natgillin/translations-raw huggingface dataset:
Twenty-one applications received related to the more complex type-II variations.
Enaindvajset prejetih vlog se je nanašalo na kompleksnejše spremembe tipa II.
Similar biological medicinal products: An overarching guideline on similar biological medicines was finalised in November 2005.
Podobna biološka zdravila: novembra 2005 so bile dokončno oblikovane skupne smernice o podobnih bioloških zdravilih.
Several class-labelling procedures were performed for HIV products.
Za zdravila za zdravljenje HIV je bilo izpeljanih več postopkov označevanja razreda.
6 ENCOURAGING RESEARCH AND DEVELOPMENT OF MEDICINES
6 SPODBUJANJE RAZISKAV IN RAZVOJA ZDRAVIL
When appropriate, further follow-up was undertaken to inform the Rapporteur and to assess the need for the collection of additional data from the marketing authorisation holders or the amendment of the product information via a type-II variation.
Če je bilo primerno, so bili sproženi nadaljnji ukrepi za obveščanje poročevalca in oceno potrebe po zbiranju dodatnih podatkov od imetnikov dovoljenj za promet z zdravilom ali spremembi informacij o izdelku prek spremembe tipa II.
As part of the consultation process, a major public conference was organised in December 2005, with the participation of industry, regulators, academia, healthcare professionals and patients.
Kot del postopka posvetovanja je bila decembra 2005 organizirana pomembna javna konferenca, na kateri so sodelovali panožna podjetja, zakonodajalci, akademska javnost, zdravstveni strokovnjaki in bolniki.
the European Commission, as well as interested parties, who provided valuable feedback during the public consultation on guidelines and procedures.
in zainteresiranih strani, ki so med javnimi posvetovanji o smernicah in postopkih zagotovili dragocene povratne informacije.
As the EU institutions progressed their discussions in 2005 on new EU legislation on medicines for children, over half of the designation opinions in 2005 were for conditions that affect children.
Medtem ko so institucije EU v letu 2005 nadaljevale razprave o novi zakonodaji EU za zdravila za otroke, se je več kot polovica mnenj o določitvi zdravila kot zdravila sirote v letu 2005 nanašala na bolezni, ki prizadenejo otroke.
Conclusion of the safety review of COX-2 inhibitors
zaključkom presoje varnosti zaviralcev COX-2;
In 2005, the EMEA received and validated 3 new applications for maximum residue limits (MRLs).
V letu 2005 je EMEA prejela in potrdila 3 nove vloge za najvišje mejne vrednosti ostankov (maximum residue limits - MRL).
A similar sub-group was created of CMD(v) representatives, an observer of the Commission and the EMEA to draw up such a list for veterinary medicinal products.
Podobna podskupina je bila sestavljena iz predstavnikov CMD(v), opazovalca iz Komisije in EMEA za pripravo takšnega seznama za veterinarska zdravila.
In order to allow the development of these activities within a broader and more structured environment, the Management Board adopted, in December 2005, a ‘Framework of Interaction' between the EMEA and patients' and consumers' organisations.
Da se omogoči razvoj teh dejavnosti v širšem in bolj strukturiranem okolju, je upravni odbor decembra 2005 sprejel "okvir za sodelovanje" med EMEA ter organizacijami bolnikov in potrošnikov.
The reform of EU pharmaceutical legislation, implementation of the EMEA's Road Map to 2010 and dealing with pharmacovigilance issues required alertness, steadfastness and commitment to the important task of promoting public health.
Reforma farmacevtske zakonodaje EU, izvajanje usmeritvenega načrta Agencije do leta 2010 in obravnavanje vprašanj farmakovigilance so zahtevali pozornost, odločnost in zavezanost pomembni nalogi spodbujanja javnega zdravja.
In addition, the EMEA set up an initiative reminding all marketing authorisation holders of their obligation to submit existing data not yet submitted to the competent authorities, in particular data relating to paediatric use of authorised medicines.
Poleg tega je EMEA vzpostavila pobudo, ki vse imetnike dovoljenj za promet z zdravilom opozarja na njihovo obveznost, da pristojnim organom predložijo obstoječe podatke, ki jih še niso predložili, zlasti podatke o pediatrični uporabi zdravil, za katera je že bilo izdano dovoljenje.
A new initiative in 2005 was the publication of summaries of certain post-authorisation opinions, namely opinions on extension of indications and on the addition of new contra-indications or warnings.
Nova pobuda v letu 2005 je bila objava povzetkov določenih mnenj po izdaji dovoljenja, in sicer mnenj o razširitvi terapevtskih indikacij in dodanih kontraindikacijah ali opozorilih.
Once adopted products containing the listed substances can be used by veterinarians for the treatment of horses under the conditions of the ‘cascade principle' providing a minimum 6-month withdrawal period is applied.
Po sprejetju lahko veterinarji uporabljajo izdelke, ki vsebujejo snovi s seznama za zdravljenje konjev pod pogoji "kaskadnega načela", če se uporablja minimalna šestmesečna karenca.
Medicines for paediatric use
Zdravila za pediatrično uporabo
Two scientific advice requests received in 2005 were eligible for free advice under the pilot scheme for free scientific advice for veterinary medicines for minor uses and minor species (MUMS).
Dva zahtevka za znanstveno svetovanje, prejeta v letu 2005, sta bila upravičena do brezplačnega svetovanja v okviru pilotnega programa za brezplačno znanstveno svetovanje za veterinarska zdravila za manjšo uporabo in manj pomembne živalske vrste (MUMS).
Compassionate use: A guideline was drafted in preparation for the submission of any request by Member States for CHMP opinions.
Sočutna uporaba: oblikovan je bil osnutek smernic v pripravah na predložitev zahtevkov držav članic za mnenja CHMP.
The European Surveillance Strategy (ESS), which focuses on improved cooperation between all EU competent authorities and the EMEA in the field of pharmacovigilance for veterinary medicinal products, was revived, with the EMEA Secretariat now as a partner.
Ponovno je oživela evropska strategija nadzorovanja (European Surveillance Strategy - ESS), ki namenja glavno pozornost izboljšanemu sodelovanju med vsemi pristojnimi organi in EMEA na področju farmakovigilance za veterinarska zdravila, pri čemer sekretariat EMEA sedaj sodeluje kot partner.
Implementation of additional tools provided by the revised EU pharmaceutical legislation for monitoring the safety of medicines
izvajanjem dodatnih orodij, ki jih zagotavlja revidirana farmacevtska zakonodaja EU za spremljanje varnosti zdravil;
The CVMP launched a public consultation for a number of guidelines proposing the adaptation of data requirements for the testing of veterinary medicines for minor uses and minor species regarding quality, safety, including maximum residue limits (MRLs), and efficacy, while ensuring public health.
CVMP je organiziral javno posvetovanje za številne smernice in predlagal prilagoditev podatkovnih zahtev za preizkušanje veterinarskih zdravil za manjšo uporabo in manj pomembne vrste v zvezi s kakovostjo, varnostjo, vključno z najvišjimi mejnimi vrednostmi ostankov (MRL), in učinkovitostjo ter hkratnim zagotavljanjem javnega zdravja.
Following on from the developments in human medicines, the Committee reviewed the safety of COX-2 inhibitors and NSAIDs used in animals, looking in particular at potential exposure of consumers.
Na podlagi razvoja dogodkov v humani medicini je Odbor preučil varnost zaviralcev COX-2 in nesteroidnih protivnetnih zdravil (NSAID-ov), ki se uporabljajo pri živalih, pri čemer je posebno pozornost namenil zlasti morebitni izpostavljenosti potrošnikov.
Self-medication medicines: Amendments were proposed in 2005 to existing Commission guidance on the supply of non-prescription medicines, in particular relating to use of the centralised procedure for self-medication medicines.
Zdravila za samozdravljenje: v letu 2005 so bile predlagane spremembe trenutno veljavnih smernic Skupnosti o preskrbi z zdravili brez recepta, zlasti v zvezi z uporabo centraliziranega postopka za zdravila za samozdravljenje.
Addressing antimicrobial resistance by progressing a new strategy on risk management and risk assessment for antimicrobials in veterinary medicinal products
obravnavanjem protimikrobne odpornosti z razvijanjem nove strategije obvladovanja tveganja in ocene tveganja za protimikrobne snovi v veterinarskih zdravilih;
The Agency also made significant contributions to wider European public-health activities, most notably with regard to pandemic-influenza preparedness, and the preparation of new legislation on medicines for children and advanced therapies.
Agencija je pomembno prispevala tudi k širšim dejavnostim v zvezi z javnim zdravjem v Evropi, in sicer predvsem glede pripravljenosti na pandemijo gripe ter v zvezi z novo zakonodajo o zdravilih za otroke in zdravilih za napredno zdravljenje.
EMEA budget: revenue
Proračun EMEA: prihodki
These include the publication of a summary of the European public assessment report (EPAR) in a manner that is easily understandable to the public, the publication of withdrawals of marketing-authorisation applications prior to an opinion, and the publication of refusals of marketing authorisations.
Te vključujejo objavo povzetka evropskega javnega poročila o oceni zdravila (European public assessment report - EPAR) na način, ki je javnosti hitro razumljiv, objavo umikov vlog za izdajo dovoljenj za promet z zdravilom pred izdajo mnenja in objavo zavrnitev dovoljenj za promet z zdravilom.
Public health impact of opinions in 2005 Of the medicinal products intended for the European market for which a positive opinion was adopted: 2 are for use in cancer therapy, including the treatment of lung cancer - one of the highest causes of cancer-related deaths in the EU 7 are anti-infectives, of which 2 are for the treatment of HIV and AIDS 4 are for the treatment of metabolic disorders, of which 1 offers a new route of administration for diabetes patients by allowing insulin to be delivered via the lungs 5 are for the treatment of diseases of the central nervous system and sensory organs 6 are for the diagnosis or treatment of cardiovascular or pulmonary diseases.
Vpliv mnenj na javno zdravje v letu 2005 Med zdravili, namenjenimi evropskemu trgu, za katere je bilo sprejeto pozitivno mnenje: se 2 uporabljata za zdravljenje raka, vključno za zdravljenje pljučnega raka - enega od najpogostejših vzrokov smrti zaradi raka v EU; je 7 antiinfekcijskih zdravil, od katerih se 2 uporabljata za zdravljenje HIV in AIDS; se 4 uporabljajo za zdravljenje motenj presnove, od katerih 1 ponuja nov način dajanja zdravila bolnikom s sladkorno boleznijo, saj omogoča vnos insulina skozi pljuča; je 5 zdravil za zdravljenje bolezni centralnega živčnega sistema in čutil; je 6 zdravil za diagnosticiranje ali zdravljenje kardiovaskularnih ali pljučnih bolezni.
On the basis of this, the Committee for Medicinal Products for Veterinary Use (CVMP) gave more guidance on advisable treatment in the case of accidental human injection.
Na podlagi tega je Odbor za zdravila za uporabo v veterinarski medicini (CVMP) zagotovil več smernic o priporočljivem zdravljenju v primeru nenamernega vnosa v človeka.
Summary of the annual report of the European Medicines Agency
Povzetek letnega poročila Evropske agencije za zdravila za leto 2005
This covers a large number of projects, which are essentially designed to increase efficiency of the European medicines network, to provide better information to patients and users of medicinal products, and to contribute to the safe and effective use of these products.
Ta pokriva veliko število projektov, oblikovanih predvsem za povečanje učinkovitosti Evropske mreže zdravil, zagotavljanje boljših informacij bolnikom in uporabnikom zdravil ter prispevanje k varni in učinkoviti uporabi teh izdelkov.
Public health impact of post-authorisation activities
Vpliv dejavnosti po izdaji dovoljenja na javno zdravje
These tools enable the analysis of safety data of medicines against complex criteria to highlight potential trends for further investigation in the context of the assurance of product safety.
Ta orodja omogočajo analizo podatkov o varnosti zdravil glede na kompleksna merila za poudarek možnih trendov za nadaljnje preiskave v okviru zagotovitve varnosti izdelka.
The CVMP, in consultation with the Federation of Veterinarians in Europe, prepared a proposal for a list of essential substances for the treatment of horses following the request from the European Commission.
CVMP je v posvetovanju s Federacijo veterinarjev Evrope na zahtevo Evropske komisije pripravil predlog za seznam bistvenih snovi za zdravljenje konjev.
A number of ‘Dear Doctor Letters' were agreed by the CHMP, in addition to public statements.
CHMP je poleg izjav za javnost odobril tudi številna pisma "Spoštovani zdravnik".
Work on the completion of phase 2a of EudraCT, the European Clinical Trails registration database, was delayed due to unforeseen difficulties with the final steps of the upgrade to version
Prišlo je do zamud pri zaključku faze 2a EudraCT, sistema zbirke podatkov o registraciji evropskih kliničnih preizkušanj, zaradi nepredvidenih težav pri zadnjih korakih nadgradnje različice 3.0.0.
The new legal basis puts the Agency in a stronger position to fulfil its public and animal health mandate.
Nova pravna podlaga Agenciji zagotavlja boljša izhodišča za izpolnjevanje njenega mandata glede zdravja ljudi in živali.
EMEA budget: expenditure
Proračun EMEA: odhodki
The revised pharmaceutical legislation opens the way for new types of applications to be made to the Agency.
Revidirana farmacevtska zakonodaja odpira pot novim vrstam vlog, ki se predložijo Agenciji.
EMEA has worked on its pandemic influenza preparedness since 2003 and has put in place an innovative and proactive approach for the accelerated assessment and approval of new vaccines against a pandemic influenza.
EMEA dela na pripravljenosti na pandemijo influence že od leta 2003, v sklopu česar je vzpostavila inovativen in proaktiven pristop za pospešeno vrednotenje in odobritev novih cepiv za pandemijo influence.
Some streamlining of the scientific advice procedure meant that, despite the increase in requests, the Agency was able to deliver more and faster scientific advice in 2005 than in previous years.
Racionalizacija postopka znanstvenega svetovanja je omogočila, da je bila Agencija v letu 2005 kljub povečanju števila zahtevkov sposobna zagotoviti obsežnejše in hitrejše znanstveno svetovanje v primerjavi s prejšnjimi leti.
The SME Office aims to facilitate communication with SMEs through dedicated personnel within the Agency who respond to practical or procedural enquiries, monitor applications, and organise workshops and training sessions for SMEs.
Urad za MSP si prizadeva za boljšo komunikacijo z malimi in srednje velikimi podjetji, in sicer s pomočjo predanega osebja znotraj Agencije, ki odgovarja na praktične ali postopkovne poizvedbe, spremlja vloge ter organizira delavnice in usposabljanja za mala in srednje velika podjetja.
The opinions concerned 2 medicinal products for the treatment of HIV.
Mnenja so se nanašala na 2 zdravili za zdravljenje HIV.
Initiation of a review of mifepristone-containing medicinal products (Mifegyne) due to safety and efficacy concerns.
začetkom presoje zdravil, ki vsebujejo mifepriston (Mifegyne), zaradi pomislekov o njihovi varnosti in učinkovitosti.
The measures already taken to expedite the assessment procedures for vaccines and conventional medicines have been welcomed and are necessary.
Ukrepi, ki so že bili sprejeti za pospešitev postopkov vrednotenja cepiv in konvencionalnih zdravil, so bili dobro sprejeti in izkazalo se je, da so nujno potrebni.
The centralised procedure is optional for immunological veterinary medicines for animal diseases that are subject to Community prophylactic measures.
Centralizirani postopek ni obvezen za imunološka veterinarska zdravila za živalske bolezni, za katere veljajo profilaktični ukrepi Skupnosti.
Now, with a decade of very solid progress behind it, and a good long-term plan in place to guide its forward evolution, the Agency is in better shape than ever to pursue its mission for the protection and promotion of health in Europe.
Danes, ko ima za seboj desetletje zelo solidnega napredka in narejen dober dolgoročni načrt, ki bo usmerjal njen nadaljnji razvoj, je Agencija bolj kot kdaj koli pripravljena nadaljevati svoje poslanstvo, t.j.
The CVMP gave 3 positive opinions for the establishment of MRLs and 8 opinions for the extension of existing MRLs to other species.
CVMP je predložil 3 pozitivna mnenja za določitev najvišjih mejnih vrednosti ostankov in 8 mnenj za razširitev obstoječih najvišjih mejnih vrednosti ostankov na druge vrste.
In addition to its activities relating to development of a pandemic influenza vaccine, the EMEA also looked at antivirals and issued guidelines in October 2005 on the use of these medicines in the event of a pandemic.
Poleg dejavnosti v zvezi z razvojem cepiva za pandemijo influence se je EMEA ukvarjala tudi s protivirusnimi zdravili in oktobra 2005 objavila smernice za uporabo teh zdravil v primeru pandemije.
The Mutual Recognition Facilitation Group (MRFG) and the Veterinary Mutual Recognition Facilitation Group (VMRFG), which coordinated and facilitated the operations of the mutual recognition procedure for human and veterinary medicinal products respectively over the past ten years, both held their final meetings in October 2005.
Skupina za poenostavitev medsebojnega priznavanja (Mutual Recognition Facilitation GroupMRFG) in Skupina za poenostavitev medsebojnega veterinarskega priznavanja (Veterinary Mutual Recognition Facilitation Group - VMRFG), ki sta v zadnjih desetih letih usklajevali in lajšali delovanje postopka za medsebojno priznavanje za zdravila za humano in veterinarsko uporabo, sta imeli svoji zadnji zasedanji oktobra 2005.
The membership of the Management Board finally reached its full complement during the year under review, as new representatives of patients' organisations and doctors' and veterinarians' associations appointed by the Council of Ministers joined in the work.
Lansko leto je upravni odbor dosegel svojo popolno sestavo, saj so se pridružili novi predstavniki organizacij bolnikov in združenj zdravnikov ter veterinarjev, ki jih je imenoval Svet ministrov.
Building and equipment-related expenditure (including EU telematics)
Izdatki za stavbe in opremo (vključno s telematiko EU) 27 105 000 EUR
Suspected adverse reactions in dogs and cats were most frequently reported.
Najpogosteje se je poročalo o sumih na neželene učinke pri psih in mačkah.
The CVMP prepared a simple guide on veterinary pharmacovigilance, targeted primarily at veterinarians, in order to encourage reporting of adverse drug reactions.
CVMP je pripravil preprost priročnik o veterinarski farmakovigilanci, ki je namenjen predvsem veterinarjem, za spodbujanje poročanja o neželenih učinkih zdravil.
Contra-indications and warnings: A total of 5 new contra-indications were introduced for 11 medicinal products used in the fields of HIV, immunosuppression, osteoporosis and metabolic diseases.
Kontraindikacije in opozorila: uvedenih je bilo skupaj 5 kontraindikacij za 11 zdravil, ki se uporabljajo za zdravljenje HIV, imunosupresije, osteoporoze in bolezni presnove.
The new CHMP Working Party on Similar Biological Medicinal Products was established in 2005.
Leta 2005 je bila ustanovljena nova delovna skupina o podobnih bioloških zdravilih CHMP.
Generic medicines: Detailed guidance was published and existing guidance updated in 2005 concerning all aspects relating to the submission to the EMEA and assessment by the CHMP of generic medicines.
Generična zdravila: v letu 2005 so bile izdane podrobne smernice in posodobljene trenutno veljavne smernice v zvezi z vsemi vidiki, ki se nanašajo na predložitev vlog na EMEA in vrednotenje generičnih zdravil s strani CHMP.
The new pharmaceutical legislation also gives the Agency new tasks to improve product-related information.
Nova farmacevtska zakonodaja nalaga Agenciji nove naloge za izboljšanje informacij o izdelkih.
EudraGMP: Work on the development of this system, the Community database of manufacturing authorisations and of certificates of good manufacturing practice, began.
EudraGMP (dobra proizvodna praksa): začel se je razvoj tega sistema, zbirke podatkov Skupnosti o dovoljenjih za izdelavo in potrdilih o dobri proizvodni praksi.
While EMEA is not directly involved in this process, it does contribute to encouraging research and development in the pharmaceutical industry, ultimately improving access of patients to new and important medicines.
Čeprav EMEA ni neposredno vključena v ta proces, pa vseeno prispeva k spodbujanju raziskav in razvoja v farmacevtski industriji ter tako v končni fazi izboljšuje dostop bolnikov do novih in pomembnih zdravil.
Altogether, more than 1,000 post-authorisation procedures were finalised in 2005, including 628 notifications for type-I variations, 505 opinions for type-II variations (50% relating to safety and efficacy, and 50% relating to quality changes) and 15 opinions for line extensions.
V letu 2005 je bilo skupno dokončno obdelanih več kot 1000 postopkov po izdaji dovoljenja za promet z zdravilom, vključno s 628 obvestili za spremembe tipa I, 505 mnenji za spremembe tipa II (50 % v zvezi z varnostjo in učinkovitostjo in 50 % v zvezi s spremembami kakovosti) in 15 mnenji za razširitev terapevtskih indikacij.
While only few scientific advice applications for MUMS products have been received since the scheme was introduced in October 2003, industry have confirmed high interest.
Čeprav je bilo od začetka programa v oktobru 2003 prejetih le malo zahtevkov za znanstveno svetovanje za izdelke MUMS, pa so panožna podjetja pokazala veliko zanimanje.
The EMEA continued efforts to address the shortage of essential medicines to the veterinary practitioner particularly for minor uses and minor species (MUMS), focusing in particular on the implementation of recommendations of the position paper regarding availability of products for minor uses and minor species.
EMEA si je še naprej prizadevala obravnavati vprašanje pomanjkanja glavnih zdravil za veterinarje, zlasti za manjšo uporabo in manj pomembne vrste (MUMS), pri čemer je glavno pozornost namenjala izvajanju priporočil dokumenta o stališčih v zvezi z razpoložljivostjo izdelkov za manjšo uporabo in manj pomembne vrste.
New regulatory tools for the evaluation of medicines
Nova regulativna orodja za vrednotenje zdravil
The EMEA Management Board adopted criteria in September 2005 for the participation of patients' or consumers' organisations in EMEA activities.
Upravni odbor EMEA je septembra 2005 sprejel merila za sodelovanje organizacij bolnikov ali potrošnikov pri dejavnostih EMEA.
The scope of medicines for which the centralised procedure is optional has been broadened to allow for certain circumstances of expected benefit to public health, and now also includes self-medication products and generic medicines.
Obseg zdravil, za katera centraliziran postopek ni obvezen, se je razširil z namenom zagotoviti rešitev za določene okoliščine pričakovanih koristi za zdravje ljudi, tako da sedaj vključuje tudi izdelke za samozdravljenje in generična zdravila.
New opportunities for early informal discussions in the form of briefing meetings were introduced and a pilot procedure established to facilitate the evaluation of whether emerging approaches can be considered as medicinal products and thus have access to the centralised procedure.
Oblikovane so bile nove možnosti za zgodnje neformalne razprave v obliki informativnih sestankov, vzpostavljen pa je bil tudi pilotni postopek za poenostavitev vrednotenja, ali se lahko nastajajoče pristope obravnava kot zdravila in tako lahko imajo dostop do centraliziranega postopka.
First production versions of the EudraVigilance datawarehouse and pharmacointelligence tools were delivered for testing.
Prve proizvodne različice podatkovnega skladišča EudraVigilance in orodij farmakointeligence so bile dostavljene za namene preizkušanja.
Availability of veterinary medicines
Razpoložljivost veterinarskih zdravil