natgillin/translations-raw huggingface dataset:
Decision No 1/2018 of the EPA Committee set up by the Stepping Stone Economic Partnership Agreement between Côte d'Ivoire, of the one part, and the European Community and its Member States, of the other part,
Sklep št. 1/2018 Odbora SGP, ustanovljenega z Vmesnim sporazumom o gospodarskem partnerstvu med Slonokoščeno obalo na eni strani ter Evropsko skupnostjo in njenimi državami članicami na drugi strani,
of 22 March 2018
z dne 22. marca 2018
regarding the adoption of the rules of procedure of the EPA Committee [2018/1088]
o sprejetju poslovnika Odbora SGP [2018/1088]
Having regard to the Stepping Stone Economic Partnership Agreement between Côte d'Ivoire, of the one part, and the European Community and its Member States, of the other part, (‘the Agreement’) signed in Abidjan on 26 November 2008 and in Brussels on 22 January 2009, and provisionally applied since 3 September 2016, and in particular Article 73 thereof,
ob upoštevanju Vmesnega sporazuma o gospodarskem partnerstvu med Slonokoščeno obalo na eni strani ter Evropsko skupnostjo in njenimi državami članicami na drugi strani (v nadaljnjem besedilu: Sporazum), podpisanega 26. novembra 2008 v Abidžanu in 22. januarja 2009 v Bruslju, ki se začasno uporablja od 3. septembra 2016, in zlasti člena 73 Sporazuma,
Whereas the Agreement provides that the EPA Committee is to determine the rules governing its organisation and operation,
ob upoštevanju, da je v Sporazumu določeno, da Odbor SGP določi svoja pravila organizacije in delovanja –
The rules of procedure of the EPA Committee are established as set out in the Annex.
Poslovnik Odbora SGP je določen v Prilogi.
This Decision shall enter into force on the date of its signature.
Ta sklep začne veljati na dan podpisa.
Done at Abidjan, 22 March 2018.
V Abidžanu, 22. marca 2018
For the Republic of Côte d'Ivoire
Za Republiko Slonokoščeno obalo
OJ L 59, 3.3.2009, p. 3.
UL L 59, 3.3.2009, str. 3.
set up by the stepping stone economic partnership Agreement between Côte d'Ivoire, of the one part, and the European Community and its Member States, of the other part
ustanovljenega z Vmesnim Sporazumom o gospodarskem partnerstvu med Slonokoščeno obalo na eni strani ter Evropsko skupnostjo in njenimi državami članicami na drugi strani
The EPA Committee shall be composed of representatives of the members of the Council of the European Union and of the European Commission, of the one part, and representatives of Côte d'Ivoire, at ministerial or senior official level, of the other part.
Odbor SGP sestavljajo predstavniki članov Sveta Evropske unije in Evropske komisije na eni strani ter predstavniki Slonokoščene obale na ministrski ravni ali ravni visokih uradnikov na drugi strani.
Reference to ‘the Parties’ in the rules of procedure is in accordance with the definition provided for in Article 72 of the Agreement.
Sklicevanje na „pogodbenici“ v poslovniku pomeni sklicevanje na pogodbenici v skladu z opredelitvijo iz člena 72 Sporazuma.
The EPA Committee shall be chaired alternately for periods of 12 months by a representative of the European Union and by a representative of Côte d'Ivoire.
Odboru SGP izmenično po 12 mesecev predsedujeta predstavnik Evropske unije in predstavnik Republike Slonokoščene obale.
The first period shall begin on the date of the first meeting of the EPA Committee provided for in the Agreement and shall end on 31 December of the following year.
Obdobje prvega predsedovanja se začne na dan prve seje Odbora SGP v skladu s Sporazumom in konča 31. decembra naslednje leto.
The first Chairperson of the EPA Committee (the ‘Chairperson’) shall be a representative of Côte d'Ivoire.
Prvi predsednik Odbora SGP (v nadaljnjem besedilu: predsednik) je predstavnik Slonokoščene obale.
Representatives of the West African Economic and Monetary Union (WAEMU) and the Economic Community of West African States (ECOWAS) commissions may be invited by the Parties to attend EPA Committee meetings.
Na seje Odbora SGP pogodbenici lahko povabita predstavnike komisije Ekonomske in monetarne unije Zahodne Afrike (WAEMU) in komisije Gospodarske skupnosti zahodnoafriških držav (ECOWAS).
The Parties may also decide to invite representatives of civil society and the private sector, as well as experts, on an ad hoc basis, to meetings of the EPA Committee as observers.
Pogodbenici se lahko tudi odločita, da na ad hoc osnovi na seje Odbora SGP kot opazovalce povabita predstavnike civilne družbe in zasebnega sektorja ter strokovnjake.
The EPA Committee shall meet at regular intervals, not exceeding a period of one year, and shall hold extraordinary meetings whenever circumstances so require, if the Parties so agree.
Odbor SGP se sestaja redno, najmanj enkrat letno, in lahko skliče izredne seje, kadar to zahtevajo okoliščine in če se pogodbenici tako dogovorita.
Each meeting of the EPA Committee shall be held at a date and place agreed by the Parties.
O času in kraju vsake seje Odbora SGP se dogovorita pogodbenici.
Meetings of the EPA Committee shall be convened by the Chairperson.
Seje Odbora SGP skliče predsedsednik.
Before each meeting, the Chairperson shall be informed of the intended composition of the Côte d'Ivoire and of the European Union delegations.
Predsednik je pred vsako sejo obveščen o načrtovani sestavi delegacij Slonokoščene obale in Evropske unije.
Officials of the European Commission and of Côte d'Ivoire shall act alternately for periods of 12 months as the secretariat of the EPA Committee (the ‘secretariat’).
Uradniki Evropske komisije in Slonokoščene obale izmenično opravljajo funkcijo sekretariata Odbora SGP (v nadaljnjem besedilu: sekretariat) za obdobja 12 mesecev.
Those periods shall coincide with the alternating Chair of the EPA Committee by the European Union and by Côte d'Ivoire.
Ta obdobja sovpadajo z obdobji predsedovanja Odboru SGP, ki ga izmenično izvajata Evropska unija in Slonokoščena obala.
The Party providing the Chairperson shall also run the secretariat.
Funkcijo sekretariata opravlja pogodbenica, čigar predsednik predseduje Odboru SGP.
For the effective performance of its tasks, the EPA Committee may set up under its authority sub-committees responsible for dealing with specific subjects under the Agreement.
Za učinkovito izvajanje svojih nalog lahko Odbor SGP ustanovi pododbore, ki delujejo pod njegovo pristojnostjo in so zadolženi za obravnavo posebnih vprašanj v okviru Sporazuma.
To this end, the EPA Committee shall determine the composition and tasks of such sub-committees.
V ta namen Odbor SGP določi sestavo in naloge takih pododborov.
Where the deliberations of the EPA Committee are based on written supporting documents, such documents shall be numbered and circulated by the secretariat as EPA Committee documents.
Kadar posvetovanja Odbora SGP temeljijo na pisnih spremljajočih dokumentih, sekretariat Odbora SGP take dokumente oštevilči in razpošlje kot dokumente Odbora SGP.
All correspondence addressed to the EPA Committee shall be directed to the secretariat.
Vsa korespondenca, naslovljena na Odbor SGP, se posreduje sekretariatu.
The secretariat shall ensure that correspondence addressed to the EPA Committee is forwarded to the Chairperson and, where appropriate, circulated as EPA Committee documents to the designated correspondents of the Parties provided for in Article 73 of the Agreement (the ‘correspondents’).
Sekretariat zagotovi, da se korespondenca, naslovljena na Odbor SGP, posreduje predsedniku in po potrebi razpošlje kot dokumenti Odbora SGP določenim korespondentom pogodbenic iz člena 73 Sporazuma (v nadaljnjem besedilu: korespondenti).
Correspondence from the Chairperson shall be sent to the correspondents by the secretariat and, where appropriate, circulated as EPA Committee documents.
Korespondenco, ki prihaja s strani predsednika, sekretariat pošlje korespondentom in po potrebi razpošlje kot dokumente Odbora SGP.
A provisional agenda for each meeting shall be drawn up by the secretariat on the basis of proposals made by the Parties.
Sekretariat na podlagi predlogov pogodbenic za vsako sejo pripravi začasni dnevni red.
It shall be forwarded by the secretariat to the correspondents no later than 15 days before the start of the meeting.
Najpozneje 15 dni pred začetkom seje ga posreduje korespondentom.
The provisional agenda shall include the items for which a request for inclusion in the agenda has been received by the secretariat no later than 21 days before the start of the meeting, and for which the relevant supporting documents have been received by the secretariat no later than the date of dispatch of that provisional agenda.
Začasni dnevni red vsebuje točke, za katere je sekretariat najpozneje 21 dni pred začetkom seje prejel prošnjo za uvrstitev na dnevni red in za katere je sekretariat najpozneje na dan razpošiljanja dnevnega reda prejel spremljajoče dokumente.
The agenda shall be adopted by the EPA Committee at the beginning of each meeting.
Dnevni red na začetku vsake seje potrdi Odbor SGP.
Items other than those listed on the provisional agenda may be placed on the agenda if the Parties so agree.
Če se pogodbenici strinjata, se na dnevni red lahko uvrstijo tudi točke, ki niso bile uvrščene na začasni dnevni red.
The Chairperson, in agreement with the Parties, may invite experts to attend the EPA Committee's meetings in order to provide information on specific subjects.
Predsednik lahko v soglasju s pogodbenicama na sejo Odbora SGP povabi strokovnjake, da se pridobijo informacije o določenih temah.
With the agreement of the Parties, the secretariat may shorten the time limit specified in paragraph 1 in order to take account of the requirements of a particular case.
Sekretariat lahko v soglasju s pogodbenicama skrajša rok iz odstavka 1, da se upoštevajo zahteve posamezne zadeve.
Draft minutes of each meeting shall be drawn up by the secretariat as soon as possible.
Sekretariat čim prej pripravi osnutek zapisnika seje.
The minutes shall, as a general rule, summarise each item on the agenda, specifying where applicable:
V zapisniku se praviloma povzame vsako točko dnevnega reda in po potrebi navede naslednje:
all the documents submitted to the EPA Committee;
vse dokumente, predložene Odboru SGP;
any statement that a member of the EPA Committee has asked to be entered;
morebitne izjave, za vnos katerih so zaprosili člani Odbora SGP;
the decisions adopted, recommendations made, statements agreed upon and conclusions adopted on specific items.
sprejete sklepe, dana priporočila, dogovorjene izjave in sprejete sklepne ugotovitve o posameznih točkah.
The minutes shall also include a list of the persons attending the EPA Committee meeting and a list of the members of the delegations accompanying them.
Zapisnik vključuje tudi seznam udeležencev seje Odbora SGP in seznam članov delegacij, ki so jih spremljali.
The minutes shall be approved in writing by both Parties within two months of the date of the meeting.
Pogodbenici v roku dveh mesecev od dneva seje pisno potrdita zapisnik.
Once approved, two copies of the minutes shall be signed by the secretariat, and each of the Parties shall receive an original copy of these authentic documents.
Po potrditvi sekretariat podpiše dva izvoda zapisnika, vsaka od pogodbenic pa prejme po en izvirnik teh verodostojnih dokumentov.
The EPA Committee shall adopt its decisions and recommendations by consensus.
Odbor SGP sklepe in priporočila sprejema soglasno.
The EPA Committee may decide to submit any general matter, which is of mutual interest to the African, Caribbean and Pacific States (ACP) and the European Union (‘ACP-EU’), that arises in relation to the implementation of the Agreement to the ACP-EU Council of Ministers as defined in Article 15 of the the Partnership Agreement between the members of the African, Caribbean and Pacific Group of States, of the one part, and the European Community and its Member States, of the other part (the ‘Cotonou Agreement’).
Odbor SGP lahko sklene, da bo vsa splošna vprašanja, ki so v skupnem interesu afriških, karibskih in pacifiških države (AKP) in Evropske unije (AKP-EU), ki se pojavijo v okviru izvajanja Sporazuma, predložil ministrskemu svetu AKP-EU, kakor je opredeljen v členu 15 Sporazuma o partnerstvu med članicami skupine afriških, karibskih in pacifiških držav na eni strani ter Evropsko skupnostjo in njenimi državami članicami na drugi (Sporazum iz Cotonouja).
In the period between meetings, the EPA Committee may adopt decisions or recommendations by written procedure if both Parties so agree.
V obdobju med sejami lahko Odbor SGP sprejema sklepe ali priporočila s pisnim postopkom, če se pogodbenici tako dogovorita.
A written procedure shall consist of an exchange of notes between the Parties.
Pisni postopek se izvede z izmenjavo not med pogodbenicama.
Each decision or recommendation of the EPA Committee shall be entitled, respectively, ‘Decision’ or ‘Recommendation’ followed by a serial number, the date of its adoption and a description of its subject matter.
Vsak sklep ali priporočilo Odbora SGP se naslovi „Sklep“ ali „Priporočilo“, naslovu pa sledijo zaporedna številka, datum sprejetja in opis predmeta urejanja.
Each decision or recommendation shall indicate the date of its entry into force.
V vsakem sklepu ali priporočilu je določen datum začetka njegove veljavnosti.
Decisions and recommendations adopted by the EPA Committee shall be authenticated by a representative of the European Commission on behalf of the European Union and by a representative of Côte d'Ivoire.
Sklepe in priporočila, ki jih sprejme Odbor SGP, overita predstavnik Evropske komisije v imenu Evropske unije in predstavnik Slonokoščene obale.
Decisions and recommendations shall be forwarded to the Parties as EPA Committee documents.
Sklepi in priporočila se posredujejo pogodbenicama kot dokumenti Odbora SGP.
Public access
Dostop javnosti
Unless otherwise decided by the Parties, meetings of the EPA Committee shall not be public.
Če pogodbenici ne določita drugače, seje Odbora SGP niso javne.
Each Party may decide to publish the decisions of the EPA Committee in its respective official publication.
Vsaka pogodbenica se lahko odloči objaviti sklepe Odbora SGP v svojem uradnem listu.
Language regime
Jezikovna ureditev
The working language of the EPA Committee shall be the official language common to the Parties.
Delovni jezik Odbora SGP je uradni jezik, skupen pogodbenicama.
The EPA Committee shall discuss and adopt decisions and recommendations on the basis of documentation and proposals prepared in the language referred to in paragraph 1.
Odbor SGP razpravlja in sprejema sklepe in prirporočila na podlagi dokumentacije in predlogov, pripravljenih v jeziku iz odstavka 1.
Expenditure
Stroški
Each Party shall meet any expenses it incurs as a result of attending the meetings of the EPA Committee, both with regard to staff, travel and subsistence expenditure as well as with regard to postal and telecommunications expenditure.
Vsaka pogodbenica krije svoje stroške v zvezi z osebjem, potjo in bivanjem ter poštnimi in telekomunikacijskimi storitvami, nastale zaradi udeležbe na sejah Odbora SGP.
Expenditure in connection with the organisation of meetings and reproduction of documents shall be borne by the Party hosting the meeting.
Stroške, povezane z organizacijo sej in razmnoževanjem dokumentov, krije pogodbenica, ki je gostiteljica seje.
Expenditure in connection with the provision of interpretation services at meetings and translation of documents into the working language shall be borne by the Party hosting the meeting.
Stroške, povezane s tolmačenjem na sejah in prevodom dokumentov v delovni jezik, krije pogodbenica, ki je gostiteljica seje.
Expenditure in connection with the provision of interpretation services and translation of documents into or from other official languages of the institutions of the European Union shall be borne by the European Union.
Stroške v zvezi s tolmačenjem in prevajanjem dokumentov iz drugih uradnih jezikov institucij Evropske unije ali v te jezike krije Evropska unija.
Decision No 2/JP/2018
Sklep št. 2/JP/2018
of 17 July 2018
z dne 17. julija 2018
of the Joint Committee established under the Agreement on Mutual Recognition between the European Community and Japan [2018/1104]
Skupnega odbora, ustanovljenega v okviru Sporazuma o vzajemnem priznavanju med Evropsko skupnostjo in Japonsko [2018/1104]
Having regard to the Agreement on Mutual Recognition between the European Community and Japan (hereinafter ‘Agreement’) and in particular paragraph 3 of Article 8 thereof;
ob upoštevanju Sporazuma o vzajemnem priznavanju med Evropsko skupnostjo in Japonsko (v nadaljnjem besedilu: Sporazum) ter zlasti odstavka 3 člena 8 Sporazuma,
The new operational scope of the categories of medicinal products subject to the Sectoral Annex of this Agreement, done at Brussels on April 4, 2001 now includes the following categories:
kemične farmacevtske izdelke;
Chemical pharmaceuticals;
homeopatska zdravila (če se obravnavajo kot zdravila in zanje veljajo zahteve glede dobre proizvodne prakse na Japonskem);
Homeopathic medicinal products (as long as treated as medicinal products and subject to the GMP requirements in Japan);
vitamine, minerale in zdravila na osnovi rastlin (če se štejejo za zdravila v obeh pogodbenicah);
Vitamins, minerals and herbal medicines (if considered as medicinal products in both Parties);
biološke farmacevtske izdelke, vključno z imunološkimi zdravili in cepivi, ki spadajo v naslednje kategorije:
Biological pharmaceuticals, including immunologicals and vaccines, belonging to the following categories;
zdravila, narejena iz celične kulture z uporabo naravnih mikroorganizmov ali trajnih celičnih linij;
Medicinal products produced by cell culture utilising natural microorganisms or established cell lines;
zdravila, narejena iz celične kulture z uporabo rekombinantnih mikroorganizmov ali trajnih celičnih linij, in
Medicinal products produced by cell culture utilising recombinant microorganisms or established cell lines; and
zdravila, pridobljena iz netransgenih rastlin in netransgenih živali;
Medicinal products derived from non-transgenic plants and non-transgenic animals;
aktivne farmacevtske sestavine za katero koli od prej navedenih kategorij in
Active pharmaceutical ingredients (APIs) for any of the above categories; and
sterilne proizvode, ki spadajo v katero koli od prej navedenih kategorij.
Sterile products belonging to any of the above categories.
Ta sklep, sestavljen v dveh izvodih, podpišeta sopredsednika.
This Decision, done in duplicate, shall be signed by the co-chairs.
Sklep začne veljati na dan zadnjega podpisa.
The Decision shall be effective from the date of the later of these signatures.
Podpisano v Tokiu, 17. julija 2018
Signed in Tokyo, 17 July 2018.
V imenu Japonske
On behalf of Japan
Podpisano v Bruslju, 28. junija 2018
Signed in Brussels, 28 June 2018.
V imenu Evropske skupnosti
On behalf of the European Community
Za namene sektorske priloge o dobri proizvodni praksi biološki farmacevtski izdelki vključujejo izdelke, ki jih Ministrstvo za zdravstvo, delo in socialno skrbstvo v skladu z zakoni in drugimi predpisi Japonske ni nujno opredelilo kot „biološke izdelke“, vendar bi se za biološke izdelke šteli v EU.
For the purpose of the Sectoral Annex on GMP, biological pharmaceuticals include products which are not necessarily designated by the Ministry of Health, Labour and Welfare as ‘biological products’ in accordance with laws and regulations of Japan but which would be considered as biological products in the EU.
ob upoštevanju, da Skupni odbor potrdi operativno področje uporabe proizvodov sektorske priloge o dobri proizvodni praksi za zdravila (v nadaljnjem besedilu: sektorska priloga), ki ga je na svojem 6. zasedanju določil pododbor, ustanovljen na podlagi sektorske priloge –
Whereas the Joint Committee is to confirm the operational product scope of the Sectoral Annex on Good Manufacturing Practice for Medicinal Products (hereinafter ‘Sectoral Annex’), established by the Sub-committee under the Sectoral Annex in its 6th Meeting;
SKLENIL:
Decision No 1/2017 of the EPA Committee established by the Interim Agreement establishing a framework for an Economic Partnership Agreement between the Eastern and Southern Africa States, on the one part, and the European Community and its Member States, on the other part,
Sklep št. 1/2017 Odbora SGP, ustanovljenega z Začasnim sporazumom o določitvi okvira za sporazum o gospodarskem partnerstvu med državami Vzhodne in Južne Afrike na eni strani ter Evropsko skupnostjo in njenimi državami članicami na drugi strani,
of 3 October 2017
z dne 3. oktobra 2017
regarding the accession of the Republic of Croatia to the European Union and changes in the list of countries and territories associated with the European Union [2018/1144]
glede pristopa Republike Hrvaške k Evropski uniji in sprememb seznama držav in ozemelj, pridruženih Evropski uniji [2018/1144]
THE EPA COMMITTEE,
ODBOR SGP JE –
Having regard to the Interim Agreement establishing a framework for an Economic Partnership Agreement between the Eastern and Southern Africa States, on the one part, and the European Community and its Member States, on the other part (‘the Agreement’), signed in Grand Baie on 29 August 2009 and provisionally applied since 14 May 2012, and in particular Articles 63, 67 and 70 thereof,
ob upoštevanju Začasnega sporazuma o določitvi okvira za sporazum o gospodarskem partnerstvu med državami Vzhodne in Južne Afrike na eni strani ter Evropsko skupnostjo in njenimi državami članicami na drugi strani (v nadaljnjem besedilu: Sporazum), ki je bil podpisan v Grand Baie 29. avgusta 2009 in se začasno uporablja od 14. maja 2012, in zlasti členov 63, 67 in 70 Sporazuma,
Having regard to the Treaty concerning the accession of the Republic of Croatia to the European Union, and the act of accession to the Agreement deposited by the Republic of Croatia on 22 March 2017,
ob upoštevanju Pogodbe o pristopu Republike Hrvaške k Evropski uniji in Akta o pristopu k Sporazumu, ki ga je Republika Hrvaška deponirala 22. marca 2017,
Pursuant to Article 63 of the Agreement, the Agreement applies, on the one hand, to the territories in which the Treaty on the Functioning of the European Union applies and under the conditions laid down in that Treaty, and, on the other hand, to the territories of the Signatory Eastern and Southern Africa States (‘ESA States’).
V skladu s členom 63 Sporazuma se Sporazum na eni strani uporablja za ozemlja, na katerih se uporablja Pogodba o delovanju Evropske unije, in v skladu s pogoji, določenimi v navedeni pogodbi, ter na drugi strani za ozemlja držav podpisnic Vzhodne in Južne Afrike (v nadaljnjem besedilu: države ESA).
Pursuant to Article 67(3) of the Agreement, the EPA Committee may decide on any amending measures that might be necessary following the accession of new Member States to the European Union.
V skladu s členom 67(3) Sporazuma lahko Odbor SGP odloča o kakršnih koli ukrepih o spremembah, ki bi lahko bili potrebni po pristopu novih držav članic k Evropski uniji.
Article 70 of the Agreement provides that the Annexes and Protocols to the Agreement form an integral part thereof and may be reviewed and or amended by the EPA Committee.
Člen 70 Sporazuma določa, da so priloge in protokoli k Sporazumu njegov sestavni del, Odbor SGP pa jih lahko pregleda in/ali spremeni.
Following the change of status of Mayotte and Saint-Barthélemy, and the entry into force of Council Decision 2013/755/EU, the list of overseas countries and territories in Annex IX to Protocol 1 to the Agreement should be updated,
Zaradi spremembe položaja Mayotta in otoka Saint-Barthélemy ter začetka veljavnosti Sklepa Sveta 2013/755/EU bi bilo treba seznam čezmorskih držav in ozemelj iz Priloge IX k Protokolu 1 k Sporazumu posodobiti –
The Republic of Croatia, as a a Party to the Agreement, shall, in the same manner as the other Member States of the Union, respectively adopt and take note of the texts of the Agreement, as well as the Annexes, Protocols and Declarations attached thereto.
Republika Hrvaška se kot pogodbenica Sporazuma tako kot druge države članice Unije seznani z besedili Sporazuma in priloženimi prilogami, protokoli in izjavami ter jih sprejme.
The Agreement is amended as follows:
Sporazum se spremeni:
Article 69 is replaced by the following:
člen 69 se nadomesti z naslednjim: