natgillin/translations-raw huggingface dataset:
Da bi zagotovili enake pogoje v vseh državah članicah za podelitev prisilnih licenc za proizvodnjo in prodajo farmacevtskih izdelkov, kadar so ti namenjeni za izvoz, in da bi se izognili izkrivljanju konkurence za gospodarske subjekte na enotnem trgu, je potrebno, da se Sklep izvaja enotno.
Uniform implementation of the Decision is needed to ensure that the conditions for the granting of compulsory licences for the manufacture and sale of pharmaceutical products, when such products are intended for export, are the same in all Member States and to avoid distortion of competition for operators in the single market.
Morala bi se uporabljati tudi enotna pravila, da se prepreči ponovni uvoz farmacevtskih izdelkov, proizvedenih v skladu s Sklepom, na ozemlje Skupnosti.
Uniform rules should also be applied to prevent re-importation into the territory of the Community of pharmaceutical products manufactured pursuant to the Decision.
Namen te uredbe je postati del širše evropske in mednarodne dejavnosti za reševanje težav v javnem zdravju, s katerimi se soočajo najmanj razvite države in druge države v razvoju, ter predvsem izboljšati dostop do cenovno dostopnih varnih in učinkovitih zdravil, vključno z odmerki kombinacij zdravil, katerih kakovost je zagotovljena.
This Regulation is intended to be part of wider European and international action to address public health problems faced by least developed countries and other developing countries, and in particular to improve access to affordable medicines which are safe and effective, including fixed-dose combinations, and whose quality is guaranteed.
V povezavi s tem bodo na voljo postopki, določeni v farmacevtski zakonodaji Skupnosti, ki bodo zagotavljali znanstveno kakovost teh izdelkov, še zlasti postopek iz člena 58 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 UL L 136, 30.4.2004, str.
In that connection, the procedures laid down in Community pharmaceutical legislation guaranteeing the scientific quality of such products will be available, in particular that provided for in Article 58 of 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 OJ L 136, 30.4.2004, p.
Ker je sistem prisilnega licenciranja, vzpostavljen s to uredbo, namenjen reševanju težav v javnem zdravju, bi se moral uporabljati v dobri veri.
As the compulsory licensing system set up by this Regulation is intended to address public health problems, it should be used in good faith.
Tega sistema države ne bi smele uporabljati za uresničevanje industrijskih ali trgovinskih ciljev.
This system should not be used by countries to pursue industrial or commercial policy objectives.
Namen te uredbe je, da se ustvari varen pravni okvir in da se preprečijo spori.
This Regulation is designed to create a secure legal framework and to discourage litigation.
Ker je ta uredba del širše dejavnosti za reševanje vprašanja dostopa do cenovno dostopnih zdravil za države v razvoju, je Komisija opredelila dopolnilne ukrepe v svojem akcijskem programu (pospešeni ukrepi v boju proti HIV/AIDS, malariji in tuberkulozi v okviru odpravljanja revščine) in v Sporočilu Komisije o skladni evropski politiki za zunanje ukrepe v boju proti HIV/AIDS, malariji in tuberkulozi.
As this Regulation is part of wider action to address the issue of access to affordable medicines for developing countries, complementary actions are set out in the Commission Programme for Action: Accelerated action on HIV/AIDS, malaria and tuberculosis in the context of poverty reduction and in the Commission Communication on a Coherent European Policy Framework for External Action to Confront HIV/AIDS, Malaria and Tuberculosis.
Potreben je nenehen nujen napredek, ki vključuje ukrepe za podporo raziskav v boju proti tem boleznim in ukrepe za povečanje zmogljivosti v deželah v razvoju.
Continued urgent progress is necessary, including actions to support research to combat these diseases and to enhance capacity in developing countries.
Nujno je, da izdelki, proizvedeni v skladu s to uredbo, dosežejo samo tiste, ki jih potrebujejo, in niso preusmerjeni od tistih, katerim so bili namenjeni.
It is imperative that products manufactured pursuant to this Regulation reach only those who need them and are not diverted from those for whom they were intended.
Prisilne licence po tej uredbi morajo zato pridobitelju licence naložiti jasne pogoje glede dejanj, ki jih obsega licenca, opredelitve farmacevtskih izdelkov, proizvedenih po licenci, in držav, v katere se bodo ti izdelki izvozili.
The issuing of compulsory licences under this Regulation must therefore impose clear conditions upon the licensee as regards the acts covered by the licence, the identification of the pharmaceutical products manufactured under the licence and the countries to which the products will be exported.
Predvideti bi bilo treba carinsko ukrepanje na zunanjih mejah za obravnavo izdelkov, proizvedenih in prodanih za izvoz po prisilni licenci, ki jih nekdo poskuša ponovno uvoziti na ozemlje Skupnosti.
Provision should be made for customs action at external borders to deal with products manufactured and sold for export under a compulsory licence which a person attempts to re-import into the territory of the Community.
Če so bili farmacevtski izdelki, proizvedeni po prisilni licenci, zaseženi v skladu s to uredbo, se lahko pristojni organ v skladu z nacionalno zakonodajo in zato, da se zagotovi uporaba zaseženih farmacevtskih izdelkov za predvideni namen, odloči poslati te izdelke v ustrezno državo uvoznico v skladu s podeljeno prisilno licenco.
Where pharmaceutical products produced under a compulsory licence have been seized under this Regulation, the competent authority may, in accordance with national legislation and with a view to ensuring that the intended use is made of the seized pharmaceutical products, decide to send the products to the relevant importing country according to the compulsory licence which has been granted.
Da bi se izognili pospeševanju prekomerne proizvodnje in možnemu preusmerjanju farmacevtskih izdelkov, bi morali pristojni organi upoštevati obstoječe prisilne licence za enake izdelke in države, kot tudi vzporedne uporabe, ki jih je navedel vložnik zahteve.
To avoid facilitating overproduction and possible diversion of products, the competent authorities should take into account existing compulsory licences for the same products and countries, as well as parallel applications indicated by the applicant.
Ker ciljev te uredbe, ki jih je treba sprejeti, in sicer uvedbe usklajenih postopkov za podelitev prisilnih licenc, ki prispevajo k učinkovitemu izvajanju sistema, vzpostavljenega s Sklepom, države članice ne morejo zadovoljivo doseči zaradi možnosti, ki so po Sklepu na voljo državam izvoznicam, in se lahko zato zaradi možnih vplivov na gospodarske subjekte na notranjem trgu lažje dosežejo na ravni Skupnosti, lahko Skupnost sprejme ukrepe v skladu z načelom subsidiarnosti iz člena 5 Pogodbe.
Since the objectives of this Regulation, in particular the establishment of harmonised procedures for the granting of compulsory licences which contribute to the effective implementation of the system set up by the Decision, cannot be sufficiently achieved by the Member States because of the options available to exporting countries under the Decision and can therefore, by reason of the potential effects on operators in the internal market, be better achieved at Community level, the Community may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty.
Skladno z načelom sorazmernosti iz navedenega člena, ta uredba ne presega tistega, kar je potrebno za doseganje navedenih ciljev.
In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives.
Skupnost priznava, da je nadvse zaželeno, da se podpira prenos tehnologije in vzpostavljanje zmogljivosti v državah, ki imajo nezadostne proizvodne zmogljivosti v farmacevtskem sektorju ali jih sploh nimajo, in se tako spodbuja in povečuje lastna proizvodnja farmacevtskih izdelkov v teh državah.
The Community recognises the utmost desirability of promoting the transfer of technology and capacity-building to countries with insufficient or no manufacturing capacity in the pharmaceutical sector, in order to facilitate and increase the production of pharmaceutical products by those countries.
Za zagotovitev učinkovite obdelave zahtev za pridobitev prisilne licence v skladu s to uredbo bi morale imeti države članice možnost predpisati izključno formalne ali upravne pogoje, kot so pravila glede jezika zahteve, obrazca, ki se mora uporabljati, opredelitve patentov in/ali dodatnih varstvenih certifikatov, v zvezi s katerimi se zahteva prisilna licenca, in pravila o zahtevah v elektronski obliki.
In order to ensure the efficient processing of applications for compulsory licences under this Regulation, Member States should have the ability to prescribe purely formal or administrative requirements, such as rules on the language of the application, the form to be used, the identification of the patent(s) and/or supplementary protection certificate(s) in respect of which a compulsory licence is sought, and rules on applications made in electronic form.
Namen preproste formule za določitev nadomestila je pospešiti postopek podelitve prisilnih licenc v primeru izrednih razmer v državi ali v drugih skrajno nujnih okoliščinah ali v primerih javne nekomercialne uporabe v skladu s točko (b) 31. člena Sporazuma TRIPS.
The simple formula for setting remuneration is intended to accelerate the process of granting a compulsory licence in cases of national emergency or other circumstances of extreme urgency or in cases of public non-commercial use under Article 31(b) of the TRIPS Agreement.
Delež 4 % bi se lahko uporabil kot referenčna točka za razprave o ustreznem nadomestilu v okoliščinah, ki so drugačne od zgoraj navedenih –
The figure of 4% could be used as a reference point for deliberations on adequate remuneration in circumstances other than those listed above,
Ta uredba uvaja postopek za podelitev prisilnih licenc v zvezi s patenti in dodatnimi varstvenimi certifikati za proizvodnjo in prodajo farmacevtskih izdelkov, kadar so takšni izdelki namenjeni izvozu v upravičene države uvoznice, ki potrebujejo takšne izdelke za reševanje težav v zvezi z javnim zdravjem.
This Regulation establishes a procedure for the grant of compulsory licences in relation to patents and supplementary protection certificates concerning the manufacture and sale of pharmaceutical products, when such products are intended for export to eligible importing countries in need of such products in order to address public health problems.
Države članice podelijo prisilno licenco vsaki osebi, ki vloži zahtevo v skladu s členom 6 in ob upoštevanju pogojev, določenih v členih 6 do 10.
Member States shall grant a compulsory licence to any person making an application in accordance with Article 6 and subject to the conditions set out in Articles 6 to 10.
"farmacevtski izdelek" pomeni kateri koli izdelek v farmacevtskem sektorju, vključno z zdravili, kot so določena v členu 1(2) Direktive 2001/83/ES Evropskega parlamenta in Sveta z dne 6. novembra 2001 o zakoniku Skupnosti o zdravilih za uporabo v humani medicini UL L 311, 28.11.2001, str.
"pharmaceutical product" means any product of the pharmaceutical sector, including medicinal products as defined in Article 1(2) of 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 OJ L 311, 28.11.2001, p.
Direktiva, kakor je bila nazadnje spremenjena z Direktivo 2004/24/ES (UL L 136, 30.4.2004, str.
Directive as last amended by Directive 2004/24/EC (OJ L 136, 30.4.2004, p.
, učinkovinami in opremo za diagnosticiranje ex vivo;
, active ingredients and diagnostic kits ex vivo;
"imetnik pravice" pomeni imetnika katerega koli patenta ali dodatnega varstvenega certifikata, v zvezi s katerim je bila vložena zahteva za pridobitev prisilne licence v skladu s to uredbo;
"rights-holder" means the holder of any patent or supplementary protection certificate in relation to which a compulsory licence has been applied for under this Regulation;
"država uvoznica" pomeni državo, v katero se bo izvažal farmacevtski izdelek;
"importing country" means the country to which the pharmaceutical product is to be exported;
"pristojni organ" pomeni za namene členov 1 do 11, 16 in 17 kateri koli nacionalni organ, ki je pristojen za podelitev prisilnih licenc v skladu s to uredbo v posamezni državi članici.
"competent authority" for the purposes of Articles 1 to 11, 16 and 17 means any national authority having competence to grant compulsory licences under this Regulation in a given Member State.
Pristojni organ, kakor je opredeljen v členu 2(4), je tisti, ki je pristojen za podelitev prisilnih licenc po nacionalnem patentnem pravu, razen če zadevna država članica določi drugače.
The competent authority as defined in Article 2(4) shall be that which has competence for the granting of compulsory licences under national patent law, unless the Member State determines otherwise.
Države članice o imenovanem pristojnem organu iz člena 2(4) uradno obvestijo Komisijo.
Member States shall notify the Commission of the designated competent authority as defined in Article 2(4).
Uradna obvestila se objavijo v Uradnem listu Evropske unije.
Notifications shall be published in the Official Journal of the European Union.
Upravičene države uvoznice
Eligible importing countries
Upravičene države uvoznice so naslednje:
The following are eligible importing countries:
vsaka najmanj razvita država, ki je kot taka navedena na seznamu Združenih narodov;
any least-developed country appearing as such in the United Nations list;
vsaka članica STO, ki ni najmanj razvita država članica iz točke (a), ki je Svet za TRIPS obvestila o svoji nameri, da bo uporabila sistem kot uvoznica, vključno s tem, ali bo sistem uporabljala v celoti ali omejeno;
any member of the WTO, other than the least-developed country members referred to in point (a), that has made a notification to the Council for TRIPs of its intention to use the system as an importer, including whether it will use the system in whole or in a limited way;
vsaka država, ki ni članica STO, vendar je na seznamu Odbora OECD za razvojno pomoč med državami z nizkim dohodkom, katerih bruto nacionalni proizvod na prebivalca znaša manj kot 745 USD, in ki je Komisijo uradno obvestila o svoji nameri, da bo uporabila sistem kot uvoznica, vključno s tem, ali bo sistem uporabljala v celoti ali omejeno.
any country that is not a member of the WTO, but is listed in the OECD Development Assistance Committee's list of low-income countries with a gross national product per capita of less than USD 745, and has made a notification to the Commission of its intention to use the system as an importer, including whether it will use the system in whole or in a limited way.
Vendar vsaka članica STO, ki je STO podala izjavo, da sistema ne bo uporabljala kot članica STO uvoznica, ni upravičena država uvoznica.
However, any WTO member that has made a declaration to the WTO that it will not use the system as an importing WTO member is not an eligible importing country.
Razširitev na najmanj razvite države in države v razvoju, ki niso članice STO
Extension to least-developed and developing countries which are not members of the WTO
Naslednje določbe se uporabljajo za upravičene države uvoznice po členu 4, ki niso članice STO:
The following provisions shall apply to importing countries eligible under Article 4 which are not WTO members:
država uvoznica pošlje uradno obvestilo iz člena 8(1) neposredno Komisiji, ;
the importing country shall make the notification referred to in Article 8(1) directly to the Commission;
država uvoznica v uradnem obvestilu iz člena 8(1) izjavi, da bo sistem uporabljala za reševanje problemov javnega zdravja in ne kot instrument za doseganje ciljev industrijske ali trgovinske politike ter da bo sprejela ukrepe iz odstavka 4 Sklepa;
the importing country shall, in the notification referred to in Article 8(1), state that it will use the system to address public health problems and not as an instrument to pursue industrial or commercial policy objectives and that it will adopt the measures referred to in paragraph 4 of the Decision;
pristojni organ lahko na zahtevo imetnika pravice ali na lastno pobudo, če nacionalna zakonodaja pristojnemu organu dovoljuje delovanje na lastno pobudo, prekliče prisilno licenco, podeljeno v skladu s tem členom, če država uvoznica ni izpolnila svojih obveznost iz točke (b).
the competent authority may, at the request of the rights-holder, or on its own initiative if national law allows the competent authority to act on its own initiative, terminate a compulsory licence granted pursuant to this Article if the importing country has failed to honour its obligations referred to in point (b).
Pred preklicem prisilne licence pristojni organ upošteva vsa mnenja, ki jih izrazijo organi iz člena 6(3)(f).
Before terminating a compulsory licence, the competent authority shall take into account any views expressed by the bodies referred to in Article 6(3)(f).
Zahteva za prisilno licenco
Application for a compulsory licence
Vsaka oseba lahko vloži zahtevo za pridobitev prisilne licence po tej uredbi pri pristojnem organu v državi članici ali članicah, kjer patenti ali dodatni varstveni certifikati veljajo in obsegajo njene načrtovane dejavnosti proizvodnje in prodaje za izvoz.
Any person may submit an application for a compulsory licence under this Regulation to a competent authority in the Member State or States where patents or supplementary protection certificates have effect and cover his intended activities of manufacture and sale for export.
Oseba, ki vloži zahtevo za pridobitev prisilne licence pri organih več kot ene države za isti izdelek, to v vseh svojih zahtevah navede skupaj s podatki o količinah in zadevnih državah uvoznicah.
If the person applying for a compulsory licence is submitting applications to authorities in more than one country for the same product, he shall indicate that fact in each application, together with details of the quantities and importing countries concerned.
Zahteva iz odstavka 1 vsebuje:
The application pursuant to paragraph 1 shall set out the following:
nevarovano ime farmacevtskega izdelka ali izdelkov, ki jih namerava vložnik proizvajati in prodajati za izvoz v skladu s prisilno licenco;
the non-proprietary name of the pharmaceutical product or products which the applicant intends to manufacture and sell for export under the compulsory licence;
količino farmacevtskega izdelka, ki jo namerava vložnik proizvesti v skladu s prisilno licenco;
the amount of pharmaceutical product which the applicant seeks to produce under the compulsory licence;
državo ali države uvoznice;
the importing country or countries;
dokazila o prejšnjih pogajanjih z imetnikom pravice v skladu s členom 9, kjer je to potrebno;
where applicable, evidence of prior negotiation with the rights-holder pursuant to Article 9;
dokazila o posebni zahtevi:
evidence of a specific request from:
pooblaščenih zastopnikov države ali držav uvoznic, ali
authorised representatives of the importing country or countries; or
nevladne organizacije s formalnim pooblastilom ene ali več držav uvoznic ali
a non-governmental organisation acting with the formal authorisation of one or more importing countries; or
organov OZN ali drugih mednarodnih zdravstvenih organizacij s formalnim pooblastilom ene ali več držav uvoznic,
UN bodies or other international health organisations acting with the formal authorisation of one or more importing countries,
z navedbo zahtevane količine izdelka.
indicating the quantity of product required.
Nacionalna zakonodaja lahko predpiše zgolj formalne ali upravne pogoje, potrebne za učinkovito obravnavo zahteve.
Purely formal or administrative requirements necessary for the efficient processing of the application may be prescribed under national law.
Takšni pogoji po nepotrebnem ne povečajo stroškov ali bremen vložnika, v vsakem primeru pa zaradi njih postopek za podelitev prisilne licence po tej uredbi ni bolj otežen, kot je postopek za podelitev drugih prisilnih licenc po nacionalni zakonodaji.
Such requirements shall not add unnecessarily to the costs or burdens placed upon the applicant and, in any event, shall not render the procedure for granting compulsory licences under this Regulation more burdensome than the procedure for the granting of other compulsory licences under national law.
Pravice imetnika pravice
Rights of the rights-holder
Pristojni organ nemudoma uradno obvesti imetnika pravice o zahtevi za pridobitev prisilne licence.
The competent authority shall notify the rights-holder without delay of the application for a compulsory licence.
Pred podelitvijo prisilne licence da pristojni organ imetniku pravice možnost, da poda pripombe k zahtevi in da pristojnemu organu sporoči kakršne koli pomembne informacije v zvezi z zahtevo.
Before the grant of the compulsory licence, the competent authority shall give the rights-holder an opportunity to comment on the application and to provide the competent authority with any relevant information regarding the application.
da je vsaka država uvoznica, navedena v zahtevi, ki je članica STO, v skladu s Sklepom uradno obvestila STO ali
each importing country cited in the application which is a WTO member has made a notification to the WTO pursuant to the Decision,
da je vsaka država uvoznica, navedena v zahtevi, ki ni članica STO, glede vsakega izdelka iz zahteve, v skladu s to uredbo poslala Komisiji uradno obvestilo ki:
each importing country cited in the application which is not a WTO member has made a notification to the Commission pursuant to this Regulation in respect of each of the products covered by the application that:
natančno navaja naziv in pričakovano količino potrebnega izdelka;
specifies the names and expected quantities of the product(s) needed;
potrjuje, da je država na enega od načinov, določenih v Prilogi k Sklepu, ugotovila, da ima v farmacevtskem sektorju v zvezi z določenim izdelkom ali izdelki nezadostne proizvodne zmogljivosti ali pa jih sploh nima, razen če je država uvoznica ena od najmanj razvitih držav;
unless the importing country is a least-developed country, confirms that the country has established that it had insufficient or no manufacturing capacity in the pharmaceutical sector in relation to a particular product or products in one of the ways set out in the Annex to the Decision;
potrjuje, da je v primerih, ko je farmacevtski izdelek patentiran na ozemlju države uvoznice, ta država uvoznica podelila ali namerava podeliti prisilno licenco za uvoz zadevnega izdelka v skladu s 31. členom Sporazuma TRIPS in določbami Sklepa.
confirms that where a pharmaceutical product is patented in the territory of the importing country, that importing country has granted or intends to grant a compulsory licence for import of the product concerned in accordance with Article 31 of the TRIPS Agreement and the provisions of the Decision.
Ta odstavek ne posega v prožnost, ki jo imajo najmanj razvite države po Sklepu Sveta za TRIPS z dne 27. junija 2002.
This paragraph is without prejudice to the flexibility that least-developed countries have under the Decision of the Council for TRIPS of 27 June 2002.