding the review of profitability of such medicines after their authorisation, in the light of a new Commission guideline.
V skladu z novimi smernicami Komisije namerava Agencija racionalizirati izvajanje zakonodajnih zahtev v zvezi z ocenjevanjem dobičkonosnosti takih zdravil po pridobitvi dovoljenja za promet.
Parallel-distribution notifications (Input)
Obvestila o vzporedni distribuciji (Vhodni podatek)
To strengthen this trend and to facilitate the availability of medicines, the Agency will work with the Heads of Veterinary Medicines Agencies to implement new measures to provide support to companies considering applications for limited markets and/or for regional diseases.
Da bi te smernice okrepili in omogočili lažjo dostopnost zdravil, bo Agencija sodelovala z vodji agencij za veterinarska zdravila, da se bodo izvedli novi ukrepi za pomoč podjetjem, ki se zanimajo za dovoljenja za omejene trge in/ali lokalne bolezni.
The EMEA will continue to be involved in the work of the ICH, VICH and Codex Alimentarius, will participate in international standardisation activities, and will further collaborate with the WHO, the World Organisation for Animal Health and other international organisations.
EMEA bo še naprej vključena v delo ICH, VICH, Codexa Alimentariusa ter bo sodelovala pri mednarodnih dejavnostih na področju standardizacije.
Implement initiatives in cooperation with the Heads of Veterinary Medicines Agencies aimed at facilitating greater availability of veterinary medicines, particularly through measures to assist micro, small and medium-sized veterinary enterprises and companies seeking to authorise products for minor species and/or limited markets.
Izvajati pobude v sodelovanju z vodji agencij za zdravila za uporabo v veterinarski medicini s ciljem, da se omogoči večja dostopnost zdravil za uporabo v veterinarski medicini, zlasti z ukrepi za pomoč mikro, malim in srednje velikim veterinarskim podjetjem in družbam, ki želijo pridobiti dovoljenje za promet z zdravili za manj pomembne vrste in/ali za omejene trge.
Continue to improve the safety-monitoring of medicines for human and veterinary use
Nadalje izboljšati spremljanje varnosti zdravil za uporabo v humani in veterinarski medicini
Strengthen the European medicines network
Okrepiti Evropsko mrežo zdravil
Post-authorisation activities
2.5 Dejavnosti po izdaji dovoljenja
Sampling from the market in different countries is carried out by national inspectorates and testing is performed by official medicines-control laboratories coordinated by the European Directorate for the Quality of Medicines and HealthCare (EDQM).
Vzorčenje s trgov v različnih državah opravljajo nacionalni inšpektorati, preskušanje pa izvajajo uradni laboratoriji za kontrolo
This will be the sixth year of implementation by the Agency, with national competent authorities, of the EU telematics programme.
Leto 2008 bo šesto leto izvajanja programa EU telematskih projektov s strani Agencije v sodelovanju z nacionalnimi odgovornimi organi.
The Agency's Committee on Herbal Medicinal Products (HMPC) provides scientific opinions on questions relating to herbal medicines; establishes Community herbal monographs for traditional and well-established herbal medicinal products; establishes a draft list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products; provides opinions on herbal substances as needed; and evaluates referrals and arbitrations concerning traditional herbal medicinal products.
Odbor za zdravila rastlinskega izvora (HMPC) pripravlja strokovna mnenja o vprašanjih v zvezi z zdravili rastlinskega izvora, oblikuje monografije rastlin Skupnosti za tradicionalna in dobro uveljavljena zdravila rastlinskega izvora ter pripravlja osnutek seznama snovi rastlinskega izvora, pripravkov in njihovih kombinacij za uporabo v tradicionalnih zdravilih rastlinskega izvora.
on the Internet at www.emea.europa.eu by e-mail request to info@emea.europa.eu by fax to (44-20) 74 18 86 70 by writing to:
na internetu na naslovu www.emea.europa.eu na podlagi zahtevka, ki ga pošljete na elektronski naslov info@emea.europa.eu po faksu na št. (44-20) 7418 8670 pisno na naslov:
For enquiries concerning PMF certificates
Za vprašanja v zvezi s potrdili PMF
Applications for designation (input) Opinions on designation (output)
Vloge za določitev (vhodni podatek) Mnenja o določitvah (izhodni podatek)
SME Office contact point:
Kontaktna oseba Urada za mala in srednje velika podjetja:
The EMEA will work with the Heads of Veterinary Medicines Agencies to implement initiatives to be adopted by the EMEA Management Board aimed at facilitating greater availability of veterinary medicines through a set of measures to assist companies seeking to authorise products for minor species and/or limited markets.
EMEA bo sodelovala z vodji agencij za veterinarska zdravila pri izvajanju pobud, ki jih bo sprejel upravni odbor EMEA, katerih namen bo omogočiti večjo dostopnost veterinarskih zdravil, z ukrepi, ki bodo nudili pomoč podjetjem, ki bodo želela pridobiti dovoljenje za promet z zdravili za manj pomembne vrste in/ali omejene trge.
Arbitration and Community referrals
2.8 Arbitraža in napotitve Skupnosti
Scientific advice and follow-up requests Protocol assistance and follow-up requests
Zahtevki za znanstveno svetovanje in spremljanje Zahtevki za pomoč pri protokolu in spremljanje
The EMEA issues plasma-master-file (PMF) and vaccine-antigen-master-file (VAMF) certificates of a medicinal product in conformity with the arrangements laid down by Community legislation.
Agencija EMEA izdaja potrdila o glavnem dosjeju o plazmi (PMF) in glavnem dosjeju o antigenih cepiva (VAMF) v skladu z zakonodajo Skupnosti.
The Agency expects that the number of certificate requests will increase in 2008 by
Agencija pričakuje, da se bo število prošenj za potrdila v letu 2008 povečalo za 20 %.
In order to complete the development of EudraVigilance Veterinary, the Agency's Management Board adopted the EudraVigilance Veterinary Action Plan.
Upravni odbor Agencije je sprejel akcijski načrt veterinarskega sistema EudraVigilance (EudraVigilance Veterinary Action Plan), da bi dokončali razvoj veterinarskega sistema EudraVigilance.
A separate programme encompassing all information-management activities in the Agency will be launched to implement this objective.
Za dosego tega cilja bo Agencija začela izvajati poseben program, ki bo obsegal vse dejavnosti, ki zadevajo upravljanje informacij v Agenciji.
Project management
Projektno vodenje
Applications for initial evaluation (Input)
Vloge za začetno oceno (Vhodni podatek)
This will be done through the implementation of the EudraVigilance Action Plan, which helps the European medicines network to improve the quality of data submitted to the database.
Drugo področje dejavnosti bo zadevalo nenehne izboljšave podatkovne baze sistema EudraVigilance, kar bo Agenciji omogočilo izvajanje akcijskega načrta EudraVigilance, ki pomaga Evropski mreži zdravil izboljšati kakovost podatkov, posredovanih v podatkovno bazo.
ANNEXES
Priloge
In preparation for the implementation of legislation on advanced-therapy medicinal products, the Agency will develop guidance in the fields of post-authorisation follow-up on efficacy, adverse reactions and risk-management of these products.
Začetna obvestila skupaj izvajanje zakonodaje o zdravilih za napredne terapije razvila smernice za spremljanje učinkovitosti po izdaji dovoljenja za promet, neželenih učinkov ter obvladovanja tveganja pri teh zdravilih.
E-mail: certificate@emea.europa.eu authorised medicines for human or veterinary use
Za vprašanja v zvezi z dovoljenji za zdravila E-pošta: certificate@emea.europa.eu za uporabo v humani medicini in zdravila
Out-of-hours telephone: (44) 78 80 55 06 97
Telefon zunaj uradnih ur: (44)-7880 55 06 97
Martin HARVEY ALLCHURCH Direct telephone (44-20) 74 18 84 27 E-mail: press@emea.europa.eu
Martin HARVEY ALLCHURCH Direktni telefon (44-20) 74 18 84 27 E-pošta: press@emea.europa.eu
Function group & Grade Permanent posts
Funkcionalna skupina in stopnja
CVMP Committee for Medicinal Products for Veterinary Use
CVMP Odbor za zdravila za uporabo v veterinarski medicini
Initial evaluation
2.3 Začetna ocena
Establishment of maximum residue limits for veterinary medicines
2.4 Določitev mejne vrednosti ostankov za zdravila za uporabo v veterinarski medicini
Occupied as per
Zasedenost na dan