natgillin/translations-raw huggingface dataset:
(c) Ali je treba določiti najvišjo ali začasno mejno vrednost ostanka za farmakološko aktivno snov v zdravilih za uporabo v veterinarski medicini, raven navedene najvišje dovoljene vrednosti ostankov in po potrebi kakršne koli pogoje ali omejitve za uporabo zadevne snovi.
(c) whether or not a maximum residue limit or a provisional maximum residue limit should be established for a pharmacologically active substance in veterinary medicinal products, the level of that maximum residue limit and, where appropriate, any conditions or restrictions for the use of the substance concerned;
Ta del besedila je nepotreben, zato bi ga bilo treba črtati.
Should be deleted as it is unnecessary.
Člen 7 – odstavek 1 a (novo)
Article 7 - paragraph 1 a (new)
Nominalna karenca pri zdravilih za uporabo v veterinarski medicini, ki nimajo mejne vrednosti ostankov za kopitarje, niso vključena v Prilogo IV Uredbe (EGS) št. 2377/90 ali člen 13(2) te uredbe in katerih uporaba „ni v skladu s povzetkom značilnosti zdravil“, kakor je opredeljeno v členu 1(16) Direktive 2001/82/ES, in se uporabljajo „v skladu s določbami kaskadnega postopka“ ter se ne dajejo v mišico ali podkožno, je šest mesecev.
Veterinary medicinal products which do not have a maximum residue limit for equidae , which are not included in Annex IV of Regulation (EEC) No 2377/90 or in Article 13(2) of this Regulation, and which are used "off-label", as defined in Article 1(16) of Directive 2001/82/EC, and "under the provisions of the cascade" and not administered intra-muscularly or subcutaneously, shall have a nominal withdrawal period of six months.
Nujno je treba racionalizirati določbe o mejnih vrednostih ostankov za kopitarje, da bi zaščitili njihovo zdravje in dobro počutje brez trajnega umika iz prehranjevalne verige in brez tveganja za potrošnike.
There is an urgent need to rationalise the provisions with regard to MRLs in equidae to protect their health and welfare without permanent withdrawal from the food chain and without any risk to consumers.
Kopitarje bi bilo treba zdraviti z najboljšim, kar omogoča sodobna znanost.
Equidae should be treated with the best of what modern science can offer.
Strokovno pregledani znanstveni izsledki jasno kažejo, da takšnih ostankov npr. od oralne ali intravenozne uporabe po šestih mesecih ne bi bilo v mišičnem mesu, kar omogoča precejšnjo časovno varnostno rezervo.
Peer-reviewed science clearly indicates that no such residues would exist in muscle meat e.g. from oral or intravenous administration after six months, which allows a large safety margin on time.
Člen 7 – odstavek 1 b (novo)
Article 7 - paragraph 1 b (new)
Nominalna karenca za uporabo farmacevtskih izdelkov s farmakološko aktivnimi sestavinami, ki niso na seznamu „bistvenih“ snovi ali na „pozitivnem seznamu“ za kopitarje iz člena 10(3) Direktive 2001/82/ES in se ne dajejo v mišico ali podkožno, je šest mesecev.
The use of pharmaceuticals containing pharmacologically active ingredients not on "the essential" substances list or the "positive list" for equidae referred to in Article 10(3) of Directive 2001/82/EC and not administered intra-muscularly or subcutaneously, shall have a nominal withdrawal period of six months.
Člen 8 – odstavek 2
Article 8 - paragraph 2
Agencija zagotovi, da je mnenje Odbora podano v 210 dneh od prejma veljavne vloge v skladu s členom 3 in odstavkom 1 tega člena.
The Agency shall ensure that the opinion of the Committee is given within 210 days following the receipt of a valid application in accordance with Article 3 and paragraph 1 of this Article.
Ta časovni rok se prekliče, kadar Agencija zahteva predložitev dodatnih informacij o zadevni snovi v določenem obdobju, preklic pa traja do predložitve zahtevanih dodatnih informacij.
This time limit shall be suspended when the Agency requests the submission of supplementary information on the given substance within a specific time period, and until such time as the supplementary information requested has been provided.
Agencija zagotovi, da je mnenje Odbora podano v 210 dneh od prejema veljavne vloge v skladu s členom 3 in odstavkom 1 tega člena.
The Agency shall ensure that the opinion of the Committee is given within 210 days following the receipt of a valid application in accordance with Article 3 and paragraph 1 of this Article.
Ta časovni rok se prekliče, če in kadar Agencija zahteva predložitev dodatnih informacij o zadevni snovi v določenem obdobju, preklic pa traja do predložitve zahtevanih dodatnih informacij.
This time limit shall be suspended if and when the Agency requests the submission of supplementary information on the given substance within a specific time period, and until such time as the supplementary information requested has been provided.
Predlog spremembe je namenjen pojasnitvi besedila.
This amendment clarifies the text.
Člen 8 – odstavek 4 a (novo)
Article 8 - paragraph 4 a (new )
V posebnih primerih, kjer je dovoljenje nujno za zagotovitev zaščite človekovega zdravja ter zdravja in blaginje živali, lahko Komisija v skladu z regulativnim postopkom s pregledom iz člena 21(3) določi začasno najvišjo mejno vrednost za obdobje največ pet let.
In specific cases where urgent authorisation is required to ensure the protection of human health and animal health and welfare, the Commission may, in accordance with the regulatory procedure with scrutiny referred to in Article 21(3), establish a provisional maximum residue limit for a period not exceeding five years.
V nekaterih primerih je morda potrebno izdati nujno dovoljenje za uporabo zdravil ali drugih proizvodov za boj proti boleznim živali ali za zagotovitev njihovega dobrega počutja (npr. v boju proti prenašalcem novih kužnih bolezni ali pri farmakološkem zdravljenju nekaterih epidemij).
It may in some cases be necessary to proceed to an urgent authorisation for the use of medicines or other products for combating animal diseases or ensuring animal welfare (e.g. when fighting carriers of newly appeared infectious diseases or in the pharmacological treatment of certain epidemics).
Kadar to zahteva resnost položaja in da bi odvrnili veliko škodo za zdravje in dobro počutje živali, mora biti za določitev začasnih MVO na voljo nujni postopek.
Where the seriousness of the situation calls for it and in order to avert major damage to animal health and welfare, an emergency procedure should be available for setting a provisional MRL.
Člen 9 – odstavek 1
Article 9 - paragraph 1
Za snovi, ki niso namenjene za uporabo v zdravilih za uporabo v veterinarski medicini, ki se dajajo na trg Skupnosti, in kadar ni bila vložena nobena vloga za takšne snovi v skladu s členom 3, lahko Komisija ali države članice posredujejo Agenciji zahtevek za mnenje o mejnih vrednostih ostankov.
For substances not intended for use in veterinary medicinal products to be placed on the market in the Community and where no application for such substances has been made in accordance with Article 3, the Commission or Member States may forward to the Agency requests for an opinion on maximum residue limits.
Komisija , države članice ali tretja stran, ki zastopa upravičene interese, lahko posredujejo Agenciji zahtevke za mnenje o mejnih vrednostih ostankov za farmakološko aktivne snovi v enem od naslednjih primerov:
The Commission, Member States or a third party pursuing legitimate interests may forward to the Agency requests for an opinion on maximum residue limits for pharmacologically active substances in any of the following circumstances:
Uporabljajo se členi 4 do 8.
Articles 4 to 8 shall apply.
(a) zadevna snov je odobrena za uporabo v zdravilu za uporabo v veterinarski medicini v tretji državi in v zvezi s to snovjo ni bila predložena nobena vloga v skladu s členom 3, ali
(a) the substance in question is authorised for use in a veterinary medicinal product in a third country and no application in respect of that substance has been submitted pursuant to Article 3, or
(b) zadevna snov je vključena v zdravilo, namenjeno za uporabo v skladu s členom 11 Direktive 2001/82/ES, vendar v zvezi s to snovjo ni bila predložena nobena vloga v skladu s členom 3, ali
(b) the substance in question is included in a medicinal product intended to be used pursuant to Article 11 of Directive 2001/82/EC but no application in respect of that substance has been submitted pursuant to Article 3, or
(c) zadevna snov je vključena v biocidni proizvod, ki se uporablja pri vzreji živali, mejna vrednost ostankov pa mora biti določena v skladu s členom 10(2)(ii)(b) Direktive 98/8/ES, ali
(c) the substance in question is included in a biocidal product used in animal-rearing and a maximum residue limit must be established pursuant to Article 10(2)(ii)(b) of Directive 98/8/EC, or
(d) zadevna snov se lahko uporablja za učinkovito zdravljenje živali, kadar gre za manj pomembne vrste ali uporabe v manjši meri, za katere še ni specifičnih zdavil.
(d) the substance in question can be used to treat animals effectively, in the case of minor species or minor uses, where no specific medicines yet exist.
V okoliščinah iz odstavka 1(d), ko gre za manj pomembne vrste ali uporabe v manjši meri, lahko zahtevek Agenciji posreduje zainteresirana stran ali organizacija.
In the circumstances of paragraph 1 (d), where minor species or uses are concerned, the request may be forwarded to the Agency by an interested party or organisation.
Uporabljajo se členi 4 do 7.
Articles 4 to 7 shall apply.
Zahtevki za mnenje iz odstavka 1 tega člena izpolnjujejo zahteve glede oblike in vsebine, ki jih določi Komisija v skladu s členom 12(1).
The applications for an opinion which are referred to in paragraph 1 of this Article shall comply with the format and content requirements laid down by the Commission pursuant to Article 12(1).
Namen predloga spremembe je na uporaben in pozitiven način pojasniti besedilo člena 9.
The amendment seeks to make a useful and positive clarification to the wording in Article 9.
Uvedba možnosti za določanje mejnih vrednosti ostankov brez dovoljenja za promet bi bila učinkovito orodje za razpoložljivost.
Creating possibilities to fix MRLs in the absence of a marketing authorisation would be a powerful tool for availability.
Organizacijam proizvajalcev in znanstvenikom bi omogočila, da predloži vlogo za mejno vrednost ostankov, farmacevtske družbe pa bi spodbudila k razvoju zdravil za uporabo v veterinarski medicini, zlasti za manj pomembne vrste ali uporabe v manjši meri.
It would enable producer's organisations and scientists to submit an application for an MRL and would provide an incentive to pharmaceutical companies to develop veterinary medicinal products - particularly for minor species or minor uses.
Zlasti bi obravnavala pomisleke proizvajalcev medu in čebelarjev glede razpoložljivosti zdravil.
It would in particular address the medicines availability concerns expressed by honey producers and bee keepers.
Člen 9 – odstavek 3 a (novo)
Article 9 — paragraph 3 a (new)
Odstavki 1 do 3 se smiselno uporabljajo za dovoljene farmakološko aktivne snovi, pri katerih so stroški za postopek določanja mejnih vrednosti ostankov zaradi manjše razširjenosti živalske vrste ali zaradi njenega manjšega gospodarskega pomena (uporaba v manjši meri) nesorazmerni z ekonomskim donosom snovi.
Paragraphs 1 to 3 shall apply mutatis mutandis to authorised pharmacologically active substances for which the cost of the procedure for establishing residue limits is disproportionate in relation to the economic revenue from the substance on account of the limited distribution of the animal species or their minor economic significance (‘minor uses’).
V primeru ekstrapolacije med različnimi živalskimi vrstami je za določitev mejnih vrednosti ostankov treba uporabiti varnostni faktor .
In the event of extrapolation between different animal species, a safety factor shall be applied when setting maximum residue limits.
Komisija lahko v skladu z regulativnim postopkom s pregledom iz člena 20(3) določi natančnejše pogoje uporabe tega odstavka.
The Commission may, in accordance with the regulatory procedure with scrutiny referred to in Article 20(3), establish more precise requirements for the application of this paragraph.
Ekstrapolacija, ki jo ureja člen 5, ne razreši vseh težav manjše dostopnosti zdravil za uporabo v veterinarski medicini pri živalskih vrstah manjšega gospodarskega pomena ali pri katerih postopek določitve mejnih vrednosti ostankov zaradi manjše prodaje ne bi bil smiseln za gospodarstvo.
Extrapolation, as referred to in Article 5, does not solve all the problems relating to the limited availability of veterinary medicinal products for animal species of minor economic significance or for species for which a procedure setting limits would not make economic sense on account of the low levels of revenue involved.
Predlog spremembe poskuša rešiti težavo, ki je pogosto zelo resna z vidika zaščite in zdravja živali, čeprav bi bila poglobljena razprava nedvomno še vedno dobrodošla.
The amendment seeks to solve this real problem, which is often a serious one for animal protection and animal health, although a more in—depth discussion would certainly still be desirable.
Kadar Komisija, vložnik po členu 3 ali država članica po členu 9 na podlagi novih podatkov meni, da je potrebna proučitev mnenja za varovanje zdravja ljudi in živali, lahko od Agencije zahteva izdajo novega mnenja o zadevni vsebini.
Where the Commission, the applicant under Article 3, or a Member State under Article 9, as a result of new information, considers that a review of an opinion is necessary in order to protect human or animal health, it may request the Agency to issue a new opinion on the substances in question.
Kadar Komisija, vsaka oseba, ki predloži vlogo za mnenje v skladu s členom 3 , ali država članica po členu 9 na podlagi novih podatkov meni, da je potrebna proučitev mnenja za varovanje zdravja ljudi in živali, lahko od Agencije zahteva izdajo novega mnenja o zadevni vsebini.
Where the Commission, any person who has submitted an application for an opinion pursuant to Article 3, or a Member State under Article 9, as a result of new information, considers that a review of an opinion is necessary in order to protect human or animal health, it may request the Agency to issue a new opinion on the substances in question.
Zahtevku mora biti priloženo pojasnilo vprašanja, ki ga je treba obravnavati.
That request shall be accompanied by information explaining the issue to be addressed.
Člen 8(2) in (4) oziroma člen 9(2) in (3) se uporabljata za novo mnenje.
Article 8(2) and (4) or Article 9(2) and (3) respectively shall apply to the new opinion.
Člen 8(2) do (4) oziroma člen 9(2) in (3) se uporabljata za novo mnenje.
Article 8(2) to (4) or Article 9(2) and (3) respectively shall apply to the new opinion.
Predlagano novo besedilo natančno določa, kdo lahko zahteva proučitev in v kakšnih okoliščinah lahko to stori, in sicer:
The proposed new text makes it clear who may request a review and under what circumstances, namely:
– osebe, ki so predložile vlogo za mnenje v skladu s členom 3, lahko zahtevajo njeno preučitev, ter
- persons who have applied for an opinion pursuant to Article 3 may request a review thereof, and
– Komisija in države članice lahko zahtevajo preučitev ne le v zvezi z mnenji, ki so jih zahtevale v skladu s členom 9, ampak tudi v zvezi s tistimi, za katera so v skladu s členom 3 predložile vlogo tretje strani.
- the Commission and the Member States may request a review not only in respect of the opinions which they have promoted pursuant to Article 9, but also in respect of those promoted by third parties pursuant to Article 3.
Člen 12 – odstavek 1 – uvodni del
Article 12 — paragraph 1 — introductory part
Komisija v skladu z regulativnim postopkom iz člena 20(2) in v posvetovanju z Agencijo sprejme naslednje :
In accordance with the regulatory procedure referred to in Article 20(2), the Commission shall, in consultation with the Agency, adopt the following :
Komisija v posvetovanju z Agencijo sprejme pravila o :
The Commission shall, in consultation with the Agency, adopt rules on :
Člen 12 – odstavek 1 – pododstavek 1 a (novo)
Article 12 — paragraph 1 — subparagraph 1 a (new)
V primeru točke a) poteka določitev v skladu z regulativnim postopkom iz člena 21(2) in v primeru točke b) v skladu z regulativnim postopkom s pregledom iz člena 21(3).
Decisions shall be made, in the case of point (a), in accordance with the regulatory procedure referred to in Article 21(2) and, in the case of point (b), in accordance with the regulatory procedure with scrutiny referred to in Article 21(3).
Določitev metodologije za oceno tveganja in upravljanja s tveganjem je osrednji vidik te uredbe, zato bi moral pri njenem sprejetju sodelovati tudi Evropski parlament.
Defining the methodology of the risk assessment and of risk management is a central aspect of this regulation and the European Parliament should therefore be involved in its adoption.
Zato se predlaga, da se regulativni postopek spremeni v regulativni postopek s pregledom.
Therefore, a change from the regulatory procedure to the regulatory procedure with scrutiny is proposed.
Isti postopek se med drugim predvidi tudi za določitev ekstrapolacije v odstavku 2 tega člena.
Moreover, the same procedure is provided for in the case of decisions on extrapolation in paragraph 2.
Člen 12 – odstavek 2 – pododstavek 1
Article 12 - paragraph 2 - subparagraph 1
Komisija v posvetovanju z Agencijo sprejme pravila o uporabi mejnih vrednosti ostankov posameznega živila za drugo živilo enake vrste ali ene ali več vrst za druge vrste, kakor je navedeno v členu 5.
The Commission shall, in consultation with the Agency, adopt rules on the use of a maximum residue level of a particular foodstuff for another foodstuff of the same species, or of one or more species for other species as referred to in Article 5.
Navedena pravila določajo, kako in v kakšnih okoliščinah se lahko uporabijo znanstveni podatki o ostankih v posameznem živilu ali vrsti ali več vrstah za določanje mejnih vrednosti ostankov v drugih živilih ali drugih vrstah.
Those rules shall specify how and under what circumstances scientific data on residues in a particular foodstuff or in a species or more species may be used for setting a maximum residue limit in other foodstuffs, or other species.
Komisija v posvetovanju z Agencijo in zainteresiranimi stranmi sprejme pravila o uporabi mejnih vrednosti ostankov posameznega živila za drugo živilo enake vrste ali ene ali več vrst za druge vrste, kakor je navedeno v členu 5.
The Commission shall, in consultation with the Agency and interested parties , adopt rules on the use of a maximum residue level of a particular foodstuff for another foodstuff of the same species, or of one or more species for other species as referred to in Article 5.
Posvetovanje z zainteresiranimi stranmi je del ustaljene prakse politike Komisije za boljšo ureditev.
Consultation of stakeholders forms part of the standard practice of the Commission's better regulation policy.
Člen 13 – odstavek 2 – točka (d)
Article 13 – paragraph 2 – point (d)
(d) prepoved dajanja snovi.
(d) a prohibition on the administration of a substance.
(d) prepoved prisotnosti snovi ali njenih ostankov v proizvodu živalskega izvora .
(d) a prohibition on the presence of a substance or residues thereof in a product of animal origin .
Če prisotnost snovi ali njenih ostankov v kakršni koli količini v živilih živalskega izvora predstavlja nevarnost za zdravje ljudi, je treba prepovedati prodajo takšnih proizvodov.
If the presence of a substance or residues thereof in animal-based foods constitutes a human health risk, irrespective of the quantity present, the marketing of products in which it may be detected should be banned.
Prepoved dajanja snovi ni dovolj, poleg tega pa Evropa nima možnosti prepovedi dajanja snovi v tretjih državah.
It is not enough to prohibit its administration.
Tako besedilo bi pomenilo, da je snov prepovedana le v evropskih proizvodih in ne tudi v uvoženih.
Furthermore, Europe cannot ban the administration of a substance in third countries, so the wording would mean that a substance would be prohibited in European products only, and not in imported products.
Člen 13 – odstavek 3
Article 13 — paragraph 3
Mejno vrednost ostankov je treba določiti, kadar se zdi to potrebno za varovanje zdravja ljudi na podlagi mnenja Agencije v skladu s členi 4, 9 ali 10 ali glede na strinjanje Skupnosti z določitvijo najvišje dovoljene vrednosti ostankov za farmakološko aktivno snov, namenjeno za uporabo v zdravilih za uporabo v veterinarski medicini v Codex Alimentarius .
A maximum residue limit shall be laid down where it appears necessary for the protection of human health pursuant to an opinion of the Agency in accordance with Articles 4, 9 or 10 or pursuant to a vote by the Community in favour of the establishment of a maximum residue limit for a pharmacologically active substance intended for use in a veterinary medicinal product in the Codex Alimentarius .
V zadnjem primeru se dodatna ocena Agencije ne zahteva.
In the latter case an additional assessment by the Agency is not required.
Mejno vrednost ostankov je treba določiti, kadar se zdi to potrebno za varovanje zdravja ljudi :
A maximum residue limit shall be laid down where it appears necessary for the protection of human health :
(a) na podlagi mnenja Agencije v skladu s členi 4, 9 ali 10 ; ali
(a) pursuant to an opinion of the Agency in accordance with the Articles 4, 9 or 10; or
(b) glede na glasovanje Delegacije Skupnosti pri Codexu Alimentariusu za določitev najvišje dovoljene vrednosti ostankov za farmakološko aktivno snov, namenjeno za uporabo v zdravilih za uporabo v veterinarski medicini , pod pogojem, da je imel predstavnik Skupnosti v Codexu Alimentariusu omenjene znanstvene podatke na voljo pred glasovanjem v komisiji Codex Alimentarius.
(b) pursuant to a vote by the Community Delegation at the Codex Alimentarius in favour of the establishment of a maximum residue limit for a pharmacologically active substance intended for use in a veterinary medicinal product, provided that the scientific data taken into consideration have been made available to the Community representative in Codex Alimentarius prior to the vote in the Codex Alimentarius Commission .
V tem primeru se dodatna ocena Agencije ne zahteva.
In this case an additional assessment by the Agency is not required.
Predlog spremembe zagotavlja večjo preglednost odločitev v Codexu.
This amendment shall increase the transparency of Codex decisions.
Člen 13 – odstavek 4 – pododstavek 1
Article 13 - paragraph 4 - subparagraph 1
Začasna mejna vrednost ostankov se lahko določi za farmakološko aktivno snov, kadar so znanstveni podatki nepopolni, pod pogojem, da ni razloga za domnevo, da ostanki zadevne snovi na predlagani ravni ogrožajo zdravje ljudi.
A provisional maximum residue limit may be established for a pharmacologically active substance in cases where scientific data are incomplete, provided that there are no grounds for supposing that residues of the substance concerned at the level proposed present a hazard for human health.
Začasna mejna vrednost ostankov se lahko določi za farmakološko aktivno snov, kadar so znanstveni podatki nepopolni, pod pogojem, da ni razloga za domnevo, da ostanki zadevne snovi na predlagani ravni predstavljajo tveganje za zdravje ljudi.
A provisional maximum residue limit may be established for a pharmacologically active substance in cases where scientific data are incomplete, provided that there are no grounds for supposing that residues of the substance concerned at the level proposed present a risk for human health.
Člen 13 – odstavek 6 – uvodni del in točka (a)
Article 13 – paragraph 6 – introductory part and point (a)
Dajanje snovi živalim za proizvodnjo živil je prepovedano na podlagi mnenja v skladu s členi 4, 9 ali 10 v katerem koli od naslednjih primerov:
The administration of a substance to food-producing animals shall be prohibited, pursuant to an opinion in accordance with Articles 4, 9 or 10, in either of the following circumstances: