natgillin/translations-raw huggingface dataset:
The rapporteur shall inform the Paediatric Committee without delay in writing about details of contacts with the applicant.
Poročevalec takoj pisno obvesti Odbor za pediatrijo o podrobnostih stikov z vlagateljem.
The opinion shall be duly reasoned and a statement of reasons for the conclusion reached shall be annexed to the new opinion, which shall become definitive.
Mnenje se ustrezno utemelji in novemu mnenju, ki je dokončno, se priloži obrazložitev sprejete odločitve.
If, within the 30-day period referred to in paragraph 2, the applicant does not request re-examination, the opinion of the Paediatric Committee shall become definitive.
Če vlagatelj v 30-ih dneh iz odstavka 2 ne zaprosi za ponovni pregled, postane mnenje Odbora za pediatrijo dokončno.
The Agency shall adopt a decision within a period not exceeding 10 days following receipt of the Paediatric Committee's definitive opinion.
Agencija sprejme sklep v 10-ih dneh po prejemu dokončnega mnenja Odbora za pediatrijo.
This decision shall be communicated to the applicant in writing and shall annex the definitive opinion of the Paediatric Committee.
Ta sklep se posreduje vlagatelju v pisni obliki, skupaj z dokončnim mnenjem Odbora za pediatrijo.
In the case of a class waiver as referred to in Article 12, the Agency shall adopt a decision within ten days following receipt of the opinion of the Paediatric Committee as referred to in Article 13(3).
V primeru opustitve za skupino iz člena 12 Agencija v 10-ih dneh po prejemu mnenja Odbora za pediatrijo sprejme sklep, kot je navedeno v členu 13(3).
This decision shall annex the opinion of the Paediatric Committee.
Temu sklepu se priloži mnenje Odbora za pediatrijo.
Decisions of the Agency shall be made public after deletion of any information of a commercially confidential nature.
Sklepi Agencije se objavijo po tem, ko se črtajo vse morebitne informacije poslovno zaupne narave.
Any legal or natural person developing 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.
Vsaka pravna ali fizična oseba, ki razvija zdravilo, namenjeno za pediatrično uporabo, lahko pred predložitvijo načrta pediatričnih raziskav in med njegovim izvajanjem Agencijo zaprosi za nasvet o načrtu in izvedbi različnih raziskav 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.
In addition, this legal or natural person may request advice on the design and conduct of pharmacovigilance and risk management systems as referred to in Article 34.
Poleg tega lahko ta pravna ali fizična oseba zaprosi za nasvet o načrtu in izvedbi sistema farmakovigilance in sistema obvladovanja tveganja iz člena 34.
The Agency shall provide advice under this Article free of charge.
Agencija nasvete iz tega člena zagotavlja brezplačno.
MARKETING AUTHORISATION PROCEDURES
POSTOPKI ZA PRIDOBITEV DOVOLJENJA ZA PROMET
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.
Za postopke za pridobitev dovoljenja za promet iz tega naslova veljajo določbe Uredbe (ES) št. 726/2004 ali Direktive 2001/83/ES, če v tem naslovu ni drugače določeno.
Marketing authorisation procedures for applications falling within the scope of Articles 7 and 8
Postopki za pridobitev dovoljenja za promet za vloge, ki spadajo v področje uporabe členov 7 in 8
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 Article 7(1) of this Regulation which includes one or more paediatric indications on the basis of studies conducted in compliance with an agreed paediatric investigation plan.
Vloge za dovoljenje za promet iz člena 7(1) te uredbe, ki vsebuje eno ali več pediatričnih indikacij na podlagi rezultatov študij, izvedenih v skladu z dogovorjenim načrtom pediatričnih raziskav, se lahko predložijo v skladu s postopkom, določenim v členih 5 do 15 Uredbe (ES) št. 726/2004.
Where authorisation is granted, the results of all those studies shall be included in the summary of product characteristics and, if appropriate, in the package leaflet of the medicinal product, provided that the competent authority deems the information to be of use to patients, whether or not all the paediatric indications concerned were approved by the competent authority.
Če je dovoljenje izdano, se rezultati vseh teh študij, ne glede na to, ali je pristojni organ odobril vse zadevne pediatrične indikacije, vključijo v povzetek glavnih značilnosti zdravila in, če je to potrebno, v navodilo za uporabo zdravila, pod pogojem, da pristojni organ meni, da so informacije koristne za bolnike.
Where a marketing authorisation is granted or varied, any waiver or deferral which has been granted pursuant to this Regulation shall be recorded in the summary of product characteristics and, if appropriate, in the package leaflet of the medicinal product concerned.
Kadar je dovoljenje za promet izdano ali spremenjeno, se vse opustitve ali odlogi, ki so bili odobreni v skladu s to uredbo, vključijo v povzetek glavnih značilnosti zdravila in, če je to primerno, v navodilo za uporabo zadevnega zdravila.
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.
Če je vloga skladna z vsemi ukrepi iz dogovorjenega in izvedenega načrta pediatričnih raziskav in če povzetek glavnih značilnosti zdravila odraža rezultate študij, izvedenih v skladu z dogovorjenim načrtom pediatričnih raziskav, pristojni organ v dovoljenje za promet vključi izjavo o skladnosti vloge z dogovorjenim in izvedenim načrtom pediatričnih raziskav.
For the purpose of the application of Article 45(3), this statement shall also indicate whether significant studies contained in the agreed Paediatric Investigation Plan have been completed after the entry into force of this Regulation.
Za namen vloge iz člena 45(3) je v tej izjavi navedeno tudi, ali so bile po začetku veljavnosti te uredbe zaključene pomembne študije iz dogovorjenega načrta pediatričnih raziskav.
In the case of medicinal products authorised under Directive 2001/83/EC, an application as referred to in Article 8 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.
Kadar gre za zdravila, odobrena v skladu z Direktivo 2001/83/ES, se vloga iz člena 8 te uredbe lahko predloži za odobritev nove indikacije, vključno z razširitvijo dovoljenja za uporabo pri pediatrični populaciji, nove farmacevtske oblike ali nove poti uporabe zdravila, v skladu s postopkom, določenim v členih 32, 33 in 34 Direktive 2001/83/ES.
That application shall comply with the requirement laid down in point (a) of Article 7(1).
Vloga mora ustrezati zahtevi iz točke (a) člena 7(1).
The procedure shall be limited to the assessment of the specific sections of the summary of product characteristics to be varied.
Postopek se omeji na presojo določenih delov povzetka glavnih značilnosti zdravila, ki bodo predmet spremembe.
Paediatric use marketing authorisation
Dovoljenje za promet za pediatrično uporabo
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.
Predložitev vloge za dovoljenje za promet za pediatrično uporabo nikakor ne izključuje pravice, da se zaprosi za dovoljenje za promet za druge indikacije.
An application for a paediatric use marketing authorisation shall be accompanied by the particulars and documents necessary to establish quality, safety and efficacy in the paediatric population, including any specific data needed to support an appropriate strength, pharmaceutical form or route of administration for the product, in accordance with an agreed paediatric investigation plan.
Vlogi za dovoljenje za promet za pediatrično uporabo se priložijo podatki in dokumenti, ki so potrebni za dokazovanje kakovosti, varnosti in učinkovitosti pri pediatrični populaciji, vključno z vsemi specifičnimi podatki, ki so potrebni za potrditev primerne jakosti, farmacevtske oblike ali poti uporabe zdravila, v skladu z dogovorjenim načrtom pediatričnih raziskav.
The application shall also include the decision of the Agency agreeing the paediatric investigation plan concerned.
Vloga mora vsebovati tudi sklep Agencije o soglasju z zadevnim načrtom pediatričnih raziskav.
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.
Podatki, vključeni v dosje zdravila, ki je ali je bilo odobreno v državi članici ali v Skupnosti, so lahko, v skladu s členom 14(11) Uredbe (ES) št. 726/2004 ali členom 10 Direktive 2001/83/ES, če je to primerno, navedeni v vlogi za dovoljenje za promet za pediatrično uporabo.
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.
Zdravilo, za katerega je bilo izdano 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.
Without prejudice to Article 3(2) of Regulation (EC) No 726/2004, an application for a paediatric use marketing authorisation may be made in accordance with the procedure laid down in Articles 5 to 15 of Regulation (EC) No 726/2004.
Ne glede na določbo člena 3(2) Uredbe (ES) št. 726/2004 se lahko vloga za dovoljenje za promet za pediatrično uporabo poda v skladu s postopkom, določenim v členih 5 do 15 Uredbe (ES) št. 726/2004.
Where a medicinal product is granted a marketing authorisation for a paediatric indication, the label shall display the symbol agreed in accordance with paragraph 2.
Če se za zdravilo izda dovoljenje za promet za pediatrično indikacijo, oznaka prikazuje znak, ki je bil sprejet v skladu z odstavkom 2.
The package leaflet shall contain an explanation of the meaning of the symbol.
Navodilo za uporabo zdravila vsebuje razlago pomena znaka.
By 26 January 2008, the Commission shall select a symbol following a recommendation of the Paediatric Committee.
Do 26. januarja 2008 Komisija na predlog Odbora za pediatrijo izbere znak.
The Commission shall make the symbol public.
Komisija znak objavi.
The provisions of this Article shall also apply to medicinal products authorised before the entry into force of this Regulation, and to medicinal products authorised after the entry into force of this Regulation but before the symbol has been made public, if they are authorised for paediatric indications.
Določbe tega člena se uporabljajo tudi za zdravila, ki so bila odobrena za pediatrične indikacije pred začetkom ali po začetku veljavnosti te uredbe, vendar pred objavo znaka.
In this case, the symbol and the explanation referred to in paragraph 1 shall be included in the labelling and package leaflet respectively of the medicinal products concerned not later than two years after the symbol has been made public.
V tem primeru se znak in razlaga iz odstavka 1 vključita na ovojnino in v navodilo za uporabo zadevnega zdravila najkasneje v dveh letih po objavi znaka.
POST-AUTHORISATION REQUIREMENTS
ZAHTEVE PO PRIDOBITVI 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, within two years of the date on which the paediatric indication is authorised, place the product on the market taking into account the paediatric indication.
Kadar so zdravila po izvedbi dogovorjenega načrta pediatričnih raziskav odobrena za pediatrično indikacijo in so ta zdravila že dana v promet z drugimi indikacijami, imetnik dovoljenja za promet v dveh letih po datumu odobritve pediatrične indikacije da zdravilo v promet z upoštevanjem pediatrične indikacije.
A register, coordinated by the Agency, and made publicly available, shall mention these deadlines.
Register, ki ga usklajuje Agencija in je na voljo javnosti, vsebuje podatke o rokih.
In the following cases, the applicant shall detail the measures to ensure the follow-up of efficacy and of possible adverse reactions to the paediatric use of the medicinal product:
Vlagatelj podrobno določi ukrepe, s katerimi se zagotovi spremljanje učinkovitosti in morebitnih neželenih učinkov pri pediatrični uporabi zdravila v naslednjih primerih vlog:
applications for a marketing authorisation that includes a paediatric indication;
vloge za dovoljenje za promet, ki vsebuje pediatrično indikacijo;
applications to include a paediatric indication in an existing marketing authorisation;
vloge za vključitev pediatrične indikacije v obstoječe dovoljenje za promet;
applications for a paediatric use marketing authorisation.
vloge za dovoljenje za promet za pediatrično uporabo.
Where there is particular cause for concern, the competent authority shall require, as a condition for granting marketing authorisation, that a risk management system be set up or that specific post-marketing studies be performed and submitted for review.
Če obstaja poseben razlog za zaskrbljenost, pristojni organ kot pogoj za izdajo dovoljenja za promet zahteva, da se vzpostavi sistem obvladovanja tveganja ali da se izvedejo določene študije po začetku trženja, ki se predložijo v pregled.
The risk management system shall comprise a set of pharmacovigilance activities and interventions designed to identify, characterise, prevent or minimise risks relating to medicinal products, including the assessment of the effectiveness of those interventions.
Sistem obvladovanja tveganja obsega sklop dejavnosti farmakovigilance in intervencij, namenjenih identifikaciji, opisu, preprečevanju ali zmanjševanju tveganj, povezanih z zdravili, vključno z oceno učinkovitosti teh intervencij.
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.
Ocena učinkovitosti kakršnih koli 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.
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.
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 to paragraphs 1 and 2, the provisions on pharmacovigilance as laid down in Regulation (EC) No 726/2004 and in Directive 2001/83/EC shall apply to marketing authorisations for medicinal products which include a paediatric indication.
Poleg odstavkov 1 in 2 se pri dovoljenjih za promet zdravil s pediatrično indikacijo uporabljajo tudi določbe o farmakovigilenci, navedene v Uredbi (ES) št. 726/2004 in Direktivi 2001/83/ES.
In the case of a deferral, the marketing authorisation holder shall submit an annual report to the Agency providing an update on progress with paediatric studies in accordance with the decision of the Agency agreeing the paediatric investigation plan and granting a deferral.
V primeru odloga, imetnik dovoljenja za promet Agenciji predloži letno poročilo, s katerim jo obvesti o napredku v pediatričnih študijah v skladu s sklepom Agencije o soglasju z načrtom pediatričnih raziskav in odlogu.
The Agency shall inform the competent authority if it is found that the marketing authorisation holder has failed to comply with the decision of the Agency agreeing the paediatric investigation plan and granting a deferral.
Če Agencija ugotovi, da imetnik dovoljenja za promet ni ravnal v skladu s sklepom Agencije o soglasju z načrtom pediatričnih raziskav in odlogu, o tem obvesti pristojni organ.
The Agency shall draw up guidelines relating to the application of this Article.
Agencija določi smernice za uporabo tega člena.
If a medicinal product is authorised for a paediatric indication and the marketing authorisation holder has benefited from rewards or incentives under Article 36, 37 or 38, and these periods of protection have expired, and if the marketing authorisation holder intends to discontinue placing the medicinal product on the market, the marketing authorisation holder shall transfer the marketing authorisation or allow a third party, which has declared its intention to continue to place the medicinal product in question on the market, to use the pharmaceutical, pre-clinical and clinical documentation contained in the file of the medicinal product on the basis of Article 10c of Directive 2001/83/EC.
Če je zdravilo odobreno za pediatrično indikacijo in če je imel imetnik dovoljenja za promet koristi od nagrad ali spodbud iz členov 36, 37 ali 38, ta obdobja varstva pa so potekla, in če imetnik dovoljenja za promet namerava prenehati dajati zdravilo v promet, imetnik dovoljenja za promet to dovoljenje prenese ali dovoli tretji osebi, ki je izrazila namen nadaljevati z dajanjem zadevnega zdravila v promet, uporabo farmacevtske, predklinične in klinične dokumentacije, ki jo vsebuje dosje zdravila na podlagi člena 10c Direktive 2001/83/ES.
The marketing authorisation holder shall inform the Agency of its intention to discontinue the placing on the market of the product no less than six months before the discontinuation.
Imetnik dovoljenja za promet o svoji nameri, da zdravila ne bo več dajal v promet, obvesti Agencijo vsaj šest mesecev pred tem.
The Agency shall make this fact public.
Agencija to dejstvo objavi.
REWARDS AND INCENTIVES
NAGRADE IN SPODBUDE
Where an application under Article 7 or 8 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 Articles 13(1) and 13(2) of Regulation (EEC) No 1768/92.
Če vloga iz člena 7 ali 8 vsebuje rezultate vseh študij, izvedenih v skladu z dogovorjenim načrtom pediatričnih raziskav, je imetnik patenta ali dodatnega varstvenega certifikata upravičen do šestmesečnega podaljšanja obdobja iz členov 13(1) in 13(2) Uredbe (EGS) št. 1768/92.
The first subparagraph shall also apply where completion of the agreed paediatric investigation plan fails to lead to the authorisation of a paediatric indication, but the results of the studies conducted are reflected in the summary of product characteristics and, if appropriate, in the package leaflet of the medicinal product concerned.
Prvi pododstavek se uporablja tudi, če izvedba dogovorjenega načrta pediatričnih raziskav ne privede do odobritve pediatrične indikacije, vendar se rezultati izvedenih študij odražajo v povzetku glavnih značilnosti zdravila in, če je to primerno, v navodilu za uporabo zadevnega zdravila.
The inclusion in a marketing authorisation of the statement referred to in Article 28(3) shall be used for the purposes of applying paragraph 1 of this Article.
Vključitev izjave iz člena 28(3) v dovoljenje za promet se uporablja za namene uporabe odstavka 1 tega člena.
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 granted only if the product is authorised in all Member States.
Če se uporabijo postopki, določeni v Direktivi 2001/83/ES, se šestmesečno podaljšanje obdobja iz odstavka 1 odobri samo, če je zdravilo odobreno v vseh državah članicah.
Paragraphs 1, 2 and 3 shall apply to products that are protected by a supplementary protection certificate under Regulation (EEC) No 1768/92, or under a patent which qualifies for the granting of the supplementary protection certificate.
Odstavki 1, 2 in 3 se uporabljajo za zdravila, ki so zaščitena z dodatnim varstvenim certifikatom v skladu z Uredbo (EGS) št. 1768/92 ali s patentom, ki omogoča podelitev dodatnega varstvenega certifikata.
They shall not apply to medicinal products designated as orphan medicinal products pursuant to Regulation (EC) No 141/2000.
Ne uporabljajo se za zdravila, določena kot zdravila sirote v skladu z Uredbo (ES) št. 141/2000.
In the case of an application under Article 8 which leads to the authorisation of a new paediatric indication, paragraphs 1, 2 and 3 shall not apply if the applicant applies for, and obtains, a one-year extension of the period of marketing protection for the medicinal product concerned, on the grounds that this new paediatric indication brings a significant clinical benefit in comparison with existing therapies, in accordance with Article 14(11) of Regulation (EC) No 726/2004 or the fourth subparagraph of Article 10(1) of Directive 2001/83/EC.
V primeru vloge iz člena 8, na podlagi katere se odobri nova pediatrična indikacija, se odstavki 1, 2 in 3 ne uporabljajo, če vlagatelj zaprosi in pridobi enoletno podaljšanje obdobja tržne zaščite za zadevno zdravilo, zato ker ta nova pediatrična indikacija pomeni pomembno klinično korist v primerjavi z obstoječimi terapijami, v skladu s členom 14(11) Uredbe (ES) št. 726/2004 ali četrtim pododstavkom člena 10(1) Direktive 2001/83/ES.
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 Article 28(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.
Kadar 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 raziskav ter je izjava iz člena 28(3) te uredbe posledično vključena v izdanem dovoljenju za promet, se desetletno obdobje iz člena 8(1) Uredbe (ES) št. 141/2000 podaljša na dvanajst let.