natgillin/translations-raw huggingface dataset:
Države članice v enem letu od začetka veljavnosti te uredbe sporočijo Komisiji podrobne podatke o vseh ukrepih, ki so jih sprejele za podporo raziskavam in razvoju ter dostopnosti zdravil za pediatrično uporabo.
Within one year of the entry into force of this Regulation, 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.
Ti podatki se na zahtevo Komisije redno posodabljajo.
This information shall be updated regularly at the request of the Commission.
Ta seznam se redno posodablja
This inventory shall be updated regularly
in je dostopen javnosti
and shall be accessible to the public
V letu po začetku veljavnosti te uredbe se oblikuje posebni evropski program za raziskave na področju zdravil za otroke z namenom podpore študijam, povezanim z obstoječimi farmacevtskimi izdelki oziroma obstoječimi aktivnimi snovmi, ki niso dodatno zaščiteni s patentom ali certifikatom.
Within one year of the adoption of this Regulation, a specific European programme for research into medicinal products for children shall be established to provide support for studies relating to existing pharmaceutical products or existing active substances not covered by a patent or a supplementary protection certificate.
Program Skupnosti se imenuje MICE (Medicines Investigation for the Children of Europe).
This Community programme shall be called MICE (Medicines Investigation for the Children of Europe).
Evropski parlament in Svet na predlog Komisije in v skladu s pogoji, določenimi s Pogodbo, sprejmeta finančna pravila v zvezi z oblikovanjem in delovanjem programa.
On a proposal from the Commission, the European Parliament and the Council shall, acting under the conditions laid down in the Treaty, adopt financial rules governing the establishment and operation of the programme.
Razpisi naj bodo, kolikor je le mogoče, osnovani na takšni ravni financiranja, ki bo omogočala celotno oziroma vsaj večinsko pokrivanje stroškov, nastalih med naročenimi študijami.
Calls for proposals shall, wherever possible, be based on a level of funding that will cover all, or at least a very large part of, the costs generated by the studies requested.
Naslov VI
TITLE VI
Sporočanje in koordinacija
Communication and coordination
Z odstopanjem od te določbe, agencija poskrbi, da je del teh informacij dostopen javnosti.
By way of derogation from the latter provision, the Agency shall arrange for part of this information to be accessible to the public.
Agencija objavi podrobnosti rezultatov vseh dokončanih študij, izvedenih v skladu z dogovorjenim načrtom pediatričnih raziskav, predčasno končanih ali ne, in tudi podrobnosti rezultatov vseh študij, ki so jih financirale Skupnost in države članice za podporo raziskovanja, razvoja in razpoložljivosti zdravil za pediatrično uporabo, vključno z vsemi študijami, ki jih financira program MICE, skupaj z, kjer je primerno, vsemi pomembnimi sklepi za zdravila v istem terapevtskem razredu, ki pokrivajo isto predlagano pediatrično uporabo.
Details of the results of all completed studies conducted in accordance with an agreed paediatric investigation plan, whether terminated prematurely or not, as well as details of the results of all studies funded by the Community and the Member States to support research into, and the development and availability of, medicinal products for paediatric use, including any studies funded by the MICE programme, shall be published by the Agency with, whenever applicable, all relevant conclusions for medicinal products in the same therapeutic class that cover the same proposed paediatric use.
Komisija na predlog agencije in v posvetovanjih z državami članicami in zainteresiranimi strankami pripravi smernico o naravi podatkov iz odstavka 1, ki se vnesejo v evropsko zbirko podatkov, ustanovljeno s členom 11 Direktive 2001/20/ES
The Commission shall, on a proposal by the Agency and in consultation with Member States and interested parties, 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,
, o vsebini podatkov, ki morajo biti dostopni javnosti pri uporabi odstavka 1 ter o odgovornostih in nalogah agencije v zvezi s tem.
on the content of the information to be made accessible to the public in application of paragraph 1 and on the Agency's responsibilities and tasks in this connection.
Pediatrične študije glede proizvodov, odobrenih v Skupnosti, ki so na dan začetka veljavnosti uredbe že dokončane, se predložijo v enem letu od začetka veljavnosti te uredbe v presojo pristojnemu organu.
Within one year of the entry into force of this Regulation, any paediatric studies already completed, by the date of entry into force, in respect of products authorised in the Community shall be submitted for assessment to the competent authority.
Pristojni organ, kot je to primerno, posodobi povzetek glavnih značilnosti proizvoda in navodila za uporabo in skladno spremeni dovoljenje za promet.
The competent authority shall, as appropriate, update the summary of product characteristics and package leaflet, and shall vary the marketing authorisation accordingly.
Pristojni organi si izmenjajo informacije glede predloženih študij in njihovih vplivov na katero koli dovoljenje za promet.
Competent authorities shall exchange information regarding the studies submitted and their implications for any marketing authorisations concerned.
Agencija koordinira izmenjavo informacij.
The Agency shall coordinate the exchange of information.
Odbor za pediatrijo pri presoji vlog za načrte pediatričnih preiskav,
All existing paediatric studies, as referred to in paragraph 1,
in odlogov ter pristojni organi pri presoji vlog, predloženih v skladu s
and deferrals and by competent authorities when assessing applications submitted pursuant to
členi 12, 13 ali 35
Articles 12, 13 or 35
Pri nagradah in spodbudah iz
No paediatric studies, as referred to in paragraph 1, which have at the date of entry into force of this Regulation already been submitted for assessment in a third country, shall be taken into consideration for the rewards and incentives provided for in
Prvi odstavek se uporablja ne glede na to, ali imetnik dovoljenja za promet namerava zaprositi za pediatrično indikacijo.
The first paragraph shall apply whether or not the marketing authorisation holder intends to apply for a paediatric indication.
Pristojni organ, kot je to primerno, posodobi povzetek glavnih značilnosti proizvoda in navodila za uporabo ter skladno spremeni dovoljenje za promet.
The competent authority shall, as appropriate, update the summary of product characteristics and package leaflet, and shall vary the marketing authorisation accordingly.
Pristojni organi si izmenjajo informacije glede predloženih študij in njihovih vplivov na zadevno dovoljenje za promet.
Competent authorities shall exchange information regarding the studies submitted and their implications for any marketing authorisations concerned.
Pristojbine, podpora skupnosti, kazni in poročila
Fees, Community funding, penalties and reports
Uporablja se Uredba Sveta (ES) št. 297/95
Council Regulation (EC) No 297/95
z dne 10. februarja 1995 o pristojbinah, ki se plačujejo Evropski agenciji za vrednotenje zdravil
of 10 February 1995 on fees payable to the European Agency for the Evaluation of Medicinal Products
UL L 35, 15.2.1995, str.
OJ L 35, 15.2.1995, p.
Uredba, kakor je bila nazadnje spremenjena z Uredbo Komisije (ES) št. 494/2003 (UL L 73, 19.3.2003, str.
Regulation as last amended by Commission Regulation (EC) No 494/2003 (OJ L 73, 19.3.2003, p.
Presoje Odbora za pediatrijo so brezplačne za:
Assessments of the following by the Paediatric Committee shall be free of charge:
vloge za odlog;
applications for deferral;
načrte pediatričnih preiskav;
paediatric investigation plans;
oceno skladnosti z dogovorjenim načrtom pediatričnih preiskav.
compliance with the agreed paediatric investigation plan.
Prispevek Skupnosti, opredeljen v členu 67 Uredbe (ES) št. 726/2004,
The Community contribution provided for in Article 67 of Regulation (EC) No 726/2004 shall
krije vidike
cover the
dela Odbora za pediatrijo, vključno z znanstveno podporo strokovnjakov, in agencije, vključno s presojo načrtov pediatričnih preiskav, znanstvenimi nasveti ter vsemi opustitvami pristojbin, opredeljenimi v tej uredbi, in podpira delovanje agencije v skladu s
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
členoma 5 in 45
Articles 5 and 45
Kazni so učinkovite, sorazmerne in odvračilne
The penalties shall be effective,
ter, kolikor je to možno, usklajene
proportionate, dissuasive and, wherever possible, harmonised
Države članice obvestijo Komisijo o teh določbah najpozneje do […].
Member States shall inform the Commission of these provisions no later than […].
Takoj, ko je mogoče, sporočijo naknadne spremembe.
They shall notify any subsequent alterations as soon as possible.
Države članice takoj obvestijo Komisijo o vsaki pravdi, začeti zaradi kršitve te uredbe.
Member States shall inform the Commission immediately of any litigation instituted for infringement of this Regulation.
Komisija lahko na prošnjo agencije naloži denarne kazni za kršitev določb te uredbe ali izvedbenih ukrepov, o zdravilih, odobrenih 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
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
(2) te uredbe.
(2) of this Regulation.
Komisija objavi imena vpletenih imetnikov dovoljenj za promet
The Commission shall publish the names of the marketing authorisation holders involved
in vseh, ki kršijo določbe te uredbe ali druge določbe, sprejete v skladu s to uredbo
, and also of anyone infringing the provisions of this Regulation or of any regulations adopted pursuant to it,
, ter zneske in razloge za naložene denarne kazni.
and the amounts of and reasons for the financial penalties imposed.
Komisija na podlagi poročila agencije in vsaj enkrat na leto objavi seznam podjetij, ki so prejela nagrade in spodbude iz te uredbe, in podjetij, ki niso izpolnila obveznosti iz te uredbe.
On the basis of a report from the Agency and at least on an annual basis, the Commission shall publish a list of the companies 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 zagotovijo agenciji te podatke.
The Member States shall provide this information to the Agency.
Komisija še zlasti opravi analizo nagrad in spodbud iz člena 40 in 41 s finančno oceno stroškov raziskav in dobička, doseženega zaradi teh spodbud.
The Commission shall, in particular, carry out an analysis of the incentive and reward operations under Articles 40 and 41, with a financial assessment relating to the research costs and profits resulting from such incentives.
Če analiza v sistemu odkrije neujemanje med rezultati raziskav ali dosežkov, se predlaga sprememba omenjenih členov.
Should the analysis show the mechanism to be ill-suited to the results sought or achieved, an amendment of the aforementioned articles shall be proposed.
Komisija po posvetovanju z agencijo sprejme primerne določbe za izvajanje nalog Odbora za pediatrijo iz
The Commission shall, after consulting the Agency, adopt appropriate provisions for the performance of the tasks of the Paediatric Committee referred to in
v obliki uredbe v skladu s postopkom iz
in the form of a Regulation in accordance with the procedure referred to in
Komisiji pomaga Stalni odbor za zdravila za humano uporabo, ustanovljen s členom 121 Direktive 2001/83/ES.
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.
Za sklicevanje na ta odstavek se uporabljata člena 5 in 7 Odločbe 1999/468/ES ob upoštevanju določb člena 8 Odločbe.
Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.
Obdobje, določeno v členu 5(6) Odločbe 1999/468/ES, je tri mesece.
The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months.
V členu 7 se doda odstavek 3:
In Article 7, the following paragraph 3 is added:
Vloga za podaljšanje veljavnosti že podeljenega certifikata z uporabo člena 13(3) te uredbe in iz
The application for an extension of the duration of a certificate already granted in application of Article 13(3) of this Regulation and of
člena 40
Article 40
*] se vloži najpozneje v
of the European Parliament and of the Council (Paediatric Regulation)*] shall be lodged not later than
šestih mesecih
six months
pred prenehanjem certifikata.
before the expiry of the certificate.
* UL L […], […], str. […].
* OJ L [...], [...], p. [...].
Člen 8 se spremeni:
Article 8 shall be amended as follows:
v odstavku 1 se doda naslednja točka (d):
in paragraph 1, the following point (d) is added:
Če prijava za certifikat vključuje prošnjo za podaljšanje veljavnosti z uporabo člena 13(3) te uredbe in
where the application for a certificate includes a request for an extended duration in application of Article 13(3) of this Regulation and
(Uredba o pediatriji)], se priloži:
(Paediatric Regulation)]:
kopija izjave o skladnosti z dogovorjenim načrtom pediatričnih preiskav iz
a copy of the statement indicating compliance with an agreed completed paediatric investigation plan as referred to in
(Uredba o pediatriji)];
(Paediatric Regulation)];
če je to potrebno, h kopiji dovoljenj za dajanje proizvoda v promet iz točke (b), kopije dovoljenj za dajanje proizvoda v promet v vseh drugih državah članicah, kot določa
where necessary, in addition to the copy of the authorisations to place the product on the market as referred to in point (b), copies of the authorisations to place the product on the market of all other Member States, as referred to in
člen 40
Article 40
(Uredba o pediatriji)].
(Paediatric Regulation)].
vstavi se naslednji odstavek 1a:
the following paragraph 1a is inserted:
Vloga za podaljšanje veljavnosti že podeljenega certifikata vsebuje:
The application for an extension of the duration of a certificate already granted shall contain:
kopijo že podeljenega certifikata;
a copy of the certificate already granted;
kopijo izjave o skladnosti z dogovorjenim načrtom pediatričnih preiskav iz
a copy of the statement indicating compliance with an agreed completed paediatric investigation plan as referred to in
kopije dovoljenj za dajanje proizvoda v promet v vseh državah članicah.
copies of the authorisations to place the product on the market of all Member States.
odstavek 2 se nadomesti:
paragraph 2 is replaced by the following:
Države članice lahko določijo plačilo pristojbine ob vložitvi prijave za izdajo certifikata in ob vložitvi prijave za podaljšanje veljavnosti certifikata.
Member States may provide that a fee is to be payable upon application for a certificate and upon application for the extension of the duration of a certificate.
Člen 9 se spremeni:
Article 9 is amended as follows:
v odstavku 1 se doda naslednji pododstavek:
in paragraph 1, the following subparagraph is added:
Prijava za podaljšanje veljavnosti že podeljenega certifikata se vloži pri pristojnem uradu za industrijsko lastnino v državi članici, ki je podelila certifikat.
The application for an extension of the duration of a certificate already granted shall be lodged with the competent industrial property office of the Member State which granted the certificate.
doda se naslednji odstavek 3:
the following paragraph 3 is added:
Uradno obvestilo mora dodatno vsebovati prošnjo za podaljšanje veljavnosti certifikata pri uporabi
The notification shall additionally contain the request for an extended duration of the certificate in application of
V členu 11 se doda naslednji odstavek 3:
In Article 11, the following paragraph 3 is added:
Odstavka 1 in 2 se uporabljata za uradno obvestilo o dejstvu, da je podaljšanje veljavnosti že podeljenega certifikata odobreno ali zavrnjeno.
Paragraphs 1 and 2 shall apply to the notification of the fact that an extension of the duration of a certificate already granted has been granted or rejected.
V členu 13 se doda naslednji odstavek 3:
In Article 13, the following paragraph 3 is added:
Obdobja, določena v odstavkih 1 in 2, se podaljšajo za šest mesecev v primeru uporabe
The periods laid down in paragraphs 1 and 2 shall be extended by six months in the case of application of
V tem primeru se obdobje, določeno v odstavku 1 tega člena, lahko podaljša samo enkrat.
In that case, the duration of the period laid down in paragraph 1 of this Article may be extended only once.
V členu 6 Direktive 2001/83/ES se prvi pododstavek odstavka 1 nadomesti:
In Article 6 of Directive 2001/83/EC, the first subparagraph of paragraph 1 is replaced by the following:
(Uredba o pediatriji)] Evropskega parlamenta in Sveta*.
the European Parliament and of the Council (Paediatric Regulation)*].
* UL L […], […], str. […].
* OJ L […], […], p. […].
Člen 56(1) se nadomesti z:
Article 56(1) is replaced by the following:
Odbor za zdravila za humano uporabo, ki je odgovoren za pripravo mnenj agencije o vseh vprašanjih v zvezi z oceno zdravil za humano uporabo;
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 mnenj agencije o vseh vprašanjih v zvezi z oceno zdravil za veterinarsko uporabo;
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 sirote;
the Committee on Orphan Medicinal Products;
Odbor za zeliščna zdravila;
the Committee on Herbal Medicinal Products;
Odbor za pediatrijo;
the Paediatric Committee;
Sekretariat, ki zagotavlja tehnično, znanstveno in administrativno podporo odborom in zagotavlja ustrezno sodelovanje med njimi;
a Secretariat, which shall provide technical, scientific and administrative support for the committees and ensure appropriate coordination between them;
Izvršilni direktor, ki izvršuje dolžnosti določene v členu 64;
an Executive Director, who shall exercise the responsibilities set out in Article 64;
Upravni odbor, ki izvršuje dolžnosti določene v členih 65, 66 in 67.
a Management Board, which shall exercise the responsibilities set out in Articles 65, 66 and 67.
Vstavi se naslednji člen 73a:
The following Article 73a is inserted:
Člen 73a
Article 73a
Odločitve agencije na podlagi z Uredbo (ES) št. …/
Decisions taken by the Agency under Regulation (EC) No […/
(Uredba o pediatriji)] Evropskega parlamenta in Sveta* so lahko predmet presoje Sodišča Evropskih skupnosti v skladu s pogoji, določenimi v členu 230 Pogodbe.
of the European Parliament and of the Council (Paediatric Regulation)*] may 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.
Končne določbe
final provisions
(1), se ne uporablja za veljavne vloge, ki so ob začetku veljavnosti te uredbe v postopku odločanja.
(1) shall not apply to valid applications pending at the time of entry into force of this Regulation.
Pediatrične študije, ki so se začele pred začetkom veljavnosti te uredbe in niso bile uporabljene za nobeno drugo presojo, se lahko vključijo v načrt pediatričnih preiskav
Paediatric studies initiated prior to the entry into force of this Regulation, and which have not been used for any other assessment, shall be eligible to be included in a paediatric investigation plan
Vloga, predložene v skladu s členoma 12 in 13, ki vsebuje ugotovitve iz sestavljenih študij z dogovorjenimi načrti pediatričnih preiskav, predloženimi agenciji pred začetkom veljavnosti te uredbe, se obravnava kot vloga v skladu s to uredbo, sprejeta odločitev pa se začne uporabljati z dnem, ko začne veljati uredba.
An application submitted pursuant to Articles 12 and 13 which contains findings from aggregate studies with agreed paediatric investigation plans and which has been submitted to the Agency before the entry into force of this Regulation shall be treated as an application under this Regulation and the resultant decision shall be applied from the date on which the Regulation enters into force.
od dneva začetka veljavnosti te uredbe.
following the date of entry into force of this Regulation.
Člena 35 in 36
Articles 35 and 36
6 mesecev od dneva začetka veljavnosti te uredbe.
6 months following the date of entry into force of this Regulation.
Zakonodajna resolucija Evropskega parlamenta o predlogu Direktive Sveta o spremembi Direktive 77/388/EGS glede poenostavitve obveznosti v zvezi z davkom na dodano vrednost ( KOM(2004)0728 – C6-0024/2005 – 2004/0261(CNS) )
European Parliament legislative resolution on the proposal for a Council directive amending Directive 77/388/EEC with a view to simplifying value added tax obligations ( COM(2004)0728 – C6-0024/2005 – 2004/0261(CNS) )
ob upoštevanju predloga Komisije Svetu ( COM(2004)0728 ) Še ni objavljeno v Uradnem listu.
having regard to the Commission proposal to the Council ( COM(2004)0728 ) Not yet published in OJ.
ob upoštevanju člena 93 Pogodbe ES, v skladu s katerim se je Svet posvetoval s Parlamentom ( C6-0024/2005 ),
having regard to Article 93 of the EC Treaty, pursuant to which the Council consulted Parliament ( C6-0024/2005 ),
ob upoštevanju poročila Odbora za ekonomske in monetarne zadeve ( A6-0228/2005 ),
having regard to the report of the Committee on Economic and Monetary Affairs ( A6-0228/2005 ),
Besedilo, ki ga predlaga Komisija Spremembe Parlamenta Sprememba 1 ČLEN 1, TOČKA 4 Člen 22 b, točka C, odstavek 1, pododstavek 2 (Direktiva 77/388/EGS)
Text proposed by the Commission Amendments by Parliament Amendment 1 ARTICLE 1, POINT 4 Article 22 b, point C, paragraph 1, subparagraph 2 (Directive 77/388/EEC)
Davčni zavezanec predloži potrebne podatke za registracijo po shemi enkratne obdavčitve
The taxable person shall provide the information necessary for his registration under the one-stop scheme
v jeziku države članice identifikacije
in the language of the Member State of identification
Sprememba 2 ČLEN 1, TOČKA 4 Člen 22 b, točka C, odstavek 2, pododstavek 1 (Direktiva 77/388/EGS) 2.
Amendment 2 Article 1, point 4 Article 22 b, point C, paragraph 2, subparagraph 1 (Directive 77/388/EEC) 2.
Država članica identifikacije registrira davčnega zavezanca iz odstavka 1 v
The Member State of identification shall register the taxable person referred to in paragraph 1 within
razumnem roku.
a reasonable period of time.
20 dneh.
20 days.
Sprememba 3
Amendment 3
ČLEN 1, TOČKA 4 Člen 22 b, točka C, odstavek 3 (Direktiva 77/388/EGS) 3.
Article 1, point 4 Article 22 b, point C, paragraph 3 (Directive 77/388/EEC) 3.
Vsak davčni zavezanec obvesti državo članico identifikacije
Every taxable person shall notify the Member State of identification
v 20 dneh
within 20 days
o vsaki morebitni spremembi podatkov registracije, ki so predloženi v skladu s členom 1.
of any modification of the registration data provided pursuant to paragraph 1.
Država članica identifikacije
The Member State of identification shall