natgillin/translations-raw huggingface dataset:
(2) za podrobno opredelitev razlogov za odobritev odloga.
(2) to define further the grounds for granting a deferral.
Odbor za pediatrijo istočasno s sprejetjem pozitivnega mnenja v skladu s
At the same time as the Paediatric Committee adopts a positive opinion under
členom 22
Article 22
(1) na lastno pobudo ali na podlagi predloženega vlagateljevega zahtevka v skladu s
(1), it shall, of its own motion or following a request submitted by the applicant under
členom 25
Article 25,
, sprejme mnenje v korist odloga začetka ali končanja nekaterih ali vseh ukrepov iz načrta pediatričnih preiskav, če so izpolnjeni pogoji, določeni v
adopt an opinion, if the conditions specified in
členu 25
Article 25
Takoj, ko Odbor za pediatrijo sprejme mnenje v korist odloga iz odstavka 1, se uporabi postopek, določen v poglavju 4.
As soon as the Paediatric Committee adopts an opinion in favour of deferral, as referred to in paragraph 1, the procedure laid down in Chapter 4 shall apply.
Sprememba načrta pediatričnih preiskav
modification of a paediatric investigation plan
v 60 dneh
Within 60 days
pregleda te spremembe
, the Paediatric Committee shall review these changes
ali zahtevek za odlog ali spregled,
or the request for a deferral or a waiver
in sprejme mnenje, s katerim predlaga njihovo zavrnitev ali odobritev
and adopt an opinion proposing their refusal or acceptance
in po možnosti predvidi rok, do katerega vlagatelj predloži spremenjeni načrt pediatričnih raziskav
and, wherever possible, propose a deadline for submission by the applicant of an amended paediatric investigation plan
Oddelek 4
section 4
Skladnost z načrtom pediatričnih preiskav
compliance with the paediatric investigation plan
Odbor za pediatrijo je lahko zaprošen za svoje mnenje o tem, ali so izvedene vlagateljeve študije v skladu z dogovorjenim načrtom pediatričnih preiskav, v naslednjih primerih:
The Paediatric Committee may, in the following cases, be requested to give its opinion as to whether studies conducted by the applicant are in compliance with the agreed paediatric investigation plan:
s strani vlagatelja, pred predložitvijo vloge za dovoljenje za promet ali variacije iz
by the applicant, prior to submitting an application for marketing authorisation or variation as referred to in
s strani agencije ali pristojnega organa, ko potrjuje vlogo iz točke (a), ki ne vključuje mnenja o skladnosti, sprejetega na zahtevo iz točke (a);
by the Agency, or the competent authority, when validating an application, as referred to in point (a), which does not include an opinion concerning compliance adopted following a request under point (a);
s strani Odbora za zdravila za humano uporabo ali pristojnega organa, ko presoja vlogo iz točke (a), če obstaja dvom glede skladnosti in če še ni bilo dano mnenje na zahtevo iz točke (a) ali (b).
by the Committee for Medicinal Products for Human Use, or the competent authority, when assessing an application, as referred to in point (a), where there is doubt concerning compliance and an opinion has not been given already following a request under points (a) or (b).
Države članice upoštevajo takšno mnenje.
Member States shall take account of such an opinion.
Če pristojni organ, ko znanstveno presoja veljavno vlogo, ugotovi, da študije niso skladne z dogovorjenim načrtom pediatričnih preiskav, proizvod ni upravičen do nagrade, zagotovljene v
If, when conducting the scientific assessment of a valid application, the competent authority concludes that the studies are not compliant with the agreed paediatric investigation plan, the product shall not be eligible for the rewards provided for in
členih 40 in 41
Articles 40 and 41
Poglavje 4
chapter 4
Vlagatelj lahko Agenciji v 30 dneh od prejema mnenja Odbora za pediatrijo predloži pisno zahtevo s podrobnimi utemeljitvami za ponovni pregled mnenja.
Within 30 days of receiving the opinion of the Paediatric Committee, the applicant may submit to the Agency a written request, on detailed grounds, for a re-examination of the opinion.
V 30 dneh od prejema zahtevka za ponovni pregled iz odstavka 1, Odbor za pediatrijo, po imenovanju novega poročevalca,
Within 30 days of receiving a request for re-examination pursuant to paragraph 1, the Paediatric Committee, having appointed a new rapporteur,
ki lahko vlagatelju zastavlja vprašanja neposredno,
who shall be able to question the applicant directly,
izda novo mnenje, s katerim potrdi ali spremeni svoje predhodno mnenje.
shall issue a new opinion confirming or revising its previous opinion.
Poročevalec nemudoma v pisni obliki obvesti Odbor o podrobnostih pogovora z vlagateljem.
The rapporteur shall inform the Paediatric Committee without delay in writing about the details of contacts with the applicant.
Če vlagatelj v roku 30 dni iz odstavka 1 ne zaprosi za ponovni pregled, postane mnenje Odbora za pediatrijo dokončno.
If, within the 30-day period referred to in paragraph 1, the applicant does not request re-examination, the opinion of the Paediatric Committee shall become definitive.
Agencija sprejme odločitev
The Agency shall adopt a decision
v 15 dneh po prejemu končne odločitve Odbora za pediatrijo
within a period not exceeding 15 days following receipt of the Paediatric Committee's definitive opinion
se sprejeta odločitev agencije objavi.
, the Agency shall adopt a decision, which shall be published.
Poglavje 5
chapter 5
Druge določbe
miscellaneous provisions
Sponzor zdravila, ki je namenjeno pediatrični uporabi, lahko pred predložitvijo načrta pediatričnih preiskav in med njegovim izvajanjem zaprosi agencijo za nasvet o načrtu in izvedbi različnih preiskav in študij, ki so potrebne za ugotovitev kakovosti, varnosti in učinkovitosti zdravila pri pediatrični populaciji v skladu s členom 57(1)(n) Uredbe (ES) št. 726/2004.
The sponsor of a medicinal product intended for paediatric use may, prior to the submission of a paediatric investigation plan and during its implementation, request advice from the Agency on the design and conduct of the various tests and studies necessary to demonstrate the quality, safety and efficacy of the medicinal product in the paediatric population in accordance with Article 57(1)(n) of Regulation (EC) No 726/2004.
Poleg tega lahko sponzor zaprosi za nasvet o načrtu in o izvedbi farmakovigilence in sistemih obvladovanja tveganja iz
In addition, the sponsor may request advice on the design and conduct of pharmacovigilance and risk management systems as referred to in
člena 39
Article 39
Agencija zagotovi nasvet iz tega člena brezplačno.
The Agency shall provide advice under this Article free of charge.
Naslov III
TITLE III
Postopki za pridobitev dovoljenja za promet
Marketing authorisation procedures
Razen, če je v tem naslovu drugače določeno, se za postopke za pridobitev dovoljenja za promet, ki se uporabljajo za dovoljenja za promet, urejena v tem naslovu, uporabljajo določbe Uredbe (ES) št. 726/2004 ali Direktive 2001/83/ES.
Save where otherwise provided in this Title, marketing authorisation procedures for the marketing authorisations covered by this Title shall be governed by the provisions laid down in Regulation (EC) No 726/2004 or in Directive 2001/83/EC.
Postopki za pridobitev dovoljenja za promet, za vloge, ki spadajo v področje uporabe
Marketing authorisation procedures for applications falling within the scope of
Vloge za dovoljenje za promet iz
Applications may be submitted in accordance with the procedure laid down in Articles 5 to 15 of Regulation (EC) No 726/2004 for a marketing authorisation as referred to in
člena 12
Article 12
(1) te uredbe, ki vsebuje eno ali več pediatričnih indikacij, ki so izbrane glede na rezultate študij, izvedenih v skladu z dogovorjenim načrtom pediatričnih preiskav, se lahko predložijo v skladu s postopkom, določenim v členih 5 do 15 Uredbe (ES) št. 726/2004.
(1) of this Regulation which includes one or more paediatric indications selected on the basis of studies conducted in compliance with an agreed paediatric investigation plan.
Če je dovoljenje odobreno, se
Where authorisation is granted,
rezultati teh študij vključijo v povzetek glavnih značilnosti zdravila in, če je to primerno, v navodila za uporabo proizvoda,
the results of those studies shall be included in the summary of product characteristics and, if appropriate, in the package leaflet of the medicinal product,
vendar le pod pogojem, če pristojni organ presodi, da gre za informacijo, ki je koristna za bolnike
provided that the competent authority deems the information to be of use to patients,
Če je vloga skladna z vsemi ukrepi iz dokončanega dogovorjenega načrta pediatričnih preiskav in če povzetek glavnih značilnosti proizvoda odraža rezultate študij, izvedenih v skladu z dogovorjenim načrtom pediatričnih preiskav, pristojni organ vključi izjavo o skladnosti vloge z dokončanim dogovorjenim načrtom pediatričnih preiskav v dovoljenje za promet.
If the application complies with all the measures contained in the agreed completed paediatric investigation plan and if the summary of product characteristics reflects the results of studies conducted in compliance with that agreed paediatric investigation plan, the competent authority shall include within the marketing authorisation a statement indicating compliance of the application with the agreed completed paediatric investigation plan.
V primeru zdravil, odobrenih v skladu z Direktivo 2001/83/ES, se vloga iz
In the case of medicinal products authorised under Directive 2001/83/EC, an application as referred to in
te uredbe lahko vloži za odobritev nove indikacije, vključno z razširitvijo dovoljenja za uporabo pri pediatrični populaciji, za odobritev nove farmacevtske oblike ali nove poti uporabe zdravila v skladu s postopkom, določenim v členih 32, 33 in 34 Direktive 2001/83/ES.
of this Regulation may be submitted, in accordance with the procedure laid down in Articles 32, 33 and 34 of Directive 2001/83/EC, for authorisation of a new indication, including the extension of an authorisation for use in the paediatric population, a new pharmaceutical form or a new route of administration.
Vloga mora ustrezati zahtevi, iz točke (a)
That application shall comply with the requirement laid down in point (a) of
Postopek se omeji na presojo določenih delov povzetka glavnih značilnosti proizvoda, ki bo predmet spremembe.
The procedure shall be limited to the assessment of the specific sections of the summary of product characteristics to be varied.
Dovoljenje za promet za pediatrično uporabo
paediatric use marketing authorisation
Za namene te uredbe dovoljenje za promet za pediatrično uporabo pomeni dovoljenje za promet, odobreno za zdravilo za humano uporabo, ki ni zavarovano z dodatnim varstvenim certifikatom v skladu z Uredbo (EGS) št. 1768/92 ali s patentom, ki omogoča podelitev dodatnega varstvenega certifikata za izključno terapevtske indikacije, ki so pomembne za uporabo pri pediatrični populaciji ali njenih delov, vključno s primerno jakostjo, farmacevtsko obliko ali načinom uporabe tega proizvoda.
For the purposes of this Regulation, a paediatric use marketing authorisation shall mean a marketing authorisation granted in respect of a medicinal product for human use which is not protected by a supplementary protection certificate under Regulation (EEC) No 1768/92 or by a patent which qualifies for the granting of the supplementary protection certificate, covering exclusively therapeutic indications which are relevant for use in the paediatric population, or subsets thereof, including the appropriate strength, pharmaceutical form or route of administration for that product.
Predložitev vloge za dovoljenje za promet za pediatrično uporabo ne izključuje pravice, da se zaprosi za dovoljenje za promet za druge indikacije.
Submission of an application for a paediatric use marketing authorisation shall in no way preclude the right to apply for a marketing authorisation for other indications.
Vloga mora vsebovati tudi odločitev agencije o dogovoru zadevnega načrta pediatričnih preiskav.
The application shall also include the decision of the Agency agreeing the paediatric investigation plan concerned.
Če je ali je bilo zdravilo odobreno v državi članici ali Skupnosti, so lahko podatki, vključeni v dosje tega proizvoda, v skladu s členom 14(11) Uredbe (ES) št. 726/2004 ali členom 10 Direktive 2001/83/ES navedeni v vlogi za dovoljenje za promet za pediatrično uporabo, če je to primerno.
Where a medicinal product is or has been authorised in a Member State or in the Community, data contained in the dossier on that product may, where appropriate, be referred to, in accordance with Article 14(11) of Regulation (EC) No 726/2004 or Article 10 of Directive 2001/83/EC, in an application for a paediatric use marketing authorisation.
Zdravilo, za katerega je bilo odobreno dovoljenje za promet za pediatrično uporabo, lahko obdrži ime katerega koli zdravila, ki vsebuje enako zdravilno učinkovino in za katerega je isti imetnik pridobil dovoljenje za uporabo pri odraslih.
The medicinal product in respect of which a paediatric use marketing authorisation is granted may retain the name of any medicinal product which contains the same active substance and in respect of which the same holder has been granted authorisation for use in adults.
pediatrično uvajanje vsebuje ime zdravila
and, below it, the European logo
in evropski logo pod imenom.
for any paediatric presentation.
Logo se izbere na otroškem natečaju.
That logo shall be selected following a design competition for children.
Prvi pododstavek se uporabi ne glede na to, ali je ime zdravila izmišljeno ali gre za splošno ime iz člena 1(20) ali (21) Direktive 2001/83/ES.
The first paragraph shall apply whether the name of the medicinal product is an invented name or a common name as referred to in Article 1(20) and (21), respectively, of Directive 2001/83/EC.
Določbe tega člena se uporabljajo tudi za zdravila, ki so bila odobrena pred uveljavitvijo uredbe, izključno pa se nanašajo na pediatrične indikacije.
The provisions of this Article shall also apply to medicinal products authorised prior to the entry into force of this Regulation and covering paediatric indications only.
Naslov IV
TITLE IV
Zahteve po izdaji dovoljenja
Post-authorisation requirements
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
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,
po možnosti v enem letu
wherever possible within one year and no later than
Za prikaz rokov pristojni organi oblikujejo javno dostopen register.
A publicly accessible register shall be set up by the competent authorities in order to indicate these deadlines.
Vsako tako odstopanje mora biti ustrezno utemeljeno.
Any such derogations shall be justified on duly substantiated grounds..
Vlagatelj v naslednjih primerih poleg normalnih zahtev za spremljanje po začetku trženja podrobno določi ukrepe, s katerimi se zagotovi spremljanje izvajanja učinkovitosti in možnih neželenih učinkov pri pediatrični uporabi zdravila:
In the following cases, the applicant shall detail, in addition to the normal requirements for post-marketing monitoring, the measures to ensure the follow-up of efficacy and of possible adverse reactions to the paediatric use of the medicinal product:
vloge za dovoljenje za promet, ki vsebuje pediatrično indikacijo;
applications for a marketing authorisation that includes a paediatric indication;
vloge za vključitev pediatrične indikacije v obstoječe dovoljenje za promet;
applications to include a paediatric indication in an existing marketing authorisation;
vloge za dovoljenje za promet za pediatrično uporabo.
applications for a paediatric use marketing authorisation.
Ocena učinkovitosti vseh sistemov obvladovanja tveganja in rezultati vseh izvedenih študij se vključijo v z zadnjimi podatki dopolnjena redna poročila o varnosti iz člena 104(6) Direktive 2001/83/ES in člena 24(3) Uredbe (ES) št. 726/2004.
Assessment of the effectiveness of any risk management system and the results of any studies performed shall be included in the periodic safety update reports referred to in Article 104(6) of Directive 2001/83/EC and Article 24(3) of Regulation (EC) No 726/2004.
Poleg tega lahko pristojni organ zahteva predložitev dodatnih poročil o oceni učinkovitosti vseh sistemov za zmanjšanje tveganj in rezultate vseh takšnih izvedenih študij.
In addition, the competent authority may request submission of additional reports assessing the effectiveness of any risk minimisation system and the results of any such studies performed.
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.
Farmakovigilančni podatki o škodljivih učinkih, predloženi pred trženjem in po njem, se združijo v register, ki je na voljo javnosti.
Pharmacovigilance data on adverse reactions reported before and after marketing shall be collated in a register that is made publicly available.
Če agencija ugotovi, da imetnik dovoljenja za promet ni izpolnil odločbe agencije o strinjanju z načrtom pediatričnih preiskav in odobritvi odloga, o tem obvesti pristojni organ.
The Agency shall inform the competent authority if it is found that the marketing authorisation holder has failed to comply with the decision of Agency agreeing the paediatric investigation plan and granting a deferral.
Z namenom doseganja popolne neodvisnosti je treba 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.
Če je zdravilo odobreno za pediatrično indikacijo in je imetnik dovoljenja za trženje užival ugodnosti iz določb člena 40, člena 41 ali člena 42, če imetnik dovoljenja za trženje preneha dajati zdravilo v promet, imetnik dovoljenja za trženje 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, in cases where a medicinal product is authorised for a paediatric indication and the marketing authorisation holder has benefited from the provisions of Articles 40, 41 or 42, the marketing authorisation holder ceases to market the medicinal product, 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 10c of Directive 2001/83/EC.
Imetnik dovoljenja za trženje 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 cease marketing the product and the Agency will make this fact public.
Naslov V
TITLE V
Nagrade in spodbude
Rewards and incentives
Če vloga v skladu s
Where an application under
členom 12 ali 13
Articles 12 or 13
vsebuje rezultate vseh študij, izvedenih v skladu z dogovorjenim načrtom pediatričnih preiskav, je imetnik patenta ali dodatnega varstvenega certifikata upravičen do šestmesečnega podaljšanja obdobja iz
includes the results of all studies conducted in compliance with an agreed paediatric investigation plan, the holder of the patent or supplementary protection certificate shall be entitled to a six-month extension of the period referred to in
odstavkov 1 in 2 člena 13
Article 13(1) and (2)
Vključitev izjave iz
The inclusion in a marketing authorisation of the statement referred to in
člena 33
Article 33
(3) v dovoljenje za promet se uporablja za namen uporabe odstavka 1.
(3) shall be used for the purposes of applying paragraph 1 of this Article.
Če se uporabijo postopki, določeni v Direktivi 2001/83/ES, se šestmesečno podaljšanje obdobja iz odstavka 1
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
odobri v
granted in the
državah članicah
Member States
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
, 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.
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 European Union.
Če je predložena vloga za dovoljenje za promet za zdravilo, določeno kot zdravilo sirota v skladu z Uredbo (ES) št. 141/2000, in ta vloga vsebuje rezultate vseh študij, izvedenih v skladu z dogovorjenim načrtom pediatričnih preiskav, in je izjava iz
Where an application for a marketing authorisation is submitted in respect of a medicinal product designated as an orphan medicinal product pursuant to Regulation (EC) No 141/2000 and that application includes the results of all studies conducted in compliance with an agreed paediatric investigation plan, and the statement referred to in
(3) te uredbe posledično vsebovana v odobrenem dovoljenju za promet, se desetletno obdobje iz člena 8(1) Uredbe (ES) št. 141/2000 podaljša na dvanajst let.
(3) of this Regulation is subsequently included in the marketing authorisation granted, the ten-year period referred to in Article 8(1) of Regulation (EC) No 141/2000 shall be extended to twelve years.
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 medicinal products are fulfilled, the authorisation holder may have recourse to whichever of the two procedures he chooses.
Če je dovoljenje za promet za pediatrično uporabo odobreno v skladu s členi 5 do 15 Uredbe (ES) št. 726/2004, se uporabljajo podatki in obdobja tržne zaščite iz člena 14(11) uredbe.
Where a paediatric use marketing authorisation is granted in accordance with Articles 5 to 15 of Regulation (EC) No 726/2004, the data and marketing protection periods referred to in Article 14(11) of that Regulation shall apply.
Če je dovoljenje za promet za pediatrično uporabo odobreno v skladu s postopkom, določenim v Direktivi 2001/83/ES, se uporabljajo podatki in obdobja tržne zaščite iz člena 10(1) direktive.
Where a paediatric use marketing authorisation is granted in accordance with the procedures laid down in Directive 2001/83/EC, the data and marketing protection periods referred to in Article 10(1) of that Directive shall apply.
Zdravila za pediatrično uporabo so poleg nagrad in spodbud iz
In addition to the rewards and incentives provided for in
členov 40, 41 in 42
Articles 40, 41 and 42
lahko upravičena do spodbud Skupnosti ali držav članic, ki so zagotovljene za podporo raziskavam in razvoju ter dostopnosti zdravil za pediatrično uporabo.
, medicinal products for paediatric use may be eligible for incentives provided by the Community or by the Member States to support research into, and the development and availability of, medicinal products for paediatric use.