natgillin/translations-raw huggingface dataset:
A potential applicant for a marketing authorisation may request the advice of the Agency on whether a specific medicinal product being developed for a specific therapeutic indication falls within one of the categories set out in Article 2 and fulfils the requirement laid down in Article 4(1)(c).
Možni prosilec za dovoljenje za promet lahko zaprosi za nasvete Agencije o tem, ali posamezno zdravilo, ki se razvija za določeno terapevtsko indikacijo, sodi v eno od kategorij iz člena 2 in izpolnjuje zahtevo iz člena 4(1)(c).
The Agency shall develop guidelines concerning the scientific application and the practical arrangements necessary to implement this Regulation.
Agencija oblikuje smernice o znanstvenih vidikih in potrebnih praktičnih postopkih za izvajanje te uredbe.
The guidelines shall be adopted after consultation with stakeholders and a favourable opinion of the Commission.
Smernice se sprejmejo po posvetu z interesnimi skupinami in na podlagi pozitivnega mnenja Komisije.
This Regulation shall apply to applications pending at the time of its entry into force.
Ta uredba se uporablja za vloge, ki so nerešene ob začetku njene veljavnosti.
Commission Regulation (EC) No 508/2006
Uredba Komisije (ES) št. 508/2006
amending Regulation (EC) No 174/1999 as regards export licences for milk powder exported to the Dominican Republic
o spremembi Uredbe (ES) št. 174/1999 glede izvoznih dovoljenj za mleko v prahu, ki se izvaža v Dominikansko republiko
Having regard to Council Regulation (EC) No 1255/1999 of 17 May 1999 on the common organisation of the market in milk and milk products [1], and in particular Article 30(1) thereof,
ob upoštevanju Uredbe Sveta (ES) št. 1255/1999 z dne 17. maja 1999 o skupni organizaciji trga mleka in mlečnih izdelkov [1], in zlasti člena 30(1) Uredbe,
Article 20a of Commission Regulation (EC) No 174/1999 of 26 January 1999 laying down special detailed rules for the application of Council Regulation (EEC) No 804/68 as regards export licences and export refunds in the case of milk and milk products [2] lays down the rules for administering the milk powder quota for export to the Dominican Republic under the Memorandum of Understanding between the European Community and the Dominican Republic, approved by Council Decision 98/486/EC [3].
Člen 20a Uredbe Komisije (ES) št. 174/1999 z dne 26. januarja 1999 o posebnih podrobnih pravilih za uporabo Uredbe Sveta (EGS) št. 804/68 glede izvoznih dovoljenj in izvoznih nadomestil za mleko in mlečne izdelke [2] določa pravila za upravljanje kvote mleka v prahu za izvoz v Dominikansko republiko na podlagi Memoranduma o soglasju med Evropsko skupnostjo in Dominikansko republiko, potrjenega s Sklepom Sveta 98/486/ES [3].
Given an increasing interest for milk powder in retail packs in the Dominican Republic it is appropriate to include the product code 0402 10 11 9000 in the list of products eligible for an export licence under Article 20a of Regulation (EC) No 174/1999.
Zaradi čedalje večjega zanimanja za mleko v prahu v maloprodajni embalaži v Dominikanski republiki je ustrezno vključiti oznako proizvoda 0402 10 11 9000 na seznam proizvodov, ki izpolnjujejo pogoje za izvozno dovoljenje po členu 20a Uredbe (ES) št. 174/1999.
Since there might be a considerable period of time between the day on which a licence application has been lodged and the time of actual export, experience has shown that it is very difficult to foresee which will be the final packaging of the product on the day of its export.
Ker utegne od datuma vloge za izvozno dovoljenje do dejanskega izvoza miniti precej časa, je po izkušnjah sodeč zelo težko predvideti, kakšna bo končna embalaža proizvoda na dan izvoza.
To solve this problem it should be allowed to switch products provided that they have an identical export refund rate and provided the exporter makes such request before completion of the export formalities.
To težavo bi odpravili tako, da bi bilo mogoče zamenjati proizvode, če je stopnja njihovega izvoznega nadomestila enaka in če izvoznik za to zaprosi pred zaključkom izvoznih formalnosti.
Paragraph 4(a) of Article 20a reserves a part of the quota to those exporters who can prove that they have exported the products concerned during each of the three calendar years prior to the period for submission of applications.
Po odstavku 4(a) člena 20a je del kvote rezerviran za izvoznike, ki lahko dokažejo, da so izvažali zadevne proizvode v vsakem od treh koledarskih let pred časom za vložitev zahtevkov.
It appears, due to specific temporary circumstances in the Dominican Republic, that some traditional exporters have not been able to actually export in one of the reference years, although they can prove regularity in their export patterns.
Kaže, da nekateri tradicionalni izvozniki zaradi specifičnih začasnih razmer v Dominikanski republiki niso mogli dejansko izvažati v enem od referenčnih let, čeprav lahko dokažejo, da redno izvažajo.
It is therefore appropriate to extend the reference period.
Zato je primerno referenčno obdobje podaljšati.
Article 20a of Regulation (EC) No 174/1999 is amended as follows:
Člen 20a Uredbe (ES) št. 174/1999 se spremeni:
In paragraph 3, product code 0402 10 11 9000 is inserted before code 0402 10 19 9000;
V odstavku 3 se pred kodo 0402 10 11 9000 vstavi koda proizvoda 0402 10 19 9000;
In paragraph 4, point (a) is replaced by the following:
Točka (a) odstavka 4 se nadomesti z:
the first part, equal to 80 % or 17920 t, shall be distributed among Community exporters who can prove that they have exported products as referred to in paragraph 3 to the Dominican Republic during at least three of the four calendar years prior to the period for submission of applications;’
prvi del, enak 80 % ali 17920 t, se porazdeli med izvoznike Skupnosti, ki lahko dokažejo, da so izvažali proizvode iz odstavka 3 v Dominikansko republiko v vsaj treh od štirih koledarskih let pred časom za vložitev zahtevkov;“;
The following paragraph 18 is added:
Doda se odstavek 18:
By way of derogation from Article 5(1), licence holders may on request obtain a change of the code in Section 16 of the export licence to another code referred to in paragraph 3 of this Article, where the refund is identical.
Z odstopanjem od člena 5(1) lahko imetniki dovoljenj zaprosijo za zamenjavo kode v Oddelku 16 izvoznega dovoljenja z drugo kodo, navedeno v odstavku 3 tega člena, kadar je nadomestilo enako.
Such request shall be lodged before completion of the formalities referred to in Article 5 or 26 of Regulation (EC) No 800/1999.
Zahtevek zanjo se vloži pred zaključkom formalnosti iz člena 5 ali 26 Uredbe (ES) št. 800/1999.
Within two working days after a product code change, the competent authorities of the Member State shall report to the Commission:
V dveh delovnih dneh po spremembi kode proizvoda pristojni organi države članice Komisiji sporočijo:
the name and the address of the licence holder,
ime in naslov imetnika dovoljenja;
the serial number of the licence or the licence extract and the date of issue,
serijsko številko dovoljenja ali izpisek iz dovoljenja ter datum izdaje;
the initial product code,
izvorno kodo proizvoda;
the final product code.’
končno kodo proizvoda.“
It shall only apply to export licences applied for in accordance with Article 20a of Regulation (EC) No 174/1999 as from 1 April 2006.
Uporablja se samo za izvozna dovoljenja, za katera je bil zahtevek vložen v skladu s členom 20a Uredbe (ES) št. 174/1999 od 1. aprila 2006.
Regulation last amended by Regulation (EC) No 409/2006 (OJ L 71, 10.3.2006, p. 5).
Uredba, kakor je bila nazadnje spremenjena z Uredbo (ES) št. 409/2006 (UL L 71, 10.3.2006, str. 5).
OJ L 218, 6.8.1998, p. 45.
UL L 218, 6.8.1998, str. 45.
Council Regulation (EC) No 509/2006
Uredba Sveta (ES) št. 509/2006
on agricultural products and foodstuffs as traditional specialities guaranteed
o zajamčenih tradicionalnih posebnostih kmetijskih proizvodov in živil
The production, manufacture and distribution of agricultural products and foodstuffs play an important role in the Community economy.
Pridelava, proizvodnja in distribucija kmetijskih proizvodov in živil imajo pomembno vlogo v gospodarstvu Skupnosti.
The diversification of agricultural production should be encouraged.
Treba bi bilo spodbujati raznolikost kmetijske proizvodnje, da se na trgih doseže boljše ravnovesje med ponudbo in povpraševanjem.
The promotion of traditional products with specific characteristics could be of considerable benefit to the rural economy, particularly in less-favoured or remote areas, both by improving the income of farmers and by retaining the rural population in these areas.
Spodbujanje tradicionalnih proizvodov, ki imajo določene značilnosti, lahko zelo koristi gospodarstvu na podeželju, zlasti na področjih z omejenimi možnostmi ali na odmaknjenih območjih, tako da na eni strani zagotavlja izboljšanje prihodkov kmetov in na drugi strani ohranjanje podeželskega prebivalstva na teh območjih.
For the sound running of the internal market in foodstuffs, economic operators should be provided with instruments allowing them to enhance the market value of their products while protecting consumers against improper practices and guaranteeing fair trade.
Za dobro delovanje notranjega trga za živila bi morali biti gospodarskim subjektom na razpolago instrumenti, s pomočjo katerih bi lahko povečali tržno vrednost svojih proizvodov, pri čemer mora biti zagotovljeno varstvo potrošnikov pred nedovoljenimi praksami in pošteno trgovanje.
Council Regulation (EEC) No 2082/92 of 14 July 1992 on certificates of specific character for agricultural products and foodstuffs [2] defines the certificates of specific character, and the term ‘traditional speciality guaranteed’ was introduced by Commission Regulation (EEC) No 1848/93 [3], which lays down the detailed rules for applying Regulation (EEC) No 2082/92.
V Uredbi Sveta (EGS) št. 2082/92 z dne 14. julija 1992 o certifikatih o posebnih lastnostih za kmetijske proizvode in živila [2] so bili opredeljeni certifikati o posebnih lastnostih, pojem „zajamčena tradicionalna posebnost“ pa je bil uveden z Uredbo Komisije (EGS) št. 1848/93 o določitvi podrobnih pravil za uporabo Uredbe (EGS) št. 2082/92 [3].
The certificates of specific character, more commonly referred to as ‘traditional specialities guaranteed’, meet consumer demand for traditional products with specific characteristics.
Certifikati o posebnih lastnostih, pogosteje imenovani „zajamčene tradicionalne posebnosti“, so odgovor na zahteve potrošnikov po tradicionalnih proizvodih s posebnimi lastnostmi.
Given the diversity of products on the market and the abundance of information concerning them, consumers should, in order to be able to make better choices, be provided with clear and succinct information regarding the specific characteristics of these foodstuffs.
Zaradi raznolikosti proizvodov na trgu in množice informacij o njih bi morale biti potrošniku na voljo jasne in jedrnate informacije o poreklu proizvoda, ki mu omogočajo najboljšo izbiro.
With a view to clarification, the term ‘certificate of specific character’ should be abandoned in favour of ‘traditional speciality guaranteed’ alone, which is easier to understand and, in order to make the goal of this Regulation more explicit for producers and consumers alike, the term ‘specific character’ should be precisely defined and a definition of the term ‘traditional’ should be introduced.
Zaradi večje jasnosti bi bilo treba opustiti izraz „certifikat o posebnih lastnostih“ in uporabljati le izraz „zajamčena tradicionalna posebnost“, ki je bolj razumljiv, in da bi bil za proizvajalce in potrošnike cilj te uredbe bolj jasen, bi bilo treba natančneje opredeliti pojem „posebne lastnosti“ in vključiti v uredbo opredelitev pojma „tradicionalen“.
Certain producers would like to derive market value from traditional agricultural products or traditional foodstuffs the inherent characteristics of which distinguish them clearly from similar products or foodstuffs.
Nekateri proizvajalci želijo povečati tržno vrednost tradicionalnih kmetijskih proizvodov ali živil, ker se ta zaradi njim lastnih značilnostmi jasno razlikujejo od drugih podobnih proizvodov ali živil.
In order to protect the consumer, the traditional speciality guaranteed should be subject to inspection.
Zaradi zagotavljanja varstva potrošnikov bi bilo treba zajamčeno tradicionalno posebnost nadzorovati.
Such a voluntary system, enabling operators to make known the quality of an agricultural product or a foodstuff throughout the Community, should offer every guarantee in order to ensure that any references which may be made to the quality in the trade are substantiated.
Tak prostovoljni sistem, ki bi gospodarskim subjektom omogočal, da kakovost kmetijskega proizvoda ali živila uveljavljajo v celotni Skupnosti, bi moral pri trženju s temi živili nuditi vsa jamstva za dejansko utemeljenost sklicevanj na to kakovost.
The labelling of agricultural products and foodstuffs is subject to the general rules laid down in Directive 2000/13/EC of the European Parliament and of the Council of 20 March 2000 on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs [4].
Za označevanje kmetijskih proizvodov in živil veljajo splošna pravila iz Direktive 2000/13/ES Evropskega parlamenta in Sveta z dne 20. marca 2000 o približevanju zakonodaje držav članic o označevanju, predstavljanju in oglaševanju živil [4].
In view of their specific character, however, special additional provisions should be adopted for traditional specialities guaranteed.
Zaradi njihove posebne narave bi bilo treba sprejeti dodatne posebne določbe za zajamčene tradicionalne posebnosti.
In order to make for easier and quicker identification of traditional specialities guaranteed produced within the Community, use of the indication ‘traditional speciality guaranteed’ or the associated Community symbol should be made obligatory on their labelling, while affording operators a reasonable amount of time to adjust to this requirement.
Da bi omogočili hitrejšo in lažjo identifikacijo zajamčenih tradicionalnih posebnosti, proizvedenih na območju Skupnosti, bi bilo treba za označevanje predpisati obvezno uporabo označbe „zajamčena tradicionalna posebnost“ ali ustreznega znaka Skupnosti, pri čemer pa bi bilo treba predvideti razumen rok, v katerem se gospodarski subjekti lahko prilagodijo tej obveznosti.
To ensure compliance with, and the consistency of, the traditional specialities guaranteed, producers organised into groups should themselves define specific characteristics in a product specification.
Da bi zagotovili upoštevanje in usklajenost zajamčenih tradicionalnih posebnosti, bi morali proizvajalci, ki so organizirani v skupine, v specifikaciji proizvoda sami opredeliti posebne lastnosti.
The option of registering a traditional speciality guaranteed should be open to third-country producers.
Možnost registracije zajamčene tradicionalne posebnosti bi morala biti odprta tudi za proizvajalce iz tretjih držav.
The traditional specialities guaranteed protected within the Community should be subject to control arrangements, based on Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules [5], as well as control arrangements to ensure that operators comply with the product specification before marketing agricultural products and foodstuffs.
Za zajamčene tradicionalne posebnosti, zaščitene v Skupnosti, bi morale veljati nadzorne ureditve, ki bi temeljile na sistemu pregledov na podlagi Uredbe (ES) št. 882/2004 Evropskega parlamenta in Sveta z dne 29. aprila 2004 o izvajanju uradnega nadzora, da se zagotovi preverjanje skladnosti z zakonodajo o krmi in živilih ter s pravili o zdravstvenem varstvu živali in zaščiti živali [5], ter nadzorne ureditve, ki bi zagotavljale, da gospodarski subjekti pred trženjem kmetijskih proizvodov in živil upoštevajo specifikacijo proizvoda.
To qualify for protection, traditional specialities guaranteed should be registered at Community level.
Da bi bile upravičene do zaščite v državah članicah, bi morale biti zajamčene tradicionalne posebnosti registrirane na ravni Skupnosti.
Entry in a register should also provide information to those involved in the trade and to consumers.
Vpis v register naj omogoči tudi zagotavljanje informacij gospodarskim subjektom in potrošnikom.
The national authorities of the Member State concerned should scrutinise each application for registration in accordance with minimum common rules, including a procedure for raising objections at national level, in order to ensure that the agricultural product or foodstuff concerned is traditional and has specific characteristics.
Za zagotovitev, da je zadevni kmetijski proizvod ali živilo tradicionalno in ima posebne lastnosti, bi morali vloge preučevati nacionalni organi zadevne države članice z upoštevanjem minimalnih skupnih določb, ki bi vključevale nacionalni postopek ugovora.
The Commission should subsequently undertake a scrutiny to ensure a uniform approach towards applications for registration lodged by the Member States and by third-country producers.
Komisija bi nato morala biti vključena v postopek preučitve vlog, s čimer bi zagotovila enoten pristop glede vlog za registracijo, ki jih predložijo proizvajalci držav članic, in tistih, ki jih predložijo proizvajalci iz tretjih držav.
In order to improve the efficiency of the registration procedure, vexatious and unjustified objections should not be entertained and the grounds on which the Commission assesses the admissibility of objections sent to it should be specified.
Da bi bil postopek registracije bolj učinkovit, bi se bilo treba izogniti obravnavanju šikanoznih in neutemeljenih ugovorov, zato bi bilo treba podrobno opredeliti razloge, na podlagi katerih Komisija oceni dopustnost prejetih ugovorov.
The right to object should be granted to citizens of third countries with a legitimate interest, under the same criteria as those applying to Community producers.
Pravico do ugovora bi bilo treba zagotoviti državljanom tretjih držav z upravičenim interesom po enakih merilih, kot se uporabljajo za proizvajalce Skupnosti.
These criteria should be evaluated in relation to the territory of the Community.
Ta merila bi bilo treba oceniti glede na ozemlje Skupnosti.
In the light of the experience gained, the period for consultations where objections are made should be adjusted.
Glede na pridobljene izkušnje bi bilo treba prilagoditi rok za posvetovanja, na katerih se podajo ugovori.
Provisions should be introduced to clarify the scope of the protection granted under this Regulation, stating in particular that this Regulation should apply without prejudice to existing rules concerning trademarks and geographical indications.
Predvideti bi bilo treba določbe za razjasnitev obsega zaščite po tej uredbi, ki bi poudarile, da je treba to uredbo uporabljati brez poseganja v obstoječa pravila v zvezi z blagovnimi znamkami in geografskimi označbami.
In order to avoid creating unfair conditions of competition, any producer, including third-country producers, should be able to use either a registered name together with a particular indication and, where appropriate, the Community symbol associated with the indication ‘traditional specialities guaranteed’ or a name registered as such, provided that the agricultural product or foodstuff which is produced or processed complies with the requirements of the relevant specification and the producer employs the services of authorities or bodies for verification in accordance with this Regulation.
Zaradi preprečevanja ustvarjanja neenakih konkurenčnih pogojev je treba vsakemu proizvajalcu, vključno s proizvajalci iz tretjih držav, omogočiti uporabo registriranega imena, skupaj z določeno označbo, in, kjer je primerno, z znakom Skupnosti, ob navedbi označbe „zajamčena tradicionalna posebnost“ ali registriranega imena kot takega, če proizveden ali predelan kmetijski proizvod ali živilo ustreza zahtevam zadevne specifikacije in če v skladu z določbami te uredbe proizvajalec koristi storitve organov za preverjanje.
If they are to be attractive to producers and reliable for consumers, indications relating to the specific character of an agricultural product or a foodstuff should be granted legal protection and be subject to controls.
Da bi bile označbe posebnih lastnosti tradicionalnega kmetijskega proizvoda ali živila privlačne za proizvajalce in da bi uživale zaupanje potrošnikov, bi jim bilo treba zagotoviti pravno varstvo in jih nadzorovati.
Member States should be authorised to charge a fee to cover the costs incurred.
Državam članicam bi moralo biti dovoljeno, da zaračunavajo takse za kritje nastalih stroškov.
The measures necessary for the implementation of this Regulation should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission [6].
Ukrepe, potrebne za izvajanje te uredbe, bi bilo treba sprejeti v skladu s Sklepom Sveta 1999/468/ES z dne 28. junija 1999 o določitvi postopkov za uresničevanje Komisiji podeljenih izvedbenih pooblastil [6].
Provisions should be introduced to identify the rules in this Regulation that apply to applications for registration which reach the Commission before its entry into force.
Predvideti bi bilo treba določbe za opredelitev pravil te uredbe, ki naj se uporabljajo za vloge za registracijo, ki jih Komisija prejme pred začetkom veljavnosti te uredbe.
Operators should be permitted a reasonable amount of time to adapt both the private control bodies and the labelling of agricultural products and foodstuffs marketed as traditional specialities guaranteed.
Gospodarski subjekti bi morali imeti na razpolago razumen rok za prilagoditev zasebnih nadzornih organov in označevanje kmetijskih proizvodov in živil kot zajamčenih tradicionalnih posebnosti.
In the interests of clarity and transparency, Regulation (EEC) No 2082/92 should be repealed and replaced by this Regulation,
Zaradi jasnosti in preglednosti bi bilo treba Uredbo (EGS) št. 2082/92 razveljaviti in jo nadomestiti s to uredbo –
This Regulation lays down the rules under which a traditional speciality guaranteed may be recognised for:
Ta uredba določa pravila, po katerih se lahko prizna zajamčena tradicionalna posebnost za:
the agricultural products intended for human consumption listed in Annex I to the Treaty;
kmetijske proizvode namenjene za prehrano ljudi, ki so navedeni v Prilogi I k Pogodbi;
the foodstuffs listed in Annex I to this Regulation.
živila, navedena v Prilogi I k tej uredbi.
Annex I hereto may be amended in accordance with the procedure referred to in Article 18(2).
Priloga I se lahko spremeni v skladu s postopkom iz člena 18(2).
This Regulation shall apply without prejudice to other specific Community provisions.
Ta uredba se uporablja brez poseganja v druge posebne predpise Skupnosti.
Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations and of rules on Information Society Services [7] shall not apply to the traditional specialities guaranteed covered by this Regulation.
Direktiva 98/34/ES Evropskega parlamenta in Sveta z dne 22. junija 1998 o določitvi postopka za zbiranje informacij na področju tehničnih standardov in tehničnih predpisov o storitvah informacijske družbe [7] se ne uporablja za zajamčene tradicionalne posebnosti, ki so predmet te uredbe.
‘specific character’ means the characteristic or set of characteristics which distinguishes an agricultural product or a foodstuff clearly from other similar products or foodstuffs of the same category;
„posebne lastnosti“ pomenijo lastnost ali skupek lastnosti, ki jasno razlikujejo kmetijski proizvod ali živilo od drugih podobnih proizvodov ali živil, ki spadajo v isto kategorijo;