natgillin/translations-raw huggingface dataset:
(28) Za povečanje dostopnosti podatkov o uporabi zdravil pri otrocih in za izogibanje ponavljajočim se študijam pri otrocih, ki ne prispevajo k skupnemu znanju, bi morala evropska zbirka podatkov, predvidena v členu 11 Direktive 2001/20/ES, vključiti informacijski vir o vseh tekočih, predčasno končanih in dokončanih pediatričnih študijah, ki so bile izvedene v Skupnosti in tretjih državah.
(28) In order to increase the availability of information on the use of medicines in children, and to avoid the repetition of studies in children which do not add to the collective knowledge, the European database provided for in Article 11 of Directive 2001/20/EC should include an information resource of all ongoing, prematurely terminated, and completed paediatric studies conducted both in the Community and in third countries.
(28) Za povečanje dostopnosti podatkov o uporabi zdravil pri otrocih in za izogibanje ponavljajočim se študijam pri otrocih, ki ne prispevajo k skupnemu znanju, bi morala evropska zbirka podatkov, predvidena v členu 11 Direktive 2001/20/ES, vključiti evropski register kliničnih poskusov zdravil za pediatrično uporabo o vseh tekočih, predčasno končanih in dokončanih pediatričnih študijah, ki so bile izvedene v Skupnosti in tretjih državah.
(28) In order to increase the availability of information on the use of medicines in children, and to avoid the repetition of studies in children which do not add to the collective knowledge, the European database provided for in Article 11 of Directive 2001/20/EC should include a European register of clinical trials of medicinal products for paediatric use comprising all ongoing, prematurely terminated, and completed paediatric studies conducted both in the Community and in third countries.
Take študije je treba vključiti tudi v baze podatkov kliničnih preiskav, ki se trenutno izvajajo na nacionalni ravni.
Such studies should also be entered in the databases of clinical investigations currently in operation at national level.
Študij pri otrocih, ki so že bile izvedene v tretjih državah, ni treba ponoviti.
Studies in children already performed in third countries should not be repeated.
Vseeno pa, če je to neizogibno, morajo biti mogoče nadzorne študije.
However, if unavoidable, control studies should be possible.
Treba se je izogniti nepotrebnim študijam pri otrocih in zato se ne smejo ponoviti študije pri pediatričnih bolnikih, ki so že bile izvedene v tretjih državah.
Unnecessary studies in children should be avoided and therefore studies in paediatric patients already performed in third countries, should not be repeated.
(29) Odbor za pediatrijo bi moral po posvetovanju s Komisijo, državami članicami in zainteresiranimi strankami sprejeti seznam terapevtskih potreb otrok in ga redno posodabljati.
(29) An inventory of therapeutic needs of children should be adopted by the Paediatric Committee after consultation with the Commission, the Member States and interested parties, and regularly updated.
Seznam bi moral opredeliti obstoječa zdravila, uporabljena pri otrocih, in poudariti terapevtske potrebe otrok ter prednostne naloge za raziskave in razvoj.
The inventory should identify the existing medicines used by children and highlight the therapeutic needs of children and the priorities for research and development.
Na ta način bi podjetja lažje ugotovila možnosti za poslovni razvoj, Odbor za pediatrijo bi bolje ocenil potrebo po zdravilih in študijah pri presoji osnutkov načrtov pediatričnih preiskav, opustitev in odlogov, strokovnjaki zdravstvenega varstva in bolniki pa bi imeli na voljo vir informacij za pomoč pri njihovih odločitvah o izbiri zdravil.
In this way, companies should be able to identify easily opportunities for business development; the Paediatric Committee should be able to better judge the need for medicines and studies when assessing draft paediatric investigation plans, waivers and deferrals; and healthcare professionals and patients should have an information source available to support their decisions as to which medicines to choose.
UVODNA IZJAVA 30
RECITAL 30
(30) Klinični preskusi pri pediatrični populaciji lahko zahtevajo posebno strokovno znanje, posebno metodologijo in v nekaterih primerih posebne pripomočke ter bi morali biti izvršeni s strani primerno usposobljenih raziskovalcev.
(30) Clinical trials in the paediatric population may require specific expertise, specific methodology and, in some cases, specific facilities and should be carried out by appropriately trained investigators.
Mreža, ki bi povezovala obstoječe nacionalne in evropske pobude ter študijske centre z namenom, da se na evropski ravni ustvarijo potrebna pooblastila, bi olajšala sodelovanje in izogibanje podvajanju študij.
A network linking together existing national and European initiatives and study centres in order to build up the necessary competences at a European level, would help facilitating co-operation and avoiding duplication of studies.
Ta mreža bi morala prispevati h krepitvi temeljev evropskega raziskovalnega prostora v zvezi z okvirnimi programi Skupnosti na področju raziskav, tehnološkega razvoja in predstavitvenih dejavnosti, koristiti pediatrični populaciji in delovati kot informacijski in strokovni vir za industrijo.
This network should contribute to the work of strengthening the foundations of the European Research Area in the context of Community Framework Programmes for Research, Technological Development and Demonstration Activities, benefit the paediatric population and provide a source of information and expertise for industry.
Mreža, ki bi povezovala obstoječe nacionalne in evropske pobude ter študijske centre in upoštevala mednarodne podatke z namenom, da se na evropski ravni ustvarijo potrebna pooblastila, bi olajšala sodelovanje in izogibanje podvajanju študij.
A network linking together existing national and European initiatives and study centres and taking account of international data in order to build up the necessary competences at a European level, would help facilitating co-operation and avoiding duplication of studies.
Bistvenega pomena je imeti kar se da veliko zbirko podatkov in biti seznanjen z izkušnjami, pridobljenimi iz raziskav na svetovni ravni.
It is essential to have the biggest database possible and to be familiar with the experience gained from research at world level.
Ta uredba ureja razvoj zdravil za humano uporabo z namenom, da se zadosti posebnim terapevtskim potrebam pediatrične populacije, ne da bi otroke izpostavljali nepotrebnim kliničnim preskusom ter v skladu z Direktivo 2001/20/ES.
This Regulation lays down rules concerning the development of medicinal products for human use in order to meet the specific therapeutic needs of the paediatric population, without subjecting children to unnecessary clinical trials and in compliance with Directive 2001/20/EC.
Ta uredba ureja razvoj zdravil za humano uporabo z namenom, da se zadosti posebnim terapevtskim potrebam pediatrične populacije, ne da bi otroke izpostavljali nepotrebnim kliničnim preskusom in drugim (zlasti v primeru zdravil, ki jih že uporabljajo otroci, ki imajo redke prirojene bolezni) ter v skladu z Direktivo 2001/20/ES.
This Regulation lays down rules concerning the development of medicinal products for human use in order to meet the specific therapeutic needs of the paediatric population, without subjecting children to unnecessary clinical or others trials (particularly in the case of medicinal products which are already used by children suffering from rare congenital conditions) and in compliance with Directive 2001/20/EC.
Ta predlog spremembe bo omogočil, da se izognemo konfliktom z drugimi obstoječimi zakoni in predpisi, po katerih so klinični podatki v zvezi s pediatrično populacijo že zahtevani, zlasti v primeru zdravil, ki so se že izkazala kot pomembna za otroke z redkimi prirojenimi boleznimi, kot je hemofilija.
This amendment will make it possible to avoid conflict with other existing laws and regulations under which clinical data relating to the paediatric population are already required, particularly in the case of medicinal products which have already proved to be of value to children suffering from rare congenital conditions such as haemophilia.
Preskusi niso samo klinični, ampak tudi laboratorijski in drugi.
Trials are not only clinical but also laboratory and other types.
POGLAVJE 1 A (novo)
CHAPTER 1 A (new)
Poglavje 1a
Chapter 1a
Opredelitev potreb
Identification of needs
Te podatke posredujejo agenciji med letom po začetku veljavnosti te uredbe.
They shall forward those data to the Agency in the course of the year following the entry into force of this Regulation.
Odbor za pediatrijo pripravi smernice o vsebini in obliki zbranih podatkov.
The Paediatric Committee shall provide guidance on the content and the format of the data to be collected.
Člen 2b
Article 2b
Agencija objavi seznam v dveh letih od začetka veljavnosti in ga redno posodablja, vključno s podatki preskusov, izvedenih v tretjih državah.
The Agency shall publish the inventory within two years of the entry into force of this Regulation and shall update it regularly, including the data from trials carried out in third countries.
Ta seznam je namenjen tudi za določitev prednostnih nalog pri raziskavah.
This inventory shall also be aimed at establishing research priorities.
Člen 2c
Article 2c
Odbor za pediatrijo prav tako zagotovi optimizacijo virov, pri čemer se upošteva izvedljivost študij po najboljših stroških (človeških in finančnih) ter ustreznost protokolov z namenom zagotavljanja odgovorov na klinična vprašanja kar se da hitro in enostavno.
The Paediatric Committee shall also ensure resource optimisation, account being taken of the feasibility of studies at best cost (human and financial) and the suitability of protocols with a view to providing answers to clinical questions as quickly and as straightforwardly as possible.
Upravni odbor agencije na predlog izvršnega direktorja in po posvetovanju s Komisijo, državami članicami in zainteresiranimi strankami v enem letu od začetka veljavnosti te uredbe sprejme izvedbeno strategijo za zagon in delovanje evropske mreže.
Within one year of the entry into force of this Regulation, the Management Board of the Agency shall, on a proposal from the Executive Director and following consultation with the Commission, the Member States and interested parties, adopt an implementing strategy for the launching and operation of the European network.
Ta mreža mora biti, kjer je to primerno, združljiva s krepitvijo temeljev evropskega raziskovalnega prostora v zvezi z okvirnimi programi Skupnosti na področju raziskav, tehnološkega razvoja in predstavitvenih dejavnosti.
This network must, where appropriate, be compatible with the work of strengthening the foundations of the European Research Area in the context of the Community Framework Programmes for Research, Technological Development and Demonstration Activities.
Člen 2d
Article 2d
Komisija in države članice v enem letu od začetka veljavnosti te uredbe ustanovijo evropski pediatrični raziskovalni program za financiranje študij o uporabi zdravil (še zlasti tistih, ki niso vključena v patente ali dodatne varstvene certifikate).
Within one year of the entry into force of this Regulation the Commission and the Member States shall establish a European paediatrics research programme under which studies into the use of medicinal products (in particular ones which are not covered by patents or supplementary certificates) shall be financed.
Program upošteva prednostne naloge iz člena 2b, pododstavka 2.
The programme shall take into account the priorities referred to in the second paragraph of Article 2b.
To poglavje obravnava razvoj zdravil za uporabo v humani medicini z namenom zadovoljitve posebnih terapevtskih potreb pediatrične populacije.
This chapter is concerned with the development of medicinal products for human use with a view to meeting the specific therapeutic needs of the paediatric population.
Treba se je izogniti nesmiselnim poskusom in spodbuditi farmacevtska podjetja k zagotovitvi boljšega odziva na te posebne potrebe.
Pointless trials should be avoided and pharmaceutical companies should be encouraged to provide a better response to those particular needs.
Členi – ki v bistvu ustrezajo členom 41, 42 in 43 predloga Uredbe – obravnavajo razvoj zdravil za uporabo v humani medicini z namenom zadovoljitve posebnih terapevtskih potreb pediatrične populacije.
The articles - which essentially reproduce Articles 41, 42 and 43 of the proposal for a regulation - are concerned with the development of medicinal products for human use with a view to meeting the specific therapeutic needs of the paediatric population.
Če naj se to izvede, morajo javni organi držav članic in EU zagotoviti, da se zadovolji vse potrebe, ne glede na interes, ki so ga v spodbujevalnem mehanizmu pokazala farmacevtska podjetja.
If this is to be done, both the Member States’ and the EU’s public authorities must ensure that all needs are met, irrespective of the interest shown by pharmaceutical companies in the incentive mechanism.
Zato je treba opredelitev terapevtskih potreb v pediatriji postaviti za osnovni cilj, kar bo omogočilo tudi boljše oblikovanje načrtov preiskav in njihovih prednostnih nalog.
Hence the identification of therapeutic needs in paediatrics should be made a basic objective which will also enable investigation plans and the priorities thereof to be better formulated.
Bistveno je, da informacije in podatki, ki jih agencija zbere o preskusih, vključenih v načrte pediatričnih preiskav, vključujejo tudi informacije in podatke preskusov, ki se izvedejo v tretjih državah.
It is essential that the information and data which the Agency collects on trials contained in paediatric investigation plans should also include information and data from trials carried out in third countries.
ČLEN 3, ODSTAVEK 1, PODODSTAVEK 1
ARTICLE 3, PARAGRAPH 1, SUBPARAGRAPH 1
Znotraj Evropske agencije za zdravila, ustanovljene z Uredbo (ES) št. 726/2004, v nadaljevanju „agencija“, se ustanovi Odbor za pediatrijo.
A Paediatric Committee is established within the European Medicines Agency set up under Regulation (EC) No 726/2004, hereinafter “the Agency”.
Najpozneje šest mesecev po začetku veljavnosti te uredbe se znotraj Evropske agencije za zdravila, ustanovljene z Uredbo (ES) št. 726/2004, v nadaljevanju „agencija“, ustanovi Odbor za pediatrijo.
Not later than 6 months after the entry into force of this Regulation, a Paediatric Committee shall be established within the European Medicines Agency set up under Regulation (EC) No 726/2004, hereinafter “the Agency”.
Razvoj novih zdravil se ne sme preložiti.
The development of new medicines must not be delayed.
Evropska agencija za zdravila (EMEA) ima že veliko strokovnega znanja v pediatričnem sektorju.
EMEA does already dispose of significant expertise in the paediatric sector.
Zato mora biti mogoče začeti delo Odbora za pediatrijo v šestih mesecih.
Accordingly it should be possible to start the work of the Paediatric Committee within six month.
ČLEN 4, ODSTAVEK 1, TOČKA (C)
ARTICLE 4, PARAGRAPH 1, POINT (C)
(c) šest oseb, ki jih imenuje Komisija na podlagi javnega poziva za izraz interesa, z namenom zastopanja pediatrov in interesov združenj bolnikov .
(c) six persons appointed by the Commission, on the basis of a public call for expressions of interest, in order to represent paediatricians and the interests of patient associations.
(c) deset oseb, ki jih imenuje Komisija po posvetovanju z Evropskim parlamentom na podlagi javnega poziva za izraz interesa, z namenom zastopanja pediatrov in ostalih zdravnikov, specializiranih za zdravljenje otrok, splošnih zdravnikov, farmacevtov, strokovnjakov farmakovigilence in na področju javnega zdravja, starševskih združenj in socialnih organov .
(c) ten persons appointed by the Commission after consulting the European Parliament , on the basis of a public call for expressions of interest, in order to represent paediatricians , other physicians specialising in the treatment of children, general practitioners, pharmacists, pharmacovigilance and public-health specialists, parents’ associations and welfare bodies.
Sestavo Odbora za pediatrijo je treba razširiti tako, da bo vključeval različne kategorije izvajalcev pediatrične oskrbe, da bi Odboru omogočili pridobitev celovitega pregleda nad razmerami in pediatričnimi potrebami.
The composition of the Paediatric Committee should be broadened to include various categories of paediatric-care practitioners, so as to enable the committee to acquire a comprehensive overview of the situation and of paediatric needs.
Treba je tudi zagotoviti, da je na vsakem sestanku na voljo zadostno število ljudi za sprejemanje potrebnih odločitev.
It should also be ensured that at each meeting an adequate number of people are available to take the requisite decisions
Ne samo pediatri, ampak tudi ostali zdravniki, specializirani za zdravljenje otrok (onkologi, kardiologi itd.), morajo imeti priložnost, da sodelujejo v Odboru za pediatrijo.
Not only paediatricians, but also other physicians who have specialised in the treatment of children (oncologists, cardiologists, etc.) should have the possibility of participating in the Paediatric Committee.
Farmacevti imajo edinstveno znanje na farmacevtskem področju zaradi specializiranega usposabljanja, ki jim omogoča, da postanejo strokovnjaki za zdravila
Pharmacists have unique knowledge in the pharmaceutical field because of their specialised training which leads them to become experts in medicinal products
Direktiva 85/433/ES .
Directive 85/433/EC .
Takšno specializirano farmacevtsko znanje bi občutno prispevalo k dejavnostim Odbora za pediatrijo.
Such specialised pharmaceutical knowledge would make an essential contribution to the activities of the Paediatric Committee.
Razen tega imajo farmacevti ključno vlogo pri svetovanju bolnikom in njihovim negovalcem o najboljšem načinu zdravljenja, zaradi enostavnega dostopa do njih so prvi, na katere se bolniki obrnejo s vprašanji ali težavami v zvezi z zdravljenjem.
In addition, pharmacists play a key role in advising patients and their carers on the best use of medicinal treatment, their easy accessibility making them the first port of call for patients with questions or problems related to their medication.
Zato bi vključitev farmacevtov v Odbor za pediatrijo zagotovila celovito zastopanost interesnih skupin.
Therefore the inclusion of a pharmacist in the Paediatric Committee would ensure that comprehensive stakeholder representation is achieved.
Pri pripravi mnenj si Odbor za pediatrijo prizadeva doseči znanstveno soglasje.
When preparing its opinions, the Paediatric Committee shall use its best endeavours to reach a scientific consensus.
Če ga ne more doseči, mnenje sestavlja stališče večine članov in odklonilna stališča skupaj z razlogi, na katerih temeljijo.
If such a consensus cannot be reached, the opinion shall consist of the position of the majority of members and divergent positions, with the grounds on which they are based.
Če ga ne more doseči, se mnenje sprejme s strani večine članov.
If such a consensus cannot be reached, the opinion shall be the one adopted by the majority of members .
Mnenje navaja odklonilna stališča skupaj z razlogi, na katerih temeljijo.
The opinion shall mention the divergent positions, with the grounds on which they are based.
Mnenje se nemudoma javno objavi.
The opinion shall be made public immediately.
Predstavniki Komisije in izvršni direktor agencije ali njegov predstavniki se lahko udeležujejo vseh sestankov Odbora za pediatrijo.
All meetings of the Paediatric Committee may be attended by representatives of the Commission, the Executive Director of the Agency or his representatives .
Dva predstavnika Komisije, in izvršni direktor agencije ali njegov predstavnik se lahko udeležujejo vseh sestankov Odbora za pediatrijo.
All meetings of the Paediatric Committee may be attended by two representatives of the Commission, the Executive Director of the Agency or his representative .
Za zagotovitev pravilne institucionalne zastopanosti Komisije in agencije.
To ensure the correct institutional representation of the Commission and the Agency.
ČLEN 6, ODSTAVEK 2
ARTICLE 6, PARAGRAPH 2
Vsi posredni interesi, povezani s farmacevtsko industrijo, se vnesejo v register, ki ga vodi agencija in je dostopen javnosti.
All indirect interests that could relate to the pharmaceutical industry shall be entered in a register held by the Agency which the public may consult.
Register se letno posodablja.
The register shall be updated annually.
Vsi neposredni ali posredni interesi, povezani s farmacevtsko industrijo, se vnesejo v register, ki ga vodi agencija in je dostopen javnosti.
All direct and/or indirect interests that could relate to the pharmaceutical industry shall be entered in a register held by the Agency which the public may consult.
ČLEN 7, ODSTAVEK 1, TOČKA G
ARTICLE 7, PARAGRAPH 1, POINT (g)
(g) znanstveno pomagati pri pripravi vseh dokumentov, povezanih z izpolnjevanjem ciljev te uredbe;
(g) to assist scientifically in the elaboration of any documents related to the fulfilment of the objectives of this Regulation;
(g) brezplačno znanstveno pomagati pri pripravi vseh dokumentov, povezanih z izpolnjevanjem ciljev te uredbe;
(g) to provide scientific assistance, free of charge, in the elaboration of any documents related to the fulfilment of the objectives of this Regulation;
Na ta način je naloga Odbora za pediatrijo v skladu s členom 27 pričujoče uredbe, ki določa, da Agencija za strokovne nasvete ne sme zahtevati plačila.
To bring this task of the Paediatric Committee into line with Article 27 of the regulation, which states that the Agency must provide advice free of charge.
ČLEN 7, ODSTAVEK 1, TOČKA H (A) (novo)
ARTICLE 7, PARAGRAPH 1, POINT (h a) (new)
h (a) pripraviti posebni seznam potreb po zdravilih za pediatrično uporabo in zagotoviti njegovo redno posodabljanje;
(ha) to establish a specific inventory of paediatric medicinal product needs and update it on a regular basis;
Gre za uskladitev nalog Odbora za pediatrijo s členom 42 pričujoče uredbe, ki določa pripravo in spremljanje tovrstnega seznama, ki je zelo pomemben za opredeljevanje potreb in določanje potrebnih raziskovalnih smernic.
To bring the Paediatric Committee’s tasks into line with Article 42 of the regulation which provides for the establishment and upkeep of this inventory, which is extremely important for the purposes of identifying needs and avenues of research to be explored.
ČLEN 7, ODSTAVEK 1, TOČKA (H A) (novo)
ARTICLE 7, PARAGRAPH 1, POINT (H A) (new)
(ha) podpirati promocijske kampanje o vlogi Odbora in ureditev, ki so na voljo za opravljanje pediatričnih farmacevtskih poskusov.
(ha) to promote publicity campaigns on the role of the Committee and the arrangements available for the conducting of paediatric pharmaceuticals trials.
Do sedaj je bilo malo otrok, na katerih bi lahko izvedli poskuse novih farmacevtskih izdelkov za pediatrično uporabo v skladu s sedanjimi varnostnimi predpisi, določenimi z zakonom, eden od razlogov za omejen razvoj te vrste izdelka.
To date, the very low availability of children on whom tests on new pharmaceutical products for paediatric use can be conducted in compliance with the current safety rules provided for by the law has been one of the reasons for the scarce development of this type of product.
Zato je toliko bolj pomembno, da se v zvezi s temi vprašanji izvajajo promocijske kampanje.
This makes it all the more important for a publicity campaign to be conducted in relation to these issues.
Odbor za pediatrijo pri izpolnjevanju svojih nalog preuči, ali lahko predlagane študije prinesejo pomembno terapevtsko korist pediatrični populaciji.
When carrying out its tasks, the Paediatric Committee shall consider whether or not any proposed studies can be expected to be of significant therapeutic benefit to the paediatric population.
Prav tako upošteva, med drugim, vsa mnenja, odločbe ali nasvete pristojnih organov tretjih držav.
It shall also take into account, inter alia, any opinions, decisions or advice given by the competent authorities of third countries.