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splošna dokumentacija
1 Pravna redakcija
izobraževanje
Splošna dokumentacija o instrumentih in postopkih monetarne politike Evrosistema'
General documentation on Eurosystem monetary policy instruments and procedures'
2 Pravna redakcija
delo in sociala
DRUGO
Splošna dokumentacija sama po sebi ne daje pravic nasprotnim strankam, niti jim ne nalaga obveznosti.
The "General documentation" does not in itself confer rights on counterparties nor impose obligations.
3 Pravna redakcija
izobraževanje
Splošna dokumentacija o instrumentih in postopkih monetarne politike Evrosistema' Diskontni papirji, izdani z namenom umikanja likvidnosti
General documentation on Eurosystem monetary policy instruments and procedures' Discount paper, issued with the aim of liquidity absorption
4 Objavljeno
gospodarstvo
Ur. l. RS, št. MP 2006-114
Vsem opazovalkam, sprejetim na zasedanje pogodbenic, se pošljejo ali drugače dostavijo enaki dokumenti, ki so na splošno na voljo pogodbenicam, razen dokumentacije, ki vsebuje zaupne poslovne podatke.
All observers admitted to a Meeting of the Parties shall be sent or otherwise provided the same documentation generally available to Parties, except documentation containing business-confidential data.
5 Objavljeno
pravo
Ur. l. RS, št. MP 18-1062
Za vzdrževanje in tehnično kontrolo vzdrževanja zrakoplova, motorja, propelerja, dela in opreme zrakoplova in za izdelovanje tehničnotehnološke dokumentacije mora izvajalec, ki ga pooblasti Uprava, izpolnjevati, poleg splošnih tudi, posebne pogoje glede delovnih prostorov, opremljenosti s tehničnimi sredstvi za delo, strokovnega osebja za to delo ter operativnotehničnih postopkov.
For maintenance and technical control of maintenance of aircraft, engines, propellers, parts and equipment of aircraft and for the production of technical technological documentation, a manufacturer authorities by the Administration must meet in addition to general also special conditions in relation to working premises, technical equipment for work, professional personnel for this work and operating technical procedures.
6 Objavljeno
pravo
Ur. l. RS, št. MP 18-1062
Za vzdrževanje in tehnično kontrolo vzdrževanja zrakoplova, motorja, propelerja, dela in opreme zrakoplova in za izdelovanje tehničnotehnološke dokumentacije mora izvajalec, ki ga pooblasti Uprava, izpolnjevati, poleg splošnih tudi, posebne pogoje glede delovnih prostorov, opremljenosti s tehničnimi sredstvi za delo, strokovnega osebja za to delo ter operativnotehničnih postopkov.
Rules on health conditions for performing work of aviation and other professional personnel and concerning special conditions for performing health examinations of aviation and other professional personnel that a health organisation of associated labour must meet (Ur.l. SFRY, no. 81/89).
7 Objavljeno
pravo
Ur. l. RS, št. MP 18-1062
Izdelavo in spremembe na zrakoplovu, motorju, propelerju, delu in opremi zrakoplova, ter izdelavo tehničnotehnološke dokumentacije za izdelavo in spremembe sme opravljati organizacija, ki poleg splošnih pogojev za opravljanje gospodarske dejavnosti izpolnjuje posebne pogoje, zlasti glede delovnih prostorov, opremljenosti s tehničnimi sredstvi za delo, strokovnega osebja za izdelavo zrakoplovov, ter operativno tehničnih postopkov.
Manufacture of and changes to an aircraft, engine, propeller, parts and equipment of an aircraft, and the production of technical technological documentation for manufacture and changes may be carried out by an organisation which in addition to general conditions for performing business activities meets special conditions, in particular in relation to working premises, being equipped with technical means for work, professional personnel for the manufacture of aircraft, and operating technical procedures.
8 Objavljeno
pravo
Ur. l. RS, št. MP 18-1062
(1) Nihče ne sme načrtovati ali izdelovati zrakoplova, motorja, propelerja, dela in opreme zrakoplova, opravljati vzdrževanja, sprememb ali popravil na takih izdelkih oziroma izdelovati tehnične dokumentacije za taka dela, če ne izpolnjuje splošnih pogojev za opravljanje dejavnosti in če nima veljavne licence z ustreznimi pooblastili, oziroma če nima ustreznega potrdila ali spričevala, ki ga je izdala Uprava za opravljanje takega dela, pa še to samo v obsegu, kot je navedeno v tej licenci, potrdilu ali spričevalu.
(1) Nobody may design or manufacture an aircraft, engine, propeller, parts or fittings of aircraft, carry out maintenance, changes or repairs on such products or produce technical documentation for such work if he does not meet general conditions for performing the activity and if he does not have a valid license with suitable authorities, or if he does not have the appropriate /confirmation/ or certificate issued by the Administration for carrying out such work, and may only do this to the extent stated in this license, /confirmation/ or certificate.
9 Objavljeno
pravo
Ur. l. RS, št. MP 18-1062
1. ne organizira sistema zagotavljanja kvalitete na predpisan način (9. člen), 2. načrtuje ali izdeluje zrakoplov, motor, propeler, del in opremo zrakoplova, opravlja vzdrževanje, spremembe ali popravila na takih izdelkih, oziroma izdeluje tehnično dokumentacijo za takšna dela, če ne izpolnjuje splošnih pogojev za opravljanje dejavnosti in če nima veljavne licence z ustreznimi pooblastili, oziroma, če nima ustreznega potrdila ali spričevala, ki ga je izdala Uprava za opravljanje takega dela (prvi odstavek 38. člena).
1. does not organise a system of quality assurance in the prescribed manner (Article 9), 2. designs or manufactures an aircraft, engine, propeller, parts and fittings of an aircraft, performs maintenance, adaptations or repairs on such products or produces technical documentation for such work if he does not meet general conditions for performing the activity and if he does not have a valid license with suitable authorities, or if he does not have a suitable /confirmation/ or certificate that the Administration has issued him for performing such work (first paragraph of Article 38).
10 Končna redakcija
pravo
CELEX: 32000L0009
Tehnične specifikacije naj bodo vključene v splošno dokumentacijo ali v tehnične specifikacije, določene za vsako pogodbo posebej.
Technical specifications should be included in the general documentation or in the technical specifications peculiar to each contract.
11 Končna redakcija
CELEX: 32004L0080
Pomožni organ prosilcu na prošnjo nudi splošne smernice in informacije o tem, kako izpolniti prošnjo, in o morebitni dokazni dokumentaciji.
The assisting authority shall, upon the request of the applicant, provide him or her with general guidance and information on how the application should be completed and what supporting documentation may be required.
12 Končna redakcija
CELEX: 32004R0397
Ugotovljeno je bilo tudi, da računovodska dokumentacija podjetja ni v skladu s splošno priznanimi računovodskimi načeli (GAAP) Pakistana, zlasti kar zadeva vrednotenje inventarja.
Evidence was also found that the company's accounting records were not in line with the Generally Accepted Accounting Principles (GAAP) of Pakistan, in particular regarding inventory valuation.
13 Končna redakcija
pravo
CELEX: 32000L0009
V nekaterih državah članicah lahko glavni izvajalci v splošni dokumentaciji ali specifikacijah, ki so določene za vsako pogodbo posebej, trenutno navedejo nadzorne in inšpekcijske postopke.
In certain Member States at the moment in the general documentation or specifications peculiar to each contract, main contractors may indicate the control and inspection procedures.
14 Končna redakcija
EU
DRUGO: TRANS
Bistvene zahteve, ki niso že vključene v veljavne tehnične normative in standarde in se nanašajo na varnost in druge okoliščine ter so v splošnem interesu, je potrebno upoštevati in v razpisni dokumentaciji posebej navesti.
Essential requirements which are not included in the technical norms and standards in force and are relating to safety and other circumstances in the general interest shall be adhered to, and explicitly stated in the tender documents.
15 Končna redakcija
finance
CELEX: 32002D0731
Vsako nespoštovanje teh splošnih načel pri pripravi nacionalnega izvedbenega načrta mora zadevna država članica utemeljiti na podlagi dokumentacije, v kateri opredeli načela, ki jih ne želi uporabiti, in tehnične, upravne ali gospodarske razloge, ki njihovo nespoštovanje utemeljujejo.
Any non-adherence to these general principles in the elaboration of a national implementation plan should be justified by the Member State concerned on the basis of a file setting out the principles it wishes not to apply and the technical, administrative or economic reasons which justify the non-adherence.
16 Končna redakcija
EU
DRUGO: TRANS
1. če standardi, tehnična soglasja ali splošne tehnične specifikacije oziroma projektna dokumentacija ne vsebujejo nobenega določila, ki bi nakazovala na ugotavljanje skladnosti, ali če ni tehničnih sredstev za zadovoljivo ugotavljanje skladnosti izdelka ali storitve s temi standardi, tehničnimi soglasji ali splošnimi tehničnimi specifikacijami oziroma projektno dokumentacijo,
1. if standards, technical approvals or general technical specifications or project documents do not include any provisions for establishing conformity, or, if there are no technical means to satisfactorily establish the conformity of a product or service with these standards, technical approvals or general technical specifications or project documents,
17 Končna redakcija
DRUGO
Èe trendi v prometu, nihanja ali neprožnost tarif ali druge okolišĂ¨ine kažejo, da je konkurenca v prometu znotraj skupnega trga na doloèenem geografskem obmoèju, na eni prometni povezavi ali veè takšnih povezavah ali pri prevozu potnikov ali blaga, ki pripada eni doloèeni kategoriji ali veè takim kategorijam, omejena ali izkrivljena, se lahko Komisija odloèi opraviti splošne poizvedbe o zadevnem sektorju, v okviru katerih od prevoznih podjetij v tem sektorju lahko zahteva, da predložijo podatke in dokumentacijo, ki je potrebna za uveljavitev naèel iz èlenov od 2 do 8.
If trends in transport, fluctuations in or inflexibility of transport rates, or other circumstances, suggest that competition in transport is being restricted or distorted within the common market in a specific geographical area, or over one or more transport links, or in respect of the carriage of passengers or goods belonging to one or more specific categories, the Commission may decide to conduct a general inquiry into the sector concerned, in the course of which it may request transport undertakings in that sector to supply the information and documentation necessary for giving effect to the principles formulated in Articles 2 to 8.
18 Pravna redakcija
DRUGO
Naročniki vključijo tehnične specifikacije v splošno dokumentacijo ali v razpisno dokumentacijo, ki se nanaša na posamezno javno naročilo.
Contracting entities shall include the technical specifications in the general documents or the contract documents relating to each contract.
19 Pravna redakcija
promet
CELEX: 31992D0097
Poleg tega in glede na vrsto naročila se razpisni dokumentaciji doda "zapis o splošnih podatkih".
In addition, and depending on the nature of the contract, the tender dossier shall be accompanied by a 'note of general information'.
20 Pravna redakcija
finance
CELEX: 32003L0063
(5) V zvezi z delom dokumentacije o kakovosti (kemijski, farmacevtski in biološki) se uporabljajo vse monografije, vključno s splošnimi monografijami in splošnimi poglavji Evropske farmakopeje.
(5) With respect to the quality part (chemical, pharmaceutical and biological) of the dossier, all monographs including general monographs and general chapters of the European Pharmacopoeia are applicable.
21 Pravna redakcija
DRUGO
Tehnične specifikacije, opredeljene v Prilogi III, se navedejo v splošnih dokumentih ali razpisni dokumentaciji v zvezi z vsakim naročilom posebej.
The technical specifications defined in Annex III shall be given in the general or contractual documents relating to each contract.
22 Pravna redakcija
DRUGO
Dokumentacija sistema kakovosti mora zagotavljati splošno razumevanje politik in postopkov kakovosti, kot so programi kakovosti, načrti, priročniki in evidence.
This quality system documentation must ensure a common understanding of the quality policies and procedures such as quality programmes, plans, manuals and records.
23 Pravna redakcija
promet
CELEX: 31992D0097
splošno dokumentacijo, ki zajema zlasti zakone in predpise v zvezi s tehničnim področjem, zajetim v naročilu, ali katero koli drugo navedbo, ki omogoča dostop do teh zakonov in predpisov.
general documentation comprising, in particular, the laws and regulations relating to the technical field covered by the contract, or any other reference enabling access to such laws and regulations.
24 Pravna redakcija
DRUGO
ker je medtem treba pripraviti dokumentacije, ki se morajo predložiti za ocenjevanje proizvodov, vključenih v nacionalne sezname, v skladu s smernicami, vzpostavljenimi za dodatke na splošno;
whereas, in the meantime, the dossiers to be submitted with a view to assessing products included in the national lists must be prepared according to the guidelines established for additives in general;
25 Pravna redakcija
promet
CELEX: 31992D0097
informirati ponudnike v razpisni dokumentaciji o merilih za izbiro in prednostni obravnavi, ki so določene v teh splošnih predpisih, zlasti tistih v zvezi s spodbujanjem uporabe človeških virov iz ČDO.
inform tenderers in the tender dossier of the selection criteria and preferences provided for in these general regulations, particularly those relating to the encouragement of the use of OCT human resources.
26 Pravna redakcija
DRUGO
Naročniki morajo za skladnost z ustreznimi določbami o postopkih javnega naročanja v železniškem sektorju in zlasti z Direktivo 93/38/EGS fn vključiti tehnične specifikacije v splošno dokumentacijo ali v pogoje vsake pogodbe.
To comply with the appropriate provisions on procurement procedures in the rail sector and in particular Directive 93/38/EEC(7), the contracting entities should include technical specifications in the general documents or in the terms and conditions for each contract.
27 Pravna redakcija
promet
CELEX: 31996R1488
Komisija skupaj z državami članicami vsem zainteresiranim podjetjem, organizacijam in ustanovam na območju Skupnosti na zahtevo posreduje dokumentacijo o splošnih značilnostih programov MEDA in zahtevah za sodelovanje v programih.
The Commission shall provide, in liaison with Member States, on request, to all interested firms, organizations and institutions throughout the Community, documentation on the general aspects of the MEDA programmes and the requirements for participation in the programmes.
28 Pravna redakcija
DRUGO
Priloga temelji na podatkih o splošnih možnostih za zmanjšanje emisij žvepla, zlasti o učinkovitosti tehnologije za nadzor nad emisijami in stroški, ki jih vsebuje uradna dokumentacija izvršilnega organa in njegovih pomožnih organov.
The Annex is based on information on general options for the reduction of sulphur emissions and in particular on emission control technology performance and costs contained in official documentation of the executive body and its subsidiary bodies.
29 Pravna redakcija
izobraževanje
CELEX: 32004D0100
Takšno sofinanciranje se lahko delno izvaja tudi v naravi pod pogojem, da se prispevek ovrednoti glede na dejansko nastale stroške, ki se dokažejo z računovodsko dokumentacijo, ali glede na stroške, ki se na splošno dosegajo na zadevnem trgu.
Such co-financing may be partly contributed in kind, provided the contribution is valued at no more than the cost actually incurred and evidenced by accounting documents or the cost generally obtaining on the market in question.
30 Pravna redakcija
promet
CELEX: 31992D0097
Uspešni ponudnik za naročilo za gradbena dela ali dobave, če ni drugače predvideno v razpisni dokumentaciji, v 30 dneh od prejetja obvestila o dodelitvi naročila od naročnika predloži naročniku garancijo za izvedbo v obliki, ki je predpisana v splošnih pogojih.
Unless otherwise provided by the tender dossier, the successful tenderer for a works or supply contract shall, within 30 days of receipt of the notification of award from the contracting authority furnish to the contracting authority a performance guarantee in the form specified in the general conditions.
31 Pravna redakcija
promet
CELEX: 32000R2698
` 4. Komisija skupaj z državami èlanicami in ob ustrezni uporabi interneta vsem zainteresiranim podjetjem, organizacijam in ustanovam na obmoèju Skupnosti na zahtevo posreduje dokumentacijo o splošnih znaèilnostih programov MEDA in zahtevah za sodelovanje v programih.
`4. The Commission shall provide, in liaison with Member States, on request, to all interested firms, organisations and institutions throughout the Community, documentation on the general aspects of the MEDA programmes and the requirements for participation in the programmes, making appropriate use of the Internet.
32 Pravna redakcija
DRUGO
Komisija v povezavi z državami članicami zagotovi vsem zainteresiranim podjetjem, organizacijam in ustanovam iz Skupnosti na njihovo zahtevo vso potrebno dokumentacijo o splošnih vidikih programov, navedenih v tej uredbi, in pogoje za sodelovanje v teh programih, za kar ustrezno uporabi internet.
The Commission, acting in liaison with the Member States, shall provide all interested businesses, organisations and institutions in the Community, at their request, with the necessary documentation on the general aspects of programmes referred to in this Regulation and the conditions for participation in those programmes, making appropriate use of the Internet.
33 Pravna redakcija
DRUGO
Brez poseganja v direktivi št. 77/62/EGS in št. 90/531/EGS države članice sprejmejo potrebne ukrepe za zagotovitev, da se naročniki iz Priloge II pri nakupu opreme za zračno plovbo v splošni dokumentaciji ali v specifikacijah za vsak posamezen nakup sklicujejo na specifikacije, ki so sprejete v skladu s to direktivo.
Without prejudice to Directives 77/62/EEC and 90/531/EEC the Member States shall take whatever steps are necessary to ensure that in the general documents or specifications relating to each contract the awarding civil entities defined in Annex II refer to the specifications adopted in accordance with this Directive when purchasing air-navigation equipment.
34 Pravna redakcija
DRUGO
Aktivnosti v okviru vključujejo pogovore z osebjem, pregled obratovalnih pogojev in opreme ter pregled zapisov, napisnih postopkov in druge ustrezne dokumentacije, z namenom, da se ovrednotijo okoljska uspešnost presojane dejavnosti in ugotovi, ali ta dejavnost izpolnjuje ustrezne standarde, predpise ali zastavljene splošne in posamične cilje in ali je vzpostavljeni sistem vodenja okoljskih nalog učinkovit in primeren.
Audit activities shall include discussions with personnel, inspection of operating conditions and equipment and reviewing of records, written procedures and other relevant documentation, with the objective of evaluating the environmental performance of the activity being audited to determine whether it meets the applicable standards, regulations or objectives and targets set and whether the system in place to manage environmental responsibilities is effective and appropriate.
35 Pravna redakcija
DRUGO
Komisija za slinavko in parkljevko ter druge kužne bolezni živali pri Mednarodnem uradu za kužne bolezni živali (OIE) je ocenila dokumentacijo o iztrebljanju slinavke in parkljevke, ki jo je predložil poslanec Združenega kraljestva, in skladno z Resolucijo št. XVII (Obnovitev priznanja pravnega položaja slinavke in parkljevke držav članic), ki jo je sprejel Mednarodni komite OIE na svojem 65. splošnem zasedanju (maj 1997), je 21. januarja 2002 je ponovno priznala tej državi prejšnji status države brez slinavke in parkljevke, v kateri se ne izvaja cepljenje.
The Foot-and-Mouth Disease and Other Epizootics Commission of the Office International des Epizooties (OIE) evaluated documentation concerning the eradication of foot-and-mouth disease, submitted by the Delegate of the United Kingdom, and, in accordance with Resolution No XVII (Restoration of recognition of the foot and mouth disease status of Member Countries) adopted by the OIE International Committee during its 65th General Session (May 1997), recognised on 21 January 2002 that this country has regained its previously recognised FMD-free status without vaccination.
36 Pravna redakcija
obramba
CELEX: 32003R1497
(2) vse rastline v vsebniku pripadajo istemu križancu in v njem ni različnih križancev; (3) so rastline v vsebniku lahko prepoznavne kot umetno razmnoženi osebki z visoko stopnjo enakosti v velikosti in rasti, čistoči, nedotaknjenosti koreninskega sistema ter splošni odsotnosti poškodb ali ran na njih, kar bi jih lahko povezovalo s prosto živečimi rastlinami; (4) rastline ne kažejo značilnosti da bi bile odvzete iz narave, kot so poškodbe od žuželk ali drugih živali, gliv ali alg na listih, ali mehaničnih poškodb korenin, listov ali drugih delov, povzročenih z nabiranjem; in (5) pošiljko spremlja dokumentacija, kot je račun, ki ga je podpisal pošiljatelj, na katerem je jasno navedeno število rastlin..
(2) all plants within a container are of the same hybrid, with no mixing of different hybrids within a container; (3) plants within a container can be readily recognised as artificially propagated specimens by exhibiting a high degree of uniformity in size and stage of growth, cleanliness, intact root systems, and general absence of damage or injury that could be attributable to plants originating in the wild; (4) plants do not exhibit characteristics of wild origin, such as damage by insects or other animals, fungi or algae adhering to leaves, or mechanical damage to roots, leaves, or other parts resulting from collection; and (5) shipments are accompanied by documentation, such as an invoice, which clearly states the number of plants and is signed by the shipper.
37 Pravna redakcija
gospodarstvo
CELEX: 32003R2287
(12) Izvajanje ribolovnih možnosti mora biti v skladu z zadevno zakonodajo Skupnosti in zlasti z Uredbo Komisije (EGS) št. 1381/87 z dne 20. maja 1987 o določitvi podrobnih pravil o označevanju in dokumentaciji ribiških plovil fn, Uredbo Sveta (EGS) št. 2807/83 z dne 22. septembra 1983 o podrobnih pravilih za vodenje evidenc podatkov o ulovu rib držav članic fn, Uredbo Sveta (EGS) št. 2847/93 z dne 12. oktobra 1993 o oblikovanju nadzornega sistema na področju skupne ribiške politike fn, Uredbo Sveta (ES) št. 1626/94 z dne 27. junija 1994 o nekaterih tehničnih ukrepih za ohranjanje ribolovnih virov v Sredozemlju fn, Uredbo Sveta (ES) št. 1627/94 z dne 27. junija 1994 o splošnih določbah o posebnih dovoljenjih za gospodarski ribolov fn, Uredbo (ES) št. 66/98, Uredb Sveta (ES) št. 88/98 z dne 18. decembra 1997 o nekaterih tehničnih ukrepih za ohranjanje ribolovnih virov v vodah Baltskega morja, Beltov in Oresunda fn, Uredbo Sveta (ES) št. 850/98 z dne 30. marca 1998 za ohranjanje ribolovnih virov s tehničnimi ukrepi za varovanje nedoraslih morskih organizmo v fn in Uredbo Sveta (ES) št. 1434/98 z dne 29. junija 1998 o določitvi pogojev, pod katerimi se sled iztovarja za druge namene in ne za neposredno prehrano ljudi fn.
(12) The execution of fishing opportunities should be in accordance with the Community legislation on the matter, and in particular with Commission Regulation (EEC) No 1381/87 of 20 May 1987 establishing detailed rules concerning the marking and documentation of fishing vessels fn, Council Regulation (EEC) No 2807/83 of 22 September 1983 laying down detailed rules for recording information on Member States' catches of fish fn, Council Regulation (EEC) No 2847/93 of 12 October 1993 establishing a control system applicable to the common fisheries policy fn, Council Regulation (EC) No 1626/94 of 27 June 1994 laying down certain technical measures for the conservation of fishery resources in the Mediterranean fn, Council Regulation (EC) No 1627/94 of 27 June 1994 laying down general provisions concerning special fishing permits fn, Regulation (EC) No 66/98, Council Regulation (EC) No 88/98 of 18 December 1997 laying down certain technical measures for the conservation of fishery resources in the waters of the Baltic Sea, the Belts and the Sound fn, Council Regulation (EC) No 850/98 of 30 March 1998 for the conservation of fishery resources through technical measures for the protection of juveniles of marine organisms fn and, Council Regulation (EC) No 1434/98 of 29 June 1998 specifying conditions under which herring may be landed for purposes other than direct human consumption fn.
38 Prevajalska redakcija
izobraževanje
CELEX: 31998L0008
SPLOŠNA NAČELA ZA OCENJEVANJE DOKUMENTACIJE ZA BIOCIDNE PRIPRAVKE VSEBINA
COMMON PRINCIPLES FOR THE EVALUATION OF DOSSIERS FOR BIOCIDAL PRODUCTS DEFINITIONS
39 Prevajalska redakcija
izobraževanje
CELEX: 31996L0098
Ta dokumentacija sistema kakovosti mora zagotavljati splošno razumevanje programov kakovosti, načrtov, navodil in evidenc.
That quality-system documentation must ensure common understanding of the quality programmes, plans, manuals and records.
40 Prevajalska redakcija
izobraževanje
CELEX: 31993D0465
Dokumentacija o sistemu kakovosti mora zagotavljati splošno razumevanje programov kakovosti, planov, priročnikov in zapisov.
This quality system documentation must ensure a common understanding of the quality programmes, plans, manuals and records.
41 Prevajalska redakcija
izobraževanje
CELEX: 32001R2491
Pridelovalec opravi navzkrižno kontrolo podatkov na označbi iz točke 7 splošnih določb s podatki na spremni dokumentaciji.
The operator shall crosscheck the information on the label referred to in point 7 of the general provisions with the information on the accompanying documents.
42 Prevajalska redakcija
izobraževanje
CELEX: 31995L0016
Ta dokumentacija sistema zagotavljanja kakovosti mora omogočati splošno razumevanje programov, načrtov, priročnikov in zapisov.
This quality assurance system documentation must ensure a common understanding of the quality programmes, plans, manuals and records.
43 Prevajalska redakcija
izobraževanje
CELEX: 32003L0063
V zvezi z delom dokumentacije o kakovosti (kemijski, farmacevtski in biološki) se uporabljajo vse monografije, vključno s splošnimi monografijami in splošnimi poglavji Evropske farmakopeje.
With respect to the quality part (chemical, pharmaceutical and biological) of the dossier, all monographs including general monographs and general chapters of the European Pharmacopoeia are applicable.
44 Prevajalska redakcija
izobraževanje
CELEX: 31984L0587
ker mora biti za olajšanje pregledovanja obravnavanih dodatkov dokumentacija zasnovana v skladu s splošnimi smernicami, ki jih določi Svet;
whereas, to facilitate examination of the additives in question, dossiers must be drawn up in accordance with common guidelines to be determined by the Council;
45 Prevajalska redakcija
izobraževanje
CELEX: 32004L0080
Pomožni organ prosilcu na prošnjo nudi splošne smernice in informacije o tem, kako izpolniti prošnjo, in o morebitni dokazni dokumentaciji.
The assisting authority shall, upon the request of the applicant, provide him or her with general guidance and information on how the application should be completed and what supporting documentation may be required.
46 Prevajalska redakcija
izobraževanje
CELEX: 31995L0016
Ta dokumentacija sistema zagotavljanja kakovosti mora zagotavljati splošno razumevanje programov, načrtov, priročnikov in zapisov o kakovosti.
This quality assurance system documentation must ensure a common understanding of the quality programmes, plans, manuals and quality records.
47 Prevajalska redakcija
izobraževanje
CELEX: 31998L0008
je ugotovljeno glede na sedanje znanstveno in strokovno znanje in je razvidno iz ocene dokumentacije iz člena 8, v skladu s splošnimi načeli za presojo dokumentacije, določenimi v Prilogi VI, da je tedaj, ko se uporablja, kot je dovoljeno in ob upoštevanju:
it is established, in the light of current scientific and technical knowledge, and is shown from appraisal of the dossier provided for in Article 8, according to the common principles for the evaluation of dossiers as laid down in Annex VI, that, when used as authorised and having regard to:
48 Prevajalska redakcija
izobraževanje
CELEX: 31996L0098
Dokumentacija sistema kakovosti mora zagotavljati splošno razumevanje kakovostnih strategij in postopkov, kot so programi kakovosti, načrti, navodila in evidence.
The quality-system documentation must ensure common understanding of the quality policies and procedures such as quality programmes, plans, manuals and records.
49 Prevajalska redakcija
izobraževanje
CELEX: 32000R0451
Določi se, da države članice pošljejo osnutek poročila o svoji oceni Komisiji, splošno v 12 mesecih po tem, ko so prijavitelji predložili popolno dokumentacijo.
It should be established that Member States should send draft reports of their evaluations to the Commission generally within 12 months after the dossiers submitted by notifiers have been considered complete.
50 Prevajalska redakcija
izobraževanje
CELEX: 31983L0228
ker mora taka dokumentacija omogočiti preverjanje, ali ti proizvodi ustrezajo splošnim načelom, določenim v direktivi, glede vključitve novih proizvodov v Prilogo;
Whereas such dossiers must make it possible to verify that the products in question comply with the general principles laid down in the Directive in respect of the inclusion of new products in the Annex;
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