natgillin/translations-raw huggingface dataset:
Predlog spremembe za uskladitev s predlogom spremembe člena 5(4).
Amendment consistent with the amendment to Article 5(4).
Člen 10, odstavek 1, točka e
Article 10, paragraph 1, point (e)
(e) trajanje licence;
(e) the duration of the licence
(e) trajanje licence in pogoji za njeno izdajo,
(e) the duration of the licence and the conditions for its issue ;
Namen spremembe je doseči skladnost z Uvodno izjavo 7, ki določa, da "bi morale prisilne licence, izdane po tej uredbi, pridobitelju licence naložiti jasne pogoje glede aktov, ki jih zajema licenca."
In order to be consistent with Recital 7 which states that 'compulsory licences issued under this regulation should therefore impose clear conditions upon the licensee as regards the acts covered by the licence'.
Odstavek 1 se ne uporablja v primeru ponovnega izvoza v članico STO uvoznico, navedeno v zahtevku ter opredeljeno na embalaži in dokumentaciji, povezani z izdelkom, ali v primeru uvedbe tranzitnega postopka ali postopka carinskega skladiščenja, vnosa v prosto cono ali prosto skladišče blaga za namene ponovnega izvoza v navedeno članico STO uvoznico.
Paragraph 1 shall not apply in the case of re-export to the importing WTO member cited in the application and identified in the packaging and documentation associated with the product, or placing under a transit or customs warehouse procedure or in a free zone or free warehouse for the purpose of re-export to that importing WTO member .
Odstavek 1 se ne uporablja v primeru ponovnega izvoza v državo uvoznico, navedeno v zahtevku ter opredeljeno na embalaži in dokumentaciji, povezani z izdelkom, ali v primeru uvedbe tranzitnega postopka ali postopka carinskega skladiščenja, vnosa v prosto cono ali prosto skladišče blaga za namene ponovnega izvoza v navedeno državo uvoznico.
Paragraph 1 shall not apply in the case of re-export to the importing country cited in the application and identified in the packaging and documentation associated with the product, or placing under a transit or customs warehouse procedure or in a free zone or free warehouse for the purpose of re-export to that importing country .
Zato je treba obseg uredbe razširiti, da vključi tudi države v razvoju in najmanj razvitih držav.
Therefore, the scope of the regulation should be extended to include also developing countries and least-developed countries
Kadar se upravičeno sumi, da se izdelki, za katere se uporablja prisilna licenca po tej uredbi, v nasprotju s členom 11(1) uvažajo v Skupnost, carinski organi prekinejo sprostitev zadevnih izdelkov ali ga zadržijo za toliko časa, kolikor je potrebno za pridobitev odločbe zadevnega nacionalnega organa o stanju blaga.
Where there is reason to suspect that, contrary to Article 11(1), products subject of a compulsory licence under this Regulation are being imported into the Community, customs authorities shall suspend the release of, or detain, the products concerned for the time necessary to obtain a decision of the relevant national authority on the character of the merchandise.
Obdobje prekinitve ali zadržanja ne presega 10 delovnih dni, razen v primeru posebnih okoliščin, ko se lahko to obdobje podaljša za največ 10 delovnih dni.
The period of suspension or detention shall not exceed 10 working days unless special circumstances apply, in which case the period may be extended by a maximum of 10 working days.
Ob izteku navedenega obdobja se izdelki sprostijo, pod pogojem, da so bile opravljene vse carinske formalnosti.
Upon expiry of that period, the products shall be released, provided that all customs formalities have been complied with.
Če se izdelki, za katere se uporablja prisilna licenca po tej uredbi, v nasprotju s členom 11(1) uvažajo v Skupnost, s čimer se kršijo določbe člena 5(3) in členov 6, 7 and 8, carinski organi prekinejo sprostitev zadevnih izdelkov ali ga zadržijo za toliko časa, kolikor je potrebno za pridobitev odločbe zadevnega organa o stanju blaga.
If , contrary to Article 11(1), products subject of a compulsory licence under this Regulation are being imported into the Community, in breach of the provisions laid down in Article 5(3) and Articles 6, 7 and 8, customs authorities shall suspend the release of, or detain, the products concerned for the time necessary to obtain a decision of the competent authority on the character of the merchandise.
Pristojni ogran na lastno pobudo ali utemeljeno pobudo imetnika pravice ali licence odloča, če se tak uvoz dovoli.
The competent authority shall have the authority to review, on its own initiative or upon reasoned request by the right holder or the licensee, whether such importation is taking place.
O prekinitvi sprostitve ali zadržanju izdelkov so takoj obveščeni zadevni nacionalni organ in proizvajalec ali izvoznik zadevnih izdelkov, prejeti morajo tudi vse razpoložljive podatke glede zadevnih izdelkov.
The relevant national authority and the manufacturer or exporter of the products concerned shall be informed without delay of the suspended release or detention of the products and shall receive all information available with respect to the products concerned.
Ustrezno se upoštevajo nacionalne določbe o varstvu osebnih podatkov, poslovne in industrijske tajnosti ter poklicne in upravne zaupnosti.
Due account shall be taken of national provisions on the protection of personal data, commercial and industrial secrecy and professional and administrative confidentiality.
Uvoznik, kadar je primerno tudi izvoznik, ima zadostno možnost, da zadevnemu nacionalnemu organu predloži podatke, ki se mu v zvezi z izdelki zdijo primerni.
The importer, and where appropriate, the exporter, shall be given ample opportunity to supply the relevant national authority with the information which it deems appropriate regarding the products.
O prekinitvi sprostitve ali zadržanju izdelkov so takoj obveščeni pristojni organ, imetnik pravice, proizvajalec ali izvoznik zadevnih izdelkov, prejeti morajo tudi vse razpoložljive podatke glede zadevnih izdelkov.
The competent authority , the right holder and the manufacturer or exporter of the products concerned shall be informed without delay of the suspended release or detention of the products and shall receive all information available with respect to the products concerned.
Ustrezno se upoštevajo nacionalne določbe o varstvu osebnih podatkov, poslovne in industrijske tajnosti ter poklicne in upravne zaupnosti.
Due account shall be taken of national provisions on the protection of personal data and commercial and industrial secrecy and professional and administrative confidentiality.
Uvoznik, kadar je primerno tudi izvoznik, ima zadostno možnost, da pristojnemu organu predloži podatke, ki se mu v zvezi z izdelki zdijo primerni.
The importer, and where appropriate, the exporter, shall be given ample opportunity to supply the competent authority with the information which it deems appropriate regarding the products.
Člen 12, odstavek 2a (novo)
Article 12, paragraph 2 a (new)
Možnost, ki jo ima imetnik pravice, da predloži ustrezne podatke, je lahko zelo koristna za državni organ, ki je pristojen za ugotavljanje morebitnih kršitev prepovedi o ponovnem uvozu v Skupnost.
Enabling the right holder to supply the relevant information could be extremely helpful for the national authority responsible for monitoring infringements of the ban on reimporting products into the Community.
Razen tega nedovoljen način uporabe prisilne licence neposredno škoduje imetniku pravice.
Moreover, the right holder is directly damaged by any fraudulent use of the compulsory licence.
Postopek prekinitve ali zadržanja blaga se izvaja na stroške uvoznika.
The procedure of suspension or detention of the goods is carried out at the expense of the importer.
Če navedenih stroškov od uvoznika ni mogoče izterjati, se jih lahko izterja v skladu z nacionalno zakonodajo od katere koli druge osebe, odgovorne za poskus nezakonitega uvoza.
If it is not possible to recover those expenses from the importer, they may, in accordance with national legislation, be recovered from any other person responsible for the attempted illicit importation.
Če zadevni nacionalni organ ugotovi , da so bili izdelki, katerih sprostitev so carinski organi prekinili ali so jih zadržali, namenjeni uvozu v Skupnost v nasprotju s prepovedjo iz člena 11(1), ta organ zagotovi, da bo te izdelke zasegel in odstranil v skladu z nacionalno zakonodajo.
If the relevant national authority finds that products suspended for release or detained by customs authorities were intended for import into the Community contrary to the prohibition in Article 11 (1), that authority shall ensure that these products are seized and disposed of in accordance with national legislation.
Ti postopki se izvedejo na stroške uvoznika.
These procedures are carried out at the expense of the importer.
Če navedenih stroškov od uvoznika ni mogoče izterjati, se jih lahko izterja v skladu z nacionalno zakonodajo od katere koli druge osebe, odgovorne za poskus nezakonitega uvoza.
If it is not possible to recover these expenses from the importer, they may, in accordance with national legislation, be recovered from any other person responsible for the attempted illicit importation.
Če se potrdi , da so bili izdelki, katerih sprostitev so carinski organi prekinili ali so jih zadržali, namenjeni uvozu v Skupnost v nasprotju s prepovedjo iz člena 11(1), pristojni organ zagotovi, da bo te izdelke zasegel in odstranil v skladu z nacionalno zakonodajo.
If it is confirmed that products suspended for release or detained by customs authorities were intended for import into the Community contrary to the prohibition in Article 11 (1), the competent authority shall ensure that these products are seized and disposed of in accordance with national legislation.
Sestava, predlagana v osnutku uredbe, je preveč nejasna.
The wording in the proposal for a regulation is too vague.
Zaplenitev nezakonito uvoženih izdelkov v Evropsko unijo ali v eno od držav članic se lahko izvede le na podlagi potrdila o kršitvah določil te uredbe.
Products imported illegally into the European Union or one of its Member States may only be seized on the basis of confirmation of a breach of the provisions of this regulation.
Odprava določil v zvezi s prevzemom stroškov zaradi zaplenitve je namenjena le izogibanju odvečnemu izražanju z določili, spremenjenimi v odstavku 3 tega člena.
The provisions on payment of the expense occasioned by the seizure of products have been deleted solely in order to avoid unnecessary repetition in relation to the (amended) provisions contained in paragraph 3 of this Article.
Člen 12, odstavek 4a (novo)
Article 12, paragraph 4 a (new)
4(a) Postopek prekinitve ali zadržanja ali zasega blaga se izvaja na stroške uvoznika.
4a The procedure of suspension or detention or seizure of the goods is carried out at the expense of the importer.
Člen 12, odstavek 5
Article 12, paragraph 5
Če se po nadaljnjem nadzoru zadevnega nacionalnega organa ugotovi, da izdelki, katerih sprostitev so carinski organi prekinili ali so jih zadržali, ne kršijo prepovedi iz člena 11(1), carinski organ te izdelke sprosti prejemniku pod pogojem, da so bile opravljene vse carinske formalnosti.
Where products suspended for release or detained by customs authorities subsequent to further control by the relevant national authority are found not to violate the prohibition in Article 11(1), the customs authority shall release the products to the consignee, provided that all customs formalities have been complied with.
Člen 12, odstavek 6
Article 12, paragraph 6
Zadevni nacionalni organ Komisijo obvesti o vsaki odločbi glede zasega ali uničenja, ki so sprejete v skladu s to uredbo.
The relevant national authority shall inform the Commission of any decisions on seizure or destruction which are adopted pursuant to this Regulation.
Pristojni organ Komisijo obvesti o vsaki odločbi glede zasega ali uničenja, ki so sprejete v skladu s to uredbo.
The competent authority shall inform the Commission of any decisions on seizure or destruction which are adopted pursuant to this Regulation.
Namen te spremembe je terminološka prilagoditev preostalemu besedilu Uredbe, ki se sklicuje samo na pristojne organe.
This amendment brings the terminology into line with the remaining text of the regulation, which refers only to the competent authority.
Ob upoštevanju zadostnega varstva zakonitih interesov pridobitelja licence, se lahko prisilna licenca, ki je podeljena v skladu s to uredbo, prekliče z določbo pristojnega organa ali enega izmed organov, omenjenih v členu 16 v obeh naslednjih primerih:
Subject to adequate protection of the legitimate interests of the licensee, a compulsory licence granted pursuant to this Regulation may be terminated by a decision of the competent authority or by one of the bodies referred to under Article 16 in either of the following cases:
Ob upoštevanju zadostnega varstva zakonitih interesov pridobitelja licence se lahko prisilna licenca, ki je podeljena v skladu s to uredbo, prekliče z določbo pristojnega organa ali enega izmed organov, omenjenih v členu 16, če pridobitelj licence ne spoštuje pogojev licence.
Subject to adequate protection of the legitimate interests of the licensee, a compulsory licence granted pursuant to this Regulation may be terminated by a decision of the competent authority or by one of the bodies referred to under Article 16 if the conditions of the licence are not respected by the licensee.
(a) če pridobitelj licence ne spoštuje pogojev licence ;
(a) if the conditions of the licence are not respected by the licensee ;
(b) če in ko okoliščine, ki so vodile do podelitve licence, ne obstajajo več in je malo verjetno, da bodo ponovno nastopile.
(b) if and when the circumstances which led to the grant of the licence cease to exist and are unlikely to recur .
Pristojni organ je pooblaščen, da na lastno pobudo ali na utemeljeno zahtevo imetnika pravice ali pridobitelja licence preveri, ali gre za katerega koli od navedenih dveh primerov .
The competent authority shall have the authority to review, on its own initiative or upon reasoned request by the right holder or the licensee, whether either of those situations applies.
Pristojni organ je pooblaščen, da na utemeljeno zahtevo imetnika pravice ali pridobitelja licence preveri, ali se spoštujejo pogoji licence .
The competent authority shall have the authority to review, upon reasoned request by the right holder or the licensee, whether the conditions of the licence have been respected .
To preverjanje temelji na oceni, izdelane v državi uvoznici.
This review shall be based on the assessment made in the importing country.
Možnost preklica prisilne licence pomeni, da lahko evropska vlada nadomesti vlado države uvoznice pri določanju, kdaj obstaja položaj, ki upravičuje uporabo sistema.
The possibility of terminating a compulsory licence means that a European government might substitute the government of the importing country in determining when a situation that justifies the application of the system subsists.
Odločitev za razglasitev izrednega stanja na nacionalni ravni ali drugih okoliščin skrajne nuje ter dokazovanje pomanjkanja ali neučinkovitost proizvodnih zmogljivosti je v pristojnosti države uvoznice, in ne izvoznice.
The decision to declare a situation of national emergency or other circumstances of extreme urgency, as well as of establishing the lack or insufficiency of manufacturing capacity, is the competence of the importing country, and not that of the exporting country.
Deklaracija iz Dohe je jasno uvedla pravico članic STO, da samostojno določijo, kaj je izredno stanje na nacionalni ravni ali druge okoliščine skrajne nuje.
The Doha Declaration explicitly reinforced WTO Members’ right to autonomously determine what constitutes a national emergency or other circumstances of extreme urgency.
Zato prenos te presoje izrednega stanja v državi uvoznici na organe države izvoznice ni v skladu z Deklaracijo iz Dohe.
Therefore, a transfer of this judgement of emergency in the importing country to the authorities of the exporting country is not consistent with the Doha Declaration.
V razumnem času po preklicu licence pridobitelj licence poskrbi, da je vsak izdelek, ki je v njegovi lasti, hrambi ali pod njegovo pristojnostjo ali nadzorom na njegove stroške preusmerjen v države v stiski ali drugače, kot določi pristojni organ, ki se posvetuje z imetnikom pravice.
Within a reasonable time following termination of the licence, the licensee shall arrange for any product in his possession, custody, power or control to be redirected at his expense to countries in need or otherwise as prescribed by the competent authority in consultation with the right holder.
Po preklicu licence ima pristojni organ pravico določiti razumen rok, v katerem mora pridobitelj licence poskrbeti, da je vsak izdelek, ki je v njegovi lasti, hrambi ali pod njegovo pristojnostjo ali nadzorom na njegove stroške preusmerjen v države v stiski ali drugače, kot določi pristojni organ, ki se posvetuje z imetnikom pravice.
Following termination of the licence, the competent authority shall be entitled to establish a reasonable period of time within which the licensee shall arrange for any product in his possession, custody, power or control to be redirected at his expense to countries in need or otherwise as prescribed by the competent authority in consultation with the right holder.
Ker ima pristojni organ pravico preklicati prisilno licenco, mora tudi določiti rok, v katerem je pridobitelj licence dolžan poskrbeti, da je vsak izdelek, ki je v njegovi lasti, hrambi ali pod njegovo pristojnostjo ali nadzorom, preusmerjen.
Given that the competent authority is entitled to terminate a compulsory licence, it must also be able to determine the period of time within which the licensee shall arrange for any product in his possession, custody, power or control to be redirected.
Pritožbe proti kateri koli odločbi pristojnega organa in spori glede izpolnjevanja pogojev licence se predložijo primernemu organu, ki je po nacionalni zakonodaji za to odgovoren.
Appeals against any decision of the competent authority, and disputes concerning compliance with the conditions of the licence, shall be heard by the appropriate body responsible under national law.
Pritožbe proti odločbi o dodelitvi prisilne licence ne smejo imeti odložilnega učinka v zvezi z licenco.
Appeals against a decision to grant a compulsory licence shall not have a suspensory effect in relation to the licence.
Osnutek Uredbe dovoljuje pritožbe proti kateremu koli sklepu pristojnega organa.
The draft Regulation permits appeals against any decision by the competent authority.
Sistem, ki ga uvaja osnutek Uredbe, bo deloval v smislu spora ali nestrinjanja z imetnikom patenta, v sektorju, v katerem so sodni postopki zelo pogosti.
The system established by the draft Regulation will operate in a context of conflict or disagreement with the patentee, in a sector where litigation is extremely frequent.
Če pravica do pritožbe ni ustrezno urejena, si lahko imetnik patenta na sodiščih zagotovi pravno varstvo in za dolgo obdobje zaustavi dobavo zdravil.
If the right to appeal is not appropriately regulated, the patentee may be able to obtain injunctive relief from the courts and block for a long time the supply of medicines.
Možnost uporabe takšnih ukrepov povzroča veliko negotovost za morebitne dobavitelje in lahko še dodatno zmanjša zanimanje možnih dobaviteljev za delovanje v skladu s sistemom.
The possibility of obtaining this type of measures creates a high uncertainty for prospective suppliers and may further reduce the interest of potential suppliers to operate under the system.
Kot je določeno v več nacionalnih predpisih, pritožba imetnika patenta ne sme odložiti izpolnitve licence.
As established in many national regulations, an appeal by the patentee should not suspend the execution of the compulsory licence.
Kadar zahtevek za prisilno licenco zadeva zdravilo, odobreno v skladu s členom 6 Direktive 2001/83/EC, se določbe člena 24(4) in (5) ter člena 14(4) in (5) Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta
Where the application for a compulsory licence concerns a medicinal product authorised in accordance with Article 6 of Directive 2001/83/EC, the provisions of Article 24(4) and (5) and of Article 14(4) and (5) of Regulation (EC) No 726/2004 of the European Parliament and the Council
UL L 136, 30.4.2004, str.
OJ L 136, 30.4.2004, p.
1. ne uporabljajo.
1. shall not apply.
Za namene uporabe tega odstavka in z odstopanjem od člena 10(1) Direktive 2001/83/ES vlagatelju ni treba predložiti rezultatov predkliničnih testov in kliničnih poskusov, če lahko dokaže, da je zadevni izdelek generik referenčnega zdravila, ki je ali je bil odobren po členu 6 navedene direktive ali po členu 3 Uredbe (ES) št. 726/2004.
For the purpose of the application of this paragraph, and by way of derogation from Article 10(1) of Directive 2001/83/EC, the applicant shall not be required to provide the results of pre-clinical tests and of clinical trials if he can demonstrate that the product concerned is a generic of a reference medicinal product which is or has been authorised under Article 6 of that Directive or under Article 3 of Regulation (EC) No 726/2004.
Kadar zahtevek za prisilno licenco zadeva zdravilo, vlagatelj lahko izkoristi postopek za pridobitev
Where the application for a compulsory licence concerns a medicinal product, the applicant may avail himself of
a) znanstvenega mnenja, ki ga določa člen 58 Uredbe (ES) št. 726/2004 , ali
a) the scientific opinion procedure as provided for under Article 58 of Regulation (EC) No 726/2004, or
Če zahtevek za prisilno licenco zadeva zdravilo in vlagatelj za prisilno licenco ni imetnik dovoljenja za promet, ki je veljavno v Skupnosti za zadevni izdelek, lahko izkoristi postopek za pridobitev znanstvenega mnenja, ki ga določa člen 58 Uredbe (ES) št. 726/2004 ali kateri koli podoben postopek , ki ga določa nacionalna zakonodaja.
Where the application for a compulsory licence concerns a medicinal product and the applicant for the compulsory licence is not the holder of a marketing authorisation valid within the Community for the product concerned, he may avail himself of the scientific opinion procedure provided for under Article 58 of Regulation (EC) No 726/2004 or any similar procedure provided under national law .
Če zahteva za kateri koli zgoraj omenjeni postopek zadeva izdelek, ki je generik referenčnega zdravila, ki je ali je bil odobren po členu 6 Direktive 2001/83/ES, zaščitna obdobja, določena v členu 14(11) Uredbe (ES) št. 726/2004 in v členih 10(1) ter 10(5) Direktive 2001/83/ES, ne veljajo.
If a request for any of the above procedures concerns a product which is a generic of a reference medicinal product which is or has been authorised under Article 6 of Directive 2001/83/EC, the protection periods set out in Article 14(11) of Regulation (EC) No 726/2004 and in Articles 10(1) and 10(5) of Directive 2001/83/ECshall not apply.
Za namene pridobitve znanstvenega mnenja v skladu z odstavkom 2 in z odstopanjem od člena 10(1) Direktive 2001/83/ES vlagatelju ni treba predložiti rezultatov predkliničnih testov in kliničnih poskusov, če lahko dokaže, da je zadevni izdelek generik referenčnega zdravila, ki je ali je bil odobren po členu 6 navedene direktive ali po členu 3 Uredbe (ES) št. 726/2004.
For the purposes of obtaining a scientific opinion under paragraph (2) and by way of derogation from Article 10(1) of Directive 2001/83/EC, the applicant shall not be required to provide the results of pre-clinical tests and of clinical trials if he can demonstrate that the product concerned is a generic of a reference medicinal product which is or has been authorised under Article 6 of that Directive or Article 3 of Regulation (EC) No 726/2004.
Vsebina člena 16 ni dovolj jasna in jo je treba spremeniti.
The content of Article 16 is not entirely clear and needs to be reformulated .
Člen 16, odstavek 3 a (novo)
Article 16, paragraph 3 a (new)