natgillin/translations-raw huggingface dataset:
Ta uredba ureja razvoj zdravil za humano uporabo z namenom, da se zadosti posebnim terapevtskim potrebam pediatrične populacije, ne da bi otroke izpostavljali nepotrebnim kliničnim
This Regulation lays down rules concerning the development of medicinal products for human use in order to meet the specific therapeutic needs of the paediatric population, without subjecting children to unnecessary clinical
in drugim
or other
, zlasti v primeru zdravil, ki jih že uporabljajo otroci, ki imajo redke prirojene bolezni,
(particularly in the case of medicinal products which are already used by children suffering from rare congenital conditions)
ter v skladu z Direktivo 2001/20/ES.
and in compliance with Directive 2001/20/EC.
Poleg opredelitev pojmov, določenih v členu 1 Direktive 2001/83/ES, se za namene te uredbe uporabljajo naslednje opredelitve:
In addition to the definitions laid down in Article 1 of Directive 2001/83/EC, the following definitions shall apply for the purposes of this Regulation:
pomeni zdravilo, ki je odobreno za uporabo pri delu ali pri celotni pediatrični populaciji in so podrobnosti o odobreni indikaciji opredeljene v povzetku glavnih značilnosti zdravila, pripravljenem v skladu s členom 11 Direktive 2001/83/ES.
means a medicinal product which is authorised for use in part or all of the paediatric population and in respect of which the details of the authorised indication are specified in the summary of the product characteristics drawn up in accordance with Article 11 of Directive 2001/83/EC.
Opredelitev potreb
IDENTIFICATION OF NEEDS
Države članice zberejo vse razpoložljive podatke o vseh obstoječih in potrebnih uporabah zdravil in oblikujejo seznam potreb, ki niso vključene v pediatrični populaciji.
The Member States shall collect all available data on all existing and necessary uses of medicinal products and shall draw up an inventory of the needs which are not covered in the paediatric population.
Odbor za pediatrijo, ustanovljen v skladu s členom 7, pripravi smernice o vsebini in obliki zbranih podatkov.
The Paediatric Committee set up under Article 7 shall provide guidance on the content and the format of the data to be collected.
Odbor za pediatrijo na podlagi podatkov iz člena 3 in po posvetovanju s Komisijo, državami članicami in zainteresiranimi strankami oblikuje poseben seznam potreb po pediatričnih zdravilih.
On the basis of the information referred to in Article 3 and after consulting the Commission, the Member States and the interested parties, the Paediatric Committee shall draw up a specific inventory of paediatric medicinal product needs.
Pri sestavi seznama terapevtskih potreb se upošteva razširjenost bolezni v pediatrični populaciji, pomembnost zdravljenja bolezni, dostopnost in primernost alternativnih zdravljenj bolezni v pediatrični populaciji, vključno z učinkovitostjo in profilom neželenih učinkov teh zdravljenj, vključno z vsemi enotnimi pediatričnimi vprašanji o varnosti.
In establishing the inventory of therapeutic needs, account shall be taken of the prevalence of the conditions in the paediatric population, the seriousness of the conditions to be treated, the availability and suitability of alternative treatments for the conditions in the paediatric population, including the efficacy and the adverse reaction profile of those treatments, and any unique paediatric safety issues.
Agencija objavi seznam v dveh letih od začetka veljavnosti te uredbe in ga redno posodablja, vključujoč izsledke preskusov, izvedenih v tretjih državah.
The Agency shall publish the inventory within two years of the entry into force of this Regulation and shall update it regularly, including the data from trials carried out in third countries.
Agencija z znanstveno podporo Odbora za pediatrijo razvije evropsko mrežo iz obstoječih nacionalnih in evropskih mrež, raziskovalcev in središč posebnim strokovnim znanjem za izvajanje študij v pediatrični populaciji.
The Agency shall, with the scientific support of the Paediatric Committee, develop a European network of existing national and European networks, investigators and centres with specific expertise in the performance of studies in the paediatric population.
Komisija in države članice v enem letu od začetka veljavnosti te uredbe ustanovijo evropski pediatrični raziskovalni program za financiranje študij o uporabi zdravil (še zlasti tistih, ki niso vključena v patente ali dodatne varstvene certifikate).
Within one year of the entry into force of this Regulation, the Commission and the Member States shall establish a European paediatrics research programme under which studies into the use of medicinal products (in particular ones which are not covered by patents or supplementary certificates) shall be financed.
Program upošteva prednostne naloge iz člena 4, pododstavka 3.
The programme shall take into account the priorities referred to in the third paragraph of Article 4.
Poglavje 3
CHAPTER 3
Odbor za pediatrijo
PAEDIATRIC COMMITTEE
Najpozneje šest mesecev po začetku veljavnosti te uredbe
Not later than 6 months after the entry into force of this Regulation,
se znotraj
shall be
Kadar ta uredba ne določa drugače, se za Odbor za pediatrijo uporablja Uredba (ES) št. 726/2004.
Save where otherwise provided in this Regulation, Regulation (EC) No 726/2004 shall apply to the Paediatric Committee.
Izvršni direktor agencije zagotovi ustrezno sodelovanje med Odborom za pediatrijo in Odborom za zdravila za humano uporabo, Odborom za zdravila sirote, njihovimi delovnimi skupinami ter vsemi ostalimi skupinami za znanstveno svetovanje.
The Executive Director of the Agency shall ensure appropriate co-ordination between the Paediatric Committee and the Committee for Medicinal Products for Human Use, the Committee for Orphan Medicinal Products, their working parties and any other scientific advisory groups.
Agencija pripravi posebne postopke za možna posvetovanja med njimi.
The Agency shall draw up specific procedures for possible consultations between them.
Odbor za pediatrijo sestavljajo naslednji člani:
The Paediatric Committee shall be composed of the following members:
pet članov Odbora za zdravila za humano uporabo, ki jih le-ta imenuje;
five members of the Committee for Medicinal Products for Human Use, appointed by the latter;
ena oseba, imenovana od vsake države članice, katere nacionalni pristojni organ ni zastopan med člani, ki jih je imenoval Odbor za zdravila za humano uporabo;
one person appointed by each Member State whose national competent authority is not represented through the members appointed by the Committee for Medicinal Products for Human Use;
oseb, ki jih imenuje Komisija
persons appointed by the Commission,
po posvetovanju z Evropskim parlamentom
after consulting the European Parliament
na podlagi javnega poziva za izraz interesa, z namenom zastopanja pediatrov in
, on the basis of a public call for expressions of interest, in order to represent paediatricians
ostalih zdravnikov, specializiranih za zdravljenje otrok, splošnih zdravnikov, farmacevtov, strokovnjakov na področju farmakovigilence in javnega zdravja ter združenj staršev
, other physicians specialising in the treatment of children, general practitioners, pharmacists, pharmacovigilance and public-health specialists and parents"
Za namene iz točke (b) države članice sodelujejo v skladu z usmeritvami izvršnega direktorja agencije z namenom, da se zagotovi, da končna sestava Odbora za pediatrijo zajema znanstvena področja, pomembna za pediatrična zdravila in vključuje vsaj: farmacevtski razvoj, pediatrično medicino, pediatrično farmacijo, pediatrično farmakologijo, pediatrične raziskave, farmakovigilenco in etiko.
For the purposes of point (b), the Member States shall cooperate, under the coordination of the Executive Director of the Agency, in order to ensure that the final composition of the Paediatric Committee covers the scientific areas relevant to paediatric medicinal products, and including at least: pharmaceutical development, paediatric medicine, paediatric pharmacy, paediatric pharmacology, paediatric research, pharmacovigilance and ethics.
Člani Odbora za pediatrijo so imenovani za mandat treh let, ki je obnovljiv.
The members of the Paediatric Committee shall be appointed for a renewable period of three years.
Na sejah Odbora za pediatrijo jih lahko spremljajo strokovnjaki.
At meetings of the Paediatric Committee, they may be accompanied by experts.
Odbor za pediatrijo izvoli svojega predsednika izmed svojih članov za mandat treh let, ki se lahko enkrat obnovi.
The Paediatric Committee shall elect its Chairman from among its members for a term of three years renewable once.
Agencija objavi imena in znanstvene kvalifikacije članov.
The names and scientific qualifications of the members shall be published by the Agency.
Če ga ne more doseči, mnenje
If such a consensus cannot be reached, the opinion shall
večina članov.
the majority of members
odklonilna stališča skupaj z razlogi, na katerih temeljijo.
divergent positions, with the grounds on which they are based.
Mnenje se nemudoma objavi.
The opinion shall be made public immediately.
Odbor za pediatrijo sprejme poslovnik za izvajanje svojih nalog.
The Paediatric Committee shall draw up its own rules of procedure for the implementation of its tasks.
Poslovnik začne veljati po prejemu pozitivnega mnenja upravnega odbora agencije in nato Komisije.
The rules of procedure shall enter into force after receiving a favourable opinion from the Management Board of the Agency and, subsequently, from the Commission.
predstavnika Komisije, in izvršni direktor agencije ali
representatives of the Commission, the Executive Director of the Agency or his
Člani Odbora za pediatrijo in njegovi strokovnjaki delujejo v javnem interesu in neodvisno.
Members of the Paediatric Committee and its experts shall undertake to act in the public interest and in an independent manner.
Ne smejo imeti finančnih ali drugih interesov v farmacevtski industriji, ki bi lahko vplivali na njihovo nepristranskost.
They shall not have financial or other interests in the pharmaceutical industry that could affect their impartiality.
neposredni ali
direct or
posredni interesi, povezani s farmacevtsko industrijo, se vnesejo v register, ki ga vodi agencija in je dostopen javnosti.
indirect interests that could relate to the pharmaceutical industry shall be entered in a register held by the Agency which the public may consult.
Člani Odbora za pediatrijo in njegovi strokovnjaki se morajo na vsakem sestanku, ob upoštevanju dnevnega reda, izreči o posebnih interesih, ki bi lahko ovirali njihovo neodvisnost.
Members of the Paediatric Committee and its experts shall declare at each meeting any specific interests which could be considered to be prejudicial to their independence with respect to the points on the agenda.
Člani Odbora za pediatrijo in njegovi strokovnjaki tudi po prenehanju svoje funkcije ne smejo razkriti nobenih informacij, ki spadajo v obveznost poslovne skrivnosti.
Members of the Paediatric Committee and its experts shall be required, even after their duties have ceased, not to disclose any information of the kind covered by the obligation of professional secrecy.
Naloge Odbora za pediatrijo vključujejo naslednje:
The tasks of the Paediatric Committee shall include the following:
in odloge ter o njih oblikovati mnenje;
formulate an opinion thereon;
na zahtevo Odbora ali pristojnega organa presoditi vse podatke, zbrane v skladu z dogovorjenim načrtom pediatričnih preiskav, in oblikovati mnenje o
at the request of the Committee for Medicinal Products for Human Use or a competent authority, to assess any data generated in accordance with an agreed paediatric investigation
, varnosti in učinkovitosti zdravila za uporabo pri pediatrični populaciji;
formulate an opinion on the quality, safety or efficacy of the medicinal product for use in the paediatric population;
svetovati o vsebini in obliki podatkov, ki se bodo zbirali za raziskavo iz
to advise on the content and format of data to be collected for the survey referred to in
člena 3
Article 3
, in sprejeti seznam terapevtskih potreb iz
and to adopt an inventory of therapeutic needs as referred to in
člena 4
Article 4
podpirati in svetovati agenciji o uvedbi evropske mreže iz
to support and advise the Agency on establishing the European network referred to in
pri pripravi vseh dokumentov, povezanih z izpolnjevanjem ciljev te uredbe;
in the elaboration of any documents related to the fulfilment of the objectives of this Regulation;
na zahtevo izvršnega direktorja agencije ali Komisije zagotoviti nasvet o vseh vprašanjih, povezanih z zdravili za pediatrično uporabo
to provide advice on any question related to medicinal products for paediatric use, at the request of the Executive Director of the Agency or the
pripraviti poseben seznam potreb po pediatričnih zdravilih in zagotoviti njegovo redno posodabljanje ter ga dati na voljo zainteresiranim strankam (strokovnjakom, podjetjem, bolnikom itd.);
to establish a specific inventory of paediatric medicinal product needs, update it on a regular basis and make it available to interested parties (professionals, enterprises, patients, etc);
podpirati informacijske kampanje o vlogi Odbora in ureditev, ki so na voljo za opravljanje pediatričnih farmacevtskih poskusov.
to promote information campaigns on the role of the Committee and the arrangements available for the conducting of paediatric pharmaceuticals trials.
Prav tako upošteva, med drugim, vsa mnenja, odločbe ali nasvete pristojnih organov tretjih držav.
It shall also take into account, inter alia, any opinions, decisions or advice issued by the competent authorities of third countries.
Splošne zahteve za pridobitev dovoljenja
general authorisation requirements
Vloga za dovoljenje za promet v skladu s členom 6 Direktive 2001/83/ES glede zdravila za humano uporabo, ki ob začetku veljavnosti te uredbe ni odobreno v Skupnosti, se šteje za veljavno samo, če poleg podatkov in dokumentov iz člena 8(3) Direktive 2001/83/ES vsebuje eno izmed naslednjih prilog:
An application for marketing authorisation under Article 6 of Directive 2001/83/EC in respect of a medicinal product for human use which is not authorised in the Community at the time of entry into force of this Regulation shall be regarded as valid only if it includes, in addition to the particulars and documents referred to in Article 8(3) of Directive 2001/83/EC, one of the following:
rezultate vseh izvedenih študij in podrobnosti o vseh podatkih, zbranih v skladu z dogovorjenim načrtom pediatričnih preiskav;
the results of all studies performed and details of all information collected in compliance with an agreed paediatric investigation plan;
odločitev agencije o odobritvi odloga
a decision of the Agency granting a
pediatrične študije, ki trenutno potekajo v zvezi s proizvodom, časovni okvir, v katerem naj bi se zaključile, in mnenje agencije o tem vprašanju.
ongoing paediatric studies on the product, the scheduled date for completion of the studies and the Agency's opinion on these points.
Za namene točke (a) se tudi odločitev agencije o strinjanju z zadevnim načrtom pediatričnih preiskav vključi v vlogo.
For the purposes of point (a), the decision of the Agency agreeing the paediatric investigation plan concerned shall also be included in the application.
Dokumenti, predloženi v skladu z odstavkom 1, se nanašajo na vse dele pediatrične populacije.
The documents submitted pursuant to paragraph 1 shall, cumulatively, cover all subsets of the paediatric population.
V primeru odobrenih zdravil, ki so zavarovana bodisi z dodatnim varstvenim certifikatom v skladu z Uredbo (EGS) št. 1768/92 bodisi s patentom, ki omogoča podelitev dodatnega varstvenega certifikata, se
In the case of authorised medicinal products which are protected either 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,
te uredbe uporablja za vloge za odobritev novih indikacij, vključno s pediatričnimi, novih farmacevtskih oblik in novih poti uporabe zdravila.
of this Regulation shall apply to applications for authorisation of new indications, including paediatric indications, new pharmaceutical forms and new routes of administration.
UL L 159, 27.6.2003, str.
OJ L 159, 27.6.2003, p.
Prvi odstavek se ravno tako uporablja, če vlagatelj dokaže, da je zdravilo pomembna terapevtska, znanstvena ali tehnična inovacija v skladu z določbami Uredbe (ES) št. 726/2004, in še zlasti člena 3(2)(b) Uredbe.
The first paragraph shall also apply where the applicant shows that the medicinal product constitutes a significant therapeutic, scientific or technical innovation in accordance with the provisions of Regulation (EC) No 726/2004 and, in particular, Article 3(2)(b) thereof.
Člena 12 in 13
Articles 12 and 13
se ne uporabljata za proizvode, odobrene v skladu s členi 10, 10a, 13 do 16 ali 16a do 16i Direktive 2001/83/ES.
shall not apply to products authorised under Articles 10, 10a, 13 to 16 or 16a to 16i of Directive 2001/83/EC.
Predložitev podatkov iz točke (a)
Production of the information referred to in point (a) of
člena 12(1)
Article 12
določeno zdravilo ali razred zdravil verjetno ni učinkovito ali varno za del ali celotno pediatrično populacijo;
that the specific medicinal product or class of medicinal products is likely to be ineffective or unsafe in part or all of the paediatric population;
se bolezen ali stanje, za katerega je zdravilo ali razred zdravil namenjen, pojavi samo pri odraslih populacijah;
that the disease or condition for which the specific medicinal product or class is intended occurs only in adult populations;
določeno zdravilo v okviru obstoječih zdravljenj ne kaže posebne terapevtske koristi za pediatrične bolnike.
that the specific medicinal product does not represent a significant therapeutic benefit over existing treatments for paediatric patients.
Odbor za pediatrijo lahko na lastno pobudo sprejme mnenje iz razlogov, določenih v
The Paediatric Committee may of its own motion adopt an opinion, on the grounds set out in
členu 16(1),
Article 16
V primeru
In the case of a class waiver, only
Vlagatelj lahko iz razlogov, določenih v
The applicant may, on the grounds set out in
členu 16(1)
Article 16
Po prejemu vloge Odbor za pediatrijo imenuje poročevalca in v največ 60 dneh sprejme
appoint a rapporteur and shall within a maximum period of 60 days
Odbor za pediatrijo lahko, kadarkoli je to primerno, zaprosi vlagatelja, da dopolni predložene podatke in dokumente.
Whenever appropriate, the Paediatric Committee may request the applicant to supplement the particulars and documents submitted.
Če Odbor za pediatrijo uporabi to možnost, se 60-dnevni rok začasno ustavi, dokler niso predložene dodatne zahtevane informacije.
Where the Paediatric Committee avails itself of this option, the 60-day time-limit shall be suspended until such time as the supplementary information requested has been provided.
obvesti vlagatelja.
within no more than seven working days
V primeru spremembe, ki vpliva na
In the case of a change affecting a class waiver,
členih 12 in 13
Articles 12 and 13
Oddelek 1
section 1
Vloge za dogovor
requests for agreement
Za vlogo v skladu s točkami (a) ali (d)
Where the intention is to apply in accordance with points (a) or (d) of
, se pripravi in predloži načrt pediatričnih preiskav agenciji skupaj s prošnjo za dogovor.
(1), a paediatric investigation plan shall be drawn up and submitted to the Agency with a request for agreement.
Poleg tega se opišejo vsi ukrepi za prilagoditev formulacije zdravila na takšen način, da je njegova uporaba bolj sprejemljiva, lažja, varnejša in učinkovitejša pri različnih delih pediatrične populacije.
In addition, it shall describe any measures to adapt the formulation of the medicinal product so as to make its use more acceptable, easier, safer or more effective for different subsets of the paediatric population.
V primeru vlog iz
In the case of applications as referred to in
členov 12 in 13
Articles 12 and 13
vključno s kratkim poročilom,
including a summary report may
predloži z vlogo za dogovor
be submitted with a request for agreement,
čim prej po
at the earliest after
dokončnem oblikovanju
completion of
faze II
phase II of
Če vloga ne prispe do datuma dokončnega oblikovanja humanih farmakinetskih študij, vlagatelj predloži tekoče pediatrične študije in rok, do katerega naj bi se zaključile.
Should an application not be submitted upon completion of the human pharmaco-kinetic studies, the applicant shall supply the ongoing paediatric studies and the scheduled date for their completion.
od prejema vloge iz odstavka 1 preveri veljavnost
days of receiving the request referred to in paragraph 1, the Agency shall verify the validity of the
Kadar je to primerno, lahko agencija od vlagatelja zahteva predložitev dodatnih podrobnosti in dokumentov, pri čemer se rok
Whenever appropriate, the Agency may ask the applicant to submit additional particulars and documents, in which case the time-limit of
začasno ustavi, dokler niso predložene dodatne zahtevane informacije.
days shall be suspended until such time as the supplementary information requested has been provided.
mnenje o tem, ali bodo predlagane študije zagotovile potrebne podatke o pogojih, v katerih se zdravilo lahko uporabi za zdravljenje pediatrične populacije ali njenega dela in ali pričakovane terapevtske koristi upravičujejo predlagane študije.
adopt an opinion as to whether or not the proposed studies will ensure the generation of the necessary data determining the conditions in which the medicinal product may be used to treat the paediatric population or subsets thereof, and as to whether or not the expected therapeutic benefits justify the studies proposed.
Vlagatelj ali Odbor za pediatrijo lahko v enakem roku zahtevata sestanek.
Within the same period, either the applicant or the Paediatric Committee may request a meeting.
Odbor za pediatrijo lahko v roku 60 dni, iz odstavka 1, zahteva od vlagatelja, da predlaga spremembe načrta, pri čemer se rok iz odstavka 1 za sprejetje končnega mnenja podaljša za največ 60 dni.
Within the 60-day period referred to in paragraph 1, the Paediatric Committee may request the applicant to propose modifications to the plan, in which case the time-limit referred to in paragraph 1 for the adoption of the final opinion shall be extended for a maximum of 60 days.
Rok se začasno ustavi, dokler
The time-limit shall be suspended until such time as the
zahtevane spremembe
requested have been
Če Odbor za pediatrijo po preučitvi načrta pediatričnih preiskav odloči, da se za zadevno zdravilo uporabi
If, having considered a paediatric investigation plan, the Paediatric Committee concludes that
(1)(a), (b) ali (c), sprejme negativno mnenje na podlagi
(1)(a), (b) or (c) applies to the medicinal product concerned, it shall adopt a negative opinion under
člena 22
Article 22
členom 17
Article 17
, nato se uporabi postopek, določen v poglavju 4.
, whereupon the procedure laid down in Chapter 4 shall apply.
Oddelek 2
section 2
člena 21
Article 21
(1) se lahko zahteva odlog glede začetka ali končanja nekaterih ali vseh ukrepov, določenih v tem načrtu.
(1), a request may be made for deferral of the initiation or completion of some or all of the measures set out in that plan.
Takšen odlog je upravičen iz znanstvenih in tehničnih razlogov ali iz razloga povezanega z javnim zdravjem.
Such deferral shall be justified on scientific and technical grounds or on grounds related to public health.
V vsakem primeru se odlog odobri, če je primerno študije pri odraslih izvesti pred začetkom študij v pediatrični populaciji ali če bodo študije v pediatrični populaciji trajale dlje kot študije pri odraslih.
In any case, a deferral shall be granted when it is appropriate to conduct studies in adults prior to initiating studies in the paediatric population or when studies in the paediatric population will take longer to conduct than studies in adults.
Komisija lahko na podlagi izkušenj, ki so posledica ravnanj iz tega člena, sprejme določbe v skladu s postopkom iz
On the basis of the experience acquired as a result of the operation of this Article, the Commission may adopt provisions in accordance with the procedure referred to in
člena 54
Article 54