natgillin/translations-raw huggingface dataset:
(v nadaljnjem besedilu "agencija") je primerno ustanoviti znanstveni odbor, Odbor za pediatrijo s strokovnim znanjem in pristojnostmi za razvoj in presojo vseh vidikov zdravil za zdravljenje pediatrične populacije.
, hereinafter "the Agency", with expertise and competence in the development and assessment of all aspects of medicinal products to treat paediatric populations.
V ta namen mora biti Odbor neodvisen od farmacevtske industrije in mora imeti člane s priznano in dokumentirano mednarodno ravnjo izkušenj in znanja v tej industriji.
To this end 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.
Odbor za pediatrijo bi moral biti primarno odgovoren za
The Paediatric Committee should be primarily responsible for the assessment and agreement of
znanstveno in etično
scientific and ethical
Pri vsem svojem delu bi Odbor za pediatrijo moral
In all its work the Paediatric Committee should
zagotoviti, da imajo študije o otrocih možne pomembne terapevtske koristi za pediatrične bolnike.
make sure that studies in children have significant potential therapeutic benefits for paediatric patients.
Možne koristi je treba ovrednotiti glede na kratkoročna in dolgoročna tveganja za sodelujoče v kliničnih študijah, da se izogne
The potential benefits must be weighed against the short and long term risks of participating in the clinical studies in order
nepotrebnim študijam
to avoid unnecessary studies
Odbor za pediatrijo
The Paediatric Committee
bi moral 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.
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.
Za agencijo je treba oblikovati postopke za dogovor o načrtu in za spremembe načrta pediatričnih preiskav, dokumenta, na katerem bi morala temeljiti razvoj in odobritev zdravil za otroke.
Procedures should be established for the Agency to agree and modify a paediatric investigation plan, the document upon which the development and authorisation of medicines for children should be based.
Ker je pediatrična populacija v bistvu sestavljena iz številnih podpopulacij, bi moral načrt pediatričnih preiskav natančno določiti, katere podpopulacije je treba raziskati, na kakšen način in kdaj.
Because the paediatric population is in fact made up of a number of subpopulations, the paediatric investigation plan should specify which subpopulations need to be studied, by what means and by when.
Uvedba načrta pediatričnih preiskav v pravni okvir glede zdravil za humano uporabo ima za cilj zagotovitev, da razvoj zdravil
The introduction of the paediatric investigation plan in the legal framework concerning medicinal products for human use aims at ensuring that development of medicines
, ki se bodo lahko uporabljala v pediatriji
that are potentially to be used
, postane sestavni del razvoja zdravil, vključen v razvojni program za odrasle.
for children becomes an integral part of the development of medicinal products, integrated into the development programme for adults.
Zato je treba načrte pediatričnih preiskav predložiti na začetku razvoja proizvoda, dovolj zgodaj, da se lahko izvedejo študije pri otrocih
Thus, paediatric investigation plans should be submitted early during product development, in time for studies to be conducted in children
in po možnosti še
, wherever possible
preden se predložijo vloge za dovoljenje za promet.
before marketing authorisation applications are submitted.
, da se predstavijo
new medicinal products
v skladu z dogovorjenim načrtom pediatričnih preiskav,
in accordance with an agreed paediatric investigation plan
ki so končane v času izpolnitve
that are completed at the time of the filing of the
vloge za odobritev trženja ali vloge za novo indikacijo, novo farmacevtsko obliko ali nov način uporabe zdravila.
marketing authorisation application or an application for a new indication, new pharmaceutical form or new route of administration.
Glede na dejstvo, da se polovice zdravil za pediatrično uporabo ne testira, je treba v okviru raziskovalnih programov Skupnosti predvideti sredstva za financiranje raziskav zdravil za pediatrično uporabo, ki niso zaščitena s patentom ali dodatnim varstvenim certifikatom.
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 vzpostaviti raziskovalni program Skupnosti zdravil za otroke (Medicines Investigation for the Children of Europe – MICE).
It is necessary to establish a Community programme for research into medicinal products for children (Medicines Investigation for the Children of Europe - MICE).
razredov zdravil, ki jih potem objavi agencija.
or part of classes of medicinal products, to be then published by the Agency.
V nekaterih primerih bi morala agencija odložiti začetek ali dokončanje nekaterih ali vseh ukrepov iz načrta pediatričnih preiskav z namenom, da se zagotovi izvedba raziskav samo, če je to varno in etično ter če zahteva za podatke o raziskavah pri otrocih ne onemogoča ali zadržuje odobritve zdravil za druge populacije.
In certain cases, the Agency should defer the initiation or completion of some or all of the measures contained in a paediatric investigation plan, with a view to ensuring that research is done only when it is safe and ethical to do so and that the requirement for study data in children does not block or delay the authorisation of medicines for other populations.
Agencija bi morala zagotoviti brezplačen znanstveni nasvet kot spodbudo za sponzorje, ki razvijajo zdravila za otroke.
Free scientific advice should be provided by the Agency as an incentive to sponsors developing medicines for children.
Obstoječih postopkov za pridobitev dovoljenja za promet z zdravili za humano uporabo ni treba spreminjati.
The existing procedures for the marketing authorisation of medicinal products for human use should not be changed.
Z določbo
Provision should be made
bi bilo
for the
treba Odbor
Paediatric Committee
V podatke o proizvodu je treba vključiti podatke o rezultatih študij pri otrocih, kot tudi o statusu načrta pediatričnih preiskav,
To provide healthcare professionals and patients with information on the safe and effective use of medicines in
in odloge, da se zagotovi strokovnjakom zdravstvenega varstva ter bolnikom informacije o varni in učinkoviti uporabi zdravil pri otrocih ter da se zagotovi transparentnost ukrepa.
, information regarding the results of studies in children, as well as on the status of the paediatric investigation plans, waivers and deferrals, should be included in product information.
Ko so bili usklajeni vsi ukrepi v načrtu pediatričnih preiskav, je treba to dejstvo zapisati v dovoljenje za promet in ga obravnavati kot osnovo, na podlagi katere lahko podjetja pridobijo nagrado za skladnost.
When all the measures in the paediatric investigation plan have been complied with, that fact should be recorded in the marketing authorisation, and should then be the basis upon which companies can obtain the rewards for compliance.
zdravila, ki ima odobreno indikacijo za uporabo pri otrocih na podlagi dogovorjenega načrta pediatričnih preiskav,
a specially designed European logo to be displayed below
Z namenom uvedbe spodbud za odobrene proizvode, ki niso več zavarovani s pravicami intelektualne lastnine, je nujno potrebno ustvariti nov tip dovoljenja za promet: dovoljenje za promet za pediatrično uporabo.
In order to establish incentives for authorised products no longer covered by intellectual property rights, it is necessary to establish a new type of marketing authorisation, the Paediatric Use Marketing Authorisation.
Dovoljenje za promet za pediatrično uporabo je treba odobriti v okviru obstoječih postopkov za pridobitev dovoljenja za promet, vendar se uporablja posebej za zdravila, razvita izključno za uporabo pri otrocih.
A Paediatric Use Marketing Authorisation should be granted through existing marketing authorisation procedures but should apply specifically for medicinal products developed exclusively for use in children.
Za ime zdravila, ki ima dovoljenje za promet za pediatrično uporabo, je treba omogočiti uporabo obstoječe blagovne znamke odgovarjajočega proizvoda, odobrenega za odrasle, z namenom, da se izkoristi prepoznavanje blagovne znamke ob hkratni koristi, ki izhaja iz omejenosti podatkov, v zvezi z novim dovoljenjem za promet.
It should be possible for the name of the medicinal product granted a Paediatric Use Marketing Authorisation to utilise the existing brand name of the corresponding product authorised for adults, in order to capitalise on existing brand recognition while benefiting from the data exclusivity associated with a new marketing authorisation.
Vloga za dovoljenje za promet za pediatrično uporabo bi morala vključevati predložitev podatkov o uporabi proizvoda pri pediatrični populaciji, ki so bili zbrani v skladu z dogovorjenim načrtom pediatričnih preiskav.
An application for a Paediatric Use Marketing Authorisation should include the submission of data concerning use of the product in the paediatric population, collected in accordance with an agreed paediatric investigation plan.
Ti podatki lahko izhajajo iz objavljene literature ali iz novih študij.
These data may be derived from the published literature or from new studies.
Poleg tega bi se morala vloga za dovoljenje za promet za pediatrično uporabo nanašati na podatke, ki so vsebovani v dosjeju zdravila, ki je ali je bilo odobreno v Skupnosti.
An application for a Paediatric Use Marketing Authorisation should also be able to refer to data contained in the dossier of a medicinal product which is or has been authorised in the Community.
Uredba bi morala vključiti ukrepe za povečanje dostopa populacij Skupnosti do novih zdravil, ki so preskušena in prilagojena za pediatrično uporabo, in minimalizirati možnost za obsežne nagrade in spodbude Skupnosti, ki bi bile odobrene, ne da bi deli pediatrične populacije Skupnosti imeli koristi od dostopnosti novo odobrenih zdravil.
This Regulation should include measures to maximise access of the Community population to new medicinal products tested and adapted for paediatric use, and minimise the chance of Community-wide rewards and incentives being granted without sections of the Community paediatric population benefiting from the availability of a newly authorised medicine.
Vloga za dovoljenje za promet vključno z vlogo za dovoljenje za promet za pediatrično uporabo, ki vsebuje rezultate študij izvedenih v skladu z dogovorjenim načrtom pediatričnih preiskav, bi morala biti upravičena do centraliziranega postopka Skupnosti, določenega v členih 5 do 15 Uredbe (ES) št.
An application for a marketing authorisation, including an application for a Paediatric Use Marketing Authorisation, which contains the results of studies conducted in compliance with an agreed paediatric investigation plan should be eligible for the Community centralised procedure set out in Articles 5 to 15 of Regulation (EC) No
Če je bila pediatrična indikacija za proizvod, ki je že v prometu za druge indikacije, odobrena na podlagi dogovorjenega načrta pediatričnih preiskav, bi moral biti imetnik dovoljenja za promet zavezan dati proizvod v promet, ob upoštevanju pediatrične informacije, v roku dveh let od datuma odobritve indikacije.
When an agreed paediatric investigation plan has led to the authorisation of a paediatric indication for a product already marketed for other indications, the marketing authorisation holder should be obliged to place the product on the market taking into account the paediatric information within two years following the date of approval of the indication.
V posebnih primerih, ki jih povzročijo upravne zamude ali v izrednih okoliščinah, lahko pristojni organ odobri odstopanje od tega roka.
The competent authorities should be able, in specific cases affected by administrative delays, or in exceptional circumstances, to grant derogations from this provision.
Uvesti je treba neobvezni postopek, s katerim se omogoči pridobitev posameznega mnenja, ki velja za celotno področje Skupnosti, za nacionalno odobrena zdravila, če podatki o otrocih na podlagi dogovorjenega načrta pediatričnih preiskav tvorijo del vloge za dovoljenje za promet.
An optional procedure should be established to make it possible to obtain a single Community-wide opinion for a nationally authorised medicinal product when data on children following an agreed paediatric investigation plan form part of the marketing authorisation application.
Za dosego tega, se lahko uporabi postopek, določen v členih 32 do 34 Direktive 2001/83/ES.
To achieve this, the procedure set out in Articles 32 to 34 of Directive 2001/83/EC may be used.
Pomembno je zagotoviti, da je farmakovigilenca nad zdravili prilagojena, z namenom, da se zadovoljijo posebni izzivi zbiranja podatkov o varnosti pri otrocih, vključno s podatki o možnih dolgoročnih učinkih.
It is essential to ensure that pharmacovigilance mechanisms are adapted to meet the specific challenges of collecting safety data in children, including data on possible long-term effects.
Tako bi morala biti dodatna zahteva za vlagatelja vloge za dovoljenje za promet, ki vključuje rezultate študij izvedenih v skladu z dogovorjenim načrtom pediatričnih preiskav, obveznost, da prikaže, kako namerava zagotoviti dolgoročno spremljanje izvajanja možnih neželenih učinkov uporabe zdravila in učinkovitost pri pediatrični populaciji.
Therefore, an additional requirement for applying for a marketing authorisation that includes the results of studies conducted in compliance with an agreed paediatric investigation plan should be an obligation for the applicant to indicate how he proposes to ensure the long-term follow-up of possible adverse reactions to the use of the medicinal product and efficacy in the paediatric population.
Poleg tega, kjer obstaja poseben razlog za skrb,
Additionally, where there is a particular cause for concern,
predložitev in izvajanje sistema obvladovanja tveganja in/ali, da izvede posebne študije po začetku trženja kot pogoj za dovoljenje za promet.
the applicant to submit and implement a risk management system and/or perform specific post-marketing studies as a condition of the marketing authorisation.
Za proizvode, za katere se zahteva predložitev pediatričnih podatkov, je pod pogoji, če so usklajeni z vsemi ukrepi, vključenimi v dogovorjen načrt pediatričnih preiskav,
For products falling within the scope of the requirement to submit paediatric data, if all the measures included in the agreed paediatric investigation plan are complied with, if
oziroma so bili sproženi postopki za pričetek njegovega trženja v skladu z določili Direktive 2004/27/ES
marketing procedures are in progress in accordance with the provisions of Directive 2004/27/EC
in če so pomembni podatki o rezultatih študij vključeni v podatke o proizvodu, treba odobriti nagrado, v obliki 6-mesečnega podaljšanja veljavnosti dodatnega varstvenega certifikata, uvedenega z Uredbo Sveta (EGS) št. 1768/92 UL L 182, 2.7.1992, str.1.
and if relevant information on the results of studies is included in product information, a reward should be granted in the form of a 6-month extension of the Supplementary Protection Certificate created by Council Regulation (EEC) No 1768/92 OJ L 182, 2.7.1992, p.
Ker je nagrada namenjena izvajanju študij pri otrocih in ne za prikaz, da je proizvod varen in učinkovit pri otrocih, je treba nagrado zagotoviti tudi, če se pediatrična indikacija ne odobri.
Because the reward is for conducting studies in children and not for demonstrating that a product is safe and effective in children, the reward should be granted even when a paediatric indication is not authorised.
Vendar je za izpopolnitev dostopnih podatkov o uporabi zdravil pri pediatrični populaciji potrebno, da se pomembni podatki o uporabi pri pediatrični populaciji vključijo v podatke o odobrenem proizvodu.
However, to improve the information available on the use of medicines in the paediatric population, relevant information on use in paediatric populations should be included in authorised product information.
V skladu z Uredbo (ES) št. 141/2000 Evropskega parlamenta in Sveta z dne 16. decembra 1999 o zdravilih sirotah UL L 18, 22.1.2000, str.
Under Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products OJ L 18, 22.1.2000, p.
je zdravilom, določenim kot zdravila sirote, zagotovljena desetletna tržna ekskluzivnost na podlagi odobrenega dovoljenja za promet za indikacije sirot.
, medicinal products designated as orphan medicinal products gain ten years of market exclusivity on the granting of a marketing authorisation for the orphan indication.
Ker takšni proizvodi pogosto niso zavarovani s patentom, nagrada podaljšanje veljavnosti dodatnega varstvenega certifikata ni mogoča, in če so zavarovani s patentom, bo takšno podaljšanje veljavnosti povzročilo dvojno spodbudo.
As such products are frequently not patent-protected, the reward of Supplementary Protection Certificate extension cannot be applied and when they are patent-protected, such an extension would provide a double incentive.
Zato bi se moralo namesto podaljšanja veljavnosti dodatnega varstvenega certifikata za zdravila sirote podaljšati desetletno obdobje tržne ekskluzivnosti , na dvanajst let, če je v celoti izpolnjena zahteva o podatkih o uporabi pri otrocih.
Therefore, for orphan medicinal products, instead of extension of the Supplementary Protection Certificate, the ten-year period of orphan market exclusivity should be extended to twelve years if the requirement for data on use in children is fully met.
Ukrepi, predvideni v tej uredbe, ne bi smeli izključiti delovanja drugih spodbud ali nagrad.
The measures provided for in this Regulation should not preclude the operation of other incentives or rewards.
Za zagotovitev transparentnosti različnih ukrepov, dostopnih na ravni Skupnosti in držav članic, bi Komisija morala na podlagi informacij, zagotovljenih s strani držav članic, pripraviti podroben seznam vseh razpoložljivih spodbud.
To ensure transparency on the different measures available at Community and Member State levels, the Commission should draw up a detailed list of all the incentives available, on the basis of information provided by the Member States.
Ukrepi, določeni v tej uredbi, vključno z dogovorom o načrtih pediatričnih preiskav, ne bi smeli biti podlaga za pridobivanje drugih spodbud Skupnosti za podporo raziskavam, kot je denarna podpora raziskovalnim projektom v okviru večletnih okvirnih programov Skupnosti na področju raziskav, tehnološkega razvoja in predstavitvenih dejavnosti.
The measures set out in this Regulation, including the agreement of paediatric investigation plans, should not be grounds for obtaining any other Community incentives to support research, such as the funding of research projects under the multi-annual Community Framework Programmes for Research, Technological Development and Demonstration Activities.
Za povečanje dostopnosti podatkov o uporabi zdravil pri otrocih in za izogibanje ponavljajočim se študijam pri otrocih, ki ne prispevajo k skupnemu znanju, bi morala evropska zbirka podatkov, predvidena v členu 11 Direktive 2001/20/ES, vključiti
In order to increase the availability of information on the use of medicines in children, and to avoid the repetition of studies in children which do not add to the collective knowledge, the European database provided for in Article 11 of Directive 2001/20/EC should include
evropski register kliničnih poskusov zdravil za pediatrično uporabo
a European register of clinical trials of medicinal products for paediatric use comprising
o vseh tekočih, predčasno končanih in dokončanih pediatričnih študijah, ki so bile izvedene v Skupnosti in tretjih državah.
all ongoing, prematurely terminated, and completed paediatric studies conducted both in the Community and in third countries.
Pediatrične študije, ki so že bile izvedene v tretjih državah, ni treba ponoviti.
Studies in children already performed in third countries should not be repeated.
preskusi pri pediatrični populaciji lahko zahtevajo posebno strokovno znanje, posebno metodologijo in v nekaterih primerih posebne pripomočke ter bi morali biti izvršeni s strani primerno usposobljenih raziskovalcev.
trials in the paediatric population may require specific expertise, specific methodology and, in some cases, specific facilities and should be carried out by appropriately trained investigators.
Mreža, ki bi povezovala obstoječe nacionalne in evropske pobude ter študijske centre
A network linking together existing national and European initiatives and study centres
in upoštevala podatke, ki obstajajo na mednarodni ravni,
and taking account of international data
z namenom, da se na evropski ravni ustvarijo potrebna pooblastila, bi olajšala sodelovanje in izogibanje podvajanju študij.
in order to build up the necessary competences at a European level, would help facilitating co-operation and avoiding duplication of studies.
Farmacevtska podjetja lahko za nekatere odobrene proizvode že imajo podatke o varnosti in učinkovitosti pri otrocih.
For certain authorised products, pharmaceutical companies may already hold data on safety or efficacy in children.
Za izpopolnitev dostopnih informacij o uporabi zdravil pri pediatričnih populacijah bi morali od podjetij, ki imajo takšne podatke, zahtevati, da jih predložijo vsem pristojnim organom, kjer so proizvodi odobreni.
To improve the information available on the use of medicines in the paediatric populations, companies holding such data should be required to submit them to all competent authorities where the product is authorised.
Na ta način se podatki lahko presodijo in, če je potrebno, za namene strokovnjakov zdravstvenega varstva in bolnikov vključijo v podatke o odobrenem proizvodu.
In this way the data can be assessed and, if appropriate, information should be included in the authorised product information aimed at healthcare professionals and patients.
Financiranje Skupnosti bi moralo biti predvideno za
Community funding should be envisaged to
delovanja Odbora za pediatrijo in agencije, ki so rezultat izvajanja te uredbe, kot je presoja načrtov pediatričnih preiskav, opustitve pristojbin, predvidenih za znanstveni nasvet ter informacijske ukrepe in ukrepe transparentnosti, vključno z zbirko podatkov pediatričnih študij in mrežo.
work of the Paediatric Committee and of the Agency resulting from the implementation of this Regulation, such as the assessment of paediatric investigation plans, fee waivers for scientific advice, and information and transparency measures, including the database of paediatric studies and the network.
Potrebne ukrepe za izvajanje te uredbe je treba sprejeti v skladu z Odločbo Sveta 1999/468/ES z dne 28. junija 1999 o določitvi postopkov za uresničevanje Komisiji podeljenih izvedbenih pooblastil UL L 184, 17.7.1999, str.
The measures necessary for the implementation of this Regulation should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission OJ L 184, 17.7.1999, p.
Poglavje 1
chapter 1