FrancophonIA/DGT-Translation_Memory huggingface dataset:
English: When appointing experts, the Committee shall define their tasks and specify the time-limit for the completion of these tasks.
Slovenian: Pri imenovanju strokovnjakov Odbor opredeli njihove naloge in določi rok za dokončanje nalog.
English: In the cases referred to in Articles 29 and 30, before issuing its opinion, the Committee shall provide the marketing authorization holder with an opportunity to present written or oral explanations.
Slovenian: V primerih iz členov 29 in 30, Odbor, preden da svoje mnenje, imetniku dovoljenja za promet z zdravilom da možnost, da da pisno ali ustno obrazložitev.
English: In the case referred to in Article 31, the marketing authorization holder may be asked to explain himself orally or in writing.
Slovenian: V primeru iz člena 31 se od imetnika dovoljenja za promet z zdravilom lahko zahteva, da obrazložitev da ustno ali v pisni obliki.
English: If it considers it appropriate, the Committee may invite any other person to provide information relating to the matter before it.
Slovenian: Če je primerno, lahko Odbor povabi katero koli drugo osebo, da preskrbi informacije v zvezi z zadevo, ki jo Odbor obravnava.
English: The Committee may suspend the time limit referred to in paragraph 1 in order to allow the marketing authorization holder to prepare explanations.
Slovenian: Odbor lahko začasno prekine časovni rok iz odstavka 1, da imetniku dovoljenja za promet z zdravilom omogoči, da pripravi obrazložitve.
English: The Agency shall forthwith inform the marketing authorization holder where the opinion of the Committee is that:
Slovenian: Agencija takoj obvesti imetnika dovoljenja za promet z zdravilom, kadar Odbor meni:
English: the application does not satisfy the criteria for authorization, or
Slovenian: da vloga ne zadošča merilom za pridobitev dovoljenja za promet, ali
English: the summary of the product characteristics proposed by the applicant in accordance with Article 11 should be amended, or
Slovenian: da je treba dopolniti povzetek glavnih značilnosti zdravila, ki ga predlaga vlagatelj v skladu s členom 11, ali
English: the authorization should be granted subject to conditions, with regard to conditions considered essential for the safe and effective use of the medicinal product including pharmacovigilance, or
Slovenian: da je izdajo dovoljenja treba odobriti z določenimi pogoji, glede na pogoje, ki so bistveni za varno in učinkovito uporabo zdravila, vključno s farmakovigilanco, ali
English: a marketing authorization should be suspended, varied or withdrawn.
Slovenian: da je treba dovoljenje za promet z zdravilom začasno preklicati, spremeniti ali ukiniti.
English: Within 15 days of the receipt of the opinion, the marketing authorization holder may notify the Agency in writing of his intention to appeal.
Slovenian: V roku 15 dni od prejetja mnenja imetnik dovoljenja za promet z zdravilom lahko v pisni obliki uradno obvesti Agencijo, da se bo pritožil.
English: In that case, he shall forward the detailed grounds for appeal to the Agency within 60 days of receipt of the opinion.
Slovenian: V tem primeru v 60 dneh od prejetja mnenja Agenciji pošlje podrobne utemeljitve za pritožbo.
English: Within 60 days of receipt of the grounds for appeal, the Committee shall consider whether its opinion should be revised, and the conclusions reached on the appeal shall be annexed to the assessment report referred to in paragraph 5.
Slovenian: V 60 dneh po prejetju utemeljitev Odbor pretehta, ali mora svoje mnenje ponovno preučiti in sklepe, sprejete glede pritožbe, priloži k poročilu o oceni zdravila iz odstavka 5.
English: Within 30 days of its adoption, the Agency shall forward the final opinion of the Committee to the Member States, the Commission and the marketing authorization holder together with a report describing the assessment of the medicinal product and stating the reasons for its conclusions.
Slovenian: V 30 dneh od sprejetja mnenja, Agencija pošlje končno mnenje Odbora državam članicam, Komisiji in imetniku dovoljenja za promet z zdravilom, skupaj s poročilom o oceni zdravila in navede razloge za tak sklep.
English: In the event of an opinion in favour of granting or maintaining an authorization to place the medicinal product concerned on the market, the following documents shall be annexed to the opinion.
Slovenian: Če gre za mnenje, ki je v prid izdaji dovoljenja za promet ali ohranitvi dovoljenja za dajanje zadevnega zdravila v promet, se k mnenju priložijo naslednji dokumenti:
English: a draft summary of the product characteristics, as referred to in Article 11;
Slovenian: osnutek povzetka glavnih značilnosti zdravila, kot je določeno v členu 11;
English: any conditions affecting the authorization within the meaning of paragraph 4.
Slovenian: pogoji, ki vplivajo na izdajo dovoljenja v smislu odstavka 4.
English: Within 30 days of the receipt of the opinion, the Commission shall prepare a draft of the decision to be taken in respect of the application, taking into account Community law.
Slovenian: V 30 dneh po prejetju mnenja, Komisija pripravi osnutek odločbe, ki jo je treba sprejeti glede vloge, ob upoštevanju zakonodaje Skupnosti.
English: In the event of a draft decision which envisages the granting of marketing authorization, the documents referred to in Article 32(5)(a) and (b) shall be annexed.
Slovenian: Če osnutek odločbe predvideva izdajo dovoljenja za promet z zdravilom, je treba priložiti dokumente iz člena 32(5)(a) in (b).
English: Where, exceptionally, the draft decision is not in accordance with the opinion of the Agency, the Commission shall also annex a detailed explanation of the reasons for the differences.
Slovenian: Kadar, izjemoma, osnutek odločbe ni v skladu z mnenjem Agencije, Komisija priloži tudi podrobno obrazložitev razlogov za razhajanja.
English: The draft decision shall be forwarded to the Member States and the applicant.
Slovenian: Osnutek odločbe pošlje državam članicam in vlagatelju.
English: A final decision on the application shall be adopted in accordance with the procedure referred to in Article 121(2).
Slovenian: Končna odločba glede vloge se sprejme v skladu s postopkom iz člena 121(2).
English: The rules of procedure of the Standing Committee established by Article 121(1) shall be adjusted to take account of the tasks incumbent upon it in accordance with this Chapter.
Slovenian: Poslovnik Stalnega odbora, ustanovljenega s členom 121(1), se prilagodi ob upoštevanju nalog, za katere je zadolžen v skladu s tem poglavjem.
English: These adjustments shall involve the following:
Slovenian: Prilagoditve vključujejo naslednje:
English: except in cases referred to in the third paragraph of Article 33, the opinion of the Standing Committee shall be obtained in writing,
Slovenian: razen v primeru, navedenem v tretjem odstavku člena 33, se pridobi pisno mnenje Stalnega odbora,
English: each Member State is allowed at least 28 days to forward written observations on the draft decision to the Commission,
Slovenian: vsaka država članica imajo na voljo najmanj 28 dni, da Komisiji predloži pisne pripombe na osnutek odločbe,
English: each Member State is able to require in writing that the draft decision be discussed by the Standing Committee, giving its reasons in detail.
Slovenian: vsaka država članica sme v pisni obliki zahtevati, da o osnutku odločbe razpravlja tudi Stalni odbor, ki podrobno navede svoje razloge.
English: Where, in the opinion of the Commission, the written observations of a Member State raise important new questions of a scientific or technical nature which have not been addressed in the opinion of the Agency, the Chairman shall suspend the procedure and refer the application back to the Agency for further consideration.
Slovenian: Kadar po mnenju Komisije pisne pripombe države članice odpirajo pomembna nova vprašanja znanstvene ali tehnične narave, ki niso bila navedena v mnenju Agencije, predsednik začasno ustavi postopek in vlogo vrne Agenciji v nadaljnjo obravnavo.
English: The provisions necessary for the implementation of this paragraph shall be adopted by the Commission in accordance with the procedure referred to in Article 121(2).
Slovenian: Določbe, potrebne za izvajanje tega odstavka, sprejme Komisija v skladu s postopkom iz člena 121(2).
English: A decision as referred to in paragraph 1 shall be addressed to the Member States concerned by the matter and reported to the marketing authorization holder.
Slovenian: Odločba, navedena v odstavku 1, se naslovi na države članice, ki jih odločba zadeva, obvesti pa se tudi imetnika dovoljenja za promet z zdravilom.
English: The Member States shall either grant or withdraw marketing authorization, or vary the terms of a marketing authorization as necessary to comply with the decision within 30 days of its notification.
Slovenian: Države članice odobrijo ali zavrnejo izdajo dovoljenja za promet z zdravilom, ali spremenijo pogoje izdaje dovoljenja za promet z zdravilom, kot je potrebno v skladu z odločbo, v 30 dneh od uradnega obvestila.
English: They shall inform the Commission and the Agency thereof.
Slovenian: Države članice o tem obvestijo Komisijo in Agencijo.
English: Any application by the marketing authorization holder to vary a marketing authorization which has been granted in accordance with the provisions of this Chapter shall be submitted to all the Member States which have previously authorized the medicinal product concerned.
Slovenian: Vsaka vloga imetnika dovoljenja za promet z zdravilom za spremembo dovoljenja za promet, ki je bilo odobreno v skladu z določbami tega poglavja, se predloži vsem državam članicam, ki so predhodno izdale dovoljenje za promet z zadevnim zdravilom.
English: The Commission shall, in consultation with the Agency, adopt appropriate arrangements for the examination of variations to the terms of a marketing authorization.
Slovenian: Komisija po posvetu z Agencijo sprejme ustrezne dogovore za preučitev sprememb pogojev dovoljenja za promet z zdravilom.
English: These arrangements shall include a notification system or administration procedures concerning minor variations and define precisely the concept of "a minor variation".
Slovenian: Dogovori vključujejo sistem obveščanja ali upravne postopke v zvezi z manjšimi spremembami in natančno opredelitev pojma "manjša sprememba".
English: These arrangements shall be adopted by the Commission in the form of an implementing Regulation in accordance with the procedure referred to in Article 121(2).
Slovenian: Komisija sprejeme dogovore v obliki izvedbene Uredbe v skladu s postopkom iz člena 121(2).
English: In case of arbitration submitted to the Commission, the procedure laid down in Articles 32, 33 and 34 shall apply by analogy to variations made to marketing authorizations.
Slovenian: V primeru arbitraže, predložene Komisiji, se smiselno uporabi postopek iz členov 32, 33 in 34 tudi za spremembe dovoljenj za promet z zdravili.
English: Where a Member State considers that the variation of a marketing authorization which has been granted in accordance with the provisions of this Chapter or its suspension or withdrawal is necessary for the protection of public health, the Member State concerned shall forthwith refer the matter to the Agency for the application of the procedures laid down in Articles 32, 33 and 34.
Slovenian: Kadar država članica meni, da je potrebna sprememba dovoljenja za promet z zdravilom, ki je bilo odobreno v skladu z določbami tega poglavja, ali začasni preklic ali ukinitev zaradi varovanja javnega zdravja, zadevna država članica takoj predloži zadevo Agenciji za uporabo postopkov iz členov 32, 33 in 34.
English: Without prejudice to the provisions of Article 31, in exceptional cases, where urgent action is essential to protect public health, until a definitive decision is adopted a Member State may suspend the marketing and the use of the medicinal product concerned on its territory.
Slovenian: Brez poseganja v določbe člena 31, lahko država članica v izjemnih primerih, kadar je hitro ukrepanje bistveno za zaščito javnega zdravja, do sprejetja dokončne odločitve začasno ustavi prodajo in uporabo zadevnega zdravila na svojem ozemlju.
English: It shall inform the Commission and the other Member States no later than the following working day of the reasons for its action.
Slovenian: O vzrokih takega ukrepanja obvesti Komisijo in ostale države članice najpozneje naslednji delovni dan.
English: Articles 35 and 36 shall apply by analogy to medicinal products authorized by Member States following an opinion of the Committee given in accordance with Article 4 of Directive 87/22/EEC before 1 January 1995.
Slovenian: Člena 35 in 36 se smiselno uporabljata za zdravila, za katere so države članice izdale dovoljenja na podlagi mnenja Odbora, ki ga je dal v skladu s členom 4 Direktive 87/22/EGS pred 1. januarjem 1995.
English: The Agency shall publish an annual report on the operation of the procedures laid down in this Chapter and shall forward that report to the European Parliament and the Council for information.
Slovenian: Agencija objavi letno poročilo o izvajanju postopkov iz tega poglavja ter poročilo pošlje Evropskemu parlamentu in Svetu v informacijo.
English: By 1 January 2001, the Commission shall publish a detailed review of the operation of the procedures laid down in this Chapter and shall propose any amendments which may be necessary to improve these procedures.
Slovenian: Do 1. januarja 2001 Komisija objavi podroben pregled izvajanja postopkov iz tega poglavja ter predlaga morebitne spremembe, potrebne za izboljšanje teh postopkov.
English: The Council shall decide, under the conditions provided for in the Treaty, on the Commission proposal within one year of its submission.
Slovenian: Svet odloča o predlogu Komisije pod pogoji, določenimi v Pogodbi, v roku enega leta po predložitvi.
English: The provisions referred to in Articles 27 to 34 shall not apply to the homeopathic medicinal products referred to in Article 16(2).
Slovenian: Določbe členov 27 do 34 se ne uporabljajo za homeopatska zdravila iz člena 16(2).
English: MANUFACTURE AND IMPORTATION
Slovenian: PROIZVODNJA IN UVOZ
English: Member States shall take all appropriate measures to ensure that the manufacture of the medicinal products within their territory is subject to the holding of an authorization.
Slovenian: Države članice sprejmejo vse potrebne ukrepe, da na svojem ozemlju zagotovijo proizvodnjo zdravil na podlagi izdanega dovoljenja.
English: This manufacturing authorization shall be required nothwithstanding that the medicinal products manufactured are intended for export.
Slovenian: Dovoljenje za proizvodnjo zdravil se zahteva tudi, če so proizvedena zdravila namenjena za izvoz.
English: The authorization referred to in paragraph 1 shall be required for both total and partial manufacture, and for the various processes of dividing up, packaging or presentation.
Slovenian: Dovoljenje iz odstavka 1 se zahteva za celoten in del postopka proizvodnje, ter za različne postopke delitve zdravila na manjše enote, pakiranja ali opremljanja zdravil.
English: However, such authorization shall not be required for preparation, dividing up, changes in packaging or presentation where these processes are carried out, solely for retail supply, by pharmacists in dispensing pharmacies or by persons legally authorized in the Member States to carry out such processes.
Slovenian: To dovoljenje se ne zahteva za pripravo, delitev zdravila na manjše enote, spremembe v pakiranju ali opremljanju zdravil, kadar se ti postopki izvajajo izključno za promet na drobno prek farmacevtov v lekarnah ali prek oseb, ki so v državah članicah zakonito pooblaščene za izvajanje tovrstnih postopkov.
English: Authorization referred to in paragraph 1 shall also be required for imports coming from third countries into a Member State;
Slovenian: Dovoljenje iz odstavka 1 se zahteva tudi za uvoz zdravil iz tretjih držav v državo članico;
English: this Title and Article 118 shall have corresponding application to such imports as they have to manufacture.
Slovenian: ta naslov in člen 118 se uporabljata hkrati za uvoz in za proizvodnjo.
English: In order to obtain the manufacturing authorization, the applicant shall meet at least the following requirements:
Slovenian: Za pridobitev dovoljenja za proizvodnjo zdravila mora vlagatelj izpolnjevati najmanj naslednje zahteve:
English: specify the medicinal products and pharmaceutical forms which are to be manufactured or imported and also the place where they are to be manufactured and/or controlled;
Slovenian: navede zdravila in farmacevtske oblike, ki jih bo proizvajal ali uvažal, ter mesto proizvodnje in/ali kontrole;
English: have at his disposal, for the manufacture or import of the above, suitable and sufficient premises, technical equipment and control facilities complying with the legal requirements which the Member State concerned lays down as regards both manufacture and control and the storage of medicinal products, in accordance with Article 20;
Slovenian: za proizvodnjo ali uvoz zdravil mora imeti na voljo primerne in ustrezne prostore, tehnično opremo ter potrebno opremo za kontrolo, ki so v skladu s pravnimi zahtevami, ki jih je zadevna država članica določila za proizvodnjo in kontrolo ter shranjevanje zdravil, skladno s členom 20;
English: have at his disposal the services of at least one qualified person within the meaning of Article 48.
Slovenian: imeti mora na voljo najmanj eno odgovorno osebo v smislu člena 48.
English: The applicant shall provide particulars in support of the above in his application.
Slovenian: Vlagatelj v svoji vlogi predloži podrobne podatke o razpolaganju z zgoraj naštetim.
English: The competent authority of the Member State shall issue the manufacturing authorization only after having made sure of the accuracy of the particulars supplied pursuant to Article 41, by means of an inquiry carried out by its agents.
Slovenian: Pristojni organ države članice izda dovoljenje za proizvodnjo zdravil potem, ko njegovi zastopniki s pregledom preverijo točnost podrobnih podatkov, predloženih v skladu s členom 41.
English: In order to ensure that the requirements referred to in Article 41 are complied with, authorization may be made conditional on the carrying out of certain obligations imposed either when authorization is granted or at a later date.
Slovenian: Da se zagotovi izpolnjevanje zahtev iz člena 41, se dovoljenje lahko izda pogojno glede na izpolnjevanje nekaterih obveznosti, ki se vlagatelju naložijo ob izdaji dovoljenja ali pozneje.
English: The authorization shall apply only to the premises specified in the application and to the medicinal products and pharmaceutical forms specified in that same application.
Slovenian: Dovoljenje velja samo za prostore, navedene v vlogi, ter za zdravila in farmacevtske oblike, navedene v isti vlogi.
English: The Member States shall take all appropriate measures to ensure that the time taken for the procedure for granting the manufacturing authorization does not exceed 90 days from the day on which the competent authority receives the application.
Slovenian: Države članice sprejmejo vse potrebne ukrepe, da zagotovijo, da čas, potreben za postopek izdaje dovoljenja za proizvodnjo ne presega 90 dni od dneva, ko pristojni organ prejme vlogo.
English: If the holder of the manufacturing authorization requests a change in any of the particulars referred to in points (a) and (b) of the first paragraph of Article 41, the time taken for the procedure relating to this request shall not exceed 30 days.
Slovenian: Če imetnik dovoljenja za proizvodnjo zahteva spremembo katerega koli podrobnega podatka iz točk (a) in (b) prvega odstavka člena 41, čas postopka v zvezi s to zahtevo ne presega 30 dni.
English: In exceptional cases this period of time may be extended to 90 days.
Slovenian: V izjemnih primerih se sme rok podaljšati na 90 dni.
English: The competent authority of the Member State may require from the applicant further information concerning the particulars supplied pursuant to Article 41 and concerning the qualified person referred to in Article 48;
Slovenian: Pristojni organ države članice od vlagatelja lahko zahteva nadaljnje informacije o predloženih podrobnih podatkih na podlagi člena 41 in v zvezi z odgovorno osebo, omenjeno v členu 48;
English: where the competent authority concerned exercises this right, application of the time-limits referred to in Article 43 and 44 shall be suspended until the additional data required have been supplied.
Slovenian: kadar zadevni pristojni organ uporabi to pravico, časovni roki iz členov 43 in 44 prenehajo teči do predložitve zahtevanih dodatnih podatkov.
English: The holder of a manufacturing authorization shall at least be obliged:
Slovenian: Imetnik dovoljenja za proizvodnjo mora obvezno najmanj:
English: to have at his disposal the services of staff who comply with the legal requirements existing in the Member State concerned both as regards manufacture and controls;
Slovenian: imeti na voljo storitve osebja, ki izpolnjuje pravne zahteve, ki obstajajo v državi članici, glede proizvodnje in kontrole;
English: to dispose of the authorized medicinal products only in accordance with the legislation of the Member States concerned;
Slovenian: imeti na voljo zdravila, za katera je bilo izdano dovoljenje za promet samo v skladu z zakonodajo zadevnih držav članic;
English: to give prior notice to the competent authority of any changes he may wish to make to any of the particulars supplied pursuant to Article 41;
Slovenian: predhodno obvestiti pristojni organ o vseh spremembah, ki jih želi izvesti v zvezi s katerimi koli podrobnimi podatki na podlagi člena 41;
English: the competent authority shall, in any event, be immediately informed if the qualified person referred to in Article 48 is replaced unexpectedly;
Slovenian: pristojni organ mora biti v vsakem primeru takoj obveščen, če se odgovorna oseba iz člena 48 nepričakovano zamenja;
English: to allow the agents of the competent authority of the Member State concerned access to his premises at any time;
Slovenian: dovoliti zastopnikom pristojnega organa zadevne države članice dostop do prostorov ob vsakem času;
English: to enable the qualified person referred to in Article 48 to carry out his duties, for example by placing at his disposal all the necessary facilities;
Slovenian: omogočiti odgovorni osebi iz člena 48, da opravlja svoje dolžnosti, na primer s tem, da so ji na voljo vsa potrebna sredstva;
English: to comply with the principles and guidelines of good manufacturing practice for medicinal products as laid down by Community law.
Slovenian: upoštevati načela in smernice dobre proizvodne prakse za zdravila, kot to določa zakonodaja Skupnosti.
English: The principles and guidelines of good manufacturing practices for medicinal products referred to in Article 46(f) shall be adopted in the form of a directive, in accordance with the procedure referred to in Article 121(2).
Slovenian: Načela in smernice dobrih proizvodnih praks za zdravila iz člena 46(f) se sprejmejo v obliki direktive v skladu s postopkom iz člena 121(2).
English: Detailed guidelines in line with those principles will be published by the Commission and revised necessary to take account of technical and scientific progress.
Slovenian: Podrobne smernice, usklajene s temi načeli, bo Komisija objavila in ponovno pregledala ob potrebnem upoštevanju tehničnega in znanstvenega napredka.
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, in accordance with the conditions laid down in Article 49, responsible in particular for carrying out the duties specified in Article 51.
Slovenian: Države članice sprejmejo vse potrebne ukrepe, da zagotovijo, da ima imetnik dovoljenja za proizvodnjo trajno in nenehno na voljo najmanj eno odgovorno osebo, v skladu s pogoji iz člena 49, ki je odgovorna zlasti za izvajanje dolžnosti, opredeljenih v členu 51.