natgillin/translations-raw huggingface dataset:
The competent authority which carried out the inspection shall communicate the content of those reports to the inspected entity.
Pristojni organ, ki je opravil inšpekcijski pregled, vsebino navedenih poročil pošlje pregledanemu subjektu.
Before adopting the report, the competent authority shall give the inspected entity concerned the opportunity to submit comments.’;
Pred sprejetjem poročila pristojni organ pregledanemu subjektu da možnost, da predloži pripombe.“;
If the outcome of the inspection as referred to in points (a), (b) and (c) of paragraph 1 or the outcome of an inspection of a distributor of medicinal products or active substances or a manufacturer of excipients used as starting materials is that the inspected entity does not comply with the legal requirements and/or the principles and guidelines of good manufacturing practice or good distribution practices as provided for by Union law, the information shall be entered in the Union database as provided for in paragraph 6.’;
Če rezultat inšpekcijskega pregleda iz točk (a), (b) in (c) odstavka 1 ali rezultat inšpekcijskega pregleda pri distributerju zdravil ali zdravilnih učinkovin ali pri izdelovalcu pomožnih snovi, ki se uporabljajo kot vhodne snovi, pokaže, da pregledan subjekt ne izpolnjuje pravnih zahtev in/ali načel in smernic dobre proizvodne prakse ali dobre distribucijske prakse iz zakonodaje Unije, se te informacije vnesejo v podatkovno bazo Unije, kot določa odstavek 6.“;
If the outcome of the inspection referred to in paragraph 1(d) is that the marketing authorisation holder does not comply with the pharmacovigilance system as described in the pharmacovigilance system master file and with Title IX, the competent authority of the Member State concerned shall bring the deficiencies to the attention of the marketing authorisation holder and give him the opportunity to submit comments.
Če rezultat inšpekcijskega pregleda iz točke (d) odstavka 1 pokaže, da imetnik dovoljenja za promet z zdravilom ne ravna v skladu s sistemom farmakovigilance, kot je opisano v glavnem dosjeju o sistemu farmakovigilance in naslovom IX, pristojni organ zadevne države članice imetnika dovoljenja za promet z zdravilom opozori na pomanjkljivosti in mu da možnost, da predloži pripombe.
In such case the Member State concerned shall inform the other Member States, the Agency and the Commission.
V takem primeru zadevna država članica obvesti druge države članice, Agencijo in Komisijo.
Where appropriate, the Member State concerned shall take the necessary measures to ensure that a marketing authorisation holder is subject to effective, proportionate and dissuasive penalties.’.
Kadar je primerno, zadevna država članica sprejme potrebne ukrepe za zagotovitev, da za imetnika dovoljenja za promet veljajo učinkovite, sorazmerne in odvračilne kazni.“;
Article 116 is replaced by the following:
člen 116 se nadomesti z naslednjim:
‘Article 116
„Člen 116
The competent authorities shall suspend, revoke or vary a marketing authorisation if the view is taken that the medicinal product is harmful or that it lacks therapeutic efficacy, or that the risk-benefit balance is not favourable, or that its qualitative and quantitative composition is not as declared.
Pristojni organi začasno prekličejo, ukinejo ali spremenijo dovoljenje za promet z zdravilom, kadar se pokaže, da je zdravilo škodljivo ali ni terapevtsko učinkovito ali razmerje med tveganji in koristjo ni ugodno ali kadar njegova kakovostna in količinska sestava ne ustrezata deklarirani sestavi.
Therapeutic efficacy shall be considered to be lacking when it is concluded that therapeutic results cannot be obtained from the medicinal product.
Šteje se, da zdravilo terapevtsko ni učinkovito, če se ugotovi, da z njim ni mogoče doseči terapevtskih rezultatov.
A marketing authorisation may also be suspended, revoked or varied where the particulars supporting the application as provided for in Articles 8, 10 or 11 are incorrect or have not been amended in accordance with Article 23, or where any conditions referred to in Articles 21a, 22 or 22a have not been fulfilled or where the controls referred to in Article 112 have not been carried out.’.
Dovoljenje za promet se lahko začasno prekliče, ukine ali spremeni, kadar so podrobni podatki v vlogi, kot je določeno v členih 8, 10 ali 11, nepravilni ali niso bili spremenjeni v skladu s členom 23 ali kadar pogoji ali obveznosti iz členov 21a, 22 ali 22a niso bili izpolnjeni ali kontrole iz člena 112 niso bile opravljene.“;
Article 117 is amended as follows:
člen 117 se spremeni:
the medicinal product is harmful; or’;
zdravilo je škodljivo; ali“;
the risk-benefit balance is not favourable; or’;
razmerje med tveganji in koristjo ni ugodno; ali“;
The competent authority may, for a medicinal product for which the supply has been prohibited or which has been withdrawn from the market in accordance with paragraphs 1 and 2, in exceptional circumstances during a transitional period allow the supply of the medicinal product to patients who are already being treated with the medicinal product.’.
Pristojni organ lahko za zdravilo, katerega dobave so bile prepovedane ali je umaknjen s tržišča v skladu z odstavkoma 1 in 2, v izrednih okoliščinah med prehodnim obdobjem dovoli izdajanje zdravila bolnikom, ki se s tem zdravilom že zdravijo.“;
‘Article 121a
„Člen 121a
The delegation of powers shall be automatically extended for periods of an identical duration, unless the European Parliament or the Council revokes it in accordance with Article 121b.
Prenos pooblastil se samodejno podaljša za enako dolgo obdobje, razen če ga Evropski parlament ali Svet prekliče v skladu s členom 121b.
As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.
Takoj ko Komisija sprejme delegirani akt, o njem sočasno uradno obvesti Evropski parlament in Svet.
The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in Articles 121b and 121c.
Pooblastilo za sprejetje delegiranih aktov je prenešeno na Komisijo pod pogoji iz členov 121b in 121c.
The delegation of powers referred to in Article 22b may be revoked at any time by the European Parliament or by the Council.
Pooblastil iz člena 22b lahko kadar koli prekliče Evropski parlament ali Svet.
The institution which has commenced an internal procedure for deciding whether to revoke the delegation of powers shall endeavour to inform the other institution and the Commission within a reasonable time before the final decision is taken, indicating the delegated powers which could be subject to revocation and possible reasons for a revocation.
Institucija, ki je začela notranji postopek o morebitnem preklicu pooblastila, o tem obvesti drugo institucijo in Komisijo v razumnem roku pred sprejetjem končne odločitve ter pri tem navede pooblastila, ki bi se lahko preklicala, in možne razloge za preklic.
At the initiative of the European Parliament or the Council that period shall be extended by 2 months.
Odločitev se objavi se v Uradnem listu Evropske unije. Člen 121c
If, on expiry of the period referred to in paragraph 1, neither the European Parliament nor the Council has objected to the delegated act, it shall be published in the Official Journal of the European Union and shall enter into force on the date stated therein.
1. Evropski parlament ali Svet lahko nasprotuje delegiranemu aktu v dveh mesecih od datuma uradnega obvestila.
The delegated act may be published in the Official Journal of the European Union and enter into force before the expiry of that period if the European Parliament and the Council have both informed the Commission of their intention not to raise objections.
Na pobudo Evropskega parlamenta ali Sveta se navedeni rok lahko podaljša za dva meseca.
If either the European Parliament or the Council objects to the delegated act within the period referred to in paragraph 1, it shall not enter into force.
Če do izteka roka iz odstavka 1 niti Evropski parlament niti Svet ne nasprotuje delegiranemu aktu, se akt objavi v Uradnem listu Evropske unije in začne veljati na dan, ki je v njem določen. Delegirani akt se lahko objavi v Uradnem listu Evropske unije in začne veljati pred iztekom tega roka, če Evropski parlament in Svet obvestita Komisijo o nameri, da delegiranemu aktu ne bosta nasprotovala.
The institution which objects shall state the reasons for objecting to the delegated act.’.
Če Evropski parlament ali Svet nasprotuje delegiranemu aktu, akt ne začne veljati. Institucija, ki nasprotuje, navede razloge za nasprotovanje delegiranemu aktu.“;
Article 122(2) is replaced by the following:
člen 122(2) se nadomesti z naslednjim:
Upon reasoned request, Member States shall send electronically the reports referred to in Article 111(3) to the competent authorities of another Member State or to the Agency.’.
Na utemeljeno zahtevo države članice pristojnim organom druge države članice ali Agenciji elektronsko pošljejo poročila iz člena 111(3).“;
Article 123(4) is replaced by the following:
člen 123(4) se nadomesti z naslednjim:
The Agency shall make public annually a list of the medicinal products for which marketing authorisations have been refused, revoked or suspended, whose supply has been prohibited or which have been withdrawn from the market.’.
Agencija vsako leto objavi seznam zdravil za katera je bilo zavrnjeno, začasno umaknjeno ali preklicano dovoljenje za promet, katerih dobave so bile prepovedane ali ki so bila umaknjena s trga.“;
In Article 126a, paragraphs 2 and 3 are replaced by the following:
v členu 126a se odstavka 2 in 3 nadomestita z naslednjim:
When a Member State avails itself of this possibility, it shall adopt the necessary measures in order to ensure that the requirements of this Directive are complied with, in particular those referred to in Titles V, VI, VIII, IX and XI.
Kadar država članica izkoristi to možnost, sprejme potrebne ukrepe za zagotovitev, da so izpolnjene zahteve iz te direktive, zlasti tiste iz naslovov V, VI, VIII, IX in XI.
Member States may decide that Article 63(1) and (2) shall not apply to medicinal products authorised under paragraph 1.
Države članice lahko sklenejo, da se člen 63(1) in (2) ne uporablja za zdravila, odobrena v skladu z odstavkom 1.
Before granting such a marketing authorisation, a Member State:
Pred izdajo takšnega dovoljenja za promet z zdravilom država članica:
shall notify the marketing authorisation holder, in the Member State in which the medicinal product concerned is authorised, of the proposal to grant a marketing authorisation under this Article in respect of the medicinal product concerned.
uradno obvesti imetnika dovoljenja za promet z zdravilom v državi članici, v kateri je zadevno zdravilo odobreno, o predlogu za izdajo dovoljenja za promet z zdravilom na podlagi tega člena, kar zadeva zadevno zdravilo;
may request the competent authority in that Member State to submit copies of the assessment report referred to in Article 21(4) and of the marketing authorisation in force in respect of the medicinal product concerned.
od pristojnega organa v tej državi lahko zahteva, da predloži izvod poročila o oceni zdravila iz člena 21(4) ter izvod veljavnega dovoljenja za promet z zadevnim zdravilom.
If so requested, the competent authority in that Member State shall supply, within 30 days of receipt of the request, a copy of the assessment report and the marketing authorisation in respect of the medicinal product concerned.’.
V primeru takšne zahteve pristojni organ v tej državi v 30 dneh od prejema zahteve predloži izvod poročila o oceni zdravila in dovoljenje za promet z zadevnim zdravilom.“;
Article 127a is replaced by the following:
člen 127a se nadomesti z naslednjim:
‘Article 127a
„Člen 127a
When a medicinal product is to be authorised in accordance with Regulation (EC) No 726/2004, and the Committee for Medicinal Products for Human Use in its opinion refers to recommended conditions or restrictions as provided for in points (c), (ca), (cb) or (cc) of Article 9(4) thereof, the Commission may adopt a decision addressed to the Member States, in accordance with Articles 33 and 34 of this Directive, for the implementation of those conditions or restrictions.’.
Kadar se zdravilo odobri v skladu z Uredbo (ES) št. 726/2004 in Odbor za zdravila za uporabo v humani medicini v svojem mnenju opozori na priporočene pogoje ali omejitve, kot je določeno v točkah (c), (ca), (cb) ali (cc) člena 9(4) Uredbe, Komisija lahko sprejme odločbo, naslovljeno na države članice, v skladu s postopkom iz členov 33 in 34 te direktive, za izvajanje navedenih pogojev ali omejitev.“.
With regard to the obligation on the part of the marketing authorisation holder to maintain and make available on request a pharmacovigilance system master file in respect of one or more medicinal products provided for in Article 104(3)(b) of Directive 2001/83/EC as amended by this Directive, the Member States shall ensure that that obligation applies to marketing authorisations granted before 21 July 2011 as from either:
Glede obveznosti imetnika dovoljenja za promet z zdravilom, da vodi in na zahtevo daje na voljo glavni dosje o sistemu farmakovigilance glede enega ali več zdravil iz točke (b) člena 104(3) te direktive, države članice zagotovijo, da obveznost velja za dovoljenja za promet z zdravilom, izdana pred 21. julijem 2011 ali od:
the date on which those marketing authorisations are renewed; or
datuma, ko so ta dovoljenja za promet z zdravilom podaljšana; ali
the expiry of a period of 3 years starting from 21 July 2011,
po izteku triletnega obdobja od 21. julija 2011,
whichever is earlier.
kar nastopi prej.
The Member States shall ensure that the procedure provided for in Articles 107m to 107q of Directive 2001/83/EC as amended by this Directive applies only to studies which have commenced after 21 July 2011.
Države članice zagotovijo, da se postopek, določen v členih 107m do 107q Direktive 2001/83/ES, kakor je bila spremenjena s to direktivo, uporablja samo za študije, ki so se začele po 21. julijem 2011.
With regard to the obligation on the part of the marketing authorisation holder to submit information on suspected adverse reactions electronically to the Eudravigilance database, provided for in Article 107(3) of Directive 2001/83/EC as amended by this Directive, the Member States shall ensure that this obligation applies as from 6 months after the functionalities of the database are established and have been announced by the Agency.
Glede obveznosti imetnikov dovoljenj za promet z zdravili, da po elektronski poti predložijo informacije o domnevnih neželenih učinkih podatkovni bazi Eudravigilance, kot je določeno v členu 107(3) Direktive 2001/83/ES, kot je bila spremenjena s to direktivo, države članice zagotovijo, da te obveznosti veljajo 6 mesecev po vzpostavitvi funkcionalnosti podatkovne baze in ko je Agencija to objavila.
Until the Agency can ensure the functionalities of the Eudravigilance database as specified in Article 24 of Regulation (EC) No 726/2004 as amended by Regulation (EU) No 1235/2010 [14] of the European Parliament and of the Council, marketing authorisation holders shall report, within 15 days of the day on which the holder concerned gained knowledge of the event, all serious suspected adverse reactions that occur in the Union, to the competent authority of the Member State on whose territory the incident occurred and shall report all serious suspected adverse reactions that occur on the territory of a third country to the Agency and, if requested, to the competent authorities of the Member States in which the medicinal product is authorised.
Dokler Agencija ne more zagotoviti funkcionalnosti podatkovne baze Eudravigilance, kot je določeno v členu 24 Uredbe (ES) št. 726/2004, kakor je bila spremenjena z Uredbo (EU) št. 1235/2010 [14] Evropskega parlamenta in Sveta, imetniki dovoljenj za promet v 15 dneh po dnevu, ko so zadevni imetniki seznanjeni z domnevnimi resnimi neželenimi učinki, o vseh takšnih učinkih, ki se pojavijo v Uniji, poročajo pristojnim organom države članice, na katere ozemlju so se pojavili, o vseh domnevnih resnih neželenih učinkih, ki se pojavijo na ozemlju tretjih držav, pa poročajo Agenciji in na zahtevo pristojnim organom držav članic, v katerih je zdravilo odobreno.
Until the Agency can ensure the functionalities of the Eudravigilance database as specified in Article 24 of Regulation (EC) No 726/2004 as amended by Regulation (EU) No 1235/2010, the competent authority of a Member State may require marketing authorisation holders to report to it all non-serious suspected adverse reactions that occur on the territory of that Member State, within 90 days of the day on which the marketing authorisation holder concerned gained knowledge of the event.
Dokler Agencija ne more zagotoviti funkcionalnosti podatkovne baze Eudravigilance, kot je določeno v členu 24 Uredbe (ES) št. 726/2004, kakor je bila spremenjena z Uredbo (EU) št. 1235/2010, lahko pristojni organ države članice od imetnikov dovoljenj za promet z zdravili zahteva, da mu poročajo o vseh domnevnih neželenih učinkih, ki niso resni in se pojavijo na ozemlju te države članice, v 90 dneh po dnevu, ko so bili zadevni imetniki dovoljenj za promet z zdravili seznanjeni s tem.
During this period, Member States shall ensure that the reports referred to in paragraph 4 that relate to events that occurred in their territory are promptly made available to the Eudravigilance database, and in any case within 15 days of the notification of suspected serious adverse reactions.
V tem obdobju države članice zagotovijo, da so poročila iz odstavka 4 v zvezi z dogodki na njihovem ozemlju, sproti na voljo podatkovni bazi Eudravigilance, v vsakem primeru pa v 15 dneh po obvestilu o domnevnih resnih neželenih učinkih.
With regard to the obligation on the part of the marketing authorisation holder to submit periodic safety update reports to the Agency as provided for in Article 107b(1) of Directive 2001/83/EC as amended by this Directive, the national competent authorities shall ensure that this obligation applies as from 12 months after the functionalities of the repository have been established and have been announced by the Agency.
Kar zadeva obveznosti, da morajo imetniki dovoljenj za promet z zdravili Agenciji predložiti redna posodobljena poročila o varnosti zdravila, kot je določeno v členu 107b(1) Direktive 2001/83/ES, kakor je bila spremenjena s to direktivo, pristojni nacionalni organi zagotovijo, da te obveznosti veljajo od 12. meseca po tem, ko je bila vzpostavljena funkcionalnost arhiva in je Agencija to objavila.
Until the Agency can ensure the functionalities agreed for the repository of the periodic safety update reports, the marketing authorisation holders shall submit the periodic safety reports to all Member States in which the medicinal product has been authorised.
Dokler Agencija ne more zagotoviti dogovorjenih funkcionalnosti arhiva rednih posodobljenih poročil o varnosti zdravil, se imetnikom dovoljenj za promet z zdravili naloži obveznost, da redna posodobljena poročila o varnosti zdravil predložijo vsem državam članicam, v katerih so zadevna zdravila za humano uporabo odobrena.
Member States shall adopt and publish, by 21 July 2012 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive.
Države članice najpozneje do 21. julija 2012 sprejmejo in objavijo zakone in druge predpise, potrebne za uskladitev s to direktivo.
They shall apply those provisions from 21 July 2012.
Navedene predpise uporabljajo od 21. julija 2012.
OJ C 306, 16.12.2009, p. 28.
UL C 306, 16.12.2009, str. 28.
OJ C 79, 27.3.2010, p. 50.
UL C 79, 27.3.2010, str. 50.
OJ C 229, 23.9.2009, p. 19.
UL C 229, 23.9.2009, str. 19.
Position of the European Parliament of 22 September 2010 [not yet published in the Official Journal] and Council Decision of 29 November 2010.
Stališče Evropskega parlamenta z dne 22. septembra 2010 (še ni objavljeno v Uradnem listu) in odločitev Sveta z dne 29. novembra 2010.
OJ L 262, 14.10.2003, p. 22.’.
UL L 262, 14.10.2003, p. 22.“;
where such obligation has been laid down as a condition in the marketing authorisation in accordance with Article 21a or Article 22; or
kadar je taka obveznost predpisana kot pogoj v dovoljenju za promet z zdravilom v skladu s členom 21a ali členom 22; ali
when requested by a competent authority on the basis of concerns relating to pharmacovigilance data or due to the lack of periodic safety update reports relating to an active substance after the marketing authorisation has been granted.
ko to zahteva pristojni organ na podlagi pomislekov glede podatkov o farmakovigilanci ali zato, ker niso bila predložena redna posodobljena poročila o varnostnih podatkih, povezanih z zdravilno učinkovino, po tem ko je bilo izdano dovoljenje za promet z zdravilom.
The power to adopt the delegated acts referred to in Article 22b shall be conferred on the Commission for a period of 5 years from 20 January 2011.
Pooblastilo za sprejemanje delegiranih aktov iz člena 22b se prenese na Komisijo za obdobje 5 let z začetkom 20. januarja 2011.
The Commission shall draw up a report in respect of the delegated powers not later than 6 months before the end of the 5 year period.
Komisija pripravi poročilo o prenesenih pooblastilih najpozneje 6 mesecev pred iztekom petletnega obdobja.
The decision of revocation shall put an end to the delegation of the powers specified in that decision. It shall take effect immediately or at a later date specified therein.
Z odločitvijo o preklicu prenehajo veljati pooblastila, navedena v tej odločitvi.
It shall not affect the validity of the delegated acts already in force. It shall be published in the Official Journal of the European Union.
Odločitev začne veljati takoj ali na dan, ki je v njej določen.
Article 121c 1. The European Parliament or the Council may object to a delegated act within a period of 2 months from the date of notification.
Odločitev ne vpliva na veljavnost že veljavnih delegiranih aktov.
On page 98, Article 2(1), introductory wording:
Stran 98, člen 2(1), uvodni stavek:
‘21 July 2011’,
„po 21. julijem 2011“
‘21 July 2012’;
„pred 21. julijem 2012“.
on page 98, Article 2(1)(b):
Stran 98, člen 2(1)(b):
the expiry of a period of 3 years starting from 21 July 2011’,
„po izteku triletnega obdobja od 21. julija 2011,“.
21 July 2015’;
„21. julija 2015,“.
on page 98, Article 2(2):
Stran 98, člen 2(2):
‘21 July 2012’.
„po 21. juliju 2012“.
for: ‘b)
besedilo:
read: ‘b)
se glasi:
Commission Directive 2010/85/EU
Direktiva Komisije 2010/85/EU
amending Council Directive 91/414/EEC to include zinc phosphide as active substance and amending Decision 2008/941/EC
o spremembi Direktive Sveta 91/414/EGS zaradi vključitve cinkovega fosfida kot aktivne snovi in o spremembi Odločbe 2008/941/ES
That list included zinc phosphide.
Navedeni seznam je vključeval cinkov fosfid.
In accordance with Article 24e of Regulation (EC) No 2229/2004 the applicant withdrew its support of the inclusion of that active substance in Annex I to Directive 91/414/EEC within 2 months from receipt of the draft assessment report.
V skladu s členom 24(e) Uredbe (ES) št. 2229/2004 je vlagatelj umaknil svoj zahtevek za vključitev aktivne snovi v Prilogo I k Direktivi 91/414/EGS v dveh mesecih od prejema osnutka poročila o oceni.
Consequently, Commission Decision 2008/941/EC of 8 December 2008 concerning the non-inclusion of certain active substances in Annex I to Council Directive 91/414/EEC and the withdrawal of authorisations for plant protection products containing these substances [4] was adopted on the non-inclusion of zinc phosphide.
Zato je bila v zvezi z nevključitvijo cinkovega fosfida sprejeta Odločba Komisije 2008/941/ES z dne 8. decembra 2008 o nevključitvi nekaterih aktivnih snovi v Prilogo I k Direktivi Sveta 91/414/EGS in o preklicu registracij fitofarmacevtskih sredstev, ki vsebujejo te snovi [4].