natgillin/translations-raw huggingface dataset:
The detailed and critical summaries regarding safety and efficacy must explain the relevance of any data submitted which concern a product different from the product intended for marketing.
Mešane vloge za pridobitev dovoljenja za promet z zdravilom so vloge, v katerih so v delih 3 in/ali 4 dokumentacije navedene študije varnosti in učinkovitosti, ki jih je opravil predlagatelj, ter bibliografska sklicevanja.
A judgement must be made whether or not the product studied can be considered as similar to the product, for which application for a marketing authorisation has been made in spite of the existing differences.
Vsi drugi deli so pripravljeni v skladu s strukturo, opisano v delu I naslova I te priloge.
Post-marketing experience with other products containing the same constituents is of particular importance and applicants shall put a special emphasis on this issue.
Pristojni organ za vsak primer posebej sprejme predlagano strukturo, ki jo predloži predlagatelj.
For applications based on Article 13b, a dossier containing Parts 1, 2, 3 and 4 shall be provided for the combination veterinary medicinal product.
NASLOV IV
It shall not be necessary to provide studies on the safety and efficacy of each active substance.
Zahteve za vloge za pridobitev dovoljenja za promet za posebna zdravila za uporabo v veterinarski medicini
It shall nevertheless be possible to include information on the individual substances in the application for a fixed combination.
V tem delu so določene posebne zahteve za zdravila za uporabo v veterinarski medicini glede na učinkovine, ki jih vsebujejo.
The submission of data on each individual active substance, in conjunction with the required user safety studies, residues depletion studies and clinical studies on the fixed combination product, may be considered a suitable justification for omitting data on the combination product, based on animal welfare grounds and unnecessary testing on animals, unless there is suspected interaction leading to added toxicity.
Imunološka zdravila za uporabo v veterinarski medicini
Where applicable, information regarding the manufacturing sites and the safety evaluation of adventitious agents shall be provided.
A. GLAVNA DOKUMENTACIJA O ANTIGENU CEPIVA
Informed consent applications
Koncept glavne datoteke o antigenu cepiva se uvede za posebna imunološka zdravila za uporabo v veterinarski medicini in brez poseganja v določbe oddelka C dela 2 naslova II o učinkovinah.
Applications based on Article 13c shall contain the data described in Part 1 of Title 1 of this Annex, provided that the marketing authorisation holder for the original veterinary medicinal product has given the applicant his consent to refer to the content of Parts 2, 3 and 4 of the dossier of that product.
V tej prilogi pomeni glavna datoteka o antigenu cepiva samostojen del vloge za pridobitev dovoljenja za promet s cepivom, ki vsebuje vse pomembne podatke o kakovosti vsake posamezne učinkovine, ki je del zdravila za uporabo v veterinarski medicini.
In this case, there is no need to submit quality, safety and efficacy detailed and critical summaries.
Samostojni del je lahko skupen enemu ali več enovalentnim in/ali kombiniranim cepivom, ki jih predlaga isti predlagatelj ali imetnik dovoljenja za promet z zdravilom.
Documentation for applications in exceptional circumstances
Agencija sprejme znanstvene smernice za predložitev in oceno glavne datoteke o antigenu cepiva.
A marketing authorisation may be granted subject to certain specific obligations requiring the applicant to introduce specific procedures, in particular concerning the safety and efficacy of the veterinary medicinal product, when, as provided for in Article 26(3) of this Directive, the applicant can show that he is unable to provide comprehensive data on the efficacy and safety under normal conditions of use.
Pri predložitvi in oceni glavne datoteke o antigenu cepiva se upošteva smernica, ki jo je Komisija objavila v Pravilih, ki urejajo zdravila v Evropski uniji, zvezek 6B, Obvestilo predlagateljem.
The identification of essential requirements for all applications mentioned in this section should be subject to guidelines which shall be adopted by the Agency.
B. DOKUMENTACIJA ZA VEČ SEVOV
Mixed marketing authorisation applications
Koncept dokumentacije za več sevov se uvede za nekatera imunološka zdravila za uporabo v veterinarski medicini (slinavka in parkljevka, aviarna influenca, bolezen modrikastega jezika) in brez poseganja v določbe oddelka C dela 2 naslova II o učinkovinah.
Mixed marketing authorisation applications are applications where Part(s) 3 and/or 4 of the dossier consist of safety and efficacy studies carried out by the applicant as well as bibliographical references.
Dokumentacija za več sevov je ena dokumentacija, ki vsebuje ustrezne podatke za edinstveno in natančno znanstveno oceno različnih vrst sevov ali kombinacij sevov, na podlagi katere se lahko odobrijo cepiva proti virusom z različnimi antigeni.
All other part(s) are in accordance with the structure described in Part 1 of Title I of this Annex.
Agencija sprejme znanstvene smernice za predložitev in oceno dokumentacije za več sevov.
The competent authority shall accept the proposed format presented by the applicant on a case-by-case basis.
Pri predložitvi in oceni dokumentacije za več sevov se upošteva smernica, ki jo je Komisija objavila v Pravilih, ki urejajo zdravila v Evropski uniji, zvezek 6B, Obvestilo predlagateljem.
TITLE IV
V tem oddelku so določene posebne zahteve o uporabi delov 2 in 3 naslova I za homeopatska zdravila za uporabo v veterinarski medicini, opredeljena v členu 1(8).
Requirements for marketing authorisation applications for particular veterinary medicinal products
Določbe iz dela 2 se uporabljajo za dokumente, predložene v skladu s členom 18 pri poenostavljeni registraciji homeopatskih zdravil za uporabo v veterinarski medicini iz člena 17(1), in za dokumente za pridobitev dovoljenja za druga homeopatska zdravila za uporabo v veterinarski medicini iz člena 19(1) z naslednjimi spremembami.
This part lays down specific requirements for identified veterinary medicinal products related to the nature of the active substances contained therein.
Terminologija
Immunological veterinary medicinal products
Latinsko ime homeopatske surovine, opisane v dokumentaciji vloge za pridobitev dovoljenja za promet z zdravilom, mora biti v skladu z latinskim imenom v Evropski farmakopeji ali, če to v njej ni navedeno, uradni farmakopeji države članice.
A. VACCINE ANTIGEN MASTER FILE
Če je ustrezno, se navedejo tradicionalna imena, ki se uporabljajo v posameznih državah članicah.
For particular immunological veterinary medicinal products and by derogation from the provisions of Title II, Part 2 Section C on active substances, the concept of a Vaccine Antigen Master File is introduced.
Kontrola vhodnih snovi
For the purpose of this Annex, a Vaccine Antigen Master File means a stand-alone part of the marketing authorisation application dossier for a vaccine, which contains all relevant information on quality concerning each of the active substances, which are part of this veterinary medicinal product.
Podrobni podatki in dokumenti o vhodnih snoveh, tj. o vseh uporabljenih snoveh, vključno s surovinami in intermediati do končnih razredčin, ki bodo vključene v končno homeopatsko zdravilo, ki so priloženi vlogi, se dopolnijo z dodatnimi podatki o homeopatski surovini.
The stand-alone part may be common to one or more monovalent and/or combined vaccines presented by the same applicant or marketing authorisation holder.
Splošne zahteve za kakovost se uporabljajo za vse vhodne snovi in surovine ter za vmesne stopnje proizvodnega postopka do končne razredčine, ki se vključi v končno homeopatsko zdravilo.
Scientific guidelines for the submission and evaluation of a vaccine antigen master file shall be adopted by the Agency.
Kadar je prisotna toksična sestavina, jo je treba kontrolirati v končni razredčini, če je mogoče.
The procedure for the submission and evaluation of a vaccine antigen master file shall follow the guidance published by the Commission in The rules governing medicinal products in the European Union, Volume 6B, Notice to Applicants.
Če to ni mogoče zaradi visoke razredčitve, se toksična sestavina praviloma kontrolira na začetni stopnji.
B. MULTI-STRAIN DOSSIER
V celoti se mora opisati vsaka stopnja proizvodnega postopka, od vhodnih snovi do končne razredčine, ki se vključi v končni proizvod.
For certain immunological veterinary medicinal products (foot-and-mouth disease, avian influenza and bluetongue) and by derogation from the provisions of Title II, Part 2 Section C on active substances the concept of the use of a multi-strain dossier is introduced.
Če se uporabijo razredčine, se ti koraki razredčevanja izvedejo v skladu s homeopatskimi načini proizvodnje, določenimi v ustrezni monografiji Evropske farmakopeje ali, če tam niso navedeni, v uradni farmakopeji države članice.
A multi-strain dossier means a single dossier containing the relevant data for a unique and thorough scientific assessment of the different options of strains/combinations of strains permitting the authorisation of vaccines against antigenically variable viruses.
Kontrolni preskusi končnega zdravila
Scientific guidelines for the submission and evaluation of multi-strain dossiers shall be adopted by the Agency.
Splošne zahteve za kakovost se uporabljajo za končna homeopatska zdravila za uporabo v veterinarski medicini.
The procedure for the submission and evaluation of multi-strain dossiers shall follow the guidance published by the Commission in The rules governing medicinal products in the European Union, Volume 6B, Notice to Applicants.
Predlagatelj vsako izjemo natančno utemelji.
This section sets out specific provisions on the application of Title I, Parts 2 and 3 to homeopathic veterinary medicinal products as defined in Article 1(8).
Izvede se identifikacija in določitev vseh toksikološko pomembnih sestavin.
The provisions of Part 2 shall apply to the documents submitted in accordance with Article 18 in the simplified registration of homeopathic veterinary medicinal products referred to in Article 17(1) as well as to the documents for authorisation of other homeopathic veterinary medicinal products referred to in Article 19(1) with the following modifications.
Če je mogoče utemeljiti, da identifikacija in/ali določitev vsebnosti vseh toksikološko pomembnih sestavin ni mogoča, npr. zaradi njihove razredčitve v končnem zdravilu, se kakovost dokaže s popolno potrditvijo proizvodnega postopka in postopka razredčitve.
Terminology
Testi stabilnosti
The Latin name of the homeopathic stock described in the marketing authorisation application dossier shall be in accordance with the Latin title of the European Pharmacopoeia or, in absence thereof, of an official pharmacopoeia of a Member State.
Dokaže se stabilnost končnega proizvoda.
Where relevant the traditional name(s) used in each Member State shall be provided.
Podatki o stabilnosti homeopatskih surovin se po navadi lahko prenesejo na razredčine/potence, pridobljene iz surovin.
Control of starting materials
Če identifikacija ali določitev vsebnosti učinkovine ni mogoča zaradi stopnje razredčitve, se lahko upoštevajo podatki o stabilnosti farmacevtske oblike.
The particulars and documents on the starting materials, i.e. all of the materials used including raw materials and intermediates up to the final dilution to be incorporated into the finished homeopathic veterinary medicinal product, accompanying the application shall be supplemented by additional data on the homeopathic stock.
Določbe iz dela 3 se brez poseganja v določbe Uredbe (EGS) št. 2377/90 uporabljajo za poenostavljeno registracijo homeopatskih zdravil za uporabo v veterinarski medicini iz člena 17(1) te direktive s posebno specifikacijo za snovi, vključene v homeopatske surovine za dajanje živalim za proizvodnjo živil.
The general quality requirements shall apply to all of the starting and raw materials as well as intermediate steps of the manufacturing process up to the final dilution to be incorporated into the finished homeopathic product.
Če katere koli informacije manjkajo, je to treba utemeljiti, npr. predložiti se mora utemeljitev, zakaj je mogoče dokazati sprejemljivo stopnjo varnosti, čeprav nekatere študije manjkajo.
Where a toxic component is present, this should be controlled if possible in the final dilution.
To prilogo bo spremenila Komisija v skladu s členoma 146 in 153.
However, if this is not possible because of the high dilution, the toxic component shall normally be controlled at an earlier stage.
Vsa sklicevanja na člene ali na „to direktivo“ v tej prilogi se, če ni določeno drugače, razumejo kot sklicevanja na Direktivo 2001/82/ES.
Every step of the manufacturing process from the starting materials up to the final dilution to be incorporated into the finished product must be fully described.
UL L 228, 17.8.1991, str. 70.
In case dilutions are involved, these dilution steps shall be done in accordance with the homeopathic manufacturing methods laid down in the relevant monograph of the European Pharmacopoeia or, in absence thereof, in an official pharmacopoeia of a Member State.
UL L 50, 20.2.2004, str. 44.
Control tests on the finished medicinal product
UL L 50, 20.2.2004, str. 28.
The general quality requirements shall apply to the homeopathic finished veterinary medicinal products.
UL L 358, 18.12.1986, str. 1.
Any exception shall be duly justified by the applicant.
UL L 159, 27.6.2003, str. 1.
Identification and assay of all the toxicologically relevant constituents shall be carried out.
UL L 159, 27.6.2003, str. 24.
If it can be justified that identification and/or an assay on all the toxicologically relevant constituents is not possible e.g. due to their dilution in the finished medicinal product the quality shall be demonstrated by complete validation of the manufacturing and dilution process.
UL L 106, 17.4.2001, str. 1.
Stability tests
UL L 136, 30.4.2004, str. 1.
The stability of the finished product shall be demonstrated.
UL L 311, 28.11.2001, str. 67.
Stability data from the homeopathic stocks are generally transferable to dilutions/potentisations obtained thereof.
UL L 11, 14.1.1978, str. 18.
If no identification or assay of the active substance is possible due to the degree of dilution, stability data of the pharmaceutical form may be considered.
UL L 226, 22.9.1995, str. 1.
The provisions of Part 3 shall apply to the simplified registration of homeopathic veterinary medicinal products referred to in Article 17(1) of this Directive with the following specification, without prejudice to the provisions of Regulation (EEC) No 2377/90 for substances included in the homeopathic stocks intended for administration to food-producing animal species.
UL C 24, 28.1.2004, str. 6.
Any missing information must be justified, e.g. justification must be given why demonstration of an acceptable level of safety can be supported although some studies are lacking.
UL L 224, 2.4.1990, str. 1.
This Annex will be amended by the Commission in accordance with Articles 146 and 153.
UL L 325, 12.12.2003, str. 31.
All references to Articles or to ‘this Directive’ in this Annex, unless otherwise specified, are to be understood as references to Directive 2001/82/EC.
PRILOGA III
OJ L 228, 17.8.1991, p. 70.
SEZNAM OBVEZNOSTI IZ ČLENA 136(1)
OJ L 50, 20.2.2004, p. 44.
Obveznost, da predlagatelj v skladu s členom 6(4) predloži točne informacije in dokumentacijo;
OJ L 50, 20.2.2004, p. 28.
obveznost, da vloga, ki se predloži v skladu s členom 62, vsebuje informacije iz točke (b) odstavka 2 navedenega člena;
OJ L 358, 18.12.1986, p. 1.
obveznost, da so izpolnjeni pogoji iz členov 23 in 25;
OJ L 159, 27.6.2003, p. 1.
obveznost, da so izpolnjeni pogoji iz dovoljenja za promet z zdravilom za uporabo v veterinarski medicini iz člena 36(1);
OJ L 159, 27.6.2003, p. 24.
obveznost, da se uvedejo vse potrebne spremembe pogojev za dovoljenje za promet zaradi upoštevanja tehničnega in znanstvenega napredka, in omogoči, da se zdravila za uporabo v veterinarski medicini proizvajajo in preverjajo po splošno sprejetih znanstvenih metodah, kot določa člen 58(3);
OJ L 106, 17.4.2001, p. 1.
obveznost, da se povzetek glavnih značilnosti proizvoda, navodilo za uporabo in oznaka prilagajajo znanstvenim spoznanjem, kot je določeno v členu 58(4);
OJ L 136, 30.4.2004, p. 1.
obveznost, da se v zbirki podatkov o zdravilih beležijo podatki o dajanju zdravil za uporabo v veterinarski medicini v promet in informacije o razpoložljivosti posameznega zdravila v vseh relevantnih državah članicah ter po potrebi podatki o začasnem odvzemu ali odvzemu zadevnega dovoljenja za promet ter podatki o obsegu prodaje zdravila, kot je določeno v členu 58(6) oziroma členu 58(11);
OJ L 311, 28.11.2001, p. 67.
na zahtevo pristojnega organa ali Agencije obveznost, da se v določenem roku predložijo podatki, ki dokazujejo, da ostaja razmerje med koristmi in tveganjem pozitivno, kot določa člen 58(9);
OJ L 11, 14.1.1978, p. 18.
obveznost, da se predložijo nove informacije, na podlagi katerih bi se lahko spremenili pogoji za dovoljenje za promet, obvestila o prepovedih ali omejitvah, ki so jih uvedli pristojni organi katere koli države, v kateri je zdravilo za uporabo v veterinarski medicini v prometu, ali informacije, ki bi lahko vplivale na oceno tveganj in koristi zdravila, kot določa člen 58(10);
OJ L 226, 22.9.1995, p. 1.
obveznost, da se zdravilo za uporabo v veterinarski medicini da v promet v skladu z vsebino povzetka glavnih značilnosti zdravila, oznako in navodili za uporabo, kot so navedeni v dovoljenju za promet;
OJ C 24, 28.1.2004, p. 6.
obveznost, da se v skladu s členom 76(2) beležijo in sporočajo domnevni neželeni učinki zdravil za uporabo v veterinarski medicini;
OJ L 224, 2.4.1990, p. 1.
obveznost, da se zbirajo specifični podatki o farmakovigilanci, poleg tistih, ki so našteti v členu 73(2), in v skladu s členom 76(3) izvajajo študije o varnosti zdravila po pridobitvi dovoljenja za promet;
OJ L 325, 12.12.2003, p. 31.
obveznost, da so javna obvestila o podatkih glede farmakovigilance nepristransko predstavljena in niso zavajajoča, ter obveznost, da se Agenciji sporočajo podatki, kot določa člen 77(11);
ANNEX III
obveznost, da se vodi sistem farmakovigilance za izvajanje s tem povezanih nalog, kar obsega tudi vzdrževanje glavne dokumentacije o sistemu farmakovigilance v skladu s členom 77;
LIST OF THE OBLIGATIONS REFERRED TO IN ARTICLE 136(1)
na zahtevo Agencije obveznost, da se predloži kopija glavnega dosjeja o sistemu farmakovigilance, kot določa člen 79(6);
the obligation, as an applicant, to provide accurate information and documentation as referred to in Article 6(4);
obveznost, da se izvede postopek obravnave signala in evidentirajo rezultati tega postopka v skladu s členom 81(1) in (2);
the obligation to provide, in an application submitted in accordance with Article 62, the data referred to in point (b) of paragraph 2 of that Article;
obveznost, da se Agenciji zagotovijo vse razpoložljive informacije o sklicu na interese Unije, kot določa člen 82(3).
the obligation to comply with the conditions referred to in Articles 23 and 25;
PRILOGA IV
the obligation to comply with conditions included in the marketing authorisation of the veterinary medicinal product, as referred to in Article 36(1);
KORELACIJSKA TABELA
the obligation to introduce any necessary variation to the terms of the marketing authorisation to take account of technical and scientific progress and enable the veterinary medicinal products to be manufactured and checked by means of generally accepted scientific methods, as provided for in Article 58(3);
Direktiva 2001/82/ES
the obligation to keep up to date the summary of product characteristics, package leaflet and labelling with current scientific knowledge, as provided for in Article 58(4);
Ta uredba
the obligation to record in the product database the dates when its authorised veterinary medicinal products are placed on the market and information on the availability for each veterinary medicinal product in each relevant Member State and, as applicable, the dates of any suspension or revocation of the marketing authorisations concerned, as well as data relating to the volume of sales of the medicinal product, as provided in Article 58(6) and (11) respectively;
Člen 2(1)
the obligation to provide within the time limit set at the request of a competent authority or the Agency any data demonstrating that the benefit-risk balance remains positive, as provided for in Article 58(9);
Člen 2(2)
the obligation to supply any new information which may entail a variation to the terms of the marketing authorisation, to notify any prohibition or restriction imposed by the competent authorities of any country in which the veterinary medicinal product is marketed, or to supply any information that may influence the evaluation of the risks and benefits of the medicinal product, as provided for in Article 58(10);
Člen 2(3)
the obligation to place the veterinary medicinal product on the market in accordance with the content of the summary of the product characteristics and the labelling and package leaflet as contained in the marketing authorisation;
Člen 2(2), (3) in (4)
the obligation to record and report suspected adverse events for their veterinary medicinal products, in accordance with Article 76(2);
Člen 2(4)
the obligation to collect specific pharmacovigilance data additional to the data listed in Article 73(2) and to carry out post-marketing surveillance studies in accordance with Article 76(3);
Člen 4(2)
the obligation to ensure that public announcements relating to information on pharmacovigilance concerns are presented objectively and are not misleading and to notify them to the Agency, as provided for in Article 77(11);
Člen 5(6)
the obligation to operate a pharmacovigilance system for the fulfilment of pharmacovigilance tasks, including maintenance of a pharmacovigilance system master file in accordance with Article 77;
Člen 5(1) druga poved
the obligation to submit, at the request of the Agency, a copy of its pharmacovigilance system master file(s), as provided for in Article 79(6);
Člen 38(3)
the obligation to carry out signal management process and to record the results and outcomes of that process in accordance with Article 81(1) and (2);
Člen 5(2)
the obligation to provide to the Agency all available information relating to the Union interest referral, as referred to in Article 82(3).
Člen 58(1)
ANNEX IV
Člen 6(1), (2)
CORRELATION TABLE
Člen 8(3)
Directive 2001/82/EC
Člen 6(3)
This Regulation
Člen 8(4)
Article 2(1)
Člen 8 tretja poved
Article 2(2)
Členi 113, 114 in 115
Article 2(3)
Člen 13(1)
Article 2(2),(3) and (4)
Člen 13(2)
Article 2(4)
Člen 4(8) in (9)
Article 4(2)
Člen 13(3),(4)
Article 5(6)
Člen 13(5)
Article 5(1) second sentence
Členi 38, 39 in 40
Article 38(3)
Člen 13(6)
Article 5(2)
Člen 13a
Article 58(1)
Člen 13b
Article 6(1), (2)
Člen 13c
Article 8(3)
Člen 21(1)
Article 6(3)
Člen 21(2)
Article 8(4)
Člena 28 in 29
Article 8 third sentence
Člen 26(3)
Articles 113, 114 and 115
Člena 25 in 26
Article 13(1)
Člen 27a
Article 13(2)
Člen 58(6)
Article 4(8) and (9)
Člen 27b
Article 13(3),(4)
Člena 142 in 143
Article 13(5)
Člena 49 in 52
Articles 38, 39 and 40
Člena 93 in 96
Article 13(6)
Člen 50a
Article 13a
Člena 10 in 11
Article 13b
Člen 11(4)
Article 13c
Člena 99 in 100
Article 21(1)
Člena 73 in 74
Articles 28 and 29
Člena 129 in 130
Article 26(3)
Člen 85(1), (2)
Articles 25 and 26
Člen 85(3)
Article 27a
Člena 119 in 120
Article 58(6)
Člen 79(2)
Article 27b
Člen 9(2)
Articles 142 and 143
Člen 95a
Article 92 Article 49 Article 90
V tem primeru ustrezni pristojni organ ali Agencija, kakor t je ustrezno, o tem obvesti imetnika dovoljenja za promet.
Articles 93 and 96
Pooblastilo za sprejemanje delegiranih aktov iz členov 37(4), 57(3), 106(6), 109(1), 115(3) in 118(2), 136(7) in 146(1) in (2) se prenese na Komisijo prenese za obdobje petih let od 27. januarja 2019.
Article 50a
Komisija pripravi poročilo o prenosu pooblastila najpozneje devet mesecev pred koncem petletnega obdobja.
Articles 10 and 11
Delegirani akti iz člena 118(2) ter izvedbeni akti iz členov 37(5), 57(4), 77(6), 95(8), 99(6) in 104(7) se sprejmejo pred 28. januarjem 2022.