natgillin/translations-raw huggingface dataset:
The invitation to tender shall cover a maximum of 500000 tonnes of common wheat for export to third countries with the exception of Albania, Bosnia and Herzegovina, Bulgaria, Croatia, the former Yugoslav Republic of Macedonia, Liechtenstein, Romania, Serbia and Montenegro and Switzerland.Article 2
Javni razpis zadeva največjo količino 500000 ton navadne pšenice za izvoz v vse tretje države razen v Albanijo, Bolgarijo, Bosno in Hercegovino, Hrvaško, Lihtenštajn, Nekdanjo jugoslovansko republiko Makedonijo, Romunijo, Srbijo in Črno goro ter Švico.Člen 2
OJ L 174, 7.7.2005, p. 24.
UL L 174, 7.7.2005, str. 24.
including Kosovo as defined by United Nations Security Council Resolution 1244 of 10 June 1999.’
Vključno s Kosovom, kot določa Resolucija Varnostnega sveta Združenih narodov 1244 z dne 10. junija 1999.“
Commission Regulation (EC) No 507/2006
Uredba Komisije (ES) št. 507/2006
on the conditional marketing authorisation for medicinal products for human use falling within the scope of Regulation (EC) No 726/2004 of the European Parliament and of the Council
o pogojnem dovoljenju za promet zdravil za humano uporabo, ki sodijo na področje uporabe Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta
Having regard to Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency [1], and in particular Article 14(7) thereof,
ob upoštevanju Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta z dne 31. marca 2004 o postopkih Skupnosti za pridobitev dovoljenja za promet in nadzor zdravil za humano in veterinarsko uporabo ter o ustanovitvi Evropske agencije za zdravila [1], in zlasti člena 14(7) Uredbe,
Before a medicinal product for human use is authorised for placing on the market of one or more Member States, it generally has to undergo extensive studies to ensure that it is safe, of high quality and effective for use in the target population.
Preden je zdravilo za humano uporabo odobreno za promet v eni ali več državah članicah, je treba na njem navadno opraviti obsežne raziskave, s katerimi naj bi zagotovili njegovo varnost, kakovost in učinkovitost za uporabo pri ciljni populaciji.
The rules and procedures for obtaining a marketing authorisation are laid down in Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use [2] and in Regulation (EC) No 726/2004.
Pravila in postopki za pridobitev dovoljenja za promet so določeni v Direktivi 2001/83/ES Evropskega parlamenta in Sveta z dne 6. novembra 2001 o zakoniku Skupnosti o zdravilih za uporabo v humani medicini [2] in v Uredbi (ES) št. 726/2004.
In the case of certain categories of medicinal products, however, in order to meet unmet medical needs of patients and in the interests of public health, it may be necessary to grant marketing authorisations on the basis of less complete data than is normally the case and subject to specific obligations, hereinafter ‘conditional marketing authorisations’.
Pri nekaterih kategorijah zdravil pa je za izpolnitev neizpolnjenih zdravstvenih potreb bolnikov in v interesu javnega zdravja morda treba odobriti dovoljenja za promet na podlagi manj popolnih podatkov kot sicer in ob upoštevanju posebnih obveznosti, v nadaljnjem besedilu „pogojna dovoljenja za promet“.
The categories concerned should be medicinal products which aim at the treatment, prevention or medical diagnosis of seriously debilitating or life-threatening diseases, or medicinal products to be used in emergency situations in response to public health threats recognised either by the World Health Organisation or by the Community in the framework of Decision No 2119/98/EC of the European Parliament and of the Council of 24 September 1998 setting up a network for the epidemiological surveillance and control of communicable diseases in the Community [3], or medicinal products designated as orphan medicinal products in accordance with Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products [4].
Zadevne kategorije bi morale vključevati zdravila, namenjena za zdravljenje, preprečevanje ali diagnozo hudo izčrpavajočih ali smrtno nevarnih bolezni, ali zdravila, ki se uporabljajo v nujnih primerih v odziv na tveganja za javno zdravje, ki sta jih priznali bodisi Svetovna zdravstvena organizacija bodisi Skupnost v okviru Odločbe št. 2119/98/ES Evropskega parlamenta in Sveta z dne 24. septembra 1998 o vzpostavitvi mreže epidemiološkega spremljanja in obvladovanja nalezljivih bolezni v Skupnosti [3], ali zdravila, določena kot zdravila sirote v skladu z Uredbo (ES) št. 141/2000 Evropskega parlamenta in Sveta z dne 16. decembra 1999 o zdravilih sirotah [4].
Although the data upon which an opinion on a conditional marketing authorisation is based may be less complete, the risk-benefit balance, as defined in Article 1(28a) of Directive 2001/83/EC should be positive.
Čeprav so morda podatki, na katerih temelji mnenje o pogojni odobritvi za promet, manj popolni, bi moralo biti razmerje med tveganjem in koristmi, opredeljeno v členu 1(28a) Direktive 2001/83/ES, pozitivno.
Furthermore, the benefits to public health of making the medicinal product concerned immediately available on the market should outweigh the risk inherent in the fact that additional data are still required.
Poleg tega bi morale koristi takojšnje dostopnosti zadevnega zdravila na trgu za javno zdravje prevladati nad tveganjem, ki izhaja iz dejstva, da so potrebni dodatni podatki.
Where conditional marketing authorisations are granted, they should be restricted to situations where only the clinical part of the application dossier is less complete than normal.
Odobritve pogojnih dovoljenj za promet bi morale biti omejene na primere, ko je samo klinični del vloge za pridobitev dovoljenja manj popoln kot običajno.
Incomplete pre-clinical or pharmaceutical data should be accepted only in the case of a product to be used in emergency situations, in response to public health threats.
Nepopolni predklinični ali farmacevtski podatki naj bi bili sprejemljivi samo, če se izdelek uporablja v nujnih primerih kot odziv na tveganja za javno zdravje.
In order to ensure that the right balance is struck between facilitating access to medicines for patients with unmet medical needs and preventing the authorisation of medicines with an unfavourable risk-benefit profile, it is necessary to make those marketing authorisations subject to specific obligations.
Da bi zagotovili primerno ravnotežje med lažjim dostopom do zdravil za bolnike z neizpolnjenimi zdravstvenimi potrebami in preprečevanjem odobritev zdravil z neugodnim razmerjem med koristmi in tveganjem, je treba pri teh dovoljenjih za promet upoštevati določene obveznosti.
The holder should be required to complete or initiate certain studies with a view to confirming that the risk-benefit balance is positive and resolving any questions relating to the quality, safety and efficacy of the product.
Imetnik bi moral biti dolžen dokončati ali začeti določene študije, s katerimi naj bi se potrdilo pozitivno razmerje med tveganjem in koristmi ter rešila morebitna vprašanja v zvezi s kakovostjo, varnostjo in učinkovitostjo zdravila.
Conditional marketing authorisations are distinct from marketing authorisations granted in exceptional circumstances in accordance with Article 14(8) of Regulation (EC) No 726/2004.
Pogojna dovoljenja za promet se razlikujejo od dovoljenj, odobrenih v izjemnih okoliščinah v skladu s členom 14(8) Uredbe (ES) št. 726/2004.
In the case of the conditional marketing authorisation, authorisation is granted before all data are available.
Pri pogojnem dovoljenju za promet se dovoljenje odobri, preden so na voljo vsi podatki.
The authorisation is not intended, however, to remain conditional indefinitely.
Namen dovoljenja pa ni, da bi ostalo pogojno za nedoločen čas.
Rather, once the missing data are provided, it should be possible to replace it with a marketing authorisation which is not conditional, that is to say, which is not subject to specific obligations.
Ko se zagotovijo manjkajoči podatki, bi ga namreč moralo biti mogoče zamenjati z dovoljenjem za promet, ki ni pogojno oziroma za katero ne veljajo posebne obveznosti.
In contrast, it will normally never be possible to assemble a full dossier in respect of a marketing authorisation granted in exceptional circumstances.
V nasprotju s tem pri dovoljenju, odobrenem v izjemnih okoliščinah, navadno ni mogoče zbrati popolne dokumentacije.
It should also be made clear that applications containing requests for conditional marketing authorisations may be the subject of an accelerated assessment procedure in accordance with Article 14(9) of Regulation (EC) No 726/2004.
Pojasniti je treba tudi, da so lahko vloge za odobritev pogojnih dovoljenj za promet vključene v pospešen postopek ocene v skladu s členom 14(9) Uredbe (ES) št. 726/2004.
Since the provisions of Regulation (EC) No 726/2004 apply to conditional marketing authorisations unless otherwise provided for in this Regulation, the procedure for evaluating a conditional marketing authorisation is the normal procedure laid down in Regulation (EC) No 726/2004.
Ker se za odobritve posebnih dovoljenj za promet uporabljajo določbe Uredbe (ES) št. 726/2004, razen če ta uredba ne določa drugače, je postopek za oceno pogojnega dovoljenja za promet običajni postopek iz Uredbe (ES) št. 726/2004.
In accordance with Regulation (EC) No 726/2004, conditional marketing authorisations will be valid for one year on a renewable basis.
V skladu z Uredbo (ES) št. 726/2004 bodo pogojna dovoljenja za promet veljavna eno leto in bodo obnovljiva.
The deadline for submission of a renewal application should be six months prior to the expiry of the marketing authorisation, and the opinion of the European Medicines Agency (hereinafter the Agency) on the application should be adopted within 90 days of its receipt.
Rok za oddajo vloge za podaljšanje naj bi bil šest mesecev pred potekom dovoljenja za promet, mnenje Evropske agencije za zdravila (v nadaljnjem besedilu „Agencija“) o vlogi pa naj bi bilo sprejeto v 90 dneh po prejemu.
To ensure that medicinal products are not removed from the market except for reasons related to public health, the conditional marketing authorisation should, as long as a renewal application is submitted within the deadline, remain valid until the Commission reaches a decision based on the renewal assessment procedure.
Da bi zagotovili, da zdravila ne bodo umaknjena s trga, razen zaradi razlogov javnega zdravja, naj bi pogojno dovoljenje za promet, če je vloga za podaljšanje oddana v roku, ostalo v veljavi, dokler Komisija ne sprejme odločbe na podlagi postopka ocene za podaljšanje.
Clear information should be provided to patients and healthcare professionals on the conditional nature of the authorisations.
Bolnikom in zdravstvenim delavcem bi bilo treba zagotoviti jasne informacije o pogojnosti dovoljenj.
It is therefore necessary that such information be clearly stated in the summary of product characteristics of the medicinal product concerned as well as on the package leaflet.
Zato je nujno, da so take informacije jasno navedene v povzetku glavnih značilnosti zdravila in tudi v navodilih za uporabo.
Enhanced pharmacovigilance for medicinal products granted a conditional marketing authorisation is important and is already adequately provided for in Directive 2001/83/EC and Regulation (EC) No 726/2004.
Pomembna je okrepljena farmakovigilanca za zdravila z odobrenim pogojnim dovoljenjem za promet, kar že ustrezno zagotavlja Direktiva 2001/83/ES in Uredba (ES) št. 726/2004.
However, the time schedule for submitting periodic safety update reports should be adapted to accommodate the annual renewal of conditional marketing authorisations.
Vendar pa bi bilo treba prilagoditi rok za oddajo dopolnjenih rednih poročil o varnosti, tako da bi vključeval vsakoletno podaljšanje pogojnih dovoljenj za promet.
The planning of studies and of the submission of an application for a marketing authorisation occurs at an early stage in the development of medicinal products.
Načrtovanje študij in oddaja vlog za dovoljenje za promet sta na vrsti v zgodnji fazi razvoja zdravil.
Such planning will critically depend on whether a conditional marketing authorisation is a possibility.
Tako načrtovanje bo močno odvisno od tega, ali obstaja možnost pogojnega dovoljenja za promet.
For this reason it is necessary to provide a mechanism for the Agency to give companies advice on whether a medicinal product falls within the scope of this Regulation.
Zato je nujno vzpostaviti mehanizem, v okviru katerega bo Agencija podjetjem svetovala o tem, ali zdravilo sodi na področje uporabe te uredbe.
Such advice should be an additional service to the existing scientific advice provided by the Agency.
Tako svetovanje bi bilo dodatna storitev poleg obstoječih znanstvenih nasvetov Agencije.
The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Medicinal Products for Human Use,
Ukrepi, predvideni s to uredbo, so v skladu z mnenjem Stalnega odbora za zdravila za uporabo v humani medicini –
This Regulation lays down rules on the granting of a marketing authorisation subject to specific obligations in accordance with Article 14(7) of Regulation (EC) No 726/2004, hereinafter ‘conditional marketing authorisation’.
Ta uredba določa pravila za izdajo dovoljenja za promet ob upoštevanju posebnih obveznosti v skladu s členom 14(7) Uredbe (ES) št. 726/2004, v nadaljnjem besedilu „pogojno dovoljenje za promet“.
This Regulation shall apply to medicinal products for human use that fall under Article 3(1) and (2) of Regulation (EC) No 726/2004 and belong to one of the following categories:
Ta uredba se uporablja za zdravila za humano uporabo, ki sodijo na področje uporabe člena 3(1) in (2) Uredbe (ES) št. 726/2004 in pripadajo eni od naslednjih kategorij:
medicinal products which aim at the treatment, the prevention or the medical diagnosis of seriously debilitating diseases or life-threatening diseases;
zdravila, namenjena za zdravljenje, preprečevanje ali diagnozo hudo izčrpavajočih ali smrtno nevarnih bolezni;
medicinal products to be used in emergency situations, in response to public health threats duly recognised either by the World Health Organisation or by the Community in the framework of Decision No 2119/98/EC;
zdravila, ki se uporabljajo v nujnih primerih v odziv na tveganja za javno zdravje, ki sta jih priznali bodisi Svetovna zdravstvena organizacija bodisi Skupnost v okviru Odločbe št. 2119/98/ES;
medicinal products designated as orphan medicinal products in accordance with Article 3 of Regulation (EC) No 141/2000.
zdravila, določena kot zdravila sirote v skladu s členom 3 Uredbe (ES) št. 141/2000.
Requests or proposals
Prošnje ali predlogi
A request for a conditional marketing authorisation may be presented by the applicant together with an application in accordance with Article 6 of Regulation (EC) No 726/2004.
Prošnjo za pogojno dovoljenje za promet lahko predlagatelj vloži skupaj z vlogo v skladu s členom 6 Uredbe (ES) št. 726/2004.
The request shall be accompanied by details showing that the product falls within the scope of this Regulation and satisfies the requirements laid down in Article 4(1).
Prošnjo spremlja podrobna utemeljitev, da izdelek sodi na področje uporabe te uredbe in izpolnjuje zahteve iz člena 4(1).
The Agency shall immediately inform the Commission of applications containing a request for a conditional marketing authorisation.
Agencija Komisijo takoj obvesti o vlogah, ki vsebujejo prošnjo za pogojno dovoljenje za promet.
The Committee for Medicinal Products for Human Use, hereinafter ‘the Committee’, may, in its opinion on an application submitted in accordance with Article 6 of Regulation (EC) No 726/2004, propose a conditional marketing authorisation, after having consulted the applicant.
Odbor za zdravila za humano uporabo, v nadaljevanju „Odbor“, lahko v svojem mnenju o vlogi, oddani v skladu s členom 6 Uredbe (ES) št. 726/2004, po posvetu s predlagateljem predlaga pogojno dovoljenje za promet.
A conditional marketing authorisation may be granted where the Committee finds that, although comprehensive clinical data referring to the safety and efficacy of the medicinal product have not been supplied, all the following requirements are met:
Pogojno dovoljenje za promet se lahko odobri, kadar Komisija ugotovi, da so, čeprav niso bili predloženi izčrpni klinični podatki o varnosti in učinkovitosti zdravila, izpolnjene vse naslednje zahteve:
the risk-benefit balance of the medicinal product, as defined in Article 1(28a) of Directive 2001/83/EC, is positive;
razmerje med tveganji in koristmi zdravila, kakor je opredeljeno v členu 1(28a) Direktive 2001/83/ES, je pozitivno;
it is likely that the applicant will be in a position to provide the comprehensive clinical data;
verjetno je, da bo predlagatelj lahko predložil izčrpne klinične podatke;
unmet medical needs will be fulfilled;
izpolnjene bodo nezadovoljene zdravstvene potrebe;
the benefit to public health of the immediate availability on the market of the medicinal product concerned outweighs the risk inherent in the fact that additional data are still required.
korist takojšnje dostopnosti zadevnega zdravila na trgu za javno zdravje prevlada nad tveganjem, ki izhaja iz dejstva, da so potrebni dodatni podatki.
In emergency situations as referred to in Article 2(2), a conditional marketing authorisation may be granted, subject to the requirements set out in points (a) to (d) of this paragraph, also where comprehensive pre-clinical or pharmaceutical data have not been supplied.
V nujnih primerih, navedenih v členu 2(2), se pogojno dovoljenje za promet ob upoštevanju zahtev iz točk (a) do (d) tega odstavka lahko odobri tudi takrat, kadar niso bili predloženi popolni predklinični ali farmacevtski podatki.
For the purposes of paragraph 1(c), ‘unmet medical needs’ means a condition for which there exists no satisfactory method of diagnosis, prevention or treatment authorised in the Community or, even if such a method exists, in relation to which the medicinal product concerned will be of major therapeutic advantage to those affected.
Za namen odstavka 1(c) so „nezadovoljene zdravstvene potrebe“ zdravstveno stanje, za katero v Skupnosti ni odobrena nobena zadovoljiva metoda diagnoze, preprečevanja ali zdravljenja, in tudi če taka metoda obstaja, bo zadevno zdravilo za prizadete pomenilo znatno terapevtsko prednost.
By way of specific obligations, the holder of a conditional marketing authorisation shall be required to complete ongoing studies, or to conduct new studies, with a view to confirming that the risk-benefit balance is positive and providing the additional data referred to in Article 4(1).
S posebnimi obveznostmi bo moral imetnik pogojnega dovoljenja za promet dokončati študije, ki potekajo, ali izvesti nove ter z njimi potrditi, da je razmerje med tveganji in koristmi pozitivno, in priskrbeti dodatne podatke iz člena 4(1).
In addition, specific obligations may be imposed in relation to the collection of pharmacovigilance data.
Poleg tega se lahko posebne obveznosti nanašajo na zbiranje podatkov o farmakovigilanci.
The specific obligations referred to in paragraph 1 and the timeframe for their completion shall be clearly specified in the conditional marketing authorisation.
Posebne obveznosti iz odstavka 1 in rok za njihovo izpolnitev se jasno določijo v pogojnem dovoljenju za promet.
The Agency shall make the specific obligations and the timeframe for their completion publicly available.
Agencija javnosti omogoči dostop do posebnih obveznosti in roka za njihovo izpolnitev.
After its period of validity of one year the conditional marketing authorisation may be renewed annually.
Po enoletnem obdobju veljavnosti se lahko pogojno dovoljenje za promet vsako leto podaljša.
The application for renewal shall be submitted to the Agency at least six months before the expiry of the conditional marketing authorisation, together with an interim report on the fulfilment of the specific obligations to which it is subject.
Prošnjo za podaljšanje se vloži pri Agenciji vsaj šest mesecev pred potekom pogojnega dovoljenja za promet, skupaj z vmesnim poročilom o izpolnjevanju posebnih obveznosti, ki zanj veljajo.
The Committee shall assess the application for a renewal, on the basis that the risk-benefit balance is to be confirmed, taking into account the specific obligations contained in the authorisation and the timeframe for their fulfilment, and shall formulate an opinion as to whether the specific obligations or their timeframes need to be retained or modified.
Odbor prošnjo za podaljšanje oceni na podlagi potrjenega ravnotežja med tveganji in koristmi, pri čemer upošteva posebne obveznosti v dovoljenju in rok za njihovo izpolnitev, ter oblikuje mnenje o tem, ali je treba posebne obveznosti ali njihove roke ohraniti ali spremeniti.
The Agency shall ensure that the opinion of the Committee is given within 90 days following receipt of a valid renewal application.
Agencija zagotovi, da odbor v 90 dneh po prejemu veljavne vloge za podaljšanje da svoje mnenje.
That opinion shall be made publicly available.
To mnenje je javno dostopno.
Once a renewal application has been submitted in accordance with paragraph 2, the conditional marketing authorisation shall remain valid until a decision is adopted by the Commission in accordance with Article 10 of Regulation (EC) No 726/2004.
Potem ko se v skladu z odstavkom 2 predloži vloga za podaljšanje, pogojno dovoljenje za promet ostane v veljavi, dokler Komisija ne sprejme odločbe v skladu s členom 10 Uredbe (ES) št. 726/2004.
Marketing authorisation not subject to specific obligations
Dovoljenje za promet, za katero ne veljajo posebne obveznosti
Where the specific obligations laid down in accordance with Article 5(1) have been fulfilled, the Committee may at any time adopt an opinion in favour of the granting of a marketing authorisation in accordance with Article 14(1) of Regulation (EC) No 726/2004.
Kadar so izpolnjene posebne zahteve, določene v skladu s členom 5(1), lahko Odbor kadar koli sprejme mnenje o odobritvi dovoljenja za promet v skladu s členom 14(1) Uredbe (ES) št. 726/2004.
Product Information
Podatki o zdravilu
Where a medicinal product has been granted conditional marketing authorisation in accordance with this Regulation, the information included in the summary of product characteristics and package leaflet shall contain a clear mention of that fact.
Kjer je bilo zdravilu odobreno dovoljenje za promet v skladu s to uredbo, vsebujejo podatki, vključeni v povzetek glavnih značilnosti zdravila, in navodila za uporabo zdravila jasno opredelitev tega dejstva.
The summary of product characteristics shall also contain the date on which the conditional authorisation is due for renewal.
Povzetek glavnih značilnosti zdravila vsebuje tudi datum, ko se mora pogojno dovoljenje podaljšati.
Periodic safety update reports
Redna poročila o varnosti zdravila
The periodic safety update reports provided for in Article 24(3) of Regulation (EC) No 726/2004 shall be submitted to the Agency and Member States immediately upon request or at least every six months following the granting or renewal of a conditional marketing authorisation.
Redna poročila o varnosti zdravila, predvidena v členu 24(3) Uredbe (ES) št. 726/2004, se predložijo Agenciji in državam članicam na njihovo zahtevo takoj ali vsaj vsakih šest mesecev po odobritvi ali podaljšanju pogojnega dovoljenja za promet.
Agency advice prior to marketing authorisation application
Svetovanje Agencije pred vlogo za dovoljenje za promet