Iskalni niz je ali predolg ali pa vsebuje preveč besed.
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znanstvena pridobitev
1 Objavljeno
promet
Ur. l. RS, št. MP 2010-46
- o nacionalni zakonodaji, ki ureja vprašanja gospodarske in investicijske dejavnosti, standardizacije, certifikacije, pogojev za pridobitev licenc, varstva intelektualne in industrijske lastnine, uporabe rezultatov inovacijske in znanstveno-tehnične dejavnosti;
- national legislation regulating economic and investment activities, standardisation, certification, conditions for obtaining licences, the protection of intellectual and industrial property, the practical application of the results of innovative and scientific and technical ctivities;
2 Končna redakcija
CELEX: 32004R0726
Bodočim predlagateljem, ki si prizadevajo za pridobitev dovoljenja za promet z zdravilom, je treba preskrbeti splošnejše in bolj poglobljeno znanstveno svetovanje.
Scientific advice for future applicants seeking marketing authorisation should be provided more generally and in greater depth.
3 Končna redakcija
CELEX: 32004R0726
Člani odborov in strokovnjaki, ki so odgovorni za vrednotenje zdravil, se opirajo na znanstveno vrednotenje in vire, ki so na voljo nacionalnim organom za pridobitev dovoljenja za promet.
Members of the committees and experts responsible for evaluating medicinal products shall rely on the scientific evaluation and resources available to national marketing authorisation bodies.
4 Končna redakcija
CELEX: 32004R0726
Analiza znanstvenih podatkov v dokumentaciji, ki zadeva vlogo za pridobitev dovoljenja za promet z zdravilom, traja najmanj 80 dni, razen kadar poročevalec in soporočevalec izjavita, da sta oceno zaključila predčasno.
The duration of the analysis of the scientific data in the file concerning the application for marketing authorisation must be at least 80 days, except in cases where the rapporteur and co-rapporteur declare that they have completed their assessment before that time.
5 Končna redakcija
CELEX: 32004L0028
Če predlagatelj uporabi znanstveno literaturo za pridobitev dovoljenja za promet za vrsto živali za proizvodnjo hrane in v zvezi z istim zdravilom ter zaradi pridobitve dovoljenja za drugo vrsto živali za proizvodnjo hrane predloži nove študije zaostankov v skladu z Uredbo (EGS) št. 2377/90 skupaj z nadaljnjimi kliničnimi preskušanji, potem tretji osebi ni mogoče dovoliti uporabe teh študij ali preskusov v skladu s členom 13 v obdobju treh let od izdaje dovoljenja za promet, za katerega so bili izvedeni.
If an applicant makes use of scientific literature to obtain authorisation for a food-producing species, and submits, in respect of the same medicinal product and with a view to obtaining authorisation for another food-producing species, new residue studies in accordance with Regulation (EEC) No 2377/90, together with further clinical trials, it shall not be permissible for a third party to use such studies or such trials pursuant to Article 13, for a period of three years from the grant of the authorisation for which they were carried out.
6 Končna redakcija
CELEX: 32004R0726
Izkušnje, pridobljene po sprejetju Direktive Sveta 87/22/EGS z dne 22. decembra 1986 o približevanju nacionalnih ukrepov v zvezi z dajanjem v promet visokotehnoloških zdravil, zlasti tistih, ki so pridobljena z biotehnologijo, so pokazale, da je treba oblikovati centraliziran postopek za pridobitev dovoljenja za promet, ki bo obvezen za visokotehnološka zdravila, zlasti tista, ki izvirajo iz biotehničnih postopkov, da bi tako ohranili visoko raven znanstvenega vrednotenja teh zdravil v Evropski uniji in tako ohranili zaupanje bolnikov in zdravstvenih poklicev v vrednotenje.
Experience gained since the adoption of Council Directive 87/22/EEC of 22 December 1986 on the approximation of national measures relating to the placing on the market of high-technology medicinal products, particularly those derived from biotechnology(7) has shown that it is necessary to create a centralised authorisation procedure that is compulsory for high-technology medicinal products, particularly those resulting from biotechnical processes, in order to maintain the high level of scientific evaluation of these medicinal products in the European Union and thus to preserve the confidence of patients and the medical professions in the evaluation.
7 Pravna redakcija
DRUGO
usklajevanje znanstvenega ocenjevanja kakovosti, varnosti in učinkovitosti zdravil, za katera veljajo postopki za pridobitev dovoljenja Skupnosti za promet;
the coordination of the scientific evaluation of the quality, safety and efficacy of medicinal products which are subject to Community marketing authorization procedures;
8 Pravna redakcija
finance
CELEX: 32003L0063
Splošna načela, ki se že uporabljajo za ta zdravila, je treba podrobno opredeliti z znanstvenega in strokovnega stališča ter določiti posebne zahteve ob upoštevanju standardiziranih zahtev za pridobitev dovoljenja za promet z zdravilom.
The general principles already applicable to these products should be specified from a scientific and technical point of view and the specific requirements with regard to the standardised marketing authorisation requirements should be determined.
9 Pravna redakcija
finance
CELEX: 32003L0063
a) Podrobni klinični podatki, ki jih je treba predložiti na podlagi členov 8(3)(i) in 10(1), morajo omogočati oblikovanje dovolj trdnega in znanstveno utemeljenega mnenja glede vprašanj, ali zdravilo izpolnjuje merila, ki vplivajo na pridobitev dovoljenja za promet z zdravilom.
a) The clinical particulars to be provided pursuant to Articles 8 (3) (i) and 10 (1) must enable a sufficiently well-founded and scientifically valid opinion to be formed as to whether the medicinal product satisfies the criteria governing the granting of a marketing authorisation.
10 Pravna redakcija
finance
CELEX: 32003L0063
(4) Pri sestavljanju dokumentacije za vlogo za pridobitev dovoljenja za promet z zdravilom vlagatelji upoštevajo znanstvene smernice o kakovosti, varnosti in učinkovitosti zdravil za ljudi, ki jih je sprejel Odbor za lastniška zdravila (CPMP) in objavila Evropska agencija za vrednotenje zdravil (EMEA) in druge farmacevtske smernice Skupnosti, ki jih je Komisija objavila v različnih zvezkih Pravil, ki urejajo zdravila v Evropski skupnosti.
(4) In assembling the dossier for application for marketing authorisation, applicants shall also take into account the scientific guidelines relating to the quality, safety and efficacy of medicinal products for human use as adopted by the Committee for Proprietary Medicinal Products (CPMP) and published by the European Medicine Evaluation Agency (EMEA) and the other pharmaceutical Community guidelines published by the Commission in the different volumes of The rules governing medicinal products in the European Community.
11 Prevajalska redakcija
izobraževanje
CELEX: 21998A0623(01)
pridobitev in obdelavo znanstvenih in tehnoloških podatkov ter informacij o morju;
acquisition and processing of marine scientific and technological data and information;
12 Prevajalska redakcija
izobraževanje
CELEX: 32002D1786
Za pridobitev znanstvenih informacij in nasvetov za izvedbo programa je zaželeno sodelovanje z znanstveniki in strokovnjaki mednarodnega ugleda.
In order to obtain scientific information and advice to implement the programme, cooperation with scientists and experts of international standing is desirable.
13 Prevajalska redakcija
izobraževanje
CELEX: 32004R0726
Bodočim predlagateljem, ki si prizadevajo za pridobitev dovoljenja za promet z zdravilom, je treba preskrbeti splošnejše in bolj poglobljeno znanstveno svetovanje.
Scientific advice for future applicants seeking marketing authorisation should be provided more generally and in greater depth.
14 Prevajalska redakcija
izobraževanje
CELEX: 32004R0726
Člani odborov in strokovnjaki, ki so odgovorni za vrednotenje zdravil, se opirajo na znanstveno vrednotenje in vire, ki so na voljo nacionalnim organom za pridobitev dovoljenja za promet.
Members of the committees and experts responsible for evaluating medicinal products shall rely on the scientific evaluation and resources available to national marketing authorisation bodies.
15 Prevajalska redakcija
RS
EMEA
Eden najpomembnejših načinov, kako Agencija lahko podpira inovacije in raziskave, je zagotavljanje znanstvenega svetovanja: analiza vpliva znanstvenega svetovanja, ki jo je izdelala Agencija, kaže, da ta proces bistveno povečuje možnosti za pridobitev dovoljenja za promet.
The provision of scientific advice is one of the most important ways in which the Agency can support innovation and research: analysis of the impact of scientific advice provided by the Agency shows that the procedure significantly increases the chances of obtaining a marketing authorisation.
16 Prevajalska redakcija
izobraževanje
CELEX: 31996L0051
Pri dodatkih iz člena 2(aaa) znanstveni podatki in drugi podatki iz začetne dokumentacije, oddane za pridobitev prvega dovoljenja, ne smejo biti uporabljeni v prid drugih predlagateljev v obdobju 10 let:
In the case of the additives referred to in Article 2 (aaa), the scientific data and other information in the initial dossier submitted for the purpose of the first authorization may not be used for the benefit of other applicants for a period of 10 years:
17 Prevajalska redakcija
izobraževanje
CELEX: 32004R0726
Analiza znanstvenih podatkov v dokumentaciji, ki zadeva vlogo za pridobitev dovoljenja za promet z zdravilom, traja najmanj 80 dni, razen kadar poročevalec in soporočevalec izjavita, da sta oceno zaključila predčasno.
The duration of the analysis of the scientific data in the file concerning the application for marketing authorisation must be at least 80 days, except in cases where the rapporteur and co-rapporteur declare that they have completed their assessment before that time.
18 Prevajalska redakcija
izobraževanje
CELEX: 31998R2743
Ta pristojbina se zaračuna za vlogo za znanstveno ali tehnično svetovanje v zvezi z raziskovanjem in razvojem zdravila z namenom morebitne predložitve vloge za pridobitev dovoljenja za promet ali vloge za razširitev dovoljenja za promet.
This fee shall be charged where an application is made for scientific or technical advice concerning the research and development of a medicinal product with a view to the possible submission of an application for marketing authorisation or an application to extend a marketing authorisation.
19 Prevajalska redakcija
izobraževanje
CELEX: 32002R0178
V enem letu po začetku veljavnosti te uredbe Komisija objavi seznam sistemov Skupnosti na področjih poslanstva agencije, ki državam članicam omogočajo izvajanje nekaterih nalog na področju znanstvenega vrednotenja, zlasti pregled dokumentacije za pridobitev dovoljenj.
Within one year following the entry into force of this Regulation, the Commission shall publish an inventory of Community systems existing in the fields within the mission of the Authority which make provision for Member States to carry out certain tasks in the field of scientific evaluation, in particular the examination of authorisation dossiers.
20 Prevajalska redakcija
izobraževanje
CELEX: 32003L0063
Podrobni klinični podatki, ki jih je treba predložiti na podlagi členov 8(3)(i) in 10(1), morajo omogočati oblikovanje dovolj trdnega in znanstveno utemeljenega mnenja glede vprašanj, ali zdravilo izpolnjuje merila, ki vplivajo na pridobitev dovoljenja za promet z zdravilom.
The clinical particulars to be provided pursuant to Articles 8 (3) (i) and 10 (1) must enable a sufficiently well-founded and scientifically valid opinion to be formed as to whether the medicinal product satisfies the criteria governing the granting of a marketing authorisation.
21 Prevajalska redakcija
izobraževanje
CELEX: 32003D0078
Raziskovalni projekti so namenjeni tudi doseganju znanstvenega in tehnološkega napredka za pridobitev boljšega razumevanja obnašanja in nadzora nahajališč v zvezi s pritiskom kamnin, emisijo plinov, nevarnostjo eksplozije, prezračevanjem in vsemi drugimi dejavniki, ki vplivajo na pridobivanje rud.
Research projects shall also aim to achieve scientific and technological progress with a view to gaining a better understanding of the behaviour and control of deposits in relation to rock pressure, gas emissions, the risk of explosion, ventilation and all other factors affecting mining operations.
22 Prevajalska redakcija
izobraževanje
CELEX: 32000L0033
V skladu s členom 7(2) Direktive Sveta 86/609/EGS z dne 24. novembra 1986 o približevanju zakonov in drugih predpisov držav članic o varstvu živali, ki se uporabljajo v poskusne in druge znanstvene namene [4], se poskus, v katerem se uporabljajo živali, ne opravi, če je na voljo kaka druga znanstveno zadovoljiva, smiselna in praktična metoda za pridobitev iskanega rezultata.
According to Article 7(2) of Council Directive 86/609/EEC of 24 November 1986 on the approximation of laws, regulations and administrative provisions of the Member States regarding the protection of animals used for experimental and other scientific purposes(4), an experiment entailing the use of animals shall not be performed if another scientifically satisfactory method to obtain the result sought is reasonably and practicably available.
23 Prevajalska redakcija
izobraževanje
CELEX: 32003L0063
Pri sestavljanju dokumentacije za vlogo za pridobitev dovoljenja za promet z zdravilom vlagatelji upoštevajo znanstvene smernice o kakovosti, varnosti in učinkovitosti zdravil za ljudi, ki jih je sprejel Odbor za lastniška zdravila (CPMP) in objavila Evropska agencija za vrednotenje zdravil (EMEA) in druge farmacevtske smernice Skupnosti, ki jih je Komisija objavila v različnih zvezkih Pravil, ki urejajo zdravila v Evropski skupnosti.
In assembling the dossier for application for marketing authorisation, applicants shall also take into account the scientific guidelines relating to the quality, safety and efficacy of medicinal products for human use as adopted by the Committee for Proprietary Medicinal Products (CPMP) and published by the European Medicine Evaluation Agency (EMEA) and the other pharmaceutical Community guidelines published by the Commission in the different volumes of The rules governing medicinal products in the European Community.
24 Prevajalska redakcija
izobraževanje
CELEX: 32004L0028
Če predlagatelj uporabi znanstveno literaturo za pridobitev dovoljenja za promet za vrsto živali za proizvodnjo hrane in v zvezi z istim zdravilom ter zaradi pridobitve dovoljenja za drugo vrsto živali za proizvodnjo hrane predloži nove študije zaostankov v skladu z Uredbo (EGS) št. 2377/90 skupaj z nadaljnjimi kliničnimi preskušanji, potem tretji osebi ni mogoče dovoliti uporabe teh študij ali preskusov v skladu s členom 13 v obdobju treh let od izdaje dovoljenja za promet, za katerega so bili izvedeni.
If an applicant makes use of scientific literature to obtain authorisation for a food-producing species, and submits, in respect of the same medicinal product and with a view to obtaining authorisation for another food-producing species, new residue studies in accordance with Regulation (EEC) No 2377/90, together with further clinical trials, it shall not be permissible for a third party to use such studies or such trials pursuant to Article 13, for a period of three years from the grant of the authorisation for which they were carried out.
25 Prevajalska redakcija
izobraževanje
CELEX: 32001L0020
Za zdravila, ki sodijo v obseg Dela A Priloge k Uredbi Sveta (EGS) št. 2309/93 z dne 22. julija 1993, ki določa postopke Skupnosti za pridobitev dovoljenja za promet in nadzor zdravil za ljudi in za uporabo v veterini ter ustanavlja Evropsko agencijo za vrednotenje zdravil [6], ki vključujejo izdelke, namenjene za gensko zdravljenje ali celično zdravljenje, je predhodna znanstvena ocena Evropske agencije za vrednotenje zdravil (v nadaljnjem besedilu "Agencija"), ki ji pomaga Odbor za lastniška zdravila, obvezna, preden Komisija da dovoljenje za promet.
For medicinal products falling within the scope of Part A of the Annex to Council Regulation (EEC) No 2309/93 of 22 July 1993 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products(6), which include products intended for gene therapy or cell therapy, prior scientific evaluation by the European Agency for the Evaluation of Medicinal Products (hereinafter referred to as the "Agency"), assisted by the Committee for Proprietary Medicinal Products, is mandatory before the Commission grants marketing authorisation.
26 Prevajalska redakcija
izobraževanje
CELEX: 32004R0726
Izkušnje, pridobljene po sprejetju Direktive Sveta 87/22/EGS z dne 22. decembra 1986 o približevanju nacionalnih ukrepov v zvezi z dajanjem v promet visokotehnoloških zdravil, zlasti tistih, ki so pridobljena z biotehnologijo, so pokazale, da je treba oblikovati centraliziran postopek za pridobitev dovoljenja za promet, ki bo obvezen za visokotehnološka zdravila, zlasti tista, ki izvirajo iz biotehničnih postopkov, da bi tako ohranili visoko raven znanstvenega vrednotenja teh zdravil v Evropski uniji in tako ohranili zaupanje bolnikov in zdravstvenih poklicev v vrednotenje.
Experience gained since the adoption of Council Directive 87/22/EEC of 22 December 1986 on the approximation of national measures relating to the placing on the market of high-technology medicinal products, particularly those derived from biotechnology(7) has shown that it is necessary to create a centralised authorisation procedure that is compulsory for high-technology medicinal products, particularly those resulting from biotechnical processes, in order to maintain the high level of scientific evaluation of these medicinal products in the European Union and thus to preserve the confidence of patients and the medical professions in the evaluation.
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znanstvena pridobitev