Iskalni niz je ali predolg ali pa vsebuje preveč besed.
Prevodi: en > sl
1–50/150
clinical trial of medicinal products
1 Končna redakcija
CELEX: 32004R0726
For medicinal products for human use, the period for protection of data relating to pre-clinical tests and clinical trials should be the same as that provided for in Directive 2001/83/EC.
Čas varstva podatkov v zvezi s predkliničnimi preskusi in kliničnimi preskušanji zdravil za humano uporabo mora biti enak, kot je predpisan v Direktivi 2001/83/ES.
2 Končna redakcija
CELEX: 32004L0024
The long tradition of the medicinal product makes it possible to reduce the need for clinical trials, in so far as the efficacy of the medicinal product is plausible on the basis of long-standing use and experience.
Dolga tradicija zdravila omogoča zmanjšanje potrebe po kliničnih preskušanjih, kolikor je učinkovitost zdravila verjetna na podlagi dolgotrajne uporabe in izkušenj.
3 Končna redakcija
CELEX: 32004L0027
The competent authorities shall draw up an assessment report and comments on the file as regards the results of the pharmaceutical and pre-clinical tests and the clinical trials of the medicinal product concerned.
Pristojni organi izdelajo poročilo o oceni zdravila in pripombe na dokumentacijo v zvezi z rezultati farmacevtskih in predkliničnih preskusov ter kliničnih preskušanj zadevnega zdravila.
4 Končna redakcija
CELEX: 32004R0726
For medicinal products for veterinary use, the period for protection of data relating to pre-clinical tests and clinical trials as well as safety and residue tests should be the same as that provided for in Directive 2001/82/EC.
Čas varstva podatkov v zvezi s predkliničnimi preskusi in kliničnimi preskušanji zdravil za veterinarsko uporabo kot tudi s preskusi varnosti in zaostankov mora biti enak, kot je predviden v Direktivi 2001/82/ES.
5 Končna redakcija
CELEX: 32004L0028
The competent authority shall draw up an assessment report and comments on the file as regards the results of the pharmaceutical, safety and residue tests and the pre-clinical and clinical trials of the veterinary medicinal product concerned.
Pristojni organ izdela poročilo o oceni zdravila ter komentarje o dokumentaciji glede rezultatov farmacevtskih preskusov in preskusov varnosti in zaostankov ter predkliničnih in kliničnih preskušanj za zadevno zdravilo za uporabo v veterinarski medicini.
6 Končna redakcija
CELEX: 32004L0028
Where a biological veterinary medicinal product which is similar to a reference biological veterinary medicinal product does not meet the conditions in the definition of generic medicinal products, owing to, in particular, differences relating to raw materials or in manufacturing processes of the biological veterinary medicinal product and the reference biological veterinary medicinal product, the results of appropriate pre-clinical tests or clinical trials relating to these conditions must be provided.
Če biološko zdravilo za uporabo v veterinarski medicini, ki je podobno referenčnemu biološkemu zdravilu za uporabo v veterinarski medicini, ne izpolnjuje pogojev iz definicije generičnega zdravila, zlasti zaradi razlik v zvezi s surovinami ali postopkom izdelave tega in referenčnega biološkega zdravila za uporabo v veterinarski medicini, je treba predložiti rezultate ustreznih predkliničnih preskusov ali kliničnih preskušanj v zvezi s temi pogoji.
7 Končna redakcija
CELEX: 32004R0726
The medicinal product concerned must either be the subject of an application for a marketing authorisation in accordance with Article 6 of this Regulation or must be undergoing clinical trials.
Za zadevno zdravilo je treba vložiti vlogo za pridobitev dovoljenja za promet v skladu s členom 6 te uredbe in zanj opraviti klinična preskušanja.
8 Končna redakcija
CELEX: 32004L0027
Where a biological medicinal product which is similar to a reference biological product does not meet the conditions in the definition of generic medicinal products, owing to, in particular, differences relating to raw materials or differences in manufacturing processes of the biological medicinal product and the reference biological medicinal product, the results of appropriate pre-clinical tests or clinical trials relating to these conditions must be provided.
Kadar biološko zdravilo, ki je podobno referenčnemu biološkemu zdravilu ne izpolnjuje pogojev v opredelitvi generičnih zdravil, predvsem zaradi razlik v surovinah ali razlik v procesu izdelave biološkega zdravila in referenčnega biološkega zdravila, je treba predložiti rezultate ustreznih predkliničnih preskusov ali kliničnih preskušanj v zvezi s temi pogoji.
9 Končna redakcija
CELEX: 32004L0027
Medicinal products intended for research and development trials, but without prejudice to the provisions of Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use(10).";
Zdravila, namenjena za raziskave in razvojna preskušanja, vendar brez vpliva na določbe Direktive 2001/20/ES Evropskega parlamenta in Sveta z dne 4. aprila 2001 o približevanju zakonov in drugih predpisov držav članic v zvezi z izvajanjem dobre klinične prakse pri kliničnem preskušanju zdravil za ljudi;
10 Končna redakcija
CELEX: 32004L0027
In cases where the medicinal product does not fall within the definition of a generic medicinal product as provided in paragraph 2(b) or where the bioequivalence cannot be demonstrated through bioavailability studies or in case of changes in the active substance(s), therapeutic indications, strength, pharmaceutical form or route of administration, vis-à-vis the reference medicinal product, the results of the appropriate pre-clinical tests or clinical trials shall be provided.
Kadar zdravilo ne sodi v opredelitev generičnega zdravila iz odstavka 2(b) ali če bioekvivalence ni mogoče dokazati s študijami biološke uporabnosti ali v primeru sprememb zdravilnih učinkovin, terapevtskih indikacij, jakosti, farmacevtske oblike ali poti uporabe zdravila glede na referenčno zdravilo je treba predložiti rezultate ustreznih predkliničnih preskusov ali kliničnih preskušanj.
11 Končna redakcija
CELEX: 32004R0726
There is also a need to provide for the ethical requirements of Directive 2001/20/EC of 4 April 2001 of the European Parliament and of the Council on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use(9) to apply to medicinal products authorised by the Community.
Obstaja tudi potreba poskrbeti za etične zahteve iz Direktive 2001/20/ES z dne 4. aprila 2001 Evropskega parlamenta in Sveta o približevanju zakonov in drugih predpisovdržav članic v zvezi z izvajanjem dobre klinične prakse pri kliničnem preskušanju zdravil za ljudi, ki naj se uporablja za zdravila, ki jih je odobrila Skupnost.
12 Končna redakcija
CELEX: 32004L0027
In particular, with respect to clinical trials conducted outside the Community on medicinal products destined to be authorised within the Community, it should be verified, at the time of the evaluation of the application for authorisation, that these trials were conducted in accordance with the principles of good clinical practice and the ethical requirements equivalent to the provisions of that Directive.
Predvsem za klinična preskušanja, ki se zunaj Skupnosti opravijo za zdravila, ki pridobijo dovoljenje za promet v Skupnosti, je treba ob vrednotenju vloge za pridobitev dovoljenja za promet preveriti, da so bila preskušanja izvedena v skladu z načeli dobre klinične prakse in etičnimi zahtevami, enakovrednimi določbam te direktive.
13 Končna redakcija
CELEX: 32004R0726
In particular, with respect to clinical trials conducted outside the Community on medicinal products destined to be authorised within the Community, at the time of the evaluation of the application for authorisation, it should be verified that these trials were conducted in accordance with the principles of good clinical practice and the ethical requirements equivalent to the provisions of the said Directive.
Zlasti pri kliničnih preskušanjih, opravljenih izven Skupnosti z zdravili, ki so namenjena pridobitvi dovoljenja za promet v Skupnosti, je treba v času vrednotenja vloge za pridobitev dovoljenja za promet preveriti, ali so bila ta preskušanja opravljena v skladu z načeli dobre klinične prakse in etičnih zahtev, enakovrednih določbam navedene direktive.
14 Končna redakcija
CELEX: 32004L0027
There is a need to provide for the ethical requirements of Directive 2001/20/EC of the European Parliament and the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use(7) to apply to all medicinal products authorised within the Community.
Treba je upoštevati etične zahteve Direktive 2001/20/ES Evropskega parlamenta in Sveta z dne 4. aprila 2001 o približevanju zakonov in drugih predpisov držav članic v zvezi z izvajanjem dobre klinične prakse pri kliničnem preskušanju zdravil za uporabo v humani medicini, ki mora veljati za vsa zdravila, ki pridobijo dovoljenje za promet v Skupnosti.
15 Končna redakcija
CELEX: 32004L0028
In cases where the veterinary medicinal product does not fall under the definition of a generic medicinal product set out in paragraph 2(b) or where bio-equivalence cannot be demonstrated through bioavailability studies or in the case of changes to the active substance(s), therapeutic indications, strength, pharmaceutical form or route of administration vis-à-vis the reference medicinal product, the results of the appropriate safety and residue tests and pre-clinical tests or clinical trials shall be provided.
Če zdravilo za uporabo v veterinarski medicini ne sodi v definicijo generičnega zdravila iz odstavka 2(b) ali kadar bioekvivalence ni mogoče dokazati s študijami biološke uporabnosti ali v primeru sprememb zdravilne učinkovine ali učinkovin, terapevtskih indikacij, jakosti, farmacevtske oblike ali načina dajanja glede na referenčno zdravilo, je treba predložiti rezultate ustreznih preskusov varnosti in zaostankov ter predkliničnih preskusov ali kliničnih preskušanj.
16 Končna redakcija
CELEX: 32004L0027
Where a change of classification of a medicinal product has been authorised on the basis of significant pre-clinical tests or clinical trials, the competent authority shall not refer to the results of those tests or trials when examining an application by another applicant for or holder of marketing authorisation for a change of classification of the same substance for one year after the initial change was authorised.";
Kadar se sprememba razvrstitve zdravila odobri na podlagi pomembnih predkliničnih preskusov ali kliničnih preskušanj, se pristojni organ eno leto od odobritve prvotne spremembe ne sme sklicevati na rezultate teh preskusov ali preskušanj pri preučevanju vloge drugega predlagatelja ali imetnika dovoljenja za promet z zdravilom za spremembo razvrstitve iste učinkovine.”;
17 Končna redakcija
CELEX: 32004L0024
Where the applicant can demonstrate by detailed references to published scientific literature that the constituent or the constituents of the medicinal product has or have a well-established medicinal use with recognised efficacy and an acceptable level of safety within the meaning of Directive 2001/83/EC, he/she should not be required to provide the results of pre-clinical tests or the results of clinical trials.
Kadar predlagatelj lahko s podrobnimi sklici na objavljeno znanstveno literaturo dokaže, da ima sestavina ali sestavine zdravila dobro uveljavljeno medicinsko uporabo s priznano učinkovitostjo in sprejemljivo ravnjo varnosti v smislu Direktive 2001/83/ES, mu ni treba zagotoviti rezultatov predkliničnih preskusov ali rezultatov kliničnih preskušanj.
18 Končna redakcija
CELEX: 32004L0027
In the case of medicinal products containing active substances used in the composition of authorised medicinal products but not hitherto used in combination for therapeutic purposes, the results of new pre-clinical tests or new clinical trials relating to that combination shall be provided in accordance with Article 8(3)(i), but it shall not be necessary to provide scientific references relating to each individual active substance.
Za zdravila, ki vsebujejo zdravilne učinkovine, ki so uporabljene v sestavi zdravil, ki so pridobila dovoljenje za promet, vendar tu niso uporabljene v kombinaciji za terapevtske namene, se rezultati novih predkliničnih preskusov ali novih kliničnih preskušanj v zvezi s to kombinacijo zagotovijo v skladu s členom 8(3)(i), vendar ni nujno zagotoviti znanstvenih referenc za vsako posamezno zdravilno učinkovino.
19 Končna redakcija
CELEX: 32004L0027
"Article 10 1. By way of derogation from Article 8(3)(i), and without prejudice to the law relating to the protection of industrial and commercial property, the applicant shall not be required to provide the results of pre-clinical tests and of clinical trials if he can demonstrate that the medicinal product is a generic of a reference medicinal product which is or has been authorised under Article 6 for not less than eight years in a Member State or in the Community.
"Člen 10 1. Z odstopanjem od člena 8(3)(i) in brez vpliva na zakon o varstvu industrijske in poslovne lastnine, se od predlagatelja ne zahteva predložitev rezultatov predkliničnih preskusov in kliničnih preskušanj, če lahko dokaže, da je zdravilo generična oblika zdravila, ki ima v državi članici ali v Skupnosti na podlagi člena 6 dovoljenje za promet z zdravilom najmanj osem let.
20 Končna redakcija
CELEX: 32004L0028
A Member State may introduce or retain on its territory specific rules for the safety tests and pre-clinical and clinical trials of homeopathic veterinary medicinal products intended for pet species and non-food-producing exotic species other than those referred to in Article 17(1), in accordance with the principles and characteristics of homeopathy as practised in that Member State.
Država članica lahko uvede ali zadrži na svojem ozemlju posebna pravila za preskuse varnosti ter predklinična in klinična preskušanja homeopatskih zdravil za uporabo v veterinarski medicini, namenjena hišnim živalim in eksotičnim vrstam živali, ki niso namenjene za proizvodnjo hrane, razen tistih iz člena 17(1), v skladu z načeli in značilnostmi homeopatije, ki se izvaja v tej državi članici.
21 Končna redakcija
CELEX: 32004L0028
By way of derogation from point (j) of the first subparagraph of Article 12(3), and without prejudice to the law relating to the protection of industrial and commercial property, the applicant shall not be required to provide the results of the safety and residue tests or of the pre-clinical and clinical trials if he can demonstrate that the medicinal product is a generic of a reference medicinal product which is or has been authorised under Article 5 for not less than eight years in a Member State or the Community.
Z odstopanjem od točke (j) prvega pododstavka člena 12(3) ter brez poseganja v zakonodajo, ki se nanaša na varovanje industrijske in komercialne lastnine, predlagatelju ni treba predložiti rezultatov preskusov varnosti in zaostankov ali predkliničnih in kliničnih preskušanj, če lahko dokaže, da je zdravilo za uporabo v veterinarski medicini generično zdravilo referenčnemu zdravilu, ki ima ali je imelo dovoljenje za promet v skladu s členom 5 z veljavnostjo najmanj osem let v državi članici ali Skupnosti.
22 Končna redakcija
CELEX: 32004L0027
By way of derogation from Article 8(3)(i), and without prejudice to the law relating to the protection of industrial and commercial property, the applicant shall not be required to provide the results of pre-clinical tests or clinical trials if he can demonstrate that the active substances of the medicinal product have been in well-established medicinal use within the Community for at least ten years, with recognised efficacy and an acceptable level of safety in terms of the conditions set out in Annex I.
Z odstopanjem od člena 8(3)(i) in brez vpliva na zakon o varovanju industrijske in poslovne lastnine, se od predlagatelja ne zahteva predložitev rezultatov predkliničnih preskusov ali kliničnih preskušanj, če lahko dokaže, da imajo zdravilne učinkovine zdravila že dobro uveljavljeno medicinsko uporabo v Skupnosti vsaj deset let, z znano učinkovitostjo in sprejemljivo stopnjo varnosti glede na pogoje iz Priloge I.
23 Končna redakcija
CELEX: 32004L0028
In the case of veterinary medicinal products containing active substances used in the composition of authorised veterinary medicinal products but not hitherto used in combination for therapeutic purposes, the results of safety and residue tests, if necessary, and new pre-clinical tests or new clinical trials relating to that combination shall be provided in accordance with point (j) of the first subparagraph of Article 12(3), but it shall not be necessary to provide scientific references relating to each individual active substance.
V primeru zdravil za uporabo v veterinarski medicini, ki vsebujejo zdravilne učinkovine, uporabljene v sestavi zdravila z dovoljenjem za promet za uporabo v veterinarski medicini, vendar doslej še niso bile uporabljene v kombinaciji za terapevtske namene, je treba predložiti rezultate preskusov varnosti in zaostankov, če je potrebno, ter novih predkliničnih ali kliničnih preskušanj za to kombinacijo v skladu s točko (j) prvega pododstavka člena 12(3), vendar ni treba predložiti znanstvenih referenc za vsako posamezno učinkovino.
24 Končna redakcija
CELEX: 32004L0024
Directive 2001/83/EC(4) requires that applications for authorisation to place a medicinal product on the market have to be accompanied by a dossier containing particulars and documents relating in particular to the results of physico-chemical, biological or microbiological tests as well as pharmacological and toxicological tests and clinical trials carried out on the product and thus proving its quality, safety and efficacy.
Direktiva 2001/83/ES [4] zahteva, da mora biti vlogi za izdajo dovoljenja za promet z zdravilom priložena dokumentacija, ki vsebuje podatke in listine, ki se nanašajo zlasti na rezultate fizikalno-kemijskih, bioloških ali mikrobioloških preskusov ter farmakološko-toksikoloških preskusov in kliničnih preskušanj, opravljenih na zdravilu in s tem dokazati kakovost, varnost in učinkovitost zdravila.
25 Končna redakcija
CELEX: 32004L0028
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.
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.
26 Končna redakcija
CELEX: 32004L0028
By way of derogation from point (j) of the first subparagraph of Article 12(3), and without prejudice to the law on the protection of industrial and commercial property, the applicant shall not be required to provide the results of safety and residue tests or of pre-clinical tests or clinical trials if he can demonstrate that the active substances of the veterinary medicinal product have been in well-established veterinary use within the Community for at least ten years, with recognised efficacy and an acceptable level of safety in terms of the conditions set out in Annex I. In that event, the applicant shall provide appropriate scientific literature.
Z odstopanjem od točke (j) prvega pododstavka člena 12(3) ter brez poseganja v zakonodajo, ki se nanaša na varovanje industrijske in komercialne lastnine, predlagatelju ni treba predložiti rezultatov preskusov varnosti in zaostankov ali predkliničnih in kliničnih preskušanj, če lahko dokaže, da so učinkovine zdravila za uporabo v veterinarski medicini dobro uveljavljene v veterinarski uporabi v Skupnosti vsaj 10 let s priznano učinkovitostjo in sprejemljivo stopnjo varnosti v smislu pogojev iz Priloge I. V tem primeru predlagatelj predloži ustrezno znanstveno literaturo.
27 Končna redakcija
CELEX: 32004L0028
The marketing authorisation may require the holder to indicate on the immediate packaging and/or the outer wrapping and the package leaflet, where the latter is required, other particulars essential for safety or health protection, including any special precautions relating to use and any other warnings resulting from the clinical and pharmacological trials prescribed in Article 12(3)(j) and in Articles 13 to 13d or from experience gained during the use of the veterinary medicinal product once it has been marketed.".
Dovoljenje za promet z zdravilom lahko zahteva od imetnika, da na stični in/ali zunanji ovojnini in v navodilu za uporabo, če je navodilo potrebno, navede še druge podatke pomembne za varnost ali varovanje zdravja, vključno z morebitnimi posebnimi previdnostnimi ukrepi glede uporabe ter druga opozorila, ki izhajajo iz izsledkov kliničnih in farmakoloških preskušanj iz člena 12(3)(j) in členov 13 do 13d ali iz izkušenj, pridobljenih med uporabo zdravila za uporabo v veterinarski medicini, potem ko je že v prometu.";
28 Pravna redakcija
finance
CELEX: 32003L0063
In general, clinical trials shall be done as "controlled clinical trials" if possible, randomised and as appropriate versus placebo and versus an established medicinal product of proven therapeutic value;
Na splošno se klinična preskušanja, če je mogoče, opravljajo kot "kontrolirana klinična preskušanja", naključna in kot primerna, proti placebu in proti že uveljavljenemu zdravilu z dokazano terapevtsko vrednostjo;
29 Pravna redakcija
promet
CELEX: 22001A1029(01)
The definition of medicinal products above may include medicinal products intended for clinical trials, active ingredients, chemical and biological pharmaceuticals, immunologicals, radiopharmaceuticals, stable medicinal products derived from human blood or human plasma and, where appropriate, vitamins, minerals and herbal medicines.
Zgornja opredelitev zdravil lahko vključuje zdravila, namenjena za klinične preskuse, učinkovine, kemične in biološke farmacevtske izdelke, imunološka zdravila, radiofarmacevtske izdelke, obstojna zdravila, pridobljena iz človeške krvi ali človeške plazme, ter, kjer je to primerno, vitamine, minerale in zdravila na osnovi rastlin.
30 Pravna redakcija
finance
CELEX: 32003L0063
(8) All clinical trials, conducted within the European Community, must comply with the requirements of Directive 2001/20/EC of the European Parliament and of the Council on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use(3).
(8) Vsa klinična preskušanja, ki se izvajajo znotraj Evropske skupnosti, morajo izpolnjevati zahteve Direktive 2001/20/ES Evropskega parlamenta in Sveta o približevanju zakonov in drugih predpisov držav članic v zvezi z izvajanjem dobre klinične prakse pri kliničnem preskušanju zdravil za ljudi fn.
31 Pravna redakcija
finance
CELEX: 32003L0063
In addition, the Plasma Master File shall provide a list of the medicinal products for which the Plasma Master File is valid, whether the medicinal products have been granted a marketing authorisation or are in the process of being granted such an authorisation, including medicinal products referred to in Article 2 of Directive 2001/20/EC of the European Parliament and of the Council relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use.
V glavni dokumentaciji o plazmi se navede seznam zdravil, za katere glavna dokumentacija o plazmi velja, če so zdravila že pridobila dovoljenje za promet ali so v postopku pridobivanja dovoljenja, vključno z zdravili, navedenimi v členu 2 Direktive 2001/20/ES Evropskega parlamenta in sveta o izvajanju dobre klinične prakse pri vodenju kliničnih preskušanj zdravil za ljudi.
Prevodi: en > sl
1–50/150
clinical trial of medicinal products