natgillin/translations-raw huggingface dataset:
Če so zdravila odobrena za pediatrično indikacijo na osnovi dokončnega oblikovanja dogovorjenega načrta pediatričnih preiskav in so ti proizvodi že dani v promet z drugimi indikacijami, imetnik dovoljenja za promet v dveh letih po datumu odobritve pediatrične indikacije da proizvod v promet ob upoštevanju pediatrične indikacije.
Where medicinal products are authorised for a paediatric indication following completion of an agreed paediatric investigation plan and those products have already been marketed with other indications, the marketing authorisation holder shall, within two years of the date on which the paediatric indication is authorised, place the product on the market taking into account the paediatric indication.
Če so zdravila odobrena za pediatrično indikacijo na osnovi dokončnega oblikovanja dogovorjenega načrta pediatričnih preiskav in so ti proizvodi že dani v promet z drugimi indikacijami, imetnik dovoljenja za promet po možnosti v enem letu po datumu odobritve pediatrične indikacije da proizvod v promet ob upoštevanju pediatrične indikacije in v največ dveh letih po datumu odobritve.
Where medicinal products are authorised for a paediatric indication following completion of an agreed paediatric investigation plan and those products have already been marketed with other indications, the marketing authorisation holder shall, wherever possible within one year and no later than within two years of the date on which the paediatric indication is authorised, place the product on the market taking into account the paediatric indication.
Za prikaz rokov se oblikuje javno dostopen register.
A publicly accessible register shall be set up in order to indicate these deadlines.
V izjemnih primerih, ki jih povzročijo upravne zamude, lahko pristojni organ odobri odstopanje od tega roka.
The competent authorities may, in specific cases affected by administrative delays, grant derogations from this provision.
Vsako tako odstopanje mora biti ustrezno utemeljeno.
Any such derogations shall be justified on duly substantiated grounds.
ČLEN 35, ODSTAVEK 2
ARTICLE 35, PARAGRAPH 2
Če obstaja poseben razlog za skrb, lahko pristojni organ, kot pogoj za odobritev dovoljenja za promet zahteva, da se vzpostavi sistem obvladovanja tveganja ali da se izvedejo določene študije po začetku trženja ter se predložijo v pregled.
Where there is particular cause for concern, the competent authority may require, as a condition for granting marketing authorisation, that a risk management system be set up or that specific post-marketing studies be performed and submitted for review.
Sistem obvladovanja tveganja obsega sklop dejavnosti in intervencij, namenjenih preprečitvi ali minimalizaciji tveganj, povezanih z zdravili, vključno z oceno učinkovitosti teh intervencij.
The risk management system shall comprise a set of activities and interventions designed to prevent or minimise risks relating to medicinal products, including the assessment of the effectiveness of those interventions.
Odobritev dovoljenja za promet za pediatrično indikacijo je odvisna od vzpostavitve sistema za obvladovanje tveganja s strani zadevnega podjetja.
Granting marketing authorisation for a paediatric indication shall be subject to the setting up of a risk management system by the firm concerned.
Če je treba, lahko pristojni organ zahteva izvedbo posebnih študij.
If necessary, the competent authority may also require specific studies to be performed.
Številne nedavne farmakovigilančne afere opominjajo, da se ne sme zmanjšati pomen uporabe zdravil, zlasti pri otrocih.
A number of recent pharmacovigilance affairs are a reminder that the use of medicinal products, especially on children, should never be trivialised.
Predlog uredbe je dobrodošel v zvezi z namenom spodbujanja študij o zdravilih za otroke, preden se dajo na trg, ampak njegov del o farmakovigilanci ni ustrezen.
The proposal for a regulation is welcome as regards its intention to encourage studies on medicinal products for children before they are marketed, but its pharmacovigilance section is inadequate.
Člen 35 dejansko ne zagotavlja nobenih novih ukrepov ob teh, ki že obstajajo za zdravila za odrasle.
Article 35 provides for virtually no new measures over and above what already exists for medicines intended for adults.
Vlagatelji morajo le razložiti „ukrepe za zagotovitev nadaljnje učinkovitosti in ob možnih škodljivih učinkih pediatrične uporabe zdravil“ iz odstavka 1 tega člena.
Applicants are simply required to detail ‘the measures to ensure the follow-up of efficacy and of possible adverse reactions to the paediatric use of the medicinal product’ provided for in paragraph 1 of the article.
Pristojni organ lahko vztraja pri posebnih študijah ali „sistemu za obvladovanje tveganja“, potem ko je bilo dano dovoljenje za promet, ampak le, če je „poseben razlog skrb“, kot to določa odstavek 2 tega člena.
The competent authority may insist on specific studies or a ‘risk management system’ after marketing authorisation has been given, but only where there is ‘particular cause for concern’, as paragraph 2 of the article stipulates.
Takšen sistem za obvladovanje tveganja, ki mora biti natančno opredeljen v smernicah iz člena 35(4), je treba razširiti na vsa zdravila, ki se uporabljajo v pediatriji.
Such a risk management system, to be defined precisely in the guidelines provided for in Article 35(4), ought to be extended to all medicinal products used in paediatrics.
Imetnik dovoljenja za promet brez soglasja agencije javnosti ne sme posredovati informacij o vprašanjih v zvezi z možnimi škodljivimi stranskimi učinki določenega zdravila.
The holder of the marketing authorisation may not communicate information on pharmacovigilance matters to the public without the Agency’s consent.
Smisel določila je doseči usklajenost med pristojnimi organi in imetniki dovoljenja za promet v primeru ugotovljenih težav.
To ensure that the information provided by competent authorities and marketing authorisation holder in the event of a problem being detected is consistent.
ČLEN 35, ODSTAVEK 4 A (novo)
ARTICLE 35, PARAGRAPH 4 A (new)
Z namenom doseganja popolne neodvisnosti je potrebno zagotoviti takšno javno financiranje dejavnosti v zvezi z možnimi škodljivimi stranskimi učinki zdravil, ki bo ustrezalo obsegu nalog pristojnih organov.
With a view to ensuring total independence, public funding commensurate with the tasks assigned to competent authorities shall be provided for pharmacovigilance activities.
Nadzorna dejavnost, ki jo morajo izvajati pristojni organi, se bo širila z novimi nalogami, ki jim bodo zaupane.
The supervisory activities of competent authorities will be stepped up as a result of the new tasks assigned to them.
Zaradi uspešne izvedbe slednjih je prav, da že sedaj predvidimo javno financiranje, ki je neobhodno potrebno za dobro delovanje sistema.
To enable these tasks to be performed, provision needs to be made as of now for the public funding required in order for the system to work properly.
Če je zdravilo odobreno za pediatrično indikacijo in je imetnik dovoljenja za promet užival ugodnosti iz določb člena 36, člena 37 ali člena 38, če imetnik dovoljenja za promet preneha dajati zdravilo v promet, imetnik dovoljenja za promet tretji osebi dovoli uporabljati farmacevtske, predklinične in klinične dokumente, ki jih vključuje dokumentacija za zdravilo na podlagi člena 10(c) Direktive 2001/83/ES.
If a medicinal product is authorised for a paediatric indication and the marketing authorisation holder has benefited from the provisions of Article 36, Article 37 or Article 38, if the marketing authorisation holder discontinues placing the medicinal product on the market, the marketing authorisation holder shall allow a third party to use the pharmaceutical, pre-clinical and clinical documentation contained in the file on the medicinal product on the basis of Article 10(c) of Directive 2001/83/EC.
Imetnik dovoljenja za promet obvesti agencijo o namenu, da zdravila ne bo več dajal v promet, in agencija to dejstvo objavi.
The marketing authorisation holder shall inform the Agency of its intention to discontinue the placing on the market and the Agency will make this fact public.
Obstaja tveganje, da bo imetnik dovoljenja za promet umaknil zdravilo s trga, ko bo poteklo dodatno obdobje patentnega varstva/tržne ekskluzivnosti/tržne varnosti.
There is a risk that a marketing authorisation holder will withdraw a product from the market once the additional period of patent protection / market exclusivity/ market protection has expired.
Sedanja farmacevtska zakonodaja imetnika dovoljenja za promet z ničimer ne obvezuje, da odobren proizvod obdrži na trgu.
There is nothing in current pharmaceutical legislation that obliges a MAH to keep an authorised product on the market.
Zato je pomembno zagotoviti, da proizvod še vedno lahko postane dostopen.
It is important, therefore, to ensure that the product can still be made available.
Novi člen drugim možnim imetnikom dovoljenja za promet omogoča uporabo ustrezne dokumentacije (in s tem preprečuje ponavljanje razvojnega dela) za pridobitev dovoljenja za promet za umaknjen proizvod.
The new article allows another potential MAH to use the relevant documentation (and therefore avoid repeating the development work) in order to obtain a marketing authorisation for the withdrawn product.
ČLEN 36, ODSTAVEK 3
ARTICLE 36, PARAGRAPH 3
Če se uporabijo postopki, določeni v Direktivi 2001/83/ES, se šestmesečno podaljšanje obdobja iz odstavka 1 odobri samo, če je proizvod odobren v vseh državah članicah.
Where the procedures laid down in Directive 2001/83/EC have been used, the six-month extension of the period referred to in paragraph 1 shall be granted only if the product is authorised in all Member States.
Če se uporabijo postopki, določeni v Direktivi 2001/83/ES, se šestmesečno podaljšanje obdobja iz odstavka 1 odobri v državah članicah , v katerih je proizvod odobren, oziroma če so v teku postopki v zvezi z dovolitvijo prometa zrdavil, ki so v skladu z določili Direktive 2004/27/ES.
Where the procedures laid down in Directive 2001/83/EC have been used, the six-month extension of the period referred to in paragraph 1 shall be granted in the Member States where the product is authorised; or if marketing procedures are in progress in accordance with the provisions of Directive 2004/27/EC .
Nekatera zdravstvena stanja so razširjena le v nekaterih državah članicah.
Some medical conditions are only prevalent in some Member States.
V teh primerih je nesmiselno zahtevati, da se proizvod odobri v vseh državah članicah, zato mora podaljšanje veljati za tiste države, kjer je odobreno.
In these cases it would be unreasonable to require that a product be authorised in all Member States and so the extension should apply to those states where it is authorised.
ČLEN 36, ODSTAVEK 4
ARTICLE 36, PARAGRAPH 4
Odstavki 1, 2 in 3 se uporabljajo za zdravila, ki so zaščitena z dodatnim varstvenim certifikatom v skladu z Uredbo (EGS) št. 1768/92, ali s patentom, ki omogoča podelitev dodatnega varstvenega certifikata.
Paragraphs 1, 2 and 3 shall apply to products that are protected by a supplementary protection certificate under Regulation (EEC) No 1768/92, or under a patent which qualifies for the granting of the supplementary protection certificate.
Ne uporabljajo se za zdravila, določena kot zdravila sirote v skladu z Uredbo (ES) št. 141/2000.
They shall not apply to medicinal products designated as orphan medicinal products pursuant to Regulation (EC) No 141/2000.
Ne uporabljajo se za zdravila, določena kot zdravila sirote v skladu z Uredbo (ES) št. 141/2000 , ali za proizvode, katerih zdravilna učinkovina je že imela koristi od patenta, ki pokriva isto pediatrično uporabo ali formulacijo, ali je prejela kakšno drugo obliko izključnosti podatkov ali tržne izključnosti za isto pediatrično uporabo v EU.
They shall not apply to medicinal products designated as orphan medicinal products pursuant to Regulation (EC) No 141/2000 or to products whose active substance has already benefited from a patent covering the same paediatric use or formulation or has received any other form of data exclusivity or market exclusivity for the same paediatric use in the EU.
Nov sistem podeljevanja ne sme podvajati prejšnjih koristi in podaljšanje SPC se ne sme odobriti, če proizvod že ima sekundarni patent za pediatrično uporabo.
The new award system should not duplicate previous rewards and the SPC extension should not be granted if the product already has a secondary patent for paediatric use.
ČLEN 36, ODSTAVEK 4 A (novo)
ARTICLE 36, PARAGRAPH 4 A (new)
Podaljšanje iz odstavka 1 je za zdravilo dopustno le enkrat.
The extension referred to in paragraph 1 shall be admissible only once per medicinal product.
Primerno je pojasniti, da se spodbude in nagrade ne smejo zbirati.
It is appropriate to clarify that incentives and rewards should not be accumulated.
ČLEN 37, ODSTAVEK 2
ARTICLE 37, PARAGRAPH 2
Prvi pododstavek se uporablja tudi, če dokončno oblikovanje dogovorjenega načrta pediatričnih raziskav ne privede do odobritve pediatrične indikacije, vendar se rezultati izvedenih študij odražajo v povzetku glavnih značilnosti proizvoda in, če je to primerno, v navodilih za uporabo zadevnega zdravila.
The first paragraph shall also apply where completion of the agreed paediatric investigation plan fails to lead to the authorisation of a paediatric indication, but the results of the studies conducted are reflected in the summary of product characteristics, and if appropriate, in the package leaflet of the medicinal product concerned.
Če je potrjeno, da so v določeni kategoriji pediatrične populacije, opredeljeni v skladu z merili in načini, ki jih določa Odbor za pediatrijo, izpolnjeni pogoji za uporabo postopka, določenega za zdravila sirote, lahko imetnik dovoljenja izbere in uporabi enega od obeh postopkov.
Where it is ascertained that, in a specific paediatric subpopulation identified in accordance with criteria and modalities defined by the Paediatric Committee, the conditions for recourse to the procedure laid down for orphan drugs are fulfilled, the authorisation holder may have recourse to whichever of the two procedures he chooses.
Komisija v 18 mesecih od začetka veljavnosti te uredbe objavi podroben seznam vseh spodbud Skupnosti in držav članic za podporo raziskavam in razvoju ter dostopnosti zdravil za pediatrično uporabo.
Within 18 months of the entry into force of this Regulation, the Commission shall publish a detailed inventory of all incentives provided by the Community and Member States to support research into, and the development and availability of, medicinal products for paediatric use.
Ta seznam se redno posodablja.
This inventory shall be updated regularly.
Ta seznam se redno posodablja in je dostopen javnosti.
This inventory shall be updated regularly and shall be accessible to the public .
V letu po sprejetju uredbe se oblikuje posebni evropski program za raziskave s področja zdravil za otroke z namenom podpore študijam, povezanih 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 bo imenoval 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.
S programom upravlja agencija, ki pod nadzorom Komisije pripravlja specifične razpise za zbiranje predlogov.
The programme shall be administered by the Agency which, acting under the authority of the Commission, shall issue specific calls for proposals.
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.
Smiselno je oblikovati posebni sklad v podporo študijam s področja zdravil ali snovi, ki niso več dodatno zaščitene s patentom ali certifikatom.
The aim is to set up a specific fund to assist in the conduct of studies on medicinal products or substances no longer covered by a patent or a supplementary protection certificate.
Tovrstna zdravila se namreč lahko izkažejo kot zelo učinkovita pri raziskavah, povezanih z novimi specifičnimi izdelki za otroke.
Such medicinal products can play an extremely useful role in research into new products specifically for children.
S pa tem je povezana tudi posebna finančna podpora, ki naj se v okviru Evropske agencije za zdravila namenja za tovrstne študije.
With the backing of the European agency for medicinal products, special support should be provided for such research, so as to help fund studies.
ČLEN 40, ODSTAVEK 1
ARTICLE 40, PARAGRAPH 1
Primerne podrobnosti preskusov, ki so vsebovane v dogovorjenem načrtu pediatričnih preiskav, vključno s tistimi, ki so izvedene v tretjih državah, se vnesejo v evropsko zbirko podatkov, ustanovljeno s členom 11 Direktive 2001/20/ES.
Appropriate details of trials that are contained within agreed paediatric investigation plans, including those that are carried out in third countries, shall be entered into the European database created by Article 11 of Directive 2001/20/EC.
Z odstopanjem od te določbe, agencija poskrbi, da je del teh informacij dostopen javnosti.
By way of derogation from that 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 Medicines Investigation for the Children of Europe 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.
V zadnjem času je bilo več primerov, v katerih so farmacevtska podjetja zadržala podatke iz kliničnih preskusov, ker niso pokazali učinkovitosti med preskusno populacijo, ampak so pokazali povečano tveganje škodljivih učinkov.
Recently there have been several cases in which pharmaceutical companies withheld data from clinical trials as they did not demonstrate efficacy in the trial population, but did demonstrate an increased risk of adverse events.
Vsi ti primeri vključujejo klinične preskuse v pediatrični populaciji.
These cases all involved clinical trials in the paediatric population.
Strokovnjaki zdravstvenega varstva morajo imeti dostop do podatkov iz preskusov, zlasti pediatričnih, ker je premalo podatkov o uporabi zdravil pri otrocih.
Health care professionals need to have access to trial data, particularly paediatric trials, as there is a lack of information on the use of medicines in children.
Vedno bolj se priznava potreba po javnem dostopu do podatkovnih baz o kliničnih preskusih.
The need for public accessibility of clinical trials databases is increasingly recognised.
Vsaj ena država članica (Španija) ima nacionalno zakonodajo, ki zahteva objavo vseh kliničnih preskusov, izvedenih v tej DČ, Združeno kraljestvo pa je izrazilo zavezanost razvoju zakonodaje, ki bo imela enak učinek.
At least one Member State (Spain) has national legislation requiring publication of all clinical trials conducted in that MS and the UK has expressed a commitment to develop legislation that will have the same effect.
V ZDA je bil uveden zakon (Zakon o pravičnem dostopu do kliničnih preskusov iz leta 2005), ki vzpostavlja javno podatkovno bazo rezultatov vseh kliničnih preskusov v ZDA.
A bill (Fair Access to Clinical Trials Act of 2005) has been introduced in the US that will establish a public database of the results of all US clinical trials.
Celotna podatkovna baza za klinične preskuse, ki jo vzpostavlja Direktiva 2001/20/ES, mora biti javno dostopna.
Arguably, the entire clinical trials database established by Directive 2001/20/EC should be publicly accessible.
Tega ni mogoče doseči s to uredbo.
This can not be achieved through this Regulation.
Ampak Uredba lahko obravnava in mora obravnavati javni dostop do podatkov pediatričnih kliničnih preskusov.
But the Regulation can and should address public accessibility of paediatric clinical trial data.
ČLEN 40, ODSTAVEK 2
ARTICLE 40, PARAGRAPH 2
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 detailed guidance on the nature of the information referred to in paragraph 1 to be entered in the European database created in Article 11 of Directive 2001/20/EC.
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 , o vsebini podatkov, ki morajo biti dostopni javnosti pri uporabi odstavka 1 in tega odstavka ter o odgovornostih in nalogah agencije v zvezi s tem .
The Commission shall, on a proposal by the Agency and in consultation with Member States and interested parties, draw up detailed guidance on the nature of the information referred to in paragraph 1 to be entered in the European database created in Article 11 of Directive 2001/20/EC, on the content of the information to be made accessible to the public in application of paragraph 1 and of this paragraph and on the Agency’s responsibilities and tasks in this connection.
Glej obrazložitev istega avtorja za prejšnji predlog spremembe.
See justification by the same author to the previous amendment.
ČLEN 41
ARTICLE 41
Odbor za pediatrijo na podlagi presoje iz odstavka 1 in drugih razpoložljivih informacij ter po posvetovanju s Komisijo, državami članicami in zainteresiranimi strankami, sestavi seznam terapevtskih potreb.
On the basis of the assessment under paragraph 1 and other information available, and following consultation with the Commission, the Member States and interested parties, the Paediatric Committee shall establish an inventory of therapeutic needs.
Cilji evropske mreže so med drugim tudi koordinacija študij v zvezi s pediatričnimi zdravili, vzpostavitev potrebne znanstvene in upravne pristojnosti na evropski ravni in izogibanje podvajanju študij in poskusov pri otrocih.
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 duplication of studies and testing in children.