natgillin/translations-raw huggingface dataset:
The use of invented names for regions or other geographical areas which are not meaningful information or could mislead the consumer as to the real place of provenance of the primary ingredient should be prohibited.
Uporabo izmišljenih imen regij ali drugih geografskih območij, ki ne zagotavljajo smiselnih informacij ali bi lahko zavajala potrošnika glede dejanskega kraja izvora osnovne sestavine, bi bilo treba prepovedati.
Where a primary ingredient is a food subject to specific Union provisions on the indication of the country of origin or the place of provenance, these provisions could be alternatively used for the purposes of Article 26(3)(a) of Regulation (EU) No 1169/2011.
Kadar je osnovna sestavina živilo, za katerega se uporabljajo posebne določbe Unije o navajanju države porekla ali kraja izvora, bi se lahko za namene člena 26(3)(a) Uredbe (EU) št. 1169/2011 uporabile te določbe.
Where food business operators opt to only indicate the country of origin or place of provenance of the primary ingredient as being different to that of the food, for example because of multiple or variable supply sources and particular production processes, it is appropriate to provide a framework which takes into account the various circumstances of food processing.
Kadar se nosilci živilskih dejavnosti odločijo zgolj za navedbo, da se država porekla ali kraj izvora osnovne sestavine razlikuje od države porekla ali kraja izvora živila, na primer zaradi več različnih ali spremenljivih dobavnih virov in posebnih proizvajalnih postopkov, je primerno zagotoviti okvir, ki upošteva različne okoliščine predelave živil.
The relevant indication should ensure comprehensible information to the consumer.
Zadevna navedba bi morala potrošnikom zagotoviti razumljive informacije.
Information provided with respect to primary ingredient in accordance with this Regulation should complement the information given to the consumers on the country of origin or place of provenance of the food, and should be easily visible and clearly legible and where appropriate indelible.
Informacije, zagotovljene v zvezi z osnovno sestavino v skladu s to uredbo, bi morale dopolnjevati informacije, ki potrošnike obveščajo o državi porekla ali kraju izvora živila, in bi morale biti dobro vidne, jasno berljive ter, kadar je to ustrezno, neizbrisne.
An appropriate transitional period should be established for the application of this Regulation, in accordance with Article 47 of Regulation (EU) No 1169/2011, which requires that any new food information measures should apply as from 1 April in any calendar year.
Za uporabo te uredbe bi bilo treba določiti primerno prehodno obdobje v skladu s členom 47 Uredbe (EU) št. 1169/2011, ki določa, da bi bilo treba kakršne koli nove ukrepe glede informacij o živilih uporabljati od 1. aprila vsakega koledarskega leta.
This Regulation lays down the modalities for the application of Article 26(3) of Regulation (EU) No 1169/2011 where the country of origin or place of provenance of a food is given by any means such as statements, pictorial presentation, symbols or terms, referring to places or geographical areas, except for geographic terms included in customary and generic names where those terms literally indicate origin but whose common understanding is not an indication of country of origin or place of provenance.
Ta uredba določa načine uporabe člena 26(3) Uredbe (EU) št. 1169/2011, kadar sta država porekla ali kraj izvora živila navedena na kakršen koli način, kot na primer v obliki izjav, slikovnih znakov, simbolov ali besed, in se navedba nanaša na kraje ali geografska območja, razen geografskih imen, vključenih v običajna in generična imena, ki dobesedno sicer označujejo poreklo, vendar v splošnem niso interpretirana kot dejanske navedbe države porekla ali kraja izvora.
This Regulation shall not apply to geographical indications protected under Regulation (EU) No 1151/2012, Regulation (EU) No 1308/2013, Regulation (EC) No 110/2008 or Regulation (EU) No 251/2014 or protected pursuant to international agreements, nor registered trade marks where the latter constitute an origin indication, pending the adoption of specific rules concerning the application of Article 26(3) to such indications.
Ta uredba se ne uporablja za geografske označbe, zaščitene v skladu z Uredbo (EU) št. 1151/2012, Uredbo (EU) št. 1308/2013, Uredbo (ES) št. 110/2008 ali Uredbo (EU) št. 251/2014 ali na podlagi mednarodnih sporazumov, in registrirane blagovne znamke, če gre za navedbe porekla, dokler ne bodo sprejeta posebna pravila glede uporabe člena 26(3) za takšne navedbe.
Indication of the country of origin or place of provenance of the primary ingredient
Navedba države porekla ali kraja izvora osnovne sestavine
The country of origin or the place of provenance of a primary ingredient which is not the same as the given country of origin or the given place of provenance of the food shall be given:
Država porekla ali kraj izvora osnovne sestavine, ki se razlikuje od navedene države porekla ali navedenega kraja izvora živila, se navede:
with reference to one of the following geographical areas:
s sklicem na eno od naslednjih geografskih območij:
‘EU’, ‘non-EU’ or ‘EU and non-EU’; or
„EU“, „zunaj EU“ ali „EU in zunaj EU“ ali
Region, or any other geographical area either within several Member States or within third countries, if defined as such under public international law or well understood by normally informed average consumers; or
regija ali katero koli drugo geografsko območje v več državah članicah ali tretjih državah, če je kot tako opredeljeno v mednarodnem javnem pravu ali dobro razumljivo običajno obveščenim povprečnim potrošnikom, ali
FAO Fishing area, or sea or freshwater body if defined as such under international law or well understood by normally informed average consumers; or
ribolovno območje FAO ali morje ali sladkovodno telo, če je kot tako opredeljeno v mednarodnem javnem pravu ali dobro razumljivo običajno obveščenim povprečnim potrošnikom, ali
Member State(s) or third country(ies); or
države članice ali tretje države ali
Region, or any other geographical area within a Member State or within a third country, which is well understood by normally informed average consumers; or
regija ali katero koli drugo geografsko območje v državi članici ali tretji državi, ki je dobro razumljivo običajno obveščenim povprečnim potrošnikom, ali
The country of origin or place of provenance in accordance with specific Union provisions applicable for the primary ingredient(s) as such;
država porekla ali kraj izvora v skladu s posebnimi določbami Unije, ki se uporabljajo za osnovne sestavine kot take,
or by means of a statement as follows:
ali z naslednjo izjavo:
‘(name of the primary ingredient) do/does not originate from (the country of origin or the place of provenance of the food)’ or any similar wording likely to have the same meaning for the consumer.
„(ime osnovne sestavine) izvira/ne izvira iz (država porekla ali kraj izvora živila)“ ali podobna ubeseditev, ki bi imela za potrošnike enak pomen.
Information provided pursuant to Article 2 shall be provided in a font size which is not smaller than the minimum font size as required in accordance with Article 13(2) of Regulation (EU) No 1169/2011.
Informacije, zagotovljene v skladu s členom 2, se zagotovijo v velikosti črk, ki ni manjša od najmanjše velikosti črk iz člena 13(2) Uredbe (EU) št. 1169/2011.
Without prejudice to paragraph 1, where the country of origin or place of provenance of a food is given with words, the information provided pursuant to Article 2 shall appear in the same field of vision as the indication of the country of origin or place of provenance of the food and by using a font size which has an x-height of at least 75 % of the x-height of the indication of the country of origin or place of provenance of the food.
Kadar se država porekla ali kraj izvora živila navede z besedami, so informacije, zagotovljene v skladu s členom 2, brez poseganja v odstavek 1 prikazane v istem vidnem polju kot navedba države porekla ali kraja izvora živila in v velikosti črk, pri kateri je srednji črkovni pas (x-height) vsaj 75 % srednjega črkovnega pasu navedbe države porekla ali kraja izvora živila.
Without prejudice to paragraph 1, where the country of origin or place of provenance of a food is given by means of non-scriptural form, the information provided pursuant to Article 2 shall appear in the same field of vision as the indication of the country of origin or place of provenance of the food.
Kadar se država porekla ali kraj izvora živila ne navede z besedami, so informacije, zagotovljene v skladu s členom 2, brez poseganja v odstavek 1, prikazane v istem vidnem polju kot navedba države porekla ali kraja izvora živila.
Entry into force, date of application and transitional measures
Začetek veljavnosti, datum začetka uporabe in prehodni ukrepi
It shall apply from 1 April 2020.
Uporablja se od 1. aprila 2020.
Foods placed on the market or labelled prior to the date of application of this Regulation may be marketed until the stocks are exhausted.
Živila, dana v promet ali označena pred datumom začetka uporabe te uredbe, se lahko tržijo do odprodaje zalog.
Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011 on the provision of food information to consumers amending Regulations (EC) No 1924/2006 and (EC) No 1925/2006 of the European Parliament and of the Council, and repealing Commission Directive 87/250/EEC, Council Directive 90/496/EEC, Commission Directive 1999/10/EC, Directive 2000/13/EC of the European Parliament and of the Council, Commission Directives 2002/67/EC and 2008/5/EC and Commission Regulation (EC) No 608/2004 (OJ L 304, 22.11.2011, p. 18).
Uredba (EU) št. 1169/2011 Evropskega parlamenta in Sveta z dne 25. oktobra 2011 o zagotavljanju informacij o živilih potrošnikom, spremembah uredb (ES) št. 1924/2006 in (ES) št. 1925/2006 Evropskega parlamenta in Sveta ter razveljavitvi Direktive Komisije 87/250/EGS, Direktive Sveta 90/496/EGS, Direktive Komisije 1999/10/ES, Direktive 2000/13/ES Evropskega parlamenta in Sveta, direktiv Komisije 2002/67/ES in 2008/5/ES in Uredbe Komisije (ES) št. 608/2004 (UL L 304, 22.11.2011, str. 18).
Regulation (EU) No 1151/2012 of the European Parliament and of the Council of 21 November 2012 on quality schemes for agricultural products and foodstuffs (OJ L 343, 14.12.2012, p. 1).
Uredba (EU) št. 1151/2012 Evropskega parlamenta in Sveta z dne 21. novembra 2012 o shemah kakovosti kmetijskih proizvodov in živil (UL L 343, 14.12.2012, str. 1).
Regulation (EU) No 1308/2013 of the European Parliament and of the Council of 17 December 2013 establishing a common organisation of the markets in agricultural products and repealing Council Regulations (EEC) No 922/72, (EEC) No 234/79, (EC) No 1037/2001 and (EC) No 1234/2007 (OJ L 347, 20.12.2013, p. 671).
Uredba (EU) št. 1308/2013 Evropskega parlamenta in Sveta z dne 17. decembra 2013 o vzpostavitvi skupne ureditve trgov kmetijskih proizvodov in razveljavitvi uredb Sveta (EGS) št. 922/72, (EGS) št. 234/79, (ES) št. 1037/2001 in (ES) št. 1234/2007 (UL L 347, 20.12.2013, str. 671).
Regulation (EC) No 110/2008 of the European Parliament and of the Council of 15 January 2008 on the definition, description, presentation, labelling and the protection of geographical indications of spirit drinks and repealing Council Regulation (EEC) No 1576/89 (OJ L 39, 13.2.2008, p. 16).
Uredba (ES) št. 110/2008 Evropskega parlamenta in Sveta z dne 15. januarja 2008 o opredelitvi, opisu, predstavitvi, označevanju in zaščiti geografskih označb žganih pijač ter razveljavitvi Uredbe Sveta (EGS) št. 1576/89 (UL L 39, 13.2.2008, str. 16).
Regulation (EU) No 251/2014 of the European Parliament and of the Council of 26 February 2014 on the definition, description, presentation, labelling and the protection of geographical indications of aromatised wine products and repealing Council Regulation (EEC) No 1601/91 (OJ L 84, 20.3.2014, p. 14).
Uredba (EU) št. 251/2014 Evropskega parlamenta in Sveta z dne 26. februarja 2014 o opredelitvi, opisu, predstavitvi, označevanju in zaščiti geografskih označb aromatiziranih vinskih proizvodov in o razveljavitvi Uredbe Sveta (EGS) št. 1601/91 (UL L 84, 20.3.2014, str. 14).
Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific hygiene rules for foods of animal origin (OJ L 139, 30.4.2004, p. 55).
Uredba (ES) št. 853/2004 Evropskega parlamenta in Sveta z dne 29. aprila 2004 o posebnih higienskih pravilih za živila živalskega izvora (UL L 139, 30.4.2004, str. 55).
of 29 May 2018
z dne 29. maja 2018
amending Regulation (EC) No 847/2000 as regards the definition of the concept ‘similar medicinal product’
o spremembi Uredbe (ES) št. 847/2000 glede opredelitve pojma „podobno zdravilo“
Having regard to Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products, and in particular Article 8(4) thereof,
ob upoštevanju Uredbe (ES) št. 141/2000 Evropskega parlamenta in Sveta z dne 16. decembra 1999 o zdravilih sirotah in zlasti člena 8(4) Uredbe,
Regulation (EC) No 141/2000 was adopted to promote research in the field of rare diseases.
Uredba (ES) št. 141/2000 je bila sprejeta za spodbujanje raziskav na področju redkih bolezni.
It offers undertakings that develop orphan medicinal products the prospect of obtaining market exclusivity for a certain number of years.
Podjetjem, ki razvijajo zdravila sirote, ponuja možnost za pridobitev tržne ekskluzivnosti za določeno število let.
Commission Regulation (EC) No 847/2000 provides a definition of the concept ‘similar medicinal product’, which includes specific cases defining what kind of products are to be regarded as similar for the purposes of the application of Article 8 of Regulation (EC) No 141/2000.
Uredba Komisije (ES) št. 847/2000 vsebuje opredelitev pojma „podobno zdravilo“, ki vključuje posebne primere, ki opredeljujejo vrste proizvodov, ki se štejejo za podobne za namene uporabe člena 8 Uredbe (ES) št. 141/2000.
That definition should be updated in the light of new scientific and technical knowledge, in particular, due to major developments in the field of biological medicines, and especially advanced therapy medicinal products, and in the light of experience gained with regard to the designation and regulation of orphan medicinal products.
Navedeno opredelitev bi bilo treba posodobiti ob upoštevanju novih znanstvenih in tehničnih dognanj, predvsem zaradi pomembnega napredka na področju bioloških zdravil in zlasti zdravil za napredno zdravljenje, ter ob upoštevanju izkušenj, pridobljenih v zvezi z določanjem in urejanjem zdravil sirot.
In addition, there is a need for a clear definition of the concept ‘principal molecular structural features’, which is used within the definition of the concept ‘similar active substance’, which is in turn used within the definition of the concept ‘similar medicinal product’.
Poleg tega obstaja potreba po jasni opredelitvi pojma „lastnosti osnovne molekulske strukture“, ki se uporablja v opredelitvi pojma „podobna učinkovina“, uporabljenega v opredelitvi pojma „podobno zdravilo“.
As regards the biological medicinal products, the definition of ‘principal molecular structural features’ shall capture certain molecular modifications significantly contributing to the functional characteristics of the active substance that would impact whether or not the products are considered as similar.
Kar zadeva biološka zdravila, opredelitev „lastnosti osnovne molekulske strukture“ zajema nekatere molekularne spremembe, ki znatno prispevajo k funkcionalnim značilnostim učinkovine, ki vplivajo na to, ali se zdravila štejejo za podobna ali ne.
However, for advanced therapy medicinal products the principal molecular structural features cannot be fully identified.
Vendar za zdravila za napredno zdravljenje lastnosti osnovne molekulske strukture ni mogoče v celoti ugotoviti.
Therefore, in the case of advanced therapy medicinal products the similarity between two active substances should be assessed on the basis of the biological and functional characteristics.
Zato bi bilo treba v primeru zdravil za napredno zdravljenje podobnost dveh učinkovin oceniti na podlagi bioloških in funkcionalnih značilnosti.
The definition of ‘active substance’ should be deleted as Article 8(4) of Regulation (EC) No 141/2000 does not empower the Commission to define the term ‘active substance’.
Opredelitev pojma „učinkovina“ bi bilo treba črtati, saj člen 8(4) Uredbe (ES) št. 141/2000 Komisije ne pooblašča za opredelitev pojma „učinkovina“.
The term ‘active substance’ is legally defined in Article 1(3)(a) of Directive 2001/83/EC of the European Parliament and of the Council and the scope and purpose of Article 3(3) of Regulation (EC) No 847/2000 are related to the definitions of the concepts ‘similar medicinal product’ and ‘clinical superiority’.
Izraz „učinkovina“ je pravno opredeljen v členu 1(3)(a) Direktive 2001/83/ES Evropskega parlamenta in Sveta, področje uporabe in namen člena 3(3) Uredbe (ES) št. 847/2000 pa sta povezana z opredelitvama pojmov „podobno zdravilo“ in „klinična superiornost“.
In Article 3(3) of Regulation (EC) No 847/2000, the introductory sentence and points (a), (b) and (c) are replaced by the following:
V členu 3(3) Uredbe (ES) št. 847/2000 se uvodni stavek ter točke (a), (b) in (c) nadomestijo z naslednjim: „3.
‘For the purposes of the application of Article 8 of Regulation (EC) No 141/2000 on orphan medicinal products, the following definitions shall apply:
Za namene uporabe člena 8 Uredbe (ES) št. 141/2000 o zdravilih sirotah se uporabljajo naslednje opredelitve pojmov:
deleted;
črtano;
“similar medicinal product” means a medicinal product containing a similar active substance or substances as contained in a currently authorised orphan medicinal product, and which is intended for the same therapeutic indication;
‚podobno zdravilo‘ pomeni zdravilo s podobno učinkovino ali učinkovinami, kakršne vsebuje trenutno odobreno zdravilo sirota, in ki je namenjeno za enako terapevtsko indikacijo;
“similar active substance” means an identical active substance, or an active substance with the same principal molecular structural features (but not necessarily all of the same molecular structural features) and which acts via the same mechanism.
‚podobna učinkovina‘ pomeni enako učinkovino ali učinkovino z enakimi lastnostmi osnovne molekulske strukture (vendar pa ne nujno povsem enakimi vsemi lastnostmi molekulske strukture), in ki učinkuje po enakem mehanizmu.
However, in the case of advanced therapy medicinal products, for which the principal molecular structural features cannot be fully defined, the similarity between two active substances shall be assessed on the basis of the biological and functional characteristics.
Vendar se v primeru zdravil za napredno zdravljenje, katerih lastnosti osnovne molekulske strukture ni mogoče v celoti določiti, podobnost med dvema učinkovinama oceni na podlagi bioloških in funkcionalnih značilnosti.
For the purpose of application of point (c) above, the following applies for:
Za namen uporabe točke (c) velja naslednje:
Chemical medicinal products
Kemijska zdravila
The principal molecular structural features are the relevant structural components of an active substance.
Lastnosti osnovne molekulske strukture so pomembne strukturne komponente učinkovine.
They can be the whole or part of the molecule.
Lahko sestavljajo celotno molekulo ali so del nje.
Whether the principal molecular structural features are the same between two or more molecules will be identified by comparison of their structures.
Dejstvo, ali so lastnosti osnovne molekulske strukture dveh ali več molekul enake, se ugotovi na podlagi primerjave njihovih struktur.
Isomers, mixture of isomers, complexes, esters, ethers, salts, and derivatives of the original active substance, or an active substance that differs from the original active substance only with respect to minor changes in the molecular structure, such as a structural analogue, shall be considered similar.
Izomeri, mešanica izomerov, kompleksi, estri, etri, soli in derivati izvirne učinkovine ali učinkovina, ki se od izvirne učinkovine razlikuje le glede na manjše spremembe v molekulski strukturi, kakršna je strukturni analog, se štejejo za podobne.
Synthetic polynucleotide substances, single or double stranded, consisting of two or more distinct nucleotides where:
Za sintetične polinukleotidne snovi, enoverižne ali dvoverižne, ki so sestavljene iz dveh ali več različnih nukleotidov, velja naslednje:
the difference in the nucleotide sequence of the purine and pyrimidine bases or their derivatives is not major, shall be considered similar.
če razlika v nukleotidnem zaporedju purinskih in pirimidinskih baz ali njihovih derivatov ni pomembna, se štejejo za podobne.
Therefore for antisense or interfering nucleotide substances, addition, substitution or deletion of a nucleotide not significantly affecting the kinetics of hybridisation to the target shall normally be considered similar,
Zato se protismiselne ali moteče nukleotidne snovi, pri katerih dodajanje, nadomestitev ali opustitev nukleotida znatno ne vpliva na kinetiko hibridizacije na ciljnem mestu, običajno štejejo za podobne,
the difference in structure related to modifications of the ribose or deoxyribose backbone sugars or to the replacement of the backbone sugars by synthetic analogues shall normally result in substances being considered similar.
rezultat razlike v strukturi v zvezi s spremembami riboznega ali deoksiriboznega sladkornega ogrodja ali z nadomestitvijo sladkornega ogrodja s sintetičnimi analogi so običajno snovi, ki se štejejo za podobne.
For antisense or interfering nucleotide substances, changes in the (deoxy-)ribose not significantly affecting the kinetics of hybridisation to the target would normally be considered similar.
Protismiselne ali moteče nukleotidne snovi, pri katerih pride do sprememb (deoksi)riboze, ki znatno ne vplivajo na kinetiko hibridizacije na ciljnem mestu, se običajno štejejo za podobne.
Biological medicinal products (other than advanced therapy medicinal products)
Biološka zdravila (razen zdravil za napredno zdravljenje)
The principal molecular structural features are the structural components of an active substance that are relevant for the functional characteristics of that substance.
Lastnosti osnovne molekulske strukture so strukturne sestavine učinkovine, ki so pomembne za funkcionalne značilnosti navedene snovi.
The principal molecular structural features may be composed of a therapeutic moiety or a therapeutic moiety in combination with an additional structural element(s) significantly contributing to the functional characteristics of the active substance.
Lastnosti osnovne molekulske strukture so lahko sestavljene iz terapevtskega dela učinkovine ali terapevtskega dela učinkovine v kombinaciji z dodatnimi strukturnimi elementi, ki znatno prispevajo k funkcionalnim značilnostim učinkovine.
Such an additional structural element(s) can be conjugated, fused or linked by other means to the therapeutic moiety or can be an extension of the therapeutic moiety protein backbone by additional amino acids.
Takšni dodatni strukturni elementi so lahko konjugirani, združeni ali drugače povezani s terapevtskim delom učinkovine ali pa so podaljšanje proteinskega ogrodja terapevtskega dela učinkovine z dodatnimi aminokislinami.
Substances with structural elements for which similar methods of modification or conjugation technology are used shall normally result in similar substances.
Snovi s strukturnimi elementi, za katere se uporabljajo podobne metode tehnologije spreminjanja ali konjugacije, so običajno podobne snovi.
Biological active substances that differ from the original biological substance only with respect to minor changes in the molecular structure shall be considered similar.
Biološke učinkovine, ki se od izvirne biološke snovi razlikujejo le glede na manjše spremembe v molekulski strukturi, se štejejo za podobne.
Proteinaceous substances:
Za proteinske snovi velja naslednje: