natgillin/translations-raw huggingface dataset:
Sponzor kliničnih preskušanj ali naslovnik sklepa Agencije o načrtu pediatričnih raziskav ali pa imetnik dovoljenja za promet mora Agenciji nemudoma predložiti rezultate preskušanj.
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.
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.
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.
leti po
Two years
Agencija objavi seznam
Agency shall make the inventory public
ne prej kot …
at the earliest by ...
začetka veljavnosti te uredbe.
from the entry into force of this Regulation.
in najpozneje …
and at the latest by ...
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.
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.
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 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.
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.
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.
sprejme izvedbeno strategijo za vzpostavitev in delovanje evropske mreže.
, 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, 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.
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.
Imetnik dovoljenja za promet do…* pristojnemu organu predloži v presojo vse na dan začetka veljavnosti že izvedene pediatrične študije v zvezi z zdravili, odobrenimi v Skupnosti.
By …*, 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.
Pristojni organ lahko posodobi povzetek glavnih značilnosti zdravila in navodilo za uporabo ter na podlagi tega spremeni dovoljenje za promet.
The competent authority may update the summary of product characteristics and package leaflet, and may vary the marketing authorisation accordingly.
Pristojni organi si izmenjujejo informacije glede predloženih študij in, če je to primerno, njihovih vplivov na katero koli zadevno dovoljenje za promet.
Competent authorities shall exchange information regarding the studies submitted and, as appropriate, their implications for any marketing authorisations concerned.
Agencija usklajuje izmenjavo informacij.
The Agency shall coordinate the exchange of information.
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.
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.
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.
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.
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.
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.
Odstavek 1 se uporablja ne glede na to, ali imetnik dovoljenja za promet namerava zaprositi za dovoljenje za promet pediatrične indikacije.
Paragraph 1 shall apply independent of whether or not the marketing authorisation holder intends to apply for a marketing authorisation of a paediatric indication.
Pristojni organ lahko posodobi povzetek glavnih značilnosti zdravila in navodilo za uporabo ter na podlagi tega lahko ustrezno spremeni dovoljenje za promet.
The competent authority may update the summary of product characteristics and package leaflet, and may vary the marketing authorisation accordingly.
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.
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.
Uporablja se Uredba Sveta (ES) št. 297/95 z dne 10. februarja 1995 o pristojbinah, ki se plačujejo Evropski agenciji
Council Regulation (EC) No 297/95 of 10 February 1995 on fees payable to the European
za zdravila
Medicines Agency
Uredba, kakor je bila nazadnje spremenjena z Uredbo (ES) št. 1905/2005 (UL L 304, 23.11.
Regulation as last amended by Regulation (EC) No 1905/2005 (OJ
vloge za opustitev;
applications for waiver;
načrte pediatričnih raziskav;
paediatric investigation plans;
oceno skladnosti z dogovorjenim načrtom pediatričnih raziskav.
compliance with the agreed paediatric investigation plan.
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.
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.
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.
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.
Takoj ko je to mogoče, sporočijo vse naknadne spremembe.
They shall notify any subsequent alterations as soon as possible.
Države članice Komisijo nemudoma obvestijo o vsakem postopku, sproženem zaradi kršitve te uredbe.
Member States shall inform the Commission immediately of any litigation instituted for infringement of this Regulation.
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.
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.
Najvišji zneski kot tudi pogoji in načini za pobiranje teh kazni se določijo v skladu s postopkom iz člena 51(2) te uredbe.
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.
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.
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 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.
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.
Države članice te informacije posredujejo Agenciji.
The Member States shall provide this information to the Agency.
Evropskemu parlamentu in Svetu predstavi splošno poročilo o izkušnjah, pridobljenih ob uporabi te uredbe.
, 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.
To vključuje zlasti podroben seznam vseh zdravil, odobrenih za pediatrično uporabo, od začetka veljavnosti te uredbe.
This shall include in particular a detailed inventory of all medicinal products authorised for paediatric use since its entry into force.
* Evropskemu parlamentu in Svetu predloži poročilo o izkušnjah, pridobljenih z uporabo členov 36, 37 in 38.
*, 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.
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.
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.
Če so na voljo zadostni podatki za izvedbo zanesljivih analiz, se določbe iz odstavka 3 izpolnijo istočasno kot določbe iz odstavka 2.
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.
Komisiji pomaga Stalni odbor za zdravila za ljudi, ustanovljen s členom 121 Direktive 2001/83/ES, v nadaljevanju "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".
Uredba (EGS) št. 1768/92 se spremeni , kakor sledi:
Regulation (EEC) No 1768/92 is hereby amended as follows:
* UL L ..., ..., str. ... .
* OJ L …, …, p. ….
v členu 7 se dodata nova odstavka:
in Article 7, the following paragraphs shall be added:
Prijava za podaljšanje veljavnosti že izdanega certifikata se vloži najpozneje dve leti pred iztekom veljavnosti certifikata.
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.
Ne glede na odstavek 4 se pet let po začetku veljavnosti Uredbe (ES) št. …/…
Notwithstanding paragraph 4, for five years following the entry into force of Regulation (EC) No .../...
++ Obvestilo za UL: vstaviti številko te uredbe.
++ Note to OJ: Please insert number of this Regulation
prijava za podaljšanje veljavnosti že izdanega certifikata vloži najpozneje šest mesecev pred iztekom veljavnosti certifikata.
, the application for an extension of the duration of a certificate already granted shall be lodged not later than six months before the expiry of the certificate.
člen 8 se spremeni, kakor sledi:
Article 8 shall be amended as follows:
v odstavku 1 se doda naslednja točka:
in paragraph 1, the following point shall be added:
če prijava za certifikat vključuje tudi zahtevo za podaljšanje veljavnosti:
where the application for a certificate includes a request for an extension of the duration:
ii) če je to potrebno, poleg izvoda odobritve iz točke (b), da se da zdravilo na trg, dokazilo, da ima dovoljenje za dajanje zdravila v promet v vseh drugih državah članicah, kakor določa člen 36(3) Uredbe (ES) št. …/…+ .
where necessary, in addition to the copy of the authorisations to place the product on the market as referred to in point (b), proof that it has authorisations to place the product on the market of all other Member States, as referred to in Article 36(3) of Regulation (EC) No …/…+.
vstavita se naslednja odstavka:
the following paragraphs shall be inserted:
Kadar je prijava za certifikat v postopku, mora prijava za podaljšanje veljavnosti certifikata v skladu s členom 7(3) vsebovati podatke iz odstavka 1(d) in sklic na prijavo za certifikat, ki je bila že vložena.
Where an application for a certificate is pending, an application for an extended duration in accordance with Article 7(3) shall include the particulars referred to in paragraph 1(d) and a reference to the application for a certificate already filed.
Prijava za podaljšanje veljavnosti certifikata, ki je bil že izdan, vsebuje podatke iz odstavka 1(d) in kopijo certifikata, ki je bil že izdan.
The application for an extension of the duration of a certificate already granted shall contain the particulars referred to in paragraph 1(d) and a copy of the certificate already granted.
odstavek 2 se nadomesti z naslednjim: 2.
paragraph 2 shall be replaced by the following: 2.
člen 9 se spremeni, kakor sledi:
Article 9 shall be amended as follows:
v odstavku 1 se doda naslednji pododstavek:
in paragraph 1, the following subparagraph shall be added:
Prijava za podaljšanje veljavnosti že izdanega certifikata se vloži pri pristojnem organu zadevne države članice.
The application for an extension of the duration of a certificate shall be lodged with the competent authority of the Member State concerned.
v odstavku 2 se doda naslednja točka:
in paragraph 2, the following point shall be added:
f) kadar je potrebno, navedbo, da prijava vključuje prijavo za podaljšanje veljavnosti.
where applicable, an indication that the application includes an application for an extension of the duration.
doda se novi odstavek: 3.
the following paragraph shall be added: 3.
Odstavek 2 se uporablja za obvestilo o vložitvi prijave za podaljšanje veljavnosti že podeljenega certifikata ali če je prijava za certifikat v postopku.
Paragraph 2 shall apply to the notification of the application for an extension of the duration of a certificate already granted or where an application for a certificate is pending.
Obvestilo dodatno vsebuje navedbo o prijavi za podaljšanje veljavnosti certifikata.
The notification shall additionally contain an indication of the application for an extended duration of the certificate.
v členu 10 se doda nov odstavek:
in Article 10, the following paragraph shall be added:
Odstavki 1 do 4 se smiselno uporabljajo za prijavo za podaljšanje veljavnosti.
Paragraphs 1 to 4 shall apply mutatis mutandis to the application for an extension of the duration.
v členu 11 se doda naslednji odstavek:
in Article 11, the following paragraph shall be added:
v členu 13 se doda naslednji odstavek:
in Article 13, the following paragraph shall be added:
Preklic podaljšanja veljavnosti
Revocation of an extension of the duration
Podaljšanje veljavnosti se lahko prekliče, če je bilo odobreno v nasprotju z določbami člena 36 Uredbe (ES) št. .../... + Obvestilo za UL: vstaviti številko te uredbe.
The extension of the duration may be revoked if it was granted contrary to the provisions of Article 36 of Regulation (EC) No …/… + Note to OJ: Please insert number of this Regulation.
Katera koli oseba lahko organu, ki je po nacionalni zakonodaji odgovoren za preklic ustreznega osnovnega patenta, predloži prijavo za preklic podaljšanja veljavnosti
Any person may submit an application for revocation of the extension of the duration to the body responsible under national law for the revocation of the corresponding basic patent.
člen 16 se spremeni, kakor sledi:
Article 16 shall be amended as follows:
besedilo člena 16 postane odstavek 1,
the text of Article 16 becomes paragraph 1;
doda se naslednji odstavek: 2.
the following paragraph shall be added: 2.
Če je podaljšanje veljavnosti preklicano v skladu s členom 15a, organ iz člena 9(1) o tem objavi uradno sporočilo.
If the extension of the duration is revoked in accordance with Article 15a, notification thereof shall be published by the authority referred to in Article 9(1).
člen 17 se nadomesti z naslednjim:
Article 17 shall be replaced by the following:
V členu 11 Direktive 2001/20/ES se doda naslednji odstavek:
In Article 11 of Directive 2001/20/EC, the following paragraph shall be added:
Z odstopanjem od odstavka 1, Agencija objavi del podatkov o pediatričnih kliničnih preskušanjih, ki so vneseni v evropsko zbirko podatkov, v skladu z določbami Uredbe (ES) št. …/… + Obvestilo za UL: vstaviti datum in številko te uredbe.
By way of derogation from paragraph 1, the Agency shall make public part of the information on paediatric clinical trials entered in the European database in accordance with the provisions of Regulation (EC) No …/… + Note to OJ: Please insert number and date of this Regulation.
V členu 6 Direktive 2001/83/ES se besedilo prvega pododstavka odstavka 1 nadomesti z naslednjim:
In Article 6 of Directive 2001/83/EC, the first subparagraph of paragraph 1 shall be replaced by the following:
Evropskega parlamenta in Sveta z dne … o zdravilih za pediatrično uporabo
of the European Parliament and of the Council of ... on medicinal products for paediatric use
Uredba (ES) št. 726/2004 se spremeni, kakor sledi:
Regulation (EC) No 726/2004 is hereby amended as follows:
člen 56(1) se nadomesti z naslednjim:
Article 56(1) shall be replaced by the following:
Odbor za zdravila za uporabo v humani medicini, ki je odgovoren za pripravo mnenja Agencije o kakršnem koli vprašanju, ki se nanaša na vrednotenje zdravil za uporabo v humani medicini;
the Committee for Medicinal Products for Human Use, which shall be responsible for preparing the opinion of the Agency on any question relating to the evaluation of medicinal products for human use;
Odbor za zdravila za veterinarsko uporabo, ki je odgovoren za pripravo mnenja Agencije o kakršnem koli vprašanju, ki se nanaša na vrednotenje zdravil za uporabo v veterinarski medicini;
the Committee for Medicinal Products for Veterinary Use, which shall be responsible for preparing the opinion of the Agency on any question relating to the evaluation of medicinal products for veterinary use;
Odbor za zdravila rastlinskega izvora;
the Committee on Herbal Medicinal Products;
sekretariat, ki daje tehnično, znanstveno in upravno podporo odborom in zagotavlja njihovo ustrezno medsebojno koordinacijo;
a Secretariat, which shall provide technical, scientific and administrative support for the committees and ensure appropriate coordination between them;
izvršni direktor, ki izvršuje odgovornosti, določene v členu 64;
an Executive Director, who shall exercise the responsibilities set out in Article 64;
uprava, ki izvršuje odgovornosti, določene v členih 65, 66 in 67.
a Management Board, which shall exercise the responsibilities set out in Articles 65, 66 and 67.
v členu 57(1) se doda naslednja točka:
in Article 57(1), the following point shall be added:
sprejemanje odločitev iz člena 7(1) Uredbe (ES) št. … + Obvestilo za UL: vstaviti datum in številko te uredbe.
taking decisions as referred to in Article 7(1) of Regulation (EC) No …/… + Note to OJ: Please insert number and date of this Regulation.
vstaviti številko
to OJ: Please insert number of this Regulation.
so lahko predmet tožbe pred Sodiščem Evropskih skupnosti pod pogoji, določenimi v členu 230 Pogodbe.
form the subject of an action before the Court of Justice of the European Communities under the conditions laid down in Article 230 of the Treaty.