natgillin/translations-raw huggingface dataset:
Article 59
Države članice v skladu s svojim nacionalnim pravom sprejmejo ustrezne ukrepe za svetovanje malim in srednjim podjetjem o izpolnjevanju zahtev te uredbe.
Small and medium-sized enterprises
Spremembe pogojev dovoljenja za promet
Member States shall, in accordance with their national law, take appropriate measures to advise small and medium-sized enterprises on compliance with the requirements of this Regulation.
Člen 60
Changes to the terms of the marketing authorisations
Spremembe
Article 60
Komisija z izvedbenimi akti določi seznam sprememb, za katere ni potrebna ocena.
Variations
Komisija pri sprejemanju izvedbenih aktov iz odstavka 1 upošteva naslednja merila:
The Commission shall, by means of implementing acts, establish a list of variations not requiring assessment.
potrebo po znanstveni oceni sprememb za opredelitev tveganja za javno zdravje ali zdravje živali ali za okolje;
The Commission shall take account of the following criteria when adopting the implementing acts referred to in paragraph 1:
ali spremembe vplivajo na kakovost, varnost ali učinkovitost zdravila za uporabo v veterinarski medicini;
the need for a scientific assessment of changes in order to determine the risk to public or animal health or to the environment;
ali spremembe pomenijo le manjšo spremembo povzetka glavnih značilnosti zdravila;
whether changes have an impact on the quality, safety or efficacy of the veterinary medicinal product;
ali so spremembe administrativne narave.
whether changes imply no more than a minor alteration to the summary of product characteristics;
Člen 61
whether changes are of an administrative nature.
Spremembe, za katere ni potrebna ocena
Article 61
Kadar je sprememba vključena na seznam v skladu s členom 60(1), jo imetnik dovoljenja za promet evidentira v zbirki podatkov o zdravilih v 30 dneh po začetku izvajanja spremembe ter pri tem navede, kakor je ustrezno, povzetek glavnih značilnosti zdravila in označevanja ali navodila za uporabo v skladu z jeziki iz člena 7.
Variations that do not require assessment
Če je treba, pristojni organi ali, kadar se zdravilo za uporabo v veterinarski medicini odobri s postopkom za pridobitev centraliziranegadovoljenja za promet, Komisija z izvedbenimi akti spremeni sklep o izdaji dovoljenja za promet v skladu z evidentirano spremembo iz odstavka 1 tega člena.
Where a variation is included in the list established in accordance with Article 60(1), the marketing authorisation holder shall record the change including, as applicable, the summary of product characteristics, labelling or package leaflet in languages referred to in Article 7, in the product database within 30 days following the implementation of that variation.
Pristojni organ referenčne države članice ali, v primeru spremembe pogojev nacionalnega dovoljenja za promet, pristojni organ relevantne države članice ali, kakor je ustrezno, Komisija imetnika dovoljenja za promet in pristojne organe v relevantnih državah članicah obvesti, ali je sprememba odobrena ali zavrnjena, tako da navedene informacije vnese v zbirko podatkov o zdravilih.
If necessary, competent authorities or, where the veterinary medicinal product is authorised under the centralised marketing authorisation procedure, the Commission shall, by means of implementing acts, amend the marketing authorisation in accordance with the change recorded as referred to in paragraph 1 of this Article.
Člen 62
The competent authority of the reference Member State or, in the case of variation to the terms of a national marketing authorisation, the competent authority of the relevant Member State, or the Commission, as applicable, shall inform the marketing authorisation holder and the competent authorities in the relevant Member States as to whether the variation is approved or rejected by recording that information in the product database.
Vloga za spremembe, za katere je potrebna ocena
Article 62
Kadar sprememba ni vključena na seznam, vzpostavljen v skladu s členom 60(1), imetnik dovoljenja za promet predloži vlogo za spremembo, za katero je potrebna ocena, pristojnemu organu, ki je izdal dovoljenje za promet, ali Agenciji, kakor je ustrezno.
Application for variations requiring assessment
Vloge se predložijo v elektronski obliki.
Where a variation is not included in the list established in accordance with Article 60(1), the marketing authorisation holder shall submit an application for a variation requiring assessment to the competent authority which has granted the marketing authorisation or to the Agency, as applicable.
Vloga iz odstavka 1 zajema:
The applications shall be submitted electronically.
opis spremembe;
The application referred to in paragraph 1 shall contain:
podatke iz člena 8, pomembne za spremembo;
a description of the variation;
podatke o dovoljenju za promet, ki jih zadeva vloga;
data referred to in Article 8 relevant to the variation;
kadar sprememba povzroči posledične spremembe pogojev istega dovoljenja za promet, opis teh posledičnih sprememb;
details of the marketing authorisations affected by the application;
kadar se sprememba nanaša na dovoljenja za promet, izdana s postopkom vzajemnega priznavanja ali decentraliziranim postopkom, seznam držav članic, ki so izdale ta dovoljenja za promet.
where the variation leads to consequential variations to the terms of the same marketing authorisation, a description of those consequential variations;
Člen 63
where the variation concerns marketing authorisations granted under the mutual recognition or decentralised procedures, a list of Member States which granted those marketing authorisations.
Posledične spremembe informacij o zdravilu
Article 63
Kadar sprememba vključuje posledične spremembe povzetka glavnih značilnosti zdravila, označevanja ali navodil za uporabo, se te spremembe za namene pregleda vloge za spremembo štejejo za sestavni del te spremembe.
Consequential changes to product information
Člen 64
Where a variation entails consequential changes to the summary of the product characteristics, the labelling or the package leaflet, those changes shall be considered as part of that variation for the purposes of the examination of the application for a variation.
Skupine sprememb
Article 64
Kadar imetnik dovoljenja za promet zaprosi za več sprememb, ki jih ni na seznamu, vzpostavljenem v skladu s členom 60(1), v zvezi z istim dovoljenjem za promet, ali za eno spremembo, ki je ni na omenjenem seznamu, v zvezi z več različnimi dovoljenji za promet, lahko ta imetnik dovoljenja za promet predloži eno vlogo za vse spremembe.
Groups of variations
Člen 65
When the marketing authorisation holder applies for several variations not included in the list established in accordance with Article 60(1) regarding the same marketing authorisation or for one variation not appearing in that list in respect of several different marketing authorisations, that marketing authorisation holder may submit one application for all variations.
Postopek delitve dela
Article 65
Kadar imetnik dovoljenja za promet zaprosi za eno ali več sprememb, ki so identične v vseh relevantnih državah članicah in ki jih ni na seznamu, vzpostavljenem v skladu s členom 60(1), v zvezi z več dovoljenji za promet, ki so v njegovi lasti, izdali pa so jih različni pristojni organi ali Komisija, ta imetnik dovoljenja za promet predloži identično vlogo pristojnim organom v vseh relevantnih državah članicah, če pa vloga vsebuje spremembo zdravila za uporabo v veterinarski medicini, ki je odobreno s centralnim postopkom, tudi Agenciji.
Work-sharing procedure
Kadar je katero od dovoljenj za promet iz odstavka 1 tega člena centralizirano dovoljenje za promet, Agencija oceni vlogo v skladu s postopkom iz člena 66.
When the marketing authorisation holder applies for one or more variations which are identical in all relevant Member States and which do not appear in the list established in accordance with Article 60(1) regarding several marketing authorisations which are held by the same marketing authorisation holder and which have been granted by different competent authorities or the Commission, that marketing authorisation holder shall submit an identical application to competent authorities in all relevant Member States and, where a variation to a centrally authorised veterinary medicinal product is included, to the Agency.
Kadar nobeno od dovoljenj za promet z zdravilom iz odstavka 1 tega člena ni centralizirano dovoljenje za promet, usklajevalna skupina na podlagi dogovora določi enega od pristojnih organov, ki so izdali dovoljenja za promet, da oceni vlogo v skladu s postopkom iz člena 66.
Where any of the marketing authorisations referred to in paragraph 1 of this Article is a centralised marketing authorisation, the Agency shall assess the application in accordance with the procedure laid down in Article 66.
Komisija lahko z izvedbenimi akti sprejme potrebne ukrepe, povezane s postopkom delitve dela.
Where none of the marketing authorisations referred to in paragraph 1 of this Article is a centralised marketing authorisation, the coordination group shall agree upon a competent authority among those having granted the marketing authorisations to assess the application in accordance with the procedure laid down in Article 66.
Člen 66
The Commission may, by means of implementing acts, adopt the necessary arrangements regarding the functioning of the worksharing procedure.
Postopek za spremembe, za katere je potrebna ocena
Article 66
Če vloga za spremembo izpolnjuje zahteve iz člena 62, pristojni organ ali Agencija oz. pristojni organ, dogovorjen v skladu s členom 65(3), ali pristojni organ v referenčni državi članici, kakor je ustrezno, v 15 dneh potrdi prejem veljavne vloge.
Procedure for variations requiring assessment
Če vloga ni popolna, pristojni organ, Agencija, pristojni organ, dogovorjen v skladu s členom 65(3), ali pristojni organ v referenčni državi članici, kakor je ustrezno, od imetnika dovoljenja za promet zahteva, da jo v razumnem roku dopolni z manjkajočimi informacijami in dokumentacijo.
If an application for a variation fulfils the requirements laid down in Article 62, the competent authority, the Agency, the competent authority agreed in accordance with Article 65(3), or the competent authority in the reference Member State, as applicable, shall within 15 days acknowledge receipt of a valid application.
Pristojni organ, Agencija, pristojni organ, dogovorjen v skladu s členom 65(3), ali pristojni organ v referenčni državi članici, kakor je ustrezno, oceni vlogo in v skladu s členom 33 pripravi poročilo o oceni ali mnenje o spremembi.
If the application is incomplete, the competent authority, the Agency, the competent authority agreed in accordance with Article 65(3), or the competent authority in the reference Member State, as applicable, shall require the marketing authorisation holder to provide the missing information and documentation within a reasonable time limit.
Poročilo o oceni ali mnenje se pripravi v 60 dneh od prejema veljavne vloge.
The competent authority, the Agency, the competent authority agreed in accordance with Article 65(3), or the competent authority in the reference Member State, as applicable, shall assess the application and prepare, respectively, an assessment report or an opinion, in accordance with Article 33, on the variation.
V obdobju iz odstavka 3 ustrezni pristojni organ ali Agencija, kakor je ustrezno, lahko od imetnika dovoljenja za promet zahteva, da v določenem roku predloži dodatne informacije.
That assessment report or opinion shall be prepared within 60 days following the receipt of a valid application.
Postopek se do zagotovitve dodatnih informacij začasno ustavi.
In such a case, the relevant competent authority or the Agency, as applicable, shall inform the marketing authorisation holder accordingly.
Kadar Agencija pripravi mnenje iz odstavka 3 tega člena v skladu s členom 65(2), ga posreduje vsem pristojnim organom v relevantnih državah članicah, Komisiji in imetniku dovoljenja za promet.
Within the period referred to in paragraph 3, the relevant competent authority or the Agency, as applicable, may require the marketing authorisation holder to provide supplementary information within a set time limit.
Kadar poročilo o oceni iz odstavka 3 tega člena pripravi pristojni organ, dogovorjen v skladu s členom 65(3), ali pristojni organ v referenčni državi članici, se posreduje pristojnim organom v vseh relevantnih državah članicah in imetniku dovoljenja za promet.
The procedure shall be suspended until the supplementary information has been provided.
Kadar se pristojni organ s prejetim poročilom o oceni iz odstavka 7 tega člena ne strinja, se uporabi postopek preučitve iz člena 54.
Where the opinion referred to in paragraph 3 is prepared by the Agency, the Agency shall forward it to the Commission and to the marketing authorisation holder.
Glede na rezultat postopka iz odstavka 8, če je to ustrezno, se mnenje ali poročilo o oceni iz odstavka 3 brez odlašanja pošlje imetniku dovoljenja za promet.
Where the opinion referred to in paragraph 3 of this Article is prepared by the Agency in accordance with Article 65(2), the Agency shall forward it to all competent authorities in the relevant Member States, to the Commission and to the marketing authorisation holder.
Imetnik dovoljenja za promet lahko pristojnemu organu, Agenciji, pristojnemu organu, dogovorjenemu v skladu s členom 65(3), ali pristojnemu organu v referenčni državi članici, kakor je ustrezno, v 15 dneh od prejema mnenja ali poročila o oceni pošlje pisno obvestilo, da želi ponoven pregled mnenja ali poročila o oceni.
Where the assessment report referred to in paragraph 3 of this Article is prepared by the competent authority agreed in accordance with Article 65(3), or prepared by the competent authority in the reference Member State, it shall be forwarded to the competent authorities in all relevant Member States and to the marketing authorisation holder.
Podrobni razlogi zahteve za ponoven pregled se predložijo pristojnemu organu, Agenciji, pristojnemu organu, dogovorjenemu v skladu s členom 65(3), ali pristojnemu organu v referenčni državi članici, kakor je ustrezno, v 60 dneh od prejema mnenja ali poročila o oceni.
Where a competent authority does not agree with the assessment report referred to in paragraph 7 of this Article it received, the review procedure laid down in Article 54 shall apply.
V 60 dneh od prejema razlogov za zahtevo za ponoven pregled pristojni organ, Agencija, pristojni organ, dogovorjen v skladu s členom 65(3), ali pristojni organ v referenčni državi članici, kakor je ustrezno, ponovno oceni točke mnenja ali poročila o oceni, navedene v zahtevi za ponoven pregled imetnika dovoljenja za promet, in sprejme ponovno pregledano mnenje ali poročilo o oceni.
Subject to the outcome of the procedure provided for in paragraph 8, if applicable, the opinion or the assessment report referred to in paragraph 3 shall be forwarded to the marketing authorisation holder without delay.
Ponovno pregledanemu mnenju ali poročilu o oceni se priložijo razlogi za ugotovitve.
Within 15 days of receipt of the opinion or the assessment report, the marketing authorisation holder may submit a written request to the competent authority, the Agency, the competent authority agreed in accordance with Article 65(3), or the competent authority in the reference Member State, as applicable, for a re-examination of the opinion or the assessment report.
Člen 67
Detailed grounds for requesting a re-examination shall be submitted to the competent authority, the Agency, the competent authority agreed in accordance with Article 65(3) or the competent authority in the reference Member State, as applicable, within 60 days of receipt of the opinion or the assessment report.
Ukrepi za zaključek postopkov za spremembe, za katere je potrebna ocena
Within 60 days of receipt of the grounds for the request for re-examination, the competent authority, the Agency, the competent authority agreed in accordance with Article 65(3) or the competent authority in the reference Member State, as applicable, shall re-examine the points of the opinion or the assessment report identified in the request for re-examination by the marketing authorisation holder and adopt a re-examined opinion or assessment report.
V 30 dneh po zaključku postopka iz člena 66 in prejemu popolnih prevodov povzetka glavnih značilnosti zdravila, označevanja in navodil za uporabo, ki jih predloži imetnik dovoljenja za promet, pristojni organ, Komisija ali pristojni organi v državah članicah, navedenih v skladu s točko (e) člena 62(2), kakor je ustrezno, v skladu z mnenjem ali poročilom o oceni iz člena 66 spremeni dovoljenje za promet ali zavrne spremembe ter imetnika dovoljenja za promet obvesti o razlogih za zavrnitev.
The reasons for the conclusions reached shall be annexed to the re-examined opinion or the assessment report.
V primeru centraliziranega dovoljenja za promet Komisija pripravi osnutek sklepa, ki se sprejme v zvezi s spremembo.
Article 67
Kadar osnutek sklepa ni v skladu z mnenjem Agencije, Komisija predloži podrobno obrazložitev, zakaj ni sledila mnenju Agencije.
Measures to close the procedure for variations requiring assessment
Komisija z izvedbenimi akti sprejme sklep o spremembi dovoljenja za promet ali o zavrnitvi spremembe.
Within 30 days of the completion of the procedure laid down in Article 66 and of receiving the complete translations of the summary of the product characteristics, labelling and package leaflet from the marketing authorisation holder, the competent authority, the Commission or the competent authorities in the Member States listed in accordance with point (e) of Article 62(2), as applicable, shall amend the marketing authorisation or reject the variation in line with the opinion or the assessment report referred to in Article 66 and inform the marketing authorisation holder of the grounds for the rejection.
Pristojni organ ali Komisija, kakor je ustrezno, imetnika dovoljenja za promet brez odlašanja obvesti o spremenjenem dovoljenju za promet.
In the case of a centralised marketing authorisation, the Commission shall prepare a draft decision to be taken in respect of the variation.
Pristojni organ, Komisija, Agencija ali pristojni organi v državah članicah, navedenih v skladu s točko (e) člena 62(2), kakor je ustrezno, ustrezno posodobijo zbirko podatkov o zdravilih.
Where the draft decision is not in accordance with the opinion of the Agency, the Commission shall provide a detailed explanation of the reasons for not following the opinion of the Agency.
Člen 68
The Commission shall, by means of implementing acts, adopt a decision to amend the marketing authorisation or reject the variation.
Uvedba sprememb, za katere je potrebna ocena
The competent authority or the Commission, as applicable, shall notify the marketing authorisation holder of the amended marketing authorisation without delay.
Imetnik dovoljenja za promet lahko uvede spremembo, za katero je potrebna ocena, šele po tem, ko pristojni organ ali Komisija, kakor je ustrezno, spremeni sklep o izdaji dovoljenja za promet v skladu z navedeno spremembo, določi rok za uvedbo in o tem obvesti imetnika dovoljenja za promet v skladu s členom 67(3).
The competent authority, the Commission, the Agency, or the competent authorities in the Member States listed in accordance with point (e) of Article 62(2), as applicable, shall update the product database accordingly.
Na zahtevo pristojnega organa ali Komisije imetnik dovoljenja za promet brez odlašanja zagotovi vse informacije v zvezi z uvedbo spremembe.
Article 68
Harmonizacija povzetkov glavnih značilnosti zdravila, odobrenih na nacionalni ravni
Implementation of variations requiring assessment
Člen 69
A marketing authorisation holder may implement a variation requiring assessment only after a competent authority or the Commission, as applicable, has amended the decision granting the marketing authorisation in accordance with that variation, has set a time limit for the implementation and has notified the marketing authorisation holder thereof in accordance with Article 67(3).
Obseg harmonizacije povzetka glavnih značilnosti zdravila za uporabo v veterinarski medicini
Where requested by a competent authority or the Commission, a marketing authorisation holder shall supply, without delay, any information related to the implementation of a variation.
Harmoniziran povzetek glavnih značilnosti zdravila se pripravi v skladu s postopkom iz členov 70 in 71 za:
Harmonisation of the summaries of product characteristics for nationally authorised products
referenčna zdravila za uporabo v veterinarski medicini z enako kakovostno in količinsko sestavo učinkovin ter enako farmacevtsko obliko, za katera so bila dovoljenja za promet v različnih državah članicah izdana v skladu s členom 47 za istega imetnika dovoljenja za promet;
Article 69
generična in hibridna zdravila za uporabo v veterinarski medicini.
Scope of the harmonisation of summaries of product characteristics of a veterinary medicinal product
Člen 70
A harmonised summary of product characteristics shall be prepared in accordance with the procedure laid down in Articles 70 and 71 for:
Postopek harmonizacije povzetkov glavnih značilnosti zdravila za referenčna zdravila za uporabo v veterinarski medicini
reference veterinary medicinal products which have the same qualitative and quantitative composition of their active substances and the same pharmaceutical form and for which marketing authorisations have been granted in accordance with Article 47 in different Member States for the same marketing authorisation holder;
Pristojni organi usklajevalni skupini vsako leto predložijo seznam referenčnih zdravil za uporabo v veterinarski medicini in njihove povzetke glavnih značilnosti zdravila, za katera je bilo izdano dovoljenje za promet v skladu s členom 47, če pristojni organ meni, da bi morali zanje uporabiti postopek harmonizacije povzetkov glavnih značilnosti zdravila.
generic and hybrid veterinary medicinal products.
Imetnik dovoljenja za promet lahko zaprosi za postopek harmonizacije povzetkov glavnih značilnosti zdravila za referenčno zdravilo za uporabo v veterinarski medicini tako, da usklajevalni skupini predloži seznam različnih imen tega zdravila in različne povzetke glavnih značilnosti zdravila, za katere je bilo izdano dovoljenje za promet v skladu s členom 47 v različnih državah članicah.
Article 70
Usklajevalna skupina ob upoštevanju seznamov, ki jih predložijo države članice v skladu z odstavkom 1, ali morebitnih vlog, prejetih od imetnika dovoljenja za promet v skladu z odstavkom 2, vsako leto pripravi in objavi seznam referenčnih zdravil za uporabo v veterinarski medicini, za katere se uporabi postopek harmonizacije povzetkov glavnih značilnosti zdravila, in za vsako od zadevnih referenčnih zdravil za uporabo v veterinarski medicini imenuje referenčno državo članico.
Procedure for harmonisation of summaries of product characteristics for the reference veterinary medicinal products
Pri pripravi seznama referenčnih zdravil za uporabo v veterinarski medicini, za katere se uporabi postopek harmonizacije povzetkov glavnih značilnosti zdravila, se lahko usklajevalna skupina v zvezi s harmonizacijo povzetkov glavnih značilnosti zdravila odloči za prednostno obravnavo, pri čemer upošteva priporočila Agencije o razredu ali skupini referenčnih zdravil za uporabo v veterinarski medicini, ki jih je treba harmonizirati, da bi zaščitili zdravje ljudi ali živali ali okolje, med drugim tudi z ukrepi za zmanjšanje tveganja, da bi preprečili tveganje za okolje.