natgillin/translations-raw huggingface dataset:
The introduction of the paediatric investigation plan in the legal framework concerning medicinal products for human use aims at ensuring that the development of medicinal products that are potentially to be used for the paediatric population becomes an integral part of the development of medicinal products, integrated into the development programme for adults.
Namen uvedbe načrta pediatričnih raziskav v pravni okvir, ki zadeva zdravila za uporabo v humani medicini, je zagotoviti, da postane razvoj zdravil, ki se bodo potencialno uporabljala za pediatrično populacijo, sestavni del razvoja zdravil, vključen v razvojni program za odrasle.
Thus, paediatric investigation plans should be submitted early during product development, in time for studies to be conducted in the paediatric population, where appropriate, before marketing authorisation applications are submitted.
Načrte pediatričnih raziskav bi bilo zato treba predložiti v začetni fazi razvoja izdelka, torej dovolj zgodaj, da se študije na pediatrični populaciji lahko izvedejo, če je potrebno, preden se vložijo vloge za dovoljenje za promet.
It is appropriate to set a deadline for the submission of a paediatric investigation plan in order to ensure early dialogue between the sponsor and the Paediatric Committee.
Primerno je določiti rok za predložitev načrtov pediatričnih raziskav, da se zagotovi pravočasen dialog med sponzorjem in Odborom za pediatrijo.
Furthermore, early submission of a paediatric investigation plan, combined with the submission of a deferral request as described below, will avoid delaying the authorisation for other populations.
Poleg tega bo zgodnja predložitev načrta pediatričnih raziskav, skupaj s predložitvijo spodaj opisane zahteve za odlog, pripomogla k temu, da se odloži odobritev za druge populacije.
As the development of medicinal products is a dynamic process dependent on the result of ongoing studies, provision should be made for modifying an agreed plan where necessary.
Ker je razvoj zdravil dinamičen proces, ki je odvisen od rezultata potekajočih študij, bi bilo treba predvideti način sprememb dogovorjenega načrta, kjer je to potrebno.
It is necessary to introduce a requirement for new medicinal products and for authorised medicinal products covered by a patent or a supplementary protection certificate to present either the results of studies in the paediatric population in accordance with an agreed paediatric investigation plan or proof of having obtained a waiver or deferral, at the time of filing a marketing authorisation application or an application for a new indication, new pharmaceutical form or new route of administration.
Za nova zdravila in za odobrena zdravila, zaščitena s patentom ali dodatnim varstvenim certifikatom, je treba uvesti zahtevo po predložitvi rezultatov študij na pediatrični populaciji v skladu z dogovorjenim načrtom pediatričnih raziskav ali dokazila o pridobitvi opustitve ali odloga ob vložitvi vloge za dovoljenje za promet ali vloge za novo indikacijo, novo farmacevtsko obliko ali novo pot uporabe zdravila.
The paediatric investigation plan should be the basis upon which compliance with that requirement is judged.
Načrt pediatričnih raziskav naj bo podlaga za presojo skladnosti s to zahtevo.
However, that requirement should not apply to generics or similar biological medicinal products and medicinal products authorised through the well-established medicinal use procedure, nor to homeopathic medicinal products and traditional herbal medicinal products authorised through the simplified registration procedures of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use [5].
Vendar pa se ta zahteva ne uporablja za generična zdravila ali podobna biološka zdravila in zdravila, odobrena po postopku dobro uveljavljene medicinske uporabe, ali homeopatska zdravila in tradicionalna zdravila rastlinskega izvora, odobrena po poenostavljenih postopkih registracije iz Direktive 2001/83/ES Evropskega parlamenta in Sveta z dne 6. novembra 2001 o zakoniku Skupnosti o zdravilih za uporabo v humani medicini [5].
Provision should be made for research into the paediatric use of medicinal products which are not protected by a patent or supplementary protection certificate to be financed under Community research programmes.
Treba bi bilo sprejeti določbe o raziskavah pediatrične uporabe zdravil, ki niso zaščitena s patentom ali dodatnim varstvenim certifikatom, ki se bodo financirale iz raziskovalnih programov Skupnosti.
In order to ensure that research in the paediatric population is only conducted to meet their therapeutic needs, there is a need to establish procedures for the Agency to waive the requirement referred to in Recital (11) for specific products or for classes or part of classes of medicinal products, these waivers being then made public by the Agency.
Da bi zagotovili, da se raziskave pri pediatrični populaciji izvajajo samo zaradi njihovih terapevtskih potreb, je treba za Agencijo uvesti postopke, s katerimi se opusti zahteva iz uvodne izjave (11) za določena zdravila ali skupine ali dele skupin zdravil, ki jih Agencija nato objavi.
As knowledge of science and medicine evolves over time, provision should be made for the lists of waivers to be amended.
Zaradi nenehnega razvoja v znanosti in medicini je treba predvideti določbo o spreminjanju seznamov opustitev.
However, if a waiver is revoked, that requirement should not apply for a given period in order to allow time for at least a paediatric investigation plan to be agreed and studies in the paediatric population to be initiated before an application for marketing authorisation is submitted.
Če pa se opustitev razveljavi, se zahteva ne uporablja za obdobje, ki je potrebno vsaj za izdajo soglasja z načrtom pediatričnih raziskav in za začetek izvajanja študij na pediatrični populaciji pred predložitvijo vloge za dovoljenje za promet.
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 conducted only when safe and ethical and that the requirement for study data in the paediatric population does not block or delay the authorisation of medicinal products for other populations.
V določenih primerih bi morala Agencija odložiti začetek izvajanja ali dokončanje nekaterih ali vseh ukrepov iz načrta pediatričnih raziskav, da se zagotovi izvedba raziskav samo, če je to varno in etično, ter da zahteva po podatkih o študijah na pediatrični populaciji ne onemogoča ali zadržuje odobritve zdravil za druge populacije.
Free scientific advice should be provided by the Agency as an incentive to sponsors developing medicinal products for the paediatric population.
Agencija bi morala zagotoviti brezplačno znanstveno svetovanje kot spodbudo za sponzorje, ki razvijajo zdravila za pediatrično populacijo.
To ensure scientific consistency, the Agency should manage the interface between the Paediatric Committee and the Scientific Advice Working Group of the Committee for Medicinal Products for Human Use, as well as the interaction between the Paediatric Committee and the other Community committees and working groups concerning medicinal products.
Da bi zagotovila znanstveno doslednost, bi morala Agencija usklajevati dejavnosti Odbora za pediatrijo in delovne skupine za znanstveno svetovanje Odbora za zdravila za uporabo v humani medicini ter skrbeti za vzajemno delovanje med Odborom za pediatrijo in drugimi odbori in delovnimi skupinami Skupnosti glede zdravil.
The existing procedures for the marketing authorisation of medicinal products for human use should not be changed.
Obstoječih postopkov za pridobitev dovoljenja za promet z zdravili za uporabo v humani medicini se ne sme spreminjati.
However, from the requirement referred to in Recital (11) it follows 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.
Vendar zahteva iz uvodne izjave (11) določa, da bi morali pristojni organi pri presoji veljavnosti vlog za dovoljenje za promet preveriti skladnost z dogovorjenim načrtom pediatričnih raziskav ter z vsemi opustitvami in odlogi.
The assessment of quality, safety and efficacy of medicinal products for the paediatric population and the granting of marketing authorisations should remain the remit of the competent authorities.
Presojo kakovosti, varnosti in učinkovitosti zdravil za pediatrično populacijo ter izdajo dovoljenj za promet bi morali še naprej izvajati pristojni organi.
Provision should be made for the Paediatric Committee to be asked for its opinion on compliance and on the quality, safety and efficacy of a medicinal product in the paediatric population.
Treba bi bilo sprejeti določbo, na podlagi katere se Odbor za pediatrijo zaprosi za mnenje o skladnosti ter o kakovosti, varnosti in učinkovitosti zdravil pri pediatrični populaciji.
To provide healthcare professionals and patients with information on the safe and effective use of medicinal products in the paediatric population and as a transparency measure, information on the results of studies in the paediatric population, as well as on the status of the paediatric investigation plans, waivers and deferrals, should be included in product information.
V podatke o zdravilu bi bilo treba kot ustrezen ukrep za preglednost vključiti podatke o rezultatih študij na pediatrični populaciji, pa tudi o statusu načrta pediatričnih raziskav, opustitev in odlogov, da se strokovnjakom za zdravstveno varstvo in bolnikom na ta način zagotovijo informacije o varni in učinkoviti uporabi zdravil pri pediatrični populaciji.
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.
Ko so izpolnjeni vsi ukrepi v načrtu pediatričnih raziskav, bi bilo treba to zapisati v dovoljenje za promet, ki potem predstavlja osnovo, na podlagi katere lahko podjetja pridobijo nagrado za skladnost.
In order to identify medicinal products authorised for use in the paediatric population and enable their prescription, provision should be made for the labels of medicinal products granted an indication for use in the paediatric population to display a symbol which will be selected by the Commission on a recommendation by the Paediatric Committee.
Da se identificirajo zdravila, ki so odobrena za uporabo pri pediatrični populaciji, in da se omogoči njihovo predpisovanje, bi bilo treba sprejeti določbo, da se oznaka zdravila za uporabo pri pediatrični populaciji opremi z znakom, ki ga bo izbrala Komisija na predlog Odbora za pediatrijo.
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.
Kot spodbudo za odobrene izdelke, ki niso več predmet varstva pravic intelektualne lastnine, je treba uvesti nov tip dovoljenja za promet: dovoljenje za promet za pediatrično uporabo.
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 the paediatric population.
Dovoljenje za promet za pediatrično uporabo bi bilo treba izdati v okviru obstoječih postopkov za pridobitev dovoljenja za promet, vendar naj se to uporablja izrecno za zdravila, razvita izključno za uporabo pri pediatrični populaciji.
It should be possible for the name of the medicinal product that has been granted a Paediatric Use Marketing Authorisation to retain 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.
Za ime zdravila, ki ima dovoljenje za promet za pediatrično uporabo, bi bilo treba omogočiti uporabo obstoječe blagovne znamke odgovarjajočega izdelka, odobrenega za odrasle, da se tako hkrati izkoristi prepoznavanje blagovne znamke in ekskluzivnost podatkov v zvezi z novim dovoljenjem za promet.
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.
Skupaj z vlogo za dovoljenje za promet za pediatrično uporabo bi bilo treba predložiti podatke o uporabi izdelka pri pediatrični populaciji, ki so bili zbrani v skladu z dogovorjenim načrtom pediatričnih raziskav.
These data may be derived from the published literature or from new studies.
Ti podatki lahko izhajajo iz objavljene literature ali iz novih študij.
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.
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.
This is intended to provide an additional incentive to encourage small and medium-sized enterprises, including generic companies, to develop off-patent medicinal products for the paediatric population.
S tem bi še dodatno spodbudili mala in srednje velika podjetja, vključno s podjetji generičnih zdravil, da bi razvijala zdravila za pediatrično populacijo brez patenta.
This Regulation should include measures to maximise access by the Community population to new medicinal products tested and adapted for paediatric use, and to 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.
Uredba bi morala vsebovati ukrepe, ki bodo prebivalcem Skupnosti čim bolj omogočili dostop do novih zdravil, ki so preskušena in prilagojena za pediatrično uporabo in čim bolj zmanjšali možnosti, da bi se na območju Skupnosti dodeljevale nagrade in spodbude za odobritve novih zdravil, če se s tem ne bi olajšala dostopnost do teh zdravil delom pediatrične populacije Skupnosti.
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 726/2004.
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 raziskav, bi morala biti upravičena do centraliziranega postopka Skupnosti, določenega v členih 5 do 15 Uredbe (ES) št. 726/2004.
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 of the date of approval of the indication.
Če je bilo na podlagi dogovorjenega načrta pediatričnih raziskav izdano dovoljenje za pediatrično indikacijo za zdravilo, ki je že v prometu za druge indikacije, bi se moral imetnik dovoljenja za promet zavezati, da bo izdelek ob upoštevanju pediatričnih informacij dal v promet v roku dveh let od datuma odobritve indikacije.
That requirement should relate only to products already authorised, but not to medicinal products authorised via a Paediatric Use Marketing Authorisation.
Ta zahteva se nanaša samo na izdelke, ki so že odobreni, in se ne uporablja za zdravila, ki so odobrena na podlagi dovoljenja za promet za pediatrično uporabo.
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 the paediatric population following an agreed paediatric investigation plan form part of the marketing authorisation application.
Uvesti bi bilo treba fakultativen postopek, ki bi omogočil pridobitev enotnega, za celotno področje Skupnosti veljavnega mnenja v zvezi z zdravilom, odobrenim na nacionalni ravni, če so podatki v zvezi s pediatrično populacijo zbrani na podlagi dogovorjenega načrta pediatričnih raziskav, del vloge za dovoljenje za promet.
To achieve this, the procedure set out in Articles 32, 33 and 34 of Directive 2001/83/EC could be used.
Za dosego tega se lahko uporabi postopek, določen v členih 32, 33 in 34 Direktive 2001/83/ES.
This will allow the adoption of a Community harmonised Decision on use of that medicinal product in the paediatric population and its inclusion in all national product information.
To bo omogočilo sprejetje usklajene odločbe Skupnosti o uporabi zdravil pri pediatrični populaciji in njeno vključitev v vse nacionalne podatke o zdravilu.
It is essential to ensure that pharmacovigilance mechanisms are adapted to meet the specific challenges of collecting safety data in the paediatric population, including data on possible long-term effects.
Pomembno je zagotoviti, da so mehanizmi farmakovigilance primerni za obravnavanje posebnih primerov pri zbiranju podatkov o varnosti pri pediatrični populaciji, vključno s podatki o možnih dolgoročnih učinkih.
Efficacy in the paediatric population may also need additional study following authorisation.
Za ugotavljanje učinkovitosti pri pediatrični populaciji so lahko po pridobitvi dovoljenja potrebne dodatne študije.
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.
Zato bi bilo treba v zvezi z vlogami za dovoljenje za promet, ki vključujejo rezultate študij, izvedenih v skladu z dogovorjenim načrtom pediatričnih raziskav, vpeljati dodatno zahtevo, in sicer, da mora vlagatelj prikazati, kako namerava zagotoviti dolgoročno spremljanje možnih neželenih učinkov uporabe zdravila in učinkovitosti pri pediatrični populaciji.
Additionally, where there is a particular cause for concern, the applicant should submit and implement a risk management system and/or perform specific post-marketing studies as a condition for the granting of the marketing authorisation.
Dodatno se, kadar obstojijo posebni razlogi za skrb, od vlagatelja zahteva, naj predloži in izvaja sistem obvladovanja tveganja in/ali da izvede posebne post-marketinške študije kot pogoj za pridobitev dovoljenja za promet.
It is necessary in the interests of public health to ensure the continuing availability of safe and effective medicinal products authorised for paediatric indications developed as a result of this Regulation.
Zaradi varovanja javnega zdravja je treba zagotoviti stalen dostop do varnih in učinkovitih zdravil, odobrenih za pediatrične indikacije, ki so bile razvite na osnovi te uredbe.
If a marketing authorisation holder intends to withdraw such a medicinal product from the market then arrangements should be in place so that the paediatric population can continue to have access to the medicinal product in question.
Če imetnik dovoljenja za promet namerava umakniti določeno zdravilo iz prometa, bi bilo treba zagotoviti, da bo pediatrična populacija še naprej imela dostop do zadevnega zdravila.
In order to help achieve this, the Agency should be informed in good time of any such intention and should make that intention public.
Da bi to dosegli, bi bilo treba Agencijo pravočasno obveščati o vseh takih namerah, ki bi jih bilo treba tudi objaviti.
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 [6].
Za zdravila, za katera se zahteva predložitev pediatričnih podatkov, bi bilo treba pod pogojem, da so izpolnjeni vsi ukrepi, vključeni v dogovorjen načrt pediatričnih raziskav in da je zdravilo odobreno v vseh državah članicah, ter da so ustrezni podatki o rezultatih študij vključeni v podatke o zdravilu, odobriti nagrado v obliki 6 mesečnega podaljšanja veljavnosti dodatnega varstvenega certifikata, uvedenega z Uredbo Sveta (EGS) št. 1768/92 [6].
Any decisions by Member States' authorities as regards the setting of prices for medicinal products or their inclusion in the scope of national health insurance schemes have no bearing on the granting of this reward.
Na odobritev te nagrade ne vpliva noben sklep organov držav članic glede določanja cen zdravil ali njihove vključitve v sistem nacionalnega zdravstvenega zavarovanja.
An application for an extension of the duration of the certificate pursuant to this Regulation should only be admissible where a certificate is granted pursuant to Regulation (EEC) No 1768/92.
Vloga za podaljšanje veljavnosti certifikata v skladu s to uredbo naj bo sprejemljiva samo, če je bil certifikat izdan v skladu z Uredbo (EGS) št. 1768/92.
Because the reward is for conducting studies in the paediatric population and not for demonstrating that a product is safe and effective in the paediatric population, the reward should be granted even when a paediatric indication is not authorised.
Ker je nagrada namenjena izvajanju študij pri pediatrični populaciji in ne za prikaz, da je izdelek varen in učinkovit pri pediatrični populaciji, bi bilo treba nagrado zagotoviti tudi, če se pediatrična indikacija ne odobri.
However, to improve the information available on the use of medicinal products in the paediatric population, relevant information on use in paediatric populations should be included in authorised product information.
Vendar bi bilo treba za izboljšanje dostopnosti podatkov o uporabi zdravil pri pediatrični populaciji ustrezne podatke o uporabi pri pediatrični populaciji vključiti v podatke o odobrenem zdravilu.
Under Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products [7], medicinal products designated as orphan medicinal products gain ten years of market exclusivity on the granting of a marketing authorisation for the orphan indication.
V skladu z Uredbo (ES) št. 141/2000 Evropskega parlamenta in Sveta z dne 16. decembra 1999 o zdravilih sirotah [7] je zdravilom, ki so določena kot zdravila sirote, zagotovljena desetletna tržna ekskluzivnost na podlagi izdanega dovoljenja za promet za indikacijo sirota.
As such products are frequently not patent-protected, the reward of supplementary protection certificate extension cannot be applied; when they are patent-protected, such an extension would provide a double incentive.
Ker takšni izdelki pogosto niso zaščiteni s patentom, nagrade v obliki podaljšanja veljavnosti dodatnega varstvenega certifikata ni mogoče dodeliti; če pa so zaščitena s patentom, bo takšno podaljšanje veljavnosti pomenilo dvojno spodbudo.
Therefore, for orphan medicinal products, instead of an 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 the paediatric population is fully met.
Zato bi bilo treba za zdravila sirote namesto podaljšanja veljavnosti dodatnega varstvenega certifikata desetletno obdobje tržne ekskluzivnosti za zdravila sirote podaljšati na dvanajst let, če je v celoti izpolnjena zahteva o podatkih o uporabi pri pediatrični populaciji.