FrancophonIA/DGT-Translation_Memory huggingface dataset:
English: The provisions of Part 1, A of Annex I, in so far as they concern the qualitative and quantitative composition of veterinary medicinal products in respect of active substances, shall apply to the particulars provided for in paragraph 1(b).
Slovenian: Določila dela 1, A Priloge 1, če zadevajo kakovostno in količinsko sestavo zdravil za uporabo v veterinarski medicini glede zdravilnih učinkovin, se morajo upoštevati pri podrobnih podatkih, predvidenih v odstavku 1(b).
English: The particulars mentioned in paragraph 1(f) to (l) shall appear on the outer package and on the container of the medicinal products in the language or languages of the country in which they are placed on the market.
Slovenian: Podrobni podatki, navedeni v odstavku 1(f) do (l) morajo biti na zunanji ovojnini in na vsebniku zdravila navedeni v jeziku ali jezikih države, kjer bodo v prometu.
English: Article 59
Slovenian: Člen 59
English: As regards ampoules, the particulars listed in the first paragraph of Article 58(1) shall be given on the outer package.
Slovenian: Kar zadeva ampule, morajo biti podrobni podatki, našteti v prvem odstavku člena 58(1) podani na zunanji ovojnin.
English: On the containers, however, only the following particulars shall be necessary:
Slovenian: Na vsebnikih so potrebni samo naslednji podatki:
English: quantity of the active substances,
Slovenian: količina zdravilnih učinkovin,
English: route of administration,
Slovenian: način dajanja zdravila,
English: manufacturer's batch number,
Slovenian: izdelovalčeva serijska številka,
English: date of expiry,
Slovenian: rok uporabnost,
English: the words "For animal treatment only".
Slovenian: besede "Samo za živali".
English: As regards small single-dose containers, other than ampoules, on which it is impossible to give the particulars mentioned in paragraph 1, the requirements of Article 58(1), (2) and (3), shall apply only to the outer package.
Slovenian: Pri majhnih vsebnikih z enim odmerkom, razen ampul, ki jih je nemogoče opremiti s podrobnimi podatki, navedenimi v odstavku 1, se zahteve iz člena 58(1), (2) in (3) nanašajo le na zunanjo ovojnino.
English: The particulars mentioned in the third and sixth indents of paragraph 1 shall appear on the outer package and on the container of the medicinal products in the language or languages of the country in which they are placed on the market.
Slovenian: Podrobni podatki, navedeni v tretji in šesti alinei odstavka 1 morajo biti na zunanji ovojnini ter na vsebniku zdravila navedeni v jeziku ali jezikih države, kjer bo zdravilo v prometu.
English: Article 60
Slovenian: Člen 60
English: Where there is no outer package, all the particulars which should feature on such a package pursuant to the Articles 58 and 59 shall be shown on the container.
Slovenian: V primeru, ko ni zunanje ovojnine, se morajo podrobni podatki, ki bi sicer morali biti na tej ovojnini, v skladu s členoma 58 in 59, navesti na vsebniku.
English: Article 61
Slovenian: Člen 61
English: The inclusion of a package insert in the packaging of veterinary medicinal products shall be obligatory unless all the information required by this Article can be conveyed on the container and the external packaging.
Slovenian: Navodilo za uporabo v ovojnini zdravila za uporabo v veterinarski medicini je obvezno, razen v primeru, ko je možno vse zahtevane podatke iz tega člena navesti na vsebniku in zunanji ovojnini.
English: Member States shall take all appropriate measures to ensure that the insert relates solely to the veterinary medicinal product with which it is included.
Slovenian: Države članice morajo uvesti ukrepe, da se navodilo za uporabo nanaša le na zdravilo za uporabo v veterinarski medicini, h kateremu je priloženo.
English: The insert shall be in the official language or languages of the Member State in which the medicinal product is marketed.
Slovenian: Navodilo za uporabo mora biti napisano v uradnem jeziku ali jezikih države članice, kjer bo zdravilo v prometu.
English: The package insert shall contain at least the following information, which shall conform to the particulars and documents provided pursuant to Articles 12 and 13(1) and be approved by the competent authorities:
Slovenian: Navodilo za uporabo mora vsebovati najmanj spodaj naštete podatke, ki se ujemajo s podrobnimi podatki in dokumentacijo, predloženo v skladu s členoma 12 in 13(1) in ga mora odobriti pristojni organi:
English: name or corporate name and permanent address or registered place of business of the marketing authorization holder and of the manufacturer, if different;
Slovenian: ime in naziv podjetja ter stalni naslov ali registrirani naslov poslovanja imetnika dovoljenja za promet z izdelkom in izdelovalca, če je le-ta različen;
English: name of the veterinary medicinal product and a statement of its active substances expressed qualitatively and quantitatively;
Slovenian: ime zdravila za uporabo v veterinarski medicini ter kakovostna in količinska navedba zdravilnih učinkovin;
English: The international non-proprietary names recommended by the World Health Organization shall be used wherever they exist;
Slovenian: Mednarodna nelastniška imena, ki jih priporoča Svetovna zdravstvena organizacija se morajo uporabljati kjer koli obstajajo;
English: the therapeutic indications;
Slovenian: terapevtske indikacije;
English: contra-indications and adverse reactions in so far as these particulars are necessary for the use of the veterinary medicinal product;
Slovenian: kontraindikacije ter škodljivi učinki če so ti podatki potrebni za uporabo zdravila za uporabo v veterinarski medicini;
English: the species of animal for which the veterinary medicinal product is intended, the dosage for each species, the method and route of administration and advice on correct administration, if necessary;
Slovenian: vrste živali, za katere je zdravilo za uporabo v veterinarski medicini namenjeno, odmerki za vsako vrsto, način dajanja zdravila ter nasvet za pravilno uporabo, če je to potrebno;
English: the withdrawal period, even if this is nil, in the case of veterinary medicinal products administered to food-producing animals;
Slovenian: karenca, tudi če je nična, če gre za zdravila za uporabo v veterinarski medicini, ki se daje živalim za proizvodnjo živil;
English: special storage precautions, if any;
Slovenian: previdnostni ukrepi pri shranjevanju, če ti obstajajo;
English: particulars required to be indicated pursuant to Article 26(1), if any;
Slovenian: podrobni podatki, ki jih je treba označiti v skladu s členom 26(1), če ti obstajajo;
English: special precautions for the disposal of unused medicinal products or waste materials from medicinal products, if any.
Slovenian: posebni varnostni ukrepi pri odstranjevanju neporabljenih zdravil ali odpadnih snovi iz zdravil, če le-ti obstajajo.
English: The particulars referred to in paragraph 2 shall appear in the language or languages of the country in which the product is marketed.
Slovenian: Podatki iz odstavka 2 morajo biti napisani v jeziku ali jezikih države, v kateri bo zdravilo v prometu.
English: The other information shall be clearly separate from such particulars.
Slovenian: Ostale podatke je treba jasno ločiti od teh podatkov.
English: Article 62
Slovenian: Člen 62
English: Where the provisions of this Title are not observed and a formal notice addressed to the person concerned has been ineffectual, the competent authorities of the Member States may suspend or withdraw marketing authorization.
Slovenian: V primeru, da se določila iz tega naslova ne upoštevajo in če je bila o tem zadevna oseba uradno obveščena, lahko pristojni organi držav članic začasno ukinejo ali prekličejo dovoljenje za promet z zdravilom.
English: Article 63
Slovenian: Člen 63
English: The requirements of Member States concerning conditions of supply to the public, the marking of prices on medicinal products for veterinary use and industrial property rights shall not be affected by the provisions of this Title.
Slovenian: Določila tega naslova se ne nanašajo na zahteve držav članic v pogledu pogojev dobave za javni trg, označevanja cen na zdravilih za uporabo v veterinarski medicini in pravice industrijske lastnine.
English: Article 64
Slovenian: Člen 64
English: Without prejudice to paragraph 2, homeopathic veterinary medicinal products shall be labelled in accordance with the provisions of this title and identified by the inclusion on their labels, in clearly legible form, of the words "homeopathic medicinal product for veterinary use".
Slovenian: Brez poseganja v odstavek 2, morajo biti homeopatska zdravila za uporabo v veterinarski medicini označena v skladu s določili tega naslova, na nalepki pa morajo biti jasno vidne besede "homeopatsko zdravilo za uporabo v veterinarski medicini".
English: In addition to the clear mention of the words "homeopathic veterinary medicinal product without approved therapeutic indications", the labelling and, where appropriate, package insert for the homeopathic veterinary medicinal products referred to in Article 17(1) shall bear the following information and no other information:
Slovenian: Poleg jasno navedenih besed "homeopatsko zdravilo za uporabo v veterinarski medicini brez odobrenih terapevtske indikacije", morajo biti na nalepki in, kjer je to primerno, tudi v navodilu za uporabo homeopatskega zdravila za uporabo v veterinarski medicini, navedenega v členu 17(1), navedeni samo naslednji podatki in nobeni drugi podatki:
English: the scientific name of the stock or stocks followed by the degree of dilution, using the symbols of the pharmacopoeia used in accordance with point 8 of Article 1,
Slovenian: znanstveno ime homeopatske surovine ali surovin, stopnja razredčitve, z uporabo simbolov iz farmakopeje v skladu s točko 8 iz člena 1,
English: name and address of the marketing authorization holder and, where appropriate, of the manufacturer,
Slovenian: ime in naslov imetnika dovoljenja za promet z zdravilom, in kjer je to primerno, izdelovalca,
English: method of administration and, if necessary, route,
Slovenian: način uporabe zdravila ter po potrebi način dajanja zdravila,
English: expiry date, in clear terms (month, year),
Slovenian: jasno označen rok uporabnosti (mesec, leto),
English: pharmaceutical form,
Slovenian: farmacevtska oblika,
English: contents of the sales presentation,
Slovenian: vsebina pakiranja, ki je v prodaji,
English: special storage precautions, if any,
Slovenian: posebni previdnostni ukrepi za shranjevanje, če le-ti obstajajo,
English: the target species,
Slovenian: ciljne živalske vrste,
English: a special warning if necessary for the medicinal product,
Slovenian: posebno opozorilo, če je za zdravilo to potrebno,
English: manufacturer's batch number,
Slovenian: izdelovalčeva številka serije,
English: registration number.
Slovenian: registracijska številka.
English: TITLE VI
Slovenian: NASLOV VI
English: POSSESSION, WHOLESALE DISTRIBUTION AND DISPENSING OF VETERINARY MEDICINAL PRODUCTS
Slovenian: POSEDOVANJE, PROMET NA DEBELO TER IZDAJA ZDRAVIL ZA UPORABO V VETERINARSKI MEDICINI
English: Article 65
Slovenian: Člen 65
English: Member States shall take all appropriate measures to ensure that wholesale distribution of veterinary medicinal products is subject to the holding of an authorization and to ensure that the time taken for the procedure for granting this authorization does not exceed 90 days from the date on which the competent authority receives the application.
Slovenian: Države članice morajo uvesti potrebne ukrepe za zagotovitev, da se promet na debelo z zdravili za uporabo v veterinarski medicini opravlja le na podlagi pridobljenega dovoljenja ter da čas, potreben za postopek izdaje tega dovoljenja, ne presega 90 dni od dneva, ko pristojni organ prejme vlogo.
English: Member States may exclude supplies of small quantities of veterinary medicinal products from one retailer to another from the scope of the definition of wholesale distribution.
Slovenian: Države članice lahko iz obsega opredelitve prometa na debelo izvzamejo dobavo manjših količin zdravil za uporabo v veterinarski medicini med enim in drugim trgovcem na debelo.
English: In order to obtain the authorization for distribution, the applicant shall have at his disposal technically competent staff and suitable and sufficient premises complying with the requirements laid down in the Member State concerned as regards the storage and handling of veterinary medicinal products.
Slovenian: Za pridobitev dovoljenja za promet na debelo mora predlagatelj razpolagati s tehnično usposobljenim osebjem ter imeti primerne in dovolj velike prostore v skladu z zahtevami zadevne države članice za shranjevanje ter ravnanje z zdravili za uporabo v veterinarski medicini.
English: The holder of the authorization for distribution shall be required to keep detailed records.
Slovenian: Imetnik dovoljenja za promet na debelo mora hraniti podrobne evidence.
English: The following minimum information shall be recorded in respect of each incoming or outgoing transaction:
Slovenian: Za vsako vhodno ali izhodno transakcijo mora hraniti vsaj naslednje minimalne podatke:
English: date;
Slovenian: datum;
English: precise identity of the veterinary medicinal product;
Slovenian: natančen opis zdravila za uporabo v veterinarski medicini;
English: manufacturer's batch number, expiry date;
Slovenian: izdelovalčevo serijsko številko, rok uporabnosti;
English: quantity received or supplied;
Slovenian: prejeto ali izdano količino;
English: name and address of the supplier or recipient.
Slovenian: ime in naslov dobavitelja ali prejemnika.
English: At least once a year a detailed audit shall be carried out to compare incoming and outgoing medicinal supplies with supplies currently held in stock, any discrepancies being recorded.
Slovenian: Najmanj enkrat na leto je treba opraviti natančno revizijo in primerjati prejeto in izdano količino zdravil s stanjem, ki je trenutno na zalogi, in vsakršno razliko zabeležiti.
English: These records shall be available for inspection by the competent authorities for a period of three years.
Slovenian: Ti podatki morajo biti na voljo za preglede pristojnih organov za obdobje najmanj treh let.
English: Member States shall take all appropriate measures to ensure that wholesalers supply veterinary medicinal products only to persons permitted to carry out retail activities in accordance with Article 66, or to other persons who are lawfully permitted to receive veterinary medicinal products from wholesalers.
Slovenian: Države članice morajo uvesti ustrezne ukrepe da zagotovijo, da trgovci na debelo lahko dobavljajo zdravila za uporabo v veterinarski medicini samo osebam, ki imajo dovoljenje za promet na drobno v skladu s členom 66, ali drugim osebam, ki jim je z zakonom dovoljeno, da prejemajo zdravila za uporabo v veterinarski medicini od trgovcev na debelo.
English: Article 66
Slovenian: Člen 66
English: Member States shall take all appropriate measures to ensure that the retail supply of veterinary medicinal products is conducted only by persons who are permitted to carry out such operations by the legislation of the Member State concerned.
Slovenian: Države članice morajo uvesti ustrezne ukrepe da zagotovijo, da promet na drobno z zdravili za uporabo v veterinarski medicini vodijo osebe, ki jim je v zadevni državi članici z zakonom dovoljeno opravljati tovrstne dejavnosti.
English: Any person permitted under paragraph 1 to sell veterinary medicinal products shall be required to keep detailed records. The following information shall be recorded in respect of each incoming or outgoing transaction:
Slovenian: Vsaka oseba iz odstavku 1, ki ima dovoljenje za promet na drobno zdravil za uporabo v veterinarski medicini, mora hraniti podrobne evidence za vsako vhodno ali izhodno transakcijo, ki mora vsebovati:
English: precise identity of the veterinary medicinal product;
Slovenian: točen opis zdravila za uporabo v veterinarski medicini;
English: manufacturer's batch number;
Slovenian: izdelovalčevo serijsko številko;
English: name and address of the supplier or recipient;
Slovenian: ime in naslov dobavitelja ali prejemnika;
English: where relevant, name and address of the prescribing veterinarian and a copy of the prescription.
Slovenian: kjer je to potrebno, ime in naslov veterinarja, ki izdaja recept ter kopijo recepta.
English: At least once a year a detailed audit shall be carried out, and incoming and outgoing veterinary medicinal products shall be reconciled with products currently held in stock, any discrepancies being recorded.
Slovenian: Najmanj enkrat letno se mora opraviti podrobna revizija, kjer se dobavljene in izdane količine zdravil za uporabo v veterinarski medicini primerjajo s stanjem, ki je trenutno na zalogi, vsakršno neskladje pa se zabeleži.
English: Member States may limit the number of detailed documenting requirements referred to in paragraph 2. However, these requirements shall always be applied in case of veterinary medicinal products which are intended for administration to food-producing animals and which are available only on veterinary prescription or in respect of which a withdrawal period must be observed.
Slovenian: Države članice lahko omejijo število zahtev glede podrobnih podatkov iz odstavka 2, vendar je le-te treba vedno upoštevati v primeru, ko gre za zdravila za uporabo v veterinarski medicini, ki so namenjena živalim za proizvodnjo živil in ki se izdajajo le na recept ter pri katerih je treba upoštevati karenco.
English: Not later that 1 January 1992, Member States shall communicate to the Commission a list of the veterinary medicinal products which are available without prescription.
Slovenian: Do januarja 1992 morajo države članice sporočiti Komisiji seznam zdravil za uporabo v veterinarski medicini, ki se izdajajo brez recepta.
English: After having taken note of the communication from the Member States, the Commission shall examine whether suitable measures should be proposed for drawing up a Community list of such medicinal products.
Slovenian: Na podlagi medsebojnih dogovorov z državami članicami mora Komisija preučiti, ali je treba predlagati ustrezne ukrepe za sestavo seznama tovrstnih zdravil.
English: Article 67
Slovenian: Člen 67
English: Without prejudice to stricter Community or national rules relating to dispensing veterinary medicinal products and to protect human and animal health, a prescription shall be required for dispensing to the public the following veterinary medicinal products;
Slovenian: Brez poseganja v strožja pravila Skupnosti ali nacionalna pravila, ki se nanašajo na izdajo zdravil za uporabo v veterinarski medicini na recept ter za varovanje zdravja ljudi ali živali, je recept potreben za izdajo zdravil za uporabo v veterinarski medicini za:
English: those products subject to official restrictions on supply or use, such as:
Slovenian: tista zdravila, za katera veljajo zakonske omejitve dobave ali uporabe, kot so:
English: the restrictions resulting from the implementation of the relevant United Nations conventions on narcotic and psychotropic substances,
Slovenian: omejitve, ki so posledica izvajanja ustreznih konvencij Združenih narodov o narkotičnih in psihotropnih snoveh,
English: the restrictions on the use of veterinary medicinal products resulting from Community law;
Slovenian: omejitve uporabe zdravil za uporabo v veterinarski medicini, ki so posledica zakonodaje Skupnosti;
English: those products in respect of which special precautions must be taken by the veterinarian in order to avoid any unnecessary risk to:
Slovenian: tista zdravila, pri katerih mora veterinar upoštevati previdnostne ukrepe, da se izogne nepotrebnim tveganjem za:
English: the person administering the products to the animal,
Slovenian: osebo, ki daje zdravilo živali,
English: the consumer of foodstuffs obtained from the treated animal,
Slovenian: potrošnika živil iz tako zdravljene živali,
English: the environment;
Slovenian: okolje;
English: those products intended for treatments or pathological processes which require a precise prior diagnosis or the use of which may cause effects which impede or interfere with subsequent diagnostic or therapeutic measures;
Slovenian: tista zdravila, ki so namenjena zdravljenju patoloških procesov in ki zahtevajo podrobno predhodno diagnozo, ali katerih uporaba bi lahko ovirala ali vplivala na poznejše diagnostične ali terapevtske ukrepe;
English: magistral formulae intended for animals.
Slovenian: magistralna zdravila, namenjena živalim.
English: In addition, a prescription shall be required for new veterinary medicinal products containing an active substance which has been authorized for use in a veterinary medicinal product for less than five years unless, having regard to the information and particulars provided by the applicant, or experience acquired in the practical use of the veterinary medicinal product, the competent authorities are satisfied that none of the criteria referred to in (a) to (d) of the first paragraph apply.
Slovenian: Poleg tega je recept obvezen za nova zdravila za uporabo v veterinarski medicini, ki vsebujejo zdravilno učinkovino, za katero je izdano dovoljenje za promet veljavno manj kot pet let, razen če glede na podrobne podatke, ki jih predloži predlagatelj, ali na podlagi pridobljenih izkušenj o praktični uporabi zdravila za uporabo v veterinarski medicini pristojni organi ugotovijo, da se za to ne uporablja nobeno od meril iz točk (a) in (d) prvega odstavka.
English: Article 68
Slovenian: Člen 68
English: Member States shall take all measures necessary to ensure that only persons empowered under their national legislation in force possess or have under their control veterinary medicinal products or substances which may be used as veterinary medicinal products that have anabolic, anti-infectious, anti-parasitic, anti-inflammatory, hormonal or psychotropic properties.
Slovenian: Države članice sprejmejo potrebne ukrepe, da lahko zdravila za uporabo v veterinarski medicini ali snovi, ki lahko uporabljajo kot zdravila za uporabo v veterinarski medicini z anabolnimi, protiinfekcijskimi, antiparazitskimi, protivnetnimi, hormonalnimi ali psihotropnimi lastnostmi posedujejo ali imajo pod svojim nadzorom samo osebe, ki so za to pooblaščene z veljavno nacionalno zakonodajo.
English: Member States shall maintain a register of manufacturers and dealers permitted to be in possession of active substances which may be used in the manufacture of veterinary medicinal products having the properties referred to in paragraph 1.
Slovenian: Države članice morajo voditi register izdelovalcev in trgovcev, ki jim je dovoljeno posedovanje zdravilnih učinkovin, ki se lahko uporabljajo v izdelavi zdravil za uporabo v veterinarski medicini in ki imajo lastnosti iz odstavka 1.
English: Such persons must maintain detailed records of all dealings in substances which may be used in the manufacture of veterinary medicinal products and keep these records available for inspection by the competent authorities for a period of at least three years.
Slovenian: Take osebe morajo hraniti podrobne evidence o vsem poslovanju s snovmi, ki se lahko uporabljajo za izdelavo zdravil za uporabo v veterinarski medicini ter morajo te podatke hraniti za dobo najmanj treh let za potrebe pregledov pooblaščenih organov.
English: Any amendments to be made to the list of substances referred to in paragraph 1 shall be adopted in accordance with the procedure referred to in Article 89(2).
Slovenian: Vsakršne spremembe seznama snovi iz odstavka 1 je treba sprejeti v skladu s postopkom iz člena 89(2).
English: Article 69
Slovenian: Člen 69
English: Member States shall ensure that the owners or keepers of food-producing animals can provide proof of purchase, possession and administration of veterinary medicinal products containing the substances set out in Article 68;
Slovenian: Države članice morajo zagotoviti, da so lastniki ali rejci živali za proizvodnjo živil dolžni predložiti dokaze o nakupu, posedovanju ali dajanju zdravil za uporabo v veterinarski medicini, ki vsebujejo snovi, določene v členu 68;
English: Member States may extend the scope of this obligation to other veterinary medicinal products.
Slovenian: države članice lahko razširijo področje obveznosti še na druga zdravila za uporabo v veterinarski medicini.