FrancophonIA/DGT-Translation_Memory huggingface dataset:
English: If he personally fulfils the conditions laid down in Article 49, the holder of the authorization may himself assume the responsibility referred to in paragraph 1.
Slovenian: Če imetnik dovoljenja za proizvodnjo osebno izpolnjuje pogoje iz člena 49, lahko sam prevzame odgovornost iz odstavka 1.
English: Member States shall ensure that the qualified person referred to in Article 48 fulfils the minimum conditions of qualification set out in paragraphs 2 and 3.
Slovenian: Države članice zagotovijo, da odgovorna oseba iz člena 48 izpolnjuje minimalne pogoje glede usposobljenosti, določene v odstavkih 2 in 3.
English: A 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: Odgovorna oseba ima diplomo, spričevalo ali drugo dokazilo o formalnih kvalifikacijah, ki se podeljuje ob zaključku univerzitetnega študija ali programa, ki ga zadevna država članica priznava kot enakovrednega, ki obsega najmanj štiri leta teoretičnega in praktičnega študija v eni od naštetih znanstvenih strok:
English: pharmacy, medicine, veterinary medicine, chemistry, pharmaceutical chemistry and technology, biology.
Slovenian: farmacija, medicina, veterinarska medicina, 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 a minimum duration of one year and including a training period of at least six months in a pharmacy open to the public, corroborated by an examination at university level.
Slovenian: Univerzitetni študij lahko traja najmanj tri leta in pol, kadar študiju sledi obdobje teoretičnega in praktičnega usposabljanja, ki traja najmanj eno leto in vključuje najmanj šestmesečno usposabljanje v javni lekarni in se zaključi z izpitom na univerzitetni ravni.
English: Where two university courses or two courses recognized by the State as equivalent co-exist in a Member State and where one of these extends over four years and the other over three years, the three-year course leading to a diploma, certificate or other evidence of formal qualifications awarded on completion of a university course or its recognized equivalent shall be considered to fulfil the condition of duration referred to in the second 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: Kadar v državi članici obstajata hkrati dva univerzitetna programa ali dva izobraževalna programa, ki ju država priznava kot enakovredna, in kadar eden od programov traja štiri leta in drugi tri leta, in če se triletni program zaključi z diplomo, spričevalom ali drugim dokazilom o formalnih kvalifikacijah, ki se podeljuje ob zaključku univerzitetnega študija, ali priznanega enakovrednega programa, se šteje, da kandidat izpolnjuje pogoje trajanja izobraževanja, navedenega v drugem pododstavku, če država članica priznava diplome, spričevala ali druga dokazila o formalnih kvalifikacijah, ki se podeljujejo ob zaključku obeh programov študija, kot enakovredne.
English: The course shall include theoretical and practical study bearing upon at least the following basic subjects:
Slovenian: Program mora obsegati teoretični in praktični del študija, ki temelji na najmanj naslednjih osnovnih predmetih:
English: Applied physics
Slovenian: uporabna fizika
English: General and inorganic chemistry
Slovenian: splošna in anorganska kemija
English: Organic chemistry
Slovenian: organska kemija
English: Analytical chemistry
Slovenian: analizna 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 uporabna 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 natural active substances of plant and animal origin).
Slovenian: farmakognozija (študij sestave in učinkov naravnih zdravilnih učinkovin rastlinskega in živalskega izvora).
English: Studies in these subjects should be so balanced as to enable the person concerned to fulfil the obligations specified in Article 51.
Slovenian: Študij teh predmetov mora biti uravnotežen tako, da zadevni osebi omogoča izpolnjevanje pogojev, navedenih v členu 51.
English: In so far as certain diplomas, certificates or other evidence of formal qualifications mentioned in the first subparagraph do not fulfil the criteria laid down in this paragraph, the competent authority of the Member State shall ensure that the person concerned provides evidence of adequate knowledge of the subjects involved.
Slovenian: Če diplome, spričevala ali druga dokazila o formalnih kvalifikacijah, omenjeni v prvem pododstavku, ne izpolnjujejo meril, ki jih določa ta odstavek, pristojni organ države članice zagotovi, da zadevna oseba predloži dokaz o ustreznem znanju iz naštetih predmetov.
English: The qualified person shall have acquired practical experience over at least two years, in one or more undertakings which are authorized to manufacture medicinal products, 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 medicinal products.
Slovenian: Odgovorna oseba v najmanj dveh letih pridobi praktične izkušnje v enem ali več podjetjih, ki imajo dovoljenje za izdelavo zdravil, iz dejavnosti kakovostne analize zdravil, količinske analize zdravilnih učinkovin ter preskušanja in preverjanja za potrebe zagotavljanja kakovosti zdravil.
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, če univerzitetni program traja najmanj pet let, ter za eno leto in pol, če program traja najmanj šest let.
English: A person engaging in the activities of the person referred to in Article 48 from the time of the application of Directive 75/319/EEC, in a Member State without complying with the provisions of Article 49 shall be eligible to continue to engage in those activities in the State concerned.
Slovenian: Oseba, vključena v dejavnosti iz člena 48, je od dneva uporabe Direktive 75/319/EGS v državi članici, ne glede na določbe člena 49, primerna za nadaljevanje opravljanja dejavnosti v zadevni državi.
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 48 in accordance with the laws of that State may - if he began his course prior to 21 May 1975 - be considered as qualified to carry out in that State the duties of the person referred to in Article 48 provided that he has previously engaged in the following activities for at least two years before 21 May 1985 following notification of this directive in one or more undertakings authorized to manufacture:
Slovenian: Imetnik diplome, spričevala ali drugega dokazila o formalnih kvalifikacijah, podeljene ob zaključku univerzitetnega študija — ali programa, ki ga zadevna država članica priznava kot enakovrednega — v znanstveni stroki, ki mu omogoča, da opravlja dejavnosti osebe iz člena 48 v skladu z zakonodajo te države — se lahko, če je pričel s programom pred 21. majem 1975 — šteje kot usposobljen za izvajanje nalog iz člena 48 v tej državi, pod pogojem, da je predhodno opravljal naslednje dejavnosti najmanj dve leti pred 21. majem 1985 po uradnem obvestilu o tej direktivi, v enem ali več podjetjih, ki imajo dovoljenje za izdelavo:
English: production supervision and/or qualitative and quantitative analysis of active substances, and the necessary testing and checking under the direct authority of the person referred to in Article 48 to ensure the quality of the medicinal products.
Slovenian: nadzor proizvodnje in/ali kakovostna in količinska analiza zdravilnih učinkovin, in potrebno preskušanje in preverjanje pod neposrednim nadzorom osebe iz člena 48 za zagotavljanje kakovosti zdravil.
English: If the person concerned has acquired the practical experience referred to in the first subparagraph before 21 May 1965, a further one year's practical experience in accordance with the conditions referred to in the first subparagraph will be required to be completed immediately before he engages in such activities.
Slovenian: Če je zadevna oseba pridobila praktične izkušnje iz prvega pododstavka pred 21. majem 1965, se, v skladu s pogoji iz prvega pododstavka, od osebe zahteva, da pridobi še eno dodatno leto praktičnih izkušenj pred začetkom opravljanja navedene dejavnosti.
English: Member States shall take all appropriate measures to ensure that the qualified person referred to in Article 48, without prejudice to his relationship with the holder of the manufacturing authorization, is responsible, in the context of the procedures referred to in Article 52, for securing:
Slovenian: Države članice sprejmejo vse ustrezne ukrepe, da zagotovijo, da je odgovorna oseba iz člena 48 brez poseganja v njen odnos z imetnikom dovoljenja za proizvodnjo, odgovorna v smislu postopkov iz člena 52, za zagotavljanje naslednjega:
English: in the case of medicinal products manufactured within the Member States concerned, that each batch of 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: pri zdravilih, ki se proizvajajo v zadevnih državah članicah, da je vsaka posamezna serija zdravil proizvedena in preverjena v skladu z veljavno zakonodajo v tej državi članici ter v skladu z zahtevami dovoljenja za promet z zdravilom;
English: in the case of medicinal products coming from third countries, that each production batch has undergone in the importing Member State a full qualitative analysis, a quantitative analysis of at least all the active constituents and all the other tests or checks necessary to ensure the quality of medicinal products in accordance with the requirements of the marketing authorization.
Slovenian: pri zdravilih iz tretjih držav, da je bila v državi članici uvoza v celoti izvedena kakovostna analiza vsake posamezne serije, količinska analiza vsaj vseh zdravilnih učinkovin ter vsi ostali preskusi ali preverjanja, potrebni za zagotavljanje kakovosti zdravil v skladu z zahtevami dovoljenja za promet z zdravilom.
English: The batches of medicinal products which have undergone such controls in a Member State shall be exempt from the controls if they are marketed in another Member State, accompanied by the control reports signed by the qualified person.
Slovenian: Serije zdravil, na katerih so bile v državi članici izvedene take kontrole, so oproščene kontrol, če se dajejo v promet v drugi državi članici, priložijo pa se jim poročila o kontroli, s podpisom odgovorne osebe.
English: In the case of 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 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: Pri zdravilih, uvoženih iz tretje države, kadar se Skupnost ustrezno dogovori z državo izvoznico, ki zagotovi, da za proizvajalca zdravila veljajo standardi dobre proizvodne prakse, ki so najmanj enakovredni standardom, predpisanim v Skupnosti, ter da se kontrole iz točke (b) prvega pododstavka odstavka 1 izvedejo v državi izvoznici, je odgovorna oseba razbremenjena odgovornosti za izvedbo teh kontrol.
English: In all cases and particularly where the medicinal products are released for sale, the qualified person must certify in a register or equivalent document provided for that purpose, that each production batch satisfies the provisions of this Article;
Slovenian: V vseh primerih, zlasti kadar se zdravila dajo v promet, mora usposobljena oseba potrditi v registru ali enakovrednem dokumentu, predpisanem za ta namen, da vsaka posamezna proizvodna serija izpolnjuje določbe tega člena;
English: the said register or equivalent document must be kept up to date as operations are carried out and must remain at the disposal of the agents 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: ta register ali enakovredni dokument je treba ažurirati z zadnjimi podatki v zvezi z opravljenim delom in mora biti na voljo zastopnikom pristojnega organa tako dolgo, kot to predvidevajo določbe zadevne države članice, v vsakem primeru pa najmanj pet let.
English: Member States shall ensure that the duties of qualified persons referred to in Article 48 are fulfilled, either by means of appropriate administrative measures or by making such persons subject to a professional code of conduct.
Slovenian: Države članice z ustreznimi upravnimi ukrepi ali z zavezo, da je odgovorna oseba dolžna ravnati v skladu s strokovnim kodeksom ravnanja, zagotovijo, da odgovorna oseba iz člena 48 izpolnjuje svoje dolžnosti.
English: Member States may provide for the temporary suspension of such a person upon the commencement of administrative or disciplinary procedures against him for failure to fulfil his obligations.
Slovenian: Države članice lahko predpišejo, da se taka oseba začasno suspendira, če je bil proti njej sprožen upravni ali disciplinski postopek zaradi neizpolnjevanja obveznosti.
English: The provisions of this Title shall also apply to homeopathic medicinal products.
Slovenian: Določbe tega naslova se uporabljajo tudi za homeopatska zdravila.
English: The following particulars shall appear on the outer packaging of medicinal products or, where there is no outer packaging, on the immediate packaging:
Slovenian: Na zunanji ovojnini ali, kadar zunanje ovojnine ni, na stični ovojnini zdravil se navedejo naslednji podatki:
English: the name of the medicinal product followed by the common name where the product contains only one active substance and if its name is an invented name;
Slovenian: ime zdravila, ki mu sledi splošno ime, kadar zdravilo vsebuje samo eno zdravilno učinkovino in če je ime izmišljeno;
English: where a medicinal product is available in several pharmaceutical forms and/or several strengths, the pharmaceutical form and/or the strength (baby, child or adult as appropriate) must be included in the name of the medicinal product;
Slovenian: kadar je zdravilo na voljo v več farmacevtskih oblikah in/ali jakostih, je treba farmacevtsko obliko in/ali jakost (za dojenčka, otroka ali odraslo osebo, kakor je primerno), navesti v imenu zdravila;
English: a statement of the active substances expressed qualitatively and quantitatively per dosage unit or according to the form of administration for a given volume or weight, using their common names;
Slovenian: kakovostna in količinska navedba zdravilnih učinkovin, izražena na enoto odmerka, ali glede na način uporabe zdravila za dano prostornino ali maso, z uporabo splošnih imen;
English: the pharmaceutical form and the contents by weight, by volume or by number of doses of the product;
Slovenian: farmacevtsko obliko in vsebino, izraženo v enotah mase, prostornine ali v številu odmerkov zdravila;
English: a list of those excipients known to have a recognized action or effect and included in the guidelines published pursuant to Article 65.
Slovenian: seznam pomožnih snovi, za katera je znano, da imajo priznano delovanje ali učinek in so vključena v smernice, objavljene v skladu s členom 65.
English: However, if the product is injectable, or a topical or eye preparation, all excipients must be stated;
Slovenian: Če se zdravilo injicira ali je namenjeno topikalni uporabi ali uporabi za oči, je treba navesti vse pomožne snovi;
English: the method and, if necessary, the route of administration;
Slovenian: postopek, in če je potrebno, pot uporabe zdravila;
English: a special warning that the medicinal product must be stored out of reach of children;
Slovenian: posebno opozorilo, da je zdravilo treba shranjevati nedosegljivo otrokom;
English: a special warning, if this is necessary for the medicinal product;
Slovenian: posebno opozorilo, če je glede na zdravilo to potrebno;
English: the expiry date in clear terms (month/year);
Slovenian: jasno izražen datum izteka roka uporabnosti (mesec/leto);
English: special storage precautions, if any;
Slovenian: posebna navodila za shranjevanje, če obstajajo;
English: special precautions for disposal of unused medicinal products or waste materials from medicinal products, if appropriate;
Slovenian: posebni varnostni ukrepi za odstranjevanje neuporabljenih zdravil ali iz njih nastalih odpadnih snovi, če je primerno;
English: the name and address of the holder of the authorization for placing the medicinal product on the market;
Slovenian: ime in naslov imetnika dovoljenja za promet z zdravilom;
English: the number of the authorization for placing the medicinal product on the market;
Slovenian: številko dovoljenja za promet z zdravilom;
English: the manufacturer's batch number;
Slovenian: proizvajalčeva številka serije;
English: in the case of self-medication, instructions on the use of the medicinal products.
Slovenian: če gre za zdravila, namenjena samozdravljenju, navodila za uporabo zdravil.
English: The particulars laid down in Articles 54 and 62 shall appear on immediate packagings other than those referred to in paragraphs 2 and 3.
Slovenian: Vsi podrobni podatki iz členov 54 in 62 se navedejo na stičnih ovojninah, razen tistih, omenjenih v odstavkih 2 in 3.
English: The following particulars at least shall appear on immediate packagings which take the form of blister packs and are placed in an outer packaging that complies with the requirements laid down in Articles 54 and 62.
Slovenian: Na stični ovojnini v obliki pretisnega omota, ki je vložen v zunanjo ovojnino, ki je v skladu z zahtevami iz členov 54 in 62, se navedejo najmanj naslednji podatki:
English: the name of the medicinal product as laid down in Article 54(a),
Slovenian: ime zdravila, kakor je določeno v členu 54(a),
English: the name of the holder of the authorization for placing the product on the market,
Slovenian: ime imetnika dovoljenja za promet z zdravilom,
English: the expiry date,
Slovenian: datum izteka roka uporabnosti,
English: the batch number.
Slovenian: številka serije.
English: The following particulars at least shall appear on small immediate packaging units on which the particulars laid down in Articles 54 and 62 cannot be displayed:
Slovenian: Na majhnih stičnih ovojninah, na katerih podatkov iz členov 54 in 62 ni mogoče navesti, se navedejo najmanj naslednji podatki:
English: the name of the medicinal product and, if necessary, the strength and the route of administration,
Slovenian: ime zdravila, in če je to potrebno, jakost in pot uporabe,
English: the method of administration,
Slovenian: postopek uporabe zdravila,
English: the batch number,
Slovenian: številka serije,
English: the contents by weight, by volume or by unit.
Slovenian: vsebina, izražena z maso, prostornino ali enoto.
English: The particulars referred to in Articles 54, 55 and 62 shall be easily legible, clearly comprehensible and indelible.
Slovenian: Podatki iz členov 54, 55 in 62 morajo biti čitljivi, razumljivi in neizbrisljivi.
English: Notwithstanding Article 60, Member States may require the use of certain forms of labelling of the medicinal product making it possible to ascertain:
Slovenian: Ne glede na člen 60, lahko države članice zahtevajo uporabo nekaterih posebnih oznak zdravil, da s tem omogočijo ugotavljanje:
English: the price of the medicinal product,
Slovenian: cene zdravila,
English: the reimbursement conditions of social security organizations,
Slovenian: pogojev za nadomestilo stroškov organizacij socialne varnosti,
English: the legal status for supply to the patient, in accordance with Title VI,
Slovenian: pravni status glede izdajanja zdravila bolniku v skladu z naslovom VI,
English: identification and authenticity.
Slovenian: identifikacijo in avtentičnost.
English: The inclusion in the packaging of all medicinal products of a package leaflet shall be obligatory unless all the information required by Articles 59 and 62 is directly conveyed on the outer packaging or on the immediate packaging.
Slovenian: V pakiranje zdravila je treba obvezno priložiti navodilo za uporabo, če niso vse informacije, ki jih zahtevata člena 59 in 62, neposredno navedene na zunanji ali na stični ovojnini.
English: The package leaflet shall be drawn up in accordance with the summary of the product characteristics;
Slovenian: Navodilo za uporabo je sestavljeno v skladu s povzetkom glavnih značilnostih zdravila;
English: it shall include, in the following order:
Slovenian: v naslednjem vrstnem redu vsebuje:
English: for the identification of the medicinal product:
Slovenian: za identifikacijo zdravila:
English: the name of the medicinal product, followed by the common name if the product contains only one active substance and if its name is an invented name;
Slovenian: ime zdravila, ki mu sledi splošno ime, če zdravilo vsebuje samo eno zdravilno učinkovino in če je ime zdravila izmišljeno;
English: where a medicinal product is available in several pharmaceutical forms and/or several strengths, the pharmaceutical form and/or the strength (for example, baby, child, adult) must be included in the name of the medicinal product,
Slovenian: če je zdravilo na voljo v več farmacevtskih oblikah in/ali jakostih, je treba farmacevtsko obliko in/ali jakost (npr. za dojenčka, otroka, odraslega) vključiti v ime zdravila,
English: a full statement of the active substances and excipients expressed qualitatively and a statement of the active substances expressed quantitatively, using their common names, in the case of each presentation of the medicinal product,
Slovenian: kakovostno navedbo vseh zdravilnih učinkovin in pomožnih snovi, ter količinsko navedbo zdravilnih učinkovin, izraženih s splošnim imenom za vsako posamezno obliko pakiranja zdravila,
English: the pharmaceutical form and the contents by weight, by volume or by number of doses of the product, in the case of each presentation of the product,
Slovenian: farmacevtsko obliko in vsebino, izraženo v enotah mase, prostornine ali s številom odmerkov zdravila za vsako posamezno obliko pakiranja zdravila,
English: the pharmaco-therapeutic group, or type of activity in terms easily comprehensible for the patient,
Slovenian: farmakoterapevtsko skupino ali način delovanja v bolniku lahko razumljivem jeziku,
English: the name and address of the holder of the authorization for placing the medicinal product on the market and of the manufacturer;
Slovenian: ime in naslov imetnika dovoljenja za promet z zdravilom ter proizvajalca;
English: list of information which is necessary before taking the medicinal product:
Slovenian: podatki, ki jih je treba poznati pred uporabo zdravila: seznam mora:
English: appropriate precautions for use,
Slovenian: ustrezni previdnostni ukrepi pri uporabi,