natgillin/translations-raw huggingface dataset:
the product name and active ingredient of the tiered-priced product and sufficient information to verify which disease it prevents, diagnoses or treats;
ime proizvoda in aktivno sestavino proizvoda z vzporedno oblikovano ceno ter zadostne podatke za potrjevanje, katero bolezen preprečuje, diagnosticira ali zdravi;
the price offered in relation to either of the optional price calculations set out in Article 3 in sufficient detail to enable verification.
ceno, ki je ponujena glede na katerega od izbirnih izračunov cen, določenih v členu 3, z zadostnimi podatki, da je omogočeno potrjevanje.
Instead of submitting such detailed information, the applicant may submit a certificate, issued by an independent auditor, stating that the price has been verified and corresponds to one of the criteria set out in Annex III.
Namesto predložitve teh podrobnih podatkov lahko vlagatelj predloži potrdilo, ki ga je izdal neodvisni revizor, ki navaja, da je cena potrjena in ustreza enemu od meril, določenih v Prilogi III.
The independent auditor shall be appointed in agreement between the manufacturer and the Commission.
Neodvisnega revizorja proizvajalec in Komisija določita sporazumno.
Any information submitted by the applicant to the auditor shall remain confidential;
Vsi podatki, ki jih prosilec predloži revizorju, so zaupni;
the country or countries of destination to which the applicant intends to sell the product concerned;
namembno državo ali države, kamor vlagatelj namerava prodati zadevne proizvode;
the code number based on the Combined Nomenclature as set out in Annex I to Council Regulation (EEC) No 2658/87 [5] and, where appropriate, supplemented by TARIC subdivisions, to identify unambiguously the goods concerned; and
kodno številko na podlagi kombinirane nomenklature, kot je določena v Prilogi I k Uredbi Sveta (EGS) št. 2658/87 [5], ter, po potrebi, z dodatkom pododdelkov TARIC za nedvoumno prepoznavanje zadevnega blaga; in
any measures taken by the manufacturer or exporter to make the tiered-priced product easily distinguishable from identical products offered for sale within the Union.
vse ukrepe proizvajalca ali izvoznika za enostavno razlikovanje proizvodov z vzporedno oblikovanimi cenami od enakih proizvodov, ki so naprodaj v Uniji.
Where a delay in the addition of a product to Annex I would cause a delay in responding to an urgent need for access to affordable essential medicines in a developing country, and therefore imperative grounds of urgency so require, the procedure provided for in Article 6 shall apply to delegated acts adopted pursuant to the first subparagraph.
Če vlagatelj ne dopolni vloge v roku, določenem v tem pisnem pozivu, je vloga nična.
If an application is not sufficiently detailed for a review as to substance, the Commission shall request the applicant in writing to submit such missing information.
Če Komisija ugotovi, da vloga ne izpolnjuje meril, določenih v tej uredbi, se vloga zavrne, vlagatelja pa se o tem obvesti v 15 dneh od datuma sklepa.
If the applicant does not complete the application within the time period set out in that written request, the application shall be null and void.
Vlagatelj lahko vloži spremenjeno vlogo za isti proizvod.
If the Commission finds that the application does not fulfil the criteria set out in this Regulation, the application shall be rejected and the applicant shall be informed within 15 days of the date of the decision.
Proizvodi, ki so namenjeni za donacijo prejemnikom v eni od držav, navedenih v Prilogi II, se lahko ustrezno priglasijo za namene odobritve in vključitve v Prilogo I.
Nothing shall prevent the applicant from submitting a modified application for the same product.
Prilogo I Komisija posodablja vsak drugi mesec.
Products destined to be donated to recipients in one of the countries listed in Annex II may be the subject of a notification to that effect for the purposes of approval and insertion in Annex I.
Na Komisijo se prenese pooblastilo za sprejemanje delegiranih aktov v skladu s členom 5 v zvezi s spremembo prilog II, III in IV, kadar je to potrebno za prilagoditev seznama bolezni, namembnih držav, ki jih zajema ta uredba, in formul, ki se uporabljajo za določitev produktov z vzporedno oblikovano ceno, ob upoštevanju izkušenj, pridobljenih pri njeni uporabi, ali kot odziv na zdravstveno krizo.
Annex I shall be updated every second month by the Commission.
Člen 5
The Commission shall be empowered to adopt delegated acts in accordance with Article 5 to amend Annexes II, III and IV where necessary in order to revise the list of diseases, the countries of destination covered by this Regulation, as well as the formulae used to identify tiered-priced products, in the light of the experience gained from its application or to respond to a health crisis.
Pooblastilo za sprejemanje delegiranih aktov je preneseno na Komisijo pod pogoji, določenimi v tem členu.
Article 5
Prenos pooblastila se samodejno podaljšuje za enako dolga obdobja, razen če Evropski parlament ali Svet nasprotuje temu podaljšanju najpozneje tri mesece pred koncem vsakega obdobja.
The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article.
Prenos pooblastila iz člena 4(3) in (8) lahko kadar koli prekliče Evropski parlament ali Svet.
The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the 5-year period.
Sklep začne učinkovati dan po njegovi objavi v Uradnem listu Evropske unije ali na poznejši dan, ki je določen v navedenem sklepu.
The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period.
Sklep ne vpliva na veljavnost že veljavnih delegiranih aktov.
The delegation of power referred to in Article 4(3) and (8) may be revoked at any time by the European Parliament or by the Council.
Komisija takoj po sprejetju delegiranega akta o njem sočasno uradno obvesti Evropski parlament in Svet.
A decision to revoke shall put an end to the delegation of power specified in that decision.
Delegirani akt, sprejet v skladu s členom 4(3), začne veljati le, če mu niti Evropski parlament niti Svet ne nasprotuje v roku dveh mesecev od uradnega obvestila Evropskemu parlamentu in Svetu o tem aktu ali če pred iztekom tega roka tako Evropski parlament kot Svet obvestita Komisijo, da mu ne bosta nasprotovala.
It shall not affect the validity of any delegated acts already in force.
Delegirani akt, sprejet v skladu s členom 4(8), začne veljati le, če mu niti Evropski parlament niti Svet ne nasprotuje v roku dveh mesecev od uradnega obvestila Evropskemu parlamentu in Svetu o tem aktu ali če pred iztekom tega roka tako Evropski parlament kot Svet obvestita Komisijo, da mu ne bosta nasprotovala.
As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.
Ta rok se na pobudo Evropskega parlamenta ali Sveta podaljša za štiri mesece.
A delegated act adopted pursuant to Article 4(3) shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object.
Člen 6
A delegated act adopted pursuant to Article 4(8) shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object.
V uradnem obvestilu Evropskemu parlamentu in Svetu o delegiranem aktu se navedejo razlogi za uporabo postopka v nujnih primerih iz tega člena.
That period shall be extended by four months at the initiative of the European Parliament or of the Council.
2.
Article 6
Evropski parlament ali Svet lahko nasprotuje delegiranemu aktu v skladu s postopkom iz člena 5(5) in (6).
The notification of a delegated act to the European Parliament and to the Council shall state the reasons for the use of the urgency procedure laid down in this Article.
Člen 7
Either the European Parliament or the Council may object to a delegated act in accordance with the procedure referred to in Article 5(5) and (6).
Proizvod, potrjen kot proizvod z vzporedno oblikovano ceno in naveden v Prilogi I, ostane na tem seznamu toliko časa, dokler so izpolnjeni pogoji, določeni v členu 4 in so Komisiji predložena letna prodajna poročila v skladu s členom 12.
In such a case, the Commission shall repeal the act without delay following the notification of the decision to object by the European Parliament or by the Council.
Vlagatelj Komisiji predloži podatke o vsaki spremembi glede obsega ali pogojev, določenih v členu 4, da se zagotovi izpolnjevanje navedenih zahtev.
A product approved as a tiered-priced product and listed in Annex I shall remain on that list for as long as the conditions set out in Article 4 are fulfilled and annual sales reports have been submitted to the Commission in accordance with Article 12.
Člen 9
The applicant shall submit information to the Commission on any change which has occurred with respect to the scope or conditions set out in Article 4 in order to ensure that those requirements are met.
Kadar obstaja sum, da bodo, v nasprotju s prepovedjo iz člena 2, proizvodi z vzporedno oblikovanimi cenami, uvoženi v Unijo, carinski organi ustavijo sprostitev zadevnih proizvodov ali jih zadržijo toliko časa, kolikor je potrebno za pridobitev odločbe pristojnih organov o značaju blaga.
A permanent logo, as set out in Annex V, shall be affixed to any packaging or product and any document used in connection with the approved product sold at tiered prices to countries of destination.
Po preteku tega obdobja se proizvodi sprostijo, pod pogojem, da so izpolnjene vse carinske formalnosti.
This requirement shall apply as long as the tiered-priced product concerned remains listed in Annex I.
Zadosten razlog za to, da carinski organi ustavijo sprostitev proizvodov ali jih zadržijo, je, če je na razpolago dovolj podatkov za ugotovitev, da ima zadevni proizvod vzporedno oblikovano ceno.
Article 9
Pristojni organ v zadevni državi članici in proizvajalec ali izvoznik iz Priloge I sta nemudoma obveščena o ustavljeni sprostitvi ali zadržanju proizvodov in prejmeta vse razpoložljive podatke v zvezi z zadevnimi proizvodi.
Where there is reason to suspect that, contrary to the prohibition provided for in Article 2, tiered-priced products will be imported into the Union, customs authorities shall suspend the release of, or detain, the products concerned for the time necessary to obtain a decision of the competent authorities on the character of the merchandise.
Ustrezno se upoštevajo nacionalne določbe o varstvu osebnih podatkov, poslovni in industrijski tajnosti ter poklicni in upravni zaupnosti.
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.
Uvoznik in, kadar je primerno, izvoznik morata imeti na razpolago dovolj možnosti, da pristojnim organom predložita podatke glede proizvodov, za katere sta mnenja, da so ustrezni.
Upon expiry of that period, the products shall be released, provided that all customs formalities have been complied with.
Postopek ustavitve ali zadržanja blaga se izvede na stroške uvoznika.
It shall be sufficient reason for the customs authorities to suspend the release of, or detain, products if there is sufficient information available to consider that the product in question is tiered priced.
Če povrnitve teh stroškov ni mogoče pridobiti od uvoznika, se jih lahko v skladu z nacionalno zakonodajo izterja od katere koli druge osebe, odgovorne za poskus nezakonitega uvoza.
The competent authority in the Member State concerned and the manufacturer or exporter mentioned in Annex I 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.
Člen 10
Due account shall be taken of national provisions on the protection of personal data, commercial and industrial secrecy, and professional and administrative confidentiality.
Če proizvode, katerih sprostitev so carinski organi ustavili ali so jih zadržali, pristojni organ prizna kot proizvode z vzporedno oblikovanimi cenami po tej uredbi, pristojni organ zagotovi, da se ti proizvodi zasežejo in odstranijo v skladu z nacionalno zakonodajo.
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.
Navedeni postopki se opravijo na stroške uvoznika.
The procedure of suspension or detention of the goods shall be carried out at the expense of the importer.
Kadar se za proizvode, katerih sprostitev so carinski organi ustavili ali so jih zadržali, po nadaljnjem preverjanju s strani pristojnega organa ugotovi, da ne gre za proizvode z vzporedno oblikovanimi cenami po tej uredbi, carinski organ sprosti proizvode prejemniku, pod pogojem, da so izpolnjene vse carinske formalnosti.
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.
Pristojni organ obvesti Komisijo o vseh sklepih, sprejetih na podlagi te uredbe.
If products suspended for release or detained by customs authorities are recognised by the competent authority as tiered-priced products under this Regulation, the competent authority shall ensure that those products are seized and disposed of in accordance with national legislation.
Ta uredba se ne uporablja za blago nekomercialne narave, ki je v osebni prtljagi potnikov za osebno uporabo, v okviru omejitev, določenih za oprostitev carinskih dajatev.
Those procedures shall be carried out at the expense of the importer.
Člen 12
Where products suspended for release or detained by customs authorities subsequent to further control by the competent authority are found not to qualify as tiered-priced products under this Regulation, the customs authority shall release the products to the consignee, provided that all customs formalities have been complied with.
Komisija na podlagi podatkov, ki jih zagotovijo farmacevtski proizvajalci in izvozniki, letno spremlja obseg izvoza proizvodov z vzporedno oblikovanimi cenami iz Priloge I in izvoženih v namembne države.
The competent authority shall inform the Commission of all decisions adopted pursuant to this Regulation.
V ta namen Komisija izda standarden obrazec.
Article 11
Proizvajalci in izvozniki Komisiji letno predložijo taka prodajna poročila, ki so zaupna, za vsak proizvod z vzporedno oblikovano ceno.
This Regulation shall not apply to goods of a non-commercial nature contained in travellers' personal luggage for personal use within the limits laid down in respect of relief from customs duty.
Komisija Evropskemu parlamentu in Svetu vsaki dve leti poroča o količinah, izvoženih po vzporedno oblikovanih cenah, tudi o količinah, izvoženih v okviru partnerskega sporazuma med proizvajalcem in vlado namembne države.
Article 12
Komisija v poročilu pregleda obseg držav in bolezni ter splošna merila za izvajanje člena 3.
The Commission shall monitor on an annual basis the volumes of exports of tiered-priced products listed in Annex I and exported to the countries of destination on the basis of information provided to it by pharmaceutical manufacturers and exporters.
3.
For this purpose a standard form shall be issued by the Commission.
Evropski parlament lahko v enem mesecu po tem, ko Komisija predloži poročilo, to povabi na ad hoc srečanje svojega odgovornega odbora, da bi predstavili in pojasnili morebitna vprašanja v zvezi z uporabo te uredbe.
Manufacturers and exporters shall submit such sales reports annually for each tiered-priced product to the Commission on a confidential basis.
Komisija najpozneje šest mesecev od dneva predložitve poročila Evropskemu parlamentu in Svetu to poročilo objavi.
The Commission shall report biennially to the European Parliament and to the Council on the volumes exported under tiered prices, including on the volumes exported within the framework of a partnership agreement agreed between the manufacturer and the government of a country of destination.
Člen 13
The report shall examine the scope of countries and diseases and general criteria for the implementation of Article 3.
Uporaba te uredbe v nobenem primeru ne posega v postopke, določene v Direktivi 2001/83/ES Evropskega parlamenta in Sveta [6] in Uredbi (ES) št. 726/2004 Evropskega parlamenta in Sveta [7].
The European Parliament may, within one month of submission of the Commission's report, invite the Commission to an ad hoc meeting of its responsible committee to present and explain any issues related to the application of this Regulation.
Ta uredba ne posega v pravice intelektualne lastnine ali pravice lastnikov intelektualne lastnine.
No later than six months from the date of submission of the report to the European Parliament and to the Council, the Commission shall make the report public.
Člen 14
Article 13
Uredba (ES) št. 953/2003 se razveljavi.
The application of this Regulation shall in no circumstances interfere with procedures laid down in Directive 2001/83/EC of the European Parliament and of the Council [6] and Regulation (EC) No 726/2004 of the European Parliament and of the Council [7].
Sklicevanja na razveljavljeno uredbo se štejejo za sklicevanja na to uredbo in se berejo v skladu s korelacijsko tabelo iz Priloge VII.
This Regulation shall not interfere with intellectual property rights or rights of intellectual property owners.
Člen 15
Regulation (EC) No 953/2003 is repealed.
Ta uredba je v celoti zavezujoča in se neposredno uporablja v vseh državah članicah.
References to the repealed Regulation shall be construed as references to this Regulation and shall be read in accordance with the correlation table in Annex VII.
V Strasbourgu, 11. maja 2016
Article 15
Za Evropski parlament
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
Predsednica
Done at Strasbourg, 11 May 2016.
Stališče Evropskega parlamenta z dne 9. marca 2016 (še ni objavljeno v Uradnem listu) in odločitev Sveta z dne 11. aprila 2016.
For the European Parliament
Uredba Sveta (ES) št. 953/2003 z dne 26. maja 2003 za preprečevanje preusmerjanja trgovine nekaterih ključnih zdravil v Evropsko unijo (UL L 135, 3.6.2003, str. 5).
The President
Glej Prilogo VI.
For the Council
Uredba (EU) št. 608/2013 Evropskega parlamenta in Sveta z dne 12. junija 2013 o uveljavljanju pravic intelektualne lastnine s strani carinskih organov in razveljavitvi Uredbe Sveta (ES) št. 1383/2003 (UL L 181, 29.6.2013, str. 15).
Position of the European Parliament of 9 March 2016 (not yet published in the Official Journal) and decision of the Council of 11 April 2016.
Uredba Sveta (EGS) št. 2658/87 z dne 23. julija 1987 o tarifni in statistični nomenklaturi ter skupni carinski tarifi (UL L 256, 7.9.1987, str. 1).
Council Regulation (EC) No 953/2003 of 26 May 2003 to avoid trade diversion into the European Union of certain key medicines (OJ L 135, 3.6.2003, p. 5).
Direktiva 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. 67).
See Annex VI.
Uredba (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. 1).
Regulation (EU) No 608/2013 of the European Parliament and of the Council of 12 June 2013 concerning customs enforcement of intellectual property rights and repealing Council Regulation (EC) No 1383/2003 (OJ L 181, 29.6.2013, p. 15).
PRILOGA I
Council Regulation (EEC) No 2658/87 of 23 July 1987 on the tariff and statistical nomenclature and on the Common Customs Tariff (OJ L 256, 7.9.1987, p. 1).
SEZNAM PROIZVODOV Z VZPOREDNO OBLIKOVANIMI CENAMI
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. 67).
Proizvod
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. 1).
Proizvajalec/izvoznik
ANNEX I
Namembna država
LIST OF TIERED-PRICED PRODUCTS
Posebnosti
Product
Datum odobritve
Manufacturer/exporter
Oznaka KN/TARIC [1]
Distinctive features
Armenija
Date of approval
Azerbajdžan
Afghanistan
Butan
Angola
Bocvana
Bangladesh
Zelenortski otoki
Benin
Srednjeafriška republika
Burkina Faso
Kongo
Burundi
Slonokoščena obala
Cambodia
Demokratična republika Kongo
Cape Verde
Ekvatorialna Gvineja
Central African Republic
Eritreja
Chad
Etiopija
Democratic Republic of the Congo
Gvineja Bissau
Djibouti
Indija
Equatorial Guinea
Kirgizistan
Eritrea
Lesoto
Ethiopia
Liberija
Gambia
Madagaskar
Ghana
Malavi
Haiti
Mongolija
Indonesia Kenya
Namibija
Kyrgyzstan
Nigerija
Laos
Severna Koreja
Lesotho
Ruanda
Liberia
São Tomé in Príncipe
Madagascar
Salomonovi otoki
Maldives
Južna Afrika
Mali Mauritania
Svazi
Moldova
Tadžikistan
Mongolia
Tanzanija
Mozambique
Vzhodni Timor
Namibia
Zambija
Nicaragua
Posebno pakiranje – trijezično besedilo
Niger
Posebno pakiranje – trijezično besedilo – tablete rdeče barve
North Korea
Bolnišnično pakiranje za Francijo – frankofonski trgi
Rwanda
Splošno pakiranje za izvoz, ki se uporablja v EU
Senegal
Le, če je to primerno.
Sierra Leone
PRILOGA II
Solomon Islands
NAMEMBNE DRŽAVE
South Africa
Indonezija
Sudan
Kenija
Swaziland
Mavretanija
Tajikistan
PRILOGA III
Uganda
OBSEG BOLEZNI
Vanuatu
HIV/aids, malarija, tuberkuloza in sorodne oportunistične bolezni
Yemen
PRILOGA V
Zambia
LOGOTIP
Zimbabwe
Eskulapova palica, ovita s kačo, sredi kroga iz 12 zvezd.
Distinctive access pack — trilingual text
PRILOGA VI
Distinctive access pack — trilingual text — red tablets
RAZVELJAVLJENA UREDBA S SEZNAMOM NAKNADNIH SPREMEMB
General export pack (blue) not used in EU.
Uredba Sveta (ES) št. 953/2003
Bottle (rather than blister pack) ‘A22’ embossed red tablets
Uredba Komisije (ES) št. 1876/2004
EPIVIR ORAL SOLUTION
(UL L 326, 29.10.2004, str. 22)
French hospital pack — Francophone countries
(UL L 267, 12.10.2005, str. 19)
RETROVIR ORAL SOLUTION
Uredba (EU) št. 38/2014 Evropskega parlamenta in Sveta
Distinctive access pack — Trilingual text
(UL L 18, 21.1.2014, str. 52)
Only if applicable.
Zgolj točka 3 Priloge
COUNTRIES OF DESTINATION
KORELACIJSKA TABELA
China
Ta uredba
Congo Côte d'Ivoire
Členi 1, 2 in 3
Kenya
Člen 4(2), uvodni stavek
Turkmenistan
Člen 4(2)(ii)
Vietnam Yemen
Člen 4(2)(b)
ANNEX III
Člen 4(2)(iii)
PERCENTAGES REFERRED TO IN ARTICLE 3
Člen 4(2)(c)
Percentage referred to in Article 3(a): 25 %
Člen 4(2)(iv)
Percentage referred to in Article 3(b): 15 %
Člen 4(2)(d)
ANNEX IV
Člen 4(2)(v)
SCOPE OF DISEASES
Člen 4(2)(e)
HIV/AIDS, malaria, tuberculosis and related opportunistic diseases
Člen 4(4)
ANNEX V
Člen 4(3)
LOGO
Člen 4(5)
The winged staff of Aesculapius with a coiled serpent, in the centre of a circle formed by 12 stars.
Člen 4(6)
ANNEX VI
Člen 4(7)
REPEALED REGULATION WITH LIST OF ITS SUCCESSIVE AMENDMENTS
Člen 4(8)
Council Regulation (EC) No 953/2003
Člen 4(9)
(OJ L 135, 3.6.2003, p. 5)
Člen 5a
Commission Regulation (EC) No 1876/2004
Priloge I do V
(OJ L 326, 29.10.2004, p. 22)
Priloga VI
Commission Regulation (EC) No 1662/2005
Priloga VII
(OJ L 267, 12.10.2005, p. 19)
Pooblastilo za sprejemanje delegiranih aktov iz člena 4(3) in (8) se prenese na Komisijo za obdobje petih let od 20. februarja 2014.