natgillin/translations-raw huggingface dataset:
priznava, da je oblikovanje trdnega družbeno-gospodarskega okolja za mala in srednja podjetja mogoče le, če politika v zvezi z njimi vključuje ukrepe na področju izobraževanja in usposabljanja človeških virov, oskrbe s komunikacijsko in informacijsko infrastrukturo ter preprostega dostopa do primarnih surovih ter lokalnih in regionalnih trgov;
Recognises that creating a sound socio-economic environment for SMEs is only possible if policies for them include actions in the fields of human resources education and training, of communication and information infrastructure provision, and of easy access to raw materials and to local and regional markets;
poziva k sklepanju partnerstev malih in srednjih podjetij za izmenjavo posodobljenih informacij in znanja;
Calls for the building of SME partnerships for the exchange of up-to-date information and knowledge;
priznava vlogo, ki jo lahko imajo mala in srednja podjetja pri razvoju večine sektorskih politik;
Recognises the role SMEs can play in the development of most sectoral policies;
poziva k izvajanju trdnih finančnih sistemov, ki spodbujajo mala in srednja podjetja;
Calls for the implementation of sound, pro-SME financial systems;
poudarja, da se je treba izogniti tradicionalnim praksam, kot so neuradni krediti in posojila na veliko področjih, s spodbujanjem posebej oblikovanih finančnih produktov in mikrofinanciranja;
Stresses the need to avoid traditional practices of informal credit and loans in many areas, by promoting specially designed financial products and microfinance;
priporoča zagotovitev semenskega kapitala za ustanavljanje in razvoj malih in srednjih podjetij;
Recommends that seed capital should be provided for the creation and development of SMEs;
priporoča politiko, ki olajšuje dostop do kredita, zlasti do srednje- in dolgoročnega kredita, ter krepi finančne posrednike, ki financirajo mala in srednja podjetja;
Recommends policies facilitating access to credit, especially medium and long-term credit, and the strengthening of the intermediaries active in SME financing;
poziva, da se nameni posebna pozornost mikrokreditnim vlaganjem v ženska podjetja, zlasti na področjih, kjer ženske niso povsem enakopravne;
Calls for special attention to be paid to women oriented micro-credit ventures, especially in areas where women are not fully empowered;
predlaga mednarodno podporo in financiranje regionalnih ustanov, ki delujejo v finančnem sektorju držav v razvoju, s čimer se uveljavi skupni večnacionalni pristop do dejavnosti, ki jih izvajajo mala in srednja podjetja;
Proposes international support and financing for regional institutions active in the financial sector of developing countries, thus introducing a multi-national common approach to activities carried out by SMEs;
poziva k davčnim olajšavam za mala in srednja podjetja, zlasti v njihovem začetnem obdobju;
Calls for tax incentives to be given to SMEs, especially in their start-up phase;
poziva k reformam zakonodaje, katerih cilj je pospešitev in poenostavitev registracijskih postopkov ter znižanje minimalnih kapitalskih zahtev;
Calls for regulatory reforms aimed at speeding up and simplifying registration procedures as well as lowering minimum capital requirements;
poziva k reformam sodnih postopkov za hitrejše reševanje poslovnih sporov, učinkovitejše izvajanje pogodb in zaščito lastniških pravic;
Calls for the reform of court procedures to settle business disputes faster as well as to enforce contracts and defend property rights more effectively;
naroči svojemu predsedniku, naj to resolucijo posreduje Svetu, Komisiji, vladam držav članic EU in AKP, Svetu AKP-EU in Skupni parlamentarni skupščini AKP-EU.
Instructs its President to forward this resolution to the Council, the Commission, the governments of the EU Member States and ACP, the ACP-EU Council and the ACP-EU Joint Parliamentary Assembly.
Zakonodajna resolucija Evropskega parlamenta 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 (15763/3/2005 – C6-0087/2006 – 2004/0217(COD) )
European Parliament legislative resolution 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 (15763/3/2005 – C6-0087/2006 – 2004/0217(COD) )
ob upoštevanju Skupnega stališča Sveta (15763/3/2005 – C6-0087/2006 ),
having regard to the Council common position (15763/3/2005 – C6-0087/2006 ),
o predlogu Komisije Parlamentu in Svetu ( KOM(2004)0599 ) Še ni objavljeno v Uradnem listu.
on the Commission proposal to Parliament and the Council ( COM(2004)0599 ) Not yet published in OJ.
ob upoštevanju spremenjenega predloga Komisije ( KOM(2005)0577 ) Še ni objavljeno v Uradnem listu.
having regard to the amended Commission proposal ( COM(2005)0577 ) Not yet published in OJ.
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 ),
ob upoštevanju izjav Komisije, ki so priložene k tej zakonodajni resoluciji in bodo objavljene skupaj z zakonodajnim aktom v Uradnem listu,
having regard to the Commission statement which is annexed to this legislative resolution and which will be published together with the legislative act in the Official Journal,
ob upoštevanju mnenja Evropskega ekonomsko-socialnega odbora 1
Having regard to the Opinion of the European Economic and Social Committee
Evropskega parlamenta z dne 7. septembra 2005 (še ni objavljeno v Uradnem listu), Skupno stališče Sveta z dne
of 7 September 2005 (not yet published in the Official Journal), Council Common Position of
10. marca 2006
10 March 2006
) in Stališče Evropskega parlamenta z dne
) and European Parliament Position of
1. junija 2006
1 June 2006.
Preden je zdravilo za uporabo v humani medicini dano v promet v eni ali več državah članicah, mora biti načeloma predmet obširnih študij, vključno s pred-kliničnimi preskusi in kliničnimi preskušanji, s čimer se zagotovi, da je varno, visoko kakovostno in učinkovito za uporabo pri ciljni populaciji.
Before a medicinal product for human use is placed on the market in one or more Member States, it generally has to have undergone extensive studies, including pre-clinical tests and clinical trials, to ensure that it is safe, of high quality and effective for use in the target population.
Takšne študije morda niso bile izvedene za uporabo pri pediatrični populaciji in mnogo zdravil, ki se trenutno uporablja za zdravljenje pediatrične populacije, ni bilo predmet študij ali odobrenih za takšno uporabo.
Such studies may not have been undertaken for use in the paediatric population and many of the medicinal products currently used to treat the paediatric population have not been studied or authorised for such use.
Izkazalo se je, da tržni dejavniki sami ne morejo zadostno spodbujati ustreznih raziskav, razvoja in odobritev zdravil za pediatrično populacijo.
Market forces alone have proven insufficient to stimulate adequate research into, and the development and authorisation of, medicinal products for the paediatric population.
Med težave, ki jih povzroča pomanjkanje ustrezno prilagojenih zdravil za pediatrično populacijo, sodijo nezadostni podatki o odmerjanju, ki vodijo k večjim tveganjem neželenih učinkov, tudi smrti, neučinkovitost zdravljenja zaradi premajhnega odmerjanja, terapevtski napredki, ustrezni pripravki in poti uporabe zdravila niso na voljo pediatrični populaciji, magistralni pripravki ali galenski izdelki za zdravljenje pediatrične populacije pa so lahko slabe kakovosti.
Problems resulting from the absence of suitably adapted medicinal products for the paediatric population include inadequate dosage information which leads to increased risks of adverse reactions including death, ineffective treatment through under-dosage, non-availability to the paediatric population of therapeutic advances, suitable formulations and routes of administration, as well as use of magistral or officinal formulations to treat the paediatric population which may be of poor quality.
Namen te uredbe je omogočiti razvoj in dostopnost zdravil za uporabo pri pediatrični populaciji, zagotoviti, da so zdravila za zdravljenje pediatrične populacije predmet visoko kakovostnih, etičnih raziskav in da so primerno odobrena za uporabo pri pediatrični populaciji, ter izboljšati razpoložljive informacije o uporabi zdravil pri različnih pediatričnih populacijah.
This Regulation aims to facilitate the development and accessibility of medicinal products for use in the paediatric population, to ensure that medicinal products used to treat the paediatric population are subject to ethical research of high quality and are appropriately authorised for use in the paediatric population, and to improve the information available on the use of medicinal products in the various paediatric populations.
Razlike v nacionalnih zakonskih in drugih predpisih o zdravilih lahko ovirajo trgovino znotraj Skupnosti in tako neposredno vplivajo na delovanje notranjega trga.
The differences between the national legislative, regulatory and administrative provisions on medicinal products tend to hinder intra-Community trade and therefore directly affect the operation of the internal market.
Vsak ukrep za podporo razvoju in odobritvam zdravil za pediatrično uporabo je torej utemeljen za preprečevanje in odpravljanje 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.
Uvedba sistema, ki obsega tako obveznosti kot tudi nagrade in spodbude, se je pri doseganju teh ciljev pokazala za nujno.
The establishment of a system of both obligations and rewards and incentives has proved necessary to achieve these objectives.
Ta uredba bi se morala uporabljati za vsa zdravila, ki jih potrebuje pediatrična populacija, zato bi moralo njeno področje uporabe obsegati izdelke v razvoju, ki jih je treba še odobriti, odobrene izdelke, ki so predmet varstva pravic intelektualne lastnine, in odobrene izdelke, ki niso več predmet varstva pravic intelektualne lastnine.
This Regulation should apply to all the medicinal products required for paediatric use and therefore its scope should cover products under development and yet-to-be authorised, authorised products covered by intellectual property rights and authorised products no longer covered by intellectual property rights.
treba skrbno nadzorovati in spremljati na podlagi posebnih zahtev za varstvo pediatrične populacije, ki so del kliničnih preskušanj v Skupnosti, določenih v Direktivi 2001/20/ES Evropskega parlamenta in Sveta z dne 4. aprila 2001 o približevanju zakonov in drugih predpisov držav članic v zvezi z izvajanjem dobre klinične prakse pri kliničnem preskušanju zdravil za ljudi UL L 121, 1.5.2001, str.
Public health threats from the use of untested medicinal products in the paediatric population can be safely addressed through the study of medicinal products for the paediatric population, which should be carefully controlled and monitored through the specific requirements for the protection of the paediatric population who take part in clinical trials in the Community laid down in Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use OJ L 121, 1.5.2001, p.
Za Odbor za pediatrijo veljajo določbe, ki veljajo za znanstveni odbor Agencije, kakor 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
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 naj 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.
Načrt pediatričnih raziskav bi moral vključevati podrobnosti glede časovnega poteka in predlaganih ukrepov za dokazovanje kakovosti, varnosti in učinkovitosti zdravil pri pediatrični populaciji.
The paediatric investigation plan should include details of the timing and the measures proposed to demonstrate the quality, safety and efficacy of the medicinal product in the paediatric population.
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.
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,
Thus, paediatric investigation plans should be submitted early during product development, in time for studies to be conducted in the paediatric population
če je potrebno,
, where appropriate,
preden se vložijo vloge za dovoljenje za promet.
before marketing authorisation applications are submitted.
Za nova zdravila in za odobrena zdravila, zaščitena s patentom ali dodatnim varstvenim certifikatom, je treba uvesti zahtevo po predložitvi rezultatov študij na pediatrični populaciji v skladu z dogovorjenim načrtom pediatričnih raziskav ali dokazila o pridobitvi opustitve ali odloga ob vložitvi vloge za dovoljenje za promet ali vloge za novo indikacijo, novo farmacevtsko obliko ali novo pot uporabe zdravila.
It is necessary to introduce a requirement for new medicinal products and for authorised medicinal products covered by a patent or a supplementary protection certificate to present either the results of studies in the paediatric population in accordance with an agreed paediatric investigation plan or proof of having obtained a waiver or deferral, at the time of filing a marketing authorisation application or an application for a new indication, new pharmaceutical form or new route of administration.
Načrt pediatričnih raziskav naj bo podlaga za presojo skladnosti s to zahtevo.
The paediatric investigation plan should be the basis upon which compliance with that requirement is judged.
Vendar pa se ta zahteva ne uporablja za generična zdravila ali podobna biološka zdravila in zdravila, odobrena po postopku dobro uveljavljene medicinske uporabe, ali homeopatska zdravila in tradicionalna zdravila rastlinskega izvora, odobrena po poenostavljenih postopkih registracije iz Direktive 2001/83/ES Evropskega parlamenta in Sveta z dne 6. novembra 2001 o zakoniku Skupnosti o zdravilih za uporabo v humani medicini UL L 311, 28.11.2001, str.
However, that requirement should not apply to generics or similar biological medicinal products and medicinal products authorised through the well-established medicinal use procedure, nor to homeopathic medicinal products and traditional herbal medicinal products authorised through the simplified registration procedures of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use OJ L 311, 28.11.2001, p.
Da bi zagotovili, da se raziskave pri pediatrični populaciji izvajajo samo zaradi njihovih terapevtskih potreb, je treba za Agencijo uvesti postopke, s katerimi se opusti zahteva iz uvodne izjave (11) za določena zdravila ali skupine ali dele skupin zdravil, ki jih Agencija nato objavi.
In order to ensure that research in the paediatric population is only conducted to meet their therapeutic needs, there is a need to establish procedures for the Agency to waive the requirement referred to in Recital (11) for specific products or for classes or part of classes of medicinal products, these waivers being then made public by the Agency.
Zaradi nenehnega razvoja v znanosti in medicini je treba predvideti določbo o spreminjanju seznamov opustitev.
As knowledge of science and medicine evolves over time, provision should be made for the lists of waivers to be amended.
Če pa se opustitev razveljavi, se zahteva ne uporablja za obdobje, ki je potrebno vsaj za izdajo soglasja z načrtom pediatričnih raziskav in za začetek izvajanja študij na pediatrični populaciji pred predložitvijo vloge za dovoljenje za promet.
However, if a waiver is revoked, that requirement should not apply for a given period in order to allow time for at least a paediatric investigation plan to be agreed and studies in the paediatric population to be initiated before an application for marketing authorisation is submitted.
Agencija bi morala zagotoviti brezplačno znanstveno svetovanje kot spodbudo za sponzorje, ki razvijajo zdravila za pediatrično populacijo.
Free scientific advice should be provided by the Agency as an incentive to sponsors developing medicinal products for the paediatric population.
Da bi zagotovila znanstveno doslednost, bi morala Agencija usklajevati dejavnosti Odbora za pediatrijo in delovne skupine za znanstveno svetovanje Odbora za zdravila za uporabo v humani medicini ter skrbeti za vzajemno delovanje med Odborom za pediatrijo in drugimi odbori in delovnimi skupinami Skupnosti glede zdravil.
To ensure scientific consistency, the Agency should manage the interface between the Paediatric Committee and the Scientific Advice Working Group of the Committee for Medicinal Products for Human Use, as well as the interaction between the Paediatric Committee and the other Community committees and working groups concerning medicinal products.
Obstoječih postopkov za pridobitev dovoljenja za promet z zdravili za uporabo v humani medicini se ne sme spreminjati.
The existing procedures for the marketing authorisation of medicinal products for human use should not be changed.
Vendar zahteva iz uvodne izjave (11) določa, da bi morali pristojni organi pri presoji veljavnosti vlog za dovoljenje za promet preveriti skladnost z dogovorjenim načrtom pediatričnih raziskav ter z vsemi opustitvami in odlogi.
However, from the requirement referred to in Recital (11) it follows that competent authorities should check compliance with the agreed paediatric investigation plan and any waivers and deferrals at the existing validation step for marketing authorisation applications.
Presojo kakovosti, varnosti in učinkovitosti zdravil za pediatrično populacijo ter izdajo dovoljenj za promet bi morali še naprej izvajati pristojni organi.
The assessment of quality, safety and efficacy of medicinal products for the paediatric population and the granting of marketing authorisations should remain the remit of the competent authorities.
Treba je sprejeti določbo, na podlagi katere se Odbor za pediatrijo zaprosi za mnenje o skladnosti ter o kakovosti, varnosti in učinkovitosti zdravil pri pediatrični populaciji.
Provision should be made for the Paediatric Committee to be asked for its opinion on compliance and on the quality, safety and efficacy of a medicinal product in the paediatric population.
Poleg tega bi se morala vloga za dovoljenje za promet za pediatrično uporabo nanašati na podatke, ki so vsebovani v dosjeju zdravila, ki je oziroma je bilo odobreno v Skupnosti.
An application for a Paediatric Use Marketing Authorisation should also be able to refer to data contained in the dossier of a medicinal product which is or has been authorised in the Community.
S tem bi še dodatno spodbudili mala in srednje velika podjetja, vključno s podjetji generičnih zdravil, da bi razvijala zdravila za pediatrično populacijo brez patenta.
This is intended to provide an additional incentive to encourage small and medium-sized enterprises, including generic companies, to develop off-patent medicinal products for the paediatric population.
Uredba bi morala vsebovati ukrepe, ki bodo prebivalcem Skupnosti čim bolj omogočili dostop do novih zdravil, ki so preskušena in prilagojena za pediatrično uporabo in čim bolj zmanjšali možnosti, da bi se na območju Skupnosti dodeljevale nagrade in spodbude za odobritve novih zdravil, če se s tem ne bi olajšala dostopnost do teh zdravil delom pediatrične populacije Skupnosti.
This Regulation should include measures to maximise access by the Community population to new medicinal products tested and adapted for paediatric use, and to minimise the chance of Community-wide rewards and incentives being granted without sections of the Community paediatric population benefiting from the availability of a newly authorised medicine.
Vloga za dovoljenje za promet, vključno z vlogo za dovoljenje za promet za pediatrično uporabo, ki vsebuje rezultate študij, izvedenih v skladu z dogovorjenim načrtom pediatričnih raziskav, bi morala biti upravičena do centraliziranega postopka Skupnosti, določenega v členih 5 do 15
An application for a marketing authorisation, including an application for a Paediatric Use Marketing Authorisation, which contains the results of studies conducted in compliance with an agreed paediatric investigation plan should be eligible for the Community centralised procedure set out in Articles 5 to 15 of Regulation (EC) No
Če je bilo na podlagi dogovorjenega načrta pediatričnih raziskav izdano dovoljenje za pediatrično indikacijo za zdravilo, ki je že v prometu za druge indikacije, bi se moral imetnik dovoljenja za promet zavezati, da bo izdelek ob upoštevanju pediatričnih informacij dal v promet v roku dveh let od datuma odobritve indikacije.
When an agreed paediatric investigation plan has led to the authorisation of a paediatric indication for a product already marketed for other indications, the marketing authorisation holder should be obliged to place the product on the market, taking into account the paediatric information, within two years of the date of approval of the indication.
Ta zahteva se nanaša samo na izdelke, ki so že odobreni, in se ne uporablja za zdravila, ki so odobrena na podlagi dovoljenja za promet za pediatrično uporabo.
That requirement should relate only to products already authorised, but not to medicinal products authorised via a Paediatric Use Marketing Authorisation.
Za dosego tega se lahko uporabi postopek, določen v členih 32, 33 in 34 Direktive 2001/83/ES.
To achieve this, the procedure set out in Articles 32, 33 and 34 of Directive 2001/83/EC could be used.
To bo omogočilo sprejetje usklajene odločbe Skupnosti o uporabi zdravil pri pediatrični populaciji in njeno vključitev v vse nacionalne podatke o zdravilu.
This will allow the adoption of a Community harmonised Decision on use of that medicinal product in the paediatric population and its inclusion in all national product information.
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.
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.