natgillin/translations-raw huggingface dataset:
Tako bi podjetja lažje ugotovila možnosti za poslovni razvoj; Odbor za pediatrijo bi bolje ocenil potrebo po zdravilih in študijah pri presoji osnutkov načrtov pediatričnih preiskav, opustitev in odlogov; strokovnjaki zdravstvenega varstva in bolniki pa bi imeli na voljo zanesljiv vir informacij za pomoč pri njihovih odločitvah o izbiri zdravil.
In this way, companies should be able to identify easily opportunities for business development; the Paediatric Committee should be able to better judge the need for medicines and studies when assessing draft paediatric investigation plans, waivers and deferrals; and healthcare professionals and patients should have a reliable information source available to support their decisions as to which medicines to choose.
Ta predlog spremembe navaja besedilo uvodne izjave 29.
This amendment reproduces the wording of Recital 29.
Zaradi pomembnosti določb, ki jih vsebuje, mora biti ta uvodna izjava med prvimi uvodnimi izjavami zakonodajnega predloga.
In view of the importance of the provisions which it contains, this recital should be one of the first recitals in the legislative proposal.
Ta predlog spremembe je v skladu s predlogi sprememb poglavja 2a in členov 2a do 2d.
This amendment is consistent with the amendments to Chapter 2a and Articles 2a to 2d.
(5) Ob upoštevanju dejstva, da morajo vsi predpisi o zdravilih temeljiti na varstvu javnega zdravja, mora biti ta cilj dosežen s sredstvi, ki ne ovirajo prostega pretoka zdravil znotraj Skupnosti.
(5) While taking into account the fact that any regulations on medicinal products must be fundamentally aimed at safeguarding public health, this aim must be achieved by means that do not impede the free movement of medicinal products within the Community.
Razlike v nacionalnih zakonskih in drugih določbah o zdravilih lahko ovirajo trgovino znotraj Skupnosti in posledično neposredno vplivajo na delovanje notranjega trga.
The differences between the national legislative, regulatory and administrative provisions on medicinal products tend to hinder intra-Community trade and therefore directly affect the operation of the internal market.
Vsak ukrep za podporo razvoju in odobritvam zdravil za pediatrično uporabo je torej utemeljen z namenom prepričevanja in odstranjevanja teh ovir.
Any action to promote the development and authorisation of medicinal products for paediatric use is therefore justified with a view to preventing or eliminating these obstacles.
Člen 95 Pogodbe je torej primerna pravna podlaga.
Article 95 of the Treaty is therefore the proper legal basis.
(5) Ob upoštevanju dejstva, da morajo vsi predpisi o zdravilih temeljiti na varstvu javnega zdravja, mora biti ta cilj dosežen s sredstvi, ki ne ovirajo prostega pretoka varnih zdravil znotraj Skupnosti.
(5) While taking into account the fact that any regulations on medicinal products must be fundamentally aimed at safeguarding public health, this aim must be achieved by means that do not impede the free movement of safe medicinal products within the Community.
(7) Vse pomisleke glede preskusov v pediatrični populaciji je treba uravnotežiti z etičnimi pomisleki, ki zadevajo dajanje zdravil populaciji, v okviru katere niso bila preskušena.
(7) Any concerns about conducting trials in the paediatric population should be balanced by the ethical concerns about giving medicines to a population in which they have not been tested.
Ogroženost javnega zdravja zaradi uporabe nepreskušenih zdravil pri otrocih se lahko varno predvidi s študijami o zdravilih za otroke, ki jih je treba skrbno nadzorovati in spremljati na podlagi posebnih zahtev za varstvo otrok, ki so del kliničnih preskusov v Skupnosti, določenih v Direktivi 2001/20/ES Evropskega parlamenta in Sveta, z dne 4. aprila 2004 o približevanju zakonov in drugih predpisov držav članic v zvezi z izvajanjem dobre klinične prakse pri kliničnem preskušanju zdravil za ljudi.
The public health threat from the use of untested medicines in children can be safely addressed through the study of medicines for children, which should be carefully controlled and monitored through the specific requirements for the protection of children who take part in clinical trials in the Community laid down in Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use.
(7) Vse pomisleke glede preskusov v pediatrični populaciji je treba uravnotežiti z etičnimi pomisleki, ki zadevajo dajanje zdravil populaciji, v okviru katere niso bila ustrezno preskušena.
(7) Any concerns about conducting trials in the paediatric population should be balanced by the ethical concerns about giving medicines to a population in which they have not been appropriately tested.
(8) V okviru Evropske agencije za zdravila (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.
(8) It is appropriate to create a scientific committee, the Paediatric Committee, within the European Medicines Agency, hereinafter ‘the Agency’, with expertise and competence in the development and assessment of all aspects of medicinal products to treat paediatric populations.
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.
Za to mora biti Odbor neodvisen od farmacevtske industrije in mora imeti člane s priznano in dokumentirano mednarodno ravnjo izkušenj in znanja v tej industriji.
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.
Odbor za pediatrijo bi moral biti primarno odgovoren za znanstveno in etično 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 scientific and ethical 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 zagotoviti, da imajo študije na otrocih možne pomembne terapevtske koristi za pediatrične bolnike, ki so vključeni v študije.
In all its work the Paediatric Committee should make sure that studies in children have potential significant therapeutic benefits for the paediatric patients involved in the studies .
Možne koristi je treba ovrednotiti glede na kratkoročna in dolgoročna tveganja za sodelujoče v kliničnih študijah, da se izogne nepotrebnim študijam .
The potential benefits must be weighed against the short and long term risks of participating in the clinical studies in order to avoid unnecessary studies .
Odbor za pediatrijo 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.
The Paediatric Committee 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.
Treba se je izogibati nepotrebnim študijam na otrocih in izraziti skrb v zvezi z možnimi dolgoročnimi posledicami nekaterih zdravil na rast in razvoj pediatričnih bolnikov.
Unnecessary studies in children should be avoided and the concern about potential long-term effects of certain medications on the growth and development of paediatric patients should be expressed.
Odbor za pediatrijo mora opravljati svoje dolžnosti neodvisno in v korist pediatrične populacije.
The Paediatric Committee must perform its duties autonomously and in the interests of the paediatric population.
Zato je pomembno poudariti njegovo neodvisnost od farmacevtske industrije.
It is therefore important to emphasise its independence from the pharmaceutical industry.
(10) Uvedba načrta pediatričnih preiskav v pravni okvir glede zdravil za humano uporabo ima za cilj zagotovitev, da razvoj zdravil za otroke postane sestavni del razvoja zdravil, vključen v razvojni program za odrasle.
(10) The introduction of the paediatric investigation plan in the legal framework concerning medicinal products for human use aims at ensuring that development of medicines 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, 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 before marketing authorisation applications are submitted.
(10) Uvedba načrta pediatričnih preiskav v pravni okvir glede zdravil za humano uporabo ima za cilj zagotovitev, da razvoj zdravil , ki se bodo lahko uporabljala za otroke , postane sestavni del razvoja zdravil, vključen v razvojni program za odrasle.
(10) The introduction of the paediatric investigation plan in the legal framework concerning medicinal products for human use aims at ensuring that development of medicines that are potentially to be used 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 in po možnosti še 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 , wherever possible before marketing authorisation applications are submitted.
V skladu z določili člena 21 pričujoče Uredbe je smotrno na eni strani onemogočiti zavlačevanje pri predložitvah vlog za dovoljenje za promet za zdravila, ki so namenjena odraslim, na drugi strani pa zagotoviti, da bodo vsi, ki predlagajo vloge za dovoljenja, upoštevali pomen posebnih raziskav pri otrocih.
In line with Article 21 of the regulation, the purpose of the amendment is to ensure that marketing authorisations for medicines for adults are not delayed while at the same time taking due account of the importance of the specific paediatric studies which applicants will be obliged to conduct.
Načelo zahtevanja predložitve vseh pediatričnih rezultatov skupaj z rezultati odraslih je v nasprotju s sedanjimi znanstvenimi in etičnimi standardi.
The principle of requiring the submission of all paediatric results together with adult results is contrary to current scientific and ethical standards.
To lahko pripelje do prezgodnjih ali neupravičenih preiskav na otrocih in odloži uvedbo novih zdravil za odrasle.
This could lead to premature or unwarranted investigations in children and delay the introduction of new medicines for adults.
Najemanje otrok v pediatričnih protokolih je pogosto počasno in težko, študije trajajo dlje, kot je bilo prvotno načrtovano.
Recruitment of children in paediatric protocols is often very slow and difficult and studies may last longer than initially planned.
UVODNA IZJAVA 11 a (novo)
RECITAL 11 A (new)
(11a) 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 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 (Preiskava zdravil za otroke Evrope).
It is necessary to establish the MICE (Medicines Investigation for the Children of Europe ).
Da bi spodbudili raziskave in testiranje zdravil za pediatrično rabo, je pomembno zagotoviti financiranje v okviru raziskovalnih programov Skupnosti.
It is essential to provide funding under Community research programmes to encourage research on and testing of medicinal products for paediatric use.
Brez posebnega finančnega instrumenta farmacevtska industrija ne bi imela nobene spodbude za izvajanje študij o pediatrični uporabi farmacevtskih izdelkov, ki niso vključeni v patent ali dodatni varstveni certifikat.
Without a specific financial instrument the pharmaceutical industry would have no incentive to conduct studies into paediatric applications for pharmaceutical products not covered by a patent or a Supplementary Protection Certificate.
(15) Obstoječih postopkov za pridobitev dovoljenja za promet z zdravili za humano uporabo ni treba spreminjati.
(15) The existing procedures for the marketing authorisation of medicinal products for human use should not be changed.
Vendar pa izhaja iz zahteve o predstavitvi rezultatov študij pri otrocih v skladu z dogovorjenim načrtom pediatričnih preiskav, da bi morali pristojni organi pri presoji veljavnosti vlog za dovoljenje za promet preveriti skladnost z dogovorjenim načrtom pediatričnih preiskav ter vse opustitve in odloge.
However, it follows from the requirement for the results of studies in children to be presented in accordance with an agreed paediatric investigation plan that competent authorities should check compliance with the agreed paediatric investigation plan and any waivers and deferrals at the existing validation step for marketing authorisation applications.
Presoja varnosti, kvalitete in učinkovitosti zdravil za otroke ter odobritev dovoljenja za promet bi morale ostati v presoji pristojnih organov.
The assessment of safety, quality and efficacy of medicines for children and the granting of marketing authorisations should remain the remit of the competent authorities.
Z določbo je treba ustvariti možnost , da se Odbor za pediatrijo zaprosi za mnenje o skladnosti ter o varnosti, kvaliteti in učinkovitosti zdravila pri otrocih.
Provision should be made for the possibility of asking the Paediatric Committee for an opinion on compliance and for an opinion on the safety, quality and efficacy of a medicine in children.
Z določbo je treba zagotoviti, da se Odbor za pediatrijo zaprosi za mnenje o skladnosti ter o varnosti, kvaliteti in učinkovitosti zdravila pri otrocih.
Provision should be made for asking the Paediatric Committee for an opinion on compliance and for an opinion on the safety, quality and efficacy of a medicine in children.
(21) 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.
(21) 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.
Ta zahteva se nanaša samo na proizvode, ki so že odobreni, vendar se ne bi smela uporabljati za zdravila, ki so odobrena z dovoljenjem za promet za pediatrično uporabo.
That requirement should relate only to products already authorised, but not to medicines authorised via a Paediatric Use Marketing Authorisation.
V posebnih 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.
Vsako tako odstopanje mora biti ustrezno utemeljeno.
Any such derogations should be justified on duly substantiated grounds.
V izrednih okoliščinah lahko pristojni organi odobrijo ustrezno utemeljeno odstopanje od tega roka .
In exceptional circumstances the competent authority may grant a duly substantiated derogation from this deadline.
(22) 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.
(22) 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 členih32 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.
To bo omogočilo sprejetje usklajene Odločbe Skupnosti o uporabi zdravil pri otrocih in njeno uveljavitev v vseh nacionalnih podatkih o proizvodu.
This will allow the adoption of a Community harmonised Decision on use of the medicinal product in children and its introduction in all national product information.
Medtem bi bilo zaželeno oblikovati evropski pediatrični obrazec, ki bi služil kot referenca za zbiranje vseh razpoložljivih podatkov v različnih državah članicah o farmacevtskem izdelku, ki ga želijo tržiti v Uniji, vendar je dan na trg le na nacionalni ravni.
In the meantime, it would be desirable for a European paediatric form to be drawn up to serve as a reference for the collection of all the data available in the various Member States on a pharmaceutical product desired to be marketed in the Union but at that moment placed on the market only at national level.
Koristno bi bilo vključiti postopek, ki standardizira skupine obrazcev, ki so v uporabi v državah članicah, in utira pot uvedbi neobveznega postopka, omenjenega v uvodni izjavi.
It would be useful to include a procedure that standardises the sets of forms in use in the Member States and paves the way for the introduction of the optional procedure referred to in the recital.
(23) 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.
(23) 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.
Za učinkovitost pri otrocih so lahko potrebne tudi dodatne študije po odobritvi dovoljenja.
Efficacy in children may also need additional study following authorisation.
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, je predvidena določba, ki omogoča, da se od vlagatelja zahteva predložitev in izvajanje sistema obvladovanja tveganja in/ali, da izvede posebne študije po začetku trženja kot pogoj za dovoljenje za promet.
Additionally, where there is a particular cause for concern, provision is made for the possibility of requiring the applicant to submit and implement a risk management system and/or perform specific post-marketing studies as a condition of the marketing authorisation.
Poleg tega, kjer obstaja poseben razlog za skrb, je nujno, da se na podlagi odgovornosti Odbora od vlagatelja zahteva predložitev in izvajanje sistema obvladovanja tveganja in/ali, da izvede posebne študije po začetku trženja kot pogoj za dovoljenje za promet.
Additionally, where there is a particular cause for concern, it is necessary, under the responsibility of the Committee, to require the applicant to submit and implement a risk management system and/or perform specific post-marketing studies as a condition of the marketing authorisation.
V primerih, kjer obstaja poseben razlog za skrb, je treba od vlagatelja zahtevati predložitev in izvajanje sistema obvladovanja tveganja in/ali, da izvede posebne študije po začetku trženja.
In cases that give particular cause for concern, the applicant must be required to submit and implement a risk management system and/or perform specific post-marketing studies.
UVODNA IZJAVA 24
RECITAL 24
(24) Za proizvode, za katere se zahteva predložitev pediatričnih podatkov, je pod pogoji, če so usklajeni z vsemi ukrepi, vključenimi v dogovorjen načrt pediatričnih preiskav , če je proizvod odobren v vseh državah članicah 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.
(24) 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 the product is authorised in all Member States 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.
(24) Za proizvode, za katere se zahteva predložitev pediatričnih podatkov, je pod pogoji, če so usklajeni z vsemi ukrepi, vključenimi v dogovorjen načrt pediatričnih preiskav, oziroma so bili sproženi postopki za pričetek njegovega trženja v skladu z določili Direktive 2004/27/ES 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.
(24) 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 marketing procedures are in progress in accordance with the provisions of Directive 2004/27/EC 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.
Smiselno je zagotoviti, da ne bi prihajalo do zapostavljanja prizadevanj na področju pediatričnih raziskav, ki bi izviralo iz razlik v delovanju pristojnih organov v državah članicah.
Paediatric research efforts should not be penalised solely because the competent authorities of the Member States do not all operate in the same way.
UVODNA IZJAVA 28
RECITAL 28