natgillin/translations-raw huggingface dataset:
Pharmaceutical companies would only have to present a simplified "pharmacovigilance system master file" in support of the marketing authorisation, provided a detailed file would be maintained on site.
Farmacevtska podjetja naj bi za dovoljenje za promet predložila samo poenostavljeno „glavno datoteko sistema farmakovigilance“, pod pogojem da se bo podrobna kartoteka vodila v podjetju.
pharmaceutical companies, including the innovative industry and the generic industry, for which access to market is indeed essential to ensure the competitiveness and profitability of the industry;
farmacevtska podjetja, vključno z industrijo inovativnih in generičnih zdravil, za katere je dostop na trg zares ključnega pomena za njihovo konkurenčnost in profitabilnost;
Pharmaceutical companies: improved market access and additional predictability in the absence of unjustified delays.
Farmacevtske družbe: izboljšan dostop do trga in dodatna predvidljivost brez neupravičenih zamud.
Pharmaceutical companies: legal uncertainty and lack of business predictability; lack of level playing field with potential effects on competitiveness (reduced pharmaceutical sales, R&D and employment).
Farmacevtske družbe: pomanjkanje pravne varnosti in poslovne predvidljivosti; pomanjkanje enakih pogojev s potencialnimi učinki na konkurenčnost (zmanjšana prodaja farmacevtskih izdelkov, raziskave in razvoj ter zaposlovanje).
pharmaceutical form, route of administration (may be excluded for oral solid dose forms), quantity of dosage units and, in the case of open label trials, the name/identifier and strength/potency;
farmacevtska oblika, način dajanja zdravila (pri trdnih farmacevtskih oblikah za peroralno uporabo se lahko opusti), količina enot odmerka in v primeru odprtega kliničnega preskušanja ime/identifikacijska oznaka ter odmerek/jakost;
pharmaceutical form, route of administration, quantity of dosage units, and, in the case of open label trials, the name/identifier and strength/potency;
farmacevtska oblika, način dajanja zdravila, količina enot odmerka in v primeru odprtega kliničnega preskušanja ime/identifikacijska oznaka in odmerek/jakost;
Pharmaceutical Forum
Farmacevtski forum
Pharmaceutical industry
Farmacevtska industrija
Pharmaceutical industry & Health
Farmacevtska industrija in zdravje
Pharmaceutical industry, including Marketing Authorisation Holders (innovative, generic and over-the-counter medicines sectors), manufacturers and distributers of medicines (comprising a wide range of company sizes including a high proportion of small and medium-sized enterprises -SMEs).
farmacevtska industrija, vključno z imetniki dovoljenj za promet (sektor inovativnih in generičnih zdravil ter zdravil v prosti prodaji), proizvajalci in distributerji zdravil (širok razpon velikosti podjetij, vključno z velikim deležem malih in srednje velikih podjetij – MSP).
pharmaceutical industry;
predstavniki farmacevtske industrije;
Pharmaceutical Legislation
Farmacevtska zakonodaja
Pharmaceutical legislation: - Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products- Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use
Farmacevtska zakonodaja – Direktiva 2001/82/ES Evropskega parlamenta in Sveta z dne 6. novembra 2001 o zakoniku Skupnosti o zdravilih za uporabo v veterinarski medicini– Direktiva 2001/83/ES Evropskega parlamenta in Sveta z dne 6. novembra 2001 o zakoniku Skupnosti o zdravilih za uporabo v humani medicini
Pharmaceutical manufacturing — 40 C.F.R. Part 63, Subpart GGG;
Proizvodnja farmacevtskih izdelkov – ZZP 40, 63. del, poddel GGG,
Pharmaceutical product patents
Obvezno licenciranje patentov/farmacevtski izdelki
pharmaceutical products of a kind normally used for health care, prevention of illnesses and as treatment for medical and veterinary purposes, including products used for contraception and absorbent hygiene products;
farmacevtski izdelki, ki se običajno uporabljajo za zdravstveno nego, preprečevanje bolezni in za zdravljenje v medicini in veterini, vključno z izdelki, ki se uporabljajo za preprečevanje nosečnosti, in vpojnimi higienskimi izdelki;
Pharmaceutical products; except for:
Farmacevtski izdelki; razen za:
Pharmaceutical R&D is moving out of Europe
Farmacevtske raziskave in razvoj se selijo iz Evrope
Pharmaceutical research in the EU is fragmented
Farmacevtske raziskave v EU so razdrobljene
Pharmaceuticals Forum (first meeting in 2006)
Farmacevtski forum (prvi sestanek v letu 2006)
Pharmaceuticals Forum (first meeting in 2006)
farmacevtski forum (prvo srečanje leta 2006)
Pharmaceuticals Forum (first meeting in 2006)
farmacevtski forum (prvo srečanje leta 2006),
Pharmaceuticals Package:
Paket na področju farmacevtskih izdelkov:
Pharmaceuticals policy: Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products, and Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use
politika o farmacevtskih izdelkih: Direktiva 2001/82/ES Evropskega parlamenta in Sveta z dne 6. novembra 2001 o zakoniku Skupnosti o zdravilih za uporabo v veterinarski medicini ter Direktiva 2001/83/ES Evropskega parlamenta in Sveta z dne 6. novembra 2001 o zakoniku Skupnosti o zdravilih za uporabo v humani medicini;
Pharmaceuticals were the growth leader with 3.5%, followed by basic inorganic (3.1%) and consumer chemicals and polymers (3%).
Podsektor farmacevtskih proizvodov je s 3,5 % dosegel največjo rast, sledila pa sta mu podsektorja osnovnih anorganskih kemikalij (3,1 %) ter potrošniških kemikalij in polimerov (3 %).
Pharmaceuticals: Further strengthening and rationalising of market surveillance mechanisms for medicinal products will contribute to improving the safety of patients in Europe.
Farmacevtski izdelki Nadaljnja krepitev in racionalizacija mehanizmov tržnega nadzora za zdravila bo prispevala k izboljšanju varnosti bolnikov v Evropi.
Pharmaceuticals: systemic weaknesses restrain a growing industry
Farmacevtski izdelki: sistemske slabosti omejujejo rast industrije
Pharmacists
Farmacija
pharmacists (to advise patients, dispense medicines and report ADRs)
farmacevti (ki svetujejo bolnikom, izdajajo zdravila in poročajo o neželenih učinkih zdravil),
Pharmacogenetics is still in the research and development phase, but its application in drug development and evaluation is expected, and appropriate measures should be prepared in time for this evolution.
Farmakogenetika je še vedno na stopnji raziskovanja in razvoja, vendar lahko pričakujemo njeno uporabo pri razvoju in ocenjevanju zdravil, glede na ta razvoj pa bi bilo treba pripraviti ustrezne ukrepe.
Pharmacological tests, toxicological tests, residue tests and safety tests shall be carried out in conformity with the provisions related to good laboratory practice (GLP) laid down in Directive 2004/10/EC of the European Parliament and of the Council1 and Directive 2004/9/EC of the European Parliament and of the Council2.
Farmakološki in toksikološki testi, testi ostankov in varnostni testi se izvedejo v skladu z določbami o dobri laboratorijski praksi (DLP) iz Direktive 2004/10/ES Evropskega parlamenta in Sveta1 in Direktive 2004/9/ES Evropskega Parlamenta in Sveta2.
Pharmacological, toxicological, residue and safety tests shall be carried out in conformity with the provisions related to good laboratory practice (GLP) laid down in Directive 2004/10/EC and Directive 2004/9/EC.
Farmakološki, toksikološki in varnosti testi ter testi za ugotavljanje ostankov se izvedejo v skladu z določbami dobre laboratorijske prakse (DLP) iz Direktive 2004/10/ES in Direktive 2004/9/ES.
Pharmacologically active substances in foodstuffs of animal origin
Farmakološko aktivne snovi v živilih živalskega izvora
Pharmacologically active substances in foodstuffs of animal origin
Vrednosti ostankov v živilih živalskega izvora
Pharmacovigilance
Pozornost na učinek zdravil
Pharmacovigilance (amending Directive 2001/83/EC)
Farmakovigilanca (sprememba Direktive 2001/83/ES)
Pharmacovigilance (amending Directive No 2001/83/EC) (category C)
Farmakovigilanca (sprememba Direktive 2001/83/ES) (kategorija C)
Pharmacovigilance (amending Regulation (EC) No 726/2004)
Farmakovigilanca (sprememba Uredbe (ES) št. 726/2004)
Pharmacovigilance (amending Regulation (EC) No 726/2004) (category C)
Farmakovigilanca (sprememba Uredbe (ES) št. 726/2004) (kategorija C)
Pharmacovigilance and maintenance activities accounted for 13.5% of the Agency human resource (ca. 70 FTEs) and 14.54% of the Agency costs (€ 25.2 million including support service).
Dejavnosti farmakovigilance in vzdrževanja so pomenile 13,5 % človeških virov Agencije (približno 70 EPDČ) in 14,54 % stroškov Agencije (25,2 milijona EUR vključno s podpornimi storitvami).
Pharmacovigilance data-processing
Obdelava podatkov o farmakovigilanci
Pharmacovigilance database costs (€ millions to one decimal place)
Stroški baze podatkov o farmakovigilanci (v milijonih EUR na eno decimalno mesto)
Pharmacovigilance database costs (€ millions to one decimal place)
Stroški podatkovne baze farmakovigilance (milijonov EUR na eno decimalno mesto)
Pharmacovigilance Directive
Direktiva glede farmakovigilance
Pharmacovigilance Directive (category C)
Direktiva glede farmakovigilance (kategorija C)
Pharmacovigilance involves identifying adverse events and determining what action, if any, is required.
Farmakovigilanca vključuje identifikacijo neželenih dogodkov in ugotavljanje, kakšni ukrepi so morda potrebni.
Pharmacovigilance is defined as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects of medicinal products.
Farmakovigilanca je opredeljena kot znanost in dejavnosti, povezane z odkrivanjem, ocenjevanjem, razumevanjem in preprečevanjem neželenih učinkov zdravil.
Pharmacovigilance obligations by the marketing authorisation holder
Obveznosti imetnika dovoljenja za promet glede farmakovigilance
Pharmacovigilance obligations by the marketing authorisation holder
Obveznosti imetnika dovoljenja za promet v zvezi s farmakovigilanco
Pharmacovigilance Regulation
Uredba glede farmakovigilance
Pharmacovigilance Regulation (category C)
Uredba glede farmakovigilance (kategorija C)
pharmacovigilance regulations should not exist at the expense of public services;
da pravila glede farmakovigilance ne bi smela obstajati na račun javnih storitev;
pharmacovigilance regulations should not exist at the expense of public services;
predpisi o farmakovigilanci ne bi smeli morali obstajati na stroške javnih storitev;
pharmacovigilance regulations should not exist at the expense of public services;
predpisi o farmakovigilanci ne bi smeli obstajati na račun javnih storitev;
Pharmacovigilance responsibilities of the competent authorities and the Agency
Odgovornosti pristojnih organov in Agencije v zvezi s farmakovigilanco
Pharmacovigilance responsibilities of the marketing authorisation holder
Odgovornosti imetnika dovoljenja za promet v zvezi s farmakovigilanco
Pharmacovigilance rules are necessary for the protection of public and animal health and the environment.
Pravila o farmakovigilanci so potrebna za varovanje javnega zdravja in zdravja živali ter okolja.
Pharmacovigilance rules are necessary for the protection of public health in order to prevent, detect and assess adverse effects of medicinal products placed on the market of the Community, as the full safety profile of medicinal products can only be known once they have entered the market.
Pravila o farmakoviliganci so potrebna za varovanje javnega zdravja, da se preprečijo, odkrijejo in ocenijo neželeni učinki zdravil, ki so v prometu v Skupnosti, saj so popolne varnostne lastnosti zdravila lahko poznane šele potem, ko zdravila pridejo na trg.
Pharmacovigilance rules are therefore necessary for the protection of public health in order to prevent, detect and assess adverse effects of medicinal products.
Za varovanje javnega zdravja so zato potrebna pravila v zvezi s farmakovigilanco, da se tako preprečijo, odkrijejo in ocenijo neželeni učinki zdravil.
Pharmacovigilance rules are therefore necessary for the protection of public health in order to prevent, detect and assess adverse effects of medicinal products.
Zato so potrebni predpisi o farmakoviliganci za varovanje javnega zdravja, da se preprečijo, odkrijejo in ocenijo škodljivi učinki zdravil.
Pharmacovigilance system master file: A detailed description of the pharmacovigilance system utilized by the marketing authorisation holder with respect to one or more authorised medicinal products.”
Glavna dokumentacija sistema farmakovigilance: Podroben opis sistema farmakovigilance, ki ga uporabljajo imetniki dovoljenja za promet glede enega ali več odobrenih zdravil.“
Pharmacovigilance system of the marketing authorisation holder
Sistem farmakovigilance imetnika dovoljenja za promet
Pharmacovigilance system: a system utilized by marketing authorisation holders and by Member States to fulfil the tasks and responsibilities listed in Title IX and designed to monitor the safety of authorised medicinal products and detect any change to their risk-benefit balance.
Sistem farmakovigilance: Sistem, ki ga uporabljajo imetniki dovoljenja za promet in države članice za izpolnjevanje nalog in odgovornosti, navedenih v naslovu IX, in katerega namen je spremljati odobrena zdravila in odkrivanje sprememb razmerja med tveganjem in koristmi zdravil.
Pharmacovigilance –
Farmakovigilanca
Pharmacovigilance –
farmakovigilanco
Pharmacovigilance – Community Regulation – medicinal products for human and veterinary use
Farmakovigilanca – uredba Skupnosti – zdravila za humano in veterinarsko uporabo
Pharmacovigilance –Community code relating to medicinal products for human use
zakonik Skupnosti o zdravilih za uporabo v humani medicini
Pharmacovigilance/Community code relating to medicinal products for human use
Farmakovigilanca – zakonik Skupnosti o zdravilih za uporabo v humani medicini
Pharmacovigilance/Community code relating to medicinal products for human use
Farmakovigilanca – zakonik Skupnosti – zdravila za uporabo v humani medicini
Pharmacovigilance/Community code relating to medicinal products for human use
Farmakovigilanca/zakonik Skupnosti o zdravilih za uporabo v humani medicini
Pharmacovigilance/Community regulation – medicinal products for human and veterinary use – Community procedures
Farmakovigilanca – uredba Skupnosti – zdravila za humano in veterinarsko uporabo
Pharmacovigilance/Community regulation – medicinal products for human and veterinary use – Community procedures
Farmakovigilanca/uredba Skupnosti – zdravila za humano in veterinarsko uporabo – postopki Skupnosti
Pharmacovigilance/Community regulation – medicinal products for human and veterinary use – Community procedures
Zdravila za humano in veterinarsko uporabo – postopki Skupnosti za pridobitev dovoljenja za promet in nadzor – Evropska agencija za zdravila
Phase 1
1. faza
Phase 1
Faza 1
Phase 1 runs from 2004 to 2005, phase 2 from 2006 to 2007.
Faza 1 zajema obdobje 2004–2005, faza 2 pa 2006–2007.
Phase 1 valid from
Faza 1 velja od
Phase 1 will focus on four pillars of action: 1) building a solid knowledge base on the impact and consequences of climate change for the EU, 2) integrating adaptation into EU key policy areas; 3) employing a combination of policy instruments (market-based instruments, guidelines, public-private partnerships) to ensure effective delivery of adaptation and 4) stepping up international cooperation on adaptation.
Prva faza bo osredotočena na štiri stebre ukrepov: 1) izgradnja trdne baze znanja o vplivih in posledicah podnebnih sprememb v EU, 2) vključitev prilagajanja v ključna področja politik EU, 3) uporaba kombinacije instrumentov politik (tržni instrumenti, smernice, javno-zasebna partnerstva) za zagotovitev učinkovitega izvajanja prilagoditev in 4) krepitev mednarodnega sodelovanja pri prilagajanju.
Phase 1: based on the preliminary phase, identification of yearly needs;
faza 1: temelji na začetni fazi, opredelitev letnih potreb;
Phase 1: Concept and feasibility assessment:
Faza 1: Ocena koncepta in izvedljivosti:
Phase 2
2. faza
Phase 2
Faza 2
Phase 2 of the project launched during the first Governing Board meeting on 23 and 24 September 2010 aims to recruit and train the staff of ReSPA to deliver training and networking events for officials from the administrations of the ReSPA partners, and to enhance the visibility of ReSPA and its activities.
Cilj druge faze projekta, ki se je začela med prvim sestankom upravnega odbora 23. in 24. septembra 2010, je zaposliti in usposobiti uslužbence Regionalne šole za javno upravo, da bodo izvajali izobraževanja in dogodke mreženja za uradnike uprav partnerjev Regionalne šole za javno upravo, ter izboljšati prepoznavnost šole in njenih dejavnosti.
Phase 2 valid from
Faza 2 velja od
Phase 2: publication of the specific needs;
faza 2: objava posebnih potreb;
Phase 2: R&D, demonstration, market replication:
Faza 2: Raziskave in razvoj, predstavitev, uvedba na trg:
Phase 3
3. faza
Phase 3 should focus on the maritime domain, as it concerns putting together the multitude of information sources that are monitoring activities on the open seas; the equivalent challenge of monitoring such a vast space does not arise in relation to land borders.
Tretja faza bi se morala osredotočati na pomorsko področje, saj zadeva združitev številnih informacijskih virov, ki spremljajo dejavnosti na odprtem morju; kopenske meje ne pomenijo tako velikega izziva, saj ne gre za spremljanje tako velikega območja.
Phase 3 valid from
Faza 3 velja od
Phase 3 will focus exclusively on the maritime domain.
Tretja faza se bo osredotočala izključno na področje pomorstva.
Phase 3 will include the automatic exchange of messages between economic operators and Member State Administrations for the reporting of exceptional situations, such as the results of road controls, reports of exceptions made by economic operators and definitive interruptions of movements.
Faza 3 bo zajemala avtomatično izmenjavo sporočil med gospodarskimi subjekti in upravami držav članic za poročanje o izrednih primerih, kot so rezultati nadzora cestnega prometa, poročila o izjemah, ki so jih sprejeli gospodarski subjekti, ter dokončne prekinitve gibanj.
Phase 3: analysis of all projects received; acceptance/ refusal of projects; comparative financial analysis of all valid offers received and pre-selection of three projects;
faza 3: analiza vseh prejetih projektov; sprejetje/zavrnitev projektov; primerjalna finančna analiza vseh veljavnih prejetih ponudb in predizbor treh projektov;
Phase 3: Commercialisation:
Faza 3: Trženje:
Phase 4: technical analysis and financial negotiation of the three projects selected and identification of one project, to launch phase 5;
faza 4: tehnična analiza in pogajanje o finančnih pogojih treh izbranih projektov ter izbor enega projekta za začetek faze 5;
Phase 5: technical study and analysis of budgets needs, drafting of the contract for the project selected under phase 4;
faza 5: tehnična študija in analiza proračunskih potreb, priprava osnutka pogodbe za projekt, izbran v fazi 4;
Phase 6: Inter Service Consultation further to the outcome of phase 5 and signature of the contract.
faza 6: posvetovanje med službami po izidu faze 5 in podpis pogodbe.
Phase covering the manufacture and launch of the satellites in the constellation and the installation of all ground components
Vključuje izgradnjo in izstrelitev konstelacijskih satelitov in popolno vzpostavitev prizemne komponente sistema.
Phase covering the period of operation, particularly commercial operation, of the system
Ustreza obdobju obratovanja sistema, zlasti na komercialni ravni.
Phase I (up to 2016)
Faza I (do leta 2016)
Phase II (2016 to 2020)
Faza II (2016 do 2020)
Phase II withdrawals
Umiki v fazi II
phase in a specific multilingualism policy for Europa, the Internet portal and for publications;
postopna uvedba posebne politike večjezičnosti za Europo, spletni portal in objave;
Phase out environmentally  harmful fossil fuel subsidies
Postopna odprava subvencij za škodljiva fosilna goriva
Phase out environmentally harmful fossil fuel subsidies.
postopna odprava škodljivih subvencij za fosilna goriva.
Phase out marketing of herbal products for smoking
Postopna odprava zeliščnih izdelkov za kajenje
Phase out the fiscal disincentives for second earners, and increase the availability of fulltime child-care facilities and all-day schools.
Postopoma naj odpravi odvračilne davčne ukrepe za osebe z drugim virom dohodka v gospodinjstvu ter poveča razpoložljivost otroškega varstva za poln delovni čas in celodnevnih šol.
Phase out the special pension scheme for miners with a view to fully integrating them into the general scheme.
Postopoma naj ukine posebno pokojninsko ureditev za rudarje in te popolnoma vključi v splošno ureditev.
phase out, by 1 January 2012, the balance-of-payments statistical reporting obligations imposed on payment service providers;
postopno odpravo obveznosti statističnega poročanja o plačilni bilanci, ki veljajo za ponudnike plačilnih storitev, do 1. januarja 2012;
Phase-down
postopno zmanjšanje
Phase-in (no phase-in of the 2020 targets or inclusion of phase-in)
postopno uvajanje (brez postopnega uvajanja ciljev za leto 2020 ali vključitev postopnega uvajanja),
Phase-in and super-credits are discarded from further analysis.
Postopno uvajanje in olajšave se izključijo iz nadaljnje analize.
Phase-out direct payments in their current form
Postopno opustiti neposredna plačila v njihovi sedanji obliki.
Phase-out schedule – Chapter II, Articles 4, 5 and 6
Načrt postopnega opuščanja – členi 4, 5 in 6 poglavja II
Phased-out
postopno ukinjanje
Phases / Steps
Faze/koraki
Phases 1 and 2 should cover the maritime and land external borders, having regard to changing migration patterns.
Prva in druga faza bi morali zajemati morske in kopenske zunanje meje ter upoštevati spreminjajoče se migracijske vzorce.
PHASES OF THE GALILEO PROGRAMME
RAZLIČNE FAZE PROGRAMA
Phasing in a European Energy Community is the best way to cushion the impact on Europeans of the economic and social consequences of energy challenges.
Evropejce bi lahko pred gospodarskimi in socialnimi posledicami energetskih izzivov najbolje zavarovali s postopno vzpostavitvijo evropske energetske skupnosti.
Phasing out according WTO commitments
Postopno odpravljanje v skladu z zavezami STO
Phasing out animal testing
Opuščanje testiranja na živalih
Phasing out early retirement schemes and boosting employability of workers over 50 are a necessary part of the policy response.
Postopna ukinitev shem predčasnega upokojevanja in spodbujanje zaposljivosti delavcev, starih nad 50 let, sta nujna elementa odziva politike.
Phasing out of direct payments would lead to failure of many agricultural holdings and would put additional pressure on the viability of rural areas with higher unemployment and migration.
Postopna ukinitev neposrednih plačil bi povzročila propad številnih kmetijskih gospodarstev ter bi dodatno ogrozila sposobnost preživetja podeželskih območij z višjo stopnjo brezposelnosti in preseljevanja.
Phasing out of environmentally harmful subsidies enhances resource efficiency and fosters economic growth.
S postopno ukinitvijo okolju škodljivih subvencij se krepi gospodarnost izkoriščanja virov in spodbuja gospodarska rast.
Phasing out of grant decisions: it is proposed to phase out grant agreement and use predominantly grant agreements, subject to a review in the progress made towards e-grants at the end of the current MFF (Article 277).
Postopna ukinitev sklepov o nepovratnih sredstvih: predlaga se, da se postopno ukinejo sklepi o nepovratnih sredstvih in da se uporabljajo predvsem sporazumi o nepovratnih sredstvih, in sicer v skladu s presojo doseženega napredka glede elektronskih nepovratnih sredstev ob izteku sedanjega večletnega finančnega okvira (člen 277).
Phasing out of harmful subsidies and scrutinising public support is needed.
Treba je postopoma ukiniti škodljive subvencije in preveriti javno podporo.
Phasing out opt outs
ukinitev možnosti za odstopanja;