natgillin/translations-raw huggingface dataset:
a beneficiary person, or a person acting on their behalf, to make an accessible format copy of a work or other subject matter to which the beneficiary person has lawful access for the exclusive use of the beneficiary person; and
Prvi, tretji in peti pododstavek člena 6(4) Direktive 2001/29/ES se uporabljajo za izjemo iz odstavka 1 tega člena.
an authorised entity to make an accessible format copy of a work or other subject matter to which it has lawful access, or to communicate, make available, distribute or lend an accessible format copy to a beneficiary person or another authorised entity on a non-profit basis for the purpose of exclusive use by a beneficiary person.
Države članice zagotovijo, da pogodba ne more prevladati nad izjemo iz odstavka 1.
Member States shall ensure that each accessible format copy respects the integrity of the work or other subject matter, with due consideration given to the changes required to make the work or other subject matter accessible in the alternative format.
Države članice lahko določijo, da za uporabe, dovoljene v skladu s to direktivo, če jih izvajajo pooblaščeni subjekti s sedežem na njihovem ozemlju, veljajo odškodninske sheme v okviru omejitev iz te direktive.
The exception provided for in paragraph 1 shall only be applied in certain special cases which do not conflict with a normal exploitation of the work or other subject matter and do not unreasonably prejudice the legitimate interests of the rightholder.
Člen 4
The first, third and fifth subparagraphs of Article 6(4) of Directive 2001/29/EC shall apply to the exception provided for in paragraph 1 of this Article.
Izvodi v dostopnem formatu na notranjem trgu
Member States shall ensure that the exception provided for in paragraph 1 cannot be overridden by contract.
Države članice zagotovijo, da pooblaščeni subjekt s sedežem na njihovem ozemlju lahko opravi dejanja iz točke (b) člena 3(1) za upravičeno osebo ali drug pooblaščeni subjekt s sedežem v kateri koli državi članici.
Member States may provide that uses permitted under this Directive, if undertaken by authorised entities established in their territory, be subject to compensation schemes within the limits provided for in this Directive.
Države članice prav tako zagotovijo, da upravičena oseba ali pooblaščeni subjekt s sedežem na njihovem ozemlju lahko pridobi izvod v dostopnem formatu od pooblaščenega subjekta s sedežem v kateri koli državi članici ali ima do njega dostop.
Accessible format copies in the internal market
Obveznosti pooblaščenih subjektov
Member States shall ensure that an authorised entity established in their territory may carry out the acts referred to in point (b) of Article 3(1) for a beneficiary person or another authorised entity established in any Member State.
Države članice določijo, da pooblaščeni subjekt s sedežem na njihovem ozemlju, ki opravlja dejanja iz člena 4, pripravi in upošteva svoje prakse, s katerimi zagotovi, da:
Member States shall also ensure that a beneficiary person or an authorised entity established in their territory may obtain or may have access to an accessible format copy from an authorised entity established in any Member State.
distribuira, posreduje in da na voljo razpoložljive izvode v dostopnem formatu le upravičenim osebam ali drugim pooblaščenim subjektom;
Article 5
sprejme ustrezne ukrepe za odvračanje od nedovoljene reprodukcije, distribucije, posredovanja javnosti ali dajanja izvodov v dostopnem formatu na voljo javnosti;
Obligations of authorised entities
izkazuje ustrezno skrbnost pri ravnanju z deli ali drugimi predmeti urejanja ter njihovimi izvodi v dostopnem formatu in tako ravnanje beleži ter
Member States shall provide that an authorised entity established in their territory carrying out the acts referred to in Article 4 establishes and follows its own practices to ensure that it:
objavlja in posodablja, če je to primerno, na svojem spletišču ali po drugih spletnih ali nespletnih poteh, informacije o tem, kako izpolnjuje obveznosti iz točk (a) do (c).
distributes, communicates and makes available accessible format copies only to beneficiary persons or other authorised entities;
Države članice zagotovijo, da se prakse iz prvega pododstavka pripravijo in upoštevajo ob polnem spoštovanju veljavnih pravil za obdelavo osebnih podatkov upravičenih oseb iz člena 7.
takes appropriate steps to discourage the unauthorised reproduction, distribution, communication to the public or making available to the public of accessible format copies;
Države članice zagotovijo, da pooblaščeni subjekt s sedežem na njihovem ozemlju, ki opravlja dejanja iz člena 4, na zahtevo na dostopen način zagotovi naslednje informacije upravičenim osebam, drugim pooblaščenim subjektom ali imetnikom pravic:
demonstrates due care in, and maintains records of, its handling of works or other subject matter and of accessible format copies thereof; and
seznam del ali drugih predmetov urejanja, za katere ima izvode v dostopnem formatu, in razpoložljive formate ter
publishes and updates, on its website if appropriate, or through other online or offline channels, information on how it complies with the obligations laid down in points (a) to (c).
imena in kontaktne podatke o pooblaščenih subjektih, s katerimi si je izmenjal izvode v dostopnem formatu na podlagi člena 4.
Member States shall ensure that the practices referred to in the first subparagraph are established and followed in full respect of the rules applicable to the processing of personal data of beneficiary persons referred to in Article 7.
Člen 6
Member States shall ensure that an authorised entity established in their territory carrying out the acts referred to in Article 4 provides the following information in an accessible way, on request, to beneficiary persons, other authorised entities or rightholders:
Preglednost in izmenjava informacij
the list of works or other subject matter for which it has accessible format copies and the available formats; and
Države članice pooblaščene subjekte s sedežem na njihovem ozemlju, ki opravljajo dejanja iz člena 4 te direktive ter členov 3 in 4 Uredbe (EU) 2017/1563, spodbujajo, da jim prostovoljno sporočijo svoja imena in kontaktne podatke.
the name and contact details of the authorised entities with which it has engaged in the exchange of accessible format copies pursuant to Article 4.
Države članice informacije, prejete na podlagi odstavka 1, predložijo Komisiji.
Article 6
Komisija da te informacije na voljo na spletu prek osrednje informacijske dostopne točke in jih posodablja.
Transparency and exchange of information
Člen 7
Member States shall encourage authorised entities established in their territory carrying out the acts referred to in Article 4 of this Directive and Articles 3 and 4 of Regulation (EU) 2017/1563 to communicate to them, on a voluntary basis, their names and contact details.
Varstvo osebnih podatkov
Member States shall provide the information they have received pursuant to paragraph 1 to the Commission.
Obdelava osebnih podatkov v okviru te direktive se izvede v skladu z direktivama 95/46/ES in 2002/58/ES.
The Commission shall make such information publicly available online on a central information access point and keep it up to date.
Člen 8
Article 7
Sprememba Direktive 2001/29/ES
Protection of personal data
V členu 5(3) Direktive 2001/29/ES se točka (b) nadomesti z naslednjim:
The processing of personal data carried out within the framework of this Directive shall be carried out in compliance with Directives 95/46/EC and 2002/58/EC.
uporaba v korist invalidov, ki je neposredno povezana z invalidnostjo in je nekomercialne narave, v obsegu, ki ga zahteva posamična oblika invalidnosti, brez poseganja v obveznosti držav članic na podlagi Direktive (EU) 2017/1564 Evropskega parlamenta in Sveta;
Amendment to Directive 2001/29/EC
Poročilo
In Article 5(3) of Directive 2001/29/EC, point (b) is replaced by the following:
Do 11. oktobra 2020 Komisija predstavi poročilo Evropskemu parlamentu, Svetu in Evropskemu ekonomsko-socialnemu odboru o razpoložljivosti del in drugih predmetov urejanja v dostopnih formatih na notranjem trgu, razen tistih, ki so opredeljeni v točki 1 člena 2 za upravičene osebe, in del ter drugih predmetov urejanja za invalide, razen tistih iz točke 2 člena 2.
uses, for the benefit of people with a disability, which are directly related to the disability and of a non-commercial nature, to the extent required by the specific disability, without prejudice to the obligations of Member States under Directive (EU) 2017/1564 of the European Parliament and of the Council;
Poročilo upošteva razvoj ustrezne tehnologije in vsebuje oceno o tem, ali bi bilo ustrezno razširiti področje uporabe te direktive, da bi se izboljšal dostop do tistih vrst del in drugih predmetov urejanja ter izboljšal dostop za tiste osebe z motnjami, ki niso zajete v tej direktivi.
Report
Pregled
By 11 October 2020, the Commission shall present a report to the European Parliament, the Council and the European Economic and Social Committee on the availability, in accessible formats, of works and other subject matter other than those defined in point 1 of Article 2 for beneficiary persons, and of works and other subject matter for persons with disabilities other than those referred to in point 2 of Article 2, in the internal market.
Do 11. oktobra 2023 Komisija izvede oceno te direktive in predstavi glavne ugotovitve v poročilu Evropskemu parlamentu, Svetu in Evropskemu ekonomsko-socialnemu odboru ter jim, kadar je to ustrezno, priloži predloge za spremembo te direktive.
The report shall take into account developments concerning relevant technology and shall contain an assessment of the appropriateness of broadening the scope of this Directive in order to improve access to other types of works and other subject matter and to improve access for persons with disabilities other than those covered by this Directive.
Ta ocena mora vsebovati oceno učinka odškodninskih shem, ki jih države članice določijo na podlagi člena 3(6), na razpoložljivost izvodov v dostopnem formatu za upravičene osebe ter na njihovo čezmejno izmenjavo.
Article 10
V poročilu Komisija upošteva stališča ustreznih akterjev civilne družbe, nevladnih organizacij, vključno z organizacijami, ki zastopajo invalide, in organizacijami, ki zastopajo starejše osebe.
Review
Države članice Komisiji predložijo vse potrebne podatke za pripravo poročila iz odstavka 1 tega člena in pripravo poročila iz člena 9.
By 11 October 2023, the Commission shall carry out an evaluation of this Directive and present the main findings in a report to the European Parliament, the Council and the European Economic and Social Committee, accompanied, where appropriate, by proposals for amending this Directive.
Država članica, ki na podlagi tehtnega razloga meni, da izvajanje te direktive znatno negativno vpliva na komercialno razpoložljivost del ali drugih predmetov urejanja v dostopnih formatih za upravičene osebe, lahko o tem seznani Komisijo in predloži vse pomembne dokaze.
Such evaluation shall include an assessment of the impact of compensation schemes, provided for by Member States pursuant to Article 3(6), on the availability of accessible format copies for beneficiary persons and on their cross-border exchange.
Komisija te dokaze upošteva pri pripravi poročila iz odstavka 1.
The Commission's report shall take into account the views of relevant civil society actors and of non-governmental organisations, including organisations representing persons with disabilities and those representing older persons.
Člen 11
Member States shall provide the Commission with the necessary information for the preparation of the report referred to in paragraph 1 of this Article and the preparation of the report referred to in Article 9.
Prenos
A Member State that has valid reasons to consider that the implementation of this Directive has had a significant negative impact on the commercial availability of works or other subject matter in accessible formats for beneficiary persons may bring the matter to the attention of the Commission providing all relevant evidence.
Države članice se v sprejetih predpisih sklicujejo na to direktivo ali pa sklic nanjo navedejo ob njihovi uradni objavi.
The Commission shall take that evidence into account when drawing up the report referred to in paragraph 1.
Način sklicevanja določijo države članice.
Article 11
Države članice Komisiji sporočijo besedilo temeljnih predpisov nacionalnega prava, sprejetih na področju, ki ga ureja ta direktiva.
Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 11 October 2018.
Začetek veljavnosti
When Member States adopt those measures, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication.
Člen 13
The methods of making such reference shall be laid down by Member States.
Naslovniki
Article 12
V Strasbourgu, 13. septembra 2017
Article 13
Za Svet
Addressees
UL C 125, 21.4.2017, str.
This Directive is addressed to the Member States.
27.
Done at Strasbourg, 13 September 2017.
Stališče Evropskega parlamenta z dne 6. julija 2017 (še ni objavljeno v Uradnem listu) in odločitev Sveta z dne 17. julija 2017.
For the European Parliament
Direktiva 96/9/ES Evropskega parlamenta in Sveta z dne 11. marca 1996 o pravnem varstvu baz podatkov (UL L 77, 27.3.1996, str.
For the Council
Direktiva 2001/29/ES Evropskega parlamenta in Sveta z dne 22. maja 2001 o usklajevanju določenih vidikov avtorske in sorodnih pravic v informacijski družbi (UL L 167, 22.6.2001, str.
OJ C 125, 21.4.2017, p.
10).
27.
Direktiva 2006/115/ES Evropskega parlamenta in Sveta z dne 12. decembra 2006 o pravici dajanja v najem in pravici posojanja ter o določenih pravicah, sorodnih avtorski pravici, na področju intelektualne lastnine (UL L 376, 27.12.2006, str.
Position of the European Parliament of 6 July 2017 (not yet published in the Official Journal) and decision of the Council of 17 July 2017.
28).
Directive 96/9/EC of the European Parliament and of the Council of 11 March 1996 on the legal protection of databases (OJ L 77, 27.3.1996, p.
Direktiva 2009/24/ES Evropskega parlamenta in Sveta z dne 23. aprila 2009 o pravnem varstvu računalniških programov (UL L 111, 5.5.2009, str. 16).
20).
Direktiva 2012/28/EU Evropskega parlamenta in Sveta z dne 25. oktobra 2012 o nekaterih dovoljenih uporabah osirotelih del (UL L 299, 27.10.2012, str.
Directive 2001/29/EC of the European Parliament and of the Council of 22 May 2001 on the harmonisation of certain aspects of copyright and related rights in the information society (OJ L 167, 22.6.2001, p.
5).
10).
Sklep Sveta 2014/221/EU z dne 14. aprila 2014 o podpisu, v imenu Evropske unije, Marakeške pogodbe o olajšanem dostopu do objavljenih del za slepe in slabovidne osebe ter osebe z drugimi motnjami branja (UL L 115, 17.4.2014, str.
Directive 2006/115/EC of the European Parliament and of the Council of 12 December 2006 on rental right and lending right and on certain rights related to copyright in the field of intellectual property (OJ L 376, 27.12.2006, p.
1).
28).
Mnenje Sodišča z dne 14. februarja 2017, 3/15, ECLI:EU:C:2017:114, točka 112.
Directive 2009/24/EC of the European Parliament and of the Council of 23 April 2009 on the legal protection of computer programs (OJ L 111, 5.5.2009, p.
Uredba (EU) 2017/1563 Evropskega parlamenta in Sveta z dne 13. septembra 2017 o čezmejni izmenjavi med Unijo in tretjimi državami izvodov v dostopnem formatu določenih del in drugih predmetov urejanja, zaščitenih z avtorsko pravico in sorodnimi pravicami, v korist slepih in slabovidnih oseb ter oseb z drugimi motnjami branja (glej stran 1 tega Uradnega lista).
16).
Direktiva Evropskega parlamenta in Sveta 95/46/ES z dne 24. oktobra 1995 o varstvu posameznikov pri obdelavi osebnih podatkov in o prostem pretoku takih podatkov (UL L 281, 23.11.1995, str.
Directive 2012/28/EU of the European Parliament and of the Council of 25 October 2012 on certain permitted uses of orphan works (OJ L 299, 27.10.2012, p.
31).
5).
Navedena direktiva se razveljavi in nadomesti z učinkom od 25. maja 2018 z Uredbo (EU) 2016/679 Evropskega parlamenta in Sveta z dne 27. aprila 2016 o varstvu posameznikov pri obdelavi osebnih podatkov in o prostem pretoku takih podatkov ter o razveljavitvi Direktive 95/46/ES (Splošna uredba o varstvu podatkov) (UL L 119, 4.5.2016, str. 1).
Council Decision 2014/221/EU of 14 April 2014 on the signing, on behalf of the European Union, of the Marrakesh Treaty to Facilitate Access to Published Works for Persons who are Blind, Visually Impaired, or otherwise Print Disabled (OJ L 115, 17.4.2014, p.
Direktiva 2002/58/ES Evropskega parlamenta in Sveta z dne 12. julija 2002 o obdelavi osebnih podatkov in varstvu zasebnosti na področju elektronskih komunikacij (Direktiva o zasebnosti in elektronskih komunikacijah) (UL L 201, 31.7.2002, str.
Opinion of the Court of Justice of 14 February 2017, 3/15, ECLI:EU:C:2017:114, paragraph 112.
UL C 369, 17.12.2011, str.
Regulation (EU) 2017/1563 of the European Parliament and of the Council of 13 September 2017 on the cross-border exchange between the Union and third countries of accessible format copies of certain works and other subject matter protected by copyright and related rights for the benefit of persons who are blind, visually impaired or otherwise print-disabled (see page 1 of this Official Journal).
14.
That Directive will be repealed and replaced, with effect from 25 May 2018, by Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (OJ L 119, 4.5.2016, p. 1).
Njen cilj je izboljšati razpoložljivost in čezmejno izmenjavo določenih del in drugih zaščitenih predmetov urejanja v dostopnih formatih za slepe in slabovidne osebe ter osebe z drugimi motnjami branja.
supplementing Directive 2001/83/EC of the European Parliament and of the Council as regards the principles and guidelines of good manufacturing practice for medicinal products for human use
o dopolnitvi Direktive 2001/83/ES Evropskega parlamenta in Sveta glede načel in smernic dobre proizvodne prakse za zdravila za uporabo v humani medicini
Having regard to 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 [1], and in particular the first paragraph of Article 47 thereof,
ob upoštevanju Direktive 2001/83/ES Evropskega parlamenta in Sveta z dne 6. novembra 2001 o Zakoniku Skupnosti o zdravilih za uporabo v humani medicini [1] in zlasti prvega odstavka člena 47 navedene direktive,
Commission Directive 2003/94/EC [2] applies to both medicinal products for human use and investigational medicinal products for human use.
Direktiva Komisije 2003/94/ES [2] se uporablja za zdravila za uporabo v humani medicini in zdravila za uporabo v humani medicini v preskušanju.
In accordance with Article 63(1) of Regulation (EU) No 536/2014 of the European Parliament and of the Council [3] the Commission is empowered to adopt a delegated act laying down principles of good manufacturing practice for investigational medicinal products for human use.
V skladu s členom 63(1) Uredbe (EU) št. 536/2014 Evropskega parlamenta in Sveta [3] je Komisija pooblaščena za sprejetje delegiranega akta o določitvi načel dobre proizvodne prakse za zdravila za uporabo v humani medicini v preskušanju.
It is therefore necessary to adapt the provisions of Directive 2003/94/EC by deleting the references to investigational medicinal products for human use.
Zato je treba prilagoditi določbe Direktive 2003/94/ES s črtanjem sklicevanj na zdravila za uporabo v humani medicini v preskušanju.
The definition of a pharmaceutical quality system and some terminology should be updated to reflect the international developments or the actual usage of that terminology of inspectors and manufacturers.
Opredelitev sistema farmacevtske kakovosti in nekatero terminologijo bi bilo treba posodobiti, da se upošteva razvoj na mednarodni ravni ali dejanska uporaba navedene terminologije s strani inšpektorjev in proizvajalcev.
All medicinal products for human use manufactured or imported into the Union, including medicinal products intended for export, should be manufactured in accordance with the principles and guidelines of good manufacturing practice.
Vsa zdravila za uporabo v humani medicini, proizvedena v Uniji ali uvožena v Unijo, vključno z zdravili, namenjenimi za izvoz, bi morala biti proizvedena v skladu z načeli in smernicami dobre proizvodne prakse.
However, for the manufacturer to be able to comply with those principles and guidelines, cooperation between the manufacturer and the marketing authorisation holder, when they are different legal entities, is necessary.
Da pa bi proizvajalec lahko upošteval navedena načela in smernice, je potrebno sodelovanje med proizvajalcem in imetnikom dovoljenja za promet, če sta to različni pravni osebi.
The obligations of the manufacturer and marketing authorisation holder vis-à-vis each other should be defined in a technical agreement between them.
Obveznosti proizvajalca in imetnika dovoljenja za promet z zdravilom v razmerju eden do drugega bi morale biti opredeljene v tehničnem dogovoru med njima.
The manufacturer of medicinal products has to ensure that they are fit for their intended use, comply with the requirements of the marketing authorisation and do not place patients at risk due to inadequate quality.
Proizvajalec zdravil mora zagotoviti, da njihova kakovost ustreza njihovi predvideni uporabi, da so v skladu z zahtevami za pridobitev dovoljenja za promet in da ne predstavljajo tveganja za paciente zaradi neustrezne kakovosti.
To achieve this quality objective reliably the manufacturer must implement a comprehensively designed and correctly implemented pharmaceutical quality system incorporating good manufacturing practice and quality risk management.
Za zanesljivo dosego tega cilja glede kakovosti mora proizvajalec uvesti celovito pripravljen in pravilno izveden sistem farmacevtske kakovosti, ki vključuje dobro proizvodno prakso in ukrepe za obvladovanje tveganja na področju kakovosti.
In order to ensure conformity with the principles and guidelines of good manufacturing practice, it is necessary to lay down detailed provisions on inspections by the competent authorities and on certain obligations of manufacturer.
Za zagotovitev skladnosti z načeli in smernicami dobre proizvodne prakse je treba določiti podrobne določbe v zvezi s pregledi, ki jih izvajajo pristojni organi, in nekaterimi obveznostmi proizvajalca.
It is necessary to ensure that all medicinal products available on the EU territory comply with the same quality standards, therefore medicinal products imported into the Union should be manufactured in accordance with standards which are at least equivalent to the good manufacturing practice standards laid down in the Union.
Treba je zagotoviti, da vsa zdravila, ki so na voljo na ozemlju EU, izpolnjujejo iste standarde kakovosti, zato bi morala biti zdravila, uvožena v Unijo, proizvedena ob upoštevanju standardov, ki so vsaj enakovredni standardom dobre proizvodne prakse, določenim na ravni Unije.
In order to ensure the consistent application of the principles of good manufacturing practice, manufacturers of medicinal products for human use and inspectors should consider the guidelines referred to in the second paragraph of Article 47 of Directive 2001/83/EC.
Za zagotovitev enotne uporabe načel dobre proizvodne prakse bi morali proizvajalci zdravil za uporabo v humani medicini in inšpektorji upoštevati smernice iz drugega odstavka člena 47 Direktive 2001/83/ES.
However, for advanced therapy medicinal products, the guideline referred in Article 5 of Regulation (EC) No 1394/2007 [4] should be applied.
Za zdravila za napredno zdravljenje pa se uporablja smernica iz člena 5 Uredbe (EU) št. 1394/2007 [4].