natgillin/translations-raw huggingface dataset:
predloži in izvaja sistem obvladovanja tveganja in/ali da izvede posebne post-marketinške študije kot pogoj za pridobitev dovoljenja za promet.
submit and implement a risk management system and/or perform specific post-marketing studies as a condition for the granting of the marketing authorisation.
Zaradi varovanja javnega zdravja je treba zagotoviti stalen dostop do varnih in učinkovitih zdravil, odobrenih za pediatrične indikacije, ki so bile razvite na osnovi te uredbe.
It is necessary in the interests of public health to ensure the continuing availability of safe and effective medicinal products authorised for paediatric indications developed as a result of this Regulation.
Če imetnik dovoljenja za promet namerava umakniti določeno zdravilo iz prometa, je treba zagotoviti, da bo pediatrična populacija še naprej imela dostop do zadevnega zdravila.
If a marketing authorisation holder intends to withdraw such a medicinal product from the market then arrangements should be in place so that the paediatric population can continue to have access to the medicinal product in question.
Da bi to dosegli, je treba Agencijo pravočasno obveščati o vseh takih namerah, ki jih je treba tudi objaviti.
In order to help achieve this, the Agency should be informed in good time of any such intention and should make that intention public.
Na odobritev te nagrade ne vpliva noben sklep organov držav članic glede določanja cen zdravil ali njihove vključitve v sistem nacionalnega zdravstvenega zavarovanja.
Any decisions by Member States' authorities as regards the setting of prices for medicinal products or their inclusion in the scope of national health insurance schemes have no bearing on the granting of this reward.
Vloga za podaljšanje veljavnosti certifikata v skladu s to uredbo naj bo sprejemljiva samo, če je bil certifikat izdan v skladu z Uredbo (EGS) št. 1768/92.
An application for an extension of the duration of the certificate pursuant to this Regulation should only be admissible where a certificate is granted pursuant to Regulation (EEC) No 1768/92.
Ker je nagrada namenjena izvajanju študij pri pediatrični populaciji in ne za prikaz, da je izdelek varen in učinkovit pri pediatrični populaciji, je treba nagrado zagotoviti tudi, če se pediatrična indikacija ne odobri.
Because the reward is for conducting studies in the paediatric population and not for demonstrating that a product is safe and effective in the paediatric population, the reward should be granted even when a paediatric indication is not authorised.
Vendar je za izboljšanje dostopnosti podatkov o uporabi zdravil pri pediatrični populaciji treba ustrezne podatke o uporabi pri pediatrični populaciji vključiti v podatke o odobrenem zdravilu.
However, to improve the information available on the use of medicinal products in the paediatric population, relevant information on use in paediatric populations should be included in authorised product information.
je zdravilom, ki so določena kot zdravila sirote, zagotovljena desetletna tržna ekskluzivnost na podlagi izdanega dovoljenja za promet za indikacijo sirota.
, medicinal products designated as orphan medicinal products gain ten years of market exclusivity on the granting of a marketing authorisation for the orphan indication.
Ukrepi, predvideni v tej uredbi, ne smejo onemogočiti drugih spodbud ali nagrad.
The measures provided for in this Regulation should not preclude the operation of other incentives or rewards.
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.
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.
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.
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.
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.
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.
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.
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.
Odbor za pediatrijo naj po posvetovanju s Komisijo, državami članicami in zainteresiranimi stranmi uvede seznam terapevtskih potreb pediatrične populacije in ga redno dopolnjuje.
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.
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.
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 ta način bodo podjetja lažje prepoznala možnosti za poslovni razvoj, Odbor za pediatrijo bo lahko bolje ocenil potrebo po zdravilih in študijah pri presoji osnutkov načrtov pediatričnih raziskav, opustitev in odlogov, strokovnjaki zdravstvenega varstva in bolniki pa bodo imeli na voljo vir informacij za pomoč pri njihovih odločitvah o izbiri zdravil.
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.
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.
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 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.
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.
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.
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.
Farmacevtska podjetja imajo lahko za določena odobrena zdravila že na voljo podatke o varnosti ali učinkovitosti pri pediatrični populaciji.
For certain authorised products, pharmaceutical companies may already hold data on safety or efficacy in the paediatric population.
Za izpopolnitev že dostopnih informacij o uporabi zdravil pri pediatričnih populacijah je treba od podjetij, ki imajo takšne podatke, zahtevati, da jih predložijo vsem pristojnim organom, kjer so zdravila odobrena.
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.
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.
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.
Treba je 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.
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.
Ukrepe, potrebne za izvajanje te uredbe,
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
treba sprejeti v skladu s Sklepom Sveta 1999/468/ES z dne 28. junija 1999 o določitvi postopkov za uresničevanje Komisiji podeljenih izvedbenih pooblastil UL L 184, 17.7.1999, str.
OJ L 184, 17.7.1999, p.
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.
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.
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.
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.
2) "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;
"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;
3) "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;
"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;
4) "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 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.
se ustanovi Odbor za pediatrijo v okviru Evropske agencije za zdravila, ustanovljene z Uredbo (ES) št. 726/2004, v nadaljevanju "Agencija".
, a Paediatric Committee shall be established within the European Medicines Agency set up under Regulation (EC) No 726/2004, hereinafter "the Agency".
Odbor za pediatrijo je ustanovljen, ko so imenovani njegovi člani iz člena 4(1)(a) in (b).
The Paediatric Committee shall be considered as established once the members referred to in Article 4(1)(a) and (b) have been appointed.
Agencija deluje kot sekretariat Odbora za pediatrijo in mu zagotavlja tehnično in znanstveno podporo.
The Agency shall fulfil the secretariat functions for the Paediatric Committee and shall provide it with technical and scientific support.
Za Odbor za pediatrijo se uporablja Uredba (ES) št. 726/2004, razen če ni s to uredbo določeno drugače
Save where otherwise provided for in this Regulation, Regulation (EC) No 726/2004 shall apply to the Paediatric Committee
, vključno z določbami o neodvisnosti in nepristranskosti njegovih članov
, including the provisions on the independence and impartiality of its members
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 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.
Agencija pripravi akt o posebnih postopkih za morebitna posvetovanja med njimi.
The Agency shall draw up specific procedures for possible consultations between them.
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.
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.
Teh pet članov in njihove namestnike v Odbor za pediatrijo imenuje Odbor za zdravila za uporabo v humani medicini;
These five members with their alternates shall be appointed to the Paediatric Committee 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;
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;
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 health professionals;
trije člani in trije namestniki, ki jih na podlagi javnega razpisa imenuje Komisija po posvetovanju z Evropskim parlamentom, da bi ti predstavljali združenja bolnikov.
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.
Namestniki zastopajo člane in glasujejo v njihovem imenu, kadar so ti odsotni.
The alternates shall represent and vote for the members in their absence.
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 (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 točk (c) in (d) Komisija upošteva strokovna znanja članov, imenovanih na podlagi točk (a) in (b).
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).
Člani Odbora za pediatrijo so imenovani za obdobje treh let z možnostjo ponovnega imenovanja.
The members of the Paediatric Committee shall be appointed for a renewable period of three years.
Na sejah Odbora za pediatrijo jih lahko spremljajo tudi izvedenci.
At meetings of the Paediatric Committee, they may be accompanied by experts.
Odbor za pediatrijo izvoli predsednika izmed svojih članov za obdobje treh let, z možnostjo enkratnega podaljšanja mandata.
The Paediatric Committee shall elect its Chairman from among its members for a term of three years, renewable once.
Agencija objavi imena in kvalifikacije članov.
The names and qualifications of the members shall be made public by the Agency.
To mnenje je dostopno javnosti v skladu z odstavkoma 5 in 7 člena 25.
This opinion shall be made accessible to the public pursuant to Article 25(5) and (7).
Odbor za pediatrijo pripravi poslovnik za izvajanje svojih nalog.
The Paediatric Committee shall draw up its rules of procedure for the implementation of its tasks.
Poslovnik začne veljati po prejemu pozitivnega mnenja upravnega odbora Agencije in nato Komisije.
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.
Predstavniki Komisije in izvršni direktor Agencije ali njegovi predstavniki se lahko udeležijo 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.
Naloge Odbora za pediatrijo so:
The tasks of the Paediatric Committee shall include the following:
oceniti vsebino vsakega načrta pediatrične raziskave za zdravilo, ki mu je predložen v skladu s to uredbo in o tem oblikovati mnenje;
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 upravičenost opustitev in odlogov ter o njih oblikovati mnenje;
to assess waivers and deferrals and formulate an opinion thereon;
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;
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;
svetovati glede vsebine in oblike podatkov, ki se bodo zbirali za raziskavo iz člena 42;
to advise on the content and format of data to be collected for the survey referred to in Article 42;
podpirati Agencijo in ji svetovati glede uvedbe evropske mreže iz člena 44;
to support and advise the Agency on establishing the European network referred to in Article 44;
z znanstvenega vidika pomagati pri pripravi vseh dokumentov, povezanih z izpolnjevanjem ciljev te uredbe;
to assist scientifically in the elaboration of any documents related to the fulfilment of the objectives of this Regulation;
na zahtevo izvršnega direktorja Agencije ali Komisije zagotoviti svetovanje glede vseh vprašanj v zvezi z zdravili za uporabo pri pediatrični populaciji;
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;
oblikovati poseben seznam potreb po pediatričnih zdravilih in ga redno dopolnjevati, kot je navedeno v členu 43;
to establish a specific inventory of paediatric medicinal product needs and update it on a regular basis, as referred to in Article 43;
svetovati Agenciji in Komisiji glede obveščanja o ukrepih, ki so na voljo za izvajanje raziskav zdravil za uporabo pri pediatrični populaciji;
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;
Komisiji predlagati znak iz člena 32(2).
to make a recommendation to the Commission on the symbol referred to in Article 32(2).