natgillin/translations-raw huggingface dataset:
The inspectors, appointed by the Member States pursuant to Article 15(1) of Directive 2001/20/EC, shall be made aware of and maintain confidentiality whenever they gain access to confidential information as a result of good clinical practice inspections in accordance with applicable Community requirements, national laws or international agreements.
Inšpektorji, ki jih imenujejo države članice na podlagi člena 15(1) Direktive 2001/20/ES, se zavedajo in ohranjajo zaupnost pri vsakem dostopu do zaupnih informacij zaradi inšpekcijskih pregledov dobre klinične prakse v skladu z veljavnimi zahtevami Skupnosti, nacionalno zakonodajo ali mednarodnimi sporazumi.
Member States shall ensure that inspectors have completed education at university level, or have equivalent experience, in medicine, pharmacy, pharmacology, toxicology or other relevant fields.
Države članice zagotovijo, da so inšpektorji univerzitetno izobraženi ali imajo enakovredne izkušnje na področju medicine, farmacije, farmakologije, toksikologije ali na drugih ustreznih področjih.
Member States shall ensure that inspectors receive appropriate training, that their training needs are assessed regularly and that appropriate action is taken to maintain and improve their skills.
Države članice zagotovijo, da inšpektorji pridobijo ustrezno usposobljenost, da se njihove potrebe po usposabljanju redno ocenjujejo in da se sprejmejo ustrezni ukrepi za ohranjanje in izboljševanje njihovih strokovnih znanj.
Member States shall also ensure that the inspectors have knowledge of the principles and processes that apply to the development of medicinal products and clinical research.
Države članice zagotovijo tudi, da imajo inšpektorji znanje o načelih in postopkih, ki se uporabljajo za razvijanje zdravil in klinično raziskovanje.
Inspectors shall also have knowledge of applicable Community and national legislation and guidelines applicable to the conduct of clinical trials and the granting of marketing authorisations.
Inšpektorji imajo tudi znanje o veljavni zakonodaji Skupnosti in nacionalni zakonodaji in o smernicah, ki se uporabljajo za izvajanje kliničnih preskušanj in odobritev dovoljenj za promet.
The inspectors shall be familiar with the procedures and systems for recording clinical data, and with the organisation and regulation of the healthcare system in the relevant Member States and, where appropriate, in third countries.
Inšpektorji so seznanjeni s postopki in sistemi za evidentiranje kliničnih podatkov in z organizacijo in ureditvijo sistema zdravstvenega varstva v zadevnih državah članicah ter, kjer je to primerno, v tretjih državah.
Member States shall maintain up-to-date records of the qualifications, training and experience of each inspector.
Države članice vzdržujejo posodobljene evidence o kvalifikacijah, usposabljanju in izkušnjah za vsakega inšpektorja.
Each inspector shall be provided with a document setting out standard operating procedures and giving details of the duties, responsibilities and ongoing training requirements.
Vsak inšpektor dobi dokument, ki določa standardne operativne postopke in natančno opisuje naloge, odgovornosti in stalne zahteve po usposabljanju.
Those procedures shall be maintained up to date.
Ti postopki se redno posodabljajo.
Inspectors shall be provided with suitable means of identification.
Inšpektorjem se zagotovi ustrezna sredstva za identifikacijo.
Each inspector shall sign a statement declaring any financial or other links to the parties to be inspected.
Vsak inšpektor podpiše izjavo o kakršnih koli finančnih ali drugih povezavah s strankami, ki se jih inšpekcijsko nadzira.
That statement shall be taken into consideration when inspectors are to be assigned to a specific inspection.
Ta izjava se nato upošteva pri imenovanju inšpektorjev za določen inšpekcijski pregled.
In order to ensure the presence of skills necessary for specific inspections, Member State may appoint teams of inspectors and experts with appropriate qualifications and experience to fulfil collectively the requirements necessary for conducting the inspection.
Da bi zagotovili prisotnost strokovnega znanja, potrebnega za določen inšpekcijski pregled, lahko država članica imenuje skupine inšpektorjev in strokovnjakov z ustreznimi kvalifikacijami in izkušnjami, ki kolektivno izpolnjujejo zahteve, potrebne za izvajanje inšpekcijskega pregleda.
INSPECTION PROCEDURES
INŠPEKCIJSKI NADZOR
Good clinical practice inspections may take place on any of the following occasions:
Inšpekcijski pregledi dobre klinične prakse se lahko opravijo ob kateri koli od navedenih priložnosti:
before, during or after the conduct of clinical trials;
pred, med ali po izvajanju kliničnih preskušanj;
as part of the verification of applications for marketing authorisation;
kot del preverjanja vlog za pridobitev dovoljenj za promet;
as a follow-up to the granting of authorisation.
kot nadaljevanje oz. spremljanje odobritve dovoljenja za promet.
In accordance with Article 15(1) and (2) of Directive 2001/20/EC, inspections may be requested and coordinated by the European Medicines Agency within the scope of Regulation (EC) No 726/2004 of the European Parliament and of the Council [4], especially in connection with clinical trials relating to applications through the procedure established by this Regulation.
V skladu s členom 15(1) in (2) Direktive 2001/20/ES lahko inšpekcijske preglede na področju uporabe Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta [4] zahteva in usklajuje Agencija za zdravila, zlasti v povezavi s kliničnimi preskušanji v zvezi z vlogami po postopku, ki ga določa navedena uredba.
Inspections shall be conducted in accordance with the inspection guidance documents developed to support the mutual recognition of inspection findings within the Community.
Pregledi se izvajajo v skladu z navodili za inšpekcijske preglede, ki so bila razvita kot podpora vzajemnemu priznavanju ugotovitev inšpekcijskih pregledov v Skupnosti.
Improvement and harmonisation of inspection guidance shall be achieved by the Member States, in collaboration with the Commission and the Agency, through joint inspections, agreed processes and procedures and sharing of experience and training.
Izboljšanje in uskladitev navodil za inšpekcijske preglede dosežejo države članice, v sodelovanju s Komisijo in Agencijo, s skupnimi inšpekcijskimi pregledi, dogovorjenimi procesi in postopki, z izmenjavo izkušenj ter z usposabljanjem.
Member States shall make publicly available within their territories the documents relating to the adoption of good clinical practice principles.
Države članice dajo na svojih ozemljih na razpolago javnosti dokumente o sprejemu načel dobre klinične prakse.
They shall establish the legal and administrative framework within which their good clinical practice inspections operate, with definition of the powers of inspectors for entry into clinical trial sites and access to data.
Oblikujejo tudi pravni in upravni okvir, v katerem se izvajajo inšpekcijski pregledi dobre klinične prakse, z opredelitvami pooblastil inšpektorjev za vstop na kraje, ker potekajo klinična preskušanja, in za dostop do podatkov.
In so doing they shall ensure that, on request and where appropriate, inspectors of the competent authority of the other Member States also have access to the clinical trial sites and data.
S tem zagotovijo, da imajo tudi inšpektorji pristojnega organa drugih držav članic dostop, na zahtevo in kadar je potrebno, do podatkov in krajev, kjer potekajo klinična preskušanja.
Member States shall provide for sufficient resources and shall in particular appoint an adequate number of inspectors to ensure effective verification of compliance with good clinical practice.
Države članice zagotovijo dovolj sredstev in zlasti imenujejo zadostno število inšpektorjev za zagotovitev učinkovitega preverjanja skladnosti z dobro klinično prakso.
Member States shall establish the relevant procedures for verification of good clinical practice compliance.
Države članice določijo ustrezne postopke za preverjanje skladnosti z dobro klinično prakso.
The procedures shall include the modalities for examining both the study management procedures and the conditions under which clinical trials are planned, performed, monitored and recorded, as well as follow-up measures.
Ti postopki vključujejo pogoje in načine za pregledovanje tako postopkov za upravljanje študije in pogojev, pod katerimi se načrtujejo, izvajajo, spremljajo in evidentirajo klinična preskušanja, kot tudi nadaljnjih ukrepov.
Member States shall establish the relevant procedures for the following:
Države članice določijo ustrezne postopke za:
appointing experts for accompanying inspectors in case of need;
imenovanje strokovnjakov za spremljanje inšpektorjev, ko je to potrebno;
requesting inspections/assistance from other Member States, in line with Article 15(1) of Directive 2001/20/EC and for cooperating in inspections in another Member State;
zahtevo za inšpekcijske preglede/pomoč drugih držav članic v skladu s členom 15(1) Direktive 2001/20/ES ter za sodelovanje pri inšpekcijskih pregledih v drugi državi članici;
arranging inspections in third countries.
pripravo inšpekcijskih pregledov v tretjih državah.
Member States shall maintain records of national and, if applicable, international inspections including the good clinical practice compliance status, and of their follow-up.
Države članice vzdržujejo evidenco nacionalnih in, če je ustrezno, mednarodnih inšpekcijskih pregledov, vključno s stanjem usklajenosti z dobro klinično prakso, ter njihovem nadaljevanju.
In order to harmonise the conduct of inspections by the competent authorities of the different Member States, guidance documents containing the common provisions on the conduct of those inspections shall be published by the Commission after consultation with the Member States.
Da bi uskladili izvajanje inšpekcijskih pregledov pristojnih organov različnih držav članic, Komisija po posvetovanju z državami članicami objavi navodila, ki vsebujejo skupne določbe o izvajanju navedenih pregledov.
Member States shall ensure that national inspection procedures are in compliance with the guidance documents referred in paragraph 1.
Države članice zagotovijo, da je nacionalni inšpekcijski nadzor v skladu z navodili iz odstavka 1.
The guidance documents referred to in paragraph 1 may be updated regularly according to scientific and technical development.
Navodila iz odstavka 1 se lahko redno posodabljajo v skladu z znanstvenim in tehničnim razvojem.
Member States shall lay down all necessary rules to ensure that confidentiality is respected by inspectors and other experts.
Države članice določijo vsa potrebna pravila za zagotovitev spoštovanja zaupnosti s strani inšpektorjev in drugih strokovnjakov.
With regard to personal data, the requirements of Directive 95/46/EC of the European Parliament and of the Council [5] shall be respected.
Glede osebnih podatkov se upoštevajo zahteve Direktive 95/46/ES Evropskega parlamenta in Sveta [5].
Inspection reports shall be made available by the Member States only to the recipients referred to in Article 15(2) of Directive 2001/20/EC, in accordance with national regulations of the Member States and subject to any arrangements concluded between the Community and third countries.
Poročila o pregledih dajo države članice na voljo samo prejemnikom iz člena 15(2) Direktive 2001/20/ES v skladu z nacionalnimi predpisi držav članic in ob upoštevanju dogovorov, sklenjenih med Skupnostjo in tretjimi državami.
Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 29 January 2006 at the latest.
Države članice sprejmejo zakone in druge predpise, potrebne za uskladitev s to direktivo, najpozneje do 29. januarja 2006.
They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive.
Komisiji nemudoma predložijo besedilo navedenih določb in primerjalno tabelo med temi določbami in to direktivo.
Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.
Države članice sporočijo Komisiji besedilo temeljnih določb nacionalnega prava, ki jih sprejmejo na področju, ki ga ureja da direktiva.
Done at Brussels, 8 April 2005.
V Bruslju, 8. aprila 2005
OJ L 121, 1.5.2001, p. 34.
UL L 121, 1.5.2001, str. 34.
OJ L 262, 14.10.2003, p. 22.
UL L 262, 14.10.2003, str. 22.
OJ L 311, 28.11.2003, p. 67.
UL L 311, 28.11.2003, str. 67.
Directive 2005/29/EC of the European Parliament and of the Council
Direktiva Evropskega parlamenta in Sveta 2005/29/ES
concerning unfair business-to-consumer commercial practices in the internal market and amending Council Directive 84/450/EEC, Directives 97/7/EC, 98/27/EC and 2002/65/EC of the European Parliament and of the Council and Regulation (EC) No 2006/2004 of the European Parliament and of the Council
o nepoštenih poslovnih praksah podjetij v razmerju do potrošnikov na notranjem trgu ter o spremembi Direktive Sveta 84/450/EGS, direktiv Evropskega parlamenta in Sveta 97/7/ES, 98/27/ES in 2002/65/ES ter Uredbe (ES) št. 2006/2004 Evropskega parlamenta in Sveta
(‘Unfair Commercial Practices Directive’)
(Direktiva o nepoštenih poslovnih praksah)
Article 153(1) and (3)(a) of the Treaty provides that the Community is to contribute to the attainment of a high level of consumer protection by the measures it adopts pursuant to Article 95 thereof.
Člen 153(1) in (3)(a) Pogodbe predvideva, da mora Skupnost z ukrepi, ki jih sprejme v skladu s členom 95 Pogodbe, prispevati k doseganju visoke ravni varstva potrošnikov.
In accordance with Article 14(2) of the Treaty, the internal market comprises an area without internal frontiers in which the free movement of goods and services and freedom of establishment are ensured.
V skladu s členom 14(2) Pogodbe zajema notranji trg območje brez notranjih meja, na katerem so zagotovljeni prosti pretok blaga, storitev in pravica do ustanavljanja.
The development of fair commercial practices within the area without internal frontiers is vital for the promotion of the development of cross-border activities.
Razvoj poštenih poslovnih praks na območju brez notranjih meja je bistvenega pomena za spodbujanje razvoja čezmejnih dejavnosti.
The laws of the Member States relating to unfair commercial practices show marked differences which can generate appreciable distortions of competition and obstacles to the smooth functioning of the internal market.
Zakoni držav članic, ki se nanašajo na nepoštene poslovne prakse, kažejo izrazite razlike, ki lahko povzročajo znatno izkrivljanje konkurence in nastanek ovir za nemoteno delovanje notranjega trga.
In the field of advertising, Council Directive 84/450/EEC of 10 September 1984 concerning misleading and comparative advertising [3] establishes minimum criteria for harmonising legislation on misleading advertising, but does not prevent the Member States from retaining or adopting measures which provide more extensive protection for consumers.
Na področju oglaševanja določa Direktiva Sveta 84/450/EGS z dne 10. septembra 1984 o zavajajočem in primerjalnem oglaševanju [3] minimalna merila za usklajevanje zakonodaje o zavajajočem oglaševanju, hkrati pa državam članicam ne preprečuje, da ohranijo ali sprejmejo ukrepe, ki zagotavljajo višjo raven varstva potrošnikov.
As a result, Member States' provisions on misleading advertising diverge significantly.
Predpisi držav članic o zavajajočem oglaševanju se zato znatno razlikujejo.
These disparities cause uncertainty as to which national rules apply to unfair commercial practices harming consumers' economic interests and create many barriers affecting business and consumers.
Ta neskladja povzročajo negotovost o tem, katera nacionalna pravila se uporabljajo za nepoštene poslovne prakse, ki škodijo ekonomskim interesom potrošnikov in ki ustvarjajo številne ovire ter vplivajo na podjetja in potrošnike.
These barriers increase the cost to business of exercising internal market freedoms, in particular when businesses wish to engage in cross border marketing, advertising campaigns and sales promotions.
Zaradi teh ovir imajo podjetja višje stroške pri uresničevanju svoboščin notranjega trga, zlasti če se želijo lotiti čezmejnega trženja in oglaševalskih akcij ter pospeševanja prodaje.
Such barriers also make consumers uncertain of their rights and undermine their confidence in the internal market.
Take ovire pri potrošnikih vzbujajo tudi negotovost glede njihovih pravic in zmanjšujejo njihovo zaupanje v notranji trg.
In the absence of uniform rules at Community level, obstacles to the free movement of services and goods across borders or the freedom of establishment could be justified in the light of the case-law of the Court of Justice of the European Communities as long as they seek to protect recognised public interest objectives and are proportionate to those objectives.
Ob pomanjkanju enotnih pravil na ravni Skupnosti je ovire za čezmejni prosti pretok storitev in blaga ali za pravico do ustanavljanja mogoče upravičiti na podlagi sodne prakse Sodišča Evropskih skupnosti, kolikor skušajo te ovire zaščititi priznane cilje javnega interesa in so sorazmerne s temi cilji.
In view of the Community's objectives, as set out in the provisions of the Treaty and in secondary Community law relating to freedom of movement, and in accordance with the Commission's policy on commercial communications as indicated in the Communication from the Commission entitled ‘The follow-up to the Green Paper on Commercial Communications in the Internal Market’, such obstacles should be eliminated.
Ob upoštevanju ciljev Skupnosti, kakor so podani v določbah Pogodbe in sekundarni zakonodaji Skupnosti glede prostega pretoka, ter v skladu s politiko Komisije o tržnih komunikacijah, kakor je opredeljena v Sporočilu Komisije „Spremljanje izvajanja Zelene knjige o tržnih komunikacijah na notranjem trgu“, je take ovire treba odpraviti.
These obstacles can only be eliminated by establishing uniform rules at Community level which establish a high level of consumer protection and by clarifying certain legal concepts at Community level to the extent necessary for the proper functioning of the internal market and to meet the requirement of legal certainty.
Te ovire je mogoče odpraviti samo z določitvijo enotnih pravil na ravni Skupnosti, ki bodo zagotavljala visoko raven varstva potrošnikov, in s pojasnitvijo nekaterih pravnih pojmov na ravni Skupnosti, kolikor je to potrebno za pravilno delovanje notranjega trga in za izpolnjevanje zahteve po pravni varnosti.
This Directive therefore approximates the laws of the Member States on unfair commercial practices, including unfair advertising, which directly harm consumers' economic interests and thereby indirectly harm the economic interests of legitimate competitors.
Ta direktiva torej približuje zakonodaje držav članic o nepoštenih poslovnih praksah, vključno z nepoštenim oglaševanjem, ki neposredno škodujejo ekonomskim interesom potrošnikov in na ta način posredno ekonomskim interesom zakonitih konkurentov.
In line with the principle of proportionality, this Directive protects consumers from the consequences of such unfair commercial practices where they are material but recognises that in some cases the impact on consumers may be negligible.
V skladu z načelom sorazmernosti ta direktiva varuje potrošnike pred učinki takšnih nepoštenih poslovnih praks, če so bistveni, vendar upošteva, da je lahko v nekaterih primerih vpliv na potrošnike zanemarljiv.
It neither covers nor affects the national laws on unfair commercial practices which harm only competitors' economic interests or which relate to a transaction between traders; taking full account of the principle of subsidiarity, Member States will continue to be able to regulate such practices, in conformity with Community law, if they choose to do so.
Ne zajema niti ne vpliva na posamezne nacionalne zakonodaje o nepoštenih poslovnih praksah, ki škodujejo samo ekonomskim interesom konkurentov ali zadevajo poslovanje med trgovci; države članice bodo lahko, če bodo tako želele, še naprej v skladu z zakonodajo Skupnosti urejale takšne prakse, pri čemer bodo v celoti upoštevale načelo sorazmernosti.
Nor does this Directive cover or affect the provisions of Directive 84/450/EEC on advertising which misleads business but which is not misleading for consumers and on comparative advertising.
Ta direktiva ne zajema niti ne vpliva na določbe Direktive 84/450/EGS o oglaševanju, ki je zavajajoče za podjetja, vendar ni zavajajoče za potrošnike, ter o primerjalnem oglaševanju.
Further, this Directive does not affect accepted advertising and marketing practices, such as legitimate product placement, brand differentiation or the offering of incentives which may legitimately affect consumers' perceptions of products and influence their behaviour without impairing the consumer's ability to make an informed decision.
Nadalje ta direktiva ne vpliva na sprejete oglaševalske in tržne prakse, na primer zakonito plasiranje izdelkov, razlikovanje med znamkami izdelkov ali ponujanje spodbud, ki lahko na zakonit način vplivajo na potrošnikovo dojemanje izdelkov in njegovo ravnanje, ne da bi s tem zmanjševale njegovo sposobnost sprejemanja odločitev ob poznavanju vseh pomembnih dejstev.
This Directive addresses commercial practices directly related to influencing consumers' transactional decisions in relation to products.
Ta direktiva obravnava poslovne prakse, ki so neposredno povezane z vplivanjem na odločitve potrošnikov o poslu v zvezi z izdelki.
It does not address commercial practices carried out primarily for other purposes, including for example commercial communication aimed at investors, such as annual reports and corporate promotional literature.
Ne nanaša se na poslovne prakse, ki služijo predvsem drugim namenom, vključno na primer na tržne komunikacije, namenjene vlagateljem, kakršna so letna poročila in promocijski prospekti podjetij.
It does not address legal requirements related to taste and decency which vary widely among the Member States.
Ne nanaša se na pravne zahteve glede dobrega okusa in spodobnosti, ki so zelo različne v posameznih državah članicah.
Commercial practices such as, for example, commercial solicitation in the streets, may be undesirable in Member States for cultural reasons.
Poslovne prakse, kot na primer pridobivanje strank z nagovarjanjem mimoidočih, so lahko v posameznih državah članicah iz kulturnih razlogov nezaželene.
Member States should accordingly be able to continue to ban commercial practices in their territory, in conformity with Community law, for reasons of taste and decency even where such practices do not limit consumers' freedom of choice.
Države članice morajo tako še naprej imeti možnost, da v skladu z zakonodajo Skupnosti na svojem ozemlju prepovedujejo poslovne prakse zaradi nasprotovanja dobremu okusu in spodobnosti, tudi če takšne prakse ne omejujejo potrošnikove svobode izbire.
Full account should be taken of the context of the individual case concerned in applying this Directive, in particular the general clauses thereof.
Pri uporabi te direktive, zlasti splošnih klavzul te direktive, je treba v celoti upoštevati okoliščine zadevnega posameznega primera.
This Directive directly protects consumer economic interests from unfair business-to-consumer commercial practices.
Ta direktiva neposredno ščiti ekonomske interese potrošnikov pred nepoštenimi poslovnimi praksami podjetij v razmerju do potrošnikov.
Thereby, it also indirectly protects legitimate businesses from their competitors who do not play by the rules in this Directive and thus guarantees fair competition in fields coordinated by it.
Na ta način posredno ščiti tudi podjetja, ki poslujejo zakonito, pred njihovimi konkurenti, ki ne upoštevajo pravil te direktive, in tako na področjih, ki jih ureja ta direktiva, zagotavlja pošteno konkurenco.
It is understood that there are other commercial practices which, although not harming consumers, may hurt competitors and business customers.
Razume se, da obstajajo druge poslovne prakse, ki lahko škodijo konkurentom in strankam podjetij, čeprav ne škodijo potrošnikom.