natgillin/translations-raw huggingface dataset:
A wide range of documents has now been published by the EMEA, including press releases, general information documents, annual reports and work programmes.
EMEA objavlja dolgo vrsto dokumentov, vključno s sporočili za javnost, splošnimi informativnimi dokumenti, letnimi poročili in delovnimi programi.
Phase-I Phase-II Phase-III Phase-IV
faza III. faza IV. faza
The EMEA receives safety reports from within the EU and outside concerning centrally authorised medicinal products and coordinates action relating to the safety and quality of medicinal products.
EMEA prejema varnostna poročila o centralno odobrenih zdravilih iz EU in zunaj nje ter usklajuje ukrepe, ki se nanašajo na varnost in kakovost zdravil.
Head of Sector for regulatory affairs and organisational support
Vodja Sektorja za regulativne zadeve in organizacijsko podporo
Its aim is to identify and report any potential safety issues relating to medicines and to prevent adverse drug reactions.
Njen namen je ugotoviti vsa možna sporna vprašanja glede varnosti zdravil in o njih poročati ter preprečiti neželene učinke zdravil.
• Endorsed the Road Map to 2010 long-term strategy
• odobritev dolgoročne strategije "Usmeritvenega načrta do leta 2010"
During the procedure, new clinical trials data for the COX-2 inhibitor celecoxib became available, indicating an increased cardiovascular risk.
Med postopkom so bili na voljo novi podatki o kliničnem preizkušanju za inhibitor COX-2 celekoksib, ki so pokazali povečano kardiovaskularno tveganje.
The EMEA is participating in ongoing discussions with DG Research to establish a European Technology Platform for Innovative Medicines.
EMEA sodeluje v stalnih razpravah z Generalnim direktoratom za raziskave zaradi ustanovitve evropske tehnološke platforme za inovativna zdravila.
European surveillance strategy
Evropska strategija nadzorovanja
Another perennial focus area for the Agency is the availability of medicines for European citizens.
Še eno področje, s katerim se Agencija stalno ukvarja, je razpoložljivost zdravil za evropske državljane.
It is, therefore, quite fitting that it was also the year in which the European Agency for the Evaluation of Medicinal Products changed its name to the European Medicines Agency.
Zato je bilo to leto primerno tudi za spremembo imena Evropske agencije za vrednotenje zdravil v Evropsko agencijo za zdravila.
The EMEA/CHMP Working Party with Patients Organisations reviewed the comments and contributions received following the release for consultation of the paper Recommendations and proposals for action (CPMP/5819/04) in April 2004.
Delovna skupina EMEA/CHMP za sodelovanje z organizacijami bolnikov je preučila pripombe in prispevke, ki so bili prejeti po predstavitvi dokumenta "Priporočila in predlogi za ukrepe" (CPMP/5819/04) za posvetovanje aprila 2004.
The EMEA agreed with the European Association of Euro-Pharmaceutical Companies (EAEPC) to put in place a joint performance indicator exercise to monitor the operation of the procedure.
EMEA se je dogovorila z Evropskim združenjem evrofarmacevtskih podjetij (European Association of Euro-Pharmaceutical Companies, EAEPC) o uvedbi skupnih kazalcev uspešnosti za spremljanje izvajanja postopka.
The CVMP created a Scientific Advisory Group on Antimicrobials in 2004.
CVMP je v letu 2004 oblikoval Znanstveno-svetovalno skupino za protimikrobna sredstva.
Nello MARTINI (Alternate: Silvia FABIANI)
Nello MARTINI (namestnik: Silvia FABIANI)
• Discussed large number of contributions received from patients and healthcare professionals groups, the pharmaceutical industry, national competent authorities, national health ministries, European institutions and others as part of the Road Map to 2010 consultation process
• obravnava veliko prispevkov, prejetih od skupin bolnikov in zdravstvenih strokovnjakov, farmacevtske industrije, pristojnih nacionalnih organov, nacionalnih ministrstev za zdravstvo, evropskih institucij in drugih v okviru posvetovalnega procesa o "Usmeritvenem načrtu do leta 2010"
• Work continued on the development of a regulatory and scientific environment for emerging and new technologies and therapies, and on contributing to new areas of legislation to address products for paediatric use, tissue engineered products and other public health areas such as influenza pandemic preparedness.
• Nadaljevala so se dela v zvezi z razvojem regulativnega in znanstvenega okolja za nastajajoče in nove tehnologije in terapije ter prispevki na novih področjih zakonodaje v zvezi z izdelki za uporabo v pediatriji, izdelki, pridobljenimi z inženiringom tkiv, in drugimi področji javnega zdravja, kot je pripravljenost na pandemijo influence.
In 2004, further progress was made on establishing a scientific and regulatory memory database to enhance the consistency of the advice the Agency provides.
V letu 2004 je bil dosežen dodatni napredek pri oblikovanju znanstvene in regulativne "spominske" baze podatkov za povečanje skladnosti svetovanja, ki ga izvaja Agencija.
In its strategic action plan detailed in the paper, the Agency and Committee are exploring such possibilities as provisional authorisations, adaptation of data requirements, further possibilities for extrapolation of MRLs, and the provision of assistance by the Agency to companies wanting to authorise such products.
Agencija in Odbor v strateškem akcijskem načrtu, ki je podrobno opisan v dokumentu, preučujeta možnosti, kot so začasna dovoljenja za promet, prilagoditev zahtev po podatkih, nadaljnje možnosti ekstrapolacije MRL-jev in zagotavljanje pomoči Agencije podjetjem, ki želijo dobiti dovoljenje za promet za take izdelke.
A Community marketing authorisation is valid throughout the EU and a centrally authorised medicinal product is by definition identical in all Member States.
Dovoljenje Skupnosti za promet z zdravilom velja po vsej EU, zdravilo, za katerega je izdano dovoljenje po centraliziranem postopku, pa je po definiciji enako v vseh državah članicah.
Seven applications were withdrawn by applicants prior to an opinion being given.
Sedem vlog so vlagatelji sami umaknili pred izdajo mnenja.
The resulting EMEA Road Map to 2010 sets out a clear strategy for implementing the provisions of the revised legislation and also establishes a series of concrete actions the Agency and its partners can take to further strengthen the regulation of medicines in Europe, for the benefit of all its citizens.
Rezultat teh prizadevanj je bil usmeritveni načrt EMEA do leta 2010, v katerem je opisana jasna strategija za izvedbo določb revidirane zakonodaje in ki določa vrsto konkretnih ukrepov, ki jih lahko sprejmejo Agencija in njeni partnerji, da bi še bolj okrepili ureditev zdravil v Evropi v korist vseh njenih državljanov.
Rapid procedure for updating product information
Hitri postopek za posodabljanje informacij o zdravilih
Marketing authorisation holders are required to submit a PSUR at regular intervals or upon request.
Imetniki dovoljenj za promet z zdravili morajo PSUR predložiti v rednih časovnih presledkih ali na zahtevo.
Calls for tenders were published in the Official Journal of the European Union and, also, on the EMEA website.
Javni razpisi so bili objavljeni v Uradnem listu Evropske unije in tudi na spletni strani EMEA.
Seven applications for extension or modification of MRLs were submitted in 2004.
V letu 2004 je bilo predloženih sedem vlog za razširitev ali spremembo MRL-jev.
An overarching document describing the mandate, objectives and rules of procedure for CHMP scientific advisory groups was adopted by the Committee.
Odbor je sprejel splošni dokument, v katerem so opisani naloge, cilji in postopkovna pravila za znanstveno svetovalne skupine CHMP.
Two major safety reviews involving two classes of medicines were initiated in 2004.
V letu 2004 sta se začeli izvajati dve pomembni presoji varnosti, ki sta vključevali dva razreda zdravil.
At the conclusion of the scientific evaluation, undertaken in 210 days within the Agency, the opinion of the scientific committee is transmitted to the European Commission to be transformed into a single market authorisation applying to the whole European Union.
Na koncu znanstvenega vrednotenja, ki ga Agencija opravi v 210 dneh, se mnenje znanstvenega odbora sporoči Evropski komisiji in ta izda enotno dovoljenje za promet z zdravili po vsej Evropski uniji.
Agnès SAINT-RAYMOND (from mid-October 2004)
Agnès SAINT-RAYMOND (od sredine oktobra 2004)
The EMEA Management Board s main duties are related to the management, monitoring and control of the Agency s operations and finances.
Glavne naloge upravnega odbora so povezane z upravljanjem, spremljanjem in nadziranjem poslovanja in financ Agencije.
Representatives attended from the VMRFG, IFAHEurope and the European Group for Generic Veterinary Products (EGGVP).
Sodelovali so predstavniki iz VMRFG, IFAHEvropa in Evropske skupine za generična veterinarska zdravila (European Group for Generic Veterinary Products, EGGVP).
Five applications for scientific advice were received in 2004.
V letu 2004 je bilo prejetih pet zahtevkov za znanstveno svetovanje.
At the beginning of 2004, the EMEA launched an exercise to create a new long-term strategy for the Agency that would contribute to better protection and promotion of public and animal health, improve the regulatory environment for medicinal products, and help to stimulate innovation, research and development in the EU.
V začetku leta 2004 je EMEA začela izvajati nalogo oblikovanja nove dolgoročne strategije za Agencijo, ki bi prispevala k boljši zaščiti in spodbujanju zdravja ljudi in živali, izboljšala regulativno okolje za zdravila in pomagala spodbuditi inovacije, raziskave in razvoj v EU.
As a result of the enlargement and the new legislation, the Agency underwent some significant structural changes: the composition of the Management Board was amended to accommodate the new Member State representatives and the Agency s fourth scientific committee the Committee on Herbal Medicinal Products (HMPC) was created.
Zaradi širitve in nove zakonodaje je Agencija izvedla pomembne strukturne spremembe: spremenila se je sestava upravnega odbora, saj so se mu pridružili predstavniki novih držav članic, in ustanovljen je bil četrti znanstveni odbor Agencije - Odbor za zeliščna zdravila (HMPC).
Experts in each of the areas covered have kept these topics under review and produced updated position papers periodically, to reflect the current state of knowledge.
Strokovnjaki na vsakem od teh obravnavanih področij so izvajali revizijo teh tem in občasno pripravili posodobljene dokumente o stališčih, ki so odsevali trenutna spoznanja.
They allow EU Member States and the MRA partner to mutually recognise the conclusions of inspections of manufacturers carried out by the respective inspection services of the other party and the manufacturers' certification of the conformity of each batch to its specifications without re-control at import.
Ta državam članicam EU in državam partnericam v sporazumih o medsebojnem priznavanju omogočajo medsebojno priznavanje sklepov inšpekcijskih pregledov proizvajalcev, ki jih opravijo ustrezne inšpekcijske službe druge strani, in proizvajalčevega certificiranja skladnosti vsake serije z njenimi specifikacijami brez ponovne kontrole ob uvozu.
18 of the 21 members are appointed by the CHMP and 3 members are appointed by the COMP.
Od teh 21 članov jih 18 imenuje CHMP, 3 pa COMP.
It is expected that this initiative will increase the number of reports produced and, subsequently, strengthen the basis for evaluating the safety of authorised veterinary medicinal products.
Ta pobuda naj bi povečala število izdelanih poročil in s tem okrepila podlago za vrednotenje varnosti veterinarskih zdravil z dovoljenjem za promet.
The Committee concluded that the benefit-risk balance of paroxetine remains positive, but that changes to the product information should be introduced, especially with regard to warnings of suicide-related behaviour in children and adolescents.
Odbor je sklenil, da je razmerje med tveganji in koristmi še vedno pozitivno, vendar je treba dodati spremembe v informacije o zdravilu, zlasti kar zadeva opozorila glede samomorilnega vedenja pri otrocih in mladostnikih.
The role of these groups is to advise the CHMP on specific questions addressed to them by the Committee.
Naloga teh skupin je svetovati CHMP glede posebnih vprašanj, ki jim jih posreduje Odbor.
A new task for the EMEA stemming from the new Community legislation is to improve and optimise contacts with its various stakeholders to facilitate dialogue and communication.
Nova naloga EMEA, ki izhaja iz nove zakonodaje Skupnosti, je izboljšati in optimizirati stike z različnimi interesnimi skupinami in tako pospešiti dialog in obveščanje.
• Pharmacogenetics Working Party Four temporary working parties also supported the work of the CHMP:
• Delovna skupina za farmakogenetiko CHMP so pri delu podpirale tudi štiri začasne delovne skupine:
• The EMEA took over responsibility for publication of the compilation of Community procedures for GMP inspectorates and developed a revised procedure for development of EU pharmaceutical guidelines, which takes into account new calls for transparency.
• EMEA je prevzela odgovornost za objavo zbirke postopkov Skupnosti za inšpektorate za dobro proizvodno prakso ter razvila revidiran postopek za razvoj farmacevtskih smernic EU, ki upošteva nove zahteve po preglednosti.
EU institutions and regulatory authorities
Institucije in regulativni organi EU
The Agency communicates the finalisation of a USR procedure and the new safety recommendations to healthcare professionals and patients by issuing an EMEA public statement.
Agencija sporoči zaključitev postopka USR in nova varnostna priporočila zdravstvenim strokovnjakom in bolnikom tako, da objavi izjavo EMEA za javnost.
During 2004, the EMEA participated in all meetings of the Commission s Pharmaceutical Committees for human and veterinary medicines and of the working groups established by the Pharmaceutical Committees.
V letu 2004 je EMEA sodelovala na vseh sestankih Farmacevtskih odborov Komisije za zdravila za humano in veterinarsko uporabo ter delovnih skupin, ki so jih ustanovili Farmacevtski odbori.
• Birthe BYSKOV HOLM (patients organisation representative)
• Birthe Byskov Holm (predstavnik organizacije bolnikov)
The Committee for Medicinal Products for Veterinary Use (CVMP) is responsible for formulating the Agency's scientific opinions regarding the quality, safety and efficacy of medicinal products for veterinary use and the establishment of maximum residue limits.
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je odgovoren za oblikovanje znanstvenih mnenj Agencije glede kakovosti, varnosti in učinkovitosti zdravil za uporabo v veterinarski medicini in določitve mejnih vrednosti ostankov.
Operational since 1 February 2003
Izvaja se od 1. februarja 2003
The EMEA regularly reviews annual reports for designated orphan medicinal products.
EMEA redno pregleduje letna poročila za zdravila, določena za zdravila sirote.
Initiatives undertaken in 2004 mainly related to the areas of risk identification and risk evaluation: in the field of risk identification through the further development and implementation of EudraVigilance; in the area of risk assessment by looking at a more proactive conduct of pharmacovigilance.
Pobude, ki so se izvajale v letu 2004, so se nanašale predvsem na področji opredelitve tveganja in ocene tveganja, in sicer na področju opredelitve tveganja z nadaljnjim razvojem in izvajanjem EudraVigilance, na področju ocene tveganja pa z s preučitvijo dejavnejšega izvajanja farmakovigilance.
EU-US FDA confidentiality arrangements
Dogovori o zaupnosti med EU in FDA ZDA
Arbitration procedures (either under Article 29 of Directive 2001/83/EC or Article 6(12) of Commission Regulation (EC) No 1084/2003) are initiated because of disagreement between Member States in the framework of the mutual recognition procedure.
Arbitražni postopki (na podlagi člena 29 Direktive 2001/83/ES ali člena 6(12) Uredbe Komisije (ES) št. 1084/2003) se uvedejo zaradi spora med državami članicami v okviru postopka medsebojnega priznavanja.
If food animals are treated with medicines, residues may remain in the food produced by or from them.
Uporaba zdravil pri živalih, namenjenih za proizvodnjo hrane, lahko povzroči njihove ostanke v hrani, pridobljeni od ali iz zdravljenih živali.
The CVMP decided that the benefits of using Micotil outweighed the risks, but, in order to mitigate such risks, required additional precautions and warnings to be included on the SPC and label.
CVMP je sklenil, da koristi uporabe Micotila prevladujejo nad njegovimi tveganji, vendar je treba zaradi ublažitve takih tveganj v SPC in na etiketi navesti dodatne previdnostne ukrepe in opozorila.
It protects the rights, integrity and confidentiality of the trial s subjects and ensures that data and reported results are credible and accurate.
Varuje pravice, integriteto in zaupnost vpletenih pri preizkušanju ter zagotavlja zanesljivost in točnost podatkov in rezultatov.
A total of 108 applications for orphan product designation were received in 2004, which is a 24 % increase compared to the 87 received in 2003.
V letu 2004 je bilo prejetih skupaj 108 vlog za določitev zdravil sirot, kar je 24 % več v primerjavi z letom 2003, ko je bilo prejetih 87 vlog.
Upon request from the EMEA, national competent authorities have nominated more than 100 specialised experts in the areas of pharmacovigilance, pharmacoepidemiology, epidemiology, emerging therapies (such as gene therapy) and risk communication.
Na zahtevo EMEA so pristojni nacionalni organi imenovali več kot 100 specializiranih strokovnjakov na področjih farmakovigilance, farmakoepidemiologije, epidemiologije, novih terapij (kot je gensko zdravljenje) in sporočanja tveganj.
The Committee, while taking into account the position expressed by the SAG, remains responsible for its final opinion.
upošteva stališčeteh skupin, vendar je odgovoren za svoje končno mnenje.
• Good progress was achieved on improving the quality and consistency of scientific assessment reports, with a revision of the assessor guideline and the initiation of a scientific memory database for centralised procedures.
• Napredek je bil dosežen glede izboljšanja kakovosti in doslednosti poročil o znanstvenem vrednotenju, opravljena je bila revizija smernic za ocenjevalce in začela se je ustvarjati znanstvena spominska baza podatkov za centralizirane postopke.
Referrals are initiated either in order to obtain harmonisation within the Community of the conditions of authorisation for products already authorised by the Member States (Article 34 of Directive 2001/82/EC), or in cases involving the interests of the Community or concerns relating to the protection of human or animal health or the environment (Articles 35 and 40 of Directive 2001/82/EC).
Predložitve se izvedejo, zato da se v Skupnosti zagotovi uskladitev pogojev za izdajo dovoljenja za izdelke, za katere so države članice že izdale dovoljenje (člen 34 Direktive 2001/82/ES), ali če gre za interes Skupnosti ali za vprašanja glede varovanja zdravja ljudi ali živali ali okolja (člena 35 in 40 Direktive 2001/82/ES).
The reinforcement of the partnership between EU regulatory authorities will lead to the establishment of a network of excellence.
Z okrepitvijo partnerstva med regulativnimi organi EU bo dosežena mreža odličnosti.
IT maintained high service levels throughout 2004, achieving more than 99.5 % availability to corporate users
IT je v letu 2004 ohranila visoko raven storitev in dosegla več kot 99,5-odstotno razpoložljivost za podjetja.
As regards core operations, 2004 was an extremely active year for the EMEA.
Kar zadeva glavne dejavnosti, je bilo leto 2004 za EMEA zelo živahno.
Once finalised, these training profiles will help to establish a common competency standard among EMEA staff.
Ko bodo ti profili usposabljanja dokončno oblikovani, se bo z njimi lahko dosegel skupen standard usposobljenosti za osebje EMEA.
The establishment of SAGs for HIV/viral diseases, endocrinology/diabetes, CNS/psychiatry and cardiology is planned for 2005.
V letu 2005 se načrtuje ustanovitev skupine za HIV/virusne bolezni, endokrinologijo/sladkorno bolezen, CŽS/psihiatrijo in kardiologijo.
This is an increase of 5 over the previous year, and reflects the continuing emergence of new active substances for food-producing animals.
To je 5 vlog več kot leto poprej, kar kaže na nenehno pojavljanje novih zdravilnih učinkovin pri živalih, namenjenih proizvodnji hrane.
IT completed testing of IP-based videoconferencing over the Internet successfully and used it in several Eudranet TIG meetings.
IT je uspešno končala testiranje videokonferenčnega prenašanja po IP prek interneta in ga uporabila na več sestankih Skupine za izvedbo telematike Eudranet.
Two further test results were identified with apparent out-of-specification results.
Rezultati nadaljnjih dveh preizkušanj so pokazali očitno neskladnost s specifikacijami.
Five requests for scientific advice in 2004 were for products relating to new and emerging therapies and technologies.
V letu 2004 se je pet zahtevkov za znanstveno svetovanje nanašalo na izdelke, povezane z novimi terapijami in tehnologijami.
Furthermore, an Ad hoc Expert Working Group was established to look at policy, compliance and regulatory aspects resulting from first experience with electronic reporting.
Poleg tega je bila ustanovljena ad hoc strokovna delovna skupina, ki naj bi na podlagi prvih izkušenj z elektronskim poročanjem preučila politiko, skladnost in regulativne vidike.
253 periodic safety update reports (PSURs) were reviewed in 2004.
V letu 2004 je bilo pregledanih 253 periodično dopolnjenih poročil o varnosti (periodic safety update reports, PSUR).
The Veterinary Mutual Recognition Facilitation Group (VMRFG) met at the EMEA every month (except August) in 2004, under the chairmanship of the Irish and Dutch EU presidencies.
Veterinarska skupina za poenostavitev medsebojnega priznavanja (Veterinary Mutual Recognition Facilitation Group, VMRFG) se je v letu 2004 pod irskim in nizozemskim predsedstvom sestala na EMEA vsak mesec (razen v avgustu).
Good progress was made on 8 of the 12 sets of recommendations proposed; most notably, the EMEA began publishing question and answer documents for patients, healthcare professionals, the general public and the media relating to situations where there are public health concerns.
Pri 8 izmed 12 sklopov predlaganih priporočil je bil dosežen dober napredek; predvsem je EMEA začela objavljati dokumente v obliki "vprašanj in odgovorov" za bolnike, zdravstvene strokovnjake, splošno javnost in sredstva javnega obveščanja, kadar gre za vprašanja javnega zdravja.
This improves the treatment options of metastatic carcinoma of the colon or rectum, a leading cause of death in the EU
S tem so izboljšane možnosti za zdravljenje metastatičnega karcinoma debelega črevesa ali rektuma, ki je eden glavnih razlogov za smrt v EU.
The past year also marked a milestone in the development of the EU pharmaceutical legislation and the enlargement of the EU.
Bilo je tudi mejnik v razvoju farmacevtske zakonodaje EU in širitvi EU.
This report covers activities of the EMEA in 2004.
V tem poročilu so zajete dejavnosti EMEA v letu 2004.
The referral was initiated to investigate concerns regarding user safety, in the interest of the Community, following an accidental human fatality resulting from use of this product during the treatment of animals earlier in 2004.
Namen predložitve je bilo preučiti vprašanja glede varnosti uporabnika, ki so v interesu Skupnosti, po smrti človeka zaradi uporabe tega izdelka med zdravljenjem živali v začetku leta 2004.
Alternate: Josef SUKO
Namestnik: Josef SUKO
This was compensated for by a higher number of type-II variations.
Ta upad so nadomestile številčnejše spremembe tipa II.
Following the worldwide withdrawal of Vioxx in September 2004, the CHMP began a review of all aspects of cardiovascular safety of COX-2 inhibitors at the request of the Commission.
Po tem, ko je bil septembra 2004 Vioxx umaknjen iz prodaje po vsem svetu, je CHMP na zahtevo Komisije začel preučevati vse vidike kardiovaskularne varnosti inhibitorjev COX-2.