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101–150/206
principles and guidelines
101 Pravna redakcija
promet
RECALLING that Kazakhstan'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;
UPOŠTEVAJOČ, da so upravne dejavnosti Kazashstana na jedrskem področju namenjene zagotavljanju zaščite okolja in prebivalstva na splošno, kakor tudi zaščite delavcev pred sevanjem, na podlagi mednarodno priznanih usmeritev in načel;
102 Pravna redakcija
promet
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'.
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".
103 Pravna redakcija
promet
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,
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,
104 Pravna redakcija
DRUGO
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.
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.
105 Pravna redakcija
DRUGO
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).
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).
106 Pravna redakcija
DRUGO
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).
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).
107 Pravna redakcija
promet
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,
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,
108 Pravna redakcija
DRUGO
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;
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;
109 Pravna redakcija
obramba
CELEX: 32004D0156
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.
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.
110 Pravna redakcija
finance
CELEX: 32003R1228
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.
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.
111 Pravna redakcija
finance
CELEX: 32003R1228
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.
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.
112 Pravna redakcija
DRUGO
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.
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.
113 Pravna redakcija
DRUGO
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).
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).
114 Pravna redakcija
obramba
CELEX: 32004D0156
(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.
(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.
115 Pravna redakcija
finance
CELEX: 32003R1228
4. Where appropriate, the Commission shall, acting in accordance with the procedure referred to in Article 13(2), amend the guidelines on the management and allocation of available transfer capacity of interconnections between national systems set out in the Annex, in accordance with the principles set out in Articles 5 and 6, in particular so as to include detailed guidelines on all capacity allocation methodologies applied in practice and to ensure that congestion management mechanisms evolve in a manner compatible with the objectives of the internal market.
4. V skladu s postopkom iz člena 13(2) Komisija, če je potrebno, spremeni smernice o upravljanju in dodeljevanju razpoložljivih prenosnih zmogljivosti ali povezav med nacionalnimi omrežji iz priloge k tej uredbi, skladno z načeli iz členov 5 in 6, zlasti zaradi vključevanja podrobnih smernic o vseh v praksi uporabljenih metodologijah za dodeljevanje zmogljivosti in zaradi zagotavljanja, da se mehanizmi za razreševanje prezasedenosti razvijajo na način, ki je združljiv s cilji notranjega trga.
116 Pravna redakcija
promet
(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;
(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;
117 Pravna redakcija
delo in sociala
This notice sets out the Commission's interpretation of the relevant Treaty provisions and the guiding principles according to which the Commission intends to apply the competition rules of the Treaty to the postal sector in individual cases, while maintaining the necessary safeguards for the provision of a universal service, and gives to enterprises and Member States clear guidelines so as to avoid infringements of the Treaty.
To sporočilo določa, kako Komisija razlaga ustrezne določbe Pogodbe in vodilna načela, po katerih namerava Komisija uporabljati pravila Pogodbe o konkurenci v posameznih primerih v poštnem sektorju, medtem ko ohranja potrebne zaščitne ukrepe za opravljanje univerzalne storitve, ter daje podjetjem in državam članicam jasna navodila, kako naj se izognejo kršitvam Pogodbe.
118 Pravna redakcija
DRUGO
By its Conclusions of 30 September 2002 on the International Criminal Court the General Affairs and External Relations Council has developed a set of principles attached to those Conclusions to serve as guidelines for Member States when considering the necessity and scope of possible agreements or arrangements in responding to proposals regarding the conditions to surrender persons to the International Criminal Court.
V svojih sklepih 30. septembra 2002 o Mednarodnem kazenskem sodišču je Svet za splošne zadeve in zunanje odnose oblikoval niz načel, priloženih navedenim sklepom, ki naj služijo kot smernice državam članicam pri presojanju potrebnosti in področja uporabe morebitnih sporazumov ali dogovorov, ko odgovarjajo na predloge v zvezi s pogoji za predajo oseb Mednarodnemu kazenskemu sodišču.
119 Pravna redakcija
gospodarstvo
CELEX: 32003R1831
For experiments for scientific purposes, Member States may authorise the use, as additives, of substances which are not authorised at Community level, with the exception of antibiotics, provided that the experiments are carried out in accordance with the principles and conditions laid down in Directive 87/153/EEC, Directive 83/228/EEC fn or the guidelines set out in Article 7(4) of this Regulation and provided that there is adequate official supervision.
Za poskuse v znanstvene namene lahko države članice dovolijo uporabo snovi kot dodatkov, ki na ravni Skupnosti niso dovoljene, razen antibiotikov, pod pogojem, da se poskusi izvajajo v skladu z načeli in pogoji, določenimi v Direktivi 87/153/EGS, Direktivi 83/228/EGS fn ali smernicami, določenimi v členu 7(4) te uredbe ter pod pogojem, da obstaja primeren uradni nadzor.
120 Pravna redakcija
DRUGO
TAKING INTO ACCOUNT the Declaration of the United Nations Conference on the Human Environment (Stockholm, 1972), the Cairo Guidelines and Principles for the Environmentally Sound Management of Hazardous Wastes adopted by the Governing Council of the United Nations Environment Programme (UNEP) by decision 14/30 of 17 June 1987, the recommendations of the United Nations Committee of Experts on the Transport of Dangerous Goods (formulated in 1957 and updated biennially), relevant recommendations, declarations, instruments and regulations adopted within the United Nations system and the work and studies done within other international and regional organizations,
OB UPOŠTEVANJU Deklaracije Konference Združenih narodov o človekovem okolju (Stockholm, 1972), kairskih smernic in načel za okolju varno ravnanje z nevarnimi odpadki, ki jih je sprejel Upravni svet Programa Združenih narodov za okolje (UNEP) s Sklepom 14/30 z dne 17. junija 1987, priporočil Komisije strokovnjakov Združenih narodov o prevozu nevarnega blaga (oblikovanih leta 1957 in usklajenih vsaki dve leti), ustreznih priporočil, deklaracij, dokumentov in pravilnikov, sprejetih v Združenih narodih, ter dela in študij, opravljenih v drugih mednarodnih in regionalnih organizacijah,
121 Prevajalska redakcija
izobraževanje
CELEX: 32004D0210
principles and guidelines.
načela in smernice.
122 Prevajalska redakcija
izobraževanje
CELEX: 32003L0094
Those principles and guidelines are set out in 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(3).
Navedena načela in smernice so določena v Direktivi Komisije 91/356/EGS z dne 13. junija 1991, ki določa načela in smernice dobre proizvodne prakse za zdravila za humano uporabo [3].
123 Prevajalska redakcija
izobraževanje
CELEX: 32001L0083
to comply with the principles and guidelines of good manufacturing practice for medicinal products as laid down by Community law.
upoštevati načela in smernice dobre proizvodne prakse za zdravila, kot to določa zakonodaja Skupnosti.
124 Prevajalska redakcija
izobraževanje
CELEX: 32001L0083
they must comply with the principles and guidelines of good distribution practice for medicinal products as laid down in Article 84.
ravnati morajo v skladu z načeli in smernicami dobre distribucijske prakse za zdravila, kot jih določa člen 84.
125 Prevajalska redakcija
izobraževanje
CELEX: 31991L0412
For the interpretation of these principles and guidelines of good manufacturing practice, the manufacturers and the agents of the competent authorities refer to the detailed guidelines referred to in Article 27a of Directive 81/851/EEC.
Za razlago teh načel in smernic dobre proizvodne prakse se proizvajalci in predstavniki pristojnih organov sklicujejo na podrobne smernice iz člena 27a Direktive 81/851/EGS.
126 Prevajalska redakcija
izobraževanje
CELEX: 31997R0088
The Reference Regulation sets out certain principles and guidelines governing the exemption of certain imports of bicycle parts from the extended duty.
Referenčna uredba določa nekatera načela in smernice, ki urejajo oprostitev plačila razširjene dajatve za določen uvoz delov za kolesa.
127 Prevajalska redakcija
izobraževanje
Commission Directive 91/412/EEC of 23 July 1991 laying down the principles and guidelines of good manufacturing practice for veterinary medicinal products
Uredba Sveta (EGS) št. 2309/93 z dne 22. julija 1993, ki določa postopke Skupnosti za pridobitev dovoljenja za promet in nadzor zdravil za ljudi in veterinarskih zdravil ter ustanavlja Evropsko agencijo za vrednotenje zdravil(UL L 214, 24.8.1993, str. 1), kakor je bila spremenjena z:
128 Prevajalska redakcija
izobraževanje
CELEX: 31991L0412
COMMISSION DIRECTIVE of 23 July 1991 laying down the principles and guidelines of good manufacturing practice for veterinary medicinal products (91/412/EEC)
Direktiva Komisije z dne 23. julija 1991 o določitvi načel in smernic dobre proizvodne prakse za zdravila za uporabo v veterinarski medicini (91/412/EGS)
129 Prevajalska redakcija
izobraževanje
Objectives, principles, guidelines and eligibility
Cilji, načela, smernice in upravičenost
130 Prevajalska redakcija
izobraževanje
CELEX: 32003L0063
The manufacturing process shall comply with the requirements of Commission Directive 91/356/EEC laying down the principles and guidelines of Good Manufacturing Practice (GMP) for medicinal products for human use(2) and with the principles and guidelines on GMP, published by the Commission in The rules governing medicinal products in the European Community, Volume 4.
Postopek proizvodnje mora biti v skladu z zahtevami Direktive Komisije 91/356/EGS o določitvi načel in smernic dobre proizvodne prakse (GMP) za zdravila za ljudi [4] ter z načeli in smernicami dobre proizvodne prakse, ki jih je Komisija objavila v zvezku 4 Pravil, ki urejajo zdravila v Evropski skupnosti.
131 Prevajalska redakcija
izobraževanje
CELEX: 32004L0027
"(f) to comply with the principles and guidelines of good manufacturing practice for medicinal products and to use as starting materials only active substances, which have been manufactured in accordance with the detailed guidelines on good manufacturing practice for starting materials.
` (f) upoštevati načela in smernice dobre proizvodne prakse za zdravila in uporabiti kot vhodne snovi samo zdravilne učinkovine, ki so bile izdelane v skladu s podrobnimi smernicami dobre proizvodne prakse za vhodne snovi.
132 Prevajalska redakcija
izobraževanje
CELEX: 32003L0094
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
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
133 Prevajalska redakcija
izobraževanje
CELEX: 31991L0412
This Directive lays down the principles and guidelines of good manufacturing practice for veterinary medicinal products whose manufacture requires the authorization referred to in Article 24 of Directive 81/851/EEC.
Ta direktiva določa načela insmernice dobre proizvodne prakse za zdravila za uporabo v veterinarski medicini, za katere je potrebno dovoljenje za proizvodnjo iz člena 24 Direktive 81/851/EGS.
134 Prevajalska redakcija
izobraževanje
CELEX: 31991L0412
The contract acceptor shall respect the principles and guidelines of good manufacturing practice and shall submit to inspections carried out by the competent authorities as provided for by Article 34 of Directive 81/851/EEC.
Delojemalec mora spoštovati načela in smernice dobre proizvodne prakse in mora sprejeti preglede, ki jih opravljajo pristojni organi, kakor je predvideno s členom 34 Direktive 81/851/EGS.
135 Prevajalska redakcija
izobraževanje
CELEX: 31991L0412
Whereas the principles and guidelines of good manufacturing practice should primarily concern personnel, premises and equipment, documentation, production, quality control, contracting out, complaints and product recall, and self inspection;
ker se morajo načela in smernice dobre proizvodne prakse predvsem nanašati na osebje, prostore in opremo, dokumentacijo, proizvodnjo, nadzor kakovosti, pogodbeno delo, reklamacije in odpoklic proizvoda ter na notranji nadzor;
136 Prevajalska redakcija
izobraževanje
In accordance with the Commission communication on the principles and guidelines for the Community's audiovisual policy in the digital era(17), it is not for the Commission to judge on the fulfilment of quality standards:
V skladu s sporočilom Komisije o načelih in smernicah za politiko Skupnosti glede avdiovizualne politike v digitalni dobi [17], Komisija ni pristojna za presojanje izpolnjevanja standardov kakovosti:
137 Prevajalska redakcija
izobraževanje
CELEX: 32001L0083
The principles and guidelines of good manufacturing practices for medicinal products referred to in Article 46(f) shall be adopted in the form of a directive, in accordance with the procedure referred to in Article 121(2).
Načela in smernice dobrih proizvodnih praks za zdravila iz člena 46(f) se sprejmejo v obliki direktive v skladu s postopkom iz člena 121(2).
138 Prevajalska redakcija
izobraževanje
CELEX: 32000D0821
In its Communication of 14 December 1999 on "Principles and Guidelines for the Community's Audiovisual Policy in the Digital Age", the Commission defined its priorities in the audiovisual sector for the period 2000 to 2005.
V svojem sporočilu o "Načelih in smernicah avdiovizualne politike Skupnosti v digitalni dobi" z dne 14. decembra 1999 je Komisija opredelila svoje prednostne naloge na avdiovizualnem področju za obdobje 2000 do 2005.
139 Prevajalska redakcija
izobraževanje
CELEX: 32003L0094
In order to ensure conformity with the principles and guidelines of good manufacturing practice, it is necessary to lay down detailed provisions on inspections by the competent authorities and on certain obligations of the manufacturer.
Da bi se zagotovila skladnost z načeli in smernicami dobre proizvodne prakse, je treba določiti podrobne določbe v zvezi z nadzori, ki jih izvajajo pristojni organi, in nekaterimi obveznostmi izdelovalca.
140 Prevajalska redakcija
izobraževanje
This will be done in close consultation with the Member States (see the Commission Communication of 14 December 1999 on "The principles and guidelines for the Community's audiovisual policy in the digital age", COM(1999) 657 final).
To bo narejeno v tesnem sodelovanju z državami članicami (glej Sporočilo Komisije z dne 14. decembra 1999 o "načelih in smernicah za avdiovizualno politiko Skupnosti v digitalni dobi" KOM(1999) 657 končno).
141 Prevajalska redakcija
izobraževanje
CELEX: 31991L0412
By means of the repeated inspections referred to in Article 34 of Directive 81/851/EEC, the Member States shall ensure that manufacturers respect the principles and guidelines of good manufacturing practice laid down by this Directive.
Z večkratnimi pregledi iz člena 34 Direktive 81/851/EGS države članice zagotovijo, da proizvajalci spoštujejo načela in smernice dobre proizvodne prakse, določene v tej direktivi.
142 Prevajalska redakcija
izobraževanje
CELEX: 32003L0094
All medicinal products for human use manufactured or imported into the Community, including medicinal products intended for export, are to be manufactured in accordance with the principles and guidelines of good manufacturing practice.
Vsa zdravila za uporabo v humani medicini, proizvedena v Skupnosti ali uvožena v Skupnost, vključno z zdravili, namenjenimi za izvoz, morajo biti proizvedena v skladu z načeli in smernicami dobre proizvodne prakse.
143 Prevajalska redakcija
izobraževanje
CELEX: 31991L0412
Whereas all veterinary medicinal products manufactured or imported into the Community, including medicinal products intended for export should be manufactured in accordance with the principles and guidelines of good manufacturing practice;
ker morajo biti vsa zdravila za uporabo v veterinarski medicini, proizvedena ali uvožena v Skupnost, vključno z zdravili, namenjenimi za izvoz, proizvedena v skladu z načeli in smernicami dobre proizvodne prakse;
144 Prevajalska redakcija
izobraževanje
CELEX: 32003L0094
The contract-acceptor shall comply with the principles and guidelines of good manufacturing practice and shall submit to inspections carried out by the competent authorities pursuant to Article 111 of Directive 2001/83/EC and Article 15 of Directive 2001/20/EC.
Prevzemnik pogodbe upošteva načela in smernice dobre proizvodne prakse in dovoli nadzor, ki ga izvajajo pristojni organi v skladu s členom 111 Direktive 2001/83/ES in členom 15 Direktive 2001/20/ES.
145 Prevajalska redakcija
izobraževanje
CELEX: 32001L0083
After every inspection as referred to in paragraph 1, the officials representing the competent authority shall report on whether the manufacturer complies with the principles and guidelines of good manufacturing practice laid down in Article 47.
Po vsakem inšpekcijskem pregledu iz odstavka 1, uradne osebe, ki predstavljajo pristojni organ, poročajo, ali izdelovalec ravna po načelih in smernicah dobre proizvodne prakse, določene v členu 47.
146 Prevajalska redakcija
izobraževanje
CELEX: 32003L0094
For the interpretation of the principles and guidelines of good manufacturing practice, the manufacturers and the competent authorities shall take into account the detailed guidelines referred to in the second paragraph of Article 47 of Directive 2001/83/EC, published by the Commission in the "Guide to good manufacturing practice for medicinal products and for investigational medicinal products".
Za razlago načel in smernic dobre proizvodne prakse izdelovalci in pristojni organi upoštevajo podrobne smernice iz drugega odstavka člena 47 Direktive 2001/83/ES, ki jih je objavila Komisija v "Navodilih za dobro proizvodno prakso za zdravila in zdravila v preskušanju".
147 Prevajalska redakcija
izobraževanje
CELEX: 32001L0082
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.
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.
148 Prevajalska redakcija
izobraževanje
CELEX: 22004D0023
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(2) is to be incorporated into the Agreement.
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 [2] je treba vključiti v Sporazum.
149 Prevajalska redakcija
izobraževanje
CELEX: 32004D0192
Priority will be given to developing principles and guidelines for best practice on the prudent use of antimicrobial agents in human medicine together with competent authorities and to activities that foster education and intervention programmes aimed at the health professionals and hospitals to combat antimicrobial resistance.
Prednost bo imelo razvijanje načel in smernic za dobro prakso glede preudarne uporabe antibiotikov v humani medicini v sodelovanju s pristojnimi organi ter dejavnosti, ki spodbujajo vzgojo, in programi ukrepanja, namenjeni zdravstvenim delavcem in bolnišnicam pri obvladovanju odpornosti proti antibiotikom.
150 Prevajalska redakcija
izobraževanje
CELEX: 32004L0027
If the outcome of the inspection as referred to in paragraph 1 is that the manufacturer does not comply with the principles and guidelines of good manufacturing practice as provided for by Community legislation, the information shall be entered in the Community database as referred to in paragraph 6.";
Če rezultat inšpekcijskega pregleda iz odstavka 1 pokaže, da izdelovalec ne izpolnjuje načel in smernic dobre proizvodne prakse iz zakonodaje Skupnosti, se te informacije vnesejo v podatkovno bazo Skupnosti, kot določa odstavek 6.` ;
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principles and guidelines