natgillin/translations-raw huggingface dataset:
The competent authorities shall submit annually to the coordination group a list of reference veterinary medicinal products and their summary of product characteristics for which a marketing authorisation has been granted in accordance with Article 47 if, according to the competent authority, they should be subject to the procedure for harmonisation of their summaries of product characteristics.
Na zahtevo pristojnega organa v referenčni državi članici iz odstavka 3 tega člena imetnik dovoljenja za promet usklajevalni skupini predloži povzetek, v katerem navede razlike med povzetki glavnih značilnosti zdravila, predlog za harmoniziran povzetek glavnih značilnosti zdravila, navodila za uporabo in označevanja v skladu s členom 7, k temu pa priloži ustrezne obstoječe podporne podatke, ki so predloženi v skladu s členom 8 in ki so pomembni za zadevni predlog za harmonizacijo.
The marketing authorisation holder may apply for the procedure of harmonisation of summaries of product characteristics for a reference veterinary medicinal product by submitting to the coordination group the list of different names of this veterinary medicinal product and the different summaries of product characteristics for which a marketing authorisation has been granted in accordance with Article 47 in different Member States.
V 180 dneh od prejema informacij iz odstavka 5 pristojni organ v referenčni državi članici v posvetovanju z imetnikom dovoljenja za promet preuči dokumente, predložene v skladu z odstavkom 5, pripravi poročilo ter ga predloži usklajevalni skupini in imetniku dovoljenja za promet.
The coordination group shall, taking into account the lists provided by the Member States in accordance with paragraph 1 or any application received from a marketing authorisation holder in accordance with paragraph 2, draw up annually and publish a list of reference veterinary medicinal products which shall be subject to harmonisation of their summaries of product characteristics and shall appoint a reference Member State for each reference veterinary medicinal product concerned.
Po prejemu poročila in če usklajevalna skupina soglaša glede harmoniziranega povzetka glavnih značilnosti zdravila, pristojni organ v referenčni državi članici zabeleži, da je dosežen dogovor, zaključi postopek, o tem obvesti imetnika dovoljenja za promet in mu posreduje harmoniziran povzetek glavnih značilnosti zdravila.
When drawing up the list of reference veterinary medicinal products which shall be subject to harmonisation of their summaries of product characteristics, the coordination group may decide on prioritising its work on harmonisation of summaries of product characteristics, taking into account the recommendations of the Agency on class or group of reference veterinary medicinal products that shall be harmonised in order to protect human or animal health or the environment, including mitigation measures to prevent the risk to the environment.
Imetnik dovoljenja za promet pristojnim organom vsake relevantne države članice v skladu s členom 7 predloži potrebne prevode povzetka glavnih značilnosti zdravila, navodil za uporabo in označevanja v roku, ki ga določi usklajevalna skupina.
On the request of the competent authority in the reference Member State referred to in paragraph 3 of this Article, the marketing authorisation holder shall provide the coordination group with a summary that specifies the differences between the summaries of product characteristics, its proposal for a harmonised summary of product characteristics, package leaflet and labelling in accordance with Article 7, supported by the appropriate existing data submitted in accordance with Article 8 and which are relevant to the proposal for harmonisation concerned.
Na podlagi dogovora v skladu z odstavkom 7 pristojni organi vsake relevantne države članice v 30 dneh po prejemu prevodov iz odstavka 8 spremenijo dovoljenje za promet v skladu s dogovorom.
Within 180 days of receipt of the information referred to in paragraph 5, the competent authority in the reference Member State shall examine, in consultation with the marketing authorisation holder, the documents submitted in accordance with paragraph 5, prepare a report and submit it to the coordination group and to the marketing authorisation holder.
Pristojni organ v referenčni državi članici pred začetkom postopka iz odstavka 11 sprejme vse ustrezne korake za dosego dogovora v usklajevalni skupini.
After receipt of the report, if the coordination group agrees by consensus on the harmonised summary of product characteristics, the competent authority in the reference Member State shall record that there is an agreement, close the procedure, inform the marketing authorisation holder accordingly and transmit to the same marketing authorisation holder the harmonised summary of product characteristics.
Kadar po prizadevanjih iz odstavka 10 tega člena dogovor za harmoniziran povzetek glavnih značilnosti zdravila ni dosežen, se ustrezno uporabi napotitveni postopek zaradi interesov Unije v skladu s členoma 83 in 84.
The marketing authorisation holder shall submit to the competent authorities in each relevant Member State the necessary translations of the summary of product characteristics, package leaflet and labelling in accordance with Article 7, within the time limit set by the coordination group.
Da bi se ohranila dosežena raven harmonizacije povzetka glavnih značilnosti zdravila, se za vsako prihodnjo spremembo zadevnih dovoljenj za promet uporabi postopek vzajemnega priznavanja.
Following an agreement in accordance with paragraph 7, the competent authorities in each relevant Member State shall amend the marketing authorisation in conformity with the agreement within 30 days of receipt of the translations referred to in paragraph 8.
Člen 71
The competent authority in the reference Member State shall take any appropriate steps in order to seek an agreement within the coordination group before the initiation of the procedure referred to in paragraph 11.
Postopek harmonizacije povzetkov glavnih značilnosti zdravila za generična in hibridna zdravila za uporabo v veterinarski medicini
Where the agreement is not reached because of lack of consensus in favour of a harmonised summary of product characteristics following the efforts referred to in paragraph 10 of this Article, the procedure for a Union interest referral referred to in Articles 83 and 84 shall apply.
Ko je postopek iz člena 70 končan in je dosežen dogovor o harmoniziranem povzetku glavnih značilnosti zdravila za referenčno zdravilo za uporabo v veterinarski medicini, imetniki dovoljenj za promet z generičnimi zdravili za uporabo v veterinarski medicini v 60 dneh po tem, ko pristojni organi v vsaki državi članici sprejmejo odločitev v skladu s členom 62, zaprosijo za harmonizacijo naslednjih oddelkov povzetka glavnih značilnosti zdravila za zadevna generična zdravila, kakor je ustrezno:
In order to maintain the level of harmonisation of the summary of product characteristics achieved, any future variation of the marketing authorisations concerned shall follow the mutual recognition procedure.
klinične informacije iz točke (c) člena 35(1);
Article 71
karenca.
Procedure for harmonisation of summaries of product characteristics for generic and hybrid veterinary medicinal products
Ne glede na odstavek 1 v primeru dovoljenja za promet za hibridno zdravilo za uporabo v veterinarski medicini, ki je podprto z dodatnimi predkliničnimi študijami ali kliničnimi preskušanji, ustreznih oddelkov povzetka glavnih značilnosti zdravila iz odstavka 1 ni treba harmonizirati.
When the procedure referred to in Article 70 has been closed and a harmonised summary of product characteristics for a reference veterinary medicinal product has been agreed, the marketing authorisation holders of generic veterinary medicinal products shall apply, within 60 days of the decision by the competent authorities in each Member State and in accordance with Article 62, for the harmonisation of the following sections of the summary of product characteristics for the generic veterinary medicinal products concerned, as applicable:
Imetniki dovoljenj za promet z generičnimi in hibridnimi zdravili za uporabo v veterinarski medicini zagotovijo, da so povzetki glavnih značilnosti zdravila bistveno podobni povzetkom za referenčna zdravila za uporabo v veterinarski medicini.
clinical information referred to in point (c) of Article 35(1);
Člen 72
the withdrawal period.
Dokumentacija o varstvu okolja in ocena tveganja za okolje nekaterih zdravil za uporabo v veterinarski medicini
By way of derogation from paragraph 1, in the case of a marketing authorisation for a hybrid veterinary medicinal product supported by additional pre-clinical studies or clinical trials, the relevant sections of the summary of product characteristics referred to in paragraph 1 shall not be considered to be subject to harmonisation.
Seznam iz člena 70(1) ne vsebuje nobenega referenčnega zdravila za uporabo v veterinarski medicini, za katerega je bilo izdano dovoljenje pred 1. oktobrom 2005, ki je opredeljeno kot potencialno škodljivo za okolje in za katerega ni bila opravljena ocena tveganja za okolje.
The marketing authorisation holders of generic and hybrid veterinary medicinal products shall ensure that the summaries of products characteristics of their products shall be essentially similar to those of the reference veterinary medicinal products.
Kadar je dovoljenje za referenčno zdravilo za uporabo v veterinarski medicini izdano pred 1. oktobrom 2005 in je zdravilo je opredeljeno kot potencialno škodljivo za okolje in zanj ni bila opravljena ocena tveganja za okolje, pristojni organ od imetnika dovoljenja za promet zahteva, da posodobi ustrezno dokumentacijo o varstvu okolja iz točke (b) člena 8(1), pri čemer je treba upoštevati pregled iz člena 156, in, če je to ustrezno, oceno tveganja za okolje za generična zdravila za uporabo v veterinarski medicini, ki se nanašajo na takšna referenčna zdravila za uporabo v veterinarski medicini.
Article 72
Farmakovigilanca
Environmental safety documentation and environmental risk assessment of certain veterinary medicinal products
Člen 73
The list referred to in Article 70(1) shall not contain any reference veterinary medicinal product authorised before 1 October 2005 and which is identified as potentially harmful to the environment and has not been subject to an environmental risk assessment.
Sistem farmakovigilance Unije
Where the reference veterinary medicinal product is authorised before 1 October 2005 and is identified as potentially harmful to the environment and has not been subject to an environmental risk assessment, the competent authority shall request the marketing authorisation holder to update the relevant environmental safety documentation referred to in point (b) of Article 8(1), taking into account the review referred to in Article 156, and, if applicable, the environmental risk assessment of generic veterinary medicinal products of such reference medicinal products.
Države članice, Komisija, Agencija in imetniki dovoljenj za promet sodelujejo pri vzpostavitvi in vzdrževanju sistema farmakovigilance Unije za izvajanje nalog farmakovigilance v zvezi z varnostjo in učinkovitostjo odobrenih zdravil za uporabo v veterinarski medicini, da bi zagotovili stalno ocenjevanje razmerja med tveganji in koristmi zdravila.
Pharmacovigilance
Pristojni organi, Agencija in imetniki dovoljenj za promet z zdravili sprejmejo potrebne ukrepe za omogočanje in spodbujanje poročanja o naslednjih domnevnih neželenih dogodkih:
Article 73
kakršnem koli neugodnem in nepričakovanem odzivu katere koli živali na zdravilo za uporabo v veterinarski medicini;
Union pharmacovigilance system
kakršni koli ugotovitvi o izostanku učinkovitosti zdravila za uporabo v veterinarski medicini pri zdravljenju živali z njim, ne glede na to, ali to je ali ni v skladu s povzetkom glavnih značilnosti zdravila;
Member States, the Commission, the Agency and marketing authorisation holders shall collaborate in setting up and maintaining a Union pharmacovigilance system to carry out pharmacovigilance tasks with respect to the safety and efficacy of authorised veterinary medicinal products in order to ensure continuous assessment of the benefit-risk balance.
kakršnih koli okoljskih nesrečah, ki jih opazijo po tem, ko živali dajo zdravilo za uporabo v veterinarski medicini;
Competent authorities, the Agency and marketing authorisation holders shall take the necessary measures to make available means to report and encourage reporting of the following suspected adverse events:
kakršnem koli škodljivemu učinku zdravila za uporabo v veterinarski medicini na ljudi, ki so mu bili izpostavljeni;
any unfavourable and unintended reaction in any animal to a veterinary medicinal product;
kakršnem koli odkritju farmakološke učinkovine ali ostanka označevalca v proizvodu živalskega izvora, katerega količina presega mejne vrednosti ostankov, določene v skladu z Uredbo (ES) št. 470/2009, po izteku določenega obdobja karence.
any observation of a lack of efficacy of a veterinary medicinal product following its administration to an animal, whether or not in accordance with the summary of product characteristics;
kakršnem koli sumu prenosa povzročitelja okužbe prek zdravila za uporabo v veterinarski medicini;
any environmental incidents observed following the administration of a veterinary medicinal product to an animal;
kakršnem koli neugodnem in nepričakovanem odzivu živali na zdravilo za uporabo v humani medicini;
any noxious reaction in humans exposed to a veterinary medicinal product;
Člen 74
any finding of a pharmacologically active substance or marker residue in a product of animal origin exceeding the maximum levels of residues established in accordance with Regulation (EC) No 470/2009 after the set withdrawal period has been respected;
Zbirka podatkov Unije o farmakovigilanci
any suspected transmission of an infectious agent via a veterinary medicinal product;
Agencija v sodelovanju z državami članicami vzpostavi in vzdržuje zbirko podatkov Unije o farmakovigilanci za poročanje o domnevnih neželenih dogodkih iz člena 73(2) in njihovem evidentiranju (v nadaljnjem besedilu: zbirka podatkov o farmakovigilanci), ki vključuje tudi informacije o usposobljeni osebi, odgovorni za farmakovigilanco, kot je določeno v členu 77(8), referenčne številke glavnega dosjeja o sistemu farmakovigilance, rezultate in izide postopka obravnave signala in rezultate inšpekcijskih pregledov farmakovigilance v skladu s členom 126.
any unfavourable and unintended reaction in an animal to a medicinal product for human use.
Zbirka podatkov o farmakovigilanci je povezana z zbirko podatkov o zdravilih iz člena 55.
Article 74
Agencija v sodelovanju z državami članicami in Komisijo pripravi funkcionalne specifikacije za zbirko podatkov o farmakovigilanci.
Union pharmacovigilance database
Agencija zagotovi, da se informacije naložijo v zbirko podatkov o farmakovigilanci in postanejo dostopne v skladu s členom 75.
The Agency shall, in collaboration with Member States, establish and maintain a Union pharmacovigilance database for the reporting and recording of suspected adverse events referred to in Article 73(2) (the ‘pharmacovigilance database’), which shall also include the information on qualified person responsible for pharmacovigilance as referred to in Article 77(8), the reference numbers of the pharmacovigilance system master file, the results and outcomes of the signal management process and results of pharmacovigilance inspections in accordance with Article 126.
Sistem zbirke podatkov o farmakovigilanci se vzpostavi kot mreža za obdelavo podatkov, ki omogoča prenos podatkov med državami članicami, Komisijo, Agencijo in imetniki dovoljenj za promet, s čimer se zagotovi, da se v primeru opozorila, povezanega s podatki o farmakovigilanci, lahko preučijo možnosti za obvladovanje tveganja in vsi ustrezni ukrepi iz členov 129, 130 in 134.
The pharmacovigilance database shall be interconnected with the product database referred to in Article 55.
Člen 75
The Agency shall, in collaboration with the Member States and the Commission, draw up the functional specifications for the pharmacovigilance database.
Dostop do zbirke podatkov o farmakovigilanci
The Agency shall ensure that information reported is uploaded in the pharmacovigilance database and made accessible in accordance with Article 75.
Pristojni organi imajo celovit dostop do zbirke podatkov o farmakovigilanci.
The system of the pharmacovigilance database shall be established as a data-processing network allowing transmission of data between Member States, the Commission, the Agency and the marketing authorisation holders to ensure that in the event of an alert related to pharmacovigilance data, options for risk management and any appropriate measures can be considered as referred to in Articles 129, 130 and 134.
Imetniki dovoljenj za promet imajo dostop do zbirke podatkov o farmakovigilanci v zvezi s podatki, povezanimi z zdravili za uporabo v veterinarski medicini, za katera imajo dovoljenje za promet, in drugimi nezaupnimi podatki, povezanimi z zdravili za uporabo v veterinarski medicini, za katera nimajo dovoljenja za promet, in sicer v obsegu, ki je potreben, da lahko izpolnijo svoje obveznosti v zvezi s farmakovigilanco iz členov 77, 78 in 81.
Article 75
Splošna javnost ima dostop do zbirke podatkov o farmakovigilanci brez možnosti, da bi lahko spreminjala informacije v njej, kar zadeva naslednje informacije:
Access to the pharmacovigilance database
število in, najpozneje v dveh letih od 28. januarja 2022, pojavnost domnevnih neželenih dogodkov, sporočenih vsako leto in razčlenjenih po zdravilih za uporabo v veterinarski medicini, živalskih vrstah in vrsti domnevnih neželenih dogodkov;
The competent authorities shall have full access to the pharmacovigilance database.
rezultate in izide iz člena 81(1), ki izhajajo iz postopka obravnave signala, ki ga izvaja imetnik dovoljenja za promet z zdravili za uporabo v veterinarski medicini ali skupinami zdravil za uporabo v veterinarski medicini.
Marketing authorisation holders shall have access to the pharmacovigilance database with respect to data related to the veterinary medicinal products for which they hold a marketing authorisation and to other non-confidential data related to veterinary medicinal products for which they do not hold a marketing authorisation to the extent necessary for them to comply with their pharmacovigilance responsibilities as referred to in Articles 77, 78 and 81.
Člen 76
The general public shall have access to the pharmacovigilance database, without the possibility to change the information therein, as regards the following information:
Poročanje o domnevnih neželenih dogodkih in njihovo evidentiranje
the number and at the latest within two years from 28 January 2022 the incidence of suspected adverse events reported each year, broken down by veterinary medicinal product, animal species and type of suspected adverse event;
Pristojni organi v 30 dneh od prejema poročila o domnevnem neželenem dogodku v zbirki podatkov o farmakovigilanci evidentirajo vse domnevne neželene dogodke, o katerih so bili obveščeni in ki so se zgodili na ozemlju njihove države članice.
the results and outcomes referred to in Article 81(1) that arise from the signal management process performed by the marketing authorisation holder for veterinary medicinal products or groups of veterinary medicinal products.
Imetniki dovoljenj za promet brez odlašanja in najpozneje v 30 dneh od prejema poročila o domnevnem neželenem dogodku v zbirki podatkov o farmakovigilanci evidentirajo vse domnevne neželene dogodke, o katerih so bili obveščeni in ki so se v zvezi z njihovimi odobrenimi zdravili za uporabo v veterinarski medicini zgodili v Uniji ali tretji državi ali pa se je o njih poročalo v znanstveni literaturi.
Article 76
Agencija lahko zahteva, da imetnik dovoljenja za promet z zdravili za uporabo v veterinarski medicini, odobrenimi s centraliziranim postopkom, ali z zdravili za uporabo v veterinarski medicini, odobrenimi na nacionalni ravni, če se zanje uporablja napotitveni postopek zaradi interesov Unije iz člena 82, poleg podatkov iz člena 73(2) zbere specifične podatke o farmakovigilanci in izvede študije o varnosti zdravila po pridobitvi dovoljenja za promet.
Reporting and recording of suspected adverse events
Agencija navede podrobne razloge za to zahtevo, določi primeren rok in o tem obvesti pristojne organe.
Competent authorities shall record in the pharmacovigilance database all suspected adverse events which were reported to them and that occurred in the territory of their Member State, within 30 days of receipt of the suspected adverse event report.
Pristojni organi lahko od imetnika nacionalnega dovoljenja za promet z zdravilom za uporabo v veterinarski medicini zahtevajo, da poleg podatkov iz člena 73(2) zbere specifične podatke o farmakovigilanci in izvede študije o varnosti zdravila po pridobitvi dovoljenja za promet.
Marketing authorisation holders shall record in the pharmacovigilance database all suspected adverse events which were reported to them and that occurred within the Union or in a third country or that have been published in the scientific literature with regard to their authorised veterinary medicinal products, without delay and no later than within 30 days of receipt of the suspected adverse event report.
Pristojni organ navede podrobne razloge za to zahtevo, določi primeren rok ter o tem obvesti druge pristojne organe in Agencijo.
The Agency may request the holder of a marketing authorisation for centrally authorised veterinary medicinal products, or for nationally authorised veterinary medicinal products in cases where they fall within the scope of a Union interest referral referred to in Article 82, to collect specific pharmacovigilance data additional to the data listed in Article 73(2) and to carry out post-marketing surveillance studies.
Člen 77
The Agency shall state in detail the reasons for the request, set an appropriate time limit and inform competent authorities thereof.
Odgovornosti imetnika dovoljenja za promet v zvezi s farmakovigilanco
Competent authorities may request the holder of a marketing authorisation for nationally authorised veterinary medicinal products to collect specific pharmacovigilance data, additional to the data listed in Article 73(2) and to carry out post-marketing surveillance studies.
Imetniki dovoljenj za promet vzpostavijo in vzdržujejo sistem za zbiranje, združevanje in ocenjevanje informacij o domnevnih neželenih dogodkih v zvezi z njihovimi odobrenimi zdravili za uporabo v veterinarski medicini, kar jim omogoča izpolnjevanje njihovih odgovornosti v zvezi s farmakovigilanco (v nadaljnjem besedilu: sistem farmakovigilance).
The competent authority shall state in detail the reasons for the request, set an appropriate time limit and inform other competent authorities and the Agency thereof.
Imetnik dovoljenja za promet ima enega ali več sklopov glavnega dosjeja o sistemu farmakovigilance, v katerih je podrobno opisan sistem farmakovigilance v zvezi z odobrenimi zdravili za uporabo v veterinarski medicini.
Article 77
Imetnik dovoljenja za promet ima za vsako zdravilo za uporabo v veterinarski medicini največ en sklop glavnega dosjeja o sistemu farmakovigilance.
Pharmacovigilance responsibilities of the marketing authorisation holder
Imetnik dovoljenja za promet določi lokalnega ali regionalnega zastopnika, ki prejema poročila o domnevnih neželenih dogodkih, ki se lahko sporazumeva v jezikih relevantnih držav članic.
Marketing authorisation holders shall establish and maintain a system for collecting, collating and evaluating information on the suspected adverse events concerning their authorised veterinary medicinal products, enabling them to fulfil their pharmacovigilance responsibilities (‘pharmacovigilance system’).
Imetnik dovoljenja za promet je odgovoren za farmakovigilanco zdravila za uporabo v veterinarski medicini, za katero ima dovoljenje za promet, in z ustreznimi sredstvi redno ocenjuje razmerje med koristmi in tveganji tega zdravila ter po potrebi sprejme ustrezne ukrepe.