Iskalni niz je ali predolg ali pa vsebuje preveč besed.
Prevodi: sl > en
1–50/89
dovoljenje za preskušanje zdravil
1 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.
2 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.
3 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.";
4 Končna redakcija
CELEX: 32004L0028
Če meni, da je to potrebno zaradi zdravja ljudi in živali, lahko država članica zahteva, da imetnik dovoljenja za promet z imunološkim zdravilom za uporabo v veterinarski medicini predloži vzorce vsake serije iz zbirnega vsebnika in/ali zdravila za uporabo v veterinarski medicini v preskušanje uradnemu kontrolnemu laboratoriju za analizno preskušanje zdravil, preden se zdravilo sprosti v promet.
Where it considers it necessary for reasons of human or animal health, a Member State may require the marketing authorisation holder for an immunological veterinary medicinal product to submit samples of batches of the bulk product and/or veterinary medicinal product for control by an Official Medicines Control Laboratory before the product is put into circulation.
5 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.
6 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.
7 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.
8 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.
9 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.
10 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.
11 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.
12 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.
13 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.
14 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.".
15 Pravna redakcija
finance
CELEX: 32003L0063
Zaključno poročilo hrani naročnik preskušanja ali poznejši lastnik še pet let po izteku dovoljenja za promet z zdravilom.
The final report shall be retained by the sponsor or subsequent owner, for five years after the medicinal product is no longer authorised.
16 Pravna redakcija
finance
CELEX: 32003L0063
Za pridobitev dovoljenja za promet z zdravilom je treba predložiti vlogo za pridobitev dovoljenja, ki vključuje podrobne podatke in dokumente o rezultatih preskusov in preskušanj, opravljenih na zdravilu.
With the view to obtaining a marketing authorisation, an application dossier containing particulars and documents relating to the results of tests and trials carried out on this medicinal product must be submitted.
17 Pravna redakcija
DRUGO
Vzorec za preskušanje varnosti mora biti vzet iz serije ali serij, izdelanih v skladu s procesom izdelave, opisanim v vlogi za pridobitev dovoljenja za promet z zdravilom.
The sample used for safety testing shall be taken from a batch or batches produced according to the manufacturing process described in the application for marketing authorization.
18 Pravna redakcija
finance
CELEX: 32003L0063
Naročnik preskušanja ali drug lastnik podatkov hrani vso ostalo dokumentacijo, ki se nanaša na preskušanje, vse dokler ima zdravilo dovoljenje za promet.
The sponsor or other owner of the data shall retain all other documentation pertaining to the trial as long as the product is authorised.
19 Pravna redakcija
DRUGO
Vzorci, ki se uporabljajo za preskušanje učinkovitosti je treba vzeti iz serije ali več serij, izdelanih v skladu s procesom izdelave, opisanim v vlogi za pridobitev dovoljenja za promet z zdravilom.
The samples used for efficacy trials shall be taken from a batch or batches produced according to the manufacturing process described in the application for marketing authorization.
20 Pravna redakcija
DRUGO
Vse trditve predlagatelja glede lastnosti, učinkov ter uporabe zdravila morajo biti podprte z rezultati specifičnih preskušanj, in jih mora vsebovati vloga za pridobitev dovoljenja za promet z zdravilom.
All claims made by the applicant with regard to the properties, effects and use of the product, shall be fully supported by results of specific trials contained in the application for marketing authorization.
21 Pravna redakcija
finance
CELEX: 32003L0063
Pri preskušanjih, ki jih opravlja Evropska skupnost, pa se imetnik dovoljenja za promet z zdravilom dodatno dogovori za arhiviranje dokumentacije v skladu z določbami Direktive 2001/20/ES in podrobnimi izvedbenimi smernicami.
In addition for trials conducted within the European Community, the marketing authorisation holder shall make any additional arrangements for archiving of documentation in accordance with the provisions of Directive 2001/20/EC and implementing detailed guidelines.
22 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:
23 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.
24 Pravna redakcija
DRUGO
Živalim se ne sme dajati nikakršnih zdravil za uporabo v veterinarski medicini brez izdanega dovoljenja za promet z zdravilom, razen v primeru preskušanj zdravil za uporabo v veterinarski medicini iz člena 21(3)(j), ki so jih sprejeli pristojni organi po prijavi ali odobritvi, v skladu z veljavnimi nacionalnimi predpisi.
No veterinary medicinal product may be administered to animals unless the marketing authorization has been issued, except for the tests of veterinary medicinal products referred to in Article 12(3)(j) which have been accepted by the competent national authorities, following notification or authorization, in accordance with the national rules in force.
25 Pravna redakcija
DRUGO
Usposobljena oseba si mora v enem ali več podjetjih, ki imajo dovoljenje za izdelavo najmanj dve leti pridobivati praktične izkušnje na področju analize kakovosti zdravil, količinske analize zdravilnih učinkovin ter preskušanja in preverjanja, ki je potrebno za zagotovitev kakovosti zdravil za uporabo v veterinarski medicini.
The qualified person shall have acquired practical experience over at least two years, in one or more undertakings which are authorized manufacturers, in the activities of qualitative analysis of medicinal products, of quantitative analysis of active substances and of the testing and checking necessary to ensure the quality of veterinary medicinal products.
26 Pravna redakcija
finance
CELEX: 32003L0063
Da se poenostavijo obstoječi postopki za oceno takih cepiv, tako pri izdaji prvega dovoljenja za promet z zdravilom kot pri vseh poznejših spremembah dovoljenja, zaradi sprememb postopka proizvodnje in preskušanja posameznih antigenov, vključenih v kombinirana cepiva, je treba uvesti nov sistem na podlagi koncepta glavne dokumentacije o antigenu cepiva (VAMF).
In order to simplify the existing procedures for the assessment of such vaccines, both for the granting of a first marketing authorisation and for subsequent changes to it due to modifications to the manufacturing process and testing of individual antigens involved in combined vaccines, a new system based on the concept of a vaccine antigen master file (VAMF) should be introduced.
27 Pravna redakcija
DRUGO
Država članica lahko zahteva, če meni, da je potrebno, da imetnik dovoljenja za promet z imunološkim zdravilom predloži vzorce vsake serije, iz zbirnega vsebnika in/ali zdravila v preskušanje državnemu laboratoriju, ali pooblaščenemu laboratoriju, preden se zdravilo sprosti v promet.
Where it considers it necessary, a Member State may require the marketing authorization holder for immunological products to submit samples from the batches of the bulk and/or medical product for examination by a State laboratory or an approved laboratory before entry into circulation.
28 Pravna redakcija
finance
CELEX: 32003L0063
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.
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.
29 Pravna redakcija
DRUGO
Zaželeno je točneje predpisati primere, v katerih za pridobitev dovoljenja za promet z zdravili za uporabo v veterinarski medicini, ki je bistveno podobno inovativnemu zdravilu rezultati farmakoloških in toksikoloških preskusov ali kliničnih preskušanj niso potrebni, pri tem pa je treba zagotoviti, da inovativne oblike niso postavljene v slabši položaj.
It is advisable to stipulate more precisely the cases in which the results of pharmacological and toxicological tests or clinical trials do not have to be provided with a view to obtaining authorization for a veterinary medicinal product which is essentially similar to an innovative product, while ensuring that innovative forms are not placed at a disadvantage.
30 Pravna redakcija
promet
CELEX: 22001A1029(01)
S certifikatom, ki ga izdajo potrjene proizvodne ustanove in se nanaša na vsako serijo, namenjeno za izvoz, kakor je navedeno v odstavku 4, se na podlagi preskušanja, ki ga pri proizvodnji zdravil zahtevajo zakoni,predpisi in upravnimi določbami vsake pogodbenice, navedeni v oddelku I dela B te sektorske priloge, potrjuje, da je vsaka serija zdravil izdelana v skladu z zahtevami veljavnega dovoljenja za promet ali veljavne specifikacije izdelka pogodbenice uvoznice.
In the certificate issued by the confirmed manufacturing facilities and related to each batch to be exported, as referred to in paragraph 4, it will be certified, through the testing which is required for the manufacturing of medicinal products in accordance with the laws, regulations and administrative provisions of each party specified in Section I of Part B of this Sectoral Annex, that each batch of medicinal products is manufactured as required by the applicable marketing authorisation or product specifications of the importing party.
31 Pravna redakcija
promet
CELEX: 22001A1029(01)
V zvezi s členom 2(2) tega sporazuma vsaka pogodbenica na podlagi sprejetja potrditve proizvodne ustanove, ki jo opravijo pristojni organi druge pogodbenice, v zvezi z zdravili, za katera je bilo izdano dovoljenje za promet ali za katera se uporabljajo specifikacije izdelka, sprejme certifikat o skladnosti vsake serije z dovoljenjem za promet ali specifikacijami izdelka, ki ga izdajo potrjene proizvodne ustanove, ter uvoznike izvzame iz obveznosti preskušanja vsake serije v skladu z zakoni, predpisi in upravnimi določbami vsake pogodbenice, navedenimi v oddelku I dela B te sektorske priloge, ob upoštevanju enakovrednosti zahtev DPP obeh pogodbenic, pod pogojem, da:
With respect to Article 2(2) of this Agreement, each party shall, as a result of the acceptance of confirmation of manufacturing facilities carried out by the competent authorities of the other party, accept, regarding the medicinal products for which its marketing authorisation has been issued or for which product specifications are applicable, the certificate issued by the confirmed manufacturing facilities of the conformity of each batch to the marketing authorisation or product specifications and exempt the importers from the testing of each batch, in accordance with the laws, regulations and administrative provisions of each party specified in the Section I of Part B of this Sectoral Annex, taking into account the equivalence of GMP requirements of both parties, provided that:
32 Prevajalska redakcija
izobraževanje
CELEX: 32001L0020
za zdravila v preskušanju, ki so primerljivi izdelki iz tretje države in ki imajo dovoljenje za promet;
in the case of an investigational medicinal product which is a comparator product from a third country,
33 Prevajalska redakcija
izobraževanje
CELEX: 32001L0083
Zaključno poročilo hrani naročnik preskušanja ali poznejši lastnik še pet let po izteku dovoljenja za promet z zdravilom.
The final report shall be retained by the sponsor or subsequent owner, for five years after the medicinal product is no longer authorized.
34 Prevajalska redakcija
izobraževanje
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.
35 Prevajalska redakcija
izobraževanje
CELEX: 32001L0020
Države članice sprejmejo vse potrebne ukrepe, da bi zagotovile, da je pogoj za proizvodnjo ali uvoz zdravil v preskušanju, dovoljenje za promet.
Member States shall take all appropriate measures to ensure that the manufacture or importation of investigational medicinal products is subject to the holding of authorisation.
36 Prevajalska redakcija
izobraževanje
CELEX: 32003L0094
V primeru zdravila v preskušanju, za katero je bilo izdano dovoljenje za promet, izdelovalec zdravila v preskušanju v sodelovanju s sponzorjem obvesti imetnika dovoljenja za promet o vseh pomanjkljivostih, ki bi lahko bile povezane z odobrenim zdravilom.
In the case of an investigational medicinal product for which a marketing authorisation has been issued, the manufacturer of the investigational medicinal product shall, in cooperation with the sponsor, inform the marketing authorisation holder of any defect that could be related to the authorised medicinal product.
37 Prevajalska redakcija
izobraževanje
CELEX: 32001L0083
Naročnik preskušanja ali drug lastnik podatkov hrani vso ostalo dokumentacijo, ki se nanaša na preskušanje, vse dokler ima zdravilo dovoljenje za promet.
The sponsor or other owner of the data shall retain all other documentation pertaining to the trial as long as the product is authorized.
38 Prevajalska redakcija
RS
EMEA
Imetnik dovoljenja za promet z zdravilom se obvezuje, da bo spremljal in poročal o toksičnosti v vseh potekajočih in načrtovanih kliničnih preskušanjih.
The MAH has committed to monitor and report toxicity in all ongoing and planned clinical trials.
39 Prevajalska redakcija
izobraževanje
CELEX: 32001L0083
Presoditi je treba, ali se zdravilo v preskušanju lahko šteje kot podobno zdravilu, za katerega bo izdano dovoljenje za promet z zdravilom, kljub obstoječim razlikam.
A judgment must be made whether the product studied can be considered as similar to the product which will be granted a marketing authorisation in spite of the existing differences.
40 Prevajalska redakcija
RS
EMEA
Ce bodo rezultati preskušanja pozitivni, bo dan predolog za spremembo dovoljenja za promet z zdravilom, da se bosta razširila podrocje uporabe in nacin odmerjanja pri nosecnicah.
Assuming positive results of the trial, a marketing authorization variation will be submitted to expand the indication and dosing of pregnant women.
41 Prevajalska redakcija
RS
EMEA
Izkušnje po pridobitvi dovoljenja za promet z zdravilom V preglednici 6 so navedeni klinično pomembni neželeni učinki o katerih so poročali po pridobitvi dovoljenja za promet z zdravilom, o nekaterih so poročali v kliničnih preskušanjih o drugih pa ne.
Post-marketing experience Clinically significant adverse reactions are listed in Table 6, if they have been reported during post approval use of VELCADE and may or may not have been reported in clinical trials.
42 Prevajalska redakcija
izobraževanje
CELEX: 32003L0094
Ta direktiva določa načela in smernice dobre proizvodne prakse v zvezi z zdravili za ljudi, za izdelavo katerih je potrebno dovoljenje iz člena 40 Direktive 2001/83/ES, ter v zvezi z zdravili za ljudi v preskušanju, za izdelavo katerih je potrebno dovoljenje iz člena 13 Direktive 2001/20/ES.
This Directive lays down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use whose manufacture requires the authorisation referred to in Article 40 of Directive 2001/83/EC and in respect of investigational medicinal products for human use whose manufacture requires the authorisation referred to in Article 13 of Directive 2001/20/EC.
43 Prevajalska redakcija
izobraževanje
CELEX: 32001L0020
neželeni učinki, katerih narava ali resnost se ne ujemata z veljavnimi podatki o izdelku (npr. brošura za raziskovalca o zdravilu v preskušanju ali povzetek temeljnih značilnosti zdravila za zdravila, ki imajo dovoljenje za promet).
an adverse reaction, the nature or severity of which is not consistent with the applicable product information (e.g. investigator's brochure for an unauthorised investigational product or summary of product characteristics for an authorised product).
44 Prevajalska redakcija
RS
EMEA
Kategorije pogostnosti v nadaljevanju navedenih neželenih učinkov temeljijo na podatkih, pridobljenih v kliničnih preskušanjih in ob spremljanju zdravila po pridobitvi dovoljenja za promet.
Frequency categories for the events below have been based on clinical trials and postmarketing data.
45 Prevajalska redakcija
izobraževanje
CELEX: 32001L0020
preskušanje se izvaja z zdravili, ki imajo v zadevni državi članici dovoljenje za promet v smislu Direktive 65/65/EGS in ki so izdelana ali uvožena v skladu z določbami Direktive 75/319/EGS,
the trial is conducted with medicinal products with, in the Member States concerned by the study, a marketing authorisation within the meaning of Directive 65/65/EEC, manufactured or imported in accordance with the provisions of Directive 75/319/EEC;
46 Prevajalska redakcija
RS
EMEA
CHMP je pregledal podatke iz kliničnih preskušanj, epidemioloških študij in spontanih poročil o neželenih učinkih zdravila, ki so jih predložili imetniki dovoljenja za promet z zdravilom.
The CHMP reviewed the data submitted by Marketing Authorisation Holders from clinical trials, epidemiological studies, and spontaneous reporting of adverse drug reactions.
47 Prevajalska redakcija
izobraževanje
CELEX: 32001L0083
Farmakoepidemiološka študija ali klinično preskušanje, izvedeno v skladu s pogoji dovoljenja za promet z zdravilom, katere cilj je opredelitev ali količinska določitev tveganja glede varnosti v zvezi z odobrenim zdravilom.
A pharmacoepidemiological study or a clinical trial carried out in accordance with the terms of the marketing authorisation, conducted with the aim of identifying or quantifying a safety hazard relating to an authorised medicinal product.
48 Prevajalska redakcija
RS
EMEA
Na osnovi kliničnih preskušanj z drugimi eritropoetini z dovoljenjem za prometje pričakovati, da bo do neželenih učinkov prišlo pri približno 8 % bolnikov, ki se jih zdravi z eritropoetinom.
Based on the results from clinical trials with other authorized erythropoietins approximately 8% of patients treated with erythropoietin are expected to experience adverse reactions.
49 Prevajalska redakcija
izobraževanje
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.
50 Prevajalska redakcija
izobraževanje
CELEX: 32001L0082
Študija o varnosti zdravila po pridobitvi dovoljenja za promet: 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.
Post-marketing surveillance studies: 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.
Prevodi: sl > en
1–50/89
dovoljenje za preskušanje zdravil