natgillin/translations-raw huggingface dataset:
The measures provided for in this Regulation should not preclude the operation of other incentives or rewards.
Ukrepi, predvideni v tej uredbi, ne smejo onemogočiti drugih spodbud ali nagrad.
To ensure transparency on the different measures available at Community and Member State levels, the Commission should draw up a detailed list of all the incentives available, on the basis of information provided by the Member States.
Za zagotovitev preglednosti različnih ukrepov na ravni Skupnosti in držav članic bi morala Komisija na podlagi informacij, ki jih posredujejo države članice, pripraviti podroben seznam vseh razpoložljivih spodbud.
The measures set out in this Regulation, including the agreement of paediatric investigation plans, should not be grounds for obtaining any other Community incentives to support research, such as the funding of research projects under the multi-annual Community Framework Programmes for Research, Technological Development and Demonstration Activities.
Ukrepi, določeni v tej uredbi, vključno s soglasji z načrti pediatričnih raziskav, ne smejo biti podlaga za pridobivanje drugih spodbud Skupnosti za podporo raziskavam, kot je financiranje raziskovalnih projektov v okviru večletnih okvirnih programov Skupnosti za raziskave, tehnološki razvoj in predstavitvene dejavnosti.
In order to increase the availability of information on the use of medicinal products in the paediatric population, and to avoid unnecessary repetition of studies in the paediatric population 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.
Da bi izboljšali dostopnost do informacij o uporabi zdravil pri pediatrični populaciji in se izognili nepotrebnim ponavljajočim se študijam na pediatrični populaciji, ki ne prispevajo k skupnemu znanju, naj Evropska zbirka podatkov, predvidena v členu 11 Direktive 2001/20/ES, vsebuje Evropski register kliničnih preskušanj zdravil za pediatrično uporabo, vključno z vsemi tekočimi, predčasno zaključenimi in dokončanimi pediatričnimi študijami, ki so bile izvedene v Skupnosti in v tretjih državah.
Part of the information concerning paediatric clinical trials entered into the database, as well as details of the results of all paediatric clinical trials submitted to the competent authorities, should be made public by the Agency.
Agencija naj objavi tisti del informacij, ki zadevajo pediatrična klinična preskušanja, vključena v podatkovno bazo, kot tudi podrobnosti rezultatov vseh pediatričnih kliničnih preskušanj, predloženih pristojnim organom.
An inventory of the therapeutic needs of the paediatric population should be established by the Paediatric Committee after consultation with the Commission, the Member States and interested parties, and should be regularly updated.
Odbor za pediatrijo naj po posvetovanju s Komisijo, državami članicami in zainteresiranimi stranmi uvede seznam terapevtskih potreb pediatrične populacije in ga redno dopolnjuje.
The inventory should identify the existing medicinal products used by the paediatric population and highlight the therapeutic needs of that population and the priorities for research and development.
Na seznamu bi morala biti opredeljena obstoječa zdravila, ki se uporabljajo pri pediatrični populaciji, in poudarjene terapevtske potrebe te populacije ter prednostne naloge za raziskave in razvoj.
In this way, companies should be able easily to identify opportunities for business development; the Paediatric Committee should be able better to judge the need for medicinal products 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 medicinal products to choose.
Na ta način bi podjetja lažje prepoznala možnosti za poslovni razvoj, Odbor za pediatrijo bi lahko bolje ocenil potrebo po zdravilih in študijah pri presoji osnutkov načrtov pediatričnih raziskav, opustitev in odlogov, strokovnjaki zdravstvenega varstva in bolniki pa bi imeli na voljo vir informacij za pomoč pri njihovih odločitvah o izbiri zdravil.
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.
Klinična preskušanja pri pediatrični populaciji lahko zahtevajo posebno strokovno znanje, posebno metodologijo in v nekaterih primerih posebne pripomočke, zato bi jih morali izvajati primerno usposobljeni raziskovalci.
A network, which links existing national and Community initiatives and study centres in order to build up the necessary competences at Community level, and which takes account of Community and third country data, would help facilitate cooperation and avoid unnecessary duplication of studies.
Mreža, ki povezuje obstoječe nacionalne pobude in pobude Skupnosti ter študijske centre, da se na ravni Skupnosti ustvarijo potrebna pooblastila, in ki upošteva podatke Skupnosti in tretjih držav, bi pripomogla sodelovanju in izogibanju nepotrebnega podvajanja študij.
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.
Ta mreža naj bi prispevala h krepitvi temeljev Evropskega raziskovalnega prostora v zvezi z okvirnimi programi Skupnosti za raziskave, tehnološki razvoj in predstavitvene dejavnosti, koristila pediatrični populaciji in delovala kot informacijski in strokovni vir za industrijo.
For certain authorised products, pharmaceutical companies may already hold data on safety or efficacy in the paediatric population.
Farmacevtska podjetja imajo lahko za določena odobrena zdravila že na voljo podatke o varnosti ali učinkovitosti pri pediatrični populaciji.
To improve the information available on the use of medicinal products in the paediatric populations, companies holding such data should be required to submit them to all competent authorities where the product is authorised.
Za izpopolnitev že dostopnih informacij o uporabi zdravil pri pediatričnih populacijah bi bilo treba od podjetij, ki imajo takšne podatke, zahtevati, da jih predložijo vsem pristojnim organom, kjer so zdravila odobrena.
In this way the data could be assessed and, if appropriate, information should be included in the authorised product information aimed at healthcare professionals and patients.
Na ta način se podatki lahko ocenijo in, če je to primerno, vnesejo v podatke o odobrenem zdravilu, ki so namenjeni strokovnjakom zdravstvenega varstva in bolnikom.
Community funding should be provided to cover all aspects of the work of the Paediatric Committee and of the Agency resulting from the implementation of this Regulation, such as the assessment of paediatric investigation plans, fee waivers for scientific advice, and information and transparency measures, including the database of paediatric studies and the network.
Treba bi bilo predvideti financiranje s strani Skupnosti za vse dejavnosti Odbora za pediatrijo in Agencije, ki so posledica izvajanja te uredbe, kot so presoja načrtov pediatričnih raziskav, opustitve pristojbin, predvidenih za znanstveno svetovanje, ter ukrepi za zagotavljanje informacij in preglednosti, vključno z zbirko podatkov pediatričnih študij in mreže.
The measures necessary for the implementation of this Regulation should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission [8].
Ukrepe, potrebne za izvajanje te uredbe, bi bilo treba sprejeti v skladu s Sklepom Sveta 1999/468/ES z dne 28. junija 1999 o določitvi postopkov za uresničevanje Komisiji podeljenih izvedbenih pooblastil [8].
Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004 should therefore be amended accordingly.
Uredbo (EGS) št. 1768/92, Direktivo 2001/20/ES, Direktivo 2001/83/ES in Uredbo (ES) št. 726/2004 bi bilo zato treba ustrezno spremeniti.
Since the objective of this Regulation, namely improving availability of medicinal products tested for paediatric use, cannot be sufficiently achieved by the Member States and can therefore be better achieved at Community level, given that this will make it possible to take advantage of the widest possible market and avoid the dispersion of limited resources, the Community may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty.
Ker cilja te uredbe, in sicer izboljšanja dostopnosti zdravil, preskušenih za pediatrično uporabo, države članice ne morejo same zadovoljivo doseči in ga je zato lažje doseči na ravni Skupnosti, pod pogojem, da bo to omogočilo izkoristiti najširši možen trg in se izogniti razpršitvi omejenih virov, lahko Skupnost sprejme ukrepe v skladu z načelom subsidiarnosti iz člena 5 Pogodbe.
In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve this objective,
V skladu z načelom sorazmernosti iz istega člena, ta uredba ne prekoračuje okvirov, potrebnih za doseganje tega cilja —
Subject matter and definitions
Vsebina in opredelitev pojmov
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 the paediatric population to unnecessary clinical or other trials and in compliance with Directive 2001/20/EC.
Ta uredba določa pravila razvoja zdravil za uporabo v humani medicini z namenom, da se zadosti posebnim terapevtskim potrebam pediatrične populacije, ne da bi pri tem pediatrično populacijo izpostavljali nepotrebnim kliničnim ali drugim preskušanjem, ter v skladu z Direktivo 2001/20/ES.
In addition to the definitions laid down in Article 1 of Directive 2001/83/EC, the following definitions shall apply for the purposes of this Regulation:
Poleg opredelitev pojmov, določenih v členu 1 Direktive 2001/83/ES, se v tej uredbi uporabljajo naslednje opredelitve:
‘paediatric population’ means that part of the population aged between birth and 18 years;
„pediatrična populacija“ je del populacije od rojstva do dopolnjene starosti 18 let;
‘paediatric investigation plan’ means a research and development programme aimed at ensuring that the necessary data are generated determining the conditions in which a medicinal product may be authorised to treat the paediatric population;
„načrt pediatričnih raziskav“ je raziskovalni in razvojni program, katerega namen je, da se zagotovi zbiranje potrebnih podatkov, ki določajo pogoje, pod katerimi je lahko zdravilo odobreno za zdravljenje pediatrične populacije;
‘medicinal product authorised for a paediatric indication’ means a medicinal product which is authorised for use in part or all of the paediatric population and in respect of which the details of the authorised indication are specified in the summary of the product characteristics drawn up in accordance with Article 11 of Directive 2001/83/EC;
„zdravilo, odobreno za pediatrično indikacijo“ je zdravilo, ki je odobreno za uporabo pri delu ali pri celotni pediatrični populaciji in za katerega so podatki o odobreni indikaciji opredeljeni v povzetku glavnih značilnosti zdravila, sestavljenem v skladu s členom 11 Direktive 2001/83/ES;
‘paediatric use marketing authorisation’ means a marketing authorisation granted in respect of a medicinal product for human use which is not protected by a supplementary protection certificate under Regulation (EEC) No 1768/92 or by a patent which qualifies for the granting of the supplementary protection certificate, covering exclusively therapeutic indications which are relevant for use in the paediatric population, or subsets thereof, including the appropriate strength, pharmaceutical form or route of administration for that product.
„dovoljenje za promet za pediatrično uporabo“ je dovoljenje za promet, izdano za zdravilo za uporabo v humani medicini, ki ni zaščiteno z dodatnim varstvenim certifikatom v skladu z Uredbo (EGS) št. 1768/92 ali s patentom, ki omogoča podelitev dodatnega varstvenega certifikata za izključno terapevtske indikacije, ki so pomembne za uporabo pri pediatrični populaciji ali pri njenih delih, vključno s primerno jakostjo, farmacevtsko obliko ali potjo uporabe tega zdravila.
Paediatric committee
Odbor za pediatrijo
By 26 July 2007, a Paediatric Committee shall be established within the European Medicines Agency set up under Regulation (EC) No 726/2004, hereinafter ‘the Agency’.
Do 26. julija 2007 se ustanovi Odbor za pediatrijo v okviru Evropske agencije za zdravila, ustanovljene z Uredbo (ES) št. 726/2004, v nadaljevanju „Agencija“.
The Paediatric Committee shall be considered as established once the members referred to in Article 4(1)(a) and (b) have been appointed.
Odbor za pediatrijo je ustanovljen, ko so imenovani njegovi člani iz člena 4(1)(a) in (b).
The Agency shall fulfil the secretariat functions for the Paediatric Committee and shall provide it with technical and scientific support.
Agencija deluje kot sekretariat Odbora za pediatrijo in mu zagotavlja tehnično in znanstveno podporo.
Save where otherwise provided for in this Regulation, Regulation (EC) No 726/2004 shall apply to the Paediatric Committee, including the provisions on the independence and impartiality of its members.
Za Odbor za pediatrijo se uporablja Uredba (ES) št. 726/2004, razen če ni s to uredbo določeno drugače, vključno z določbami o neodvisnosti in nepristranskosti njegovih članov.
The Executive Director of the Agency shall ensure appropriate coordination between the Paediatric Committee and the Committee for Medicinal Products for Human Use, the Committee for Orphan Medicinal Products, their working parties and any other scientific advisory groups.
Izvršni direktor Agencije zagotavlja ustrezno sodelovanje Odbora za pediatrijo in Odbora za zdravila za uporabo v humani medicini ter Odbora za zdravila sirote, njihovih delovnih skupin ter vseh drugih skupin za znanstveno svetovanje.
The Agency shall draw up specific procedures for possible consultations between them.
Agencija pripravi akt o posebnih postopkih za morebitna posvetovanja med njimi.
The Paediatric Committee shall be composed of the following members:
Odbor za pediatrijo sestavljajo naslednji člani:
five members, with their alternates, of the Committee for Medicinal Products for Human Use, having been appointed to that Committee in accordance with Article 61(1) of Regulation (EC) No 726/2004.
pet članov Odbora za zdravila za uporabo v humani medicini in njihovi namestniki, ki so bili imenovani v navedeni Odbor v skladu s členom 61(1) Uredbe (ES) št. 726/2004.
These five members with their alternates shall be appointed to the Paediatric Committee by the Committee for Medicinal Products for Human Use;
Teh pet članov in njihove namestnike v Odbor za pediatrijo imenuje Odbor za zdravila za uporabo v humani medicini;
one member and one alternate appointed by each Member State whose national competent authority is not represented through the members appointed by the Committee for Medicinal Products for Human Use;
po en član in en namestnik, ki ga imenuje vsaka država članica, katere nacionalnih pristojnih organov ne zastopajo člani, ki jih je imenoval Odbor za zdravila za uporabo v humani medicini;
three members and three alternates appointed by the Commission, on the basis of a public call for expressions of interest, after consulting the European Parliament, in order to represent health professionals;
trije člani in trije namestniki, ki jih na podlagi javnega razpisa imenuje Komisija po posvetovanju z Evropskim parlamentom, da bi ti predstavljali zdravstvene delavce;
three members and three alternates appointed by the Commission, on the basis of a public call for expressions of interest, after consulting the European Parliament, in order to represent patient associations.
trije člani in trije namestniki, ki jih na podlagi javnega razpisa imenuje Komisija po posvetovanju z Evropskim parlamentom, da bi ti predstavljali združenja bolnikov.
The alternates shall represent and vote for the members in their absence.
Namestniki zastopajo člane in glasujejo v njihovem imenu, kadar so ti odsotni.
For the purposes of points (a) and (b), Member States shall cooperate, under the coordination of the Executive Director of the Agency, in order to ensure that the final composition of the Paediatric Committee, including members and alternates, covers the scientific areas relevant to paediatric medicinal products, and including at least: pharmaceutical development, paediatric medicine, general practitioners, paediatric pharmacy, paediatric pharmacology, paediatric research, pharmacovigilance, ethics and public health.
Za namene iz točk (a) in (b) izvršni direktor Agencije usklajuje sodelovanje držav članic, da bi se zagotovilo, da končna sestava Odbora za pediatrijo, vključno s člani in namestniki, zajema znanstvena področja, pomembna za pediatrična zdravila, in vključuje vsaj: farmacevtski razvoj, pediatrično medicino, splošne zdravnike, pediatrično farmacijo, pediatrično farmakologijo, pediatrične raziskave, farmakovigilanco, etiko in javno zdravje.
For the purposes of points (c) and (d), the Commission shall take into account the expertise provided by the members appointed under points (a) and (b).
Za namene točk (c) in (d) Komisija upošteva strokovna znanja članov, imenovanih na podlagi točk (a) in (b).
The members of the Paediatric Committee shall be appointed for a renewable period of three years.
Člani Odbora za pediatrijo so imenovani za obdobje treh let z možnostjo ponovnega imenovanja.
At meetings of the Paediatric Committee, they may be accompanied by experts.
Na sejah Odbora za pediatrijo jih lahko spremljajo tudi izvedenci.
The Paediatric Committee shall elect its Chairman from among its members for a term of three years, renewable once.
Odbor za pediatrijo izvoli predsednika izmed svojih članov za obdobje treh let, z možnostjo enkratnega podaljšanja mandata.
The names and qualifications of the members shall be made public by the Agency.
Agencija objavi imena in kvalifikacije članov.
When preparing its opinions, the Paediatric Committee shall use its best endeavours to reach a scientific consensus.
Pri pripravi mnenj si Odbor za pediatrijo po svojih najboljših močeh prizadeva doseči soglasje na znanstveni podlagi.
If such a consensus cannot be reached, the Paediatric Committee shall adopt an opinion consisting of the position of the majority of the members.
Če takega soglasja ni mogoče doseči, Odbor za pediatrijo sprejme mnenje, ki predstavlja stališče večine članov.
The opinion shall mention the divergent positions, with the grounds on which they are based.
V mnenju se navedejo različna stališča, vključno z njihovimi utemeljitvami.
This opinion shall be made accessible to the public pursuant to Article 25(5) and (7).
To mnenje je dostopno javnosti v skladu z odstavkoma 5 in 7 člena 25.
The Paediatric Committee shall draw up its rules of procedure for the implementation of its tasks.
Odbor za pediatrijo pripravi poslovnik za izvajanje svojih nalog.
The rules of procedure shall enter into force after receiving a favourable opinion from the Management Board of the Agency and, subsequently, from the Commission.
Poslovnik začne veljati po prejemu pozitivnega mnenja upravnega odbora Agencije in nato Komisije.
All meetings of the Paediatric Committee may be attended by representatives of the Commission, the Executive Director of the Agency or his representatives.
Predstavniki Komisije in izvršni direktor Agencije ali njegovi predstavniki se lahko udeležijo vseh sestankov Odbora za pediatrijo.
The tasks of the Paediatric Committee shall include the following:
Naloge Odbora za pediatrijo so:
to assess the content of any paediatric investigation plan for a medicinal product submitted to it in accordance with this Regulation and formulate an opinion thereon;
oceniti vsebino vsakega načrta pediatrične raziskave za zdravilo, ki mu je predložen v skladu s to uredbo in o tem oblikovati mnenje;
to assess waivers and deferrals and formulate an opinion thereon;
oceniti upravičenost opustitev in odlogov ter o njih oblikovati mnenje;
at the request of the Committee for Medicinal Products for Human Use, a competent authority or the applicant, to assess compliance of the application for a Marketing Authorisation with the agreed paediatric investigation plan concerned and formulate an opinion thereon;
na zahtevo Odbora za zdravila za uporabo v humani medicini, pristojnega organa ali vlagatelja oceniti skladnost vloge za dovoljenje za promet z zadevnim dogovorjenim načrtom pediatričnih raziskav in o tem oblikovati mnenje;
at the request of the Committee for Medicinal Products for Human Use or a competent authority, to assess any data generated in accordance with an agreed paediatric investigation plan and formulate an opinion on the quality, safety or efficacy of the medicinal product for use in the paediatric population;
na zahtevo Odbora za zdravila za uporabo v humani medicini ali pristojnega organa oceniti vse podatke, zbrane v skladu z dogovorjenim načrtom pediatričnih raziskav in oblikovati mnenje o kakovosti, varnosti ali učinkovitosti zdravila za uporabo pri pediatrični populaciji;
to advise on the content and format of data to be collected for the survey referred to in Article 42;
svetovati glede vsebine in oblike podatkov, ki se bodo zbirali za raziskavo iz člena 42;
to support and advise the Agency on establishing the European network referred to in Article 44;
podpirati Agencijo in ji svetovati glede uvedbe evropske mreže iz člena 44;
to assist scientifically in the elaboration of any documents related to the fulfilment of the objectives of this Regulation;
z znanstvenega vidika pomagati pri pripravi vseh dokumentov, povezanih z izpolnjevanjem ciljev te uredbe;
to provide advice on any question related to medicinal products for use in the paediatric population, at the request of the Executive Director of the Agency or the Commission;
na zahtevo izvršnega direktorja Agencije ali Komisije zagotoviti svetovanje glede vseh vprašanj v zvezi z zdravili za uporabo pri pediatrični populaciji;
to establish a specific inventory of paediatric medicinal product needs and update it on a regular basis, as referred to in Article 43;
oblikovati poseben seznam potreb po pediatričnih zdravilih in ga redno dopolnjevati, kot je navedeno v členu 43;
to advise the Agency and the Commission regarding the communication of arrangements available for conducting research into medicinal products for use in the paediatric population;
svetovati Agenciji in Komisiji glede obveščanja o ukrepih, ki so na voljo za izvajanje raziskav zdravil za uporabo pri pediatrični populaciji;
to make a recommendation to the Commission on the symbol referred to in Article 32(2).
Komisiji predlagati znak iz člena 32(2).
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 and/or fulfil a therapeutic need of the paediatric population.
Odbor za pediatrijo pri opravljanju svojih nalog preuči, ali lahko predlagane študije prinesejo pomembno terapevtsko korist in/ali zadovoljijo terapevtske potrebe pediatrične populacije.
The Paediatric Committee shall take into account any information available to it, including any opinions, decisions or advice given by the competent authorities of third countries.
Odbor za pediatrijo upošteva vse informacije, ki so mu na voljo, vključno z vsemi mnenji, sklepi ali nasveti, ki jih predložijo pristojni organi tretjih držav.
MARKETING AUTHORISATION REQUIREMENTS
ZAHTEVE GLEDE PRIDOBITVE DOVOLJENJA ZA PROMET
General authorisation requirements
Splošne zahteve glede dovoljenja