natgillin/translations-raw huggingface dataset:
Complaints and product recall
Nosilci dejavnosti poslovanja s krmo vzpostavijo sistem za takojšnji umik medicirane krme ali vmesnih proizvodov iz prometa in po potrebi za odpoklic medicirane krme ali vmesnih proizvodov iz distribucijske mreže, če se izkaže, da ne izpolnjujejo zahtev iz te uredbe.
Feed business operators placing medicated feed and intermediate products on the market shall implement a system for registering and processing complaints.
Nosilci dejavnosti poslovanja s krmo s pisnimi postopki določijo ciljni kraj za odpoklicane proizvode, preden gredo taki proizvodi spet v promet, pa nosilci dejavnosti poslovanja s krmo ponovno ocenijo njihovo kakovost, da bi zagotovili izpolnjevanje zahtev Unije glede varnosti krme.
Feed business operators shall put in place a system for the prompt withdrawal from the market of medicated feed or intermediate products and, if necessary, for the recall of medicated feed or intermediate products from the distribution network in case they fail to comply with the requirements of this Regulation.
ODDELEK 8
Feed business operators shall define by means of written procedures the destination of any recalled products, and before such products are put back into circulation the feed business operators shall carry out a quality-control reassessment to ensure that the Union feed safety requirements are complied with.
Dodatne zahteve za mobilne mešalce
SECTION 8
Mobilni mešalci imajo v vozilu na voljo izvod naslednjih dokumentov v uradnem jeziku države članice, v kateri poteka proizvodnja medicirane krme:
Additional requirements for mobile mixers
odobritev pristojnega organa države članice, v kateri je mobilni mešalec odobren, da lahko zadevni mobilni mešalec proizvaja medicirano krmo;
Mobile mixers shall have a copy of the following documents available in the vehicle, in the official language of the Member State where the manufacture of medicated feed takes place:
načrt kontrole kakovosti iz oddelka 4 te priloge;
the approval of the designated mobile mixer for the manufacture of medicated feed from the competent authority from the Member State where the mobile mixer is approved;
načrt čiščenja iz oddelka 1 te priloge;
the quality control plan provided for in Section 4 of this Annex;
seznam oseb, odgovornih za proizvodnjo medicirane krme iz oddelka 2 te priloge.
the cleaning plan referred to in Section 1 of this Annex;
Mobilni mešalci sprejmejo vse ustrezne previdnostne ukrepe za preprečitev širjenja bolezni.
the list of persons responsible for the manufacture of medicated feed referred to in Section 2 of this Annex.
Vozila, ki se uporabljajo za proizvodnjo medicirane krme, se po vsaki uporabi za proizvodnjo medicirane krme očistijo, da se prepreči vsakršno tveganje za navzkrižno kontaminacijo.
Mobile mixers shall take all the appropriate precautionary measures to prevent the spread of diseases.
Če so na voljo številke registrskih tablic vozil, mobilni mešalci uporabljajo samo tista vozila, katerih številka registrske tablice je bila priglašena pristojnemu organu.
Vehicles used for the manufacture of medicated feed shall be cleaned after each use for the manufacture of medicated feed to avoid any risk of cross-contamination.
PRILOGA II
Where vehicle registration plate numbers are available, mobile mixers shall use only those vehicles whose vehicle registration plate numbers have been notified to the competent authority.
SEZNAM PROTIMIKROBNIH UČINKOVIN IZ ČLENA 7(3)
ANNEX II
Učinkovina
LIST OF ANTIMICROBIAL ACTIVE SUBSTANCES AS REFERRED TO IN ARTICLE 7(3)
amoksicilin
Active substance
amprol
Amoxicillin
apramicin
Amprolium
klortetraciklin
Apramycin
kolistin
Chlortetracycline
doksiciklin
Colistin
florfenikol
Doxycycline
flumekin
Florfenicol
linkomicin
Flumequine
neomicin
Lincomycin
spektinomicin
Neomycin
sulfonamidi
Spectinomycin
tetraciklin
Sulfonamides
oksitetraciklin
Tetracycline
oksolinska kislina
Oxytetracycline
paromomicin
Oxolinix Acid
penicilin V
Penicillin V
tilmikozin
Tiamulin
trimetoprim
Tiamfenicol
tilozin
Tilmicosin
tilvalozin
Tylosin
POSEBNE ZAHTEVE GLEDE OZNAČEVANJA IZ ČLENA 9(1)
Valnemulin
Oznake za medicirano krmo in vmesne proizvode vključujejo naslednje podatke, navedene na enostaven, jasen in lahko razumljiv način za končne uporabnike:
Tylvalosin
izraz „medicirana krma“ ali „vmesni proizvod za proizvodnjo medicirane krme“, kot je ustrezno;
ANNEX III
številko odobritve nosilca dejavnosti poslovanja s krmo, odgovornega za označevanje.
SPECIFIC LABELLING REQUIREMENTS REFERRED TO IN ARTICLE 9(1)
V primerih, ko proizvajalec ni nosilec dejavnosti poslovanja s krmo, odgovoren za označevanje, se zagotovi naslednje:
The label of medicated feed and intermediate products shall include the following particulars, in a simple, clear and easily understandable manner for the end users:
ime ali trgovsko ime in naslov proizvajalca ali
the expression ‘Medicated feed’ or ‘Intermediate product for the manufacturing of medicated feed’ as appropriate;
številka odobritve proizvajalca;
the approval number of the feed business operator responsible for the labelling.
učinkovine z imenom, dodano količino (mg/kg) in zdravili za uporabo v veterinarski medicini pod naslovom „zdravila“ s številko dovoljenja za promet in imetnikom dovoljenja za promet;
In cases where the manufacturer is not the feed business operator responsible for the labelling, the following shall be provided:
morebitne kontraindikacije zdravil za uporabo v veterinarski medicini in neželene dogodke, če so ti podatki potrebni za uporabo;
the name or business name and address of the manufacturer; or
karenco ali navedbo „ni karence“ v primeru medicirane krme ali vmesnega proizvoda za živali za proizvodnjo živil;
the approval number of the manufacturer;
v primeru medicirane krme za živali, ki niso namenjene proizvodnji živil, razen za kožuharje, opozorilo, da je medicirana krma namenjena le za zdravljenje živali ter da jo je treba hraniti zunaj pogleda in dosega otrok;
the active substances with name, added amount (mg/kg), and the veterinary medicinal products with its marketing authorisation number and the marketing authorisation holder, preceded by the heading ‘medication’;
brezplačno telefonsko številko ali drugo ustrezno sredstvo komunikacije, kjer lahko imetnik živali poleg obveznih podatkov dobi zloženko za posamezno zdravilo za uporabo v veterinarski medicini;
any contra-indications of the veterinary medicinal products and adverse events in so far as those particulars are necessary for the use;
navodila za uporabo v skladu z veterinarskim receptom za medicirano krmo ali povzetek glavnih značilnosti zdravila;
in the case of a medicated feed or of intermediate product intended for food-producing animals, the withdrawal period or the indication ‘no withdrawal period’;
minimalen rok skladiščenja, ki upošteva rok uporabnosti zdravil za uporabo v veterinarski medicini in se izrazi z besedami „porabiti do …“ in datumom, ter posebna navodila za skladiščenje, če je to ustrezno;
in the case of medicated feed for non-food-producing animals, except fur animals, a warning that the medicated feed is only for the treatment of animals and a warning that it must be kept out of the sight and reach of children;
informacije o tem, da neustrezno odlaganje medicirane krme pomeni resno grožnjo za okolje in lahko, kjer je to ustrezno, prispeva k mikrobni odpornosti.
a free telephone number or other appropriate means of communication in order to allow the animal keeper to obtain, in addition to the mandatory particulars, the package leaflet of each veterinary medicinal product;
Točke 1 do 10 se ne uporabljajo za mobilne mešalce, ki proizvajajo izključno medicirano krmo in ne dobavljajo nobenih sestavin.
the instructions for use in line with the veterinary prescription for medicated feed or the summary of the product characteristics;
PRILOGA IV
the minimum storage life, which shall take into account the expiry dates of the veterinary medicinal products and shall be expressed as ‘use before…’, followed by the date, and special storage precautions, if appropriate;
DOVOLJENA ODSTOPANJA OD NAVEDENE SESTAVE MEDICIRANE KRME ALI VMESNIH PROIZVODOV IZ ČLENA 9(3)
information that inappropriate disposal of medicated feed poses serious threats to the environment and may, where relevant, contribute to antimicrobial resistance.
Odstopanja iz te priloge vključujejo samo tehnična odstopanja.
Points 1 to 10 shall not apply to mobile mixers exclusively manufacturing the medicated feed without supplying any components.
Kadar se ugotovi, da sestava medicirane krme ali vmesnega proizvoda odstopa od količine protimikrobne učinkovine, navedene na oznaki, se uporabi 10-odstotno odstopanje.
ANNEX IV
Za druge učinkovine se uporabljajo naslednja odstopanja:
PERMITTED TOLERANCES FOR THE COMPOSITIONAL LABELLING OF MEDICATED FEED OR INTERMEDIATE PRODUCTS AS REFERRED TO IN ARTICLE 9(3)
Učinkovina na kg medicirane krme ali vmesnega proizvoda
The tolerances laid down in this Annex shall only include technical deviations.
Odstopanje
Where the composition of a medicated feed or an intermediate product is found to deviate from the amount of an antimicrobial active substance indicated on the label, a tolerance of 10 % shall apply.
PRILOGA V
For the other active substances, the following tolerances shall apply:
INFORMACIJE, KI MORAJO BITI VKLJUČENE V VETERINARSKI RECEPT ZA MEDICIRANO KRMO IZ ČLENA 16(6)
Active substance per kg of medicated feed or intermediate products
VETERINARSKI RECEPT ZA MEDICIRANO KRMO
Tolerance
Polno ime in kontaktni podatki veterinarja, vključno s poklicno identifikacijsko številko, če je na voljo.
ANNEX V
Datum izdaje, edinstvena številka recepta, datum, ko poteče veljavnost recepta (če je rok veljavnosti krajši kot rok iz člena 16(8)) ter podpis ali enakovredna elektronska oblika identifikacije veterinarja.
INFORMATION TO BE INCLUDED IN THE VETERINARY PRESCRIPTION FOR MEDICATED FEED AS REFERRED TO IN ARTICLE 16(6)
Polno ime in kontaktni podatki imetnika živali in identifikacijska številka ustanove, če obstaja.
VETERINARY PRESCRIPTION FOR MEDICATED FEED
Identifikacija (vključno s kategorijo, vrsto in starostjo) in število živali ali, kadar je to ustrezno, teža živali.
Full name and contact details of the veterinarian including, if available, the professional number.
Diagnosticirana bolezen, ki jo je treba zdraviti.
Issue date, unique number of prescription, expiry date of prescription (if the validity is shorter than that referred to in Article 16(8)) and signature or an equivalent electronic form of identification of the veterinarian.
V primeru imunoloških zdravil za uporabo v veterinarski medicini ali antiparazitikov brez protimikrobnega učinka, bolezni, ki jih je treba preprečiti.
Full name and contact details of the animal keeper, and identification number of the establishment, if existing.
Oznaka (ime in številka dovoljenja za promet) zdravila ali zdravil za uporabo v veterinarski medicini, vključno z imenom učinkovine ali učinkovin.
Identification (including category, species and age) and number of animals or, where appropriate, the weight of the animals.
Če je recept za zdravilo za uporabo v veterinarski medicini izdano v skladu s členom 107(4), členom 112, členom 113 ali členom 114 Uredbe (EU) 2019/6, se predloži izjava o tem.
Diagnosed disease to be treated.
Stopnja vsebnosti zdravila ali zdravil za uporabo v veterinarski medicini in učinkovine ali učinkovin (količina na enoto teže medicirane krme).
In the case of immunological veterinary medicinal products or antiparasitics without antimicrobial effects, disease to be prevented.
Količina medicirane krme.
Designation (name and marketing authorisation number) of the veterinary medicinal product or products, including the name of the active substance or substances.
Navodila za uporabo za imetnika živali, vključno s trajanjem zdravljenja.
If the veterinary medicinal product is prescribed under Article 107(4), Article 112, Article 113 or Article 114, of Regulation (EU) 2019/6, a statement to that effect.
Odstotek medicirane krme v dnevnem obroku ali količina medicirane krme na žival na dan.
Inclusion rate of the veterinary medicinal product or products and active substance or substances (quantity per weight unit of medicated feed).
Pri živalih za proizvodnjo živil karenca, tudi če je karenca nič.
Quantity of medicated feed.
Morebitna opozorila, potrebna za zagotovitev pravilne uporabe, vključno s previdno uporabo protimikrobnih snovi, kjer je to ustrezno.
Instructions for use for the animal keeper, including the duration of the treatment.
Pri živalih za proizvodnjo živil in kožuharje navedba ‚Tega recepta ni dovoljeno ponovno uporabiti‘.
Percentage of medicated feed in the daily ration or quantity of medicated feed per animal and day.
Naslednje navedbe vnese dobavitelj medicirane krme ali mešalec na kmetijskem gospodarstvu, kot je ustrezno:
For food-producing animals, withdrawal period, even if such period is zero.
ime ali trgovsko ime in naslov,
Any warnings necessary to ensure the proper use including, where relevant, to ensure prudent use of antimicrobials.
datum dostave ali mešanja na kmetijskem gospodarstvu,
For food-producing animals and fur animals, the mention ‘This prescription shall not be re-used’.
številka serije medicirane krme, dobavljene na podlagi veterinarskega recepta za medicirano krmo, razen za mešalce na kmetijskih gospodarstvih.
The following mentions to be completed by the supplier of the medicated feed or the on-farm mixer, as appropriate:
Podpis dobavitelja imetniku živali ali mešalca na kmetijskem gospodarstvu.
name or business name and address,
PRILOGA VI
date of delivery or of on-farm mixing,
KORELACIJSKA TABELA IZ ČLENA 25
batch number of medicated feed delivered under the veterinary prescription for medicated feed, except for on-farm mixers.
Direktiva 90/167/EGS
Signature of supplier to the animal keeper or of on-farm mixer.
Ta uredba
ANNEX VI
Člen 3(1)
CORRELATION TABLE REFERRED TO IN ARTICLE 25
Člen 5(1)
Directive 90/167/EEC
Člen 3(2)
This Regulation
člen 4(1)
Article 3(1)
Členi 4, 5(2), 6, 7(1), 13, 16 in Priloga I
Article 5(1)
Člen 4(2)
Article 3(2)
Člen 5(2)
Article 4(1)
Člena 4 in 7 ter Priloga I
Articles 4, 5(2), 6, 7(1), 13, 16 and Annex I
Člen 9 in Priloga III
Article 4(2)
Člen 8(1) in (2)
Article 5(2)
Člen 8(3)
Articles 4, 7 and Annex I
Člen 17(6)
Article 9 and Annex III
Člen 9(1)
Article 8(1) and (2)
Člena 13 ter 17(1) in (2)
Article 8(3)
Člen 9(2)
Article 17(6)
Člen 9(3)
Article 9(1)
Člen 12(1)
Articles 13.17(1) and (2)
Člen 17(3), (4) in (5)
Article 9(2)
Člen 17(7)
Article 9(3)
Člen 12(2)
Article 12(1)
Priloga A
Article 17(3), (4) and (5)
Priloga V
Article 17(7)
Priloga B
Article 12(2)
Priloga II
Annex A
Priloga IV
Annex V
Pooblastilo za sprejemanje delegiranih aktov iz členov 7 in 19 se prenese na Komisijo za obdobje petih let od 27. januarja 2019.
Annex B
Komisija pripravi poročilo o prenosu pooblastila najpozneje devet mesecev pred koncem petletnega obdobja.
Regulation (EU) 2019/5 of the European Parliament and of the Council
Uredba (EU) 2019/5 Evropskega parlamenta in Sveta
amending Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, Regulation (EC) No 1901/2006 on medicinal products for paediatric use and Directive 2001/83/EC on the Community code relating to medicinal products for human use
o spremembi Uredbe (ES) št. 726/2004 o postopkih Skupnosti za pridobitev dovoljenja za promet in nadzor zdravil za humano in veterinarsko uporabo ter o ustanovitvi Evropske agencije za zdravila, Uredbe (ES) št. 1901/2006 o zdravilih za pediatrično uporabo in Direktive 2001/83/ES o zakoniku Skupnosti o zdravilih za uporabo v humani medicini
Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114 and Article 168(4)(c) thereof,
ob upoštevanju Pogodbe o delovanju Evropske unije ter zlasti člena 114 in točke (c) člena 168(4) Pogodbe,
Directive 2001/82/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council constituted the Union regulatory framework for the manufacture, authorisation and distribution of veterinary medicinal products.
Direktiva 2001/82/ES Evropskega parlamenta in Sveta ter Uredba (ES) št. 726/2004 Evropskega parlamenta in Sveta sta predstavljali regulativni okvir Unije za proizvodnjo zdravil za uporabo v veterinarski medicini, pridobitev dovoljenj za promet z njimi ter za njihovo distribucijo.
In the light of experience and following the assessment by the Commission of the functioning of the internal market for veterinary medicinal products, the regulatory framework for veterinary medicinal products has been reviewed, and Regulation (EU) 2019/6 of the European Parliament and of the Council on veterinary medicinal products has been adopted, with a view to harmonisation of the laws of the Member States.
Ob upoštevanju izkušenj in na podlagi ocene Komisije glede delovanja notranjega trga za zdravila za uporabo v veterinarski medicini je bil z namenom harmonizacije zakonodaje držav članic regulativni okvir za zdravila za uporabo v veterinarski medicini pregledan, sprejeta pa je bila tudi Uredba (EU) 2019/6 Evropskega parlamenta in Sveta o zdravilih za uporabo v veterinarski medicini.
It is appropriate to maintain in Regulation (EC) No 726/2004 certain provisions relating to veterinary medicinal products, in particular those relating to the European Medicines Agency (‘the Agency’), but as the procedures applicable to the centralised marketing authorisation of veterinary medicinal products are laid down in Regulation (EU) 2019/6, the parts of Regulation (EC) No 726/2004 that relate to procedures for such marketing authorisations and that are covered by Regulation (EU) 2019/6 should be repealed.
V Uredbi (ES) št. 726/2004 je primerno ohraniti nekatere določbe, ki se nanašajo na zdravila za uporabo v veterinarski medicini, zlasti tiste glede Evropske agencije za zdravila (v nadaljnjem besedilu: Agencija), ker pa so postopki, ki se uporabljajo za centralizirana dovoljenja za promet z zdravili za uporabo v veterinarski medicini, določeni v Uredbi (EU) 2019/6, bi bilo treba dele Uredbe (ES) št. 726/2004, ki se nanašajo na postopke za pridobitev takšnih dovoljenj za promet in ki so zajeti z Uredbo (EU) 2019/6, razveljaviti.
The costs of the procedures and services associated with the operation of Regulation (EC) No 726/2004 need to be recovered from undertakings making medicinal products available on the market and from undertakings seeking authorisation.
Stroške postopkov in storitev, povezanih z izvajanjem Uredbe (ES) št. 726/2004, morajo kriti podjetja, ki dajejo zdravila v promet, in podjetja, ki želijo pridobiti dovoljenje.
As Council Regulation (EC) No 297/95 and Regulation (EU) No 658/2014 of the European Parliament and of the Council establish the fees payable to the Agency for the services it provides, it is not necessary to maintain any provisions on the structure and level of those fees in Regulation (EC) No 726/2004.
Uredba Sveta (ES) št. 297/95 in Uredba (EU) št. 658/2014 Evropskega parlamenta in Sveta določata pristojbine, ki se plačujejo Agenciji za storitve, ki jih zagotavlja, zato v Uredbi (ES) št. 726/2004 ni treba ohraniti kakršnih koli določb o strukturi in ravni teh pristojbin.
However, in order to ensure that the entire current legal framework for fees payable to the Agency in relation to medicinal products for human use and veterinary medicinal products remains unchanged until an agreement on changes thereto has been reached, it is appropriate to provide that Commission Regulation (EC) No 2049/2005 remain in force and continue to apply unless and until repealed.
Vendar pa je za zagotovitev, da bo celotni veljavni pravni okvir za pristojbine, ki se plačujejo Agenciji v povezavi z zdravili za uporabo v humani medicini in zdravili za uporabo v veterinarski medicini, ostal nespremenjen, dokler se ne doseže dogovor o njegovih spremembah, primerno določiti, da bo Uredba Komisije (ES) št. 2049/2005 ostala veljavna in se bo uporabljala, razen če in dokler ne bo razveljavljena.
When reviewing the regulatory framework for fees payable to the Agency, the Commission should pay attention to potential risks related to the fluctuations in the fee revenue of the Agency.
Pri pregledu regulativnega okvira za pristojbine, ki se plačujejo Agenciji, bi morala biti Komisija pozorna na morebitna tveganja v zvezi z nihanji v prihodkih, ki jih Agencija prejme od pristojbin.
Before a medicinal product for human use is authorised for placing on the market of one or more Member States, it generally has to undergo extensive studies to ensure that it is safe, of high quality and effective for use in the target population.
Preden je zdravilo za uporabo v humani medicini odobreno za promet v eni ali več državah članicah, je treba na njem navadno opraviti obsežne raziskave, s katerimi naj bi zagotovili njegovo varnost, kakovost in učinkovitost za uporabo pri ciljni populaciji.
However, in the case of certain categories of medicinal products for human use, in order to meet unmet medical needs of patients and in the interest of public health, it may be necessary to grant marketing authorisations on the basis of less complete data than is normally the case.
Vendar pa se pri nekaterih kategorijah zdravil za uporabo v humani medicini lahko zgodi, da je zaradi izpolnjevanja neizpolnjenih zdravstvenih potreb bolnikov in v interesu javnega zdravja treba odobriti dovoljenja za promet na podlagi manj popolnih podatkov kot sicer.
Such marketing authorisations should be granted subject to specific obligations.
Takšna dovoljenja za promet bi bilo treba izdati le, če so izpolnjene posebne obveznosti.
The categories of medicinal products for human use concerned should be the medicinal products, including orphan medicinal products, that aim at the treatment, prevention or medical diagnosis of seriously debilitating or life-threatening diseases, or that are intended to be used in emergency situations in response to public health threats.
Zadevne kategorije zdravil za uporabo v humani medicini bi morale biti zdravila, vključno z zdravili sirote, namenjena za zdravljenje, preprečevanje ali diagnozo resno izčrpavajočih ali življenjsko nevarnih bolezni, ali zdravila, ki se uporabljajo v nujnih primerih v odziv na tveganja za javno zdravje.
Detailed rules on those marketing authorisations which are subject to specific obligations are specified in Commission Regulation (EC) No 507/2006.
Podrobna pravila glede teh dovoljenj za promet, pri katerih je treba upoštevati posebne obveznosti, so navedena v Uredbi Komisije (ES) št. 507/2006.
Those rules should be maintained, but it is appropriate to consolidate them by moving their core elements into Regulation (EC) No 726/2004, while maintaining a delegation of powers that allows the Commission to supplement Regulation (EC) No 726/2004 by adjusting the procedures and provisions for granting and renewal of such marketing authorisations and by specifying the categories of medicinal products that fulfill the requirements of that Regulation for being granted a marketing authorisation subject to specific obligations.
Ta pravila bi bilo treba ohraniti, vendar jih je primerno konsolidirati, in sicer tako, da se v Uredbo (ES) št. 726/2004 vključijo njihovi ključni elementi ter ohrani prenos pooblastil, ki bo Komisiji omogočil dopolnitev Uredbe (ES) št. 726/2004 s prilagoditvijo postopkov in določb za izdajo in podaljšanje takih dovoljenj za promet, ter z navedbo kategorij zdravil, ki izpolnjujejo zahteve navedene uredbe za izdajo dovoljenja za promet, pod pogoji, da se upoštevajo posebne obveznosti.
Marketing authorisations for medicinal products for human use are granted by a competent authority of a Member State pursuant to Directive 2001/83/EC of the European Parliament and of the Council or by the Commission pursuant to Regulation (EC) No 726/2004.
Dovoljenja za promet za zdravila za uporabo v humani medicini izda pristojni organ države članice v skladu z Direktivo 2001/83/ES Evropskega Parlamenta in Sveta ali Komisija v skladu z Uredbo (ES) št. 726/2004.