natgillin/translations-raw huggingface dataset:
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:
Vloga za dovoljenje za promet, v skladu s členom 6 Direktive 2001/83/ES, z zdravilom za uporabo v humani medicini, ki ob začetku veljavnosti te uredbe še ni odobreno v Skupnosti, se šteje za popolno samo, če poleg podatkov in dokumentov iz člena 8(3) Direktive 2001/83/ES vsebuje eno od naslednjega:
the results of all studies performed and details of all information collected in compliance with an agreed paediatric investigation plan;
rezultate vseh izvedenih študij in podrobnosti o vseh informacijah, zbranih v skladu z dogovorjenim načrtom pediatričnih raziskav;
a decision of the Agency granting a product-specific waiver;
sklep Agencije o opustitvi za določeno zdravilo;
a decision of the Agency granting a class waiver pursuant to Article 11;
sklep Agencije o opustitvi za skupino zdravil v skladu s členom 11;
a decision of the Agency granting a deferral.
sklep Agencije o odlogu.
For the purposes of point (a), the decision of the Agency agreeing the paediatric investigation plan concerned shall also be included in the application.
Za namene točke (a) se v vlogo vključi tudi sklep Agencije o soglasju z zadevnim načrtom pediatričnih raziskav.
The documents submitted pursuant to paragraph 1 shall, cumulatively, cover all subsets of the paediatric population.
Dokumenti, predloženi v skladu z odstavkom 1, se skupaj nanašajo na vse dele pediatrične populacije.
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, Article 7 of this Regulation shall apply to applications for authorisation of new indications, including paediatric indications, new pharmaceutical forms and new routes of administration.
Kadar gre za odobrena zdravila, ki so zaščitena bodisi z dodatnim varstvenim certifikatom v skladu z Uredbo (EGS) št. 1768/92, bodisi s patentom, ki omogoča podelitev dodatnega varstvenega certifikata, se člen 7 te uredbe uporablja za vloge za odobritev novih indikacij, vključno s pediatričnimi indikacijami, novih farmacevtskih oblik in novih poti uporabe zdravila.
For the purposes of the first subparagraph, the documents referred to in Article 7(1) shall cover both the existing and the new indications, pharmaceutical forms and routes of administration.
Za namene prvega pododstavka, dokumenti iz člena 7(1) zajemajo tako obstoječe kot tudi nove indikacije, farmacevtske oblike in poti uporabe zdravila.
Articles 7 and 8 shall not apply to products authorised under Articles 10, 10a, 13 to 16 or 16a to 16i of Directive 2001/83/EC.
Člena 7 in 8 se ne uporabljata za zdravila, odobrena v skladu s členi 10, 10a, 13 do 16 ali 16a do 16i Direktive 2001/83/ES.
In consultation with the Member States, the Agency and other interested parties, the Commission shall draw up the detailed arrangements concerning the format and content which applications for agreement or modification of a paediatric investigation plan and requests for waivers or deferrals must follow in order to be considered valid and concerning the operation of the compliance check referred to in Articles 23 and 28(3).
Komisija v posvetovanju z državami članicami, Agencijo in drugimi zainteresiranimi stranmi, določi podrobna pravila glede oblike in vsebine, ki se jih mora upoštevati v prošnjah za soglasje ali spremembo načrta pediatričnih raziskav ter v prošnjah za opustitve ali odloge, da bi se lahko štele za popolne, ter glede preverjanja skladnosti iz členov 23 in 28(3).
Waivers
Opustitve
Production of the information referred to in point (a) of Article 7(1) shall be waived for specific medicinal products or for classes of medicinal products, if there is evidence showing any of the following:
Predložitev informacij iz točke (a) člena 7(1) se za določena zdravila ali skupine zdravil opusti, če je dokazano kar koli od naslednjega:
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;
določeno zdravilo ali skupina zdravil verjetno ni učinkovita ali varna za del ali za celotno pediatrično populacijo;
that the disease or condition for which the specific medicinal product or class is intended occurs only in adult populations;
bolezen ali stanje, za katero je zdravilo ali skupina zdravil namenjena, se pojavlja samo pri odraslih populacijah;
that the specific medicinal product does not represent a significant therapeutic benefit over existing treatments for paediatric patients.
določeno zdravilo v okviru obstoječih zdravljenj ne predstavlja posebne terapevtske koristi za pediatrične bolnike.
The waiver provided for in paragraph 1 may be issued with reference either to one or more specified subsets of the paediatric population, or to one or more specified therapeutic indications, or to a combination of both.
Opustitev, predvidena v odstavku 1, se lahko izda za samo en ali več določenih delov pediatrične populacije, za samo eno ali več določenih terapevtskih indikacij ali za kombinacijo obeh.
The Paediatric Committee may of its own motion adopt an opinion, on the grounds set out in Article 11(1), to the effect that a class or a product-specific waiver, as referred to in Article 11(1), should be granted.
Odbor za pediatrijo lahko na lastno pobudo in iz razlogov, določenih v členu 11(1), sprejme mnenje o opustitvi iz člena 11(1) za določeno zdravilo ali skupino zdravil.
As soon as the Paediatric Committee adopts an opinion, the procedure laid down in Article 25 shall apply.
Takoj ko Odbor za pediatrijo sprejme mnenje, se uporabi postopek, določen v členu 25.
In the case of a class waiver, only paragraphs 6 and 7 of Article 25 shall apply.
V primeru opustitve za skupino se uporabita samo odstavka 6 in 7 člena 25.
The applicant may, on the grounds set out in Article 11(1), apply to the Agency for a product-specific waiver.
Vlagatelj lahko iz razlogov, določenih v členu 11(1), zaprosi Agencijo za opustitev za določeno zdravilo.
Following receipt of the application, the Paediatric Committee shall appoint a rapporteur and shall within 60 days adopt an opinion as to whether or not a product-specific waiver should be granted.
Odbor za pediatrijo imenuje poročevalca in v 60-ih dneh od prejema vloge sprejme mnenje o tem, ali se odobri opustitev za določeno zdravilo.
Either the applicant or the Paediatric Committee may request a meeting during that 60-day period.
Vlagatelj ali Odbor za pediatrijo lahko v tem obdobju 60-ih dni zaprosita za sestanek.
Whenever appropriate, the Paediatric Committee may request the applicant to supplement the particulars and documents submitted.
Odbor za pediatrijo lahko, kadar koli je to primerno, zaprosi vlagatelja, da dopolni predložene podatke in dokumente.
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.
Če Odbor za pediatrijo uporabi to možnost, se rok 60-ih dni začasno prekine, dokler niso predložene dodatne zahtevane informacije.
The Agency shall maintain a list of all waivers.
Agencija vodi seznam vseh opustitev.
The list shall be regularly updated (at least every year) and made available to the public.
Seznam se redno dopolnjuje (najmanj enkrat na leto) in objavlja.
The Paediatric Committee may, at any time, adopt an opinion advocating the review of a granted waiver.
Odbor za pediatrijo lahko kadar koli sprejme mnenje o upravičenosti ponovnega pregleda opustitev.
In the case of a change affecting a product-specific waiver, the procedure laid down in Article 25 shall apply.
V primeru spremembe, ki vpliva na opustitev za določeno zdravilo, se uporabi postopek, določen v členu 25.
In the case of a change affecting a class waiver, paragraphs 6 and 7 of Article 25 shall apply.
V primeru spremembe, ki vpliva na opustitev za skupino, se uporabita odstavka 6 in 7 člena 25.
If a particular product-specific or class waiver is revoked, the requirement set out in Articles 7 and 8 shall not apply for 36 months from the date of the removal from the list of waivers.
Če je opustitev za določeno zdravilo ali skupino zdravil preklicana, se zahteva določena v členih 7 in 8, ne uporablja 36 mesecev od datuma, ko je bila črtana s seznama opustitev.
Paediatric investigation plan
Načrt pediatričnih raziskav
Requests for agreement
Prošnje za soglasje
Where the intention is to apply for a marketing authorisation in accordance with Article 7(1)(a) or (d), Article 8 or Article 30, a paediatric investigation plan shall be drawn up and submitted to the Agency with a request for agreement.
Pred predložitvijo vloge za dovoljenje za promet v skladu s členi 7(1)(a) ali (d), 8 ali 30, se pripravi načrt pediatričnih raziskav in predloži Agenciji skupaj s prošnjo za soglasje.
The paediatric investigation plan shall specify the timing and the measures proposed to assess the quality, safety and efficacy of the medicinal product in all subsets of the paediatric population that may be concerned.
V načrtu pediatričnih raziskav se določijo časovni načrt in ukrepi, predlagani za presojo kakovosti, varnosti in učinkovitosti zdravila pri vseh delih pediatrične populacije, na katere bi se lahko nanašal načrt.
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.
Poleg tega se opišejo vsi ukrepi za prilagoditev farmacevtske oblike in sestave zdravila na takšen način, da je njegova uporaba bolj sprejemljiva, lažja, varnejša ali učinkovitejša pri različnih delih pediatrične populacije.
In the case of the applications for marketing authorisation referred to in Articles 7 and 8 or the applications for waiver referred to in Articles 11 and 12, the paediatric investigation plan or the application for waiver shall be submitted with a request for agreement, except in duly justified cases, not later than upon completion of the human pharmaco-kinetic studies in adults specified in Section 5.2.3 of Part I of Annex I to Directive 2001/83/EC, so as to ensure that an opinion on use in the paediatric population of the medicinal product concerned can be given at the time of the assessment of the marketing authorisation or other application concerned.
V primeru vlog za dovoljenje za promet iz členov 7 in 8 ali vlog za opustitev iz členov 11 in 12, se načrt pediatričnih raziskav ali vloge za opustitev, razen v ustrezno upravičenih primerih, predloži skupaj s prošnjo za soglasje najkasneje ob zaključku farmako-kinetičnih študij pri odraslih, določenih v oddelku 5.2.3 dela I Priloge I k Direktivi 2001/83/ES, tako da je lahko mnenje o uporabi zadevnega zdravila pri pediatrični populaciji podano v času presoje dovoljenja za promet ali druge zadevne vloge.
Within 30 days following receipt of the request referred to in paragraph 1 and in Article 15(1), the Agency shall verify the validity of the request and prepare a summary report for the Paediatric Committee.
Agencija v 30-ih dneh od prejema prošnje iz odstavka 1 in člena 15(1) preveri popolnost prošnje in pripravi zbirno poročilo za Odbor za pediatrijo.
Whenever appropriate, the Agency may ask the applicant to submit additional particulars and documents, in which case the time-limit of 30 days shall be suspended until such time as the supplementary information requested has been provided.
Kadar je to primerno, lahko Agencija od vlagatelja zahteva predložitev dodatnih podatkov in dokumentov, pri čemer se rok 30-ih dni začasno prekine, dokler niso predložene dodatne zahtevane informacije.
Following receipt of a proposed paediatric investigation plan which is valid in accordance with the provisions of Article 15(2), the Paediatric Committee shall appoint a rapporteur and shall within 60 days 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.
Odbor za pediatrijo po prejemu predlaganega načrta pediatričnih raziskav, ki je v skladu z določbami člena 15(2) popoln, imenuje poročevalca in v 60-ih dneh sprejme mnenje o tem, ali bodo predlagane študije zagotovile potrebne podatke o pogojih, v katerih se zdravilo lahko uporablja za zdravljenje pediatrične populacije ali njenih delov, in ali pričakovane terapevtske koristi upravičujejo predlagane študije.
When adopting its opinion, the Committee shall consider whether or not the measures proposed to adapt the formulation of the medicinal product for use in different subsets of the paediatric population are appropriate.
Odbor ob sprejetju mnenja presodi, ali so predlagani ukrepi primerni za prilagoditev farmacevtske oblike in sestave zdravila za uporabo pri različnih delih pediatrične populacije.
Within the same period, either the applicant or the Paediatric Committee may request a meeting.
Vlagatelj ali Odbor za pediatrijo lahko v istem obdobju zaprosita za sestanek.
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.
Odbor za pediatrijo lahko v 60-ih dneh iz odstavka 1 od vlagatelja zahteva, da predlaga spremembe načrta, pri čemer se rok iz odstavka 1 za sprejetje končnega mnenja podaljša za največ 60 dni.
In such cases, the applicant or the Paediatric Committee may request an additional meeting during this period.
V takih primerih lahko v tem obdobju vlagatelj ali Odbor za pediatrijo zaprosita za dodatni sestanek.
The time-limit shall be suspended until such time as the supplementary information requested has been provided.
Rok se začasno prekine, dokler niso predložene dodatne zahtevane informacije.
As soon as the Paediatric Committee adopts an opinion, whether positive or negative, the procedure laid down in Article 25 shall apply.
Takoj ko Odbor za pediatrijo sprejme mnenje, bodisi pozitivno bodisi negativno, se uporabi postopek, določen v členu 25.
If, having considered a paediatric investigation plan, the Paediatric Committee concludes that Article 11(1)(a), (b) or (c) applies to the medicinal product concerned, it shall adopt a negative opinion under Article 17(1).
Če Odbor za pediatrijo po preučitvi načrta pediatričnih raziskav odloči, da se za zadevno zdravilo uporabi člen 11(1)(a), (b) ali (c), sprejme negativno mnenje v skladu s členom 17(1).
In such cases, the Paediatric Committee shall adopt an opinion in favour of a waiver under Article 12, whereupon the procedure laid down in Article 25 shall apply.
Odbor za pediatrijo v takšnih primerih sprejme mnenje o opustitvi v skladu s členom 12, nato pa se uporabi postopek, določen v členu 25.
Deferrals
Odlogi
At the same time as the paediatric investigation plan is submitted under Article 16(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.
Ob predložitvi načrta pediatričnih raziskav na podlagi člena 16(1) se lahko hkrati zaprosi za odlog začetka ali dokončanja izvajanja nekaterih ali vseh ukrepov, določenih v tem načrtu.
Such deferral shall be justified on scientific and technical grounds or on grounds related to public health.
Takšen odlog je treba upravičiti iz znanstvenih in tehničnih razlogov ali iz razlogov v zvezi z javnim zdravjem.
In any event, 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.
V vsakem primeru se odlog dovoli, kadar je primerno študije na odraslih izvesti pred začetkom študij pri pediatrični populaciji ali kadar bodo študije pri pediatrični populaciji trajale dlje kot študije pri odraslih.
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 Article 51(2) to define further the grounds for granting a deferral.
Komisija lahko na podlagi izkušenj pridobljenih pri izvajanju tega člena, sprejme določbe v skladu s postopkom iz člena 51(2) za podrobno opredelitev razlogov za odlog.
At the same time as the Paediatric Committee adopts a positive opinion under Article 17(1), it shall, of its own motion or following a request submitted by the applicant under Article 20, adopt an opinion, if the conditions specified in Article 20 are met, in favour of deferring the initiation or completion of some or all of the measures in the paediatric investigation plan.
Odbor za pediatrijo hkrati s sprejetjem pozitivnega mnenja v skladu s členom 17(1) na lastno pobudo, ali na podlagi predložene vlagateljeve prošnje v skladu s členom 20, sprejme mnenje o odlogu začetka ali dokončanja izvajanja nekaterih ali vseh ukrepov iz načrta pediatričnih raziskav, če so izpolnjeni pogoji iz člena 20.
An opinion in favour of a deferral shall specify the time-limits for initiating or completing the measures concerned.
V mnenju o odlogu se določijo roki za začetek ali dokončanje izvajanja zadevnih ukrepov.
As soon as the Paediatric Committee adopts an opinion in favour of deferral, as referred to in paragraph 1, the procedure laid down in Article 25 shall apply.
Takoj ko Odbor za pediatrijo sprejme mnenje o odlogu iz odstavka 1, se uporabi postopek, določen v členu 25.
Modification of a paediatric investigation plan
Sprememba načrta pediatričnih raziskav
If, following the decision agreeing the paediatric investigation plan, the applicant encounters such difficulties with its implementation as to render the plan unworkable or no longer appropriate, the applicant may propose changes or request a deferral or a waiver, based on detailed grounds, to the Paediatric Committee.
Če se vlagatelj po sklepu o soglasju z načrtom pediatričnih raziskav sooči s težavami pri njegovem izvajanju, pri čemer se izkaže, da načrt ni izvedljiv ali ni več primeren, lahko vlagatelj na podlagi podrobnih utemeljitev Odboru za pediatrijo predlaga spremembe ali zaprosi za odlog ali opustitev.
Within 60 days, the Paediatric Committee shall review these changes or the request for a deferral or a waiver and adopt an opinion proposing their refusal or acceptance.
Odbor za pediatrijo v 60 dneh preuči te spremembe ali prošnjo za odlog ali opustitev in sprejme mnenje, s katerim predlaga, da se zavrnejo ali sprejmejo.
Compliance with the paediatric investigation plan
Skladnost z načrtom pediatričnih raziskav
The competent authority responsible for granting marketing authorisation shall verify whether an application for marketing authorisation or variation complies with the requirements laid down in Articles 7 and 8 and whether an application submitted pursuant to Article 30 complies with the agreed paediatric investigation plan.
Pristojni organ, odgovoren za izdajo dovoljenja za promet preveri, ali je vloga za dovoljenje za promet ali za spremembo dovoljenja skladna z zahtevami iz členov 7 in 8, ter ali je vloga, predložena na podlagi člena 30, skladna z dogovorjenim načrtom pediatričnih raziskav.
Where the application is submitted in accordance with the procedure set out in Articles 27 to 39 of Directive 2001/83/EC, the verification of compliance, including, as appropriate, requesting an opinion of the Paediatric Committee in accordance with paragraph 2(b) and (c) of this Article, shall be conducted by the reference Member State.
Če je vloga predložena v skladu s postopkom iz členov 27 do 39 Direktive 2001/83/ES, preverjanje skladnosti in če je to potrebno, vključno s prošnjo za mnenje Odbora za pediatrijo v skladu z odstavkom 2(b) in (c) tega člena, izvede referenčna država članica.
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:
Odbor za pediatrijo lahko za mnenje o tem, ali so študije, ki jih izvaja vlagatelj, skladne z dogovorjenim načrtom pediatričnih raziskav, v naslednjih primerih zaprosijo:
by the applicant, prior to submitting an application for marketing authorisation or variation as referred to in Articles 7, 8 and 30, respectively;
vlagatelj, in sicer pred predložitvijo vloge za dovoljenje za promet ali za spremembo dovoljenja iz členov 7, 8 ali 30;
by the Agency, or the national 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);
Agencija ali pristojni nacionalni organ, kadar preverja popolnost vloge iz točke (a), ki ne vključuje mnenja o skladnosti, sprejetega na zahtevo iz točke (a);
by the Committee for Medicinal Products for Human Use, or the national competent authority, when assessing an application, as referred to in point (a), where there is doubt concerning compliance and an opinion has not been already given following a request under points (a) or (b).
Odbor za zdravila za uporabo v humani medicini ali pristojni nacionalni organ, kadar presoja vlogo iz točke (a), če obstaja dvom glede popolnosti in če še ni bilo podano mnenje na zahtevo iz točke (a) ali (b).
In the case of point (a), the applicant shall not submit its application until the Paediatric Committee has adopted its opinion, and a copy thereof shall be annexed to the application.
V primeru točke (a) vlagatelj svoje vloge ne predloži, dokler Odbor za pediatrijo nesprejme svojega mnenja, kopija tega mnenja pa se priloži vlogi.
If the Paediatric Committee is requested to give an opinion under paragraph 2, it shall do so within 60 days of receiving the request.
Odbor za pediatrijo poda mnenje iz odstavka 2, če je zanj zaprošen, v 60-ih dneh od prejema zahtevka.
Member States shall take account of such an opinion.
Države članice takšno mnenje upoštevajo.
If, when conducting the scientific assessment of a valid application for Marketing Authorisation, the competent authority concludes that the studies are not in conformity with the agreed paediatric investigation plan, the product shall not be eligible for the rewards and incentives provided for in Articles 36, 37 and 38.
Če pristojni organ med znanstveno presojo popolne vloge za dovoljenje za promet ugotovi, da študije niso skladne z dogovorjenim načrtom pediatričnih raziskav, zdravilo ni upravičeno do nagrad in spodbud, predvidenih v členih 36, 37 in 38.
Within ten days of its receipt, the Agency shall transmit the opinion of the Paediatric Committee to the applicant.
1 Agencija posreduje vlagatelju mnenje Odbora za pediatrijo v 10-ih dneh po prejemu mnenja.
Within 30 days following receipt of the opinion of the Paediatric Committee, the applicant may submit to the Agency a written request, citing detailed grounds, for a re-examination of the opinion.
Vlagatelj lahko Agenciji v 30-ih dneh od prejema mnenja Odbora za pediatrijo predloži pisno zahtevo z navedbo podrobnih utemeljitev za ponovni pregled mnenja.
Within 30 days following receipt of a request for re-examination pursuant to paragraph 2, the Paediatric Committee, having appointed a new rapporteur, shall issue a new opinion confirming or revising its previous opinion.
Odbor za pediatrijo v 30-ih dneh od prejema zahteve za ponovni pregled iz odstavka 2, potem ko imenuje novega poročevalca, izda novo mnenje, s katerim potrdi ali spremeni svoje predhodno mnenje.
The rapporteur shall be able to question the applicant directly.
Poročevalec ima možnost neposrednega zaslišanja vlagatelja.
The applicant may also offer to be questioned.
Tudi vlagatelj lahko predlaga zaslišanje.