natgillin/translations-raw huggingface dataset:
Treba se je izogniti nepotrebnim študijam pri otrocih, zato se ne smejo ponoviti študije pri pediatričnih bolnikih, ki so že bile izvedene v tretjih državah.
Unnecessary studies in children should be avoided and therefore studies in paediatric patients already performed in third countries, should not be repeated.
ČLEN 7 A (novo)
ARTICLE 7 A (new)
Sestavi se poseben seznam zahtev glede zdravil za otroke in se ga redno posodablja ter da na voljo zainteresiranim strankam (strokovnjakom, podjetjem, bolnikom itd).
A specific inventory of requirements in respect of medicinal products for children shall be drawn up, updated regularly and made available to the interested parties (professionals, enterprises, patients, etc.).
Pomembno je sestaviti seznam, ki je na voljo zainteresiranim strankam.
It is important to draw up a list which is available to all interested parties.
ČLEN 8, ODSTAVEK 1, TOČKA D A (novo)
ARTICLE 8, PARAGRAPH 1, POINT (d a) (new)
da. pediatrične raziskave, ki trenutno potekajo v zvezi s proizvodom ,časovni okvir, v katerem naj bi se zaključile, in mnenje agencije o tem vprašanju;
(da) ongoing paediatric studies on the product, the scheduled date for completion of the studies and the Agency’s opinion on these points;
ČLEN 9, ODSTAVEK 1 A (novo)
ARTICLE 9, PARAGRAPH 1 A (new)
Po potrebi, se uporablja Uredba Komisije (ES) št. 1085/2003 o pregledu sprememb dovoljenja za promet z zdravili za uporabo v humani medicini in zdravili za uporabo v veterinarski medicini.
Where appropriate Commission Regulation (EC) No 1085/2003 concerning the examination of variations to the terms of a marketing authorisation for medicinal products for human use and veterinary medicinal products shall apply.
Prvi odstavek se ravno tako uporablja, če vlagatelj dokaže, da je zdravilo pomembna terapevtska, znanstvena ali tehnična inovacija v skladu z določbami Uredbe 726/2004/ES, in še zlasti člena 3(2)(b) Uredbe.
The first paragraph shall also apply where the applicant shows that the medicinal product constitutes a significant therapeutic, scientific or technical innovation in accordance with the provisions of Regulation726/2004/EC and, in particular, Article 3, paragraph 2, point (b) thereof.
Določba mora vključevati dovoljenje za promet za zdravilo, ki je pomembna terapevtska, znanstvena ali tehnična inovacija, kot so določeni postopki Skupnosti za dovoljenje in nadzor zdravil za uporabo v humani in veterinarski medicini in ustanovitev Evropske agencije za zdravila v členu 3(2)(b) Uredbe 726/2004/ES.
Provision should be made to include marketing authorisation for a medicinal product which constitutes a significant therapeutic, scientific or technical innovation, as in Article 3, paragraph 2, point (b) of Regulation 726/2004/EC laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency.
Določba krepi inovacije pri zdravilih.
The provision strengthens innovation in medicinal products.
ČLEN 14, ODSTAVEK 2, PODODSTAVEK 1
ARTICLE 14, PARAGRAPH 2, SUBPARAGRAPH 1
Odbor za pediatrijo v 60 dneh od prejema vloge sprejme mnenje o tem, ali bo podelil posebno opustitev za proizvod.
Within 60 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.
Po prejemu vloge Odbor za pediatrijo imenuje poročevalca in v največ 60 dneh sprejme mnenje o tem, ali bo podelil posebno opustitev za proizvod.
Following receipt of the application, the Paediatric Committee shall appoint a rapporteur and shall within a maximum period of 60 days adopt an opinion as to whether or not a product-specific waiver should be granted.
Takoj, ko Odbor za pediatrijo sprejme mnenje, se uporabi postopek, določen v poglavju 4.
As soon as the Paediatric Committee adopts an opinion, the procedure laid down in Chapter 4 shall apply.
Agencija o tem takoj obvesti vlagatelja.
The Agency shall inform the applicant accordingly without delay .
Vlagatelja se obvesti o razlogih za sprejeto odločitev.
The applicant shall be informed of the reasons for the conclusion reached.
Agencija o tem v roku največ 7 delovnih dneh obvesti vlagatelja.
The Agency shall inform the applicant accordingly within no more than seven working days .
Smiselno je natančno opredeliti časovni rok.
A firm deadline needs to be set.
Agencija vzdržuje seznam vseh opustitev.
The Agency shall maintain a list of all waivers.
Seznam se redno posodablja (najmanj vsakih šest mesecev) in je v najkrajšem možnem času na voljo javnosti.
The list shall be regularly updated (at least every six months) and made available to the public.
Pomembno je pojasniti, da se seznam opustitev redno posodablja in da na voljo javnosti z namenom preglednosti.
It is important to clarify that the list of waivers is updated regularly and made publicly available with a view to a transparency.
V primeru vlog iz členov 8 in 9 se načrt pediatričnih preiskav, če ni drugače določeno, predloži z vlogo za dogovor najkasneje ob dokončnem oblikovanju humanih farmakinetskih študij pri odraslih, določenih v oddelku 5.2.3 dela I Priloge I k Direktivi 2001/83/ES, tako da je lahko mnenje o uporabi zadevnega zdravila pri pediatrični populaciji dano v času presoje dovoljenja za promet ali druge zadevne vloge .
(1) In the case of applications as referred to in Articles 8 and 9, the paediatric investigation plan shall be submitted with a request for agreement , unless otherwise justified, not later than upon completion of the human pharmaco-kinetic studies in adults specified in Section 5.2.3 of Part I of Annex I to Directive 2001/83/EC, so as to ensure that an opinion on use in the paediatric population of the medicinal product concerned can be given at the time of the assessment of the marketing authorisation or other application concerned .
(1) V primeru vlog iz členov 8 in 9 se lahko načrt pediatričnih preiskav, vključno s kratkim poročilom, predloži z vlogo za dogovor čim prej po dokončnem oblikovanju faze II humanih farmakinetskih študij pri odraslih, da bi lahko načrte preiskav nazorno oblikovali in tako zadostili zahtevam na področju kliničnih študij, ki vključujejo otroke .
(1) In the case of applications as referred to in Articles 8 and 9, the paediatric investigation plan including a summary report may be submitted with a request for agreement, at the earliest after completion of phase II of the human pharmaco-kinetic studies in adults, so as to ensure that investigation plans can be formulated in specific terms and hence meet requirements in the field of clinical studies involving children .
Če vloga ne prispe do datuma dokončnega oblikovanja humanih farmakinetskih študij, vlagatelj predloži tekoče pediatrične raziskave in rok, do katerega naj bi se zaključile.
Should an application not be submitted upon completion of the human pharmaco-kinetic studies, the applicant shall supply the ongoing paediatric studies and the scheduled date for their completion.
Pristojni organ z vlagateljem sodeluje pri nadaljnjem upoštevanju teh točk.
The competent authority shall follow up these points with the applicant.
Najkasneje po fazi I se 90 % zdravil za preskušanje pokaže za neprimerne.
No later than after phase I, about 90% of medicinal products to be tested prove unsuitable.
Zato se ne more sprejeti empirična odločitev do konca faze II.
An empirical decision cannot therefore be taken until after phase II.
Ničesar ni, kar bi kazalo na uporabnost zbirnega poročila, ki ga pripravi agencija, kot je določeno v členu 17(2).
There is no indication on the usefulness of a summary report to be prepared by the Agency, as provided in Article 17, paragraph 2.
Pripravo zbirnega poročila agencije je treba črtati, da bi občutno zmanjšali obdobje upravne veljavnosti na največ 10 dni.
The preparation of a summary report by the Agency should be deleted to significantly reduce the administrative validation period to a maximum of 10 days.
Namesto tega bo vlagatelj predložil zbirno poročilo kot del dokumentacije.
Instead, the applicant will provide a summary report as part of the documentation.
ČLEN 17, ODSTAVEK 2
ARTICLE 17, PARAGRAPH 2
Agencija v 30 dneh od prejema vloge iz odstavka 1 preveri veljavnost vloge in pripravi zbirno poročilo za Odbor za pediatrijo.
Within 30 days of receiving the request referred to in paragraph 1, the Agency shall verify the validity of the request and shall prepare a summary report for the Paediatric Committee.
Agencija v 10 dneh od prejema vloge iz odstavka 1 preveri veljavnost vloge.
Within 10 days of receiving the request referred to in paragraph 1, the Agency shall verify the validity of the request.
ČLEN 17, ODSTAVEK 3
ARTICLE 17, PARAGRAPH 3
Kadar je to primerno, lahko agencija od vlagatelja zahteva predložitev dodatnih podrobnosti in dokumentov, pri čemer se rok 30 dni začasno ustavi, dokler niso predložene dodatne zahtevane informacije.
Whenever appropriate, the Agency may ask the applicant to submit additional particulars and documents, in which case the time‑limit of 30 days shall be suspended until such time as the supplementary information requested has been provided.
Kadar je to primerno, lahko agencija od vlagatelja zahteva predložitev dodatnih podrobnosti in dokumentov, pri čemer se rok 10 dni začasno ustavi, dokler niso predložene dodatne zahtevane informacije.
Whenever appropriate, the Agency may ask the applicant to submit additional particulars and documents, in which case the time‑limit of 10 days shall be suspended until such time as the supplementary information requested has been provided.
ČLEN 18, ODSTAVEK 1, PODODSTAVEK 1
ARTICLE 18, PARAGRAPH 1(1)
Odbor za pediatrijo v 60 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 60 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.
Po prejemu predlaganega načrta pediatričnih preiskav Odbor za pediatrijo imenuje poročevalca in v največ 60 dneh 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.
Following receipt of a proposed paediatric investigation plan which is valid, the Paediatric Committee shall appoint a rapporteur and shall within a maximum period of 60 days 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.
Če se vlagatelj po odločitvi o strinjanju z načrtom pediatričnih raziskav sooči s težavami pri njegovem izvajanju, ki so takšne, da se načrt izkaže za neizvedljivega ali ne več primernega, lahko vlagatelj Odboru za pediatrijo predlaga spremembe ali zahteva odlog ali opustitev na podlagi podrobnih utemeljitev.
If, after the decision agreeing the paediatric investigation plan, the applicant encounters difficulties with its implementation such as to render the plan unworkable or no longer appropriate, the applicant may propose changes or request a deferral or a waiver, based on detailed grounds, to the Paediatric Committee.
Odbor za pediatrijo pregleda te spremembe in sprejme mnenje, s katerim predlaga njihovo zavrnitev ali odobritev.
The Paediatric Committee shall review these changes and adopt an opinion proposing their refusal or acceptance.
Takoj, ko Odbor za pediatrijo sprejme mnenje, bodisi pozitivno bodisi negativno, se uporabi postopek, določen v poglavju 4.
As soon as the Paediatric Committee adopts an opinion, whether positive or negative, the procedure laid down in Chapter 4 shall apply.
Odbor za pediatrijo v 60 dneh pregleda te spremembe ali zahtevek za odlog ali opustitev, in sprejme mnenje, s katerim predlaga njihovo zavrnitev ali odobritev in po možnosti predvidi rok, do katerega vlagatelj predloži spremenjeni načrt pediatričnih raziskav .
Within 60 days, t he Paediatric Committee shall review these changes or the request for a deferral or a waiver and adopt an opinion proposing their refusal or acceptance and, wherever possible, propose a deadline for submission by the applicant of an amended paediatric investigation plan .
Pomembno je, da ne pride do dokončne opustitve že začetih pediatričnih raziskav in da vlagatelje z določitvijo novih rokov spodbujamo k nadaljevanju začetega dela.
This amendment seeks to encourage applicants to set a new research deadline, with a view to preventing studies in progress from being abandoned.
V skladu s členom 23 je vlagatelj upravičen, da zahteva od Odbora za pediatrijo, da sprejme spremembe ali da zahteva odlog ali opustitev in Odbor za pediatrijo je upravičen, da pregleda predlagane spremembe in prošnje za odlog ali opustitev.
Under Article 23, the applicant is entitled to request that the Paediatric Committee accept changes or to request deferral or waiver, and the Paediatric Committee is entitled to review proposed changes and requests for deferral or waiver.
Po tem, ko je Odbor za pediatrijo sprejel mnenje o predlaganih spremembah, odlogu ali opustitvi, se lahko uporabi postopek, določen v členu 26 (tj. poglavje 4), po katerem se lahko novo mnenje ponovno pregleda na podlagi upravičene zahteve.
After the Paediatric Committee has adopted its opinion on the proposed changes, deferral or waiver, the procedure laid down in Article 26 (i.e. Chapter 4) may be used, under which the new opinion may be re‑examined on the basis of a justified request.
Zato ni primerno, da Odbor za pediatrijo postavlja kakršen koli končni rok za predstavitev načrta pediatrične preiskave.
Therefore, it is not appropriate for the Paediatric Committee to set any kind of deadline for the presentation of the paediatric investigation plan.
Če se Odbor za pediatrijo odloči, da ne bo sprejel sprememb načrta pediatrične preiskave, bo vlagatelj preprosto moral izpeljati študije v skladu z odobrenim načrtom pediatrične preiskave, tj. pred predložitvijo prošnje za spremembe, odlog ali opustitev.
If the Paediatric Committee decides not to accept changes to the paediatric investigation plan, the applicant will clearly have to carry out the studies in accordance with the approved paediatric investigation plan, i.e. before the submission of requests for changes, deferral or waiver.
V skladu z ostalimi postopkovnimi določbami te uredbe, je primerno določiti enake končne roke za odločitve Odbora.
In line with other procedural provisions of this Regulation it is appropriate to set the same deadline for the decision of the Committee.
ČLEN 26, ODSTAVEK 2
ARTICLE 26, PARAGRAPH 2
V 30 dneh od prejema zahtevka za ponovni pregled iz odstavka 1, Odbor za pediatrijo, po imenovanju novega poročevalca, izda novo mnenje, s katerim potrdi ali spremeni svoje predhodno mnenje.
Within 30 days of receiving a request for re-examination pursuant to paragraph 1, the Paediatric Committee, having appointed a new rapporteur, shall issue a new opinion confirming or revising its previous opinion.
Mnenje je ustrezno utemeljeno in obrazložitev dosežene odločitve se priloži novemu mnenju, ki je dokončno.
The opinion shall be duly reasoned and a statement of reasons for the conclusion reached shall be annexed to the new opinion, which shall become definitive.
V 30 dneh od prejema zahtevka za ponovni pregled iz odstavka 1, Odbor za pediatrijo, po imenovanju novega poročevalca, ki lahko vlagatelju zastavlja vprašanja neposredno, izda novo mnenje, s katerim potrdi ali spremeni svoje predhodno mnenje.
Within 30 days of receiving a request for re-examination pursuant to paragraph 1, the Paediatric Committee, having appointed a new rapporteur, who shall be able to question the applicant directly, shall issue a new opinion confirming or revising its previous opinion.
Ravno tako se lahko vlagatelj sam ponudi za zasliševanje.
The applicant may also offer to be questioned.
Poročevalec nemudoma v pisni obliki obvesti Odbor o podrobnostih pogovora z vlagateljem.
The rapporteur shall inform the Committee without delay in writing about the details of contacts with the applicant.
Treba je zagotoviti, da poročevalec zastopa celoten Odbor in ga obvešča o pogovorih z vlagateljem.
It has to be assured that the rapporteur represents the whole Committee and keeps it informed about the contacts with the applicant.
ČLEN 26, ODSTAVEK 4
ARTICLE 26, PARAGRAPH 4
Agencija brez odlašanja sprejme odločitev.
The Agency shall adopt a decision without delay .
Ta odločitev se sporoči vlagatelju.
This decision shall be communicated to the applicant.
Agencija sprejme odločitev v 15 dneh po prejemu končne odločitve Odbora za pediatrijo .
The Agency shall adopt a decision within a period not exceeding 15 days following receipt of the Paediatric Committee’s definitive decision .
To odločitev se podrobno utemelji in brez odlašanja pisno sporoči vlagatelju.
This decision shall be communicated to the applicant in writing, with detailed grounds .
Za ustrezno preglednost mora postopek ponovnega pregleda prosilcu zagotoviti pisno obvestilo o razlogih odločitve.
To ensure adequate transparency, the re-examination procedure should provide for the comm u nication in writing of the grounds of the decision to the applicant.
ČLEN 29, ODSTAVEK 1, PODODSTAVEK 2
ARTICLE 29, PARAGRAPH 1, SUBPARAGRAPH 2
Če je dovoljenje odobreno, se rezultati teh študij, ne glede na to, če so bile vse zadevne pediatrične indikacije odobrene ali ne, vključijo v povzetek glavnih značilnosti zdravila in, če je to primerno, v navodila za uporabo proizvoda.
Where authorisation is granted, the results of those studies shall be included in the summary of product characteristics and, if appropriate, in the package leaflet of the medicinal product, whether or not all the paediatric indications concerned were approved.
Če je dovoljenje odobreno, se rezultati teh študij, ne glede na to, če so bile vse zadevne pediatrične indikacije odobrene ali ne, vključijo v povzetek glavnih značilnosti zdravila in, če je to primerno, v navodila za uporabo proizvoda, vendar le pod pogojem, če pristojni organ presodi, da gre za informacijo, ki je koristna za bolnike , ne glede na to, če so bile vse zadevne pediatrične indikacije odobrene ali ne.
Where authorisation is granted, all results of those studies shall be included in the summary of product characteristics and, if appropriate, in the package leaflet of the medicinal product, provided that the competent authority deems the information to be of use to patients, whether or not all the paediatric indications concerned were approved.
V tem primeru mora biti jasno opredeljeno, katere pediatrične indikacije so bile odobrene in katere ne.
In such cases, the information shall be set out in such a way as to distinguish clearly between the paediatric indications that have been approved and those that have not.
Študije, ki ne pripomorejo k pediatričnim indikacijam, se jasno opredelijo in razlikujejo od študij, ki imajo upravičeno pediatrično indikacijo
Studies that do not result in a paediatric indication should be clearly identified and distinguished from studies having justified a paediatric indication.
Smiselno je zagotoviti večjo preglednost določenih informacij, navedenih v povzetku glavnih značilnosti zdravila, kar pomeni tudi, da nepomembne informacije niso navedene.
Some of the information in the summary of product characteristics needs to be made clearer and the package leaflet must not be cluttered up with irrelevant information which would make it more difficult to understand.
Pojasnilo – vsi rezultati študij, izvedenih na otrocih – pozitivni ali negativni – so dragoceni in morajo biti vključeni v povzetek značilnosti zdravila.
Clarification - all results of conducted studies in children - positive or negative - are valuable and should be included in the summary of product characteristics.
ČLEN 33, ODSTAVEK 1
ARTICLE 33, PARAGRAPH 1
Če je za zdravilo odobreno dovoljenje za promet s pediatrično indikacijo, ki temelji na rezultatih študij, izvedenih v skladu z dogovorjenim načrtom pediatričnih preiskav, oznaka za kakršnokoli pediatrično uvajanje vsebuje ime zdravila, ki mu sledi veliki nadpis modre črke „P“, obkrožen z obrisom zvezde, prav tako v modri barvi.
Where a medicinal product is granted a marketing authorisation for a paediatric indication based on the results of studies conducted in compliance with an agreed paediatric investigation plan, the label shall display the name of the medicinal product followed by a superscript of the letter “P” in blue lettering surrounded by the outline of a star, also in blue, for any paediatric presentation.
Če je za zdravilo odobreno dovoljenje za promet s pediatrično indikacijo, ki temelji na rezultatih študij, izvedenih v skladu z dogovorjenim načrtom pediatričnih preiskav, oznaka za kakršno koli pediatrično uvajanje vsebuje ime zdravila in evropski logo, pod imenom.
Where a medicinal product is granted a marketing authorisation for a paediatric indication based on the results of studies conducted in compliance with an agreed paediatric investigation plan, the label shall display the name of the medicinal product and, below it, the European logo for any paediatric presentation.
Logo se izbere na natečaju za otroke.
That logo shall be selected following a design competition for children.
Logo simbolično predstavlja prispevek zdravila k zdravju.
The logo shall symbolically represent the contribution by the medicinal product to health.
Izvedbeni načrt tega natečaja pripravi agencija.
The organisational arrangements for the competition shall be a matter for the Agency.
Otroci so ciljna skupina zakonodaje.
Children are the legislation’s target group.
Takšen natečaj bi bil priložnost, da se poudarita vloga in obstoj agencije, ter da se poudari skrb ne samo agencije, ampak tudi Evropske unije.
Such a competition would be an opportunity to highlight the Agency’s role and existence and point up not only the Agency’s, but also the European Union’s concerns.
ČLEN 33, PODODSTAVEK 2 A (novo)
ARTICLE 33, SUBPARAGRAPH 2 a (new)
Določila tega člena se uporabljajo tudi za zdravila, ki so bila odobrena pred uveljavitvijo uredbe, izključno pa se nanašajo na pediatrične indikacije.
The provisions of this article shall also apply to medicinal products authorised prior to the entry into force of this regulation and covering paediatric indications only.
Omejiti zahteve po navajanju informacij iz tega člena na zgolj "PUMA" bi lahko zelo slabo vplivalo na pediatrične oblike, ki so prišle na trg še pred sprejetjem uredbe.
Restricting the use of the marking system provided for in this article to PUMAs alone could serve to discriminate against paediatric forms placed on the market prior to the adoption of the regulation.
Poleg tega bi bile lahko tovrstne navedbe bolnikom nejasne, če se ne bi navezovale na vse pediatrične indikacije na tržišču.
Furthermore, patients might find the marking system difficult to understand if it was not used all paediatric medicinal products placed on the market.