natgillin/translations-raw huggingface dataset:
To lahko zmanjša ekonomijo obsega in povezanosti, gospodarsko sinergijo in stroškovno učinkovitost, ki bi se lahko dosegla v primeru selitve in centralizacije nekaterih funkcij finančnih institucij.
This may diminish economies of scale and scope, economic synergies and cost efficiencies which could have otherwise been achieved in case of relocation and centralization of some of functions of financial institutions.
V tem pogledu lahko napredno povezovanje finančnih trgov na drobno, ki bi finančnim institucijam omogočilo ponudbo produktov na večjem trgu, spodbudi čezmejno dejavnost bank in finančnih institucij (združitve in prevzemi ali čezmejna oskrba z maloprodajnimi produkti).
In this respect, advanced integration of retail financial markets, which would allow financial institutions to sell their product mix on a greater market, may stimulate cross-border activity of banks and financial institutions (M&A or cross-border provision of retail products).
Dolgotrajne in drage večkratne zahteve za poročanje, postopek odobritve nadzora in vzajemno delovanje med nadzorniki iz domačih držav in držav gostiteljic lahko povečajo stalne stroške finančnih institucij, ker se zaradi njih podvaja nadzor in množijo zahteve za razkritje.
The lengthy and costly multiple reporting requirements, supervisory approval process and the interaction between host an home supervisors can increase fixed costs of financial institutions because they result in duplication of supervision and multiply the disclosure requirements.
Obravnava DDV pri finančnih storitvah velja za pomembno oviro, ki stroškovno učinkovitost preprečuje s selitvami, centralizacijo in povezovanjem nekaterih funkcij.
VAT treatment of financial services is considered as an important obstacle offsetting possible cost efficiencies due to relocation, centralization and integration of certain functions.
Razen tega se medskupinski DDV razume kot pomembna ovira, ki bankam in finančnim institucijam onemogoča učinkovito organiziranje čezmejnega poslovanja, ker večina od njih nima pravice ali ima le omejeno pravico do povračila DDV (drugače rečeno, stroške vsake pridobitve finančnega posla je treba povečati za nepovratni znesek v višini 15–25 %).
Moreover, the inter-group VAT is perceived as important barrier preventing banks and financial institutions to organize themselves efficiently on a cross border basis because most of them have no or only limited right to recover VAT (in other words, a cost of any acquisition of financial business has to be increased by a non recoverable amount of 15-25 %).
· Nenaklonjeno okolje (politična volja, odpor zaposlenih, zaščitni ukrepi).
· Unfavourable environment: (political will, employees´ resistance, protectionist measures)
Prihodnji izzivi
Future challenges
Zelo hitre strukturne spremembe finančnega sistema in naraščajoče število velikih čezmejnih skupin, ki so pripravljene na svetovno konkurenco, poudarja potrebo po spremljanju razvoja na področju tržne strukture in koncentracije.
The tremendous speed of structural change of the financial system and the rising number of major cross-border groups willing to compete globally accentuates the need to monitor developments in terms of market structure and concentration.
V tem pogledu postaneta pomembnejša strogo in dosledno izvajanje pravil politike konkurence in pravočasno izvajanje zakonodaje v zvezi s finančnimi storitvami.
In that respect a strict and consistent application of rules on competition policy together with a timely implementation of financial services legislation becomes more important.
Nujen je tudi razmislek o ustreznem okviru ureditve, nadzora in kriznega upravljanja, ki bi omogočil finančnim skupinam in konglomeratom, ki želijo delovati na vseevropski ravni, da dosežejo gospodarsko sinergijo, ne da bi pri tem ogrozili stabilnost in zanesljivost finančnega sistema.
Reflections about an adequate framework of regulation, supervision and crisis management, which would allow financial groups and conglomerates willing to operate on pan-European level to attain economic synergies without threatening stability and soundness of the financial system, also have gained a sense of urgency.
Vplivi konsolidacije v skladu z načelom skrbnega in varnega poslovanja
Prudential implications of consolidation
Nedavni trendi v zvezi z bonitetnim nadzorom dajejo prednost načelu nadzora v domači državi.
Recent trends concerning prudential supervision advance the home country control principle.
Direktiva o kapitalskih zahtevah uvaja pojem skupnega nadzornika.
The Capital Requirements Directive introduces the concept of consolidating supervisor.
Navaja, da je treba model ocenjevanja naložbenega tveganja hčerinske družbe v državi članici gostiteljici oceniti na podlagi vzajemnega sporazuma med nadzorniki iz domačih držav in držav gostiteljic.
It says that a risk measurement model of a subsidiary located in a host Member State has to be validated on the basis of a mutual agreement between host and home supervisors.
Vendar pa, če vzajemnega sporazuma ni in po preteku obdobja šestih mesecev, to odločitev, ki ima za finančni sistem države gostiteljice občutne presojevalne in sistemske posledice, prevzame nadzornik iz domače države (skupni nadzornik).
However, in the case of absence of a mutual agreement and after a six month period, this decision, which has considerable prudential and systemic implications for the host country financial system, is left to the home supervisor (consolidating supervisor).
Ta ukrep, ki pomembno vpliva na izvajanje bonitetnega nadzora in nadzorne strukture v EU, je treba dopolniti z uravnoteženo in jasno porazdelitvijo odgovornosti nadzornikov iz domačih držav in držav gostiteljic, posebno če se hčerinska družba v državi gostiteljici srečuje s težavami ali je v finančni krizi.
This move, which has important implications on the conduct of prudential supervision and on supervisory structures in the EU, should be complemented with a balanced and clear division of home/host supervisory responsibilities, in particular when a subsidiary in a host country encounters problems or is hit by a financial crisis.
To je zlasti pomembno za mala gospodarstva.
This is of particular importance for small economies.
Pri pospeševanju finančnega povezovanja je enako pomembno razmisliti o glavnih skrbeh javne politike.
While advancing financial integration, it is equally important to reflect on major public policy concerns.
Obravnavati je treba zlasti nevarnost možne sistemske krize, njene vire in vprašanje posojilodajalca zadnjih sredstev.
In particular, a risk of potential systemic crisis, its sources and the issue of the lender of last resort should be considered.
Sedanja raven koncentracije trgov, finančnih udeležencev in infrastruktur v EU ter njihova soodvisnost sta visoki.
The current level of concentration of markets, financial actors and infrastructures in the EU is high, and so is their interdependence.
V tem pogledu na zelo povezanih finančnih trgih nacionalni nadzorni organi, ki delujejo sami, ne morejo več učinkovito rešiti krize, ki bi se lahko razširila na nacionalne pristojnosti, spremenila v vseevropsko finančno krizo in nazadnje ogrozila stabilnost evra in evropskih gospodarstev.
In this respect, in highly integrated financial markets, a crisis which could easily spread over national jurisdictions, turn into a pan-European financial crisis and ultimately hit the stability of the Euro and European economies, can not be efficiently tackled by national supervisory authorities acting on a solo basis anymore.
Sedanja mreža nacionalnih organov v 25 državah članicah je sestavljena iz več nadzornih in izvršilnih organov z različnimi pristojnostmi, odgovornostmi in stopnjami vpletenosti v krizno upravljanje; sedanja ureditev nadzora ter pravno neobvezujoči memorandumi o dogovoru niso ustrezni in zadostni za rešitev vseevropske krize, ki jo povzročijo tržna nepopolnost ali sistemsko pomembni čezmejni finančni konglomerati.
The current networks of national authorities of the 25 Member States comprise various supervisory and regulatory bodies with differing powers, responsibilities and level of involvement in crisis management, and the present supervisory arrangements and non-legally binding memoranda of understanding, are not adequate and sufficient to tackle a pan- European crisis caused by a failure of markets or systemically important cross-border financial conglomerates.
V zvezi s tem morajo evropski zakonodajalci izvesti podrobne razprave o ustrezni strukturi nadzora finančnih trgov EU, jasni določitvi pristojnosti in odgovornosti med nadzorniki iz domačih držav in držav gostiteljic ter ustreznih postopkih za krizno upravljanje in ne bi smeli čakati na veliko vseevropsko krizo.
In this respect, European legislators should launch in-depth discussions on the appropriate structure of supervision of EU financial markets, clarification of powers and responsibilities between home and host supervisors and adequate crisis management procedures, and not wait for a major pan-European crisis.
Za nadaljnjo konsolidacijo na področju industrije finančnih storitev
Towards further consolidation in the European financial services industry
o skupnem stališču Sveta z namenom sprejetja Uredbe Evropskega parlamenta in Sveta o zdravilih za pediatrično uporabo in spremembah Uredbe (EGS) št. 1768/92, Direktive 2001/20/ES, Direktive 2001/83/ES in Uredbe (ES) št. 726/2004
on the Council common position for adopting a regulation of the European Parliament and of the Council on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004
– ob upoštevanju skupnega stališča Sveta (15763/3/2005 – C6‑0087/2006 ),
– having regard to the Council common position (15763/3/2005 – C6‑0087/2006 ),
Sprejeta besedila, 7.9.2005, P6_TA(2005)0331 . o predlogu Komisije Parlamentu in Svetu ( KOM(2004)0599 )
Texts adopted , 7.9.2005, P6_TA(2005)0331 on the Commission proposal to Parliament and the Council ( COM(2004)0599 )
– ob upoštevanju spremenjenega predloga Komisije ( KOM(2005)0577 )
– having regard to the amended Commission proposal ( COM(2005)0577 )
– ob upoštevanju priporočila za drugo obravnavo Odbora za okolje, javno zdravje in varnost hrane ( A6‑0171/2006 )
– having regard to the recommendation for second reading of the Committee on the Environment, Public Health and Food Safety ( A6‑0171/2006 ),
(5) Ob upoštevanju dejstva, da morajo vsi predpisi o zdravilih temeljiti na varstvu javnega zdravja, mora biti ta cilj dosežen s sredstvi, ki ne ovirajo prostega pretoka zdravil znotraj Skupnosti.
(5) While taking into account the fact that the regulation of medicinal products must be fundamentally aimed at safeguarding public health, this aim must be achieved by means that do not impede the free movement of safe medicinal products within the Community.
Vsak ukrep za podporo razvoju in odobritvam zdravil za pediatrično uporabo je torej utemeljen z namenom preprečevanja in nastajanja teh ovir.
Any action to promote the development and authorisation of medicinal products for paediatric use is therefore justified with a view to preventing or eliminating these obstacles.
Člen 95 je podlaga te uredbe, zato ga je potrebno navesti.
Article 95 constitutes the basis for this Regulation and should therefore be specified.
(8) V okviru Evropske agencije za zdravila (v nadaljnjem besedilu "Agencija") je primerno ustanoviti znanstveni odbor, Odbor za pediatrijo, s strokovnim znanjem in pristojnostjo glede razvoja in presoje vseh vidikov zdravil za zdravljenje pediatrične populacije.
(8) It is appropriate to create a scientific committee, the Paediatric Committee, within the European Medicines Agency, hereinafter ‘the Agency’, with expertise and competence in the development and assessment of all aspects of medicinal products to treat paediatric populations.
Zaradi tega naj bi bil Odbor za pediatrijo neodvisen od farmacevtske industrije.
To this end, the Paediatric Committee should be independent from the pharmaceutical industry.
Odbor za pediatrijo mora biti v prvi vrsti odgovoren za znanstveno presojo in izdajo soglasij z načrti pediatričnih raziskav ter za sistem opustitev in odlogov, poleg tega pa bi moral imeti odločujoč vpliv pri različnih podpornih ukrepih iz te uredbe.
The Paediatric Committee should be primarily responsible for the scientific assessment and agreement of paediatric investigation plans and for the system of waivers and deferrals thereof; it should also be central to various support measures contained in this Regulation.
Odbor za pediatrijo mora pri svojem delu upoštevati morebitne pomembne terapevtske koristi študij za pediatrične bolnike, vključene v študije, ali za širšo pediatrično populacijo, vključno s potrebo po izogibanju nepotrebnim študijam.
In its work, the Paediatric Committee should consider the potential significant therapeutic benefits for the paediatric patients involved in the studies or the paediatric population at large including the need to avoid unnecessary studies.
Odbor za pediatrijo naj upošteva obstoječe zahteve Skupnosti, vključno z Direktivo 2001/20/ES in smernico E11 Mednarodne konference o harmonizaciji (ICH), glede razvoja zdravil za pediatrično populacijo, in se izogiba zamudam pri odobritvah zdravil za druge populacije, ki nastanejo kot posledica zahtev za študije na pediatrični populaciji.
The Paediatric Committee should follow existing Community requirements, including Directive 2001/20/EC, as well as International Conference on Harmonisation (ICH) guideline E11 on the development of medicinal products for the paediatric population, and it should avoid any delay in the authorisation of medicinal products for other populations deriving from the requirements for studies in the paediatric population.
(8) V okviru Evropske agencije za zdravila (v nadaljnjem besedilu "Agencija") se ustanovi znanstveni odbor, Odbor za pediatrijo, s strokovnim znanjem in pristojnostjo glede razvoja in presoje vseh vidikov zdravil za zdravljenje pediatrične populacije.
(8) It is appropriate to create a scientific committee, the Paediatric Committee, within the European Medicines Agency, hereinafter ‘the Agency’, with expertise and competence in the development and assessment of all aspects of medicinal products to treat paediatric populations.
Za Odbor za pediatrijo veljajo določbe, ki veljajo za znanstveni odbor Agencije, kot so navedene v Uredbi (ES) št. 726/2004.
The rules on scientific committees of the Agency, as laid down in Regulation (EC) No 726/2004, should apply to the Paediatric Committee.
Člani Odbora za pediatrijo zato ne morejo imeti finančnih ali drugih interesov v farmacevtski industriji, ki bi vplivali na njihovo nepristranskost, pa naj delujejo v javnem interesu ali neodvisno, ter morajo podati letno izjavo o svojih finančnih interesih.
Members of the Paediatric Committee should therefore not have financial or other interests in the pharmaceutical industry which could affect their impartiality, should undertake to act in the public interest and in an independent manner, and should make an annual declaration of their financial interests.
V okviru 'boljše pravne ureditve' se je treba sklicevati na že sprejeta načela v drugih zakonodajah, ki morajo veljati za obstoječo uredbo, zlasti glede neodvisnosti članov odbora.
Within the ‘better regulation’ context, reference should be made to principles already adopted in other legislation which must apply under this Regulation, notably as regards the independence of members of the committee.
(10) Namen uvedbe načrta pediatričnih raziskav v pravni okvir, ki zadeva zdravila za uporabo v humani medicini, je zagotoviti, da postane razvoj zdravil, ki se bodo potencialno uporabljala za pediatrično populacijo, sestavni del razvoja zdravil, vključen v razvojni program za odrasle.
(10) The introduction of the paediatric investigation plan in the legal framework concerning medicinal products for human use aims at ensuring that the development of medicinal products that are potentially to be used for the paediatric population becomes an integral part of the development of medicinal products, integrated into the development programme for adults.
Načrte pediatričnih raziskav je zato treba predložiti v začetni fazi razvoja izdelka, torej dovolj zgodaj, da se študije na pediatrični populaciji lahko izvedejo, preden se vložijo vloge za dovoljenje za promet.
Thus, paediatric investigation plans should be submitted early during product development, in time for studies to be conducted in the paediatric population before marketing authorisation applications are submitted.
Primerno je določiti rok za predložitev načrtov pediatričnih raziskav, da se zagotovi pravočasen dialog med sponzorjem in Odborom za pediatrijo.
It is appropriate to set a deadline for the submission of a paediatric investigation plan in order to ensure early dialogue between the sponsor and the Paediatric Committee.
Ker je razvoj zdravil dinamičen proces, ki je odvisen od rezultata potekajočih študij, je treba predvideti način sprememb dogovorjenega načrta, kjer je to potrebno.
As the development of medicinal products is a dynamic process dependent on the result of ongoing studies, provision should be made for modifying an agreed plan where necessary.
Načrte pediatričnih raziskav je zato treba predložiti v začetni fazi razvoja izdelka, torej dovolj zgodaj, da se študije na pediatrični populaciji lahko izvedejo, če je potrebno, preden se vložijo vloge za dovoljenje za promet.
Thus, paediatric investigation plans should be submitted early during product development, in time for studies to be conducted in the paediatric population , where appropriate, before marketing authorisation applications are submitted.
Določi se rok za predložitev načrtov pediatričnih raziskav, da se zagotovi pravočasen dialog med sponzorjem in Odborom za pediatrijo.
It is appropriate to set a deadline for the submission of a paediatric investigation plan in order to ensure early dialogue between the sponsor and the Paediatric Committee.
Poleg tega bo zgodnja predložitev načrta pediatričnih preiskav, skupaj s predložitvijo spodaj opisane zahteve za odlog, pripomogla k temu, da se odloži odobritev za druge populacije.
Furthermore, early submission of a paediatric investigation plan, combined with the submission of a deferral request as described below, will avoid delaying the authorisation for other populations .
Namen predloga spremembe je, da se ne odlaga z odobritvijo dovoljenja za promet za zdravilo za odrasle, ob upoštevanju pomena posebnih pediatričnih raziskav, ki jih bo vlagatelj moral opraviti.
The purpose of the amendment is to ensure that marketing authorisations for medicinal products for adults are not delayed while at the same time taking due account of the importance of the specific paediatric studies which applicants will be obliged to conduct.
(24) Pomembno je zagotoviti, da so mehanizmi farmakovigilance primerni za obravnavanje posebnih primerov pri zbiranju podatkov o varnosti pri pediatrični populaciji, vključno s podatki o možnih dolgoročnih učinkih.
(24) It is essential to ensure that pharmacovigilance mechanisms are adapted to meet the specific challenges of collecting safety data in the paediatric population, including data on possible long-term effects.
Za ugotavljanje učinkovitosti pri pediatrični populaciji so lahko po pridobitvi dovoljenja potrebne dodatne študije.
Efficacy in the paediatric population may also need additional study following authorisation.
Zato je treba v zvezi z vlogami za dovoljenje za promet, ki vključujejo rezultate študij, izvedenih v skladu z dogovorjenim načrtom pediatričnih raziskav, vpeljati dodatno zahtevo, in sicer, da mora vlagatelj prikazati, kako namerava zagotoviti dolgoročno spremljanje možnih neželenih učinkov uporabe zdravila in učinkovitosti pri pediatrični populaciji.
Therefore, an additional requirement for applying for a marketing authorisation that includes the results of studies conducted in compliance with an agreed paediatric investigation plan should be an obligation for the applicant to indicate how he proposes to ensure the long-term follow-up of possible adverse reactions to the use of the medicinal product and efficacy in the paediatric population.
Dodatno je treba , kadar obstojijo posebni razlogi za skrb, predvideti tudi možnost , da se od vlagatelja zahteva, da predloži in izvaja sistem obvladovanja tveganja in/ali da izvede posebne študije po začetku trženja kot pogoj za pridobitev dovoljenja za promet.
Additionally, where there is a particular cause for concern, provision should be made for the possibility of requiring the applicant to submit and implement a risk management system and/or perform specific post-marketing studies as a condition for the granting of the marketing authorisation.
Dodatno je treba, kadar obstojijo posebni razlogi za skrb, predvideti tudi možnost, da se od vlagatelja zahteva, da predloži in izvaja sistem obvladovanja tveganja in/ali da izvede posebne študije po začetku trženja kot pogoj za pridobitev dovoljenja za promet.
Additionally, where there is a particular cause for concern, the applicant should submit and implement a risk management system and/or perform specific post-marketing studies as a condition for the granting of the marketing authorisation.
Če so posebni razlogi za skrb, se mora od vlagatelja zahtevati, da predloži ustrezen načrt obvladovanja tveganja.
Where there are particular concerns, applicants must be required to submit an appropriate risk management plan.
UVODNA IZJAVA 26
RECITAL 26
(26) Za zdravila, za katera se zahteva predložitev pediatričnih podatkov, je pod pogojem, da so izpolnjeni vsi ukrepi, vključeni v dogovorjen načrt pediatričnih raziskav in da je zdravilo odobreno v vseh državah članicah, ter da so ustrezni podatki o rezultatih študij vključeni v podatke o zdravilu, treba odobriti nagrado v obliki 6 mesečnega podaljšanja veljavnosti dodatnega varstvenega certifikata, uvedenega z Uredbo Sveta (EGS) št. 1768/92.
(26) For products falling within the scope of the requirement to submit paediatric data, if all the measures included in the agreed paediatric investigation plan are complied with, if the product is authorised in all Member States and if relevant information on the results of studies is included in product information, a reward should be granted in the form of a 6‑month extension of the supplementary protection certificate created by Council Regulation (EEC) No 1768/92.
(26) Za zdravila, za katera se zahteva predložitev pediatričnih podatkov, je pod pogojem, da so izpolnjeni vsi ukrepi, vključeni v dogovorjen načrt pediatričnih raziskav in da je zdravilo dobilo dovoljenje za promet v vseh državah članicah, ter da so ustrezni podatki o rezultatih študij vključeni v podatke o zdravilu, treba odobriti nagrado v obliki 6 mesečnega podaljšanja veljavnosti dodatnega varstvenega certifikata, uvedenega z Uredbo Sveta (EGS) št. 1768/92.
(26) For products falling within the scope of the requirement to submit paediatric data, if all the measures included in the agreed paediatric investigation plan are complied with, if the product has received a marketing authorisation in all Member States and if relevant information on the results of studies is included in product information, a reward should be granted in the form of a 6-month extension of the Supplementary Protection Certificate created by Council Regulation (EEC) No 1768/92.
Sklepi organov držav članic na področju določanja cen zdravil ali glede njihove vključitve v nacionalno zdravstveno zavarovanje v nobenem primeru ne smejo vplivati na odobritev takšne nagrade.
Any decisions by Member States’ authorities concerning the setting of prices for medicinal products or their inclusion in the scope of national health insurance schemes should have no bearing on the granting of this reward.
Na območju Unije je treba spodbujati prisotnost pediatričnih zdravil.
It is important to encourage the availability of medicinal products for paediatric use throughout the territory of the EU.
Poleg tega predlagatelji ne morejo biti oškodovani zaradi administrativnih odlogov, ki bi jih zahtevali nekateri nacionalni organi.
Moreover, applicants must not be penalised by administrative delays on the part of certain national authorities.