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product pool
1 Objavljeno
delo in sociala
Ur. l. RS, št. MP 2000-81
When the Pool agreement does not foresee the setting up of a Pool for the component parts used for the repair of the Pool containers, temporary admission without payment of import duties and taxes, and without application of import prohibitions or restrictions of economic character shall be granted to these component parts without the production of Customs documents being required on their importation and re-exportation and without the furnishing of a form of security.
Kadar sporazum o skladu ne predvideva ustanovitve sklada za sestavne dele, ki se uporabljajo za popravilo zabojnikov sklada, bo za te sestavne dele odobren začasni uvoz brez plačila uvoznih dajatev in davščin in brez uveljavljanja uvoznih prepovedi ali gospodarskih omejitev, brez predložitve carinskih listin, ki se zahtevajo za njihov uvoz in ponovni izvoz in ne da bi bilo treba priskrbeti kakršno koli varščino.
2 Objavljeno
RS
Ur. l. RS, št. MP 39
A research (Koch, 1996) has shown that low-fat products are relatively poorly represented in everyday nutrition since 42% of the interviewed persons have never taken lower-fat milk, 55% have never consumed low-fat cottage cheese, 51% has never eaten low-fat cheeses, and 50% have never consumed low-fat meat products.
Raziskava (Koch, 1996) je pokazala, da so izdelki z malo maščob v vsakodnevni prehrani sorazmerno slabo zastopani, saj kar 42% vprašanih ni nikoli zaužilo mleka z manj maščobe, 55% nikoli puste skute, 51% nikoli sirov z malo maščob in 50% nikoli pustih mesnih izdelkov.
3 Objavljeno
RS
Ur. l. RS, št. MP 2005-16
Seriously concerned about the increase in the worldwide consumption and production of cigarettes and other tobacco products, particularly in developing countries, as well as about the burden this places on families, on the poor, and on national health systems,
zaradi velike zaskrbljenosti zaradi naraščanja uporabe in proizvodnje cigaret in drugih tobačnih izdelkov po vsem svetu, še posebej v državah v razvoju, in tudi zaradi bremena za družine, revne in nacionalne zdravstvene sisteme;
4 Objavljeno
finance
WTO: Sporazum o kmetijstvu
In accordance with the Mid-Term Review Agreement that government measures of assistance, whether direct or indirect, to encourage agricultural and rural development are an integral part of the development programmes of developing countries, investment subsidies which are generally available to agriculture in developing country Members and agricultural input subsidies generally available to low-income or resource-poor producers in developing country Members shall be exempt from domestic support reduction commitments that would otherwise be applicable to such measures, as shall domestic support to producers in developing country Members to encourage diversification from growing illicit narcotic crops.
V skladu s Sporazumom o srednjeročnem pregledu, da se vladni ukrepi pomoči, bodisi posredni ali neposredni, za pospeševanje kmetijskega razvoja in razvoja podeželja, ki so sestavni del razvojnih programov držav v razvoju, subvencionirana vlaganja, ki so na splošno na voljo kmetijstvu v članicah državah v razvoju, ter subvencije za kmetijske inpute, na splošno na voljo proizvajalcem z nizkimi dohodki ali revnimi viri v članicah državah v razvoju, oprostijo obvez zniževanja domače podpore, ki bi sicer za te ukrepe veljale, kakor tudi domače podpore proizvajalcem v članicah državah v razvoju za pospeševanje nadomestne pridelave nedovoljenih narkotičnih pridelkov.
5 Končna redakcija
CELEX: 32004L0033
It may be used for the manufacture of medicinal products derived from human blood and human plasma or used in the preparation of pooled platelets, or pooled, leucocyte-depleted platelets.
Lahko se uporabi za izdelavo zdravil na osnovi človeške krvi in plazme ali v pripravkih zlitja koncentriranih trombocitov ali zlitja koncentriranih trombocitov brez levkocitov.
6 Končna redakcija
EU
DRUGO: TRANS
2. preservation of the diversity and quality of natural resources, the natural genetic pool, and productive soil;
2. ohranjanje raznovrstnosti in kakovosti naravnih dobrin, naravnega genskega sklada ter ohranjanje rodovitnosti zemljišč,
7 Končna redakcija
CELEX: 32004R0138
Only in the event of a substantial change in production or in cases of very poor harvests does this compensation not occur.
Le pri večjih spremembah proizvodnje ali ob zelo slabi letini tega pokrivanja ne bi bilo.
8 Končna redakcija
gospodarstvo
CELEX: 31999R1257
the presence of land of poor productivity, difficult cultivation and with a limited potential which cannot be increased except at excessive cost, and which is mainly suitable for extensive livestock farming,
tla s slabo produktivnostjo, oteženo pridelavo in z omejenimi potenciali, ki jih ni mogoče povečati drugače kakor s prekomernimi stroški, ter so primerna predvsem za ekstenzivno živinorejo,
9 Končna redakcija
finance
DRUGO: TRANS
First of all, the RTV Council is not what it pretends to be, but a poor product of the political ruling power, and in this example it acted like a bad ruling power and not like an elite selection by civil society. (...)
Najprej svet rtvs seveda ni to, za kar se predstavlja, temveč je slab proizvod politične oblasti, ki je tokrat ravnal kot slaba oblast, ne pa kot elitni izbor civilne družbe. (...)
10 Pravna redakcija
DRUGO
Organismus indicating poor hygiene (shelled or shucked products)
Organizmi, ki kažejo na neustrezne higienske razmere (proizvodi brez lupine/oklepa)
11 Pravna redakcija
finance
CELEX: 32003L0063
For the purposes of this chapter, active substance shall mean the seed pool of human cells and finished medicinal product shall mean seed pool of human cells formulated for the intended medical use.
V tem poglavju zdravilna učinkovina pomeni zbir matičnih snovi človeških celic in končni izdelek zbir matičnih snovi človeških celic, pripravljenih za predvideno medicinsko uporabo.
12 Pravna redakcija
gospodarstvo
CELEX: 32004R0138
Only in the event of a substantial change in production or in cases of very poor harvests does this compensation not occur.
Le pri večjih spremembah proizvodnje ali ob zelo slabi letini tega pokrivanja ne bi bilo.
13 Pravna redakcija
DRUGO
Improvements need to be made to the poor conditions for supplying fresh milk products to local markets in the FOE), which at present come mainly from imports;
Treba je izboljšati slabe pogoje preskrbe lokalnih trgov v FPD s svežimi mlečnimi izdelki, ki trenutno prihajajo večinoma iz uvoza;
14 Pravna redakcija
finance
CELEX: 32003L0063
Human somatic cell therapy medicinal products are made of a defined number (pool) of viable cells, which are derived from a manufacturing process starting either at the level of organs or tissues retrieved from a human being, or, at the level of a well defined cell bank system where the pool of cells relies on continuous cell lines.
Zdravila za somatsko celično zdravljenje za ljudi se proizvajajo iz določenega števila (zbira) preživetja sposobnih celic, ki se pridobivajo s postopkom proizvodnje, ki se začne na ravni obnovljenih organov ali tkiv iz človeka, ali na ravni dobro opredeljenega sistema celične banke, kjer se zbir celic navezuje na neprekinjene celične linije.
15 Pravna redakcija
DRUGO
whereas the implementation of this Article represents a contribution by industrialized countries to the effort requested from drug-producing countries, which are generally much poorer than the former;
ker izvajanje tega člena pomeni prispevek industrijsko razvitih držav k prizadevanju, ki so ga zahtevale države proizvajalke nedovoljenih drog, praviloma mnogo revnejše od industrijsko razvitih držav;
16 Pravna redakcija
DRUGO
The Community eco-label and the other labels should systematically exchange information on their existing product groups and on their programmes for product group development, and should where appropriate coordinate their efforts, pooling resources, expertise, and results.
Med organi za znak Skupnosti za okolje in organi za druge oznake mora sistematično potekati izmenjava informacij o obstoječih skupinah proizvodov in o njihovih programih za razvijanje skupine proizvodov ter, če je to primerno, koordinacija njihovih prizadevanj, zbiranja virov, strokovnega znanja in rezultatov.
17 Pravna redakcija
DRUGO
Where poor weather conditions in the production region result in a reduction of more than 20 % in the harvest of the producers' organization, the quantity marketed shall be that actually sold for processing during the second marketing year following the date of specific recognition.
Kadar slabe vremenske razmere v pridelovalnem območju povzročijo zmanjšanje letine organizacij proizvajalcev za več kakor 20 %, je količina na trgu tista količina, ki je bila dejansko prodana za predelavo v drugem tržnem letu po datumu posebnega priznanja.
18 Pravna redakcija
DRUGO
pool information on the capabilities of the Member States for maintaining a production of serums and vaccines or other necessary medical resources and on the stocks which might be available for intervention in the event of a major emergency and compile this information in the information system;
združuje informacije o zmožnostih držav članic za proizvodnjo serumov in cepiv ali o drugi potrebni zdravstveni pomoči in o zalogah, ki bi lahko bile na voljo za intervencijo ob večjih nesrečah, ter te informacije nalaga v informacijski sistemi;
19 Pravna redakcija
finance
CELEX: 32003L0063
In the specific case of a radio-pharmaceutical precursor intended solely for radio-labelling purposes, the primary objective shall be to present information which would address the possible consequences of poor radio-labeling efficiency or in vivo dissociation of the radio-labeled conjugate, i.e. questions related to the effects produced in the patient by free radio-nuclide.
V posebnem primeru predhodnih sestavin radiofarmacevtskega izdelka, ki je predviden izključno za radiaktivno označevanje, je prvi cilj navesti informacije, ki obravnavajo možne posledice slabe učinkovitosti radioaktivne oznake ali in vivo razkroja radioaktivno označenega konjugata, to je vprašanja v zvezi z učinki prostega radionuklida na bolnika.
20 Pravna redakcija
DRUGO
It is important for the health and productivity of dairy cattle that they are subjected to minimum stress which may lead to increase in diseases such as mastitis, foot lesions and reactions to injection site according to the opinion of the SCAWAH, the use of BST has been shown to lead to increases in these conditions, which are both painful and debilitating, and which can lead to poorer welfare and greater animal morbidity.
Za zdravje in produktivnost krav molznic je pomembno, da so izpostavljene najmanjšemu možnemu stresu, ki bi lahko povzročil povečanje števila bolezni, kot so vnetje vimena, poškodbe nog in reakcije na mestu injiciranja. Po mnenju Znanstvenega odbora za zdravje in dobro počutje živali je bilo dokazano, da uporaba govejega hormona somatotropina povečuje število navedenih bolezenskih stanj, ki so boleča in izčrpavajoča in lahko poslabšajo dobro počutje živali ter povečajo pogin živali.
21 Pravna redakcija
gospodarstvo
CELEX: 31999D0879
(9) It is important for the health and productivity of dairy cattle that they are subjected to minimum stress which may lead to increase in diseases such as mastitis, foot lesions and reactions to injection site according to the opinion of the SCAWAH, the use of BST has been shown to lead to increases in these conditions, which are both painful and debilitating, and which can lead to poorer welfare and greater animal morbidity.
(9) Za zdravje in produktivnost krav molznic je pomembno, da so izpostavljene najmanjšemu možnemu stresu, ki bi lahko povzročil povečanje števila bolezni, kot so vnetje vimena, poškodbe nog in reakcije na mestu injiciranja. Po mnenju Znanstvenega odbora za zdravje in dobro počutje živali je bilo dokazano, da uporaba govejega hormona somatotropina povečuje število navedenih bolezenskih stanj, ki so boleča in izčrpavajoča in lahko poslabšajo dobro počutje živali ter povečajo pogin živali.
22 Pravna redakcija
DRUGO
this aim can be achieved on the one hand by continuing aid to develop cow's milk production within the limits of local consumption requirements as periodically evaluated under a supply balance, and on the other hand by ceasing to apply the arrangements for an additional levy on cow's milk producers laid down in Regulation (EEC) No 3950/92 (2); the poor supply conditions typical of the outermost regions, which are completely different from those prevailing in the rest of the Community, and the need for a local production development incentive justify this derogation.
to je mogoče doseči z nadaljnjo pomočjo za razvoj proizvodnje kravjega mleka v mejah lokalnih potreb potrošnje, ki se redno ocenjujejo v okviru dobavne bilance in z odložitvijo uporabe režima dodatnih dajatev za proizvajalce kravjega mleka, določenega v Uredbi (EGS) št. 3950/92 fn ogoji preskrbe, značilni za najbolj oddaljene regije, ki so popolnoma drugačni od tistih v drugih delih Skupnosti ter potreba po spodbujanju razvoja lokalne proizvodnje upravičujejo to odstopanje.
23 Pravna redakcija
DRUGO
Where the measures provided for in paragraph 1 are undertaken by joint ventures constituted, with the aim of marketing products harvested in the FOD, by producers or producer groups or associations in those departments and natural or legal persons established in the rest of the Community, and where the partners undertake to pool the knowledge and know-how required to achieve the objective of the joint venture over a minimum period of three years, the amount of the aid specified in paragraph 2 shall be increased to 13 % of the value of the annual production marketed jointly.
Kadar ukrepe, predvidene v odstavku 1, izvajajo mešane družbe, ki jih z namenom trženja proizvodov, pridelanih v FPD, ustanovijo proizvajalci ali skupine ali združenja proizvajalcev iz teh departmajev in fizične ali pravne osebe s sedežem drugje v Skupnosti, in se partnerji zavežejo za obdobje vsaj treh let združiti znanje in izkušnje, potrebne za doseganje cilja mešane družbe, se znesek pomoči, določen v odstavku 2, poveča na 13 % vrednosti letne proizvodnje, ki jo skupno trži.
24 Pravna redakcija
gospodarstvo
CELEX: 32004R0138
However, some agricultural production units may be organised on a corporate basis and may take the form either of conventional companies (i.e. their organisational set- up is similar to that of companies which exist in other sectors of the economy) or of companies having more specific characteristics (as, for example, in the case of a farmer who, for tax reasons, creates a specific separate company for the commercial part of his economic activity, or of a group of farmers who form an association with the aim of pooling land and labour within the framework of certain types of cooperatives).
Vendar pa so lahko nekatere kmetijske proizvodne enote organizirane v obliki družb, in sicer običajnih družb (se pravi, da je njihova organizacijska struktura podobna kot pri družbah v drugih dejavnostih) ali pa družb z bolj specifičnimi značilnostmi (na primer kmetovalec, ki zaradi davčnih razlogov ustvari posebno ločeno družbo za trgovski del svoje gospodarske dejavnosti, ali pa skupina kmetovalcev, ki se poveže v združenje zaradi združevanja zemljišč in dela v okviru nekaterih vrst zadrug).
25 Pravna redakcija
DRUGO
Where marketing of the products referred to in paragraph 1 of this Article is undertaken by joint ventures constituted, with the aim of marketing produce from the Canary Islands, by producers in those islands or producer organisations as referred to in Articles 11, 13 and 14 of Regulation (EC) No 2200/96 and natural or legal persons established in the rest of the Community, and where the partners undertake to pool the knowledge and know-how required to achieve the objective of the joint venture over a minimum period of three years, the amount of the aid shall be increased to 13 % of the value of the annual production marketed jointly.
Kadar trženje proizvodov iz odstavka 1 tega člena opravljajo mešane družbe, ki jih z namenom trženja proizvodnje s Kanarskih otokov sestavljajo proizvajalci s teh otokov ali organizacije proizvajalcev iz členov 11, 13 in 14 Uredbe (ES) št. 2200/96, ter fizične ali pravne osebe s sedežem v drugih delih Skupnosti, in kadar se partnerji obvežejo, da bodo združili znanje in izkušnje, potrebne za uresničitev cilja mešane družbe za obdobje najmanj treh let, se znesek pomoči poviša na 13 % vrednosti skupno tržene letne proizvodnje.
26 Prevajalska redakcija
izobraževanje
CELEX: 32000R1896
Biocidal products to be used in swimming pools etc.
Biocidni pripravki za uporabo v plavalnih bazenih itn.
27 Prevajalska redakcija
izobraževanje
CELEX: 32004L0033
It may be used for the manufacture of medicinal products derived from human blood and human plasma or used in the preparation of pooled platelets, or pooled, leucocyte-depleted platelets.
Lahko se uporabi za izdelavo zdravil na osnovi človeške krvi in plazme ali v pripravkih zlitja koncentriranih trombocitov ali zlitja koncentriranih trombocitov brez levkocitov.
28 Prevajalska redakcija
izobraževanje
CONSCIOUS that manioc production in Thailand is concentrated in the poorest and most politically sensitive areas,
ZAVEDAJOČ SE, da je proizvodnja manioke na Tajskem zgoščena v najrevnejših in najbolj politično občutljivih območjih,
29 Prevajalska redakcija
RS
EMEA
The pooling method used and the addition of the spacer is likely to mask differences in quality between the two products.
Uporabljena metoda združevanja in dodatek podaljška po vsej verjetnosti zakrijeta razlike v kakovosti med obema zdraviloma.
30 Prevajalska redakcija
RS
EMEA
The Applicant provided in vitro data to demonstrate the in vitro equivalence between the test product and the reference product and presented justifications for the pooling of the data including a second pooling using the following grouped stages:
Predlagatelj je priskrbel in vitro podatke, da bi dokazal in vitro enakovrednost testnega zdravila in referenčnega zdravila, ter predstavil utemeljitve za združevanje podatkov, vključno z drugim združevanjem, kjer je uporabil naslednje stopnje, urejene v skupine: samo grlo (orofaringealno odlaganje, torej pogoltnjen odmerek), prvo združevanje:
31 Prevajalska redakcija
izobraževanje
CELEX: 31998R1636
Whereas the present market situation is one of mismatch of supply and demand, largely due to the poor quality of Community production;
ker je sedanji položaj na trgu s tobakom rezultat neusklajene ponudbe in povpraševanja večinoma zaradi nezadostne kakovosti proizvodnje v Skupnosti;
32 Prevajalska redakcija
izobraževanje
CELEX: 32003R0953
Price segmentation between developed country markets and the poorest developing country markets is necessary to ensure that the poorest developing countries are supplied with essential pharmaceutical products at heavily reduced prices.
Delitev cen med trgi razvitih držav in trgi najrevnejših držav v razvoju je potrebna zato, da se zagotovi, da se najrevnejše države v razvoju oskrbi z osnovnimi farmacevtskimi proizvodi po zelo znižanih cenah.
33 Prevajalska redakcija
izobraževanje
The market for existing products may nevertheless be concerned, if the pooling of R & D efforts is likely to result in the coordination of the parties' behaviour as suppliers of existing products.
Lahko pa to vseeno zadeva trg za obstoječe proizvode, če bi raziskovalne in razvojne dejavnosti povzročile usklajevanje ravnanja pogodbenic kot dobaviteljic obstoječih proizvodov.
34 Prevajalska redakcija
izobraževanje
CELEX: 32001R1452
Improvements need to be made to the poor conditions for supplying fresh milk products to local markets in the FOD, which at present come mainly from imports;
Treba je izboljšati slabe pogoje preskrbe lokalnih trgov v FPD s svežimi mlečnimi proizvodi, ki trenutno prihajajo večinoma iz uvoza;
35 Prevajalska redakcija
RS
EMEA
a) The Applicant quoted the EMEA draft guideline on orally inhaled products (OIP) which offers the possibility to pool different stages of the Andersen Cascade Impactor.
a) Predlagatelj je navedel osnutek smernice agencije EMEA za peroralno inhalirana zdravila (OIP), ki daje možnost združevanja različnih stopenj Andersenovega kaskadnega impaktorja.
36 Prevajalska redakcija
RS
EMEA
Incidence of the adverse reaction considered at least possibly related by the investigator, from pooled clinical trials involving 323 patients taking the medicinal product.
Pogostost neželenih učinkov, za katere izvajalec raziskave meni, da so verjetno povezani, v skupnih kliničnih raziskavah, ki zajemajo 323 bolnic, ki jemljejo zdravilo.
37 Prevajalska redakcija
RS
EMEA
Urogenital system and reproductive disorders - difficulty passing urine or passing urine too frequently, poor sexual performance, prolonged erections, and producing breastmilk.
Sečila, spolovila in motnje reprodukcije - težave pri uriniranju ali pogosto uriniranje, spolna neučinkovitost, podaljšana erekcija in izločanje materinega mleka.
38 Prevajalska redakcija
RS
EMEA
Thalidomide is a poor substrate for cytochrome P450 isoenzymes and therefore clinically important interactions with medicinal products metabolized by this enzyme system are unlikely.
Talidomid je slab substrat za izoencime citokroma P450, zato je verjetnost klinično pomembnih interakcij z zdravili, ki jih metabolizira ta encimski sistem, majhna.
39 Prevajalska redakcija
izobraževanje
They now agree to pool these R & D efforts by setting up a JV to complete the R & D and produce the components, which will be sold back to the parents, who will commercialise them separately.
Sedaj se dogovarjata, da bosta združili raziskave in razvoj z ustanovitvijo skupnega podjetja, da bi do konca izpeljali raziskave in razvoj ter proizvedli komponente, ki se bodo prodale nazaj matičnim družbam, ki bodo z njimi trgovale ločeno.
40 Prevajalska redakcija
izobraževanje
CELEX: 31992R1332
Whereas the situation on the market for table olives is poorly adjusted to commercial requirements with regard to both the conditions of production and the conditions of processing and marketing;
ker je stanje na trgu namiznih oljk slabo prilagojeno gospodarskim zahtevam, tako glede pogojev proizvodnje kakor pogojev predelave in trženja;
41 Prevajalska redakcija
RS
EMEA
A trend exists for udder size of the inoculated quarter, pain as reported on a visual analog scale (VAS) after palpation, and poorer milk aspect (milk production was equally affected in all groups).
Pokazal se je trend za velikost inokulirane četrti vimena, bolečino, določeno z vizualno analogno lestvico (VAS) po palpaciji in slabše lastnosti mleka (nastajanje mleka je bilo v vseh skupinah prizadeto enako).
42 Prevajalska redakcija
izobraževanje
The Community shall do its utmost to provide assistance for projects aimed at rural development and crop diversification in Thailand, and particularly in the poorest cassava-producing regions of the country.
Skupnost naredi vse za zagotavljanje pomoči za projekte, katerih cilj je razvoj podeželja in diverzifikacija posevkov na Tajskem, in zlasti v najrevnejših regijah države, kjer proizvajajo kasavo.
43 Prevajalska redakcija
RS
EMEA
Standard measures to prevent infections resulting from the use of medicinal products prepared from human blood or plasma include selection of donors, screening of individual donations and plasma pools for specific na
Med standardne ukrepe za preprečevanje okužb kot posledica uporabe zdravil, izdelanih iz človeške krvi ali plazme, sodijo selekcija darovalcev, presejalno testiranje posameznih darovanih enot in skupne količine zbrane plazme na specifične markerje okužbe in uporaba učinkovitih proizvodnih postopkov za
44 Prevajalska redakcija
izobraževanje
CELEX: 32001R1452
the poor supply conditions typical of the outermost regions, which are completely different from those prevailing in the rest of the Community, and the need for a local production development incentive justify this derogation.
slabi pogoji preskrbe, značilni za najbolj oddaljene regije, ki so popolnoma drugačni od tistih v drugih delih Skupnosti ter potreba po spodbujanju razvoja lokalne proizvodnje upravičujejo to odstopanje.
45 Prevajalska redakcija
izobraževanje
CELEX: 31998R0963
Whereas the application of the standards should eliminate poor quality products from the market, direct production to meet consumer requirements and facilitate trade on the basis of fair competition, so helping to improve profitability;
ker bi morala uporaba standardov odstraniti proizvode slabe kakovosti s trga, usmeriti proizvodnjo k zahtevam potrošnikov in spodbuditi trgovanje na podlagi lojalne konkurence, kar bi pripomoglo k izboljšanju donosnosti;
46 Prevajalska redakcija
izobraževanje
CELEX: 31997R2288
Whereas the application of the standards should eliminate poor quality products from the market, direct garlic production to meet consumer requirements and facilitate trade on the basis of fair competition, so helping to improve profitability;
ker bi morali z uporabo standardov s trga odstraniti proizvode slabe kakovosti, doseči, da bi neposredna proizvodnja česna izpolnila zahteve potrošnikov, in olajšati trgovino na podlagi poštene konkurence, s čimer bi pomagali doseči večjo donosnost;
47 Prevajalska redakcija
izobraževanje
CELEX: 31997L0012
The official institutes listed in A.2 will be responsible for checking the quality of the Elisa method, and in particular for determining, for each production batch, the number of samples to be pooled on the basis of the count obtained for the E4 serum.
Uradni inštituti, našteti v A.2, bodo odgovorni za preverjanje kakovosti metode ELISA in zlasti za določanje, pri vsaki proizvodni seriji, števila vzorcev, ki se jih združi v skupinski vzorec na podlagi titra, dobljenega za serum E4.
48 Prevajalska redakcija
RS
EMEA
Question 5 - The Applicant should justify why the product is considered equivalent when the particle size comparison with spacer is not able to demonstrate equivalence in the pool of throat + stage 0 + stage 1, pooled as desired by the Applicant with the 20 % acceptance range and pool of stages 2 + 3, as desired by the Applicant, with the 15 % acceptance range, mainly because the sample size of this comparison has not been calculated appropriately.
Peto vprašanje - Predlagatelj mora utemeljiti, zakaj se zdravilo obravnava za enakovredno, če pri primerjavi velikosti delcev ob uporabi podaljška ni mogoče dokazati enakovrednosti za skupino stopenj, ki združuje stopnjo grla + 0. stopnjo + 1. stopnjo, oblikovano po želji predlagatelja, z 20 - odstotnim razponom sprejemljivosti, ter skupino 2. in 3. stopnje, oblikovano po želji predlagatelja, s 15- odstotnim razponom sprejemljivosti, kar gre pripisati predvsem neprimernemu izračunu velikosti vzorca v tej primerjavi.
49 Prevajalska redakcija
RS
EMEA
The CHMP noted the additional data but remained of the opinion that the pooling method masked the differences between the test products and that in addition, the used spacer decreased the amount of the larger particles and increased the amount of fine particles.
Odbor CHMP je upošteval dodatne podatke, vendar je ostal mnenja, da metoda združevanja stopenj zakrije razlike med testnimi zdravili in da poleg tega uporaba podaljška zmanjša količino večjih delcev ter poveča količino drobnih delcev.
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