natgillin/translations-raw huggingface dataset:
in Article 66(g), the words ‘Article 67’ are replaced by the words ‘Article 68’;
v členu 66(g) se besedi „člen 67“ nadomestita z besedama „člen 68“;
Article 67 is amended as follows:
člen 67 se spremeni:
in paragraph 3, the first subparagraph is replaced by the following:
prvi pododstavek odstavka 3 se nadomesti z naslednjim:
‘The Agency’s revenue shall consist of a contribution from the Union and fees paid by undertakings for obtaining and maintaining Union marketing authorisations and for other services provided by the Agency, or by the coordination group as regards the fulfilment of its tasks in accordance with Articles 107c, 107e, 107g, 107k and 107q of Directive 2001/83/EC.’;
„Prihodki Agencije so sestavljeni iz prispevka Unije in pristojbin, ki jih plačajo podjetja za pridobitev in vzdrževanje dovoljenj za promet Unije ter za druge storitve, ki jih zagotavlja Agencija ali skupina za usklajevanje v zvezi z izpolnjevanjem nalog v skladu s členi 107c, 107e, 107g, 107k in 107q Direktive 2001/83/ES.“;
Activities relating to pharmacovigilance, to the operation of communications networks and to market surveillance shall be under the permanent control of the Management Board in order to guarantee the independence of the Agency.
Dejavnosti v zvezi s farmakovigilanco, delovanjem komunikacijskega omrežja in nadzorom trga so pod stalnim nadzorom uprave, da se zagotovi neodvisnost Agencije.
This shall not preclude the Agency from charging fees to marketing authorisation holders for performing these activities by the Agency on the condition that its independence is strictly guaranteed.’;
To ne izključuje zaračunavanja pristojbin imetnikom dovoljenj za promet za dejavnosti, ki jih izvaja Agencija pod pogojem, da ji je zagotovljena popolna neodvisnost.“;
Article 82(3) is replaced by the following:
člen 82(3) se nadomesti z naslednjim:
Without prejudice to the unique, Union nature of the content of the documents referred to in points (a) to (d) of Article 9(4) and in points (a) to (e) of Article 34(4), this Regulation shall not prohibit the use of two or more commercial designs for a given medicinal product for human use covered by a single marketing authorisation.’;
Brez poseganja v edinstveno naravo vsebine dokumentov Unije iz točk od (a) do (d) člena 9(4) in točk od (a) do (e) člena 34(4), ta uredba ne prepoveduje uporabe dveh ali več trgovskih imen za dano zdravilo za humano uporabo, zajeto v enem samem dovoljenju za promet.“;
in Article 83(6), the second sentence is replaced by the following:
drugi stavek člena 83(6) se nadomesti z naslednjim:
‘Article 28(1) and (2) shall apply mutatis mutandis.’;
„Smiselno se uporabi člen 28(1) in (2).“;
‘Article 87a
„Člen 87a
In order to harmonise the performance of the pharmacovigilance activities provided for in this Regulation, the Commission shall adopt implementing measures as provided for in Article 108 of Directive 2001/83/EC covering the following areas:
Za uskladitev izvajanja dejavnosti na področju farmakovigilance iz te uredbe Komisija sprejme izvedbene ukrepe, kot je določeno v členu 108 Direktive 2001/83/ES, na naslednjih področjih:
the content and maintenance of the pharmacovigilance system master file kept by the marketing authorisation holder;
vsebina in vzdrževanje glavnega dosjeja o sistemu farmakovigilance, ki ga opravlja imetnik dovoljenja za promet;
the minimum requirements for the quality system for the performance of pharmacovigilance activities by the Agency;
minimalne zahteve za sistem kakovosti za dejavnosti, ki jih izvaja Agencija na področju farmakovigilance;
the use of internationally agreed terminology, formats and standards for the performance of pharmacovigilance activities;
uporaba mednarodno dogovorjenih terminologij, oblik in standardov za izvajanje dejavnosti farmakovigilance;
the minimum requirements for the monitoring of data included in the Eudravigilance database to determine whether there are new risks or whether risks have changed;
minimalne zahteve za spremljanje podatkov v podatkovni bazi Eudravigilance, da se ugotovi, ali je prišlo do novih ali spremenjenih tveganj;
the format and content of electronic transmission of suspected adverse reactions by Member States and marketing authorisation holders;
oblika in vsebina elektronskega prenosa obvestil o domnevnih neželenih učinkih s strani držav članic in imetnikov dovoljenja za promet;
the format of protocols, abstracts and final study reports of the post-authorisation safety studies.
oblika protokolov, izvlečkov in zaključnih poročil za študije o varnosti zdravila po pridobitvi dovoljenja za promet.
Those measures shall take account of the work on international harmonisation carried out in the area of pharmacovigilance and shall, where necessary, be revised to take account of technical and scientific progress.
Navedeni ukrepi upoštevajo mednarodno usklajevalno delo, opravljeno na področju farmakovigilance in se po potrebi spremenijo, da se upošteva tehnični in znanstveni napredek.
Those measures shall be adopted in accordance with the regulatory procedure referred to in Article 87(2).
Sprejmejo se v skladu z regulativnim postopkom iz člena 87(2).
Article 87b
Člen 87b
The delegation of powers shall be automatically extended for periods of an identical duration, unless the European Parliament or the Council revokes it in accordance with Article 87c.
Prenos pooblastila se samodejno podaljša za enako dolgo obdobje, razen če Evropski parlament ali Svet pooblastilo prekliče v skladu s členom 87c.
The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in Articles 87c and 87d.
Pooblastilo za sprejetje delegiranih aktov je prenešeno na Komisijo pod pogoji, določenimi v členih 87c in 87d.
Article 87c
Člen 87c
The delegation of powers referred to in Article 10b may be revoked at any time by the European Parliament or by the Council.
Pooblastilo iz člena 10b lahko kadar koli prekliče Evropski parlament ali Svet.
At the initiative of the European Parliament or the Council that period shall be extended by 2 months.
Odločitev se objavi v Uradnem listu Evropske unije. Člen 87d
If, on expiry of the period referred to in paragraph 1, neither the European Parliament nor the Council has objected to the delegated act, it shall be published in the Official Journal of the European Union and shall enter into force on the date stated therein.
1. Evropski parlament ali Svet lahko nasprotuje delegiranemu aktu v dveh mesecih od datuma uradnega obvestila. Na pobudo Evropskega parlamenta ali Sveta se navedeni rok podaljša za dva meseca.
The delegated act may be published in the Official Journal of the European Union and enter into force before the expiry of that period if the European Parliament and the Council have both informed the Commission of their intention not to raise objections.
Če do izteka navedenega roka niti Evropski parlament niti Svet ne nasprotujeta delegiranemu aktu, se akt objavi v Uradnem listu Evropske unije in začne veljati na dan, ki je v njem določen. Delegirani akt se lahko objavi v Uradnem listu Evropske unije in začne veljati pred iztekom navedenega roka, če sta Evropski parlament in Svet obvestila Komisijo o nameri, da delegiranemu aktu ne bosta nasprotovala.
The institution which objects shall state the reasons for objecting to the delegated act.’.
Institucija, ki nasprotuje, navede razloge za nasprotovanje delegiranemu aktu.“.
Amendments to Regulation (EC) No 1394/2007
Spremembe Uredbe (ES) št. 1394/2007
Article 20(3) of Regulation (EC) No 1394/2007 is replaced by the following:
Člen 20(3) Uredbe (ES) št. 1394/2007 se nadomesti z naslednjim:
The Executive Director of the Agency shall ensure appropriate coordination between the Committee for Advanced Therapies and the other Committees of the Agency, in particular the Committee for Medicinal Products for Human Use, the Pharmacovigilance Risk Assessment Committee and the Committee for Orphan Medicinal Products, their working parties and any other scientific advisory groups.’.
Izvršni direktor Agencije zagotovi ustrezno sodelovanje med Odborom za napredno zdravljenje in drugimi odbori Agencije, zlasti Odborom za zdravila za uporabo v humani medicini, Odborom za ocenjevanje tveganja na področju farmakovigilance, Odborom za zdravila sirote, njihovimi delovnimi telesi in drugimi znanstvenimi svetovalnimi skupinami.“.
The obligation on the part of the marketing authorisation holder to maintain and make available on request a pharmacovigilance system master file in respect of one or more medicinal products for human use provided for in Article 104(3)(b) of Directive 2001/83/EC as amended by Directive 2010/84/EU, which applies to medicinal products for human use authorised pursuant to Regulation (EC) No 726/2004 by virtue of Article 21 of Regulation (EC) No 726/2004 as amended by this Regulation, shall apply to marketing authorisations granted before 2 July 2012 as from either:
Obveznost imetnika dovoljenja za promet, da vodi in na zahtevo da na voljo glavni dosje o sistemu farmakovigilance za eno ali več zdravil za uporabo v humani medicini, določenih v točki (b) člena 104(3) Direktive 2001/83/ES, kakor je bila spremenjena z Direktivo 2010/84/EU, ki se uporablja za zdravila za uporabo v humani medicini, že odobrena v skladu z Uredbo (ES) št. 726/2004 na podlagi člena 21 navedene uredbe, kakor je bila spremenjena s to uredbo, se uporablja za dovoljenja za promet, izdana pred 2. julijem 2012 ali od
the date on which those marketing authorisations are renewed; or
datuma, ko so bila ta dovoljenja za promet podaljšana; ali
the expiry of a period of 3 years starting from 2 July 2012,
od izteka treh let od 2. julija 2012,
whichever is the earlier.
pri čemer se upošteva zgodnejši datum.
The procedure provided for in Articles 107m to 107q of Directive 2001/83/EC as amended by Directive 2010/84/EU, which apply by virtue of Article 28b of Regulation (EC) No 726/2004 as amended by this Regulation, shall apply only to studies which have commenced after 2 July 2012.
Postopek iz člena od 107m do 107q Direktive 2001/83/ES, kakor je bila spremenjena z Direktivo 2010/84/EU, ki se uporablja na podlagi člena 28b Uredbe (ES) št. 726/2004, kakor je bila spremenjena s to uredbo, se uporablja le za študije, ki so se začele po 2. juliju 2012.
The obligation of the Agency under the second subparagraph of Article 28c(1) of Regulation (EC) No 726/2004 as amended by this Regulation shall apply once the full functionality of Eudravigilance has been announced by the Management Board.
Obveznost Agencije iz drugega pododstavka člena 28c(1) Uredbe (ES) št. 726/2004, kakor je bila spremenjena s to uredbo, velja, ko uprava razglasi polno delovanje Eudravigilance.
It shall apply from 2 July 2012.
Uporablja se od 2. julija 2012.
OJ C 306, 16.12.2009, p. 22.
UL C 306, 16.12.2009, str. 22.
Position of the European Parliament of 22 September 2010 (not yet published in the Official Journal) and Council Decision of 29 November 2010.
Stališče Evropskega parlamenta z dne 22. septembra 2010 (še ni objavljeno v Uradnem listu) in Sklep Sveta z dne 29. novembra 2010.
See page 74 of this Official Journal.
Glej stran 74 tega uradnega lista.
The power to adopt the delegated acts referred to in Article 10b shall be conferred on the Commission for a period of 5 years from 1 January 2011.
Pooblastilo za sprejemanje delegiranih aktov iz člena 10b se prenese na Komisijo za obdobje 5 let z začetkom 1. januarja 2011.
The Commission shall draw up a report in respect of the delegated powers not later than 6 months before the end of the 5 year period.
Komisija pripravi poročilo o pooblastilu najpozneje 6 mesecev pred koncem petletnega obdobja.
For medicinal products included in that list, 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 povzetek glavnih značilnosti zdravila in navodilo za uporabo vsebuje izjavo: ‚Za to zdravilo se izvaja dodatno spremljanje.‘.
That statement shall be preceded by a black symbol which shall be selected by the Commission following a recommendation of the Pharmacovigilance Risk Assessment Committee by 2 January 2012, and shall be followed by an appropriate standardised explanatory sentence.
Pred navedeno izjavo mora biti črn simbol, ki ga izbere Komisija po priporočilu Odbora za ocenjevanje tveganja na področju farmakovigilance do 2. januarja 2012, za njo pa mora biti ustrezna standardna obrazložitev.
The decision of revocation shall put an end to the delegation of the powers specified in that decision. It shall take effect immediately or at a later date specified therein.
Z odločitvijo o preklicu pooblastil prenehajo veljati pooblastila, navedena v tej odločitvi.
It shall not affect the validity of the delegated acts already in force. It shall be published in the Official Journal of the European Union.
Odločitev začne veljati nemudoma ali na dan, ki je v njej določen.
Article 87d 1. The European Parliament or the Council may object to a delegated act within a period of 2 months from the date of notification.
Odločitev ne vpliva na veljavnost že veljavnih delegiranih aktov.
Corrigendum to Regulation (EU) No 1235/2010 of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance of medicinal products for human use, Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, and Regulation (EC) No 1394/2007 on advanced therapy medicinal products
Popravek Uredbe (EU) št. 1235/2010 Evropskega parlamenta in Sveta z dne 15. decembra 2010 o spremembah Uredbe (ES) št. 726/2004 o postopkih Skupnosti za pridobitev dovoljenja za promet in nadzor zdravil za humano in veterinarsko uporabo ter o ustanovitvi Evropske agencije za zdravila in Uredbe (ES) št. 1394/2007 o zdravilih za napredno zdravljenje, glede farmakovigilance zdravil za uporabo v humani medicini
On page 6, Article 1(7):
Stran 6, člen 1(7):
The marketing authorisation holder shall submit the copy at the latest 7 days after receipt of the request.”;’,
Imetnik dovoljenja za promet predloži izvod najpozneje v sedmih dneh po prejemu zahteve.‘;“
In Article 16, paragraphs 1, 2 and 3 are replaced by the following:
v členu 16 se odstavki 1, 2 in 3 nadomestijo z naslednjim:
The marketing authorisation holder shall submit the copy at the latest seven days after receipt of the request.”;’.
Imetnik dovoljenja za promet predloži izvod najpozneje v sedmih dneh po prejemu zahteve.‘;“
Regulation (EU) No 1236/2010 of the European Parliament and of the Council
Uredba (EU) št. 1236/2010 Evropskega parlamenta in Sveta
laying down a scheme of control and enforcement applicable in the area covered by the Convention on future multilateral cooperation in the North-East Atlantic fisheries and repealing Council Regulation (EC) No 2791/1999
o sistemu nadzora in izvrševanja, ki se uporablja na območju Konvencije o prihodnjem večstranskem sodelovanju v ribištvu severovzhodnega Atlantika in razveljavitvi Uredbe Sveta (ES) št. 2791/1999
Having regard to the Treaty on the Functioning of the European Union, and in particular Article 43(2) thereof,
ob upoštevanju Pogodbe o delovanju Evropske unije, zlasti člena 43(2) Pogodbe,
The Convention on future multilateral cooperation in the North-East Atlantic fisheries (the Convention), was approved by the Council in Decision 81/608/EEC [3] and entered into force on 17 March 1982.
Svet je s Sklepom 81/608/EGS [3] odobril Konvencijo o prihodnjem večstranskem sodelovanju v ribištvu severovzhodnega Atlantika (v nadaljnjem besedilu: „Konvencija“), ki je začela veljati 17. marca 1982.
The Convention provides for an appropriate framework for multilateral cooperation on the rational conservation and management of fishery resources in the Area defined by the Convention (the Convention Area).
S Konvencijo je določen ustrezen okvir za večstransko sodelovanje na področju smotrnega ohranjanja in upravljanja ribolovnih virov na območju, opredeljenem z navedeno konvencijo (v nadaljnjem besedilu: „območje Konvencije“).
The North-East Atlantic Fisheries Commission (NEAFC), at its Annual Meeting on 15 November 2006, adopted a recommendation establishing a scheme of control and enforcement (the Scheme) applicable to fishing vessels operating in the waters of the Convention Area which lie beyond the waters under the fisheries jurisdiction of the Contracting Parties (the Regulatory Area).
Komisija za ribištvo severovzhodnega Atlantika („NEAFC“) je na letnem zasedanju dne 15. novembra 2006 sprejela priporočilo, v katerem je določen sistem nadzora in izvrševanja (v nadaljnjem besedilu: „sistem“), ki se uporablja za ribiška plovila, ki opravljajo dejavnost na vodah območja Konvencije, ki ležijo izven voda ribolovne sodne pristojnosti pogodbenic (v nadaljnjem besedilu: „upravno območje“).
The Scheme, which came into force on 1 May 2007, was amended by several recommendations at the Annual Meetings in November 2007, 2008 and 2009.
Sistem, ki je začel veljati 1. maja 2007, se je večkrat spremenil s priporočili iz letnih zasedanj novembra leta 2007, 2008 in 2009.
Under Articles 12 and 15 of the Convention, these recommendations came into force on 9 February 2008, 6 and 8 January 2009, and 6 February 2010 respectively.
V skladu s členoma 12 in 15 Konvencije so ta priporočila začela veljati 9. februarja 2008, 6. in 8. januarja 2009, oziroma 6. februarja 2010.
The Scheme provides for control and enforcement measures applicable to vessels flying the flag of Contracting Parties and operating in the Regulatory Area, and arrangements for inspection at sea which include inspection and surveillance procedures and infringement procedures which must be implemented by the Contracting Parties.
Sistem predvideva ukrepe nadzora in izvrševanja za plovila, ki plujejo pod zastavo pogodbenic in opravljajo dejavnost na upravnem območju, ter inšpekcijske ukrepe na morju, ki vključujejo postopke inšpekcijskega pregleda in nadzora ter postopke za ugotavljanje kršitev, ki jih morajo izvajati pogodbenice.
The Scheme provides for a new Port State Control system which will effectively close European ports to landings and transhipments of frozen fish which have not been verified to be legal by the flag state of fishing vessels flying the flag of a Contracting Party other than the port state.
Sistem določa nov sistem pomorskega državnega nadzora, ki bo v evropskih pristaniščih dejansko preprečeval iztovarjanje in pretovarjanje zamrznjenih rib, če država zastave ribiških plovil, ki plujejo pod zastavo pogodbenice, ki ni država pristanišča, ni preverila njihove zakonitosti.
Certain control provisions adopted by NEAFC have been incorporated into Union law by way of the yearly TAC and quotas Regulation, and most recently by Council Regulation (EC) No 43/2009 of 16 January 2009 fixing for 2009 the fishing opportunities and associated conditions for certain fish stocks and groups of fish stocks, applicable in Community waters and, for Community vessels, in waters where catch limitations are required [4].
Nekatere določbe o nadzoru, ki jih je sprejela NEAFC, so bile v pravo Unije prenesene z Uredbo o letnem celotnem dovoljenem ulovu (TAC) in kvotah ter nazadnje z Uredbo Sveta (ES) št. 43/2009 z dne 16. januarja 2009 o določitvi ribolovnih možnosti za leto 2009 in s tem povezanih pogojev za nekatere staleže rib in skupine staležev rib, ki se uporabljajo v vodah Skupnosti, in za plovila Skupnosti v vodah, kjer so potrebne omejitve ulova [4].
For the sake of legal certainty, such provisions which are not of a temporary nature should be the subject of a new separate regulation.
Zaradi pravne varnosti bi morale biti te določbe, ki niso začasne narave, vsebinsko zajete z novo, ločeno uredbo.
The Scheme also comprises provisions to promote compliance by vessels flying the flag of a non-Contracting Party with the control and enforcement measures in order to ensure full respect of conservation and management measures adopted by NEAFC.
Sistem vključuje tudi določbe za spodbujanje usklajenega ravnanja plovil, ki plujejo pod zastavo države, ki ni pogodbenica, z ukrepi nadzora in izvrševanja, da bi se zagotovilo popolno spoštovanje ukrepov za ohranjanje in upravljanje, ki jih je sprejela NEAFC.
NEAFC recommended removing a number of vessels from the list of vessels that have been confirmed to have engaged in illegal, unreported and unregulated fisheries.
NEAFC je priporočila umik več plovil s seznama plovil, za katera je bilo potrjeno, da se ukvarjajo z nezakonitim, neprijavljenim in ne-reguliranim ribolovom.
The incorporation of those recommendations into Union law should be ensured.
Ta priporočila bi morala biti vključena v pravni red Unije.
Article 5(2) of Council Regulation (EC) No 1224/2009 of 20 November 2009 establishing a Community control system for ensuring compliance with the rules of the common fisheries policy [5] provides that Member States shall control access to waters and resources and control activities outside EU waters carried out by vessels flying their flag.
Člen 5(2) Uredbe Sveta (ES) št. 1224/2009 z dne 20. novembra 2009 o vzpostavitvi nadzornega sistema Skupnosti za zagotavljanje skladnosti s pravili skupne ribiške politike [5] določa, da države članice nadzirajo dostop do voda in virov ter dejavnosti nadzora izven voda EU, ki jih izvajajo ribiška plovila, ki plujejo pod njihovo zastavo.
Provision should therefore be made for Member States whose vessels are authorised to fish in the Regulatory Area to assign inspectors to the Scheme to undertake monitoring and surveillance as well as adequate resources for inspection.
Zato je treba določiti, da države članice, katerih plovila so pooblaščena za ribolov na upravnem območju, sistemu dodelijo tako inšpektorje za opravljanje spremljanja in nadzora kot tudi ustrezna sredstva za inšpekcijski pregled.
In order to ensure the monitoring of fishing activities in the Convention Area, it is necessary for Member States to cooperate with one another and with the Commission and the body designated by it in applying the Scheme.
Da bi zagotovili spremljanje ribolovnih dejavnosti na območju Konvencije je za izvajanje sistema potrebno sodelovanje držav članic, Komisije in organa, ki ga imenuje Komisija.
It is the responsibility of Member States to ensure that their inspectors comply with the inspection procedures laid down by NEAFC.
Zagotovitev, da inšpektorji upoštevajo inšpekcijske postopke, ki jih je določila NEAFC, sodi v odgovornost držav članic.
The Commission should be empowered to adopt delegated acts in accordance with Article 290 of the Treaty on the Functioning of the European Union (TFEU) in respect of detailed rules concerning lists of the fishery resources to be notified, procedures for prior notification of entry into port and for the cancellation thereof as well as authorisation to land or tranship.
Komisijo bi bilo treba pooblastiti, da v skladu s členom 290 Pogodbe o delovanju Evropske unije (PDEU) sprejme delegirane akte v zvezi s podrobnimi pravili glede seznamov ribolovnih virov, ki bodo predmet uradnega obvestila, v zvezi s postopki predhodnega uradnega obveščanja in preklica predhodnega uradnega obvestila o prihodu v pristanišče ter v zvezi z dovoljenjem za iztovarjanje ali pretovarjanje.
The Commission should also be empowered to adopt delegated acts in respect of the incorporation into Union law of future amendments of those measures of the Scheme which form the subject matter of certain expressly defined non-essential elements of this Regulation and which become binding upon the Union in accordance with the terms of the Convention.
Komisijo bi bilo treba tudi pooblastiti za sprejetje delegiranih aktov v zvezi z vključitvijo v pravo Unije prihodnjih sprememb tistih ukrepov sistema, ki so predmet nekaterih izrecno opredeljenih nebistvenih elementov te uredbe in ki postanejo zavezujoče za Unijo v skladu z izrazi iz Konvencije.
It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level.
Zlasti je pomembno, da Komisija med pripravljalnim delom opravi ustrezna posvetovanja, vključno s posvetovanji na ravni strokovnjakov.