FrancophonIA/DGT-Translation_Memory huggingface dataset:
English: This system shall also take into account any available information on misuse and abuse of medicinal products which may have an impact on the evaluation of their benefits and risks.
Slovenian: Sistem upošteva vse razpoložljive informacije o nepravilni uporabi in zlorabi zdravil, ki lahko vplivajo na vrednotenje koristi in tveganj zdravila.
English: Article 103
Slovenian: Člen 103
English: The marketing authorization holder shall have permanently and continuously at his disposal an appropriately qualified person responsible for pharmacovigilance.
Slovenian: Imetnik dovoljenja za promet z zdravilom ima nenehno na voljo ustrezno usposobljeno osebo, ki je odgovorna za farmakovigilanco.
English: That qualified person shall be responsible for the following:
Slovenian: Ta usposobljena oseba je odgovorna za naslednje:
English: the establishment and maintenance of a system which ensures that information about all suspected adverse reactions which are reported to the personnel of the company, and to medical representatives, is collected and collated in order to be accessible at least at one point within the Community;
Slovenian: vzpostavitev in vzdrževanje sistema, ki zagotavlja zbiranje in primerjavo podatkov o vseh domnevnih neželenih učinkih, o katerih se poroča osebju podjetja, ter zdravstvenim sodelavcem, da so dostopni vsaj na enem mestu v Skupnosti;
English: the preparation for the competent authorities of the reports referred to in Article 104, in such form as may be laid down by those authorities, in accordance with the guidance referred to in Article 106(1);
Slovenian: pripravo poročil za pristojne organe iz člena 104, v obliki, kot jo določijo organi v skladu z navodili iz člena 106(1);
English: ensuring that any request from the competent authorities for the provision of additional information necessary for the evaluation of the benefits and risks afforded by a medicinal product is answered fully and promptly, including the provision of information about the volume of sales or prescriptions of the medicinal product concerned;
Slovenian: zagotavljanje, da se na vse zahteve pristojnih organov za predložitev dodatnih informacij, potrebnih za vrednotenje koristi in tveganj, povezanih z zdravilom, odgovori v celoti in takoj, vključno s predložitvijo podatkov o obsegu prodaje ali številu receptov, predpisanih za zadevno zdravilo;
English: the provision to the competent authorities, of any other information relevant to the evaluation of the benefits and risks afforded by a medicinal product, including appropriate information on post-authorization safety studies.
Slovenian: predložitev pristojnim organom vseh drugih informacij, ki so pomembne za vrednotenje koristi in tveganj, povezanih z zdravilom, vključno z ustreznimi informacijami iz študij o varnosti zdravila po pridobitvi dovoljenja za promet.
English: Article 104
Slovenian: Člen 104
English: The marketing authorization holder shall be required to maintain detailed records of all suspected adverse reactions occurring either in the Community or in a third country.
Slovenian: Od imetnika dovoljenja za promet z zdravilom se zahteva, da vodi podrobno dokumentacijo o vseh domnevnih neželenih učinkih, ki se pojavljajo v Skupnosti ali v tretji državi.
English: The marketing authorization holder shall be required to record and to report all suspected serious adverse reactions which are brought to his attention by a health care professional immediately to the competent authority of the Member State in whose territory the incident occurred, and in no case later than 15 calendar days following the receipt of the information.
Slovenian: Od imetnika dovoljenja za promet z zdravilom se zahteva, da vodi dokumentacijo o vseh domnevnih resnih neželenih učinkih, ki se pojavijo na njenem ozemlju in na katere je bil opozorjen s strani zdravstvenih strokovnjakov, in pristojnemu organu v državi članici poroča takoj, najpozneje pa v 15 koledarskih dneh po prejetju informacije.
English: The marketing authorization holder shall be required to record and report all other suspected serious adverse reactions which meet the reporting criteria in accordance with the guidance referred to in Article 106(1) of which he can reasonably be expected to have knowledge immediately to the competent authority of the Member State in whose territory the incident occurred, and in no case later than 15 calendar days following the receipt of the information.
Slovenian: Od imetnika dovoljenja za promet z zdravilom se zahteva, da vodi dokumentacijo in takoj poroča o vseh drugih domnevnih resnih neželenih učinkih, ki izpolnjujejo merila o poročanju v skladu z navodili, navedenimi v členu 106(1), za katere se od njega lahko smiselno pričakuje, da bo o njih obveščen, pristojnemu organu države članice, na katere ozemlju se pojavijo, najpozneje pa v 15 koledarskih dneh po prejetju informacije.
English: The marketing authorization holder shall ensure that all suspected serious and unexpected adverse reactions occurring in the territory of a third country and brought to his attention by a health care professional are reported immediately in accordance with the guidance referred to in Article 106(1), so that they are available to the Agency and to the competent authorities of the Member States where the medicinal product is authorised, and in no case later than 15 calendar days following the receipt of the information.
Slovenian: Imetnik dovoljenja za promet z zdravilom zagotovi, da o vseh domnevnih resnih in nepričakovanih neželenih učinkih, ki se pojavijo na ozemlju tretje države in na katere ga opozori zdravstveni strokovnjak, takoj poroča v skladu z navodili, navedenimi v členu 106(1), tako da so informacije na voljo Agenciji ter pristojnim organom držav članic, kjer ima zdravilo dovoljenje za promet, najpozneje pa v 15 koledarskih dneh po prejetju informacije.
English: In the case of medicinal products which have been considered within the scope of Directive 87/22/EEC, or which have benefited from the procedures of mutual recognition foreseen in Articles 17 and 18 of this Directive, Article 28(4) of this Directive, and medicinal products for which there has been a referral to the procedures foreseen by Articles 32, 33 and 34 of this Directive, the marketing authorisation holder shall additionally ensure that all suspected serious adverse reactions occurring in the Community are reported in the format and at intervals to be agreed with the reference Member State, or a competent authority acting as the reference Member State, in such a way so as to be accessible to the reference Member State.
Slovenian: Če gre za zdravila, ki jih obravnava Direktiva 87/22/EGS, ali za zdravila, ki so pridobila dovoljenje za promet po postopku medsebojnega priznavanja, predvidenega v členih 17 in 18 te direktive, v členu 28(4) te direktive, ter za zdravila, pri katerih je šlo za napotitev na postopke, predvidene s členi 32, 33 in 34 te direktive, imetnik dovoljenja za promet z zdravilom dodatno zagotovi, da se o vseh domnevnih resnih neželenih učinkih, ki se pojavijo v Skupnosti, poroča v obliki in v časovnih razmikih, o katerih se je treba dogovoriti z referenčno državo članico ali pristojnim organom, ki zastopa referenčno državo članico, na način, da je dostopna referenčni državi članici.
English: Unless other requirements have been laid down as a condition of the granting of authorisation, or subsequently as indicated in the guidance referred to in Article 106(1), records of all adverse reactions shall be submitted to the competent authorities in the form of a periodic safety update report, either immediately upon request or periodically as follows:
Slovenian: Če kot pogoj za izdajo dovoljenja niso bile postavljene drugačne zahteve, ali pozneje kakor določajo navodila, navedena v členu 106(1), se dokumentacija o vseh neželenih učinkih predloži pristojnim organom v obliki z zadnjimi podatki dopolnjenih rednih poročil o varnosti zdravila takoj na zahtevo, ali redno, kot sledi:
English: six monthly for the first two years after authorisation, annually for the subsequent two years, and at the time of the first renewal.
Slovenian: vsakih šest mesecev v prvih dveh letih po izdaji dovoljenja za promet, enkrat letno v naslednjih dveh letih in ob prvem podaljšanju dovoljenja za promet.
English: Thereafter the periodic safety update reports shall be submitted at five-yearly intervals together with the application for renewal of the authorisation.
Slovenian: Po tem obdobju se z zadnjimi podatki dopolnjena redna poročila o varnosti zdravila dostavljajo vsakih pet let, skupaj z vlogo za podaljšanje dovoljenja za promet.
English: The periodic safety update reports shall include a scientific evaluation of the benefit and risks afforded by the medicinal products.
Slovenian: Redna poročila o varnosti zdravila vsebujejo znanstveno vrednotenje koristi in tveganj, povezanih z zdravili.
English: Following the granting of a marketing authorisation, the marketing authorisation holder may request the amendment of the periods referred to in this article according to the procedure laid down by Commission Regulation (EC) No 541/95(23).
Slovenian: Po izdaji dovoljenja za promet z zdravilom lahko imetnik dovoljenja za promet zaprosi za spremembo obdobij, ki jih določa ta člen, v skladu s postopkom določenim z Uredbo Komisije (ES) št. 541/95 [23].
English: Article 105
Slovenian: Člen 105
English: The Agency, in collaboration with the Member States and the Commission shall set up a data-processing network to facilitate the exchange of pharmacovigilance information regarding medicinal products marketed in the Community intended to allow all competent authorities to share the information at the same time.
Slovenian: Agencija v sodelovanju z državami članicami ter Komisijo vzpostavi mrežo za obdelavo podatkov, ki bo omogočalo izmenjavo informacij o farmakovigilanci zdravil, ki so v prometu v Skupnosti in katerega namen je omogočiti hkratno delitev podatkov med vsemi pristojnimi organi.
English: Making use of the network foreseen in paragraph 1, Member States shall ensure that reports of suspected serious adverse reactions that have taken place on their territory are immediately made available to the Agency and the other Member States, and in any case within 15 calendar days of their notification, at the latest.
Slovenian: Z uporabo mreže predvidene v odstavku 1, države članice zagotovijo, da so poročila o domnevnih resnih neželenih učinkih, ki so se pojavili na njihovem ozemlju, takoj na voljo Agenciji ter drugim državam članicam, najpozneje pa v 15 koledarskih dneh od njihovega obvestila.
English: The Member States shall ensure that reports of suspected serious adverse reactions that have taken place on their territory are immediately made available to the marketing authorisation holder, and in any case within 15 calendar days of their notification, at the latest.
Slovenian: Države članice zagotovijo, da so poročila o domnevnih resnih neželenih učinkih, ki so se pojavili na njihovem ozemlju, takoj na voljo imetniku dovoljenja za promet z zdravilom, najpozneje pa najmanj v 15 koledarskih dneh od njihovega obvestila.
English: Article 106
Slovenian: Člen 106
English: In order to facilitate the exchange of information about pharmacovigilance within the Community, the Commission, in consultation with the Agency, Member States and interested parties, shall draw up guidance on the collection, verification and presentation of adverse reaction reports, including technical requirements for electronic exchange of pharmacovigilance information in accordance with internationally agreed formats and shall publish a reference to an internationally agreed medical terminology.
Slovenian: Za lažjo izmenjavo informacij o farmakovigilanci v Skupnosti, Komisija, v posvetovanju z Agencijo, državami članicami in zainteresiranimi strankami, izdela navodila za zbiranje, preverjanje in predstavitev poročil o neželenih učinkih, vključno s tehničnimi zahtevami za elektronsko izmenjavo podatkov o farmakovigilanci v skladu z mednarodno dogovorjenimi oblikami ter objavi napotilo na mednarodno sprejeto medicinsko terminologijo.
English: This guidance shall be published in Volume 9 of The rules governing medicinal products in the European Community and shall take account of international harmonisation work carried out in the field of pharmacovigilance.
Slovenian: Navodila se objavijo v 9. zvezku Pravil, ki urejajo zdravila v Evropski skupnosti ob upoštevanju mednarodne harmonizacije na področju farmakovigilance.
English: For the interpretation of the definitions referred to in Article 1 points 11 to 16 and the principles outlined in this Title, the marketing authorisation holder and the competent authorities shall refer to the guidance referred to in paragraph 1.
Slovenian: Za razlago opredelitev pojmov navedenih v točkah 11 do 16 člena 1 ter načel, opisanih v tem naslovu, imetnik dovoljenja za promet z zdravilom ter pristojni organi upoštevajo navodila iz odstavka 1.
English: Article 107
Slovenian: Člen 107
English: Where, as a result of the evaluation of pharmacovigilance data, a Member State considers that a marketing authorisation should be suspended, withdrawn or varied in accordance with the guidance referred to in Article 106(1), it shall forthwith inform the Agency, the other Member States and the marketing authorisation holder.
Slovenian: Kadar država članica glede na rezultate vrednotenja podatkov o farmakovigilanci meni, da je treba dovoljenje za promet z zdravilom začasno preklicati, ga ukiniti ali spremeniti v skladu z navodili iz člena 106(1), o tem takoj obvesti Agencijo, ostale države članice ter imetnika dovoljenja za promet.
English: In case of urgency, the Member State concerned may suspend the marketing authorisation of a medicinal product, provided the Agency, the Commission and the other Member States are informed at the latest on the following working day.
Slovenian: Če gre za nujen primer, lahko zadevna država članica dovoljenje za promet z zdravilom umakne, o tem pa obvesti Agencijo, Komisijo in druge države članice najpozneje naslednji delovni dan.
English: Article 108
Slovenian: Člen 108
English: Any amendments which may be necessary to update provisions of Articles 101 to 107 to take account of scientific and technical progress shall be adopted in accordance with the procedure referred to in Article 121(2).
Slovenian: Vse morebitne spremembe, potrebne za dopolnitev z zadnjimi podatki določb členov 101 do 107 zaradi upoštevanja znanstvenega in tehničnega napredka, se sprejme v skladu s postopkom iz člena 121(2).
English: SPECIAL PROVISIONS ON MEDICINAL PRODUCTS DERIVED FROM HUMAN BLOOD AND PLASMA
Slovenian: POSEBNE DOLOČBE O ZDRAVILIH, PRIDOBLJENIH IZ ČLOVEŠKE KRVI IN PLAZME
English: Article 109
Slovenian: Člen 109
English: In respect of the use of human blood or human plasma as a starting material for the manufacture of medicinal products, Member States shall take the necessary measures to prevent the transmission of infectious diseases.
Slovenian: Glede uporabe človeške krvi ali človeške plazme kot vhodne snovi za izdelavo zdravil države članice sprejmejo potrebne ukrepe za preprečevanje prenašanja nalezljivih bolezni.
English: In so far as this is covered by the amendments referred to in Article 121(1), as well as the application of the monographs of the European Pharmacopoeia regarding blood and plasma, these measures shall comprise those recommended by the Council of Europe and the World Health Organization, particularly with reference to the selection and testing of blood and plasma donors.
Slovenian: Kolikor je to zajeto s spremembami, navedenimi v členu 121(1), kot tudi z uporabo monografij Evropske farmakopeje glede krvi in plazme, ukrepi držav članic vključujejo ukrepe, ki jih priporočata Svet Evrope in Svetovna zdravstvena organizacija, zlasti kar se tiče izbora in preiskovanja darovalcev krvi in plazme.
English: Member States shall take the necessary measures to ensure that human blood and human plasma donors and donation centres are always clearly identifiable.
Slovenian: Države članice sprejmejo potrebne ukrepe, da zagotovijo, da so darovalci človeške krvi in človeške plazme ter centri za darovanje krvi vedno jasno prepoznavni.
English: All the safety guarantees referred to in paragraphs 1 and 2 must also be given by importers of human blood or human plasma from third countries.
Slovenian: Prav tako morajo uvozniki človeške krvi ali človeške plazme iz tretjih držav dati vsa jamstva glede varnosti iz odstavkov 1 in 2.
English: Article 110
Slovenian: Člen 110
English: Member States shall take the necessary measures to promote Community self-sufficiency in human blood or human plasma.
Slovenian: Države članice sprejmejo potrebne ukrepe za spodbujanje samozadostnosti Skupnosti pri oskrbi s človeško krvjo ali človeško plazmo.
English: For this purpose, they shall encourage the voluntary unpaid donation of blood and plasma and shall take the necessary measures to develop the production and use of products derived from human blood or human plasma coming from voluntary unpaid donations.
Slovenian: V ta namen spodbujajo prostovoljno, neplačano darovanje krvi in plazme ter sprejmejo potrebne ukrepe za razvoj proizvodnje in uporabe zdravil, pridobljenih iz človeške krvi ali človeške plazme, ki prihaja iz prostovoljnega in neplačanega darovanja.
English: They shall notify the Commission of such measures.
Slovenian: O takih ukrepih obvestijo Komisijo.
English: Article 111
Slovenian: Člen 111
English: The competent authority of the Member State concerned shall ensure, by means of repeated inspections, that the legal requirements governing medicinal products are complied with.
Slovenian: Pristojni organ zadevne države članice s ponavljajočimi inšpekcijskimi pregledi zagotovi, da se pravne zahteve, ki urejajo področje zdravil, izpolnjujejo.
English: Such inspections shall be carried out by officials representing the competent authority who shall be empowered to:
Slovenian: Inšpekcijske preglede opravljajo uradne osebe, ki predstavljajo pristojni organ, in so pooblaščene za:
English: inspect manufacturing or commercial establishments and any laboratories entrusted by the holder of the manufacturing authorization with the task of carrying out checks pursuant to Article 20;
Slovenian: inšpekcijski pregled proizvodnih ali poslovnih zgradb in laboratorijev, ki jim je imetnik dovoljenja za proizvodnjo zaupal nalogo izvajanja nadzora v skladu s členom 20;
English: examine any documents relating to the object of the inspection, subject to the provisions in force in the Member States on 21 May 1975 and which place restrictions on these powers with regard to the descriptions of the method of preparation.
Slovenian: pregled vseh dokumentov v zvezi s predmetom inšpekcijskega pregleda ob upoštevanju določb, ki so v državah članicah bile v veljavi na dan 21. maja 1975 in ki omejujejo ta pooblastila glede na opis metode priprave.
English: Member States shall take all appropriate steps to ensure that the manufacturing processes used in the manufacture of immunological products are properly validated and attain batch-to-batch consistency.
Slovenian: Države članice ustrezno ukrepajo, da zagotovijo, da se proizvodni procesi, uporabljeni pri proizvodnji imunoloških zdravil, primerno validirajo in da se dosega konsistentnost med serijami.
English: After every inspection as referred to in paragraph 1, the officials representing the competent authority shall report on whether the manufacturer complies with the principles and guidelines of good manufacturing practice laid down in Article 47.
Slovenian: Po vsakem inšpekcijskem pregledu iz odstavka 1, uradne osebe, ki predstavljajo pristojni organ, poročajo, ali izdelovalec ravna po načelih in smernicah dobre proizvodne prakse, določene v členu 47.
English: The content of such reports shall be communicated to the manufacturer who has to undergo the inspection.
Slovenian: Vsebina poročil se pošlje tudi proizvajalcu, pri katerem je bil opravljen inšpekcijski pregled.
English: Article 112
Slovenian: Člen 112
English: Member States shall take all appropriate measures to ensure that the holder of the marketing authorization for a medicinal product and, where appropriate, the holder of the manufacturing authorization, furnish proof of the controls carried out on the medicinal product and/or the ingredients and of the controls carried out at an intermediate stage of the manufacturing process, in accordance with the methods laid down in Article 8(3)(h).
Slovenian: Države članice sprejmejo vse ustrezne ukrepe, da zagotovijo, da imetnik dovoljenja za promet z zdravilom, in kadar je to primerno, imetnik dovoljenja za proizvodnjo, predloži dokaz o opravljenih nadzorih zdravila in/ali sestavin ter o nadzorih vmesnih faz postopka proizvodnje, v skladu s postopki, določenimi v členu 8(3)(h).
English: Article 113
Slovenian: Člen 113
English: For the purpose of implementing Article 112, Member States may require manufacturers of immunological products to submit to a competent authority copies of all the control reports signed by the qualified person in accordance with Article 51.
Slovenian: Za izvajanje člena 112 države članice lahko zahtevajo od proizvajalcev imunoloških zdravil, da pristojnemu organu predložijo izvode vseh poročil o nadzoru, ki jih podpiše odgovorna oseba v skladu s členom 51.
English: Article 114
Slovenian: Člen 114
English: Where it considers it necessary in the interests of public health, a Member State may require the holder of an authorization for marketing:
Slovenian: Kadar država članica meni, da je to potrebno v interesu javnega zdravja, lahko od imetnika dovoljenja za promet z:
English: live vaccines,
Slovenian: živimi cepivi,
English: immunological medicinal products used in the primary immunization of infants or of other groups at risk,
Slovenian: imunološkimi zdravili, ki se uporabljajo v primarni imunizaciji dojenčkov ali drugih skupin s tveganjem,
English: immunological medicinal products used in public health immunization programmes,
Slovenian: imunološkimi zdravili, ki se uporabljajo v javnih zdravstvenih programih imunizacije,
English: new immunological medicinal products or immunological medicinal products manufactured using new or altered kinds of technology or new for a particular manufacturer, during a transitional period normally specified in the marketing authorization,
Slovenian: novimi imunološkimi zdravili ali imunološkimi zdravili, proizvedenimi z uporabo novih ali spremenjenih vrst tehnologije ali novimi za določenega proizvajalca, med prehodnim obdobjem, ki je običajno navedeno v dovoljenju za promet z zdravilom,
English: to submit samples from each batch of the bulk and/or the medicinal product for examination by a State laboratory or a laboratory designated for that purpose before release on to the market unless, in the case of a batch manufactured in another Member State, the competent authority of that Member State has previously examined the batch in question and declared it to be in conformity with the approved specifications.
Slovenian: zahteva, da predloži vzorce vsake serije iz zbirnega vsebnika in/ali zdravila za pregled v državnem laboratoriju ali laboratoriju, pooblaščenem za ta namen, pred dajanjem v promet, razen v primeru serije, proizvedene v drugi državi članici, ki jo je pristojni organ te države članice predhodno že pregledal ter potrdil, da ustreza odobrenim specifikacijam.
English: Member States shall ensure that any such examination is completed within 60 days of the receipt of the samples.
Slovenian: Države članice zagotovijo, da se tak pregled opravi v 60 dneh od prejema vzorcev.