FrancophonIA/DGT-Translation_Memory huggingface dataset:
English: Where, in the interests of public health, the laws of a Member State so provide, the competent authorities may require the marketing authorization holder for medicinal products derived from human blood or human plasma to submit samples from each batch of the bulk and/or the medicinal product for testing by a State laboratory or a laboratory designated for that purpose before being released into free circulation, unless the competent authorities of another Member State have previously examined the batch in question and declared it to be in conformity with the approved specifications.
Slovenian: Če v interesu javnega zdravja zakonodaja države članice tako predpisuje, pristojni organi od imetnika dovoljenja za promet z zdravili, pridobljenimi iz človeške krvi ali človeške plazme, lahko zahtevajo, da predloži vzorce vsake serije iz zbirnega vsebnika in/ali zdravila za preskušanje v državnem laboratoriju ali laboratoriju, pooblaščenem za ta namen, pred sprostitvijo v prost promet, razen če niso zadevne serije pred tem že pregledali pristojni organi druge države članice in potrdili, da ustreza odobrenim specifikacijam.
English: Article 115
Slovenian: Člen 115
English: Member States shall take all necessary measures to ensure that the manufacturing and purifying processes used in the preparation of medicinal products derived from human blood or human plasma are properly validated, attain batch-to-batch consistency and guarantee, insofar as the state of technology permits, the absence of specific viral contamination.
Slovenian: Države članice sprejmejo vse potrebne ukrepe, da zagotovijo, da se proizvodni proces in proces čiščenja pri pripravi zdravil, pridobljenih iz človeške krvi ali človeške plazme, pravilno validirata, da se dosega konsistentnost med serijami ter jamčijo, če stanje tehnologije to dopušča, da ni prišlo do specifične virusne kontaminacije.
English: To this end manufacturers shall notify the competent authorities of the method used to reduce or eliminate pathogenic viruses liable to be transmitted by medicinal products derived from human blood or human plasma.
Slovenian: V ta namen proizvajalci uradno obvestijo pristojne organe o uporabljenem postopku za zmanjšanje ali odstranitev patogenih virusov, ki se lahko prenašajo z zdravili, pridobljenimi iz človeške krvi ali človeške plazme.
English: The competent authority may submit samples of the bulk and/or the medicinal product for testing by a State laboratory or a laboratory designated for that purpose, either during the examination of the application pursuant to Article 19, or after a marketing authorization has been granted.
Slovenian: Pristojni organ lahko predloži vzorce iz zbirnega vsebnika in/ali zdravila za preskus v državnem laboratoriju ali laboratoriju, pooblaščenem za ta namen, med preučevanjem vloge na podlagi člena 19 ali po izdaji dovoljenja za promet z zdravilom.
English: Article 116
Slovenian: Člen 116
English: The competent authorities of the Member States shall suspend or revoke an authorization to place a medicinal product on the market where that product proves to be harmful in the normal conditions of use, or where its therapeutic efficacy is lacking, or where its qualitative and quantitative composition is not as declared.
Slovenian: Pristojni organi držav članic začasno prekličejo ali ukinejo dovoljenje za dajanje zdravila v promet, kadar se pokaže, da je zdravilo škodljivo v predpisanih pogojih uporabe ali če ni terapevtsko učinkovito ali kadar njegova kakovostna in količinska sestava ne ustreza deklarirani.
English: Therapeutic efficacy is lacking when it is established that therapeutic results cannot be obtained with the medicinal product.
Slovenian: Zdravilo terapevtsko ni učinkovito, če se ugotovi, da z njim ni mogoče doseči terapevtskih rezultatov.
English: An authorization shall also be suspended or revoked where the particulars supporting the application as provided for in Articles 8, 10(1) and 11 are incorrect or have not been amended in accordance with Article 23, or where the controls referred to in Article 112 have not been carried out.
Slovenian: Dovoljenje za promet se začasno prekliče ali ukine, če so podrobni podatki v vlogi, kot to določajo členi 8, 10(1) in 11, nepravilni ali niso bili dopolnjeni v skladu s členom 23 ali kadar kontrole, navedene v členu 112, niso bile opravljene.
English: Article 117
Slovenian: Člen 117
English: Notwithstanding the measures provided for in Article 116, Member States shall take all appropriate measures to ensure that the supply of the medicinal product shall be prohibited and the medicinal product withdrawn from the market if:
Slovenian: Ne glede na ukrepe, predpisane v členu 116, države članice sprejmejo vse ustrezne ukrepe, da zagotovijo prepoved izdajanja ali umik zdravila iz prometa, če:
English: the medicinal product proves to be harmful under normal conditions of use, or
Slovenian: se pokaže, da je zdravilo v predpisanih pogojih uporabe škodljivo, ali
English: it is lacking in therapeutic efficacy, or
Slovenian: nima terapevtskega učinka, ali
English: its qualitative and quantitative composition is not as declared, or
Slovenian: kakovostna in količinska sestava zdravila ne ustreza deklarirani, ali
English: the controls on the medicinal product and/or on the ingredients and the controls at an intermediate stage of the manufacturing process have not been carried out or if some other requirement or obligation relating to the grant of the manufacturing authorization has not been fulfilled.
Slovenian: če niso bile opravljene kontrole zdravila in/ali sestavin ter kontrole vmesnih faz proizvodnega procesa ali če niso bile izpolnjene nekatere druge zahteve ali obveznosti v zvezi z izdanim dovoljenjem za proizvodnjo.
English: The competent authority may limit the prohibition to supply the product, or its withdrawal from the market, to those batches which are the subject of dispute.
Slovenian: Pristojni organ lahko omeji prepoved izdajanja zdravila ali umakne zdravilo iz prometa samo za sporne serije.
English: Article 118
Slovenian: Člen 118
English: The competent authority shall suspend or revoke the marketing authorization for a category of preparations or all preparations where any one of the requirements laid down in Article 41 is no longer met.
Slovenian: Pristojni organ ukine ali začasno prekliče dovoljenje za promet za skupino pripravkov ali vse pripravke, kadar katera koli od zahtev iz člena 41 ni več izpolnjena.
English: In addition to the measures specified in Article 117, the competent authority may suspend manufacture or imports of medicinal products coming from third countries, or suspend or revoke the manufacturing authorization for a category of preparations or all preparations where Articles 42, 46, 51 and 112 are not complied with.
Slovenian: Poleg ukrepov, navedenih v členu 117, pristojni organ lahko začasno prekine proizvodnjo ali uvoz zdravil iz tretjih držav ali ukine ali začasno prekliče dovoljenje za proizvodnjo za skupino pripravkov ali za vse pripravke, kadar določbe členov 42, 46, 51 in 112 niso izpolnjene.
English: Article 119
Slovenian: Člen 119
English: The provisions of this Title shall apply to homeopathic medicinal products, subject to the provisions of Article 14(3).
Slovenian: Določbe tega člena se uporabljajo za homeopatska zdravila ob upoštevanju določb člena 14(3).
English: TITLE XII
Slovenian: NASLOV XII
English: Article 120
Slovenian: Člen 120
English: Any changes which are necessary in order to adapt Annex I to take account of scientific and technical progress shall be adopted in accordance with the procedure referred to in Article 121(2).
Slovenian: Vse spremembe, ki so potrebne za prilagoditev Priloge 1 ob upoštevanja znanstvenega in tehničnega napredka, se sprejmejo v skladu s postopkom iz člena 121(2).
English: Article 121
Slovenian: Člen 121
English: The Commission shall be assisted by a Standing Committee on Medicinal Products for Human Use on the Adaptation to Technical Progress of the Directives on the Removal of Technical Barriers to Trade in the Medicinal Products Sector, (hereinafter referred to as the "Standing Committee").
Slovenian: Komisiji pomaga Stalni odbor za zdravila za ljudi glede prilagajanja tehničnemu napredku direktiv o odstranjevanju tehničnih ovir v trgovanju na področju zdravil (v nadaljnjem besedilu "Stalni odbor").
English: Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to Article 8 thereof.
Slovenian: Pri sklicevanju na ta odstavek se ob upoštevanju člena 8 Odločbe 1999/468/ES uporabljata člena 5 in 7, navedene odločbe.
English: The period provided for in Article 5(6) of Decision 1999/468/EC shall be set at three months.
Slovenian: Obdobje iz člena 5(6) Odločbe 1999/468/ES so trije meseci.
English: The Standing Committee shall adopt its rules of procedure.
Slovenian: Stalni odbor sprejeme svoj poslovnik.
English: TITLE XIII
Slovenian: NASLOV XIII
English: Article 122
Slovenian: Člen 122
English: Member States shall take all appropriate measures to ensure that the competent authorities concerned communicate to each other such information as is appropriate to guarantee that the requirements for the manufacturing authorizations or marketing authorizations are fulfilled.
Slovenian: Države članice sprejmejo vse ustrezne ukrepe, da zagotovijo medsebojno obveščanje med zadevnimi pristojnimi organi o informacijah, kot je ustrezno, da se zagotavlja izpolnjevanje zahtev za izdajo dovoljenj za proizvodnjo zdravil ali dovoljenj za promet z zdravili.
English: Upon reasoned request, Member States shall forthwith communicate the reports referred to in Article 111(3) to the competent authorities of another Member State.
Slovenian: Na utemeljeno zahtevo države članice takoj pošljejo poročila iz člena 111(3) pristojnim organom druge države članice.
English: If, after considering the reports, the Member State receiving the reports considers that it cannot accept the conclusions reached by the competent authorities of the Member State in which the report was established, it shall inform the competent authorities concerned of its reasons and may request further information.
Slovenian: Če država članica po pregledu prejetih poročil meni, da ne more sprejeti odločitev, ki jih je sprejel pristojni organ države članice, v kateri je bilo poročilo pripravljeno, zadevne pristojne organe obvesti o razlogih in lahko zahteva dodatne informacije.
English: The Member States concerned shall use their best endeavours to reach agreement.
Slovenian: Zadevne države članice si prizadevajo doseči soglasje.
English: If necessary, in the case of serious differences of opinion, the Commission shall be informed by one of the Member States concerned.
Slovenian: Po potrebi in če gre za resno razhajanje mnenj, ena od zadevnih držav članic o tem obvesti Komisijo.
English: Article 123
Slovenian: Člen 123
English: Each Member State shall take all the appropriate measures to ensure that decisions authorizing marketing, refusing or revoking a marketing authorization, cancelling a decision refusing or revoking a marketing authorization, prohibiting supply, or withdrawing a product from the market, together with the reasons on which such decisions are based, are brought to the attention of the Agency forthwith.
Slovenian: Vsaka država članica sprejme ustrezne ukrepe, da zagotovi takojšnje obveščanje Agencije o odločitvah glede odobritve dovoljenja za promet, zavrnitve ali preklica dovoljenja za promet z zdravilom, o razveljavitvi odločitve glede zavrnitve ali preklica dovoljenja za promet z zdravilom, o prepovedi izdajanja ali umiku zdravila iz prometa, skupaj z razlogi za take odločitve.
English: The marketing authorization holder shall be obliged to notify the Member States concerned forthwith of any action taken by him to suspend the marketing of a medicinal product or to withdraw a medicinal product from the market, together with the reasons for such action if the latter concerns the efficacy of the medicinal product or the protection of public health.
Slovenian: Imetnik dovoljenja za promet z zdravilom je dolžan takoj obvestiti zadevne države članice o vseh ukrepih, ki jih je sprejel glede umika zdravila iz prometa ali ukinitve zdravila v prometu, skupaj z razlogi za tako ukrepanje, če je to v zvezi z učinkovitostjo zdravila ali varovanjem javnega zdravja.
English: Member States shall ensure that this information is brought to the attention of the Agency.
Slovenian: Države članice zagotovijo, da je Agencija obveščena o takih informacijah.
English: Member States shall ensure that appropriate information about action taken pursuant to paragraphs 1 and 2 which may affect the protection of public health in third countries is forthwith brought to the attention of the World Health Organization, with a copy to the Agency.
Slovenian: Države članice zagotovijo, da se Svetovno zdravstveno organizacijo, ter s kopijo tudi Agencijo, takoj ustrezno obvesti o ukrepih, sprejetih v skladu z odstavkoma 1 in 2, ki lahko vplivajo na varovanje javnega zdravja v tretjih državah.
English: The Commission shall publish annually a list of the medicinal products which are prohibited in the Community.
Slovenian: Komisija vsako leto objavi seznam zdravil, ki so v skupnosti prepovedana.
English: Article 124
Slovenian: Člen 124
English: Member States shall communicate to each other all the information necessary to guarantee the quality and safety of homeopathic medicinal products manufactured and marketed within the Community, and in particular the information referred to in Articles 122 and 123.
Slovenian: Države članice se medsebojno obveščajo o vseh potrebnih informacijah za zagotavljanje kakovosti in varnosti homeopatskih zdravil, ki se proizvajajo in dajejo v promet v Skupnosti, zlasti o informacijah iz členov 122 in 123.
English: Article 125
Slovenian: Člen 125
English: Every decision referred to in this Directive which is taken by the competent authority of a Member State shall state in detail the reasons on which it is based.
Slovenian: Pristojni organ države članice navede podrobne razloge za vsako odločitev, sprejeto na podlagi te direktive.
English: Such decision shall be notified to the party concerned, together with information as to the redress available to him under the laws in force and of the time-limit allowed for access to such redress.
Slovenian: O odločitvi obvesti zainteresirano stranko skupaj z informacijo o možnosti poprave, ki je stranki na voljo po veljavni zakonodaji in o časovnem roku, v katerem je omogočeno koriščenje dane možnosti.
English: Marketing authorizations, and decisions to revoke such authorizations, shall be published by each Member State in the appropriate official publication.
Slovenian: Vsaka država članica v ustrezni uradni publikaciji objavi izdana dovoljenja za promet z zdravilom, ter sklepe o njihovem preklicu.
English: Article 126
Slovenian: Člen 126
English: An authorization to market a medicinal product shall not be refused, suspended or revoked except on the grounds set out in this Directive.
Slovenian: Dovoljenje za promet z zdravilom se sme zavrniti, umakniti ali preklicati samo na podlagi določb iz te direktive.
English: No decision concerning suspension of manufacture or of importation of medicinal products coming from third countries, prohibition of supply or withdrawal from the market of a medicinal product may be taken except on the grounds set out in Articles 117 and 118.
Slovenian: Sklep o začasni prekinitvi proizvodnje ali uvoza zdravil iz tretjih držav, o prepovedi izdajanja ali umiku zdravila iz prometa se sme sprejeti samo na podlagi določb iz členov 117 in 118.
English: Article 127
Slovenian: Člen 127
English: At the request of the manufacturer, the exporter or the authorities of an importing third country, Member States shall certify that a manufacturer of medicinal products is in possession of the manufacturing authorization.
Slovenian: Na zahtevo proizvajalca, izvoznika ali organov tretje države uvoznice, države članice potrdijo, da ima proizvajalec zdravil dovoljenja za proizvodnjo zdravil.
English: When issuing such certificates Member States shall comply with the following conditions:
Slovenian: Pri izdajanju teh potrdil države članice upoštevajo naslednje pogoje:
English: they shall have regard to the prevailing administrative arrangements of the World Health Organization;
Slovenian: obstoječe upravne dogovore Svetovne zdravstvene organizacije;
English: for medicinal products intended for export which are already authorized on their territory, they shall supply the summary of the product characteristics as approved in accordance with Article 21.
Slovenian: za zdravila, namenjena za izvoz, za katera že imajo dovoljenje za promet na svojem ozemlju, predložijo povzetek glavnih značilnosti zdravila, kot je odobren v skladu s členom 21.
English: When the manufacturer is not in possession of a marketing authorization he shall provide the authorities responsible for establishing the certificate referred to in paragraph 1, with a declaration explaining why no marketing authorization is available.
Slovenian: Če proizvajalec nima dovoljenja za promet z zdravilom, organom za izdajo potrdil iz odstavka 1 predloži izjavo z obrazložitvijo razloga, zakaj dovoljenje za promet z zdravilom ni na voljo.
English: TITLE XIV
Slovenian: NASLOV XIV
English: Article 128
Slovenian: Člen 128
English: Directives 65/65/EEC, 75/318/EEC, 75/319/EEC, 89/342/EEC, 89/343/EEC, 89/381/EEC, 92/25/EEC, 92/26/EEC, 92/27/EEC, 92/28/EEC and 92/73/EEC, amended by the Directives referred to in Annex II, Part A, are repealed, without prejudice to the obligations of the Member States concerning the time-limits for implementation set out in Annex II, Part B.
Slovenian: Direktive 65/65/EGS, 75/318/EGS, 75/319/EGS, 89/342/EGS, 89/343/EGS, 89/381/EGS, 92/25/EGS, 92/26/EGS, 92/27/EGS, 92/28/EGS in 92/73/EGS, spremenjene z direktivami iz dela A Priloge II, se razveljavijo, ne da bi posegale v obveznosti držav članic, kar zadeva časovne roke za izvajanje, določene v delu B Priloge II.
English: References to the repealed Directives shall be construed as references to this Directive and shall be read in accordance with the correlation table in Annex III.
Slovenian: Sklici na razveljavljene direktive pomenijo sklice na to direktivo in se berejo v skladu s korelacijsko preglednico v Prilogi III.
English: Article 129
Slovenian: Člen 129
English: This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Communities.
Slovenian: Ta direktiva začne veljati dvajseti dan po objavi v Uradnem listu Evropskih skupnosti.
English: Article 130
Slovenian: Člen 130
English: The President
Slovenian: Predsednica
English: Opinion of the European Parliament of 3 July 2001 (not yet published in the Official Journal) and Council Decision of 27 September 2001.
Slovenian: Mnenje Evropskega parlamenta z dne 3. julija 2001 (še ni objavljeno v Uradnem listu) ter sklepa Sveta z dne 27. septembra 2001.
English: ANALYTICAL, PHARMACOTOXICOLOGICAL AND CLINICAL STANDARDS AND PROTOCOLS IN RESPECT OF THE TESTING OF MEDICINAL PRODUCTS
Slovenian: ANALIZNI, FARMAKOLOŠKO-TOKSIKOLOŠKI IN KLINIČNI STANDARDI TER PROTOKOLI ZA PRESKUŠANJE ZDRAVIL
English: The particulars and documents accompanying an application for marketing authorization pursuant to Articles 8 and 10(1) shall be presented in four parts, in accordance with the requirements set out in this Annex and taking account of the guidance published by the Commission in The rules governing medicinal products in the European Community,Volume II:
Slovenian: Podrobni podatki in dokumenti, ki spremljajo vlogo za pridobitev dovoljenja za promet z zdravilom na podlagi členov 8 in 10(1), se predložijo v štirih delih v skladu z zahtevami, določenimi v tej prilogi ter ob upoštevanju navodil, ki jih je Komisija objavila v Pravilih, ki urejajo zdravila v Evropski skupnosti, zvezek II :
English: Notice to applicants for marketing authorizations for medicinal products for human use in the Member States of the European Community.
Slovenian: Obvestilo vlagateljem za pridobitev dovoljenj za promet z zdravili za ljudi v državah članicah Evropske skupnosti.
English: In assembling the dossier for application for marketing authorization, applicants shall take into account the Community guidelines relating to the quality, safety and efficacy of medicinal products published by the Commission in The rules governing medicinal products in the European Community, Volume III and its supplements:
Slovenian: Pri sestavljanju dosjeja za vlogo za pridobitev dovoljenja za promet z zdravilom vlagatelji upoštevajo smernice Skupnosti glede kakovosti, varnosti ter učinkovitosti zdravil, ki jih je Komisija objavila v Pravilih, ki urejajo zdravila v Evropski skupnosti, zvezek III , in dodatkih:
English: Guidelines on the quality, safety and efficacy of medicinal products for human use. All information which is relevant to the evaluation of the medicinal product concerned shall be included in the application, whether favourable or unfavourable to the product.
Slovenian: Smernice o kakovosti, varnosti in učinkovitosti zdravil za ljudi. V vlogo se vključijo vse informacije, ki so pomembne za vrednotenje zadevnega zdravila, če so zanj ugodne ali neugodne.
English: In particular, all relevant details shall be given of any incomplete or abandoned pharmacotoxicological or clinical test or trial relating to the medicinal product.
Slovenian: Zlasti se podajo vsi pomembni podatki za vsak nepopoln ali izpuščen farmakološko-toksikološki ali klinični preskus ali preskušanje v zvezi z zdravilom.
English: Moreover, in order to monitor the benefit/risk assessment after marketing authorization has been granted, any change to the data in the dossier, any new information not in the original application and all pharmacovigilance reports, shall be submitted to the competent authorities.
Slovenian: Za spremljanje ocene razmerja med koristjo in tveganjem po izdaji dovoljenja za promet se pristojnim organom predložijo vse spremembe podatkov v dosjeju, vse nove informacije, ki niso v osnovni vlogi, in vsa poročila o farmakovigilanci.
English: The general sections of this Annex give the requirements for all categories of medicinal products; they are supplemented by sections containing additional special requirements for radiopharmaceuticals and for biological medicinal products, such as immunological medicinal products derived from human blood or plasma.
Slovenian: Splošni oddelki te priloge navajajo zahteve za vse skupine zdravil; dopolnjujejo jih oddelki, ki vsebujejo dodatne posebne zahteve za radiofarmacevtske izdelke ter biološka zdravila, kot so imunološka zdravila, pridobljena iz človeške krvi ali plazme.
English: The additional special requirements for biological medicinal products are also applicable to medicinal products obtained through processes mentioned in Part A and the first indent of Part B of the Annex to Regulation (EEC) No 2309/93.
Slovenian: Dodatne posebne zahteve za biološka zdravila se uporabljajo tudi za zdravila, ki se pridobivajo po postopkih, navedenih v delu A in prvi alinei dela B Priloge k Uredbi (EGS) št. 2309/93.
English: Member States shall also ensure that all tests on animals are conducted in accordance with Council Directive 86/609/EEC of 24 November 1986 on the approximation of laws, regulation and administrative provisions of the Member States regarding the protection of animals for experimental and other scientific purposes(1).
Slovenian: Države članice zagotovijo, da se vsi poskusi na živalih izvajajo v skladu z Direktivo Sveta 86/609/EGS z dne 24. novembra 1986 o približevanju zakonov in drugih predpisov držav članic, ki se nanašajo na zaščito živali za poskusne in druge znanstvene namene [1].
English: PART I
Slovenian: DEL 1
English: SUMMARY OF THE DOSSIER
Slovenian: POVZETEK DOSJEJA
English: Administrative data
Slovenian: Administrativni podatki