natgillin/translations-raw huggingface dataset:
The first paragraph shall also apply where completion of the agreed paediatric investigation plan fails to lead to the authorisation of a paediatric indication, but the results of the studies conducted are reflected in the summary of product characteristics and, if appropriate, in the package leaflet of the medicinal product concerned.
Prvi odstavek se uporablja tudi, če izvedba dogovorjenega načrta pediatričnih raziskav ne privede do odobritve pediatrične indikacije, vendar se rezultati izvedenih študij odražajo v povzetku glavnih značilnosti zdravila in, če je to primerno, v navodilu za uporabo zadevnega zdravila.
Where a paediatric use marketing authorisation is granted in accordance with Articles 5 to 15 of Regulation (EC) No 726/2004, the data and marketing protection periods referred to in Article 14(11) of that Regulation shall apply.
Kadar je dovoljenje za promet za pediatrično uporabo izdano v skladu s členi 5 do 15 Uredbe (ES) št. 726/2004, veljata obdobji varstva podatkov in tržne zaščite iz člena 14(11) iste uredbe.
Where a paediatric use marketing authorisation is granted in accordance with the procedures laid down in Directive 2001/83/EC, the data and marketing protection periods referred to in Article 10(1) of that Directive shall apply.
Kadar je dovoljenje za promet za pediatrično uporabo izdano v skladu s postopki, določenimi v Direktivi 2001/83/ES, veljata obdobji varstva podatkov in tržne zaščite iz člena 10(1) navedene direktive.
In addition to the rewards and incentives provided for in Articles 36, 37 and 38, medicinal products for paediatric use may be eligible for incentives provided by the Community or by the Member States to support research into, and the development and availability of, medicinal products for paediatric use.
Zdravila za pediatrično uporabo so poleg nagrad in spodbud iz členov 36, 37 in 38 lahko upravičena do spodbud, ki jih Skupnost ali države članice namenjajo za podporo raziskavam, razvoju in dostopnosti zdravil za pediatrično uporabo.
By 26 January 2008, the Member States shall communicate to the Commission detailed information concerning any measures they have enacted to support research into, and the development and availability of, medicinal products for paediatric use.
Države članice do 26. januarja 2008 Komisiji sporočijo podrobne informacije o vseh ukrepih, ki so jih sprejele za podporo raziskavam, razvoju in dostopnosti zdravil za pediatrično uporabo.
This information shall be updated regularly at the request of the Commission.
Te informacije se na zahtevo Komisije redno dopolnjujejo.
By 26 July 2008, the Commission shall make publicly available a detailed inventory of all rewards and incentives provided by the Community and Member States to support research into, and the development and availability of, medicinal products for paediatric use.
Komisija do 26. julija 2008 omogoči javnosti dostop do podrobnega seznama vseh spodbud Skupnosti in držav članic za podporo raziskavam, razvoju in dostopnosti zdravil za pediatrično uporabo.
This inventory shall be updated regularly and the updates shall also be made publicly available.
Ta seznam se redno dopolnjuje, javnost pa ima dostop tudi do podatkov o dopolnitvah.
Funds for research into medicinal products for the paediatric population shall be provided for in the Community budget in order to support studies relating to medicinal products or active substances not covered by a patent or a supplementary protection certificate.
Finančna sredstva za raziskave zdravil za pediatrično populacijo se zagotovijo v proračunu Skupnosti kot podpora za študije o zdravilih ali učinkovinah, ki niso zaščitene s patentom ali dodatnim varstvenim certifikatom.
The Community funding referred to in paragraph 1 shall be delivered through the Community Framework Programmes for Research, Technological Development and Demonstration Activities or any other Community initiatives for the funding of research.
Financiranje Skupnosti iz odstavka 1 se izvaja preko okvirnih programov Skupnosti za raziskave, tehnološki razvoj in predstavitvene dejavnosti ali katerekoli druge pobude Skupnosti za financiranje raziskav.
COMMUNICATION AND COORDINATION
OBVEŠČANJE IN USKLAJEVANJE
The European database created by Article 11 of Directive 2001/20/EC shall include clinical trials carried out in third countries which are contained in an agreed paediatric investigation plan, in addition to the clinical trials referred to in Articles 1 and 2 of that Directive.
1. Evropska zbirka podatkov, vzpostavljena s členom 11 Direktive 2001/20/ES, poleg kliničnih preskušanj iz členov 1 in 2 navedene direktive vključuje tudi klinična preskušanja, ki se izvajajo v tretjih državah in so zajeta v dogovorjenem načrtu pediatričnih raziskav.
In the case of such clinical trials carried out in third countries, the details listed in Article 11 of that Directive shall be entered into the database by the addressee of the Agency's decision on a paediatric investigation plan.
V primeru teh kliničnih preskušanj ki se izvajajo v tretjih državah, se podrobnosti iz člena 11 navedene direktive vnesejo v podatkovno bazo s strani naslovnika sklepa Agencije o načrtu pediatričnih raziskav.
By way of derogation from the provisions of Article 11 of Directive 2001/20/EC, the Agency shall make public part of the information on paediatric clinical trials entered in the European database.
Z odstopanjem od določb člena 11 Direktive 2001/20/ES, Agencija objavi del podatkov o pediatričnih kliničnih preskušanjih, ki so vneseni v evropsko podatkovno bazo.
Details of the results of all the trials referred to in paragraph 1 and of any other trials submitted to competent authorities in compliance with Articles 45 and 46 shall be made public by the Agency, whether or not the trial was terminated prematurely.
Agencija objavi podrobnosti rezultatov vseh preskušanj iz odstavka 1 in vseh drugih preskušanj, ki so bili predloženi pristojnim organom v skladu s členoma 45 in 46, tudi če je bilo preskušanje predčasno zaključeno.
These results shall be submitted without delay to the Agency by the clinical trial sponsor, the addressee of the Agency's decision on a paediatric investigation plan, or by the marketing authorisation holder as appropriate.
Sponzor kliničnih preskušanj ali naslovnik sklepa Agencije o načrtu pediatričnih raziskav ali pa imetnik dovoljenja za promet Agenciji nemudoma predloži rezultate preskušanj.
In consultation with the Agency, Member States and interested parties, the Commission shall draw up guidance on the nature of the information referred to in paragraph 1 to be entered in the European database created by Article 11 of Directive 2001/20/EC, on which information shall be made accessible to the public in application of paragraph 1, on how clinical trial results shall be submitted and be made public in application of paragraph 2, and on the Agency's responsibilities and tasks in this regard.
Komisija v dogovoru z Agencijo, državami članicami in zainteresiranimi stranmi pripravi navodila glede vrste informacij iz odstavka 1, ki se vnesejo v evropsko zbirko podatkov, vzpostavljeno s členom 11 Direktive 2001/20/ES, na podlagi katere bodo podatki dostopni javnosti ob uporabi odstavka 1, glede načina predložitve ter objave rezultatov kliničnih preskušanj, kot je predvideno v odstavku 2, in glede odgovornosti in nalog Agencije v zvezi s tem.
Member States shall collect available data on all existing uses of medicinal products in the paediatric population and shall communicate these data to the Agency by 26 January 2009.
Države članice zberejo razpoložljive podatke o vseh obstoječih uporabah zdravil pri pediatrični populaciji in jih do 26. januarja 2009 sporočijo Agenciji.
The Paediatric Committee shall provide guidance on the content and the format of the data to be collected by 26 October 2007.
Odbor za pediatrijo do 26. oktobra 2007 poda navodila glede vsebine in oblike zbranih podatkov.
On the basis of the information referred to in Article 42 and after consulting the Commission, the Member States and the interested parties, the Paediatric Committee shall establish an inventory of therapeutic needs, in particular with a view to identifying research priorities.
Odbor za pediatrijo na podlagi informacij iz člena 42 in po posvetovanju s Komisijo, državami članicami in zainteresiranimi stranmi sestavi seznam terapevtskih potreb predvsem zato, da bi se določile raziskovalne prednostne naloge.
The Agency shall make the inventory public at the earliest by 26 January 2009 and at the latest by 26 January 2010 and shall update it regularly.
Agencija objavi seznam ne prej kot 26. januarja 2009 in najpozneje 26. januarja 2010 ter ga redno posodablja.
In establishing the inventory of therapeutic needs, account shall be taken of the prevalence of the conditions in the paediatric population, the seriousness of the conditions to be treated, the availability and suitability of alternative treatments for the conditions in the paediatric population, including the efficacy and the adverse reaction profile of those treatments, including any unique paediatric safety issues, and any data resulting from studies in third countries.
Pri sestavi seznama terapevtskih potreb se upošteva razširjenost obolenj v pediatrični populaciji, resnost obolenj, ki se jih zdravi, dostopnost in primernost alternativnih zdravljenj obolenj pri pediatrični populaciji, vključno z učinkovitostjo in profilom neželenih učinkov teh zdravljenj, skupaj z varnostnimi vidiki, ki se posebej nanašajo na pediatrijo, ter vse podatke, ki izhajajo iz študij tretjih držav.
The Agency shall, with the scientific support of the Paediatric Committee, develop a European network of existing national and European networks, investigators and centres with specific expertise in the performance of studies in the paediatric population.
Agencija z znanstveno podporo Odbora za pediatrijo razvija evropsko mrežo iz obstoječih nacionalnih in evropskih mrež, raziskovalcev in centrov s posebnim strokovnim znanjem za izvajanje študij pri pediatrični populaciji.
The objectives of the European network shall be, inter alia, to coordinate studies relating to paediatric medicinal products, to build up the necessary scientific and administrative competences at European level, and to avoid unnecessary duplication of studies and testing in the paediatric population.
Cilji evropske mreže so med drugim tudi usklajevanje študij v zvezi s pediatričnimi zdravili, vzpostavitev potrebne znanstvene in upravne pristojnosti na evropski ravni in izogibanje nepotrebnemu podvajanju študij in poskusov na pediatrični populaciji.
By 26 January 2008, 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.
Upravni odbor Agencije na predlog izvršnega direktorja in po posvetovanju s Komisijo, državami članicami in zainteresiranimi stranmi do 26. januarja 2008 sprejme izvedbeno strategijo za vzpostavitev in delovanje evropske mreže.
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.
Ta mreža mora, kjer je to primerno, delovati v skladu s krepitvijo temeljev Evropskega raziskovalnega prostora znotraj okvirnih programov Skupnosti na področju raziskav, tehnološkega razvoja in predstavitvenih dejavnosti.
By 26 January 2008, any paediatric studies already completed, by the date of entry into force, in respect of products authorised in the Community shall be submitted by the marketing authorisation holder for assessment to the competent authority.
Imetnik dovoljenja za promet do 26. januarja 2008 pristojnemu organu predloži v presojo vse na dan začetka veljavnosti že izvedene pediatrične študije v zvezi z zdravili, odobrenimi v Skupnosti.
The competent authority may update the summary of product characteristics and package leaflet, and may vary the marketing authorisation accordingly.
Pristojni organ lahko posodobi povzetek glavnih značilnosti zdravila in navodilo za uporabo ter na podlagi tega lahko ustrezno spremeni dovoljenje za promet.
Competent authorities shall exchange information regarding the studies submitted and, as appropriate, their implications for any marketing authorisations concerned.
Pristojni organi si izmenjujejo informacije glede predloženih študij in, če je to primerno, njihovih vplivov na katero koli zadevno dovoljenje za promet.
The Agency shall coordinate the exchange of information.
Agencija usklajuje izmenjavo informacij.
All existing paediatric studies, as referred to in paragraph 1, and all paediatric studies initiated prior to the entry into force of this Regulation shall be eligible to be included in a paediatric investigation plan, and shall be taken into consideration by the Paediatric Committee when assessing applications for paediatric investigation plans, waivers and deferrals and by competent authorities when assessing applications submitted pursuant to Article 7, 8 or 30.
Odbor za pediatrijo pri presoji vlog za načrte pediatričnih raziskav, opustitev in odlogov ter pristojni organi pri presoji vlog, predloženih v skladu s členi 7, 8 ali 30, upoštevajo vse obstoječe pediatrične študije, navedene v odstavku 1, in tudi pediatrične študije, ki so se začele izvajati pred začetkom uporabe te uredbe, ki so upravičene do vključitve v načrt pediatričnih raziskav.
Without prejudice to the previous paragraph, the rewards and incentives of Articles 36, 37 and 38 shall only be granted provided that significant studies contained in an agreed Paediatric Investigation Plan are completed after the entry into force of this Regulation.
Ne glede na predhodni odstavek se nagrade in spodbude iz členov 36, 37 in 38 dodelijo samo, če so bile pomembne študije iz dogovorjenega načrta pediatričnih raziskav zaključene po začetku veljavnosti te uredbe.
In consultation with the Agency, the Commission shall draw up guidelines to establish assessment criteria for the significance of studies for the purposes of applying paragraph 3.
V posvetovanju z agencijo Komisija pripravi smernice za določitev ocenjevalnih meril za pomen študij za namene uporabe odstavka 3.
Any other marketing authorisation holder-sponsored studies which involve the use in the paediatric population of a medicinal product covered by a marketing authorisation, whether or not they are conducted in compliance with an agreed paediatric investigation plan, shall be submitted to the competent authority within six months of completion of the studies concerned.
Vse druge študije, katerih sponzor je imetnik dovoljenja za promet in ki vključujejo uporabo zdravila, za katerega velja dovoljenje za promet, pri pediatrični populaciji, ne glede na to, ali so izvedene v skladu z dogovorjenim načrtom pediatričnih raziskav, se v šestih mesecih od izvedbe zadevnih študij predložijo pristojnemu organu.
Paragraph 1 shall apply independent of whether or not the marketing authorisation holder intends to apply for a marketing authorisation of a paediatric indication.
Odstavek 1 se uporablja ne glede na to, ali imetnik dovoljenja za promet namerava zaprositi za dovoljenje za promet pediatrične indikacije.
Fees, community funding, penalties and reports
Pristojbine, financiranje skupnosti, kazni in poročila
Where an application for a paediatric use marketing authorisation is submitted in accordance with the procedure laid down in Regulation (EC) No 726/2004, the amount of the reduced fees for the examination of the application and the maintenance of the marketing authorisation shall be fixed in accordance with Article 70 of Regulation (EC) No 726/2004.
Če je vloga za dovoljenje za promet za pediatrično uporabo vložena v skladu s postopkom, določenim v Uredbi (ES) št. 726/2004, se znesek znižane pristojbine za pregled vloge in ohranitev dovoljenja za promet določi v skladu s členom 70 Uredbe (ES) št. 726/2004.
Council Regulation (EC) No 297/95 of 10 February 1995 on fees payable to the European Medicines Agency [9] shall apply.
Uporablja se Uredba Sveta (ES) št. 297/95 z dne 10. februarja 1995 o pristojbinah, ki se plačujejo Evropski agenciji za zdravila [9].
Assessments of the following by the Paediatric Committee shall be free of charge:
Presoje Odbora za pediatrijo so brezplačne za:
applications for waiver;
vloge za opustitev;
applications for deferral;
vloge za odlog;
paediatric investigation plans;
načrte pediatričnih raziskav;
compliance with the agreed paediatric investigation plan.
oceno skladnosti z dogovorjenim načrtom pediatričnih raziskav.
The Community contribution provided for in Article 67 of Regulation (EC) No 726/2004 shall cover the work of the Paediatric Committee, including scientific support provided by experts, and of the Agency, including the assessment of paediatric investigation plans, scientific advice and any fee waivers provided for in this Regulation, and shall support the Agency's activities under Articles 41 and 44 of this Regulation.
S prispevkom Skupnosti, določenim v členu 67 Uredbe (ES) št. 726/2004, se krijejo stroški dela Odbora za pediatrijo, vključno z znanstveno podporo strokovnjakov in stroški Agencije, vključno s presojo načrtov pediatričnih raziskav, znanstvenim svetovanjem in vsemi opustitvami pristojbin, predvidenimi v tej uredbi, ter se podpira delovanje Agencije v skladu s členoma 41 in 44 te uredbe.
Without prejudice to the Protocol on the Privileges and Immunities of the European Communities, each Member State shall determine the penalties to be applied for infringement of the provisions of this Regulation or the implementing measures adopted pursuant to it in relation to medicinal products authorised through the procedures laid down in Directive 2001/83/EC and shall take all measures necessary for their implementation.
Ne glede na določbe Protokola o privilegijih in imunitetah Evropskih skupnosti vsaka država članica določi kazni za kršitve določb te uredbe ali izvedbenih ukrepov, sprejetih v skladu z njo, v zvezi z zdravili, odobrenimi po postopkih, določenih v Direktivi 2001/83/ES, ter sprejme vse potrebne ukrepe za njihovo izvajanje.
Member States shall inform the Commission of these provisions by 26 October 2007.
Države članice o teh določbah uradno obvestijo Komisijo najpozneje do 26. oktobra 2007.
They shall notify any subsequent alterations as soon as possible.
Takoj ko je to mogoče, sporočijo vse naknadne spremembe.
Member States shall inform the Commission immediately of any litigation instituted for infringement of this Regulation.
Države članice Komisijo nemudoma obvestijo o vsakem postopku, sproženem zaradi kršitve te uredbe.
At the Agency's request, the Commission may impose financial penalties for infringement of the provisions of this Regulation or the implementing measures adopted pursuant to it in relation to medicinal products authorised through the procedure laid down in Regulation (EC) No 726/2004.
Komisija lahko na zahtevo Agencije naloži denarne kazni za kršitve določb te uredbe ali izvedbenih ukrepov, sprejetih v skladu z njo, ki se nanašajo na zdravila, odobrena po postopku, določenem v Uredbi (ES) št. 726/2004.
The maximum amounts as well as the conditions and methods for collection of these penalties shall be laid down in accordance with the procedure referred to in Article 51(2) of this Regulation.
Najvišji zneski kakor tudi pogoji in načini za pobiranje teh kazni se določijo v skladu s postopkom iz člena 51(2) te uredbe.
The Commission shall make public the names of anyone infringing the provisions of this Regulation or of any implementing measures adopted pursuant to it and the amounts of, and reasons for, the financial penalties imposed.
Komisija objavi imena vseh, ki kršijo določbe te uredbe ali izvedbene ukrepe, sprejetih v skladu z njo, in zneske naloženih denarnih kazni ter razloge zanje.
On the basis of a report from the Agency, and at least on an annual basis, the Commission shall make public a list of the companies and of the products that have benefited from any of the rewards and incentives in this Regulation and the companies that have failed to comply with any of the obligations in this Regulation.
Komisija na podlagi poročila Agencije in vsaj enkrat na leto objavi seznam podjetij in zdravil, ki so prejela kakršne koli nagrade in spodbude iz te uredbe, in podjetij, ki niso izpolnila katere koli obveznosti iz te uredbe.
The Member States shall provide this information to the Agency.
Države članice te informacije posredujejo Agenciji.
By 26 January 2013, the Commission shall present to the European Parliament and the Council a general report on experience acquired as a result of the application of this Regulation.
Komisija do 26. januar 2013 Evropskemu parlamentu in Svetu predstavi splošno poročilo o izkušnjah, pridobljenih ob uporabi te uredbe.
This shall include in particular a detailed inventory of all medicinal products authorised for paediatric use since its entry into force.
To vključuje zlasti podroben seznam vseh zdravil, odobrenih za pediatrično uporabo, od začetka veljavnosti te uredbe.
By 26 January 2017, the Commission shall present a report to the European Parliament and the Council on the experience acquired as a result of the application of Articles 36, 37 and 38.
Komisija do 26. januar 2017 Evropskemu parlamentu in Svetu predloži poročilo o izkušnjah, pridobljenih z uporabo členov 36, 37 in 38.
The report shall include an analysis of the economic impact of the rewards and incentives, together with an analysis of the estimated consequences for public health of this Regulation, with a view to proposing any necessary amendments.
Poročilo vključuje analizo gospodarskih vplivov nagrad in spodbud, skupaj z analizo predvidenih posledic te uredbe za javno zdravje, da bi se lahko predlagale morebitne potrebne spremembe.
Provided that there are sufficient data available to allow robust analyses to be made, the provisions of paragraph 3 shall be fulfilled at the same time as the provisions of paragraph 2.
Če so na voljo zadostni podatki za izvedbo zanesljivih analiz, se določbe iz odstavka 3 izpolnijo istočasno kot določbe iz odstavka 2.
Standing committee
Stalni Odbor
The Commission shall be assisted by the Standing Committee on Medicinal Products for Human Use set up by Article 121 of Directive 2001/83/EC, hereinafter referred to as ‘the Committee’.
Komisiji pomaga Stalni odbor za zdravila za ljudi, ustanovljen s členom 121 Direktive 2001/83/ES, v nadaljevanju „Odbor“.
Regulation (EEC) No 1768/92 is hereby amended as follows:
Uredba (EGS) št. 1768/92 se spremeni, kakor sledi:
in Article 1, the following definition shall be added:
v členu 1 se doda opredelitev:
“Application for an extension of the duration” means an application for an extension of the duration of the certificate pursuant to Article 13(3) of this Regulation and of Article 36 of Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use.
‚prijava za podaljšanje veljavnosti‘ je prijava za podaljšanje veljavnosti certifikata v skladu s členom 13(3) te uredbe in členom 36 Uredbe (ES) št. 1901/2006 Evropskega parlamenta in Sveta z dne 12. decembra 2006 o zdravilih za pediatrično uporabo.
in Article 7, the following paragraphs shall be added:
v členu 7 se dodata nova odstavka:
The application for an extension of the duration may be made when lodging the application for a certificate or when the application for the certificate is pending and the appropriate requirements of Articles 8(1)(d) or 8(1a), respectively, are fulfilled.
Prijava za podaljšanje veljavnosti certifikata se lahko predloži skupaj s prijavo za izdajo certifikata ali ko je prijava za izdajo certifikata v postopku in so izpolnjeni ustrezni pogoji iz člena 8(1)(d) ali člena 8(1a).
The application for an extension of the duration of a certificate already granted shall be lodged not later than two years before the expiry of the certificate.
Prijava za podaljšanje veljavnosti že izdanega certifikata se vloži najpozneje dve leti pred iztekom veljavnosti certifikata.