natgillin/translations-raw huggingface dataset:
‘safe biological limits’ means the boundaries of the size of a stock within which the stock can replenish itself with high probability while allowing high yield fisheries on it;
„varne biološke meje“ pomeni omejitve velikosti staleža, znotraj katerih se lahko stalež z veliko stopnjo verjetnosti dopolnjuje, hkrati pa omogoča ribolov z velikim donosom;
‘country’ means a third country, including territories enjoying self-governing status and endowed with competencies in the area of conservation and management of living marine resources.
„država“ pomeni tretjo državo, vključno z ozemlji, ki imajo samoupravni status in pristojnosti na področju ohranjanja in upravljanja živih morskih virov.
Countries allowing non-sustainable fishing
Države, ki omogočajo netrajnostne načine ribolova
A country may be identified as a country allowing non-sustainable fishing where:
Država je lahko opredeljena kot država, ki omogoča netrajnostne načine ribolova:
it fails to cooperate in the management of a stock of common interest in full compliance with the provisions of the UNCLOS and the UNFSA, or any other international agreement or norm of international law; and
kadar pri upravljanju staleža v skupnem interesu ne sodeluje v popolnem upoštevanju določb UNCLOS in UNFSA ali drugih mednarodnih sporazumov ali norm mednarodnega prava in
either:
kadar
it fails to adopt necessary fishery management measures; or
ne sprejme potrebnih ukrepov na področju upravljanja ribištva ali
it adopts fishery management measures without due regard to the rights, interests and duties of other countries and the Union, and those fishery management measures, when considered in conjunction with measures taken by other countries and the Union, lead to fishing activities which could result in the stock being in an unsustainable state.
sprejme ukrepe za upravljanje ribištva brez potrebnega upoštevanja pravic, interesov in obveznosti drugih držav in Unije, pri čemer se zaradi takšnih ukrepov na področju upravljanja ribištva, kadar se obravnavajo v povezavi z ukrepi drugih držav in Unije, izvajajo ribolovne dejavnosti, ki bi lahko vodile v netrajnostno stanje staleža.
This condition is considered to be complied with also where the fishery management measures adopted by that country did not lead to the stock being in an unsustainable state solely due to measures adopted by others.
Ta pogoj velja za izpolnjenega, tudi če ukrepi za upravljanje ribištva, ki jih je sprejela zadevna država, niso privedli do netrajnostnega stanja staleža zgolj zaradi ukrepov, ki so jih sprejeli drugi.
Measures in respect of countries allowing non-sustainable fishing
Ukrepi v zvezi z državami, ki omogočajo netrajnostne načine ribolova
The Commission may adopt, by means of implementing acts, the following measures in respect of a country allowing non-sustainable fishing:
Komisija lahko z izvedbenimi akti sprejme ukrepe v zvezi z državo, ki omogoča netrajnostne načine ribolova, s katerimi:
identifying that country as a country allowing non-sustainable fishing;
opredeli to državo kot državo, ki omogoča netrajnostne načine ribolova;
identifying, where necessary, the specific vessels or fleets of that country to which certain measures are to apply;
po potrebi opredeli posamezna plovila ali ribiška ladjevja te države, za katero se uporabijo nekateri ukrepi;
imposing quantitative restrictions on importations of fish from the stock of common interest that have been caught under the control of that country and on importations of fishery products made of or containing such fish;
uvede količinske omejitve za uvoz rib iz staleža skupnega interesa, ki so bile ujete v okviru ribolova pod nadzorom te države, in za uvoz ribiških proizvodov, ki so proizvedeni iz rib ali vsebujejo ribe iz staleža skupnega interesa;
imposing quantitative restrictions on importations of fish of any associated species, and fishery products made of or containing such fish, when caught while conducting fisheries on the stock of common interest under the control of that country; when adopting the measure, the Commission shall, in accordance with Article 5(4) of this Regulation, in application of the principle of proportionality, determine which species and their catches fall within the scope of the measure;
uvede količinske omejitve za uvoz rib katere koli sorodne vrste in ribiških proizvodov, ki so proizvedeni iz takšnih rib ali vsebujejo takšne ribe, kadar so bile te ribe ujete v okviru ribolova staleža skupnega interesa pod nadzorom te države; pri sprejetju ukrepa Komisija v skladu s členom 5(4) te uredbe ob uporabi načela sorazmernosti določi vrste in njihov ulov, za katere velja ukrep;
imposing restrictions on the use of Union ports by vessels flying the flag of that country that fish the stock of common interest and/or associated species and by vessels transporting fish and fishery products stemming from the stock of common interest and/or associated species that have been caught either by vessels flying the flag of that country or by vessels authorised by it while flying another flag; such restrictions shall not apply in cases of force majeure or distress within the meaning of Article 18 of the UNCLOS for services strictly necessary to remedy those situations;
uvede omejitve za uporabo pristanišč Unije za plovila, ki plujejo pod zastavo te države in ki lovijo stalež skupnega interesa in/ali sorodne vrste ter za plovila, ki prevažajo ribe in ribiške proizvode, ki izvirajo iz staleža skupnega interesa in/ali sorodnih vrst, pri čemer so te ribe ulovila plovila, ki plujejo pod zastavo te države, ali plovila, ki imajo dovoljenje takšne države in plujejo pod zastavo druge države; takšne omejitve ne veljajo v primerih višje sile ali stiske v smislu člena 18 UNCLOS za storitve, ki so nujno potrebne za odpravo takšnega stanja;
prohibiting the purchase by Union economic operators of a fishing vessel flying the flag of that country;
prepove gospodarskim subjektom iz Unije nakup ribiškega plovila, ki pluje pod zastavo te države;
prohibiting the reflagging of fishing vessels flying the flag of a Member State to the flag of that country;
prepove zamenjavo zastave ribiških plovil, ki plujejo pod zastavo države članice, z zastavo te države;
prohibiting Member States from authorising the conclusion of chartering agreements whereby Union economic operators charter their vessels to economic operators of that country;
prepove državam članicam, da dovolijo sklepanje dogovorov o zakupu, s katerimi gospodarski subjekti iz Unije dajo v zakup svoja plovila gospodarskim subjektom iz te države;
prohibiting the exportation to that country of fishing vessels flying the flag of a Member State or of fishing equipment and supplies needed to fish on the stock of common interest;
prepove izvoz v to državo za ribiška plovila, ki plujejo pod zastavo države članice, ali za ribiško opremo in material, potrebna za ribolov staleža skupnega interesa;
prohibiting the conclusion of private trade arrangements between Union economic operators and that country that enable a fishing vessel flying the flag of a Member State to use fishing opportunities of that country;
prepove sklepanje zasebnih trgovinskih dogovorov med gospodarskimi subjekti Unije in te države, ki omogočajo, da ribiško plovilo, ki pluje pod zastavo države članice, uporabi ribolovne možnosti te države;
prohibiting joint fishing operations involving fishing vessels flying the flag of a Member State and fishing vessels flying the flag of that country.
prepove skupne ribolovne dejavnosti, ki vključujejo ribiška plovila, ki plujejo pod zastavo države članice, in ribiška plovila, ki plujejo pod zastavo te države.
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 8(2).
Ti izvedbeni akti se sprejmejo v skladu s postopkom pregleda iz člena 8(2).
General requirements concerning the measures adopted pursuant to this Regulation
Splošne zahteve v zvezi z ukrepi, sprejetimi na podlagi te uredbe
The measures referred to in Article 4 shall be:
Ukrepi iz člena 4 so:
related to the conservation of the stock of common interest;
povezani z ohranjanjem staleža skupnega interesa;
made effective in conjunction with restrictions on fishing by Union vessels, or on production or consumption within the Union, applicable to fish and fishery products made of or containing such fish of the species for which the measures have been adopted;
učinkoviti v povezavi z omejitvami v zvezi z ribolovom plovil Unije ali proizvodnjo ali potrošnjo v Uniji na področju rib in ribiških proizvodov, ki so proizvedeni iz rib ali vsebujejo takšne ribe in iz vrst, za katere so bili sprejeti ukrepi.
proportionate to the objectives pursued and compatible with the obligations imposed by international agreements to which the Union is a party and any other relevant norms of international law.
sorazmerni z zastavljenimi cilji in skladni z obveznostmi iz mednarodnih sporazumov, katerih stranka je Unija, in katerih koli drugih ustreznih norm mednarodnega prava.
The measures referred to in Article 4 shall take into account measures already taken pursuant to Regulation (EC) No 1005/2008.
Ukrepi iz člena 4 upoštevajo ukrepe, ki so že bili sprejeti na podlagi Uredbe (ES) št. 1005/2008.
The measures referred to in Article 4 shall not be applied in a manner which would constitute a means of arbitrary or unjustifiable discrimination between countries where the same conditions prevail or a disguised restriction on international trade.
Ukrepi iz člena 4 se ne uporabljajo kot sredstvo samovoljne ali neupravičene diskriminacije držav, kadar veljajo enaki pogoji, ali kot sredstvo prikritega omejevanja mednarodne trgovine.
When adopting the measures referred to in Article 4, the Commission shall, in order to ensure that those measures are environmentally sound, effective, proportionate and compatible with international rules, evaluate the environmental, trade, economic and social effects of those measures in the short and long terms and the administrative burden associated with their implementation.
Pri sprejemanju ukrepov iz člena 4 Komisija z namenom zagotovitve okoljske neoporečnosti, učinkovitosti, sorazmernosti in skladnosti teh ukrepov z mednarodnimi pravili oceni kratkoročne in dolgoročne okoljske, trgovinske, gospodarske in družbene učinke takšnih ukrepov ter upravno breme, povezano z njihovim izvajanjem.
The measures referred to in Article 4 shall provide for an appropriate system for their enforcement by competent authorities.
V okviru ukrepov iz člena 4 se predvidi ustrezen sistem za izvajanje teh ukrepov s strani pristojnih organov.
Procedures prior to the adoption of measures in respect to countries allowing non-sustainable fishing
Postopki pred sprejetjem ukrepov v zvezi z državami, ki omogočajo netrajnostne načine ribolova
Where the Commission considers that it is necessary to adopt measures referred to in Article 4, it shall notify the country concerned of the intention to identify it as a country allowing non-sustainable fishing.
Kadar Komisija meni, da je treba sprejeti ukrepe iz člena 4, uradno obvesti zadevno državo, da jo namerava opredeliti kot državo, ki omogoča netrajnostne načine ribolova.
In such cases, the European Parliament and the Council shall be immediately informed.
V takem primeru je treba takoj obvestiti Evropski parlament in Svet.
That notification shall include information on the reasons for the identification of that country as a country allowing non-sustainable fishing and shall describe the possible measures that may be taken in relation to it pursuant to this Regulation.
Uradno obvestilo vključuje informacije o razlogih za opredelitev te države kot države, ki omogoča netrajnostne načine ribolova, in opis možnih ukrepov, ki se lahko sprejmejo proti njej na podlagi te uredbe.
Prior to adopting measures referred to in Article 4, the Commission shall provide the country concerned with a reasonable opportunity to respond to the notification in writing and to remedy the situation within one month of receiving that notification.
Pred sprejetjem ukrepov iz člena 4 Komisija zadevni državi zagotovi ustrezno možnost, da pisno odgovori na uradno obvestilo in odpravo nepravilnosti v enem mesecu od prejetja tega uradnega obvestila.
Period of application of the measures in respect to countries allowing non-sustainable fishing
Obdobje uporabe ukrepov v zvezi z državami, ki omogočajo netrajnostne načine ribolova
The measures referred to in Article 4 shall cease to apply when the country allowing non-sustainable fishing adopts appropriate corrective measures necessary for the conservation and management of the stock of common interest and those corrective measures:
Ukrepi iz člena 4 prenehajo veljati, ko država, ki omogoča netrajnostne načine ribolova, sprejme ustrezne popravne ukrepe, ki so potrebni za ohranitev in upravljanje staleža skupnega interesa, pri čemer:
have either been adopted autonomously or have been agreed in the context of consultations with the Union and, where applicable, other countries concerned; and
so bili ti popravni ukrepi sprejeti samostojno ali pa je bil dogovor o teh ukrepih sklenjen v okviru posvetovanj z Unijo in po potrebi z drugimi zadevnimi državami in
do not undermine the effect of measures taken by the Union either autonomously, or in cooperation with other countries, for the purpose of the conservation of the fish stocks concerned.
ti popravni ukrepi ne razvrednotijo učinka ukrepov za namene ohranjanja zadevnih staležev rib, ki jih je Unija sprejela samostojno ali v sodelovanju z drugimi državami.
The Commission shall adopt implementing acts determining whether the conditions laid down in paragraph 1 have been complied with and, where necessary, providing that the measures adopted in respect of the country concerned pursuant to Article 4 cease to apply.
Komisija sprejme izvedbene akte, s katerimi določi, ali so bili upoštevani pogoji iz odstavka 1 in po potrebi določi, da prenehajo veljati ukrepi, sprejeti v skladu s členom 4 glede zadevne države.
On duly justified imperative grounds of urgency relating to unforeseen economic or social disruption, the Commission shall adopt immediately applicable implementing acts in accordance with the procedure referred to in Article 8(3) to decide that the measures adopted pursuant to Article 4 are to cease to apply.
V izredno nujnih ustrezno utemeljenih primerih, ki zadevajo nepredvidljive gospodarske ali družbene motnje, Komisija v skladu s postopkom iz člena 8(3) sprejme izvedbene akte, ki se začnejo uporabljati takoj, s katerimi odloči, da ukrepi, sprejeti na podlagi člena 4, prenehajo veljati.
The results of the evaluation referred to in Article 5(4), shall be made available to the European Parliament and the Council, in accordance with the procedure provided for in Article 10(4) of Regulation (EU) No 182/2011, together with the documents referred to therein.
Rezultati ocene iz člena 5(4) so na voljo Evropskemu parlamentu in Svetu v skladu s postopkom iz člena 10(4) Uredbe (EU) št. 182/2011, skupaj z dokumenti, navedenimi v členu 10(4) Uredbe (EU) št. 182/2011.
OJ C 229, 31.7.2012, p. 112.
UL C 229, 31.7.2012, str. 112.
Position of the European Parliament of 12 September 2012 (not yet published in the Official Journal) and decision of the Council of 25 September 2012.
Stališče Evropskega parlamenta z dne 12. septembra 2012 (še ni objavljeno v Uradnem listu) in odločitev Sveta z dne 25. septembra 2012.
Regulation (EU) No 1027/2012 of the European Parliament and of the Council
Uredba (EU) št. 1027/2012 Evropskega parlamenta in Sveta
amending Regulation (EC) No 726/2004 as regards pharmacovigilance
o spremembi Uredbe (ES) št. 726/2004, kar zadeva farmakovigilanco
In order to ensure transparency on the surveillance of authorised medicinal products, the list of medicinal products subject to additional monitoring established by 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 [3], should systematically include medicinal products that are subject to certain post-authorisation safety conditions.
Za zagotovitev preglednosti nadzora odobrenih zdravil bi moral seznam zdravil, ki bi jih bilo treba dodatno spremljati, uveden z Uredbo (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 [3], sistematično vključevati zdravila, za katera veljajo nekateri varnostni pogoji po pridobitvi dovoljenja.
Therefore, the marketing authorisation holder should be obliged to inform the European Medicines Agency of the reasons for withdrawing or interrupting the placing on the market of a medicinal product, for requesting that a marketing authorisation be revoked, or for not renewing a marketing authorisation.
Zato bi moral biti imetnik dovoljenja za promet dolžan Evropsko agencijo za zdravila obvestiti o razlogih za umik zdravila ali prekinitev dajanja zdravila v promet, zahtevo za ukinitev dovoljenja za promet ali nepodaljšanje dovoljenja za promet.
Since the objective of this Regulation, namely to provide for specific rules on pharmacovigilance and improve the safety of medicinal products for human use authorised pursuant to Regulation (EC) No 726/2004, cannot be sufficiently achieved by the Member States and can therefore be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union.
Ker cilja te uredbe, in sicer zagotoviti posebna pravila za farmakovigilanco in izboljšati varnost zdravil za uporabo v humani medicini, odobrenih v skladu z Uredbo (ES) št. 726/2004, države članice ne morejo zadovoljivo doseči in ker se ta cilj lažje doseže na ravni Unije, lahko Unija sprejme ukrepe v skladu z načelom subsidiarnosti iz člena 5 Pogodbe o Evropski uniji.
Regulation (EC) No 726/2004 should therefore be amended accordingly,
Uredbo (ES) št. 726/2004 bi bilo zato treba ustrezno spremeniti –
in Article 13(4), the second subparagraph is replaced by the following:
v členu 13(4) se drugi pododstavek nadomesti z naslednjim:
‘The marketing authorisation holder shall notify the Agency if the product ceases to be placed on the market of a Member State, either temporarily or permanently. Such notification shall, other than in exceptional circumstances, be made no less than two months before the interruption in the placing on the market of the product. The marketing authorisation holder shall inform the Agency of the reasons for such action in accordance with Article 14b.’;
„Imetnik dovoljenja za promet obvesti Agencijo, če zdravilo ni več v prometu v državi članici bodisi začasno ali stalno. Razen v izjemnih okoliščinah se tako obvestilo pošlje najmanj dva meseca pred prekinitvijo dajanja zdravila v promet. Imetnik dovoljenja za promet obvesti Agencijo o razlogih za tako ukrepanje v skladu s členom 14b.“;
The marketing authorisation holder shall notify the Agency forthwith of any action the holder takes to suspend the marketing of a medicinal product, to withdraw a medicinal product from the market, to request the withdrawal of a marketing authorisation or not to apply for the renewal of a marketing authorisation, together with the reasons for such action.
Imetnik dovoljenja za promet Agencijo takoj obvesti o vseh ukrepih, ki jih je sprejel za začasen umik zdravila iz prometa, za umik zdravila iz prometa, za zahtevo za umik dovoljenja za promet ali za nepodaljšanje dovoljenja za promet, skupaj z razlogi za tako ukrepanje.
The marketing authorisation holder shall in particular declare if such action is based on any of the grounds set out in Article 116 or Article 117(1) of Directive 2001/83/EC.
Imetnik dovoljenja za promet zlasti navede, ali tako ukrepanje temelji na katerem koli od razlogov iz člena 116 ali člena 117(1) Direktive 2001/83/ES.
The marketing authorisation holder shall also make the notification pursuant to paragraph 1 of this Article if the action is taken in a third country and such action is based on any of the grounds set out in Article 116 or Article 117(1) of Directive 2001/83/EC.
Imetnik dovoljenja za promet pošlje obvestilo v skladu z odstavkom 1 tega člena tudi, kadar ukrepa v tretji državi in kadar tak ukrep temelji na razlogih iz člena 116 ali člena 117(1) Direktive 2001/83/ES.
In the cases referred to in paragraphs 1 and 2, the Agency shall forward the information to the competent authorities of the Member States without undue delay.’;
V primerih iz odstavkov 1 in 2 Agencija informacije nemudoma posreduje pristojnim organom držav članic.“;
in Article 20, paragraph 8 is replaced by the following:
v členu 20 se odstavek 8 nadomesti z naslednjim:
Where the procedure is initiated as a result of the evaluation of data relating to pharmacovigilance, the opinion of the Agency, in accordance with paragraph 2 of this Article, shall be adopted by the Committee for Medicinal Products for Human Use on the basis of a recommendation from the Pharmacovigilance Risk Assessment Committee and Article 107j(2) of Directive 2001/83/EC shall apply.’;
Kadar se postopek začne zaradi ocene podatkov v zvezi s farmakovigilanco, Odbor za zdravila za uporabo v humani medicini v skladu z odstavkom 2 tega člena sprejme mnenje Agencije na podlagi priporočila Odbora za ocenjevanje tveganja na področju farmakovigilance in uporabi se člen 107j(2) Direktive 2001/83/ES.“;
The Agency shall, in collaboration with the Member States, set up, maintain and make public a list of medicinal products that are subject to additional monitoring.
Agencija v sodelovanju z državami članicami sestavi, posodablja in objavi seznam zdravil, ki so pod dodatnim nadzorom.
That list shall include the names and active substances of:
Navedeni seznam vsebuje imena in zdravilne učinkovine:
any biological medicinal product not covered by point (a) that was authorised after 1 January 2011;
katerega koli biološkega zdravila, ki ni zajeto v točki (a) in je bilo odobreno po 1. januarju 2011;
medicinal products that are authorised pursuant to this Regulation, subject to the conditions referred to in point (cb) of Article 9(4), point (a) of the first subparagraph of Article 10a(1) or Article 14(7) or (8);
zdravil, ki so odobrena v skladu s to uredbo in za katera veljajo pogoji iz točke (cb) člena 9(4), točke (a) prvega pododstavka člena 10a(1) ali člena 14(7) ali (8);
medicinal products that are authorised pursuant to Directive 2001/83/EC, subject to the conditions referred to in points (b) and (c) of the first paragraph of Article 21a, Article 22, or point (a) of the first subparagraph of Article 22a(1) thereof.
zdravil, odobrenih v skladu z Direktivo 2001/83/ES in za katera veljajo pogoji iz točk (b) in (c) prvega odstavka člena 21a, člena 22 ali točke (a) prvega pododstavka člena 22a(1) navedene direktive.
At the request of the Commission, following consultation with the Pharmacovigilance Risk Assessment Committee, medicinal products that are authorised pursuant to this Regulation, subject to the conditions referred to in points (c), (ca) or (cc) of Article 9(4), point (b) of the first subparagraph of Article 10a(1) or Article 21(2), may also be included in the list referred to in paragraph 1 of this Article.
Na zahtevo Komisije in po posvetu z Odborom za ocenjevanje tveganja na področju farmakovigilance se lahko pod pogoji iz točk (c), (ca) ali (cc) člena 9(4), točke (b) prvega pododstavka člena 10a(1) ali člena 21(2) na seznam iz odstavka 1 tega člena uvrstijo tudi zdravila, ki so odobrena v skladu s to uredbo.