natgillin/translations-raw huggingface dataset:
All variations in the group are consequential to a specific procedure or condition carried out pursuant to Articles 14(8) or 39(7) of Regulation (EC) No 726/2004, Article 22 of Directive 2001/83/EC or Article 26(3) of Directive 2001/82/EC.
Vse spremembe v skupini so posledica nekega postopka ali pogoja, ki se izvede v skladu s členom 14(8) ali členom 39(7) Uredbe (ES) št. 726/2004, členom 22 Direktive 2001/83/ES ali členom 26(3) Direktive 2001/82/ES.
Elements to be submitted
Elementi, ki jih je treba predložiti
A list of all the marketing authorisations affected by the notification or application.
Seznam vseh dovoljenj za promet z zdravili, na katera vpliva priglasitev ali vloga.
A description of all the variations submitted, including:
Opis vseh predloženih sprememb, med drugim:
in the case of minor variations of type IA, the date of implementation for each variation described;
pri manjših spremembah tipa IA datum začetka uveljavitve za vsako opisano spremembo;
in the case of minor variations of type IA which do not require immediate notification, a description of all minor variations of type IA made in the last 12 months to the terms of the concerned marketing authorisation(s) and which have not been already notified.
pri manjših spremembah tipa IA, ki jih ni treba takoj priglasiti, opis vseh manjših sprememb tipa IA, sprejetih v zadnjih 12 mesecih v zvezi s pogoji zadevnih dovoljenj za promet z zdravili, ki še niso bile priglašene.
All necessary documents as listed in the guidelines referred to in point (b) of Article 4(1).
Vsi potrebni dokumenti, kot so našteti v smernicah iz točke (b) člena 4(1).
Where a variation leads to or is the consequence of other variations to the terms of the same marketing authorisation, a description of the relation between these variations.
Če sprememba povzroči druge spremembe pogojev istega dovoljenja za promet z zdravilom ali je posledica takih sprememb, opis povezave med temi spremembami.
In the case of variations to centralised marketing authorisations, the relevant fee provided for in Council Regulation (EC) No 297/95 [1].6.
Pri spremembah centraliziranih dovoljenj za promet z zdravili ustrezno pristojbino iz Uredbe Sveta (ES) št. 297/95 [1].6.
In the case of variations to marketing authorisations granted by the competent authorities of Member States:
Pri spremembah dovoljenj za promet z zdravili, ki so jih izdali pristojni organi držav članic:
a list of those Member States with an indication of the reference Member State if applicable;
seznam teh držav članic z navedbo referenčne države članice, če je ustrezno;
the relevant fees provided for in the applicable national rules in the Member States concerned.
ustrezne pristojbine, predvidene v veljavnih nacionalnih predpisih vključenih držav članic.
Variations concerning a change to or addition of therapeutic indications.
Spremembe, ki se nanašajo na spremembo ali dodatek terapevtskih indikacij.
Variations concerning a change to or addition of a non-food producing target species.
Spremembe, ki se nanašajo na spremembo ali dodajanje ciljnih vrst, ki niso namenjene za prehrano ljudi.
Variations concerning the replacement or addition of a serotype, strain, antigen or combination of serotypes, strains or antigens for a veterinary vaccine against avian influenza, foot-and-mouth disease or bluetongue.
Spremembe, ki se nanašajo na nadomestitev z novim serotipom, sevom, antigenom ali sestavom serotipov, sevov ali antigenov za veterinarsko cepivo proti aviarni influenci ali influenci konj, slinavki in parkljevki ali bolezni modrikastega jezika.
Variations concerning the replacement of a strain for a veterinary vaccine against equine influenza.
Spremembe, ki se nanašajo na nadomestitev seva za veterinarsko cepivo proti influenci konj.
replacement or addition of a serotype, strain, antigen or combination of serotypes, strains or antigens for a veterinary vaccine against avian influenza, foot-and-mouth disease or bluetongue; replacement of a strain for a veterinary vaccine against equine influenza;
nadomestitve z novim serotipom, sevom, antigenom ali sestavom serotipov, sevov ali antigenov za veterinarsko cepivo proti aviarni influenci ali influenci konj, slinavki in parkljevki ali bolezni modrikastega jezika;
Commission Regulation (EC) No 1235/2008
Uredba Komisije (ES) št. 1235/2008
laying down detailed rules for implementation of Council Regulation (EC) No 834/2007 as regards the arrangements for imports of organic products from third countries
o določitvi podrobnih pravil za izvajanje Uredbe Sveta (ES) št. 834/2007 v zvezi z ureditvami za uvoz ekoloških proizvodov iz tretjih držav
Having regard to Council Regulation (EC) No 834/2007 of 28 June 2007 on organic production and labelling of organic products and repealing Regulation (EEC) No 2092/91 [1], and in particular Article 33(2), Article 38(d) and Article 40 thereof,
ob upoštevanju Uredbe Sveta (ES) št. 834/2007 z dne 28. junija 2007 o ekološki pridelavi in označevanju ekoloških proizvodov in razveljavitvi Uredbe (EGS) št. 2092/91 [1] ter zlasti člena 33(2), člena 38(d) in člena 40 Uredbe,
Articles 32 and 33 of Regulation (EC) No 834/2007 lay down general provisions for import of organic products.
Člena 32 in 33 Uredbe (ES) št. 834/2007 določata splošne določbe za uvoz ekoloških proizvodov.
With a view to guarantee that these provisions will be applied in a correct and uniform way, detailed rules and procedures for the application of those provisions should be laid down.
Za zagotovitev, da se bodo te določbe uporabljale na pravilen in enoten način, je treba določiti podrobna pravila in postopke za uporabo teh določb.
As substantial experience has been built up since 1992 with the import of products providing equivalent guarantees, a relatively short period should be given to control bodies and control authorities to request their inclusion in the list for the purpose of equivalence in accordance with Article 33 of Regulation (EC) No 834/2007.
Ker se je od leta 1992 nabralo veliko izkušenj v zvezi z uvozom proizvodov z enakovrednimi jamstvi, je treba izvajalcem nadzora in nadzornim organom dati na razpolago sorazmerno kratko obdobje, da zahtevajo njihovo vključitev na seznam za namen enakovrednosti v skladu s členom 33 Uredbe (ES) št. 834/2007.
However, as there is no experience with the direct application of Community rules on organic production and labelling of organic products outside the territory of the Community, more time should be given to control bodies and control authorities wishing to request their inclusion in the list for the purpose of compliance in accordance with Article 32 of Regulation (EC) No 834/2007.
Vendar je treba zaradi pomanjkanja izkušenj z neposredno uporabo pravil Skupnosti o ekološki pridelavi in označevanju ekoloških proizvodov zunaj ozemlja Skupnosti izvajalcem nadzora in nadzornim organom, ki želijo zahtevati svojo vključitev na seznam za namen izpolnjevanja zahtev v skladu s členom 32 Uredbe (ES) št. 834/2007, dati na voljo več časa.
Therefore a longer period should be provided for sending in the requests and for examining them.
Zato je treba zagotoviti daljše obdobje za pošiljanje zahtevkov in njihovo preučevanje.
For products imported according to Article 32 of Regulation (EC) No 834/2007, the operators concerned should be able to provide documentary evidence.
Za proizvode, uvožene v skladu s členom 32 Uredbe (ES) št. 834/2007, morajo biti zadevni izvajalci sposobni zagotoviti dokazila.
It is necessary to establish a model for this documentary evidence.
Določiti je treba vzorec za ta dokazila.
Products imported according to Article 33 of Regulation (EC) No 834/2007 should be covered by a certificate of inspection.
Proizvodi, uvoženi v skladu s členom 33 Uredbe (ES) št. 834/2007, morajo imeti potrdilo o kontrolnem pregledu.
It is necessary to lay down detailed rules with regard to the issuing of this certificate.
Določiti je treba podrobna pravila za izdajo tega potrdila.
Moreover, a procedure in order to coordinate at Community level certain controls on products imported from third countries which are intended to be marketed in the Community as organic should be laid down.
Razen tega je treba določiti postopek za usklajevanje na ravni Skupnosti nekaterih kontrol proizvodov, uvoženih iz tretjih držav, ki so namenjeni, da se v Skupnosti tržijo kot ekološki proizvodi.
Argentina, Australia, Costa Rica, India, Israel, New Zealand and Switzerland were previously listed as third countries from which imported products could be marketed in the Community as organic, under Commission Regulation (EC) No 345/2008 of 17 April 2008 laying down detailed rules for implementing the arrangements for imports from third countries provided for in Council Regulation (EEC) No 2092/91 on organic production of agricultural products and indications referring thereto on agricultural products and foodstuffs [2].
Argentina, Avstralija, Kostarika, Indija, Izrael, Nova Zelandija in Švica so bile prej naštete kot tretje države, katerih uvoženi proizvodi se v Skupnosti lahko tržijo kot ekološki proizvodi v skladu z Uredbo Komisije (ES) št. 345/2008 z dne 17. aprila 2008 o podrobnih pravilih za izvajanje ureditve uvozov iz tretjih držav v skladu z Uredbo Sveta (EGS) št. 2092/91 o ekološki pridelavi kmetijskih proizvodov in označevanju tovrstno pridelanih kmetijskih proizvodov in živil [2].
The Commission has re-examined the situation of those countries according to the criteria set out in Regulation (EC) No 834/2007, taking into consideration the production rules applied and the experience gained with the import of organic products from these third countries as previously listed under Article 11(1) of Council Regulation (EEC) No 2092/2091.
Komisija je ponovno preučila razmere v teh državah glede na merila iz Uredbe (ES) št. 834/2007, pri čemer je upoštevala veljavna pravila pridelave in pridobljene izkušnje v zvezi z uvozom ekoloških proizvodov iz teh tretjih držav, kot so našteta v členu 11(1) Uredbe Sveta (EGS) št. 2092/91.
On this basis it is concluded that the conditions for inclusion of Argentina, Australia, Costa Rica, India, Israel, and New Zealand in the list of third countries for equivalency according to Article 33(1) of Regulation (EC) No 834/2007 are fulfilled.
Na podlagi tega se sklepa, da so pogoji za vključitev Argentine, Avstralije, Kostarike, Indije, Izraela in Nove Zelandije na seznam tretjih držav glede enakovrednosti v skladu s členom 33(1) Uredbe (ES) št. 834/2007, izpolnjeni.
The European Community and the Swiss Confederation have concluded an Agreement on trade in agricultural products [3] approved by Decision 2002/309/EC of the Council and of the Commission [4].
Evropska skupnost in Švicarska konfederacija sta sklenili Sporazum o trgovini s kmetijskimi proizvodi [3], ki je bil odobren s Sklepom Sveta in Komisije 2002/309/ES [4].
Annex 9 to that Agreement covers organically produced agricultural products and foodstuffs and sets out that the Parties must take the necessary measures so that organic products complying with each other’s laws and regulations can be imported and placed on the market.
Priloga 9 tega sporazuma obravnava ekološko pridelane kmetijske proizvode in živila ter določa, da morata pogodbenici sprejeti potrebne ukrepe, da se ekološki proizvodi, ki so v skladu z zakoni in predpisi posamezne podpisnice sporazuma, lahko uvažajo in dajejo v promet.
For the sake of clarity, Switzerland should also be listed in the list of third countries for equivalency according to Article 33(1) of Regulation (EC) No 834/2007.
Zaradi jasnosti mora biti tudi Švica vključena na seznam tretjih držav z ozirom na enakovrednost v skladu s členom 33(1) Uredbe (ES) št. 834/2007.
Member States’ authorities have acquired substantial experience and expertise in the field of granting access for organic imported goods into the territory of the Community.
Organi držav članic so pridobili veliko izkušenj in strokovnega znanja na področju odobritev dostopa za uvoženo ekološko blago na ozemlje Skupnosti.
To establish and maintain the lists of third countries and control bodies and control authorities, this experience should be used and the Commission should be able to take account of reports from Member States and other experts.
Za vzpostavitev in vzdrževanje seznamov tretjih držav ter izvajalcev nadzora in nadzornih organov je treba uporabiti to izkušnjo, poleg tega mora biti Komisija sposobna upoštevati poročila držav članic in drugih strokovnjakov.
The tasks involved should be divided in a just and proportionate way.
S tem povezane naloge morajo biti razdeljene pravično in sorazmerno.
Provision should also be made for transitional measures applicable to third country applications received by the Commission before 1 January 2009, the date from which Regulation (EC) No 834/2007 applies.
Poleg tega je treba pripraviti določbo za prehodne ukrepe za vloge tretjih držav, ki jih Komisija prejme pred 1. januarjem 2009, datumom, ko začne veljati Uredba (ES) št. 834/2007.
In order not to disrupt international trade, and to facilitate the transition between the rules established by Regulation (EEC) No 2092/2091 and those established by Regulation (EC) No 834/2007, it is necessary to extend the possibility of Member States to continue to grant authorisations to importers on a case by case basis for placing on the Community market of products until the measures necessary for the functioning of the new import rules have been put in place, in particular as regards the recognition of control bodies and control authorities referred to in Article 33(3) of Regulation (EC) No 834/2007.
Da se ne prekinja mednarodna trgovina in se olajša prehod med pravili, ki jih določa Uredba (EGS) št. 2092/91, in pravili, ki jih določa Uredba (ES) št. 834/2007, je treba podaljšati možnost držav članic, da uvoznikom za vsak primer posebej še naprej izdajajo dovoljenja za dajanje proizvodov v promet na trgu Skupnosti, dokler ne začnejo veljati ukrepi, potrebni za delovanje novih uvoznih pravil, zlasti v zvezi s priznavanjem izvajalcev nadzora in nadzornih organov iz člena 33(3) Uredbe (ES) št. 834/2007.
This possibility should be gradually phased out as the list of control bodies referred to in that Article is being established.
To možnost je treba postopno ukiniti, ko se pripravi seznam izvajalcev nadzora iz tega člena.
In order to improve transparency and guarantee the application of this Regulation, an electronic system for exchange of information between the Commission, the Member States, the third countries, and the control bodies and control authorities should be foreseen.
Za izboljšanje preglednosti in zagotovitev uporabe te uredbe je treba predvideti elektronski sistem za izmenjavo informacij med Komisijo, državami članicami, tretjimi državami ter izvajalci nadzora in nadzornimi organi.
The detailed rules laid down in this Regulation replace those laid down in Commission Regulation (EC) No 345/2008 and in Commission Regulation (EC) No 605/2008 of 20 June 2008 laying down detailed rules for implementing the provisions concerning the certificate of inspection for imports from third countries under Article 11 of Council Regulation (EEC) No 2092/91 on organic production of agricultural products and indications referring thereto on agricultural products and foodstuffs [5].
Natančna pravila, določena v tej uredbi, nadomeščajo pravila iz Uredbe Komisije (ES) št. 345/2008 in Uredbe Komisije (ES) št. 605/2008 z dne 20. junija 2008 o podrobnih pravilih za izvajanje določb o potrdilih o kontrolnem pregledu za uvoz iz tretjih držav na podlagi člena 11 Uredbe Sveta (EGS) št. 2092/91 o ekološki pridelavi kmetijskih proizvodov in označevanju tovrstno pridelanih kmetijskih proizvodov in živil [5].
Those Regulations should therefore be repealed and replaced by a new Regulation.
Te uredbe je zato treba preklicati in jih nadomestiti z novo uredbo.
This Regulation lays down the detailed rules for the import of compliant products and the import of products providing equivalent guarantees as provided for in Articles 32 and 33 of Regulation (EC) No 834/2007.
Ta uredba določa natančna pravila za uvoz proizvodov, ki izpolnjujejo zahteve, in uvoz proizvodov z enakovrednimi jamstvi, kot določata člena 32 in 33 Uredbe (ES) št. 834/2007.
‘certificate of inspection’: means the certificate of inspection referred to in Article 33(1)(d) of Regulation (EC) No 834/2007 covering one consignment;
„potrdilo o kontrolnem pregledu“: pomeni potrdilo o kontrolnem pregledu iz člena 33(1)(d) Uredbe (ES) št. 834/2007, ki velja za eno pošiljko;
‘documentary evidence’: means the document referred to in Article 68 of Commission Regulation (EC) No 889/2008 [6] and in Article 6 of this Regulation, for which the model is set out in Annex II to this Regulation;
„dokazilo“: pomeni dokument iz člena 68 Uredbe Komisije (ES) št. 889/2008 [6] in iz člena 6 te uredbe, za katerega je določen vzorec v Prilogi II k tej uredbi;
‘consignment’: means a quantity of products under one or more Combined Nomenclature codes, covered by a single certificate of inspection, conveyed by the same means of transport and imported from the same third country;
„pošiljka“: pomeni količino proizvodov v okviru ene ali več oznak kombinirane nomenklature, ki imajo eno potrdilo o kontrolnem pregledu, se prevažajo z istim prevoznim sredstvom in so uvoženi iz iste tretje države;
‘first consignee’: means the natural or legal person as defined in Article 2(d) of Regulation (EC) No 889/2008;
„prvi prejemnik“: pomeni fizično ali pravno osebo, kot je opredeljena v členu 2(d) Uredbe (ES) št. 889/2008;
‘verification of the consignment’: means the verification by the relevant Member States’ authorities of the certificate of inspection to satisfy Article 13 of this Regulation, and, where these authorities consider appropriate, of the products, in relation to the requirements of Regulation (EC) No 834/2007, of Regulation (EC) No 889/2008 and of this Regulation;
„preverjanje pošiljke“: pomeni preverjanje potrdila o kontrolnem pregledu s strani pristojnih organov držav članic za izpolnjevanje člena 13 te uredbe ter, kadar se tem organom zdi primerno, preverjanje proizvodov glede na zahteve Uredbe (ES) št. 834/2007, Uredbe (ES) št. 889/2008 in te uredbe;
‘relevant Member States authorities’: means the customs authorities or other authorities, designated by the Member States;
„pristojni organi držav članic“: pomeni carinske ali druge organe, ki jih imenujejo države članice;
‘assessment report’: means the assessment report referred to in Articles 32(2) and 33(3) of Regulation (EC) No 834/2007 drawn up by an independent third party fulfilling the requirements of ISO Standard 17011 or by a relevant competent authority, which includes information on document reviews, including the descriptions referred to in Articles 4(3)(b) and 11(3)(b) of this Regulation, on office audits, including critical locations and on risk-oriented witness audits conducted in representative third countries.
„ocenjevalno poročilo“: pomeni ocenjevalno poročilo iz člena 32(2) in člena 33(3) Uredbe (ES) št. 834/2007, ki ga pripravi neodvisna tretja stranka, ki izpolnjuje zahteve iz standarda ISO 17011, ali ustrezni pristojni organ; to poročilo vsebuje informacije o pregledih dokumenta, vključno z opisi iz člena 4(3)(b) in člena 11(3)(b) te uredbe, o pregledih v pisarni, vključno s kritičnimi prostori, ter o pregledih z opazovanjem, usmerjenih na tveganje, ki se opravijo v reprezentativnih tretjih državah.
IMPORT OF COMPLIANT PRODUCTS
UVOZ PROIZVODOV, KI IZPOLNJUJEJO ZAHTEVE
List of recognised control bodies and control authorities for the purpose of compliance
Seznam priznanih izvajalcev nadzora in nadzornih organov za namene izpolnjevanja zahtev
Compilation and content of the list of recognised control bodies and control authorities for the purpose of compliance
Priprava in vsebina seznama priznanih izvajalcev nadzora in nadzornih organov za namene izpolnjevanja zahtev
The Commission shall draw up a list of control bodies and control authorities, recognised for the purpose of compliance in accordance with Article 32(2) of Regulation (EC) No 834/2007.
Komisija pripravi seznam izvajalcev nadzora in nadzornih organov, ki se priznavajo za namen izpolnjevanja zahtev v skladu s členom 32(2) Uredbe (ES) št. 834/2007.
The list shall be published in Annex I to this Regulation.
Seznam se objavi v Prilogi I k tej uredbi.
The procedures for drawing up and amending the list are defined in Articles 4, 16 and 17 of this Regulation.
Postopki za pripravo in spremembo seznama so opredeljeni v členih 4, 16 in 17 te uredbe.
The list shall be made available to the public on the Internet in accordance with Articles 16(4) and 17 of this Regulation.
Seznam bo javnosti na voljo na internetu v skladu s členom 16(4) in členom 17 te uredbe.
The list shall contain all the information necessary in respect of each control body or control authority to allow verifying whether products placed on the Community market have been controlled by a control body or authority recognised in accordance with Article 32(2) of Regulation (EC) No 834/2007 and in particular:
Seznam vsebuje vse informacije, ki so potrebne v zvezi z vsakim izvajalcem nadzora ali nadzornim organom, da se omogoči preverjanje, ali je proizvode, ki so dani v promet na trg Skupnosti, pregledal izvajalec nadzora ali nadzorni organ, priznan v skladu s členom 32(2) Uredbe (ES) št. 834/2007 ter zlasti:
the name and address of the control body or control authority, including e-mail and Internet address and their code number;
ime in naslov izvajalca nadzora ali nadzornega organa, vključno z e-poštnim in internetnim naslovom in njihovo šifro;
the third countries concerned and in which the products have their origin;
zadevne tretje države in države, v katerih imajo proizvodi poreklo;
the product categories concerned for each third country;
zadevne kategorije proizvoda za vsako tretjo državo;
the duration of the inclusion in the list;
trajanje vključitve na seznam;
the Internet address where the list of operators subject to the control system can be found, including their certification status and the product categories concerned, as well as suspended and decertified operators and products.
internetni naslov, kjer je na voljo seznam izvajalcev, ki so predmet nadzornega sistema, vključno z njihovim certifikacijskim statusom in zadevnimi kategorijami proizvoda ter suspendiranimi izvajalci in proizvodi ter izvajalci in proizvodi, ki se jim odvzame potrdilo.
Procedure for requesting inclusion in the list of recognised control bodies and control authorities for the purpose of compliance
Postopek za zahtevo vključitve na seznam priznanih izvajalcev nadzora in nadzornih organov za namene izpolnjevanja zahtev
The Commission shall consider whether to recognise and include a control body or control authority in the list provided for in Article 3 upon receipt of a request for inclusion in this list from the representative of the control body or control authority concerned.
Komisija ob prejemu zahtevka za vključitev na seznam, ki je določen v členu 3, s strani predstavnika zadevnega izvajalca nadzora ali nadzornega organa, preuči, ali naj prizna izvajalca nadzora ali nadzorni organ in ga vključi na omenjeni seznam.
Only complete requests that have been received before 31 October 2011 shall be considered, on the basis of the model of application made available by the Commission in accordance with Article 17(2), for the drawing up of the first list.
Pri pripravi prvega seznama se bodo obravnavali le popolni zahtevki, prejeti pred 31. oktobrom 2011, ki upoštevajo vzorec vloge, ki ga da na voljo Komisija v skladu s členom 17(2).
For the following calendar years, only complete requests that have been received before 31 October of each year shall be considered.
Za naslednja koledarska leta se obravnavajo le popolni zahtevki, prejeti pred 31. oktobrom vsako leto.
The request can be introduced by control bodies and control authorities established in the Community or in a third country.
Zahtevek lahko vložijo izvajalci nadzora in nadzorni organi, ustanovljeni v Skupnosti ali v tretji državi.