natgillin/translations-raw huggingface dataset:
At the request of a national competent authority, following consultation with the Pharmacovigilance Risk Assessment Committee, medicinal products that are authorised pursuant to Directive 2001/83/EC, subject to the conditions referred to in points (a), (d), (e) or (f) of the first paragraph of Article 21a, point (b) of the first subparagraph of Article 22a(1) or Article 104a(2) thereof, may also be included in the list referred to in paragraph 1 of this Article.
Na zahtevo pristojnega nacionalnega organa in po posvetovanju z Odborom za ocenjevanje tveganja na področju farmakovigilance se lahko pod pogoji iz točk (a), (d), (e) ali (f) prvega odstavka člena 21a, točke (b) prvega pododstavka člena 22a(1) ali člena 104a(2) Direktive 2001/83/ES na seznam iz odstavka 1 tega člena uvrstijo tudi zdravila, ki so odobrena v skladu z navedeno direktivo.
The list referred to in paragraph 1 shall include an electronic link to the product information and to the summary of the risk management plan.
Seznam iz odstavka 1 vsebuje elektronsko povezavo do podatkov o zdravilu in povzetka načrta za obvladovanje tveganj.
In the cases referred to in points (a) and (b) of paragraph 1 of this Article, the Agency shall remove a medicinal product from the list five years after the Union reference date referred to in Article 107c(5) of Directive 2001/83/EC.
V primerih iz točk (a) in (b) odstavka 1 tega člena Agencija umakne zdravilo s seznama pet let po referenčnem datumu Unije iz člena 107c(5) Direktive 2001/83/ES.
In the cases referred to in points (c) and (d) of paragraph 1 and in paragraph 1a of this Article, the Agency shall remove a medicinal product from the list once the conditions have been fulfilled.
V primerih iz točk (c) in (d) odstavka 1 ter iz odstavka 1a tega člena Agencija umakne zdravilo s seznama, ko so izpolnjeni pogoji.
For medicinal products included in the list referred to in paragraph 1, the summary of product characteristics and the package leaflet shall include the statement "This medicinal product is subject to additional monitoring".
Za zdravila s seznama iz odstavka 1 se v povzetek glavnih značilnosti zdravila in navodilo za uporabo vključi izjava ‚To zdravilo je pod dodatnim nadzorom‘.
That statement shall be preceded by a black symbol which shall be selected by the Commission by 2 July 2013, following a recommendation of the Pharmacovigilance Risk Assessment Committee, and shall be followed by an appropriate standardised explanatory sentence.
Pred navedeno izjavo je črn simbol, ki ga Komisija po priporočilu Odbora za ocenjevanje tveganja na področju farmakovigilance izbere do 2. julija 2013, za njo pa ustrezna standardna obrazložitev.
By 5 June 2018, the Commission shall present to the European Parliament and the Council a report on the use of the list referred to in paragraph 1 based on the experience and data provided by the Member States and the Agency.
Komisija do 5. junija 2018 Evropskemu parlamentu in Svetu predstavi poročilo o uporabi seznama iz odstavka 1 na podlagi izkušenj in podatkov, ki jih zagotovijo države članice in Agencija.
The Commission shall, if appropriate, on the basis of that report, and after consultation with the Member States and other appropriate stakeholders, present a proposal in order to adjust the provisions relating to the list referred to in paragraph 1.’;
Komisija po potrebi na podlagi navedenega poročila ter po posvetu z državami članicami in drugimi ustreznimi interesnimi stranmi predstavi predlog, z namenom da se prilagodijo določbe v zvezi s seznamom iz odstavka 1.“;
in the second subparagraph of paragraph 1, points (c) and (d) are replaced by the following:
v drugem pododstavku odstavka 1 se točki (c) in (d) nadomestita z naslednjim:
coordinating the monitoring of medicinal products which have been authorised within the Union and providing advice on the measures necessary to ensure the safe and effective use of those medicinal products, in particular by coordinating the evaluation and implementation of pharmacovigilance obligations and systems and the monitoring of such implementation;
usklajevanje spremljanja zdravil, odobrenih v Uniji, in svetovanje o ukrepih, potrebnih za zagotovitev varne in učinkovite uporabe teh zdravil, zlasti z usklajevanjem vrednotenja in izvajanja obveznosti in sistemov s področja farmakovigilance ter spremljanjem tega izvajanja;
ensuring the collation and dissemination of information on suspected adverse reactions to medicinal products authorised in the Union by means of a database which is permanently accessible to all Member States;’;
zagotavljanje zbiranja in razširjanja informacij o domnevnih neželenih učinkih zdravil, odobrenih v Uniji, s podatkovno bazo, ki je stalno dostopna vsem državam članicam;“;
in the second subparagraph of paragraph 2, point (b) is replaced by the following:
v drugem pododstavku odstavka 2 se točka (b) nadomesti z naslednjim:
marketing authorisation holders shall, by 2 July 2012 at the latest, electronically submit to the Agency information on all medicinal products for human use authorised in the Union, using the format referred to in point (a);’.
imetniki dovoljenj za promet najpozneje do 2. julija 2012 Agenciji v elektronski obliki pošljejo informacije o vseh zdravilih za uporabo v humani medicini, odobrenih v Uniji, pri čemer uporabijo obliko iz točke (a);“.
It shall apply from 5 June 2013 with the exception of Article 23(4), points (c) and (d) of the second subparagraph of Article 57(1) and point (b) of the second subparagraph of Article 57(2) of Regulation (EC) No 726/2004, as amended by this Regulation, which shall apply from 4 December 2012.
Uporablja se od 5. junija 2013, z izjemo člena 23(4), točk (c) in (d) drugega pododstavka člena 57(1) in točke (b) drugega pododstavka člena 57(2) Uredbe (ES) št. 726/2004, kakor so bili spremenjeni s to uredbo, ki se uporabljajo od 4. decembra 2012.
OJ C 181, 21.6.2012, p. 202.
UL C 181, 21.6.2012, str. 202.
Regulation (EU) No 1028/2012 of the European Parliament and of the Council
Uredba (EU) št. 1028/2012 Evropskega parlamenta in Sveta
amending Council Regulation (EC) No 1234/2007 as regards the regime of the single payment scheme and support to vine-growers
o spremembi Uredbe Sveta (ES) št. 1234/2007 v zvezi z ureditvijo sheme enotnih plačil in podpore vinogradnikom
Having regard to the Treaty on the Functioning of the European Union, and in particular the first paragraph of Article 42 and Article 43(2) thereof,
ob upoštevanju Pogodbe o delovanju Evropske unije in zlasti prvega odstavka člena 42 ter člena 43(2) Pogodbe,
Article 103o of Council Regulation (EC) No 1234/2007 of 22 October 2007 establishing a common organisation of agricultural markets and on specific provisions for certain agricultural products (Single CMO Regulation) [4] provides for a possibility for Member States to grant decoupled aid under the single payment scheme to vine-growers.
Člen 103o Uredbe Sveta (ES) št. 1234/2007 z dne 22. oktobra 2007 o vzpostavitvi skupne ureditve kmetijskih trgov in o posebnih določbah za nekatere kmetijske proizvode (Uredba o enotni SUT) [4] državam članicam omogoča, da vinogradnikom odobrijo nevezano pomoč v okviru sheme enotnih plačil.
Several Member States have used this specific support measure.
Več držav članic je uporabilo ta posebni podporni ukrep.
However, the fact that Member States may modify transfers to the single payment scheme from the support programmes once a year and that support programmes have a five-year duration whilst payment entitlements giving rise to direct payments are granted for an indeterminate period of time has resulted in administrative and budgetary burdens.
Vendar pa je dejstvo, da lahko države članice enkrat letno spremenijo prenose sredstev iz podpornih programov v shemo enotnih plačil in da podporni programi trajajo pet let, medtem ko so pravice do plačil, ki omogočajo neposredna plačila, dodeljene za nedoločen čas, povzročilo upravna in proračunska bremena.
In order to simplify the management of this specific support measure and to ensure its consistency with the objectives of the rules for direct support schemes for farmers, it is appropriate to convert it into the possibility for Member States to definitively decrease the funds allocated to the support programmes in the wine sector and thereby increase the national ceilings for direct payments.
Da se poenostavi upravljanje tega posebnega podpornega ukrepa in zagotovi njegova skladnost s cilji pravil za sheme neposrednih podpor za kmete, je ustrezno, da se ukrep spremeni tako, da državam članicam omogoči, da nepreklicno zmanjšajo sredstva, dodeljena podpornim programom v vinskem sektorju, in s tem povečajo nacionalne zgornje meje za neposredna plačila.
It is appropriate to allow Member States to continue applying the support provided for in Article 103o of Regulation (EC) No 1234/2007 for 2014.
Ustrezno je, da se državam članicam omogoči nadaljnja uporaba podpore, določene v členu 103o Uredbe (ES) št. 1234/2007, za leto 2014.
in Article 103n, the following paragraph is inserted:
v člen 103n se vstavi naslednji odstavek:
By 1 August 2013, Member States may decide to reduce, from 2015, the amount available for the support programmes referred to in Annex Xb, in order to increase their national ceilings for direct payments referred to in Article 40 of Regulation (EC) No 73/2009.
Države članice se lahko do 1. avgusta 2013 odločijo, da od leta 2015 znižajo znesek, ki je na voljo za podporne programe iz Priloge Xb, da bi povečale svoje nacionalne zgornje meje za neposredna plačila iz člena 40 Uredbe (ES) št. 73/2009.
The amount resulting from the decrease referred to in the first subparagraph shall definitively remain in the national ceilings for direct payments referred to in Article 40 of Regulation (EC) No 73/2009 and shall no longer be available for the measures listed in Articles 103p to 103y.’;
Znesek, ki izhaja iz znižanja iz prvega pododstavka, nepreklicno ostane znotraj nacionalnih zgornjih mej za neposredna plačila iz člena 40 Uredbe (ES) št. 73/2009 in ni več na razpolago za ukrepe iz členov 103p do 103y.“
Article 103o is replaced by the following:
člen 103o se nadomesti z naslednjim:
‘Article 103o
„Člen 103o
Single payment scheme and support to vine-growers
Shema enotnih plačil in podpora za vinogradnike
Member States may decide, by 1 December 2012, to provide support to vine-growers for 2014 by allocating payment entitlements within the meaning of Chapter 1 of Title III of Regulation (EC) No 73/2009.
Države članice se lahko do 1. decembra 2012 odločijo zagotoviti podporo vinogradnikom za leto 2014, tako da jim dodelijo pravice do plačila v smislu poglavja 1 naslova III Uredbe (ES) št. 73/2009.
If the amount of the support referred to in the first subparagraph is greater than the amount of support that was provided for 2013, the Member State concerned shall use the difference to allocate payment entitlements within the meaning of Chapter 1 of Title III of Regulation (EC) No 73/2009 to vine-growers in accordance with point C of Annex IX to that Regulation.
Če je znesek podpore, navedene v prvem pododstavku, višji od zneska podpore, ki je bila predvidena za leto 2013, zadevna država članica to razliko porabi, da v skladu s točko C Priloge IX k Uredbi (ES) št. 73/2009 vinogradnikom dodeli pravice do plačila v smislu poglavja 1 naslova III navedene uredbe.
Member States intending to provide support referred to in paragraph 1 shall make provision for such support in their support programmes in accordance with Article 103k(3).
Države članice, ki nameravajo zagotoviti podporo iz odstavka 1, tako podporo določijo v svojih podpornih programih v skladu s členom 103k(3).
The support for 2014 referred to in paragraph 1 shall:
Podpora za leto 2014, navedena v odstavku 1:
remain in the single payment scheme and no longer be available under Article 103k(3) for the measures listed in Articles 103p to 103y;
ostane znotraj sheme enotnih plačil in ni več na voljo na podlagi člena 103k(3) za ukrepe, navedene v členih 103p do 103y;
reduce proportionately the amount of funds available for measures listed in Articles 103p to 103y in the support programmes.’.
v podpornih programih sorazmerno zmanjša višino sredstev, ki so na voljo za ukrepe, navedene v členih 103p do 103y.“
OJ C 225, 27.7.2012, p. 174.
UL C 225, 27.7.2012, str. 174.
Regulation (EU) No 1029/2012 of the European Parliament and of the Council
Uredba (EU) št. 1029/2012 Evropskega parlamenta in Sveta
introducing emergency autonomous trade preferences for Pakistan
o uvedbi nujnih avtonomnih trgovinskih preferencialov za Pakistan
Respect for human rights, including core labour rights, and democratic principles are also an essential element of that Agreement.
Spoštovanje človekovih pravic, ki vključuje temeljne pravice delavcev, in demokratičnih načel je tudi bistveni element navedenega sporazuma.
In July and August 2010, following heavy monsoon rains, devastating floods affected extensive regions of Pakistan, notably the areas of Balochistan, Khyber Pakhtunkhwa, Punjab, Sindh and Gilgit-Baltistan.
Po močnem monsunskem deževju julija in avgusta 2010 so obsežna območja Pakistana, zlasti province Beludžistan, Kiber Paktunkva, Pandžab, Sind in Gilgit-Baltistan, prizadele uničujoče poplave.
According to United Nations sources, the flooding affected some 20 million people and 20 per cent of Pakistan's land, equivalent to at least 160000 square kilometres, and leaving up to 12 million people in need of urgent humanitarian aid.
Glede na vire Združenih narodov so prizadele približno 20 milijonov ljudi in 20 odstotkov ozemlja Pakistana, kar je vsaj 160000 kvadratnih kilometrov, zaradi česar je nujno človekoljubno pomoč potrebovalo do 12 milijonov ljudi.
Humanitarian aid is of course the primary instrument in this kind of situation and the Union has been at the forefront in this field since the beginning of the emergency, committing in excess of EUR 423 million in emergency aid to Pakistan.
Človekoljubna pomoč je v takih razmerah seveda primarni instrument, Unija pa je pri tem v ospredju že od začetka izrednih razmer, saj se je zavezala, da bo Pakistanu namenila več kot 423 milijonov EUR nujne pomoči.
It will be important to use all available means to support Pakistan's recovery from this emergency including the proposed exceptional trade measures to boost Pakistan's exports in order to contribute to its future economic development, while ensuring that consistency and coherence is maintained at all levels with a view to developing a sustainable long-term strategy.
Pomembno bo uporabiti vsa razpoložljiva sredstva ter po teh izrednih razmerah podpreti obnovo Pakistana, vključno s predlaganimi izrednimi trgovinskimi ukrepi za pospešitev izvoza Pakistana, da bi prispevali k njegovemu prihodnjemu gospodarskemu razvoju ter obenem zagotovili ohranitev doslednosti in skladnosti na vseh ravneh z namenom oblikovati trajnostno dolgoročno strategijo.
The severity of this natural disaster demands an immediate and substantial response, which would take into account the geostrategic importance of Pakistan's partnership with the Union, mainly through Pakistan's key role in the fight against terrorism, while contributing to the overall development, security and stability of the region.
Resnost te naravne nesreče zahteva takojšen in obsežen odziv, ki bi upošteval geostrateški pomen partnerstva Pakistana z Unijo, zlasti s ključno vlogo, ki jo ima Pakistan v boju proti terorizmu, hkrati pa prispeval k splošnemu razvoju, varnosti in stabilnosti regije.
The effects of the autonomous trade preferences should be able to be measured concretely in terms of job creation, poverty eradication and the sustainable development of Pakistan's working population and poor.
Učinki avtonomnih trgovinskih preferencialov bi morali biti konkretno merljivi z rezultati na področjih ustvarjanja novih delovnih mest, izkoreninjenja revščine in trajnostnega razvoja delavskega in revnega prebivalstva Pakistana.
The European Council, in a Declaration on Pakistan attached to its Conclusions of 16 September 2010, resolved to mandate Ministers to agree urgently on a comprehensive package of short, medium and longer term measures which will help underpin Pakistan's recovery and future development, comprising inter alia ambitious trade measures essential for economic recovery and growth.
(7) Evropski svet je v izjavi o Pakistanu, priloženi njegovim sklepom z dne 16. septembra 2010, sklenil, da bo ministre pooblastil, da se nujno dogovorijo o celovitem svežnju kratko-, srednje- in dolgoročnih ukrepov za pomoč pri obnovi in prihodnjemu razvoju Pakistana, ki bodo med drugim vključevali ambiciozne trgovinske ukrepe, potrebne za gospodarsko obnovo in rast.
In particular, the European Council underlined its firm commitment to grant exclusively to Pakistan increased market access to the Union through the immediate and time limited reduction of duties on key imports from Pakistan.
(8) Evropski svet je zlasti poudaril svojo trdno zavezanost, da izključno Pakistanu odobri večji dostop do trga Unije prek takojšnjega in časovno omejenega zmanjšanja dajatev za ključne izdelke, ki se uvažajo iz Pakistana.
In the light of that Declaration, the Commission proposed a package identifying 75 tariff lines specific to Pakistan's core export sectors in those areas worst hit by the floods, asserting that an increase in Pakistani exports to the Union of EUR 100 million or more a year would provide real, substantial and worthwhile assistance to the region.
Na podlagi navedene izjave je Komisija podala predlog za sveženj, ki opredeljuje 75 tarifnih vrstic, ki se nanašajo posebej na ključne izvozne panoge Pakistana na območjih, ki so jih poplave najhuje prizadele, pri čemer je zagotovila, da bi povečanje izvoza Pakistana v Unijo za 100 milijonov EUR letno ali več pomenilo dejansko, obsežno in koristno pomoč tej regiji.
Those industries are struggling to adapt to a new global trading environment.
Navedene panoge si prizadevajo prilagoditi novemu globalnemu trgovinskemu okolju.
The textiles sector is of key importance to the Pakistani economy, accounting for 8,5 % of gross domestic product and employing 38 % of the labour force, about half of which is made up of women.
Tekstilni sektor je bistvenega pomena za gospodarstvo Pakistana, saj pomeni 8,5 % bruto domačega proizvoda in zaposluje 38 % delovne sile, od katere je polovica žensk.
Given the hardship being suffered by the Pakistani people due to the devastating floods, it is therefore appropriate to extend exceptional autonomous trade preferences to Pakistan by suspending for a limited period of time all tariffs for certain products of export interest to Pakistan.
Glede na težavne okoliščine, s katerimi se zaradi zelo hudih poplav soočajo prebivalci Pakistana, je primerno izredne avtonomne trgovinske preferenciale razširiti na Pakistan, tako da se za določen čas opustijo vse tarife za določene izdelke, ki jih Pakistan želi izvažati.
The provision of such trade preferences should only cause limited adverse effects on the domestic market of the Union and should not affect negatively least developed Members of the World Trade Organisation (WTO).
Zagotovitev takih trgovinskih preferencialov bi lahko povzročila samo omejene škodljive učinke na notranji trg Unije in ne bi smela prizadeti najmanj razvitih članic Svetovne trgovinske organizacije (STO).
Those measures are proposed as part of an exceptional package, in response to the specific situation in Pakistan.
Navedeni ukrepi so predlagani kot del izrednega svežnja, namenjenega reševanju specifičnega položaja v Pakistanu.
Under no circumstances should they constitute a precedent for the Union's trade policy with other countries.
V nobenem primeru ne bi smeli pomeniti precedensa za trgovinsko politiko Unije do drugih držav.
The autonomous trade preferences will be either in the form of an exemption from customs duties upon import in the Union or in the form of tariff-rate quotas.
Avtonomni trgovinski preferenciali bodo bodisi v obliki oprostitev carin ob uvozu v Unijo bodisi v obliki tarifnih kvot.
Entitlement to benefit from the exceptional autonomous trade preferences is conditional on Pakistan's compliance with the relevant rules of origin of products and the procedures related thereto as well as involvement in effective administrative cooperation with the Union in order to prevent any risk of fraud.
Upravičenost do izkoriščanja izrednih avtonomnih trgovinskih preferencialov je odvisna od tega, ali Pakistan upošteva ustrezna pravila o poreklu izdelkov in z njimi povezane postopke ter ali je vključen v učinkovito upravno sodelovanje z Unijo zaradi preprečevanja tveganja goljufije.
Serious and systematic violations of the conditions for the entitlement to the preferential arrangement, fraud or failure to provide administrative cooperation for the verification of origin of goods should constitute reasons for a temporary suspension of the preferences.
Resne in sistematične kršitve pogojev za upravičenost do preferencialne ureditve, goljufija ali nezagotavljanje upravnega sodelovanja za preverjanje porekla blaga bi morali biti razlogi za začasno opustitev preferencialov.
For the purposes of defining the concept of originating products, certification of origin and administrative cooperation procedures, Part I, Title IV, Chapter 2, Section 1 and Section 1A of Commission Regulation (EEC) No 2454/93 of 2 July 1993 laying down provisions for the implementation of Council Regulation (EEC) No 2913/92 establishing the Community Customs Code [3], with the exception of Articles 68 to 71, 90 to 97i and 97j(2) of those Sections, should apply.
Za opredelitev pojma izdelki s poreklom, potrjevanje porekla in postopke upravnega sodelovanja bi bilo treba uporabljati oddelek 1 in oddelek 1A poglavja 2 naslova IV dela I Uredbe Komisije (EGS) št. 2454/93 z dne 2. julija 1993 o določbah za izvajanje Uredbe Sveta (EGS) št. 2913/92 o carinskem zakoniku Skupnosti [3], razen členov 68 do 71, 90 do 97i in 97j(2) teh oddelkov.
However, as regards cumulation of origin, only materials originating in the Union should be allowed to be used for such purposes.
Vendar bi bilo glede na kumulacijo porekla treba za tovrstne namene dovoliti samo uporabo materialov s poreklom iz Unije.
Regional cumulation and other types of cumulation except that with the materials originating in the Union should not apply in relation to the determination of the originating status of products covered by the autonomous trade preferences established pursuant to this Regulation in order to ensure that sufficient transformation takes place in Pakistan.
Regionalna kumulacija in druge vrste kumulacije, razen tiste z materiali s poreklom iz Unije, se ne bi smele uporabljati za določanje statusa porekla izdelkov, ki so zajeti v avtonomnih trgovinskih preferencialih v skladu s to uredbo, da se v Pakistanu zagotovijo zadostne pretvorbe.
Extending autonomous trade preferences to Pakistan requires a waiver from the obligations of the Union under Articles I and XIII of the General Agreement on Tariffs and Trade 1994 (GATT) pursuant to Article IX of the Agreement establishing the WTO.
Razširitev avtonomnih trgovinskih preferencialov na Pakistan zahteva odstopanje od obveznosti Unije na podlagi členov I in XIII Splošnega sporazuma o tarifah in trgovini iz leta 1994 (GATT) v skladu s členom IX Sporazuma o ustanovitvi STO.
The WTO General Council granted such a waiver on 14 February 2012.
Generalni svet STO je takšno odstopanje odobril 14. februarja 2012.
In order to ensure an immediate and sustainable impact on the economic recovery of Pakistan in the aftermath of the floods and in accordance with the WTO waiver, it is recommended to limit the duration of the autonomous trade preferences until 31 December 2013.
Da se zagotovi takojšen in trajnosten učinek na gospodarsko obnovo Pakistana po poplavah in v skladu z odstopanjem STO, se priporoča, da se trajanje avtonomnih trgovinskih preferencialov omeji do 31. decembra 2013.