natgillin/translations-raw huggingface dataset:
Sklepi Agencije se objavijo po tem, ko se črtajo vse morebitne informacije poslovno zaupne narave.
Decisions of the Agency shall be made public after deletion of any information of a commercially confidential nature.
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.
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.
Poleg tega lahko ta pravna ali fizična oseba zaprosi za nasvet o načrtu in izvedbi sistema farmakovigilance in sistema obvladovanja tveganja iz člena 34.
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.
Agencija nasvete iz tega člena zagotavlja brezplačno.
The Agency shall provide advice under this Article free of charge.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Vloga mora ustrezati zahtevi iz točke (a) člena 7(1).
That application shall comply with the requirement laid down in point (a) of Article 7(1).
Postopek se omeji na presojo določenih delov povzetka glavnih značilnosti zdravila, ki bodo predmet spremembe.
The procedure shall be limited to the assessment of the specific sections of the summary of product characteristics to be varied.
Predložitev vloge za dovoljenje za promet za pediatrično uporabo nikakor 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.
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.
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.
Vloga mora vsebovati tudi sklep Agencije o soglasju z zadevnim načrtom pediatričnih raziskav.
The application shall also include the decision of the Agency agreeing the paediatric investigation plan concerned.
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.
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 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.
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.
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.
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.
Če se za zdravilo izda dovoljenje za promet za pediatrično indikacijo, oznaka prikazuje znak, ki je bil sprejet v skladu z odstavkom 2.
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.
Navodilo za uporabo zdravila vsebuje razlago pomena znaka.
The package leaflet shall contain an explanation of the meaning of the symbol.
Komisija na predlog Odbora za pediatrijo izbere znak.
the Commission shall select a symbol following a recommendation of the Paediatric Committee.
Komisija znak objavi.
The Commission shall make the symbol public.
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.
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.
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.
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.
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.
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.
Register, ki ga usklajuje Agencija in je na voljo javnosti, vsebuje podatke o rokih.
A register, coordinated by the Agency, and made publicly available, shall mention these deadlines.
podrobno določi ukrepe, s katerimi se zagotovi spremljanje učinkovitosti in morebitnih neželenih učinkov pri pediatrični uporabi zdravila v naslednjih primerih vlog:
measures to ensure the follow-up of efficacy and of possible adverse reactions to the paediatric use of the medicinal product:
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.
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 določb iz odstavka 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 addition to the provisions contained in 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.
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 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 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, mora imetnik dovoljenja za promet to dovoljenje prenesti ali dovoliti 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.
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.
Imetnik dovoljenja za promet mora o svoji nameri, da zdravila ne bo več dajal v promet, obvestiti Agencijo vsaj šest mesecev pred tem.
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.
Agencija to dejstvo objavi.
The Agency shall make this fact public.
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.
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.
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 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.
Vključitev izjave iz člena 28(3) v dovoljenje za promet se uporablja za namene uporabe odstavka 1 tega člena.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Prvi odstavek 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 first paragraph 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.
Kadar je dovoljenje za promet za pediatrično uporabo izdano v skladu s členi 5 do 15 Uredbe (ES) št. 726/2004, veljata obdobji varstva podatkov in tržne zaščite iz člena 14(11) iste 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.
Kadar je dovoljenje za promet za pediatrično uporabo izdano v skladu s postopki, določenimi v Direktivi 2001/83/ES, veljata obdobji varstva podatkov in tržne zaščite iz člena 10(1) navedene 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 členov 36, 37 in 38 lahko upravičena do spodbud, ki jih Skupnost ali države članice namenjajo za podporo raziskavam, razvoju in dostopnosti zdravil za pediatrično uporabo.
In addition to the rewards and incentives provided for in Articles 36, 37 and 38, 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.
Komisiji sporočijo podrobne informacije o vseh ukrepih, ki so jih sprejele za podporo raziskavam, razvoju in dostopnosti zdravil za pediatrično uporabo.
, the Member States shall communicate to the Commission detailed information concerning any measures they have enacted to support research into, and the development and availability of, medicinal products for paediatric use.
Te informacije se na zahtevo Komisije redno dopolnjujejo.
This information shall be updated regularly at the request of the Commission.
* omogoči javnosti dostop do podrobnega seznama vseh spodbud Skupnosti in držav članic za podporo raziskavam, razvoju in dostopnosti zdravil za pediatrično uporabo.
*, the Commission shall make publicly available a detailed inventory of all rewards and incentives provided by the Community and Member States to support research into, and the development and availability of, medicinal products for paediatric use.
Ta seznam se redno dopolnjuje, javnost pa ima dostop tudi do podatkov o dopolnitvah.
This inventory shall be updated regularly and the updates shall also be made publicly available.
Finančna sredstva za raziskave zdravil za pediatrično populacijo se zagotovijo v proračunu Skupnosti kot podpora za študije o zdravilih ali učinkovinah, ki niso zaščitene s patentom ali dodatnim varstvenim certifikatom.
Funds for research into medicinal products for the paediatric population shall be provided for in the Community budget in order to support studies relating to medicinal products or active substances not covered by a patent or a supplementary protection certificate.
To financiranje Skupnosti se izvaja preko okvirnih programov Skupnosti za raziskave, tehnološki razvoj in predstavitvene dejavnosti ali katerekoli druge pobude Skupnosti za financiranje raziskav.
This Community funding shall be delivered through the Community Framework Programmes for Research, Technological Development and Demonstration Activities or any other Community initiatives for the funding of research.
Evropska zbirka podatkov, vzpostavljena s členom 11 Direktive 2001/20/ES, poleg kliničnih preskušanj iz členov 1 in 2 navedene direktive vključuje tudi klinična preskušanja, ki se izvajajo v tretjih državah in so zajeta v dogovorjenem načrtu pediatričnih raziskav.
The European database created by Article 11 of Directive 2001/20/EC shall include clinical trials carried out in third countries which are contained in an agreed paediatric investigation plan, in addition to the clinical trials referred to in Articles 1 and 2 of that Directive.
V primeru teh kliničnih preskušanj ki se izvajajo v tretjih državah, se podrobnosti iz člena 11 navedene direktive vnesejo v podatkovno bazo s strani naslovnika sklepa Agencije o načrtu pediatričnih raziskav.
In the case of such clinical trials carried out in third countries, the details listed in Article 11 of that Directive shall be entered into the database by the addressee of the Agency's decision on a paediatric investigation plan.
Z odstopanjem od določb člena 11 Direktive 2001/20/ES, Agencija objavi del podatkov o pediatričnih kliničnih preskušanjih, ki so vneseni v evropsko podatkovno bazo.
By way of derogation from the provisions of Article 11 of Directive 2001/20/EC, the Agency shall make public part of the information on paediatric clinical trials entered in the European database.
Agencija objavi podrobnosti rezultatov vseh preskušanj iz odstavka 1 in vseh drugih preskušanj, ki so bili predloženi pristojnim organom v skladu s členoma 45 in 46, tudi če je bilo preskušanje predčasno zaključeno.
Details of the results of all the trials referred to in paragraph 1 and of any other trials submitted to competent authorities in compliance with Articles 45 and 46 shall be made public by the Agency, whether or not the trial was terminated prematurely.