natgillin/translations-raw huggingface dataset:
Upravni odbor agencije na predlog izvršnega direktorja in ob upoštevanju posvetovanj s Komisijo, državami članicami in zainteresiranimi strankami v enem letu od začetka veljavnosti te uredbe sprejme izvedbeno strategijo za zagon in delovanje evropske mreže.
Within one year of the entry into force of this Regulation, 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.
ČLEN 44, ODSTAVEK 2
ARTICLE 44, PARAGRAPH 2
Odbor za pediatrijo pri presoji vlog za načrte pediatričnih preiskav, opustitev in odlogov ter pristojni organi pri presoji vlog, predloženih v skladu s členi 8, 9 ali 31, upoštevajo vse obstoječe študije, opisane v odstavku 1.
All existing paediatric studies, as referred to in paragraph 1, 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 Articles 8, 9 or 31.
Predlog ne sme zavirati izvajanja kratkoročnih pediatričnih študij.
The proposal must not be a disincentive to conduct paediatric studies in the short term.
Ta predlog spremembe pojasni, da se bodo pediatrične raziskave, ki so se začele pred začetkom veljavnosti te uredbe in niso bile predložene v presojo v tretji državi, obravnavale kot del dogovorjenega načrta pediatričnih raziskav, ko bo Uredba sprejeta.
This amendment would clarify that paediatric investigations initiated prior to entry into force of the Regulation and not submitted for assessment in a third country will be considered as part of an agreed paediatric investigation plan once the Regulation is adopted.
ČLEN 47
ARTICLE 47
Prispevek Skupnosti, opredeljen v členu 67 Uredbe (ES) št. 726/2004, krije vse vidike 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 členoma 40 in 43 te uredbe.
The Community contribution provided for in Article 67 of Regulation (EC) No 726/2004 shall cover all aspects of 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 40 and 43 of this Regulation.
Prispevek Skupnosti, opredeljen v členu 67 Uredbe (ES) št. 726/2004, krije vidike 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 členoma 40 in 43 te uredbe.
The Community contribution provided for in Article 67 of Regulation (EC) No 726/2004 shall cover the aspects of 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 40 and 43 of this Regulation.
Razen tega se ustanovi poseben program za farmacevtske raziskave v pediatriji, ki bo za raziskovanje zdravil brez patenta uporabljal vire zdravstvene politike.
In addition, a special paediatric study programme shall be established, using health policy resources, for research on off-patent medicines.
Finančne spodbude in podpora raziskavam zdravil brez patenta so pomembne zlasti na področju pediatričnih zdravil.
In particular in the area of paediatric medicinal products, financial incentives and support for research on off-patent medicines are essential.
ČLEN 47 A (novo)
ARTICLE 47 A (new)
Člen 47a
Article 47a
Prispevek Skupnosti bo podprl tudi študije, opravljene v okviru programa MICE, v katerih bodo akademske raziskave igrale pomembno vlogo.
The Community contribution will also support studies performed in the context of the MICE programme in which academic research will have a substantial role to play.
Kljub razpoložljivemu strokovnemu znanju je vedno težje opredeljevati sredstva, potrebna za izvedbo sodelovalnih mednarodnih študij, potrebnih za oceno novih zdravljenj.
Despite the expertise available, it is proving increasingly difficult to identify the resources necessary to undertake the collaborative international studies required for the evaluation of new therapies.
Prepričani smo, da obstaja veliko bolj trden pristop k statusu zdravil, ki niso dovoljena in so brez patenta.
We believe that there must be a much more robust approach to the status of drugs that are unlicensed and out of patent.
Prepričani smo, da mora celovit načrt za izboljšanje pediatričnih raziskav v Evropi presegati financiranje usklajevalne vloge agencije, in ni primerno, da se ti vidiki v celoti prepustijo neopredeljeni prihodnji zakonodaji.
We believe that a comprehensive plan to improve paediatric research in Europe must go beyond funding the coordination role of the Agency, and that to leave these aspects entirely to undefined future legislation is inappropriate.
Skrbi nas, da bi sedanji predlog predvsem spodbujal pediatrični razvoj novih zdravil in/ali zdravil, še vedno zavarovanih s patentom, ki ne bi imel velikega vpliva na status zdravil, ki niso dovoljena in niso več zavarovana s patentnim ali dodatnim varstvom.
We are concerned that the current proposal would mainly stimulate paediatric development of new and/or still patent protected drugs, with little influence on the status of drugs which are unlicensed and no longer covered by patent or supplementary protection.
ČLEN 48, ODSTAVEK 1, PODODSTAVEK 1
ARTICLE 48, PARAGRAPH 1, SUBPARAGRAPH 1
Brez poseganja v Protokol o privilegijih in imunitetah Evropskih skupnosti, vsaka država članica določi kazni za kršitve določb te uredbe ali izvedbenih ukrepov, sprejetih v skladu z njo o zdravilih, odobrenih po postopkih, določenih v Direktivi 2001/83/ES, ter zagotovi 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.
Kazni so učinkovite, sorazmerne in odvračilne.
The penalties shall be effective, proportionate and dissuasive.
Kazni so učinkovite, sorazmerne in odvračilne ter, kolikor je to možno, usklajene.
The penalties shall be effective, proportionate , dissuasive and, wherever possible, harmonised .
Velika pomena je, da pri izvajanju evropskih predpisov v vsaki od držav članic veljajo enake kazni.
Any penalties imposed in connection with implementation of a Regulation should be the same in every Member State.
ČLEN 48, ODSTAVEK 4
ARTICLE 48, PARAGRAPH 4
Komisija objavi imena vpletenih imetnikov dovoljenj za promet in zneske ter razloge za naložene denarne kazni.
The Commission shall publish the names of the marketing authorisation holders involved and the amounts of and reasons for the financial penalties imposed.
Komisija objavi imena vpletenih imetnikov dovoljenj za promet in vseh, ki kršijo določbe te Uredbe ali druge določbe, sprejete v skladu s to Uredbo , ter zneske in razloge za naložene denarne kazni.
The Commission shall publish the names of the marketing authorisation holders involved , and also of anyone infringing the provisions of this Regulation or of any regulations adopted in accordance with it, and the amounts of and reasons for the financial penalties imposed.
ČLEN 49, ODSTAVEK 2
ARTICLE 49, PARAGRAPH 2
Komisija v 6 letih od začetka veljavnosti te uredbe objavi splošno poročilo o izkušnjah, pridobljenih z njeno uporabo, ki vključuje zlasti podrobni seznam vseh odobrenih zdravil za pediatrično uporabo od začetka njene veljavnosti.
Within six years of entry into force of this Regulation, the Commission shall publish a general report on experience acquired as a result of its application, including in particular a detailed inventory of all medicinal products authorised for paediatric use since its entry into force.
Komisija še zlasti opravi analizo nagrad in spodbud iz člena 36 in 37 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 36 and 37, 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 spremembo 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.
ČLEN 52, TOČKA (1)
ARTICLE 52, POINT (1)
Člen 7, odstavek 3 (Uredba (EGS) št. 1768/92)
Article 7, paragraph 3 (Regulation (EEC) No 1768/92)
Vloga za podaljšanje veljavnosti že podeljenega certifikata z uporabo člena 13(3) te uredbe in iz člena 36 Uredbe (ES) št. […/… Evropskega parlamenta in Sveta (Uredba o pediatriji) *] se vloži najpozneje v dveh letih pred prenehanjem certifikata.
The application for an extension of the duration of a certificate already granted in application of Article 13(3) of this Regulation and of Article 36 of Regulation (EC) No […/… of the European Parliament and of the Council (Paediatric Regulation)*] shall be lodged not later than two years before the expiry of the certificate.
Vloga za podaljšanje veljavnosti že podeljenega certifikata z uporabo člena 13(3) te uredbe in iz člena 36 Uredbe (ES) št. […/… Evropskega parlamenta in Sveta (Uredba o pediatriji) *] se vloži najpozneje v šestih mesecih pred prenehanjem certifikata.
The application for an extension of the duration of a certificate already granted in application of Article 13(3) of this Regulation and of Article 36 of Regulation (EC) No […/… of the European Parliament and of the Council (Paediatric Regulation)*] shall be lodged not later than six months before the expiry of the certificate.
Predlagani dveletni rok za vložitev vloge bi bil preveč omejujoč.
The proposed two-year deadline for lodging an application would seem to be too restrictive.
ČLEN 55
ARTICLE 55
Zahteva, določena v členu 8(1), se ne uporablja za veljavne vloge, ki so ob začetku veljavnosti te uredbe v postopku odločanja.
The requirement laid down in Article 8(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, so upravičene za vključitev 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 .
Uredba ne sme zadrževati razvoja novih zdravil.
The Regulation must not delay the development of new medicines.
Pediatrične študije, ki so se začele pred začetkom veljavnosti te uredbe in niso bile uporabljene za presojo v drugem okviru, se štejejo kot del veljavnega načrta pediatričnih preiskav.
Paediatric studies initiated prior to entry into force of the Regulation and not used for assessment in another context shall be considered as part of a valid paediatric investigation plan.
Ta uredba začne veljati trideseti dan po objavi v Uradnem listu Evropske unije.
This Regulation shall enter into force on the thirtieth day following that of its publication in the Official Journal of the European Union .
Vloge, predložene v skladu s členoma 8 in 9, ki vsebujejo ugotovitve iz sestavljenih študij z dogovorjenimi načrti pediatričnih preiskav, predloženimi agenciji pred začetkom veljavnosti te uredbe, se obravnavajo kot vloga v skladu s to uredbo in posledična odločitev se začne uporabljati z dnem, ko Direktiva začne veljati.
Applications submitted pursuant to Articles 8 and 9 which contain findings from aggregate studies with agreed paediatric investigation plans which have 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 directive enters into force.
Če so bile sestavljene študije z dogovorjenim načrtom pediatričnih preiskav že opravljene in predložene agenciji pred začetkom veljavnosti Uredbe, je treba določiti prehodne ureditve, da ne bi preprečevali pediatričnih preiskav in neugodne obravnave primerov, že uporabljenih v kliničnih preskusih za odobritev zdravil.
In the event that aggregate studies with agreed paediatric investigation plans have already been undertaken and have been submitted to the Agency before the entry into force of the Regulation, provision should be made for transitional arrangements so as not to discourage paediatric research and unfavourable treatment of cases which have already engaged in clinical trials for the authorisation of medicinal products.
ČLEN 56, ODSTAVEK 2
ARTICLE 56, PARAGRAPH 2
Člen 8 se uporablja od … [ 18 meseca po začetku veljavnosti].
Article 8 shall apply from … [ 18 months following the entry into force].
Člen 8 se uporablja od … [ 12. meseca po začetku veljavnosti].
Article 8 shall apply from … [ 12 months following the entry into force].
Člen 9 se uporablja od … [ 18. meseca po začetku veljavnosti].
Article 9 shall apply from … [ 18 months following the entry into force].
Člena 31 in 2 se uporabljata od … [6 meseca po začetku veljavnosti].
Articles 31 and 32 shall apply from … [6 months following the entry into force].
Primerno je, da se pospeši izvajanje členov 8 in 9.
It is appropriate to speed up the implementation of Articles 8 and 9.
Če Komisija začne potrebno pripravljalno delo v skladu s členom 11 takoj po začetku veljavnosti te uredbe, so roki lahko krajši.
If the Commission starts the necessary preparatory work in accordance with Article 11 soon after the entry into force of this Regulation, the deadlines can be shorter.
Odboru za okolje, javno zdravje in varno hrano
for the Committee on the Environment, Public Health and Food Safety
o predlogu Uredbe Evropskega parlamenta in Sveta o zdravilih za pediatrično uporabo in spremembah Uredbe (EGS) št. 1768/92, Direktive 2001/83/ES in Uredbe (ES) št. 726/2004
on the proposal for a Regulation of the European Parliament and the Council on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/83/EC and Regulation (EC) No 726/2004
Še neobjavljeno v UL.
Not yet published in Official Journal.
Odbor za pediatrijo bi moral biti primarno odgovoren za presojo in dogovor o načrtih pediatričnih preiskav ter za sistem opustitev in odlogov ter biti tudi središče za različne podporne ukrepe, ki so vsebovani v tej uredbi.
The Paediatric Committee should be primarily responsible for the assessment and agreement of paediatric investigation plans and for the system of waivers and deferrals thereof , and it should also be central to various support measures contained in this Regulation.
Pri vsem svojem delu bi odbor za pediatrijo moral upoštevati potencialno pomembne terapevtske koristi študij pri otrocih, vključno s potrebo po izogibanju nepotrebnim študijam.
In all its work the Paediatric Committee should consider the potential significant therapeutic benefits of studies in children including the need to avoid unnecessary studies.
Moral bi slediti obstoječim zahtevam Skupnosti, vključno z Direktivo 2001/20/ES kot tudi smernico E11 Mednarodne konference o usklajevanju (ICH) o razvoju zdravil za otroke ter se izogniti vsaki zamudi pri odobritvi zdravil za druge populacije, ki je lahko posledica zahtev za študije pri otrocih.
It should follow existing Community requirements, including Directive 2001/20/EC, as well as International Conference on Harmonisation (ICH) guideline E11 on the development of medicines for children, and it should avoid any delay in the authorisation of medicines for other populations as a result of the requirements for studies in children.
Odbor za pediatrijo bi moral biti primarno odgovoren za presojo in dogovor o načrtih pediatričnih preiskav ter za sistem opustitev in odlogov ; za to mora biti Odbor neodvisen od farmacevtske industrije in mora imeti člane s priznanimi in dokumentiranimi mednarodnimi izkušnjami in znanjem v tej industriji.
The Paediatric Committee should be primarily responsible for the assessment and agreement of paediatric investigation plans and for the system of waivers and deferrals thereof ; to do this the Committee must be independent of the pharmaceutical industry and be composed of members with recognised and documented international-level experience and knowledge of that industry.
Moral bi biti tudi središče za različne podporne ukrepe, ki so vsebovani v tej uredbi.
It should also be central to various support measures contained in this Regulation.
Zato je treba načrte pediatričnih preiskav predložiti na začetku razvoja proizvoda, dovolj zgodaj, da se lahko izvedejo študije pri otrocih in, če je možno , preden se predložijo vloge za dovoljenje za promet.
Thus, paediatric investigation plans should be submitted early during product development, in time for studies to be conducted in children , and, wherever possible, before marketing authorisation applications are submitted.
UVODNA IZJAVA 11 a (novo)
RECITAL 11 a (new)
(11a) Glede na dejstvo, da se 50% zdravil za pediatrično uporabo ne testira, je treba v okviru raziskovalnih programov Skupnosti predvideti sredstva za financiranje raziskav zdravil za pediatrično uporabo, ki niso vključena v patentu ali dodatnem varstvenem certifikatu.
(11a) In view of the fact that 50% of medicinal products for paediatric use have not been tested, provision should be made for funding for research on medicines for paediatric use which are not patent-protected or do not have supplementary protection certification to be financed under Community research programmes.
Potrebno je ustanoviti MICE (Medicines Investigation for the Children of Europe).
It is necessary to establish the MICE (Medicines Investigation for the Children of Europe ).
V izjemnih primerih, ki jih povzročijo upravne zamude, lahko pristojni organ odobri odstopanje od tega roka.
The competent authorities should be able, in specific cases affected by administrative delays, to grant derogations from this provision.
ČLEN 4 a (novo)
ARTICLE 4 A (new)
Ustanovljen bo MICE (Medicines Investigation for the Children of Europe), program pediatrične študije za financiranje študij o pediatrični uporabi zdravil, ki niso vključena v patent ali dodaten varstven certifikat.
The MICE (Medicines Investigation for the Children of Europe ) paediatric study programme shall be established for the financing of studies on the paediatric use of medicinal products not covered by a patent or a supplementary protection certificate.
Predlaga se, da se v okviru raziskovalnih programov Skupnosti dodelijo ustrezna sredstva za spodbujanje študij in raziskovanja zdravil za pediatrično uporabo.
It shall be proposed that adequate funding be allocated under Community research programmes to encourage studies and research on medicinal products for paediatric use.
ČLEN 7, ODSTAVEK 1, TOČKA (H B) (novo)
ARTICLE 7, PARAGRAPH 1, POINT (H B) (new)
(hb) oceniti upravičenost proizvoda do 8-mesečnega podaljšanja veljavnosti dodatnega varstvenega certifikata z izvedbo analize neodvisno revidiranih podatkov o prodaji zadevnih proizvodov v skladu s členom 36(1).
(hb) to assess the eligibility of a product for an eight-month supplementary protection certificate extension by carrying out a review of independently audited sales figures of the products concerned in accordance with Article 36(1).
ČLEN 14, ODSTAVEK 2
ARTICLE 14, PARAGRAPH 2
Odbor za pediatrijo v 45 dneh od prejema vloge sprejme mnenje o tem, ali bo podelil posebno opustitev za proizvod.
Within 45 days of receipt of the application, the Paediatric Committee shall adopt an opinion as to whether or not a product-specific waiver should be granted.
Bodisi vlagatelj bodisi Odbor za pediatrijo lahko zaprosita za sejo v roku teh 60 dni.
Either the applicant or the Paediatric Committee may request a meeting during that 60 -day period.
Bodisi vlagatelj bodisi Odbor za pediatrijo lahko zaprosita za sejo v roku teh 45 dni.
Either the applicant or the Paediatric Committee may request a meeting during that 45 -day period.
Odbor za pediatrijo lahko, kadarkoli je to primerno, zaprosi vlagatelja da dopolni predložene podatke in dokumente.
Whenever appropriate, the Paediatric Committee may request the applicant to supplement the particulars and documents submitted.
Če Odbor za pediatrijo uporabi to možnost, se 60 -dnevni rok začasno ustavi, dokler niso predložene dodatne zahtevane informacije.
Where the Paediatric Committee avails itself of this option, the 60 -day time-limit shall be suspended until such time as the supplementary information requested has been provided.
Če Odbor za pediatrijo uporabi to možnost, se 45 -dnevni rok začasno ustavi, dokler niso predložene dodatne zahtevane informacije.
Where the Paediatric Committee avails itself of this option, the 45 -day time-limit shall be suspended until such time as the supplementary information requested has been provided.
ČLEN 18, ODSTAVEK 1, PODODSTAVEK 1
ARTICLE 18, PARAGRAPH 1, SUBPARAGRAPH 1
Odbor za pediatrijo v 45 dneh od prejema predlaganega načrta pediatričnih preiskav sprejme mnenje o tem, ali bodo predlagane študije zagotovile potrebne podatke o pogojih, v katerih se zdravilo lahko uporabi za zdravljenje pediatrične populacije ali njenega dela in ali pričakovane terapevtske koristi upravičujejo predlagane študije.
Within 45 days of receiving a proposed paediatric investigation plan which is valid, the Paediatric Committee shall adopt an opinion as to whether or not the proposed studies will ensure the generation of the necessary data determining the conditions in which the medicinal product may be used to treat the paediatric population or subsets thereof, and as to whether or not the expected therapeutic benefits justify the studies proposed.
ČLEN 18, ODSTAVEK 2
ARTICLE 18, PARAGRAPH 2
Odbor za pediatrijo lahko v roku 60 dni, iz odstavka 1, zahteva od vlagatelja, da predlaga spremembe načrta, pri čemer se rok iz odstavka 1 za sprejetje končnega mnenja podaljša za največ 60 dni.
Within the 60 -day period referred to in paragraph 1, the Paediatric Committee may request the applicant to propose modifications to the plan, in which case the time‑limit referred to in paragraph 1 for the adoption of the final opinion shall be extended for a maximum of 60 days.
V takih primerih lahko vlagatelj ali Odbor za pediatrijo v tem roku zahtevata dodatni sestanek.
In such cases, the applicant or the Paediatric Committee may request an additional meeting during this period.
Rok se začasno ustavi, dokler niso predložene dodatne zahtevane informacije.
The time-limit shall be suspended until such time as the supplementary information requested has been provided.
Odbor za pediatrijo lahko v roku 45 dni, iz odstavka 1, zahteva od vlagatelja, da predlaga spremembe načrta, pri čemer se rok iz odstavka 1 za sprejetje končnega mnenja podaljša za največ 45 dni.
Within the 45 -day period referred to in paragraph 1, the Paediatric Committee may request the applicant to propose modifications to the plan, in which case the time‑limit referred to in paragraph 1 for the adoption of the final opinion shall be extended for a maximum of 45 days.
ČLEN 24, PODODSTAVEK 3
ARTICLE 24, SUBPARAGRAPH 2
Odbor za pediatrijo mora mnenje iz prvega odstavka, če je zanj zaprošen, dati v 60 dneh od prejema zahtevka.
If the Paediatric Committee is asked to give an opinion under the first paragraph, it must do so within 60 days of receiving the request.