FrancophonIA/DGT-Translation_Memory huggingface dataset:
English: give prior notice to the competent authority of any changes which he may wish to make to any of the particulars supplied pursuant to Article 45;
Slovenian: da vnaprej obvesti pristojni organ o vseh spremembah, ki jih namerava narediti v zvezi s katero koli podrobnostjo, predloženo v skladu s členom 45;
English: the competent authority shall, in any event, be immediately informed if the qualified person referred to in Article 52 is replaced unexpectedly;
Slovenian: v vsakem primeru mora biti pristojni organ takoj obveščen o nepričakovani zamenjavi usposobljene osebe iz člena 52;
English: allow the representatives of the competent authority of the Member State concerned access to his premises at any time;
Slovenian: da dovoli predstavnikom pristojnega organa zadevne države članice vstop v prostore ob katerem koli času;
English: enable the qualified person referred to in Article 52 to carry out his duties, particularly by placing at his disposal all the necessary facilities;
Slovenian: da omogoči, da lahko usposobljena oseba iz člena 52, opravlja svoje dolžnosti, posebno da so ji na razpolago vse potrebne zmogljivosti;
English: comply with the principles and the guidelines of good manufacturing practice for medicinal products laid down by Community law;
Slovenian: da postopa v skladu z načeli in smernicami dobre proizvodne prakse za zdravila, ki jih nalaga zakonodaja Skupnosti;
English: keep detailed records of all veterinary medicinal products supplied by him, including samples, in accordance with the laws of the countries of destination.
Slovenian: da hrani podrobne evidence o vseh zdravilih za uporabo v veterinarski medicini, ki jih dobavlja, vključno z vzorci, v skladu z zakoni držav, kamor so pošiljke namenjene.
English: The following information at least shall be recorded in respect of each transaction, whether or not it is made for payment:
Slovenian: V zvezi z vsako transakcijo, ne glede na to ali je bila narejena z namenom plačila, je treba voditi evidence, ki vsebujejo najmanj naslednje podatke:
English: date,
Slovenian: datum,
English: name of veterinary medicinal product,
Slovenian: ime zdravila za uporabo v veterinarski medicini,
English: quantity supplied,
Slovenian: dobavljena količina,
English: name and address of the recipient,
Slovenian: ime in naslov prejemnika,
English: batch number.
Slovenian: številka serije
English: These records shall be available for inspection by the competent authorities for a period of at least three years.
Slovenian: Te evidence morajo biti na voljo za pregled pristojnih organov najmanj tri leta.
English: Article 51
Slovenian: Člen 51
English: The principles and guidelines of good manufacturing practice for veterinary medicinal products referred to in Article 50(f) shall be adopted in the form of a Directive addressed to the Member States in accordance with the procedure referred to in Article 89(2).
Slovenian: Načela in smernice dobre proizvodne prakse za zdravila za uporabo v veterinarski medicini iz člena 50(f) se morajo sprejeti v obliki direktive, naslovljene na države članice v skladu s postopkom, opredeljenim v členu 89(2).
English: Detailed guidelines shall be published by the Commission and revised as appropriate to take account of scientific and technical progress.
Slovenian: Podrobne smernice mora objaviti Komisija ter jih po potrebi revidirati glede na znanstveni in tehnološki napredek.
English: Article 52
Slovenian: Člen 52
English: Member States shall take all appropriate measures to ensure that the holder of the manufacturing authorization has permanently and continuously at his disposal the services of at least one qualified person who fulfils the conditions laid down in Article 53 and is responsible, in particular, for carrying out the duties specified in Article 55.
Slovenian: Države članice morajo sprejeti potrebne ukrepe da bi zagotovile, da ima imetnik dovoljenja za izdelavo neprestano in trajno na voljo storitve, ki jih opravlja najmanj ena usposobljena oseba, ki izpolnjuje pogoje, določene s členom 53, ter da je še posebej odgovorna za izvajanje nalog, opredeljenih v členu 55.
English: If he personally fulfils the conditions laid down in Article 53, the holder of the authorization may himself assume the responsibility referred to in paragraph 1.
Slovenian: Če imetnik osebno izpolnjuje pogoje, določene v členu 53, lahko sam prevzame odgovornost iz odstavka 1.
English: Member States shall ensure that the qualified person referred to in Article 52 fulfils the minimum conditions of qualification set out in paragraphs 2 and 3.
Slovenian: Države članice morajo zagotoviti, da usposobljena oseba iz člena 52 izpolnjuje minimalne pogoje usposobljenosti, določene v odstavkih 2 in 3.
English: The qualified person shall be in possession of a diploma, certificate or other evidence of formal qualifications awarded on completion of a university course of study, or a course recognized as equivalent by the Member State concerned, extending over a period of at least four years of theoretical and practical study in one of the following scientific disciplines:
Slovenian: Usposobljena oseba mora imeti diplomo, spričevalo, ali kak drug dokaz o formalni izobrazbi, pridobljeni po zaključku univerzitetnega študija, ali opravljen tečaj, ki ga zadevna država članica prizna za enakovrednega in ki obsega najmanj štiri leta teoretičnega in praktičnega študija v eni od naslednjih znanstvenih disciplin:
English: pharmacy, medicine, veterinary science, chemistry, pharmaceutical chemistry and technology, biology.
Slovenian: farmacija, medicina, veterina, kemija, farmacevtska kemija in tehnologija, biologija.
English: However, the minimum duration of the university course may be three and a half years where the course is followed by a period of theoretical and practical training of at least one year and includes a training period of at least six months in a pharmacy open to the public, corroborated by an examination at university level.
Slovenian: Vendar pa sme biti najkrajši čas univerzitetnega izobraževalnega programa tri leta in pol, če temu sledi obdobje teoretičnega in praktičnega usposabljanja v trajanju najmanj enega leta ter vključuje šest-mesečno usposabljanje v javni lekarni, ki mu sledi še izpit na univerzitetni stopnji.
English: Where two university or recognized equivalent courses coexist in a Member State and where one of these extends over four years and the other over three years, the diploma, certificate or other evidence of formal qualifications awarded on completion of the three-year university course or its recognized equivalent shall be considered to fulfil the condition of duration referred to in the first subparagraph in so far as the diplomas, certificates or other evidence of formal qualifications awarded on completion of both courses are recognized as equivalent by the State in question.
Slovenian: V primeru, da v državi članici obstajata dva univerzitetna ali priznana enakovredna izobraževalna programa in če eden od teh traja štiri leta ter drugi tri leta, se šteje, da so z diplomo, spričevalom ali drugimi dokazi o formalni izobrazbi, ki se podeljujejo ob zaključku triletnega univerzitetnega programa ali priznanega enakovrednega programa, izpolnjeni pogoji glede trajanja iz prvega pododstavka, če se diplome, spričevala ali ostali dokazi o formalni izobrazbi, ki se podeljujejo ob zaključku obeh študijskih programov v zadevni državi članici priznavajo kot enakovredni.
English: The course shall include theoretical and practical tuition bearing upon at least the following basic subjects:
Slovenian: Študijski program mora vsebovati teoretični in praktični pouk, ki vsebuje najmanj naslednje osnovne predmete:
English: experimental physics,
Slovenian: eksperimentalna fizika
English: general and inorganic chemistry,
Slovenian: splošna in anorganska kemija
English: organic chemistry,
Slovenian: organska kemija
English: analytical chemistry,
Slovenian: analitska kemija
English: pharmaceutical chemistry, including analysis of medicinal products,
Slovenian: farmacevtska kemija, vključno z analizo zdravil,
English: general and applied biochemistry (medical),
Slovenian: splošna in aplikativna biokemija (medicinska),
English: physiology,
Slovenian: fiziologija
English: microbiology,
Slovenian: mikrobiologija,
English: pharmacology,
Slovenian: farmakologija,
English: pharmaceutical technology,
Slovenian: farmacevtska tehnologija,
English: toxicology,
Slovenian: toksikologija
English: pharmacognosy (study of the composition and effects of the active principles of natural substances of plant and animal origin).
Slovenian: farmakognozija (študij sestave in učinkov aktivnih principov naravnih snovi rastlinskega in živalskega izvora).
English: Tuition in these subjects should be so balanced as to enable the person concerned to fulfil the obligations specified in Article 55.
Slovenian: Pouk teh predmetov mora biti primerno uravnovešen, da bi zadevna oseba lahko izpolnila pogoje, opredeljene v členu 55.
English: In so far as certain diplomas, certificates or other evidence of formal qualifications mentioned in this paragraph do not fulfil the criteria laid down above, the competent authority of the Member State shall ensure that the person concerned provides evidence that he has, in the subjects involved, the knowledge required for the manufacture and control of veterinary medicinal products.
Slovenian: Če nekatere diplome, spričevala ali drugi dokazi o formalni izobrazbi, navedene v tem odstavku, ne izpolnjujejo zgoraj navedenih meril, mora pristojni organ države članice zagotoviti, da zadevna oseba priskrbi dokaze, da ima, v zvezi s predmeti, znanje, ki je potrebno za izdelavo ter kontrolo zdravil za uporabo v veterinarski medicini.
English: The qualified person shall have acquired practical experience over at least two years, in one or more undertakings which are authorized manufacturers, in the activities of qualitative analysis of medicinal products, of quantitative analysis of active substances and of the testing and checking necessary to ensure the quality of veterinary medicinal products.
Slovenian: Usposobljena oseba si mora v enem ali več podjetjih, ki imajo dovoljenje za izdelavo najmanj dve leti pridobivati praktične izkušnje na področju analize kakovosti zdravil, količinske analize zdravilnih učinkovin ter preskušanja in preverjanja, ki je potrebno za zagotovitev kakovosti zdravil za uporabo v veterinarski medicini.
English: The duration of practical experience may be reduced by one year where a university course lasts for at least five years and by a year and a half where the course lasts for at least six years.
Slovenian: Trajanje praktičnega dela se lahko skrajša za eno leto v primeru, če univerzitetni program traja najmanj pet let ter za eno leto in pol, če program traja najmanj šest let.
English: A person engaging, in a Member State, in the activities of the person referred to in Article 52 at the date on which Directive 81/851/EEC became applicable, without complying with the provisions of Article 53 shall be eligible to continue to engage in those activities in the State concerned.
Slovenian: Oseba, ki se v državi članici ukvarja z dejavnostmi osebe iz člena 52 na dan, ko je začela veljati Direktiva 81/851/EGS, mora biti upravičena do nadaljevanja tovrstnih aktivnosti v zadevni državi ne da bi izpolnjevala določbe člena 53.
English: The holder of a diploma, certificate or other evidence of formal qualifications awarded on completion of a university course - or a course recognized as equivalent by the Member State concerned - in a scientific discipline allowing him to engage in the activities of the person referred to in Article 52 in accordance with the laws of that State may - if he began his course prior to 9 October 1981 - be considered as qualified to carry out in that State the duties of the person referred to in Article 52, provided that he has previously engaged in the following activities for at least two years before 9 October 1991 in one or more undertakings with a manufacturing authorization;
Slovenian: Imetnik diplome, spričevala ali drugega dokaza o formalni izobrazbi, ki mu je bila podeljena po končanem univerzitetnem študiju - ali programu, ki ga kot enakovrednega priznava država članica - v znanstveni disciplini, ki dovoljuje, da se oseba ukvarja z dejavnostmi osebe iz člena 52 v skladu z zakonodajo tiste države lahko - v primeru, da se je program začel pred 9. oktobrom 1981 - se šteje za usposobljenega za opravljanje nalog osebe iz člena 52 v tisti državi pod pogojem, da se je oseba že najmanj dve leti pred 9. oktobrom 1991 v enem ali več podjetjih z dovoljenjem za izdelavo ukvarjala z naslednjimi dejavnostmi;
English: production supervision and/or qualitative and quantitative analysis of active substances, and the necessary testing and checking under the direct authority of a person as referred to in Article 52 to ensure the quality of veterinary medicinal products.
Slovenian: nadzorom izdelave in/ali kakovostnimi in količinskimi analizami zdravilnih učinkovin in potrebnim preskušanjem ter preverjanjem, pod neposrednim strokovnim nadzorom osebe iz člena 52, da se zagotovi kakovosti zdravila za uporabo v veterinarski medicini.
English: If the person concerned has acquired the practical experience referred to in the first subparagraph before 9 October 1971, a further one year's practical experience in accordance with the conditions referred to in the first subparagraph shall be completed by him immediately before he engages in such activities.
Slovenian: Če si je zadevna oseba pridobila praktične izkušnje iz prvega pododstavka pred 9. oktobrom 1971, mora še pred pričetkom ukvarjanja s takimi dejavnostmi pridobiti dodatne enoletne praktične izkušnje v skladu s pogoji iz prvega pododstavka.
English: Article 55
Slovenian: Člen 55
English: Member States shall take all appropriate measures to ensure that the qualified person referred to in Article 52 is, without prejudice to his relationship with the holder of the manufacturing authorization, responsible, in the context of the procedures referred to in Article 56, for ensuring that:
Slovenian: Države članice morajo uvesti ustrezne ukrepe, da bi zagotovile, da bo usposobljena oseba iz člena 52, brez poseganja v odnose z imetnikom dovoljenja za proizvodnjo, odgovorna v okviru postopkov iz člena 56, da:
English: in the case of veterinary medicinal products manufactured within the Member State concerned, each batch of veterinary medicinal products has been manufactured and checked in compliance with the laws in force in that Member State and in accordance with the requirements of the marketing authorization;
Slovenian: je v primeru zdravila za uporabo v veterinarski medicini, ki se izdeluje v zadevni državi članici, vsaka serija proizvedena ter kontrolirana v skladu z zakonom, veljavnim v tej državi članici in v skladu z zahtevami, ki jih nalaga dovoljenje za promet z zdravilom;
English: in the case of veterinary medicinal products coming from third countries, each production batch imported has undergone in the importing Member State a full qualitative analysis, a quantitative analysis of at least all the active substances and all the other tests or checks necessary to ensure the quality of veterinary medicinal products in accordance with the requirements of the marketing authorization.
Slovenian: se v primeru zdravila za uporabo v veterinarski medicini, ki izhaja iz tretjih držav, za vsako uvoženo serijo v državi uvoznici opravi popolna analiza kakovosti, količinska analiza najmanj vseh zdravilnih učinkovin ter vsi ostali preskusi in preverjanja, potrebna za zagotovitev kakovosti zdravila za uporabo v veterinarski medicini v skladu z zahtevami dovoljenja za promet z zdravilom.
English: Batches of veterinary medicinal products which have undergone such controls in a Member State shall be exempt from the above controls if they are placed on the market in another Member State, accompanied by the control reports signed by the qualified person.
Slovenian: Za serije zdravil za uporabo v veterinarski medicini, za katere so bile opravljene take kontrole v državi članici, ni treba opraviti zgoraj navedenih kontrol v primeru, da so bile dane v promet v drugi državi članici, in če jih spremljajo poročila o kontroli, ki jih je podpisala usposobljena oseba.
English: In the case of veterinary medicinal products imported from a third country, where appropriate arrangements have been made by the Community with the exporting country to ensure that the manufacturer of the veterinary medicinal product applies standards of good manufacturing practice at least equivalent to those laid down by the Community and to ensure that the controls referred to under point (b) of the first subparagraph of paragraph 1 have been carried out in the exporting country, the qualified person may be relieved of responsibility for carrying out those controls.
Slovenian: V primeru, da se zdravila za uporabo v veterinarski medicini uvažajo iz tretje države, kjer so bili narejeni ustrezni dogovori med Skupnostjo in državo izvoznico glede zagotavljanja, da izdelovalec zdravila za uporabo v veterinarski medicini upošteva standarde dobre proizvodne prakse, ki morajo biti najmanj enakovredni tistim, ki jih določa Skupnost in glede zagotavljanja, da so bile kontrole iz točke (b) prvega pododstavka prvega odstavka, opravljene v državi izvoznici, je lahko usposobljena oseba oproščena odgovornosti za izvajanje tovrstnih kontrol.
English: In all cases, and particularly where the veterinary medicinal products are released for sale, the qualified person shall certify, in a register or equivalent document provided for the purpose, that each production batch satisfies the provisions of this Article;
Slovenian: V vseh primerih, še posebno kjer se zdravilo za uporabo v veterinarski medicini sprošča v promet, mora usposobljena oseba v registru ali v enakovrednem dokumentu, zagotovljenem za ta namen potrditi, da vsaka proizvodna serija zadošča določilom tega člena;
English: the said register or equivalent document shall be kept up to date as operations are carried out and shall remain at the disposal of the representatives of the competent authority for the period specified in the provisions of the Member State concerned and, in any event, for at least five years.
Slovenian: opredeljeni register ali enakovredni dokument je treba dopolnjevati hkrati s potekom obratovanja in mora biti na voljo predstavnikom pristojnega organa za dobo, ki je opredeljena z določili zadevne države, in v vsakem primeru najmanj za dobo pet let.
English: Article 56
Slovenian: Člen 56
English: Member States shall ensure that the obligations of qualified persons referred to in Article 52 are fulfilled, either by means of appropriate administrative measures or by making such persons subject to a professional code of conduct.
Slovenian: Države članice morajo zagotoviti, da bodo obveznosti usposobljene osebe iz člena 52 izpolnjene, bodisi s pomočjo ustreznih upravnih ukrepov, ali pa z uveljavitvijo profesionalnega kodeksa ravnanja za te osebe.
English: Member States may provide for the temporary suspension of such a person upon the commencement of administrative or disciplinary proceedings against him for failure to fulfil his obligations.
Slovenian: Države članice lahko določijo začasno odpustitev take osebe v primeru, če so začeli veljati upravni ali disciplinski ukrepi proti njej zaradi neizpolnjevanja svojih dolžnosti.
English: Article 57
Slovenian: Člen 57
English: The provisions of this Title shall apply to homeopathic veterinary medicinal products.
Slovenian: Določila tega naslova se uporabljajo za homeopatska zdravila za uporabo v veterinarski medicini.
English: TITLE V
Slovenian: NASLOV V
English: Article 58
Slovenian: Člen 58
English: The following information, which shall conform with the particulars and documents provided pursuant to Articles 12 and 13(1) and be approved by the competent authorities, shall appear in legible characters on containers and outer packages of medicinal products:
Slovenian: Spodaj navedeni podatki, ki morajo biti v skladu s podrobnimi podatki in z dokumentacijo, predloženo v skladu s členoma 12 in 13(1) in ki jih morajo odobriti pristojni organi, morajo biti napisani z jasnimi črkami na vsebnikih in zunanji ovojnini zdravil:
English: Name of the veterinary medicinal product, which may be a brand name or a non-proprietary name accompanied by a trade mark or the name of the manufacturer, or a scientific name or formula, with or without a trade mark, or the name of the manufacturer.
Slovenian: ime zdravila za uporabo v veterinarski medicini, ki je lahko izmišljeno ime ali nelastniško ime, ki ga spremlja blagovna znamka ali ime izdelovalca, ali znanstveno ime ali formula, z ali brez blagovne znamke ali imena izdelovalca.
English: Where the special name of a medicinal product containing only one active substance is a brand name, this name must be accompanied in legible characters by the international non-propriety name recommended by the World Health Organization, where such name exists or, where no such name exists, by the usual non-proprietary name;
Slovenian: V primeru, če je ime zdravila izmišljeno ime, in zdravilo vsebuje le eno zdravilno učinkovino in, mora to ime spremljati z jasnimi črkami izpisano mednarodno nelastniško ime, ki ga priporoča Svetovna zdravstvena organizacija, če to ime bodisi obstaja, ali če tako ime ne obstaja, običajno nelastniško ime;
English: A statement of the active substances expressed qualitatively and quantitatively per dosage unit or according to the form of administration for a particular volume or weight, using the international non-proprietary names recommended by the World Health Organization, where such names exist or, where no such names exist, the usual non-proprietary names;
Slovenian: Kakovostna in količinska navedba zdravilnih učinkovin, izraženih na enoto odmerka, ali glede na način dajanja za določen volumen ali maso, z mednarodnimi nelastniškimi imeni, ki jih priporoča Svetovna zdravstvena organizacija če taka imena obstajajo, ali če taka imena ne obstajajo, z običajnimi nelastniškimi imeni;
English: Manufacturer's batch number;
Slovenian: Izdelovalčeva serijska številka;
English: Marketing authorization number;
Slovenian: Številka dovoljenja za promet z zdravilom;
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 ali naziv podjetja ter stalni naslov ali registrirani kraj poslovanja imetnika dovoljena za promet z zdravilom ter izdelovalca, če je le ta različen;
English: The species of animal for which the veterinary medicinal product is intended;
Slovenian: Vrste živali, za katere je zdravilo za uporabo v veterinarski medicini namenjeno;
English: the method and route of administration;
Slovenian: način dajanja zdravila;
English: The withdrawal period, even if nil, in the case of veterinary medicinal products administered to food-producing animals;
Slovenian: Karenca, tudi če je nična, v primeru zdravil za uporabo v veterinarski medicini, ki se dajejo živalim za proizvodnjo živil;
English: Expiry date, in plain language;
Slovenian: Rok uporabnosti, izražen v preprostem jeziku;
English: Special storage precautions, if any;
Slovenian: Previdnost pri shranjevanju, če je to potrebno;
English: Special precautions for disposal of unused medicinal products or waste material from medicinal products, if any;
Slovenian: Posebni varnostni ukrepi pri odstranjevanju neporabljenih zdravil ali odpadnih snovi iz zdravil, če obstajajo;
English: Particulars required to be indicated pursuant to Article 26(1), if any;
Slovenian: Zahtevani podrobni podatki, ki jih je treba navesti po členu 26(1), če obstajajo;
English: The words "For animal treatment only".
Slovenian: Besede "Samo za živali".
English: The pharmaceutical form and the contents by weight, volume or number of dose-units need only be shown on the outer package.
Slovenian: Farmacevtsko obliko ter vsebino, izraženo v masi, prostornini ali številu odmerkov, je treba navesti le na zunanji ovojnini.