natgillin/translations-raw huggingface dataset:
An application for a wholesale distribution authorisation shall be submitted to the competent authority in the Member State in which the site or sites of the wholesale distributor are located.
predlagatelj ima načrt ukrepov, ki zagotavlja, da se učinkovito izvede kakršen koli umik ali odpoklic s trga, ki ga odredi pristojni organ ali Komisija ali ki se določi v sodelovanju s proizvajalcem ali imetnikom dovoljenja za promet z zadevnim zdravilom za uporabo v veterinarski medicini;
An applicant shall demonstrate in the application that the following requirements are met:
predlagatelj ima ustrezen sistem vodenja evidenc, ki zagotavlja izpolnjevanje zahtev iz člena 101;
the applicant has at its disposal technically competent staff and in particular at least one person designated as responsible person, meeting the conditions provided for in national law;
predlagatelj ima izjavo o tem, da izpolnjuje zahteve iz člena 101.
the applicant has suitable and sufficient premises complying with the requirements laid down by the relevant Member State as regards the storage and handling of veterinary medicinal products;
Države članice določijo postopke za izdajo, zavrnitev, začasni odvzem, odvzem ali spremembo dovoljenja za promet na debelo.
the applicant has a plan guaranteeing effective implementation of any withdrawal or recall from the market ordered by the competent authorities or the Commission or undertaken in cooperation with the manufacturer or marketing authorisation holder of the veterinary medicinal product concerned;
Postopki iz odstavka 3 ne trajajo dlje kot 90 dni z začetkom, če je to ustrezno, od dneva, ko pristojni organ prejme vlogo v skladu z nacionalnim pravom.
the applicant has an appropriate record-keeping system ensuring compliance with the requirements referred to in Article 101;
Pristojni organ predlagatelja:
the applicant has a statement to the effect that it fulfils the requirements referred to in Article 101.
obvesti o rezultatu vrednotenja;
Member States shall lay down procedures to grant, refuse, suspend, revoke or change a wholesale distribution authorisation.
izda, zavrne ali spremeni dovoljenje za promet na debelo ter
The procedures referred to in paragraph 3 shall not exceed 90 days, starting, if applicable, from the date on which the competent authority receives an application in accordance with national law.
vnese ustrezne informacije o dovoljenju v zbirko podatkov o proizvodnji in prometu na debelo iz člena 91.
The competent authority shall:
Člen 101
inform the applicant of the outcome of the evaluation;
Obveznosti veletrgovcev
grant, refuse or change the wholesale distribution authorisation; and
Veletrgovci pridobijo zdravila za uporabo v veterinarski medicini samo pri imetnikih dovoljenja za proizvodnjo ali drugih imetnikih dovoljenja za promet na debelo.
upload the relevant information of the authorisation in the manufacturing and wholesale distribution database referred to in Article 91.
Veletrgovec zdravila za uporabo v veterinarski medicini dobavlja samo osebam, ki imajo v državi članici dovoljenje za dejavnosti prometa na drobno v skladu s členom 103(1), drugim veletrgovcem zdravil za uporabo v veterinarski medicini na debelo in drugim osebam ali subjektom v skladu z nacionalnim pravom.
Article 101
Imetnik dovoljenja za promet na debelo ima stalno na voljo vse storitve vsaj ene osebe, odgovorne za promet na debelo.
Obligations of wholesale distributors
Veletrgovec v okviru svoje odgovornosti zagotovi ustrezno in neprekinjeno dobavo zdravila za uporabo v veterinarski medicini osebam, ki imajo dovoljenje za njegovo dobavo v skladu s členom 103(1), tako da so potrebe po zdravstvenem varstvu živali v relevantni državi članici zadovoljene.
Wholesale distributors shall obtain veterinary medicinal products only from holders of a manufacturing authorisation or from other holders of a wholesale distribution authorisation.
Veletrgovec ravna v skladu z dobro distribucijsko prakso za zdravila za uporabo v veterinarski medicini iz člena 99(6).
A wholesale distributor shall supply veterinary medicinal products only to persons permitted to carry out retail activities in a Member State in accordance with Article 103(1), other wholesale distributors of veterinary medicinal products and to other persons or entities in accordance with national law.
Veletrgovci nemudoma obvestijo pristojni organ in po potrebi imetnika dovoljenja za promet o zdravilih za uporabo v veterinarski medicini, ki jih prejmejo ali jim jih ponudijo in za katera ugotovijo ali sumijo, da so ponarejena.
The holder of a wholesale distribution authorisation shall have permanently at its disposal the services of at least one responsible person for wholesale distribution.
Veletrgovec vodi podrobne evidence z vsaj naslednjimi informacijami v zvezi z vsakim nakupom:
Wholesale distributors shall, within the limits of their responsibility, ensure appropriate and continued supply of veterinary medicinal product to persons authorised to supply it in accordance with Article 103(1), so that the needs for animal health in the relevant Member State are covered.
imenom zdravila za uporabo v veterinarski medicini, vključno s farmacevtsko obliko in jakostjo, kakor je ustrezno;
A wholesale distributor shall comply with the good distribution practice for veterinary medicinal products as referred to in Article 99(6).
datum izteka roka uporabnosti zdravila za uporabo v veterinarski medicini;
Wholesale distributors shall immediately inform the competent authority and, where applicable, the marketing authorisation holder, of veterinary medicinal products they receive or are offered which they identify as falsified or suspected to be falsified.
prejeto ali dobavljeno količino z navedbo velikosti pakiranja in števila pakiranj;
A wholesale distributor shall keep detailed records of at least the following information in respect of each transaction:
ime ali naslov podjetja in stalni naslov ali registrirani kraj poslovanja dobavitelja v primeru nakupa ali prejemnika v primeru prodaje.
name of the veterinary medicinal product including, as appropriate, pharmaceutical form and strength;
Imetnik dovoljenja za promet na debelo vsaj enkrat letno izvede podrobno revizijo zaloge ter primerja evidentirana dohodna in odhodna zdravila za uporabo v veterinarski medicini z zdravili za uporabo v veterinarski medicini, ki so trenutno na zalogi.
expiry date of the veterinary medicinal product;
Vsa odstopanja se evidentirajo.
quantity received or supplied, stating pack size and number of packs;
Te evidence so na voljo za inšpekcijske preglede pristojnih organov za obdobje petih let.
name or company name and permanent address or registered place of business of the supplier in the event of purchase or of the recipient in the event of sale.
Člen 102
At least once a year, the holder of a wholesale distribution authorisation shall carry out a detailed audit of the stock and compare the incoming and outgoing veterinary medicinal products recorded with veterinary medicinal products currently held in stock.
Vzporedni promet z zdravili za uporabo v veterinarski medicini
Any discrepancies found shall be recorded.
Za namen vzporednega prometa z zdravili za uporabo v veterinarski medicini veletrgovec zagotovi, da imata zdravilo za uporabo v veterinarski medicini, ki ga namerava pridobiti iz države članice (v nadaljnjem besedilu: izvorna država članica) in prodajati v drugi državi članici (v nadaljnjem besedilu: namembna država članica), in zdravilo za uporabo v veterinarski medicini, ki je že odobreno v namembni državi članici, skupno poreklo.
The records shall be available for inspection by the competent authorities for a period of five years.
Za zdravila za uporabo v veterinarski medicini se šteje, da imajo skupno poreklo, če izpolnjujejo vse naslednje pogoje:
Article 102
imajo enako kakovostno in količinsko sestavo učinkovin in pomožnih snovi;
Parallel trade in veterinary medicinal products
imajo enako farmacevtsko obliko;
For the purpose of parallel trade in veterinary medicinal products, the wholesale distributor shall ensure that the veterinary medicinal product it intends to obtain from a Member State (‘source Member State’) and distribute in another Member State (‘destination Member State’) share a common origin with the veterinary medicinal product already authorised in the destination Member State.
imajo enake klinične podatke in, če je ustrezno, karenco in
The veterinary medicinal products are considered as sharing a common origin if they fulfil all the following conditions:
proizvedel jih je isti proizvajalec ali proizvajalec, ki ima licenco v skladu z isto formulacijo.
they have the same qualitative and quantitative composition in terms of active substances and excipients;
Zdravilo za uporabo v veterinarski medicini, pridobljeno iz izvorne države članice, izpolnjuje zahteve glede označevanja in jezika namembne države članice.
they have the same pharmaceutical form;
Pristojni organi določijo upravne postopke za vzporedni promet z zdravili za uporabo v veterinarski medicini in upravne postopke za odobritev vloge za vzporedni promet s takimi zdravili.
they have the same clinical information and, if applicable, withdrawal period; and
Pristojni organi namembne države članice v zbirki podatkov zdravil iz člena 55 objavijo seznam zdravil za uporabo v veterinarski medicini, s katerimi poteka vzporedni promet v tej državi članici.
they have been manufactured by the same manufacturer or by a manufacturer working under licence according to the same formulation.
Veletrgovec, ki ni imetnik dovoljenja za promet z zdravili, obvesti imetnika dovoljenja za promet in pristojni organ izvorne države članice o tem, da namerava vzporedno trgovati z zdravilom za uporabo v veterinarski medicini v namembni državi članici.
The veterinary medicinal product obtained from a source Member State shall comply with the labelling and language requirements of the destination Member State.
Vsak veletrgovec, ki namerava vzporedno trgovati z zdravilom za uporabo v veterinarski medicini v namembni državi članici, izpolnjuje vsaj naslednje zahteve:
Competent authorities shall lay down administrative procedures for the parallel trade in veterinary medicinal products and administrative procedure for the approval of the application for parallel trade in such products.
predloži izjavo pristojnemu organu v namembni državi članici in sprejme ustrezne ukrepe za zagotovitev, da bo veletrgovec v izvorni državi članici obveščal o kakršnih koli vprašanjih glede farmakovigilance;
Competent authorities of the destination Member State shall, in the product database as referred to in Article 55, make available to public the list of veterinary medicinal products that are parallel traded in that Member State.
obvesti imetnika dovoljenja za promet z zdravilom v namembni državi članici o zdravilu za uporabo v veterinarski medicini, ki se bo dobavljalo iz izvorne države članice in naj bi se dalo na trg v namembni državi članici, vsaj en mesec pred predložitvijo vloge za vzporedni promet z zadevnim zdravilom za uporabo v veterinarski medicini pristojnemu organu;
A wholesale distributor that is not the marketing authorisation holder shall notify the marketing authorisation holder and the competent authority of the source Member State of its intention to parallel trade the veterinary medicinal product to a destination Member State.
pristojnemu organu namembne države članice predloži pisno izjavo, da je imetnika dovoljenja za promet v namembni državi članici obvestil v skladu s točko (b), skupaj s kopijo tega obvestila;
Each wholesale distributor intending to parallel trade a veterinary medicinal product to a destination Member State shall comply with at least the following obligations:
ne trguje z zdravilom za uporabo v veterinarski medicini, ki je bilo odpoklicano s trga izvorne države članice ali namembne države članice zaradi kakovosti, varnosti ali učinkovitosti;
submit a declaration to the competent authority in the destination Member State and take appropriate measures to ensure that the wholesale distributor in the source Member State will keep it informed of any pharmacovigilance issues;
zbira domnevne neželene dogodke in jih sporoča imetniku dovoljenja za promet z zdravilom za uporabo v veterinarski medicini, s katerim se vzporedno trguje.
notify the marketing authorisation holder in the destination Member State about the veterinary medicinal product to be obtained from the source Member State and intended to be placed on the market in the destination Member State at least one month prior to submitting to the competent authority the application for parallel trade in that veterinary medicinal product;
Na seznam iz odstavka 4 se dodajo naslednje informacije v zvezi z vsemi zdravili za uporabo v veterinarski medicini:
submit a written declaration to the competent authority of the destination Member State that the marketing authorisation holder in the destination Member State was notified in accordance with point (b) together with a copy of that notification;
ime zdravila za uporabo v veterinarski medicini;
not trade a veterinary medicinal product which has been recalled from the market of the source Member State or destination Member State for quality, safety or efficacy reasons;
učinkovine;
collect suspected adverse events and report them to the marketing authorisation holder of the parallel-traded veterinary medicinal product.
farmacevtske oblike;
The following information shall be attached to the list referred to in paragraph 4 in respect of all veterinary medicinal products:
razvrstitev zdravil za uporabo v veterinarski medicini v namembni državi članici;
name of the veterinary medicinal products;
številka dovoljenja za promet z zdravili za uporabo v veterinarski medicini v izvorni državi članici;
active substances;
številka dovoljenja za promet z zdravili za uporabo v veterinarski medicini v namembni državi članici;
pharmaceutical forms;
ime ali naziv podjetja in stalni naslov ali registrirani kraj poslovanja veletrgovca v izvorni državi članici in veletrgovca v namembni državi članici.
classification of the veterinary medicinal products in the destination Member State;
Ta člen se ne uporablja za centralno odobrena zdravila za uporabo v veterinarski medicini.
marketing authorisation number of the veterinary medicinal products in the source Member State;
Promet na drobno
marketing authorisation number of the veterinary medicinal products in the destination Member State;
Člen 103
name or company name and permanent address or registered place of business of the wholesale distributor in the source Member State and of the wholesale distributor in the destination Member State.
Promet zdravil za uporabo v veterinarski medicini na drobno in vodenje evidenc
This Article shall not apply to centrally authorised veterinary medicinal products.
Pravila o prometu zdravil za uporabo v veterinarski medicini na drobno se določijo z nacionalnim pravom, razen če je v tej uredbi določeno drugače.
Retail
Brez poseganja v člen 99(4) trgovci na drobno z zdravili za uporabo v veterinarski medicini pridobijo ta zdravila samo od imetnikov dovoljenja za promet z zdravili na debelo.
Article 103
Trgovci na drobno z zdravili za uporabo v veterinarski medicini vodijo podrobne evidence z naslednjimi informacijami v zvezi z vsako transakcijo zdravil za uporabo v veterinarski medicini, za katera je v skladu s členom 34 potreben veterinarski recept:
Retail of veterinary medicinal products and record keeping
prejeto ali dobavljeno količino;
The rules on retail of veterinary medicinal products shall be determined by national law, unless otherwise provided in this Regulation.
imenom ali nazivom podjetja in stalnim naslovom ali registriranim krajem poslovanja dobavitelja v primeru nakupa ali prejemnika v primeru prodaje;
Without prejudice to Article 99(4), retailers of veterinary medicinal products shall obtain veterinary medicinal products only from holders of a wholesale distribution authorisation.
imenom in kontaktnimi podatki veterinarja, ki izdaja recept, ter, kadar je ustrezno, kopijo veterinarskega recepta.
Retailers of veterinary medicinal products shall keep detailed records of the following information in respect of each transaction of veterinary medicinal products requiring a veterinary prescription under Article 34:
številko dovoljenja za promet z zdravili.
quantity received or supplied;
Kadar države članice menijo, da je to potrebno, lahko od trgovcev na drobno zahtevajo, da hranijo podrobne evidence o vsaki transakciji z zdravili za uporabo v veterinarski medicini, za katera ni potreben veterinarski recept.
name or company name and permanent address or registered place of business of the supplier in the event of purchase, or of the recipient in the event of sale;
Trgovec na drobno vsaj enkrat letno izvede podrobno revizijo zaloge ter primerja evidentirana dohodna in odhodna zdravila za uporabo v veterinarski medicini z zdravili za uporabo v veterinarski medicini, ki so trenutno na zalogi.
name and contact details of the prescribing veterinarian and, where appropriate, a copy of the veterinary prescription;
Rezultati podrobnih revizij in evidence iz odstavka 3 tega člena so na voljo za inšpekcijske preglede pristojnih organov v skladu s členom 123 za obdobje petih let.
marketing authorisation number.
Države članice lahko zaradi zaščite javnega zdravja in zdravja živali ali okolja določijo utemeljene in nediskriminatorne pogoje za promet na drobno z zdravili za uporabo v veterinarski medicini na njihovem ozemlju, če so ti pogoji v skladu s pravom Unije.
Where Member States consider it necessary, they may require retailers to keep detailed records of any transaction of veterinary medicinal products not subject to veterinary prescription.
Člen 104
At least once a year, a retailer shall carry out a detailed audit of the stock and compare the incoming and outgoing veterinary medicinal products recorded with veterinary medicinal products currently held in stock.
Promet z zdravili za uporabo v veterinarski medicini na drobno na daljavo
The results of the detailed audit and the records referred to in paragraph 3 of this Article shall be available for inspection by the competent authorities in accordance with Article 123 for a period of five years.
Osebe, ki jim je v skladu s členom 103(1) te uredbe dovoljeno dobavljati zdravila za uporabo v veterinarski medicini, lahko tovrstna zdravila ponujajo prek storitev informacijske družbe v smislu Direktive (EU) 2015/1535 Evropskega parlamenta in Sveta fizičnim ali pravnim osebe, ki imajo sedež v Uniji, pod pogojem, da za ta zdravila za uporabo v veterinarski medicini v skladu s členom 34 te uredbe ni potreben veterinarski recept in da so v skladu s to uredbo in veljavnim pravom namembne države članice, v kateri so v prometu na drobno.
Member States may impose conditions justified on grounds of protection of public and animal health or of the environment for the retail on their territory of veterinary medicinal products provided that such conditions comply with Union law, are proportionate and non-discriminatory.
Z odstopanjem od odstavka 1 tega člena lahko države članice dovolijo osebam, ki jim je dovoljeno dobavljati zdravila za uporabo v veterinarski medicini v skladu s členom 103(1), da ponujajo zdravila za uporabo v veterinarski medicini, za katera je v skladu s členom 34 potreben veterinarski recept, prek storitev informacijske družbe pod pogojem, da je država članica zagotovila varen sistem za takšno dobavo.
Article 104
Takšno dovoljenje se izda le osebam s sedežem na njihovem ozemlju, dobava pa se izvaja le na ozemlju te države članice.
Retail of veterinary medicinal products at a distance
Država članica iz odstavka 2 zagotovi, da se sprejmejo prilagojeni ukrepi za zagotovitev, da se pri dobavi prek storitev informacijske družbe spoštujejo zahteve v zvezi z izdajanjem veterinarskih receptov, in obvesti Komisijo in druge države članice, če uporablja odstopanje iz odstavka 2, po potrebi pa tudi sodeluje s Komisijo in drugimi državami članicami, da se preprečijo kakršne koli nenamerne posledice take dobave.
Persons permitted to supply veterinary medicinal products in accordance with Article 103(1) of this Regulation may offer veterinary medicinal products by means of information society services in the meaning of Directive (EU) 2015/1535 of the European Parliament and of the Council to natural or legal persons established in the Union provided that those veterinary medicinal products are not subject to a veterinary prescription pursuant to Article 34 of this Regulation and that they comply with this Regulation and applicable law of the Member State in which the veterinary products are retailed.
Države članice določijo pravila o ustreznih kaznih, da se zagotovi spoštovanje sprejetih nacionalnih pravil, vključno s pravili o preklicu takih dovoljenj.
By way of derogation from paragraph 1 of this Article, a Member State may allow persons permitted to supply veterinary medicinal products in accordance with Article 103(1) to offer veterinary medicinal products subject to a veterinary prescription pursuant to Article 34 by means of information society services, provided that the Member State has provided a secure system for such supplies.
Pristojni organ države članice, v kateri ima trgovec na drobno sedež, izvaja nadzor iz člena 123 nad osebami in dejavnostmi iz odstavkov 1 in 2 tega člena.
Such permission shall only be granted to persons established in their territory and supply shall only occur within the territory of that Member State.
Poleg zahtev glede informacij iz člena 6 Direktive 2000/31/ES Evropskega parlamenta in Sveta trgovci na drobno, ki ponujajo zdravila za uporabo v veterinarski medicini prek storitev informacijske družbe, zagotovijo vsaj naslednje informacije:
The Member State referred to in paragraph 2 shall ensure that adapted measures are in place in order to guarantee that the requirements relating to a veterinary prescription are respected as regards supply by means of information society services and shall notify the Commission and other Member States if it makes use of the derogation referred to in paragraph 2 and shall, when necessary, cooperate with the Commission and other Member States to avoid any unintended consequences of such supply.
kontaktne podatke pristojnega organa države članice, v kateri ima trgovec na drobno, ki ponuja zdravila za uporabo v veterinarski medicini, svoj sedež;
The Member States shall establish rules on appropriate penalties to ensure that the national rules adopted are respected, including rules on the withdrawal of such permissions.
hiperpovezavo do spletnega mesta države članice sedeža, vzpostavljenega v skladu z odstavkom 8 tega člena;
The persons and activities referred to in paragraphs 1 and 2 of this Article shall be subject to the controls referred to in Article 123 by the competent authority of the Member State in which the retailer is established.
skupni logotip, oblikovan v skladu z odstavkom 6 tega člena, ki je jasno prikazan na vseh straneh spletnega mesta, ki se nanaša na ponudbo zdravil za uporabo v veterinarski medicini za promet na daljavo, in vsebuje hiperpovezavo do vnosa trgovca na drobno na seznamu dovoljenih trgovcev na drobno iz točke (c) odstavka 8 tega člena.
In addition to the information requirements set out in Article 6 of Directive 2000/31/EC of the European Parliament and of the Council, retailers offering veterinary medicinal products by means of information society services shall provide at least the following information:
Komisija določi skupni logotip v skladu z dostavkom 7, ki je prepoznaven po vsej Uniji, hkrati pa se omogoči tudi identifikacija države članice, v kateri ima sedež oseba, ki ponuja zdravila za uporabo v veterinarski medicini za promet na daljavo.
the contact details of the competent authority of the Member State in which the retailer offering the veterinary medicinal products is established;
Logotip je jasno prikazan na spletnih mestih, kjer se ponujajo zdravila za uporabo v veterinarski medicini za promet na daljavo.
a hyperlink to the website of the Member State of establishment set up in accordance with paragraph 8 of this Article;
Komisija z izvedbenimi akti sprejme zasnovo skupnega logotipa iz odstavka 6 tega člena.