Iskalni niz je ali predolg ali pa vsebuje preveč besed.
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1–27/27
ciljni dokument
1 Objavljeno
RS
DRUGO: TRANS
V Krki pokrivamo vse tri sklope in sicer tako, da razvoj novega izdelka spremlja priprava dokumentacije v skladu z normami najzahtevnejših ciljnih trgov.
The development process at Krka is carried out at the level of complexity defined by the latest international requirements.
2 Končna redakcija
CELEX: 32004L0025
Kadar uprava ciljne družbe pravočasno prejme ločeno mnenje predstavnikov svojih zaposlenih o učinkih ponudbe na zaposlovanje, to mnenje priloži dokumentu.
Where the board of the offeree company receives in good time a separate opinion from the representatives of its employees on the effects of the bid on employment, that opinion shall be appended to the document.
3 Končna redakcija
CELEX: 32004R1590
Izvajanje programa Skupnosti za ohranjanje, opisovanje, ocenjevanje, zbiranje, dokumentiranje, razvoj in uporabo genskih virov v kmetijstvu zajema ciljno naravnane ukrepe, usklajene ukrepe in spremljevalne ukrepe.
The implementation of the Community programme for the conservation, characterisation, evaluation, collection, documentation, development and utilisation of genetic resources in agriculture includes targeted actions, concerted actions and accompanying actions.
4 Končna redakcija
CELEX: 32004L0025
Uprava ciljne družbe mora javno objaviti dokument o svojem mnenju o ponudbi in razloge, na katerem temelji to mnenje, vključno s stališči o učinkih izvedbe ponudbe na vse interese družbe, zlasti na zaposlovanje.
The board of an offeree company should be required to make public a document setting out its opinion of the bid and the reasons on which that opinion is based, including its views on the effects of implementation on all the company's interests, and specifically on employment.
5 Končna redakcija
CELEX: 32004L0025
Države članice določijo razkritje vseh informacij in dokumentov, zahtevanih v členu 6, tako, da so imetnikom vrednostnih papirjev vsaj v tistih državah članicah, na organiziranih trgih katerih so uvrščeni vrednostni papirji ciljne družbe, in predstavnikom zaposlenih ponudnika in ciljne družbe, ali če jih ni, zaposlenim samim, neovirano in takoj na razpolago.
2.Member States shall provide for the disclosure of all information and documents required by Article 6 in such a manner as to ensure that they are both readily and promptly available to the holders of securities at least in those Member States on the regulated markets of which the offeree company's securities are admitted to trading and to the representatives of the employees of the offeree company and the offeror or, where there are no such representatives, to the employees themselves.
6 Končna redakcija
CELEX: 32004R0870
Izvajanje programa Skupnosti za ohranjanje, karakterizacijo, vrednotenje, zbiranje, dokumentiranje, razvoj in uporabo genskih virov v kmetijstvu vključuje ciljno naravnane dejavnosti, usklajene dejavnosti in spremljajoče dejavnosti.
The implementation of the Community programme for the conservation, characterisation, evaluation, collection, documentation, development and utilisation of genetic resources in agriculture includes targeted actions, concerted actions and accompanying actions.
7 Končna redakcija
CELEX: 32004L0035
negativne variacije, nastale zaradi naravnih vzrokov ali kot posledica posegov, ki spadajo v običajno upravljanje območij, kakršno je opredeljeno v popisu habitata ali ciljnih dokumentih ali kakršno so predhodno izvajali lastniki ali izvajalci,
negative variations due to natural causes or resulting from intervention relating to the normal management of sites, as defined in habitat records or target documents or as carried on previously by owners or operators,
8 Končna redakcija
CELEX: 32004L0025
Države članice zagotovijo, da se od ponudnika zahteva pravočasna sestava in javna objava dokumenta o ponudbi, ki vsebuje potrebne informacije za to, da lahko imetniki vrednostnih papirjev ciljne družbe sprejmejo odločitev o ponudbi na podlagi zadostnega poznavanja dejanskega stanja.
2.Member States shall ensure that an offeror is required to draw up and make public in good time an offer document containing the information necessary to enable the holders of the offeree company's securities to reach a properly informed decision on the bid.
9 Končna redakcija
CELEX: 32004L0025
Kadar je dokument o ponudbi iz prvega pododstavka predmet predhodne odobritve nadzornega organa in je tudi odobren, se v potrebnih prevodih prizna v vseh drugih državah članicah, na trgu katerih so uvrščeni vrednostni papirji ciljne družbe, ne da bi bila za to potrebna odobritev nadzornih organov te države članice.
Where the offer document referred to in the first subparagraph is subject to the prior approval of the supervisory authority and has been approved, it shall be recognised, subject to any translation required, in any other Member State on the market of which the offeree company's securities are admitted to trading, without its being necessary to obtain the approval of the supervisory authorities of that Member State.
10 Končna redakcija
CELEX: 32004L0025
Uprava ciljne družbe pripravi in javno objavi dokument o svojem mnenju o ponudbi in razlogih, na katerih temelji, vključno s stališči o učinkih izvedbe ponudbe na vse interese podjetja, še zlasti zaposlovanja, in o strateških načrtih ponudnika za ciljno družbo, in njihovih mogočih posledicah na zaposlovanje in sedeže poslovanja družbe, kot je določeno v dokumentu o ponudbi v skladu s členom 6(3)(i).
5.The board of the offeree company shall draw up and make public a document setting out its opinion of the bid and the reasons on which it is based, including its views on the effects of implementation of the bid on all the company's interests and specifically employment, and on the offeror's strategic plans for the offeree company and their likely repercussions on employment and the locations of the company's places of business as set out in the offer document in accordance with Article 6(3)(i).
11 Končna redakcija
CELEX: 32004L0025
Ti organi lahko zahtevajo vključitev dodatnih informacij v dokument o ponudbi, le če so te informacije specifične za trg države članice ali držav članic, na katerem so uvrščeni vrednostni papirji ciljne družbe, in se nanašajo na formalnosti, ki jih je treba izpolniti za sprejem ponudbe in za prejem ustreznega nadomestila ob zaprtju ponudbe, pa tudi na davčni režim, katerega predmet je nadomestilo, ponujeno imetnikom vrednostnih papirjev.
Those authorities may require the inclusion of additional information in the offer document only if such information is specific to the market of a Member State or Member States on which the offeree company's securities are admitted to trading and relates to the formalities to be complied with to accept the bid and to receive the consideration due at the close of the bid as well as to the tax arrangements to which the consideration offered to the holders of the securities will be subject.
12 Pravna redakcija
DRUGO
Zato je treba pred zbiranjem dokumentacije o varnosti pridobiti podatke o farmakoloških raziskavah na laboratorijskih živalih ter vse relevantne podatke, pridobljene med kliničnimi študijami na ciljni živali.
Therefore the safety documentation shall always be preceded by details of pharmacological investigations undertaken in laboratory animals and all relevant information observed during clinical studies in the target animal.
13 Pravna redakcija
DRUGO
Če je le možno, je treba dokumentirati imunske mehanizme (celično/humoralni, lokalno/sistemski imunoglobulinski razredi), ki se sprožijo po dajanju imunološkega zdravila za uporabo v veterinarski medicini ciljni živali na priporočen način.
If possible, the immune mechanism (cell-mediated/humoral, local/general classes of immunoglobulin) which is initiated after the administration of the immunological veterinary medicinal product to target animals by the recommended route of administration shall be specified and documented.
14 Prevajalska redakcija
izobraževanje
CELEX: 32004L0025
Kadar uprava ciljne družbe pravočasno prejme ločeno mnenje predstavnikov svojih zaposlenih o učinkih ponudbe na zaposlovanje, to mnenje priloži dokumentu.
Where the board of the offeree company receives in good time a separate opinion from the representatives of its employees on the effects of the bid on employment, that opinion shall be appended to the document.
15 Prevajalska redakcija
izobraževanje
CELEX: 32002D0364
V kontekstu tega dokumenta se izraz "NAT" uporablja za teste za odkrivanje in/ali količinsko določitev nukleinskih kislin s pomnoževanjem ciljnega zaporedja, pomnoževanjem signala ali s hibridizacijo.
In the context of this document the term "NAT" is used for tests for the detection and/or quantification of nucleic acids by either amplification of a target sequence, by amplification of a signal or by hybridisation.
16 Prevajalska redakcija
izobraževanje
CELEX: 32004L0025
Uprava ciljne družbe mora javno objaviti dokument o svojem mnenju o ponudbi in razloge, na katerem temelji to mnenje, vključno s stališči o učinkih izvedbe ponudbe na vse interese družbe, zlasti na zaposlovanje.
The board of an offeree company should be required to make public a document setting out its opinion of the bid and the reasons on which that opinion is based, including its views on the effects of implementation on all the company's interests, and specifically on employment.
17 Prevajalska redakcija
izobraževanje
CELEX: 32004L0025
Države članice določijo razkritje vseh informacij in dokumentov, zahtevanih v členu 6, tako, da so imetnikom vrednostnih papirjev vsaj v tistih državah članicah, na organiziranih trgih katerih so uvrščeni vrednostni papirji ciljne družbe, in predstavnikom zaposlenih ponudnika in ciljne družbe, ali če jih ni, zaposlenim samim, neovirano in takoj na razpolago.
2.Member States shall provide for the disclosure of all information and documents required by Article 6 in such a manner as to ensure that they are both readily and promptly available to the holders of securities at least in those Member States on the regulated markets of which the offeree company's securities are admitted to trading and to the representatives of the employees of the offeree company and the offeror or, where there are no such representatives, to the employees themselves.
18 Prevajalska redakcija
izobraževanje
CELEX: 31996L0025
Za namene obtoka znotraj Skupnosti, se oznake, natisnjene na spremnem dokumentu, na embalaži, posodi ali na etiketi, navede v vsaj enem ali več jezikih, ki jih izmed državnih ali uradnih jezikov Skupnosti določi ciljna država.
For the purpose of circulation within the Community, the indications printed on the accompanying document, on the packaging, on the container or on a label attached thereto shall be written in at least one or several languages which the country of destination shall determine from among the national or official languages of the Community.
19 Prevajalska redakcija
izobraževanje
CELEX: 32004R0870
Izvajanje programa Skupnosti za ohranjanje, karakterizacijo, vrednotenje, zbiranje, dokumentiranje, razvoj in uporabo genskih virov v kmetijstvu vključuje ciljno naravnane dejavnosti, usklajene dejavnosti in spremljajoče dejavnosti.
The implementation of the Community programme for the conservation, characterisation, evaluation, collection, documentation, development and utilisation of genetic resources in agriculture includes targeted actions, concerted actions and accompanying actions.
20 Prevajalska redakcija
izobraževanje
CELEX: 32004L0035
negativne variacije, nastale zaradi naravnih vzrokov ali kot posledica posegov, ki spadajo v običajno upravljanje območij, kakršno je opredeljeno v popisu habitata ali ciljnih dokumentih ali kakršno so predhodno izvajali lastniki ali izvajalci,
negative variations due to natural causes or resulting from intervention relating to the normal management of sites, as defined in habitat records or target documents or as carried on previously by owners or operators,
21 Prevajalska redakcija
izobraževanje
CELEX: 32004L0025
Države članice zagotovijo, da se od ponudnika zahteva pravočasna sestava in javna objava dokumenta o ponudbi, ki vsebuje potrebne informacije za to, da lahko imetniki vrednostnih papirjev ciljne družbe sprejmejo odločitev o ponudbi na podlagi zadostnega poznavanja dejanskega stanja.
2.Member States shall ensure that an offeror is required to draw up and make public in good time an offer document containing the information necessary to enable the holders of the offeree company's securities to reach a properly informed decision on the bid.
22 Prevajalska redakcija
izobraževanje
CELEX: 32004L0025
Kadar je dokument o ponudbi iz prvega pododstavka predmet predhodne odobritve nadzornega organa in je tudi odobren, se v potrebnih prevodih prizna v vseh drugih državah članicah, na trgu katerih so uvrščeni vrednostni papirji ciljne družbe, ne da bi bila za to potrebna odobritev nadzornih organov te države članice.
Where the offer document referred to in the first subparagraph is subject to the prior approval of the supervisory authority and has been approved, it shall be recognised, subject to any translation required, in any other Member State on the market of which the offeree company's securities are admitted to trading, without its being necessary to obtain the approval of the supervisory authorities of that Member State.
23 Prevajalska redakcija
RS
EMEA
Ob upoštevanju razlogov za posvetovalni postopek in odgovorov, ki jih je zagotovil imetnik dovoljenja za promet z zdravilom, je odbor CVMP zaključil, da ni dokumentiranih dokazov na področju težav, ki se nanašajo na pomanjkljivo učinkovitost ali spremembe glede odpornosti zadevnih ciljnih patogenih organizmov, ki bi predstavljali zadržke glede zdravja živali ali ljudi.
Having considered the grounds for referral and the responses provided by the Marketing Authorisation Holder, the CVMP concludes that there is no documented evidence from the field of problems relating to lack of efficacy or any change in the resistance situation of the relevant target pathogens that would constitute a concern relating to animal or human health.
24 Prevajalska redakcija
izobraževanje
CELEX: 32004L0025
Uprava ciljne družbe pripravi in javno objavi dokument o svojem mnenju o ponudbi in razlogih, na katerih temelji, vključno s stališči o učinkih izvedbe ponudbe na vse interese podjetja, še zlasti zaposlovanja, in o strateških načrtih ponudnika za ciljno družbo, in njihovih mogočih posledicah na zaposlovanje in sedeže poslovanja družbe, kot je določeno v dokumentu o ponudbi v skladu s členom 6(3)(i).
5.The board of the offeree company shall draw up and make public a document setting out its opinion of the bid and the reasons on which it is based, including its views on the effects of implementation of the bid on all the company's interests and specifically employment, and on the offeror's strategic plans for the offeree company and their likely repercussions on employment and the locations of the company's places of business as set out in the offer document in accordance with Article 6(3)(i).
25 Prevajalska redakcija
izobraževanje
CELEX: 32004L0025
Ti organi lahko zahtevajo vključitev dodatnih informacij v dokument o ponudbi, le če so te informacije specifične za trg države članice ali držav članic, na katerem so uvrščeni vrednostni papirji ciljne družbe, in se nanašajo na formalnosti, ki jih je treba izpolniti za sprejem ponudbe in za prejem ustreznega nadomestila ob zaprtju ponudbe, pa tudi na davčni režim, katerega predmet je nadomestilo, ponujeno imetnikom vrednostnih papirjev.
Those authorities may require the inclusion of additional information in the offer document only if such information is specific to the market of a Member State or Member States on which the offeree company's securities are admitted to trading and relates to the formalities to be complied with to accept the bid and to receive the consideration due at the close of the bid as well as to the tax arrangements to which the consideration offered to the holders of the securities will be subject.
26 Prevajalska redakcija
RS
EMEA
Imetniki dovoljenj za promet so bili pozvani, naj iz dosjeja, predloženega v vsaki državi EGP, v kateri so zadevna zdravila odobrena, predložijo naslednjo dokumentacijo: a) modul I: povzetek dosjeja, vključno s povzetkom glavnih značilnosti zdravila, poročili izvedencev in celotno sestavo zdravil; b) če je potrebno, modul IV dosjeja, predloženega za pridobitev dovoljenja za promet; c) oceno periodičnih poročil o varnosti zdravila (PSUR) v zvezi z varnostjo ciljne skupine živali in morebitnim pomanjkanjem učinkovitosti.
The MAHs are requested to provide from the dossier submitted for each country of the EEA where the products are authorised: a) the Part I Summary of the dossier including SPCs, expert reports and the full composition of the products; b) if applicable, Part IV of the application dossier; c) an Assessment of the Periodic Safety Update Reports (PSURs) in relation to target animal safety and possible lack of efficacy.
27 Prevajalska redakcija
RS
EMEA
1. je bila učinkovitost odmerka 1x30 mg/ kg telesne mase na dan, ki se daje največ pet zaporednih dni, ustrezno potrjena za vse indikacije, razen za salmonelozo; 2. do zdaj ni nobenih dokumentiranih dokazov o težavah zaradi slabše učinkovitosti ali kakršnih koli sprememb odpornosti glavnih ciljnih patogenov, ki bi pomenili zadržke zaradi tveganja za zdravje živali ali ljudi; 3. ni bilo mogoče določiti primernega odmerka za zdravljenje salmonelaze; 4. mora uporaba zdravila temeljiti na testiranju občutljivosti in upoštevati uradno in lokalno protimikrobno politiko; 5. so vzpostavljene karence varne in se lahko obdržijo.
The efficacy of a dose of 1x30 mg/ kg body weight per day to be administered over a maximum period of 5 days has been substantiated for all indications, except for salmonellosis. 2. There is no documented evidence of problems relating to lack of efficacy or any change in the resistance situation of the relevant target pathogens that would constitute a concern relating to animal or human health. 3. No dose could be established for the treatment of salmonellosis. 4. The use of the product should be based on susceptibility testing and take into account official and local antimicrobial policies. 5. The established withdrawal periods are safe and can be retained.
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ciljni dokument