natgillin/translations-raw huggingface dataset:
The principles of GLP define a set of rules and criteria for a quality system concerned with the organisational process and the conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, reported and archived.
Načela dobre laboratorijske prakse določajo vrsto pravil in meril za sistem kakovosti, povezan z organizacijskim procesom in pogoji, v katerih se neklinične študije varnosti zdravja in okolja načrtujejo, izvajajo, spremljajo, poročajo in arhivirajo.
COMMUNICATIONS AND NETWORKING
KOMUNIKACIJE IN OMREŽNO POVEZOVANJE
The volume of applications for scientific assessment of medicinal products for human use was substantially higher than in 2003, with 21 more applications for orphan medicine designation, 25 more requests for scientific advice and protocol assistance, 12 more applications for initial marketing evaluation, 8 more opinions on initial marketing evaluation, and 61 more post-authorisation opinions.
Število zahtevkov za znanstveno vrednotenje zdravil za humano uporabo je bilo precej višje kot v letu 2003, pri čemer je bilo 21 zahtevkov več za določitev zdravil sirot, 25 zahtevkov več za znanstveno svetovanje in pomoč pri protokolu, 12 zahtevkov več za začetno vrednotenje in 61 vlog več za mnenje po izdaji dovoljenja.
The MMS includes an Experts database and enables the automation of many administrative documents, such as invitations, participation lists and reimbursement forms, and the setting up of a tracking system for hotel and travel details.
MMS vključuje zbirko podatkov o strokovnjakih in omogoča avtomatizacijo številnih administrativnih dokumentov, kot so povabila, seznami udeležencev in obrazci za povračilo stroškov, ter oblikovanje sistema iskanja podrobnih podatkov o hotelih in potovanjih.
Health Canada initiated assessments of Hungary and the Czech Republic following successful preMRA visits coordinated by the Commission as part of the extension of the MRA to cover new Member States.
Ustanova Health Canada je začela izvajati ocene za Madžarsko in Češko po uspešnih obiskih pred sporazumom, ki jih je koordinirala Komisija v okviru razširitve asporazumov o medsebojnem priznavanju na nove države članice.
• Despite initial delays, the preparatory work for effective operation of the Japan-EU mutual recognition agreement (MRA) was successfully concluded, allowing the operational phase of the agreement to come into force on 29 May 2004.
• Kljub začetnim zamudam so bile priprave za učinkovito izvajanje sporazuma med Japonsko in EU o medsebojnem priznavanju (mutual recognition agreement, MRA) uspešno zaključene, kar je omogočilo, da operativna faza sporazuma začne veljati 29. maja 2004.
Following the adoption of the revised pharmaceutical legislation, work on a number of guidance documents relating to the new GMP requirements for active substances was begun.
Po sprejetju revidirane farmacevtske zakonodaje so se začela dela v zvezi z vrsto usmeritvenih dokumentov glede novih zahtev dobre proizvodne prakse za zdravilne učinkovine.
The EMEA provided full secretariat and administrative support to the group.
EMEA je skupini zagotovila popolno podporo glede sekretariata in upravljanja.
Following a decision of the Management Board in 2003, a 12-month pilot project was launched, in May 2004, to grant free scientific advice to any sponsor seeking to develop veterinary medicinal products for food-producing animals that fall under the minor uses and minor species scheme.
Na podlagi odločitve upravnega odbora, sprejete v letu 2003, se je maja 2004 začel izvajati pilotni projekt za brezplačno znanstveno svetovanje vsakemu sponzorju, ki želi razviti veterinarsko zdravilo za živali, namenjene proizvodnji hrane, ki sodi v program zdravil za manjše uporabe in manj pomembne vrste.
This includes the organisation of meetings, travel and hotel arrangements for delegates and hosts, reception of visitors, the reimbursement of delegates expenses and the payment of suppliers invoices, as well as the preparation and follow-up of meeting room facilities.
Sem spada organiziranje srečanj in potovanj ter hotelske nastanitve delegatov in gostiteljev, sprejem obiskovalcev, vračilo stroškov delegatom, plačilo računov dobaviteljev ter priprava in spremljanje naprav v sejnih sobah.
An initial evaluation is conducted by the EMEA to assess the quality, safety and efficacy of every new veterinary product that is subject to the Community or centralised procedure.
EMEA izvaja začetno vrednotenje, da bi ocenila kakovost, varnost in učinkovitost vsakega novega veterinarskega zdravila, za katerega se izvaja postopek Skupnosti ali centraliziran postopek.
Panayiota KOKKINOU (Alternate: Louis PANAYI)
Panayiota KOKKINOU (namestnik: Louis PANAYI)
• Alistair KENT (patients organisation representative)
• Alistair KENT (predstavnik organizacije bolnikov)
The comments received were taken into account in the final, revised version of the Road Map, which was approved by the EMEA Management Board in December 2004.
Prejete pripombe so bile upoštevane v končni revidirani različici usmeritvenega načrta, ki ga je upravni odbor EMEA odobril decembra 2004.
This project was successfully launched in 2004, providing EMEA users with a directory (ECD) based on LDAP.
Projekt se je v letu 2004 začel uspešno izvajati in je uporabnikom EMEA zagotovil imenik (ECD), ki temelji na LDAP.
The majority of recalls were initiated by the marketing authorisation holder and were in response to problems such as the presence of particulate matter, raised impurity levels, sterility failures, dissolution test failures and unsatisfactory inspection reports.
Večino umikov je sprožil imetnik dovoljenja za promet kot odziv na težave, kot so prisotnost delcev, povišane ravni nečistoč, neustrezna sterilnost, neustreznost preizkusov raztapljanja in nezadovoljiva poročila o inšpekcijskem pregledu.
The Mutual Recognition Facilitation Group (MRFG) reports to the Heads of Medicines Agencies Human.
Skupina za poenostavitev medsebojnega priznavanja (Mutual Recognition facilitation Group, MRFG) poroča vodjem agencij za zdravila za uporabo v humani medicini.
The CHMP working parties and groups have, over time, developed positions on a wide range of topics, including variant Creutzfeldt-Jakob disease (vCJD), viral safety, influenza pandemic, new technologies and therapies, etc.
Delovne skupine CHMP so sčasoma razvile stališča glede vrste tem, vključno z varianto CreutzfeldtJakobove bolezni (vCJD), virusno varnostjo, pandemijo influence, novimi tehnologijami in terapijami itd.
With the introduction of the new EU legislation, however, and in accordance with Article 24 of Regulation (EC) No 726/2004, save in exceptional circumstances, adverse drug reactions will have to be transmitted electronically as of 20 November 2005 onwards.
Z uvedbo nove zakonodaje EU v skladu s členom 24 Uredbe (ES) št. 726/2004 pa se bodo morali od 20. novembra 2005 dalje podatki o neželenih učinkih zdravil poročati elektronsko, razen v izjemnih okoliščinah.
In one case, a confirmed out-of-specification result for one parameter (pH) was found.
V enem primeru je potrjen rezultat za en parameter (pH) pokazal neskladnost s specifikacijami.
The EMEA and CVMP continued to advance the course of greater medicines availability for minor uses and minor species.
EMEA in CVMP sta si še naprej prizadevala povečati razpoložljivost zdravil manj pogoste uporabe in za manj pogoste vrste.
The IT sector also ensures archiving and back-up of data, and maintains a high level of security and confidentiality for all data held on EMEA systems.
Sektor IT zagotavlja tudi arhiviranje in varnostno kopiranje podatkov in ohranja visoko raven varnosti in zaupnosti za vse podatke, ki se hranijo v sistemih EMEA.
The development and revision of scientific guidelines is a particularly important aspect of the work of the working parties as they contain guidance on specific scientific issues and are based on the most upto-date scientific knowledge available, providing essential information to be taken into account in the research and development of new medicines.
Razvoj in revizija znanstvenih smernic je posebno pomembno področje dela delovnih skupin, saj te smernice zadevajo posebna znanstvena vprašanja in temeljijo na najnovejših znanstvenih spoznanjih, ob tem pa zagotavljajo nujno potrebne informacije, ki jih je treba upoštevati pri raziskovanju in razvoju novih zdravil.
The other safety review related to the class of COX-2 inhibitor medicines.
Druga presoja varnosti se je nanašala na razred inhibitorjev COX-2.
Document title
Naslov dokumenta
To further improve its scientific assessment procedures, the COMP continued to actively involve experts in the designation process, with 41 experts being consulted on specific applications in 2004.
COMP je, da bi še bolj izboljšal postopke znanstvenega vrednotenja, še naprej aktivno vključeval strokovnjake v proces določitve in se z 41 strokovnjaki posvetoval o določenih vlogah.
Issues discussed included: enlargement of the EU and implementation of the new legislation; integration of the new members; the new Committee structure; quality and integrity of scientific assessments; and improvements called for following an audit of the Committee in October 2004.
Razpravljal je o širitvi EU in izvajanju nove zakonodaje, vključevanju novih članov, novi sestavi Odbora, kakovosti in celovitosti znanstvenega vrednotenja ter izboljšavah, ki so se pokazale za potrebne po reviziji Odbora oktobra
By providing scientific advice, the Agency helps companies to research and develop new medicines and to further their scientific exploration in areas such as emerging therapies.
Agencija z zagotavljanjem znanstvenega svetovanja pomaga podjetjem pri raziskavah in razvoju novih zdravil ter pospeševanju znanstvenega raziskovanja na področjih, kot so nove terapije.
The Management Board also approved the provision of free scientific advice to companies developing products for minor uses and minor species.
Upravni odbor je odobri tudi zagotavljanje brezplačnega znanstvenega svetovanja podjetjem, ki razvijajo zdravila za manjše uporabe in manj pomembne vrste.
The second step , following the PMF/VAMF evaluation and certification, sets out how the competent authorities that will grant or have granted a marketing authorisation will take into account the certification, re-certification or variation of the PMF/VAMF relating to the medicinal products concerned.
Po oceni in certificiranju PMF/VAMF "drugi korak" določa, kako morajo pristojni organi, ki bodo ali ki so dodelili dovoljenje za promet, upoštevati certificiranje, ponovno certificiranje in spremembo PMF/VAMF za zadevna zdravila.
In light of the steady growth of the Agency, a new floor providing office space for EMEA staff was fitted out in 2004.
Zaradi stalne rasti Agencije je bilo v letu 2004 opremljeno novo nadstropje s pisarniškimi prostori za osebje EMEA.
Important areas of the remaining provisions include: the implementation of conditional marketing authorisation and accelerated review procedures for the authorisation of medicinal products; expanded scope of the centralised procedure to include mandatory application to the EMEA for evaluation of medicinal products for HIV/AIDS, cancer, neurodegenerative diseases and diabetes; new pharmacovigilance and surveillance tools to increase the safety of medicines; greater emphasis on transparency, communication and the provision of information.
Pomembna področja drugih določb zajemajo: izvedbo postopkov za izdajo pogojnih dovoljenj za promet z zdravili in pospešeno vrednotenje za dovoljenje za promet z zdravili; razširjen obseg centraliziranega postopka, ki zajema obvezno oddajo vloge pri EMEA za vrednotenje zdravil za HIV/AIDS, raka, nevrodegenerativne bolezni in sladkorno bolezen; nova orodja farmakovigilance in nadzora za večjo varnost zdravil; večji poudarek na preglednosti, obveščanju in zagotavljanju informacij.
Storage capability in the data centre
Pomnilniške zmogljivosti v podatkovnem centru
Adopted in April 2004, updated in September 2004
Sprejeto aprila 2004, posodobljeno septembra 2004
Documentum, the electronic document management system, was successfully rolled out throughout the Agency during 2004.
V letu 2004 je bil sistem elektronskega vodenja dokumentacije (Documentum) uspešno vpeljan po vsej Agenciji.
MRA partners have agreed to work on harmonisation of operational aspects across the different agreements.
Države partnerice v sporazumih o medsebojnem priznavanju so se dogovorile, da si bodo prizadevale uskladiti operativne vidike med različnimi sporazumi.
Assistance with translation of the indication and active substance name is offered to those SMEs which encounter difficulties in doing so themselves.
Pomoč pri prevajanju indikacij in naziva zdravilne učinkovine nudi tistim MSP, ki imajo pri tem težave.
In 2004, as an initial trial, there was an exchange of information with the US Food and Drug Administration regarding 4 scientific advice procedures in the context of the EU-FDA confidentiality arrangements.
V letu 2004 je bila kot začetni poskus opravljena izmenjava informacij z Upravo ZDA za hrano in zdravila v zvezi s štirimi postopki znanstvenega svetovanja v okviru dogovora o zaupnosti z med EU in FDA.
Improved transparency for orphan drugs
Izboljšana preglednost za zdravila sirote
Following adoption of the guidelines on data requirements and procedures for the evaluation and certification of plasma master files (PMFs) and vaccine antigen master files (VAMFs) in February 2004, the EMEA made further progress on the implementation of Commission Directive 2003/63/EC providing the legal basis for the submission of PMFs and VAMFs.
EMEA je po sprejetju smernic o zahtevah po podatkih in o postopkih za oceno in certificiranje glavnih dosjejev plazme (PMF) in glavnih dosjejev virusnih antigenov (VAMF) februarja 2004 dosegla nadaljnji napredek pri izvajanju Direktive Komisije 2003/63/ES, ki zagotavlja pravno podlago za predložitev PMF-jev in VAMF-jev.
The views presented in this document are those of the HMPWP, which was created as a forum for exchange of experience in the field of herbal medicinal products.
V tem dokumentu so predstavljena mnenja HMPWP, ki je bil oblikovan kot forum za izmenjavo izkušenj na področju zeliščnih zdravil.
Human medicinal products only Currently excludes active substances, investigational medicinal products, medicinal gases
Trenutno so izključene učinkovine, zdravila za raziskave, medicinski plini
The EMEA received 38 quality defect reports concerning human medicinal products and 2 defect reports for veterinary medicinal products.
EMEA je prejela 38 poročil o pomanjkljivi kakovosti pri zdravilih za uporabo v humani medicini in 2 poročili o pomanjkljivostih pri zdravilih za uporabo v veterinarski medicini.
Six (75 %) of these received a positive CHMP opinion, indicating that, while SA/PA is no guarantee of a positive outcome, it appears to have a favourable influence.
Od teh jih je šest (75 %) prejelo pozitivno mnenje CHMP, kar kaže, da imata znanstveno svetovanje in pomoč pri protokolu ugoden učinek, čeprav ne zagotavljata pozitivnega rezultata.
Referral procedures under Articles 31, 36 and 37 of Directive 2001/83/EC are mainly initiated in cases involving the interests of the Community or concerns relating to the protection of public health.
Postopki predložitve v skladu s členi 31, 36 in 37 Direktive 2001/83/ES se uvedejo predvsem pri interesu Skupnosti in vprašanjih v zvezi z varovanjem javnega zdravja.
To simplify dosing and aid compliance, a once-daily regimen was introduced for a medicinal product in this class.
Zaradi poenostavitve skladnosti doziranja in pomoči je bilo za zdravilo iz tega razreda uvedeno uživanje enkrat na dan.
EC subsidy/EEA contribution
Subvencija ES/prispevek EGP
• Both the phase-1 registration system (known as EudraCT) and the EudraVigilance Clinical Trials Module were successfully deployed
• uspešno sta bila uvedena faza 1 sistema registracije (znan kot EudraCT) in modul kliničnih preizkušanj (Clinical Trials Module) EudraVigilance
The Agency received 948 post-authorisation commitments made up of follow-up measures and specific obligations in 2004.
Agencija jev letu 2004 prejela 948 obveznosti po izdaji dovoljenja za promet z zdravili, ki zajemajo nadaljnje ukrepe in posebne obveznosti.
Organisation of scientific advice at the Agency
Organizacija znanstvenega svetovanja v Agenciji
Respiratory system
Respiratorni sistem
Activities in the administration area relate to a number of functions, including managing and administering staff and seconded personnel, conducting recruitment procedures, and managing revenue, expenditure and accounts according to existing rules and regulations, as well as providing and running the necessary infrastructure services for effective functioning of the Agency.
Dejavnosti na področju administracije se nanašajo na številne naloge, ki vključujejo vodenje in upravljanje zaposlenega in začasno dodeljenega osebja, vodenje zaposlitvenih postopkov, vodenje prihodkov in odhodkov ter računov v skladu z veljavnimi pravili in predpisi ter zagotavljanje in vodenje potrebnih infrastrukturnih storitev za učinkovito delovanje Agencije.
These inspections may be necessary to verify specific aspects of the clinical or laboratory testing or manufacture and control of the product and/or to ensure compliance with GMP, GCP or GLP and quality assurance systems.
Ti inšpekcijski pregledi so lahko nujni za preveritev določenih vidikov kliničnega ali laboratorijskega preizkušanja ali izdelave in nadzora izdelka in/ali da se zagotovi skladnost z dobro proizvodno, klinično ali laboratorijsko prakso ter sistemi za zagotavljanje kakovosti.
Integrated quality management
Integrirano upravljanje kakovosti
Infrastructure services
Infrastrukturne storitve
The EMEA set up a pre-accession linguistic review process for 199 human and 41 veterinary centrally authorised products in the 9 new EU languages.
EMEA je v 9 novih jezikih EU uvedla "proces predpristopne jezikovne revizije" za 199 zdravil za humano uporabo in 41 zdravil za veterinarsko uporabo, za katera je bilo izdano dovoljenje po centraliziranem postopku.
Annex 8 IT projects and operational activities
Priloga 8 Projekti IT in operativne dejavnosti
• Greg MARKEY1 (United Kingdom)
• Greg MARKEY1 (Združeno kraljestvo)
Legal sector
Sektor za pravne zadeve
Requests for GMP inspection increased by 8 % relative to 2003, mainly due to a large number of reinspections which fell due and the impact of inspections in the context of the PMF certification scheme.
Prošnje za inšpekcijske preglede za dobro proizvodno prasko so se povečale za 8 % v primerjavi z letom 2003 predvsem zaradi veliko ponovnih inšpekcijskih pregledov, za katere se je iztekel rok, in vpliva inšpekcijskih pregledov v okviru sistema certificiranja PMF.
• Gianmartino BENZI (EMEA representative)
• Gianmartino BENZI (predstavnik EMEA)
Pharmacovigilance is a priority area for the Agency and, as a consequence, the EMEA will continue and further strengthen its efforts in order to ensure the safe use of products licensed in accordance with the centralised procedure.
Farmakovigilanca je prednostno področje za Agencijo in EMEA bo zato še naprej krepila svoja prizadevanja za zagotovitev varne uporabe izdelkov, za katere je bilo izdano dovoljenje po centraliziranem postopku.
• The CVMP's preparation for enlargement of the European Union proved more than adequate, with the restructuring of the Committee in accordance with the revised pharmaceutical legislation taking place smoothly and without any difficulty.
• Priprava CVMP na širitev Evropske unije se je izkazala za zelo ustrezno, saj se je Odbor nemoteno in brez težav preoblikoval v skladu z revidirano farmacevtsko zakonodajo.
Archiving and backup of data
Arhiviranje in varnostno kopiranje podatkov
The task of the Committee is to advise the Executive Director on the outcome of audit reports issued by the Court of Auditors, the Internal Audit Service of the European Commission, the IQM/Audit function of the Agency and any other external audit organisation.
Njegova naloga je svetovati izvršnemu direktorju o rezultatih revizijskih poročil, ki jih objavijo Računsko sodišče, Služba za notranjo revizijo Evropske komisije, služba Agencije za integrirano upravljanja kakovosti/revizijo in katera koli druga zunanja revizijska organizacija.
1 Commission Regulation (EC) No 1085/2003 of 3 June 2003 concerning the examination of variations to the terms of a marketing authorisation for medicinal products for human use and veterinary medicinal products falling within the scope of Council Regulation (EEC) No 2309/93.
Uredba Komisije (ES) št. 1085/2003 z dne 3. junija 2003 o pregledu sprememb dovoljenja za promet z zdravili za uporabo v humani medicini in zdravili za uporabo v veterinarski medicini, ki spadajo v področje Uredbe Sveta (EGS) št. 2309/93.
EU institutions and other agencies
Institucije in druge agencije EU
To maintain the highest levels of security and confidentiality for all data held on EMEA systems
Ohraniti najvišje ravni varnosti in zaupnosti vseh podatkov, ki se hranijo v sistemih EMEA.
Personnel and budget
Kadrovske zadeve in proračun
• Lars GRAMSTAD (Norway)
• Lars Gramstad (Norveška)
Veterinary immunologicals and vaccines excluded
Izključena veterinarska imunološka zdravila in cepiva
An EMEA PAT team was created in January 2004 to review the implications of PAT with a view to ensuring that the European regulatory framework and the authorities are prepared for and adequately equipped to conduct thorough and effective evaluations of PAT-based submissions.
Januarja 2004 je bila oblikovana skupina EMEA PAT, ki naj bi pregledala učinke analitske tehnologije procesa (process analytical technology, PAT) in tako zagotovila, da so evropski regulativni okvir in organi pripravljeni in ustrezno opremljeni za izvajanje temeljitega in učinkovitega vrednotenja vlog, ki temeljijo na PAT.
• Patrick SALMON2 (Ireland)
• Patrick SALMON2 (Irska)
• A programme of ongoing quality improvements in the scientific and regulatory operations of the Committee for Medicinal Products for Human Use (CHMP) and the Committee for Orphan Medicinal Products (COMP) was put in place and initiated.
• Uveden je bil program za stalne kakovostne izboljšave v znanstvenem in regulativnem delovanju Odbora za zdravila za uporabo v humani medicini (CHMP) in Odbora za zdravila sirote (COMP), ki se je začel tudi izvajati.
Helping to bring medicines for rare diseases to the market
Pomoč pri dajanju zdravil za redke bolezni na trg
• PAT team a European team of GMP inspectors and quality assessors was established to address matters relating to the implementation of process analytical technology (PAT) by manufacturers, and a training session for assessors and inspectors was organised in September with the support of the Swedish Medical Products Agency.
• Ustanovljena je bila skupina PAT - evropska skupina inšpektorjev in ocenjevalcev kakovosti za dobro proizvodno prakso - za obravnavo zadev v zvezi z izvajanjem analitske tehnologije procesa (process analytical technology, PAT) pri proizvajalcih, v septembru pa je bilo organizirano usposabljanje za ocenjevalce in inšpektorje, ki ga je podprla švedska agencija za zdravila.
The CHMP adopted an opinion on a referral under Article 31 regarding paroxetine-containing medicines in April 2004.
CHMP je aprila 2004 sprejel mnenje o predložitvi v skladu s členom 31 glede zdravil z vsebnostjo paroksetina.
Visual recording of meetings for archiving and broadcasting purposes was set up using Internet/web-based technology
Uvedeno je bilo vizualno snemanje sestankov za arhiviranje in prenašanje z uporabo internetne/spletne tehnologije.
• COMP Working Group with Interested Parties
• Delovna skupina COMP za sodelovanje z zainteresiranimi stranmi
Working parties and ad hoc groups
Delovne in ad hoc skupine