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klinično preskušanje zdravil
1 Končna redakcija
CELEX: 32004L0024
Dolga tradicija zdravila omogoča zmanjšanje potrebe po kliničnih preskušanjih, kolikor je učinkovitost zdravila verjetna na podlagi dolgotrajne uporabe in izkušenj.
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.
2 Končna redakcija
CELEX: 32004R0726
Za zadevno zdravilo je treba vložiti vlogo za pridobitev dovoljenja za promet v skladu s členom 6 te uredbe in zanj opraviti klinična preskušanja.
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.
3 Končna redakcija
CELEX: 32004L0027
Pristojni organi izdelajo poročilo o oceni zdravila in pripombe na dokumentacijo v zvezi z rezultati farmacevtskih in predkliničnih preskusov ter kliničnih preskušanj zadevnega zdravila.
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.
4 Končna redakcija
CELEX: 32004R0726
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.
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.
5 Končna redakcija
CELEX: 32004R0726
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.
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.
6 Končna redakcija
CELEX: 32004L0027
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.
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.
7 Končna redakcija
CELEX: 32004L0027
Kadar biološko zdravilo ne izpolnjuje vseh pogojev, da bi se obravnavalo kot generično zdravilo, je treba predložiti rezultate ustreznih preskusov zaradi izpolnjevanja zahtev v zvezi z varnostjo (predklinični preskusi) in učinkovitostjo (klinična preskušanja), ali obema.
When a biological medicinal product does not meet all the conditions to be considered as a generic medicinal product, the results of appropriate tests should be provided in order to fulfil the requirements related to safety (pre-clinical tests) or to efficacy (clinical tests) or to both.
8 Končna redakcija
CELEX: 32004L0028
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.
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.
9 Končna redakcija
CELEX: 32004L0027
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.”;
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.";
10 Končna redakcija
CELEX: 32004L0027
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;
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).";
11 Končna redakcija
CELEX: 32004R0726
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.
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.
12 Končna redakcija
CELEX: 32004L0027
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.
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.
13 Končna redakcija
CELEX: 32004L0024
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.
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.
14 Končna redakcija
CELEX: 32004L0027
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.
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.
15 Končna redakcija
CELEX: 32004R0726
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.
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.
16 Končna redakcija
CELEX: 32004L0027
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.
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.
17 Končna redakcija
CELEX: 32004L0027
"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.
"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.
18 Končna redakcija
CELEX: 32004L0028
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.
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.
19 Končna redakcija
CELEX: 32004L0024
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.
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.
20 Končna redakcija
CELEX: 32004L0028
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.
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.
21 Končna redakcija
CELEX: 32004L0027
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.
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.
22 Končna redakcija
CELEX: 32004L0027
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.
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.
23 Končna redakcija
CELEX: 32004L0028
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.
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.
24 Končna redakcija
CELEX: 32004L0028
Po izdaji dovoljenja za promet lahko imetnik dovoljenja za promet dovoli uporabo farmacevtske dokumentacije in dokumentacije o testih varnosti in zaostankov ter o predkliničnih in kliničnih preskušanjih, ki so sestavni del dokumentacije o zdravilu za uporabo v veterinarski medicini, za obravnavo kasnejše vloge za zdravilo za uporabo v veterinarski medicini, ki ima enako količinsko in kakovostno sestavo zdravilnih učinkovin in enako farmacevtsko obliko.
After the marketing authorisation has been granted, the marketing authorisation holder may allow use to be made of the pharmaceutical, safety and residues, pre-clinical and clinical documentation contained in the file for the veterinary medicinal product with a view to examining a subsequent application for a veterinary medicinal product having the same qualitative and quantitative composition in active substances and the same pharmaceutical form.
25 Končna redakcija
CELEX: 32004L0028
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.
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.
26 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.
27 Končna redakcija
CELEX: 32004L0028
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.";
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.".
28 Končna redakcija
CELEX: 32004L0028
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.
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.
29 Končna redakcija
CELEX: 32004L0028
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.
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.
30 Pravna redakcija
finance
CELEX: 32003L0063
Celoten postopek je treba preskusiti v kliničnih preskušanjih in opisati v podatkih o zdravilu.
The whole procedure must be tested in clinical trials and described in the product information.
31 Pravna redakcija
finance
CELEX: 32003L0063
ANALIZNI, FARMAKOLOŠKO-TOKSIKOLOŠKI IN KLINIČNI STANDARDI TER PROTOKOLI ZA PRESKUŠANJE ZDRAVIL
ANALYTICAL, PHARMACOTOXICOLOGICAL AND CLINICAL STANDARDS AND PROTOCOLS IN RESPECT OF THE TESTING OF MEDICINAL PRODUCTS
32 Pravna redakcija
finance
CELEX: 32003L0063
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;
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;
33 Pravna redakcija
finance
CELEX: 32003L0063
Včasih študije na zdravih prostovoljcih niso izvedljive, določitev odmerka in kinetike pa bo težko določiti v kliničnih preskušanjih.
Sometimes studies in healthy volunteers are not feasible and the establishment of dose and kinetics will be difficult to determine in clinical trials.
34 Pravna redakcija
DRUGO
ZAHTEVE IN ANALITSKI PROTOKOL, VARNOSTNI PRESKUSI, PREDKLINIČNI IN KLINIČNI PRESKUSI ZA PRESKUŠANJE ZDRAVIL ZA UPORABO V VETERINARSKI MEDICINI
REQUIREMENTS AND ANALYTICAL PROTOCOL, SAFETY TESTS, PRE-CLINICAL AND CLINICAL FOR TESTS OF VETERINARY MEDICINAL PRODUCTS
35 Pravna redakcija
finance
CELEX: 32003L0063
Zlasti je treba navesti vse pomembne podrobnosti o vseh nepopolnih ali opuščenih farmakološko-toksikoloških ali kliničnih preskusih ali preskušanjih zdravila in/ali dokončanih preskušanjih v zvezi s terapevtskimi indikacijami, ki jih vloga ne zajema.
In particular, all relevant details shall be given of any incomplete or abandoned pharmaco-toxicological or clinical test or trial relating to the medicinal product and/or completed trials concerning therapeutic indications not covered by the application.
36 Pravna redakcija
finance
CELEX: 32003L0063
Dokazati je treba učinkovitost zdravil za napredno zdravljenje, kakor je opisano v modulu 5. Za nekatera zdravila in za nekatere terapevtske indikacije pa morda ne bo mogoče izvajati običajnih kliničnih preskušanj.
The efficacy of advanced therapy medicinal products must be demonstrated as described in Module 5. For some products and for some therapeutic indications, however, it may not be possible to perform conventional clinical trials.
37 Pravna redakcija
DRUGO
Pristojni organi morajo izdelati poročilo o oceni zdravila ter komentarje o dokumentaciji glede rezultatov analitskih in farmakološko toksikoloških preskusov ter kliničnih preskušanj za zadevno zdravilo za uporabo v veterinarski medicini.
The competent authorities shall draw up an assessment report and comments on the dossier as regards the results of the analytical and pharmacotoxicological tests and the clinical trials of the veterinary medicinal product concerned.
38 Pravna redakcija
finance
CELEX: 32003L0063
c) Imetniki dovoljenja za promet z zdravilom morajo poskrbeti, da lastniki podatkov hranijo bistvene dokumente kliničnega preskušanja (vključno z obrazci za poročanje o primerih), razen zdravstvene dokumentacije udeleženca v preskušanju:
c) Marketing authorisation holders must arrange for essential clinical trial documents (including case report forms) other than subject's medical files, to be kept by the owners of the data:
39 Pravna redakcija
promet
CELEX: 22003A1219(01)
Direktiva 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 (UL L 121, 1.5.2001, str. 34).
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 (OJ L 121, 1.5.2001, p. 34).
40 Pravna redakcija
DRUGO
farmakoepidemiološka študija ali klinično preskušanje, ki se izvede v skladu s pogoji dovoljenja za promet z zdravilom, da bi se odkrila in raziskala morebitna tveganja glede varnosti zdravila za uporabo v veterinarski medicini, ki že ima dovoljenje za promet.
Pharmacoepidemiological study or a clinical trial carried out in accordance with the terms of the marketing authorization, conducted with the aim of identifying and investigating a safety hazard relating to an authorized veterinary medicinal product.
41 Pravna redakcija
DRUGO
Direktiva Sveta 75/318/EGS z dne 20. maja 1975 o približevanju zakonodaje držav članic v zvezi z analiznimi, farmakološko-toksikološkimi in kliničnimi standardi in protokoli za preskušanje zdravil (UL št. L 147, 9. 6. 1975, str. 1), kakor je bila spremenjena z:
Council Directive 75/318/EEC of 20 May 1975 on the approximation of the laws of the Member States relating to analytical, pharmacotoxicological and clinical standards and protocols in respect of the testing of medicinal products (OJ No L 147, 9.6.1975, p. 1), as amended by:
42 Pravna redakcija
promet
CELEX: 21999A1009(01)
Direktiva Sveta 87/19/EGS z dne 22. decembra 1996 o spremembi Direktive 75/318/EGS o približevanju zakonodaje držav članic v zvezi z analitskimi, farmakotoksikološkimi in kliničnimi standardi in protokoli za preskušanje lastniških zdravil (UL L 15, 17.1.1987, str. 31).
Council Directive 87/19/EEC of 22 December 1996 amending Directive 75/318/EEC on the approximation of the laws of the Member States relating to analytical, pharmacotoxicological and clinical standards and protocols in respect of the testing of proprietary medicinal products (OJ L 15, 17.1.1987, p 31).
43 Pravna redakcija
promet
CELEX: 21999A1009(01)
Direktiva Sveta 87/20/EGS z dne 22. decembra 1986 o spremembi Direktive 81/852/EGS o približevanju zakonodaje držav članic v zvezi z analitskimi, farmakotoksikološkimi in kliničnimi standardi in protokoli za preskušanje veterinarskih zdravil (UL L 15, 17.1.1987, str. 34).
Council Directive 87/20/EEC of 22 December 1986 amending Directive 81/852/EEC on the approximation of the laws of the Member States relating to analytical, pharmacotoxicological and clinical standards and protocols in respect of the testing of veterinary medicinal products (OJ L 15, 17.1.1987, p. 34).
44 Pravna redakcija
DRUGO
Razen v primeru, če se preskušanje izvaja s slepim testom, se morajo uporabiti določila členov 58, 59 ter 60 glede označevanja zdravil za uporabo v veterinarski medicini po analogiji za označevanje formulacij, ki so namenjene uporabi v veterinarskih kliničnih preskušanjih.
Unless the trial is conducted with a blind design, the provisions of Articles 58, 59 and 60 concerning the labelling of veterinary medicinal products shall apply by analogy to the labelling of formulations intended for use in veterinary clinical trials.
45 Pravna redakcija
promet
CELEX: 22001A1029(01)
Direktiva Sveta 87/19/EGS z dne 22. decembra 1986 o spremembi Direktive 75/318/EGS o približevanju zakonodaj držav članic, ki se nanašajo na analitične, farmakološko-toksikološke in klinične standarde in protokole za preskušanje lastniških zdravil, ter spremembe Direktive
Council Directive 87/19/EEC of 22 December 1986 amending Directive 75/318/EEC on the approximation of the laws of the Member States relating to analytical, pharmaco-toxicological and clinical standards and protocols in respect of the testing of proprietary medicinal products and amendments thereto
46 Pravna redakcija
promet
CELEX: 22001A1029(01)
Direktiva Sveta 87/20/EGS z dne 22. decembra 1986 o spremembi Direktive 81/852/EGS o približevanju zakonodaj držav članic, ki se nanašajo na analitične, farmakološko-toksikološke in klinične standarde in protokole za preskušanje veterinarskih zdravil, ter spremembe Direktive
Council Directive 87/20/EEC of 22 December 1986 amending Directive 81/852/EEC on the approximation of the laws of the Member States relating to analytical, pharmacotoxicological and clinical standards and protocols in respect of the testing of veterinary medicinal products and amendments thereto
47 Pravna redakcija
DRUGO
Direktiva Sveta z dne 19. julija 1991, ki spreminja Dodatek k Direktivi Sveta 75/318/EGS o približevanju zakonov držav članic v zvezi z analitičnimi, farmakotoksikološkimi in kliničnimi standardi in protokoli pri preskušanju zdravil (91/507/EGS) (UL L 270, 26. 9. 1991, str. 32)
Commission Directive of 19 July 1991 modifying the Appendix to Council Directive 75/318/EEC on the approximation of the laws of Member States relating to analytical, pharmacotoxicological and clinical standards and protocols in respect of the testing of medicinal products (91/507/EEC) (OJ L 270, 26.9.1991, p. 32)
48 Pravna redakcija
DRUGO
Direktiva Sveta 81/852/EGS z dne 28. septembra 1981 o približevanju zakonodaje držav članic v zvezi z analiznimi, farmakološko-toksikološkimi in kliničnimi standardi in protokoli za preskušanje veterinarskih zdravil (UL št. L 317, 6. 11. 1981, str. 16), kakor je bila spremenjena z:
Council Directive 81/852/EEC of 28 September 1981 on the approximation of the laws of the Member States relating to analytical, pharmacotoxicological and clinical standards and protocols in respect of the testing of veterinary medicinal products (OJ No L 317, 6.11.1981, p. 16), as amended by:
49 Pravna redakcija
promet
CELEX: 21999A1009(01)
Direktiva Sveta 92/18/EGS z dne 20. marca 1992 o spremembi priloge k Direktivi Sveta 81/852/EGS o približevanju zakonodaje držav članic v zvezi z analitskimi, farmakotoksikološkimi in kliničnimi standardi in protokoli za preskušanje veterinarskih zdravil (UL L 97, 10.4.1992, str. 1).
Council Directive 92/18/EEC of 20 March 1992 modifying the Annex to Council Directive 81/852/EEC on the approximation of the laws of Member States relating to analytical, pharmacotoxicological and clinical standards and protocols in respect of the testing of veterinary medicinal products (OJ L 97, 10.4.1992, p. 1).
50 Pravna redakcija
DRUGO
Direktiva Sveta z dne 22. decembra 1986, ki spreminja Direktivo 81/852/EGS o približevanju zakonov držav članic v zvezi z analitičnimi, farmakotoksikološkimi in kliničnimi standardi in protokoli pri preskušanju zdravil za veterinarsko uporabo (87/20/EGS) (UL L 15, 17. 1. 1987, str. 34)
Council Directive of 22 December 1986 amending Directive 81/852/CEE on the approximation of the laws of the Member States relating to analytical, pharmaco-toxicological and clinical standards and protocols in respect of the testing of veterinary medicinal products (87/20/EEC) (OJ L 15,17.1.1987, p. 34)
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