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51–100/199
načela in smernice
51 Pravna redakcija
DRUGO
DIREKTIVA KOMISIJE 91/356/EGS z dne 13. junija 1991, ki določa načela in smernice dobre proizvodne prakse za zdravila za humano uporabo
Commission Directive 91/356/EEC of 13 June 1991 laying down the principles and guidelines of good manufacturing practice for medicinal products for human use
52 Pravna redakcija
promet
CELEX: 31997R0088
(2) Referenčna uredba določa nekatera načela in smernice, ki urejajo oprostitev plačila razširjene dajatve za določen uvoz delov za kolesa.
(2) The Reference Regulation sets out certain principles and guidelines governing the exemption of certain imports of bicycle parts from the extended duty.
53 Pravna redakcija
promet
Direktiva Komisije 91/356/EGS z dne 13. junija 1991, ki določa načela in smernice dobre proizvodne prakse za zdravila za humano medicino, in spremembe Direktive
Commission Directive 91/356/EEC of 13 June 1991 laying down the principles and guidelines of good manufacturing practice for medicinal products for human use and amendments thereto
54 Pravna redakcija
DRUGO
Direktiva Komisije z dne 23. julija 1991, ki določa načela in smernice dobre proizvodne prakse za veterinarska zdravila (91/412/EGS)(UL L 228,17. 8. 1991, str.70)
Commission Directive of 23 July 1991 laying down the principles and guidelines of good manufacturing practice for veterinary medicinal products (91/412/EEC) (OJL 228,17.8.1991, p. 70)
55 Pravna redakcija
DRUGO
Direktiva Komisije z dne 13. junija 1991, ki določa načela in smernice dobre proizvodne prakse za zdravila za humano rabo (91/356/EGS)(UL L 193,17. 7. 1991, str.30)
Commission Directive of 13 June 1991 laying down the principles and guidelines of good manufacturing practice for medicinal products for human use (91/356/EEC)(OJL193,17.7.1991,p.30)
56 Pravna redakcija
DRUGO
Uradniki, ki predstavljajo pristojni organ, morajo po vsakem pregledu, opredeljenem v prvem odstavku poročati, ali izdelovalec upošteva načela in smernice dobre proizvodne prakse iz člena 51. Izdelovalec, pri katerem je bil opravljen pregled, mora biti seznanjen z vsebino poročila.
The officials representing the competent authority shall report after each of the inspections mentioned in the first paragraph on whether the manufacturer complies with the principles and guidelines of good manufacturing practice referred to in Article 51. The inspected manufacturer shall be informed of the content of such reports.
57 Pravna redakcija
obramba
CELEX: 32004D0156
Te smernice temeljijo na načelih za spremljanje in poročanje iz Priloge IV k navedeni direktivi.
These guidelines are based on the principles set out in Annex IV to that Directive.
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da postopa v skladu z načeli in smernicami dobre proizvodne prakse za zdravila, ki jih nalaga zakonodaja Skupnosti;
comply with the principles and the guidelines of good manufacturing practice for medicinal products laid down by Community law;
59 Pravna redakcija
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Sodelovanje med pogodbenicama spodbuja usklajevanje z mednarodnimi kriteriji, načeli in smernicami na področju kakovosti.
Cooperation between the Parties shall promote alignment with internationally agreed criteria, principles and guidelines followed in the field of quality.
60 Pravna redakcija
delo in sociala
DRUGO
Enotna monetarna politika se izvaja v skladu z načeli, instrumenti, postopki in merili, določenimi v prilogah I in II k tej smernici.
The single monetary policy shall be implemented in accordance with the principles, instruments, procedures and criteria specified in Annexes I and II to this Guideline.
61 Pravna redakcija
DRUGO
SMERNICE IN SPLOŠNA NAČELA ZA IZBIRANJE TEM, KI BODO UVRŠČENE NA DNEVNI RED RAZPRAVE O PRIMERIH KRŠITEV ČLOVEKOVIH PRAVIC, DEMOKRACIJE IN NAČELA PRAVNE DRŽAVE, PREDVIDENE S ČLENOM 50
GUIDELINES AND GENERAL PRINCIPLES TO BE FOLLOWED WHEN CHOOSING THE SUBJECTS TO BE INCLUDED ON THE AGENDA FOR THE DEBATE ON CASES OF BREACHES OF HUMAN RIGHTS, DEMOCRACY AND THE RULE OF LAW PROVIDED FOR UNDER RULE 50
62 Pravna redakcija
finance
CELEX: 32003L0063
Splošna načela, ki jih je treba uporabljati, se obravnavajo v smernici, ki upošteva lastnosti zadevnega biološkega zdravila, in jo je objavila Agencija.
The general principles to be applied are addressed in a guideline taking into account the characteristics of the concerned biological medicinal product published by the Agency.
63 Pravna redakcija
DRUGO
Komisija meni, da načeloma preselitev podjetij na nove lokacije ne predstavlja varstva okolja in torej ne daje upravičenja do pomoči na podlagi teh smernic.
The Commission takes the view that as a rule the relocation of firms to new sites does not constitute environmental protection and does not therefore give entitlement to aid under these guidelines.
64 Pravna redakcija
promet
CELEX: 22003D0154
Direktiva Komisije 91/412/EGS z dne 23. julija 1991 o določitvi načel in smernic dobre proizvodne prakse za veterinarska zdravila (UL L 228, 17.8.1991, str.70)
Commission Directive 91/412/EEC of 23 July 1991 laying down the principles and guidelines of good manufacturing practice for veterinary medicinal products (OJ L 228, 17.8.1991, p. 70)
65 Pravna redakcija
promet
Direktiva Komisije 91/412/EGS z dne 23. julija 1991 o določitvi načel in smernic dobre proizvodne prakse za veterinarska zdravila (UL L 228, 17.8.1991, str.70).
Commission Directive 91/412/EEC of 23 July 1991 laying down the principles and guidelines of good manufacturing practice for veterinary medicinal products (OJ L 228, 17.8.1991, p. 70).
66 Pravna redakcija
promet
CELEX: 22003D0154
Direktiva Komisije 91/356/EGS z dne 13. junija 1991 o določitvi načel in smernic dobre proizvodne prakse za zdravila za humano uporabo(UL L 193,17.7.1991, str.30)
Commission Directive 91/356/EEC of 13 June 1991 laying down the principles and guidelines of good manufacturing practice for medicinal products for human use (OJ L 193, 17.7.1991, p. 30)
67 Pravna redakcija
DRUGO
na podlagi teh mandatov evropski organi za standarde sprejmejo standarde v skladu z načeli, zajetimi v splošnih smernicah o sodelovanju med Komisijo in temi organi;
on the basis of those mandates, the European standardisation bodies shall adopt the standards in accordance with the principles contained in the general guidelines for cooperation between the Commission and those bodies;
68 Pravna redakcija
promet
Direktiva Komisije 91/356/EGS z dne 13. junija 1991 o določitvi načel in smernic dobre proizvodne prakse za zdravila za humano uporabo (UL L 193,17.7.1991, str.30).
Commission Directive 91/356/EEC of 13 June 1991 laying down the principles and guidelines of good manufacturing practice for medicinal products for human use (OJ L 193, 17.7.1991, p. 30).
69 Pravna redakcija
DRUGO
Priporočilo Komisije v zvezi z načelnimi smernicami ekonomskih politik držav članic in Skupnosti se posreduje pristojnemu odboru, ki Parlamentu predloži poročilo.
The recommendation from the Commission on the broad guidelines of the economic policies of the Member States and the Community shall be presented to the committee responsible which shall submit a report to Parliament.
70 Pravna redakcija
delo in sociala
DRUGO
NCB sprejmejo primerne ukrepe za izvajanje postopkov monetarne politike v skladu z načeli, instrumenti, postopki in merili, določenimi v prilogah I in II k tej smernici.
The NCBs shall take all the appropriate measures to carry out the monetary policy operations in accordance with the principles, instruments, procedures and criteria specified in Annexes I and II to this Guideline.
71 Pravna redakcija
DRUGO
Ukrepi za opredelitev stanja tehnike, za oblikovanje načel in smernic za pomembne vidike izrednega ali namernega onesnaženja morja in za ovrednotenje okvira za sodelovanje.
Actions for defining the state of the art, for the development of principles and guidance for important aspects of the accidental or deliberate marine pollution and for the evaluations of the framework for cooperation.
72 Pravna redakcija
DRUGO
Direktiva Komisije 91/356/EGS z dne 13. junija 1991 o določitvi načel in smernic dobre proizvodne prakse za zdravila za humano uporabo (UL št. L 193, 17. 7. 1991, str. 30).
Commission Directive 91/356/EEC of 13 June 1991 laying down the principles and guidelines of good manufacturing practice for medicinal products for human use (OJ No L 193, 17.7.1991, p. 30).
73 Pravna redakcija
DRUGO
zagotavljanje, da take smernice izpolnjujejo določbe člena 3 in po potrebi upoštevajo Priporočeni mednarodni kodeks prakse, Splošna načela higiene živil Codex Alimentarius.
ensure that the contents of such guides comply with the provisions of Article 3 and, where appropriate, have regard to the Recommended International Code of Practice, General Principles of Food Hygiene of the Codex Alimentarius,
74 Pravna redakcija
DRUGO
SMERNICE IN SPLOŠNA NAČELA, KI JIH JE TREBA UPOŠTEVATI PRIIZBIRI VSEBIN, KI SE JIH UVRSTI NA DNEVNI RED ZA RAZPRAVO O AKTUALNIH, NUJNIH IN POMEMBNIH VPRAŠANJIH V SKLADU S ČLENOM 50
GUIDELINES AND GENERAL PRINCIPLES TO BE FOLLOWED WHEN CHOOSING THE SUBJECTS TO BE INCLUDED ON THE AGENDA FOR THE DEBATE ON TOPICAL AND URGENT SUBJECTS OF MAJOR IMPORTANCE PROVIDED FOR UNDER RULE 50
75 Pravna redakcija
finance
CELEX: 32003R1228
(8) Za zagotavljanje hitrega prilagajanja spremenjenim okoliščinam mora ta uredba predpisati osnovna načela glede postavitve cen in dodeljevanja zmogljivosti ter obenem zagotavljati sprejetje smernic, ki natančno opredeljujejo nadaljnja pomembna načela in metodologije.
(8) This Regulation should lay down basic principles with regard to tarification and capacity allocation, whilst providing for the adoption of guidelines detailing further relevant principles and methodologies, in order to allow rapid adaptation to changed circumstances.
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promet
V tem smislu velja tudi Sklep Odbora WTO o tehničnih ovira pri trgovanju o načelih za razvoj mednarodnih standardov, smernic in priporočil v zvezi s členi 2, 5 in Prilogo 3 k navedenemu sporazumu.
In this respect, the Decision of the WTO Committee on Technical Barriers to Trade on Principles for the Development of International Standards, Guides and Recommendations with relation to Articles 2, 5 and Annex 3 of that Agreement shall also apply.
77 Pravna redakcija
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Za tolmačenje opredelitev iz točk 10 do 16 člena 1 in načel, opisanih pod tem naslovom, mora imetnik dovoljenja za promet z zdravilom ter pristojni organi, uporabljati podrobne smernice iz odstavka 1.
For the interpretation of the definitions referred to in Article 1 points 10 to 16 and principles outlined in this title, the marketing authorisation holder and the competent authorities shall refer to the detailed guidance referred to in paragraph 1.
78 Pravna redakcija
DRUGO
ker je treba vzpostaviti nov sistem upravljanja količinskih omejitev, ki temelji na načelu enotne skupne trgovinske politike, v skladu s smernicami Sodišča Evropskih skupnosti in načelom notranjega trga,
Whereas a new system for administering quantitative restrictions should be established based on the principle of a uniform common commercial policy, in accordance with the guidelines laid down by the Court of Justice of the European Communities and with the principle of the internal market;
79 Pravna redakcija
DRUGO
Ta splošna načela je treba obravnavati kot nezavezujoče smernice na schengenskem območju, njihov namen pa je prispevati k nadaljnji krepitvi policijskega in carinskega sodelovanja na tem občutljivem področju.
These general principles are to be regarded as non-binding guidelines in the Schengen area and are intended to contribute to the further enhancement of police and customs cooperation in this sensitive sphere.
80 Pravna redakcija
obramba
CELEX: 32000D0608
(1) V skladu s členom 5(2) Direktive mora uporabnik izvesti oceno uporab gensko spremenjenih mikroorganizmov (GSM) v zaprtih sistemih in pri tem upoštevati najmanj načela iz Priloge III, ki so dopolnjena s smernicami.
(1) According to Article 5(2) of this Directive, the user is required to carry out an assessment of the contained uses of genetically modified micro-organisms (GMMs), using as a minimum the principles set out in Annex III supplemented by guidance notes.
81 Pravna redakcija
finance
CELEX: 32003R1228
1. Komisija v skladu s postopkom iz člena 13(2) sprejme in spreminja smernice o zadevah iz odstavkov 2 in 3 in glede mehanizmov nadomestil med upravljavci prenosnih omrežij, če je to ustrezno in v skladu z načeli iz člena 3 in 4.
1. Where appropriate, the Commission shall, acting in accordance with the procedure referred to in Article 13(2), adopt and amend guidelines on the issues listed under paragraph 2 and 3 and relating to the inter-transmission system operator compensation mechanism, in accordance with the principles set out in Articles 3 and 4.
82 Pravna redakcija
DRUGO
Pomoč Skupnosti se izvaja s financiranjem naložbenih programov in programov za vzpostavitev institucij v skladu s programskimi načeli iz splošnih smernic, ki jih je sprejela Komisija v skladu po postopku iz člena 10(2).
The Community assistance shall be implemented by financing investment and institution-building programmes in accordance with the programming principles set out in the general guidelines adopted by the Commission in accordance with the procedure referred to in Article 10(2).
83 Pravna redakcija
DRUGO
ker je torej treba v skladu s tem ciljem in na temelju načela enotne skupne trgovinske politike vzpostaviti nov sistem upravljanja s količinskimi kvotami, v skladu s smernicami, ki jih je določilo Sodišče Evropskih skupnosti;
Whereas a new system for administering quantitative quotas should therefore be established in line with this objective and based on the principle of a uniform common commercial policy, in accordance with the guidelines laid down by the Court of Justice of the European Communities;
84 Pravna redakcija
promet
OB SKLICEVANJU, da so upravne dejavnosti Ukrajine na jedrskem področju namenjene zagotavljanju zaščite okolja in prebivalstva na splošno, pa tudi zaščite delavcev pred sevanjem, na podlagi mednarodno priznanih smernic in načel,
RECALLING that Ukraine's regulatory activity for the nuclear sector is intended to ensure the protection of the environment and population in general, as well as the protection of workers, against radiation on the basis of internationally accepted guidelines and principles;
85 Pravna redakcija
promet
OB SKLICEVANJU, da so upravne dejavnosti Ruske federacije na jedrskem področju namenjene zagotavljanju varstva okolja in prebivalstva na splošno, pa tudi varstva delavcev, pred sevanjem, na podlagi mednarodno priznanih smernic in načel,
RECALLING that the Russian Federation's regulatory activity for the nuclear sector is intended to ensure the protection of the environment and population in general, as well as the protection of workers, against radiation on the basis of internationally accepted guidelines and principles,
86 Pravna redakcija
DRUGO
Po mnenju Sveta je zaželeno, da splošna načela dobre priprave, ki izhajajo iz "Skupnih smernic za pripravo kakovostnih pravnih aktov Skupnosti", ustrezno služijo za pripravo aktov, sprejetih po naslovih V in VI, in Pogodbe o Evropski uniji.
The Council finds it desirable that the general principles of good drafting which may be drawn from the 'Common guidelines on the quality of drafting of Community legislation' serve, where appropriate, as an inspiration for the drafting of acts adopted pursuant to Titles V and VI and of the Treaty on European Union.
87 Pravna redakcija
promet
CELEX: 22004D0023
Direktiva Komisije 2003/94/ES z dne 8. oktobra 2003 o določitvi načel in smernic dobre proizvodne prakse v zvezi z zdravili za uporabo v humani medicini in zdravili za uporabo v humani medicini v preskušanju (UL L 262, 14. 10. 2003, str. 22)."
Commission Directive 2003/94/EC of 8 October 2003 laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use (OJ L 262, 14.10.2003, p. 22)."
88 Pravna redakcija
promet
želijo zagotoviti, da so nevarne kemikalije, ki se izvažajo z njihovih ozemelj, pakirane in označene tako, da sta ustrezno zavarovana zdravje ljudi in okolje, ter skladno z načeli spremenjenih Londonskih smernic in Mednarodnega kodeksa obnašanja,
Desiring to ensure that hazardous chemicals that are exported from their territory are packaged and labelled in a manner that is adequately protective of human health and the environment, consistent with the principles of the Amended London Guidelines and the International Code of Conduct,
89 Pravna redakcija
promet
CELEX: 22004D0023
(2) Direktivo Komisije 2003/94/ES z dne 8. oktobra 2003 o določitvi načel in smernic dobre proizvodne prakse v zvezi z zdravili za uporabo v humani medicini in zdravili za uporabo v humani medicini v preskušanju fn je treba vključiti v Sporazum.
(2) Commission Directive 2003/94/EC of 8 October 2003 laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use fn is to be incorporated into the Agreement.
90 Pravna redakcija
DRUGO
Splošna načela glede plačevanja informatorjev naj bi se uporabljala kot neobvezne smernice na schengenskem območju, njihov namen pa je prispevati k nadaljnjemu izboljšanju carinskega in policijskega sodelovanja na tem občutljivem področju.
The general principles governing payment of informers are to be used as non-mandatory guidelines within the Schengen area and are intended to contribute to the further improvement of customs and police cooperation in this sensitive sphere.
91 Pravna redakcija
DRUGO
Skupno število prebivalcev, vključenih v vsa območja, ki jih nazadnje izbere država članica v okviru trenutnih smernic, mora torej biti na ravni, ki upošteva raznolikost nacionalnih razmer, pri čemer pa spoštuje načela sorazmernosti in nujnosti.
The total population covered by all the areas ultimately selected by a Member State under the present guidelines must, therefore, stand at a level which takes account of the diversity of national situations, while respecting the principles of proportionality and necessity.
92 Pravna redakcija
promet
V zvezi s certificiranjem rastlin in rastlinskih proizvodov ter drugega blaga pristojni organi uporabljajo načela, določena v Mednarodnih standardih FAO za fitosanitarne ukrepe št. 7 "Sistem izdajanja izvoznih spričeval" in št. 12 "Smernice za fitosanitarna spričevala".
In respect of certification of plants and plant products and other goods, the competent authorities shall apply the principles laid down in the FAO International Standards for Phytosanitary Measures No 7 'Export Certification System' and No 12 'Guidelines for Phytosanitary Certificates'.
93 Pravna redakcija
DRUGO
V Evropi morajo načela in ukrepi, ki se nanašajo na zgoraj navedeno, ustrezati načelom in ukrepom, navedenim v smernicah za vseevropsko trajnostno upravljanje z gozdovi, kot jih je potrdila Lizbonska ministrska konferenca o varovanju gozdov v Evropi (od 2. do 4. junija 1998).
In Europe, the principles and measures referred to above shall correspond to those of the Pan-European Operational Level Guidelines for Sustainable Forest Management, as endorsed by the Lisbon Ministerial Conference on the Protection of Forests in Europe (2 to 4 June 1998).
94 Pravna redakcija
obramba
CELEX: 32004D0156
Preveritelj oceni, ali se metodologija spremljanja, ki jo uporablja upravljavec, ujema z metodologijo spremljanja za napravo, ki jo je odobril pristojni organ, z načeli za spremljanje in poročanje, predstavljenimi v oddelku 3, in smernicami, navedenimi v tej in naslednjih prilogah.
The verifier shall assess whether the monitoring methodology applied by the operator complies with the installation's monitoring methodology as approved by the competent authority, the principles for monitoring and reporting presented in section 3, and the guidelines laid down in this and subsequent Annexes.
95 Pravna redakcija
DRUGO
ker države članice spodbujajo in sodelujejo pri razvoju smernic za dobro higiensko prakso, na katere se lahko sklicujejo nosilci živilske dejavnosti in ki so po potrebi osnovane na Priporočenem mednarodnem kodeksu prakse, Splošnih načelih higiene živil Codex Alimentarius fn;
Whereas Member States shall encourage and participate in the development of guides to good hygiene practice to which food businesses may refer, based, where appropriate, on the Recommended International Code of Practice, General Principles of Food Hygiene of the Codex Alimentarius (4);
96 Pravna redakcija
DRUGO
Primerno je dati poseben poudarek potrebam malih in srednjih podjetij (MSP) ob upoštevanju Evropske listine za mala podjetja, ki jo je potrdil Evropski svet v Feiri in katere načela in osma smernica za delovanje imajo za cilj krepitev tehnološke zmogljivosti malih podjetij in lažji dostop do najboljših raziskav in tehnologij.
It is appropriate to place special emphasis on the needs of small and medium-sized enterprises (SMEs), bearing in mind the European Charter for Small Enterprises endorsed by the Feira European Council, whose principles and eighth line for action aim to strengthen the technological capacity of small enterprises, and to facilitate access to the best research and technology.
97 Pravna redakcija
promet
(viii) priznavajoč, da ta konvencija vsebuje obvezo za uporabo temeljnih varnostnih načel za jedrske objekte in ne toliko podrobnih varnostnih standardov ter da obstajajo mednarodno izoblikovane varnostne smernice, ki se od časa do časa posodabljajo, da lahko tako usmerjajo sodoben način doseganja visoke varnostne ravni;
(viii) ab ab recognising that this Convention entails a commitment to the application of fundamental safety principles for nuclear installations rather than of detailed safety standards and that there are internationally formulated safety guidelines which are updated from time to time and so can provide guidance on contemporary means of achieving a high level of safety;
98 Pravna redakcija
obramba
CELEX: 32004D0156
(2) Smernice v tej odločbi določajo podrobna merila za spremljanje in poročanje o emisijah toplogrednih plinov, ki so posledica dejavnosti, naštetih v Prilogi I k Direktivi 2003/87/ES, o toplogrednih plinih, določenih v zvezi s temi dejavnostmi, in temeljijo na načelih za spremljanje in poročanje iz Priloge IV k navedeni direktivi.
(2) The guidelines contained in this Decision set out detailed criteria for the monitoring and reporting of greenhouse gas emissions resulting from the activities listed in Annex I to Directive 2003/87/EC of greenhouse gases specified in relation to those activities, based on the principles for monitoring and reporting set out in Annex IV to that Directive.
99 Pravna redakcija
finance
CELEX: 32003R1228
3. Smernice tudi opredelijo ustrezna pravila za postopno uskladitev temeljnih načel za določanje cen za proizvajalce in odjemalce ("obremenitev") po nacionalnih tarifnih sistemih, vključno z vplivom mehanizma nadomestil med UPO na nacionalni sistem omrežnin in vzpostavitvijo ustreznih in učinkovitih lokacijskih signalov, v skladu z načeli iz člena 4.
3. The guidelines shall also determine appropriate rules leading to a progressive harmonisation of the underlying principles for the setting of charges applied to producers and consumers (load) under national tariff systems, including the reflection of the inter-TSO compensation mechanism in national network charges and the provision of appropriate and efficient locational signals, in accordance with the principles set out in Article 4.
100 Pravna redakcija
DRUGO
Izven Evrope morajo načela in ukrepi ustrezati načelom za varovanje gozdov UNCED (Rio de Janeiro, junija 1992) in, če je to primerno, merilom ali smernicam za trajnostno upravljanje z gozdovi, kakor so bili sprejeti v okviru ustreznih mednarodnih in regionalnih pobud v navedenem vrstnem redu (ITTO, montrealski proces, proces Tarapoto, pobuda za suho cono Afrike UNEP/FAO).
Outside Europe they shall correspond to the UNCED Forest Principles (Rio de Janeiro, June 1992) and, where applicable, to the criteria or guidelines for sustainable forest management as adopted under the respective international and regional initiatives (ITTO, Montreal Process, Tarapoto Process, UNEP/FAO Dry-Zone Africa Initiative).
Prevodi: sl > en
51–100/199
načela in smernice