natgillin/translations-raw huggingface dataset:
Critical expert reports on quality, safety and efficacy of the veterinary medicinal product.
Vloga vključuje oceno tveganja za okolje v zvezi s sproščanjem zdravil za uporabo v veterinarski medicini, ki vsebujejo gensko spremenjene organizme (GSO) ali so iz njih sestavljena v smislu člena 2 Direktive 2001/18/ES Evropskega parlamenta in Sveta.
ANNEX II
Informacije se predložijo v skladu z določbami Direktive 2001/18/ES in Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta in ob upoštevanju smernic, ki jih je objavila Komisija.
REQUIREMENTS REFERRED TO IN POINT (B) OF ARTICLE 8(1)
Pri vlogah za pridobitev dovoljenja za promet z zdravili za uporabo v veterinarski medicini, namenjenimi živalskim vrstam in indikacijam, ki predstavljajo manjše tržne sektorje, se lahko uporabi prožnejši pristop.
INTRODUCTION AND GENERAL PRINCIPLES
V teh primerih je treba upoštevati ustrezne znanstvene smernice in/ali znanstvene predloge.
The particulars and documents accompanying an application for marketing authorisation pursuant to Articles 12 to 13d shall be presented in accordance with the requirements set out in this Annex and shall take into account the guidance published by the Commission in The rules governing medicinal products in the European Union, Volume 6 B, Notice to applicants, Veterinary medicinal products, Presentation and Contents of the Dossier.
Ta priloga je razdeljena na štiri dele:
In assembling the dossier for application for marketing authorisation, applicants shall also take into account the current state of veterinary medicinal knowledge and the scientific guidelines relating to the quality, safety and efficacy of veterinary medicinal products published by the European Medicines Agency (Agency) and the other pharmaceutical Community guidelines published by the Commission in different volumes of The rules governing medicinal products in the European Union.
v naslovu I so opisane standardne zahteve za vloge za pridobitev dovoljenj za promet z zdravili za uporabo v veterinarski medicini, razen imunoloških zdravil za uporabo v veterinarski medicini.
For veterinary medicinal products other than immunological veterinary medicinal products, with respect to the quality (pharmaceutical) part (physico-chemical, biological and microbiological tests) of the dossier, all relevant monographs including general monographs and the general chapters of the European Pharmacopoeia are applicable.
V naslovu II so opisane standardne zahteve za vloge za pridobitev dovoljenja za promet z imunološkimi zdravili za uporabo v veterinarski medicini.
For immunological veterinary medicinal products, with respect to the quality, safety and efficacy parts of the dossier, all relevant monographs including general monographs and the general chapters of the European Pharmacopoeia are applicable.
V naslovu III so opisane posebne vloge za pridobitev dovoljenja za promet z zdravilom in posebne zahteve.
The manufacturing process shall comply with the requirements of Commission Directive 91/412/EEC laying down the principles and guidelines for veterinary medicinal products and with the principles and guidelines on Good Manufacturing Practice (GMP), published by the Commission in The rules governing medicinal products in the European Union, Volume 4.
V naslovu IV so opisane zahteve za vloge za pridobitev dovoljenja za promet s posebnimi vrstami zdravil za uporabo v veterinarski medicini.
All information which is relevant to the evaluation of the veterinary medicinal product concerned shall be included in the application, whether favourable or unfavourable to the product.
NASLOV I
In particular, all relevant details shall be given of any incomplete or abandoned test or trial relating to the veterinary medicinal product.
Zahteve za zdravila za uporabo v veterinarski medicini, razen za imunološka zdravila za uporabo v veterinarski medicini
Pharmacological, toxicological, residue and safety tests shall be carried out in conformity with the provisions related to Good Laboratory Practice (GLP) laid down in Directive 2004/10/EC of the European Parliament and of the Council and Directive 2004/9/EC of the European Parliament and of the Council.
Naslednje zahteve se uporabljajo za zdravila za uporabo v veterinarski medicini, razen za imunološka zdravila za uporabo v veterinarski medicini, razen kadar je drugače določeno v naslovu III.
Member States shall ensure that all experiments on animals are conducted in accordance with Council Directive 86/609/EEC.
DEL 1
In order to monitor the risk/benefit assessment, any new information not in the original application and all pharmacovigilance information shall be submitted to the competent authority.
Povzetek vloge
After marketing authorisation has been granted, any change to the content of the dossier shall be submitted to the competent authorities in accordance with Commission Regulations (EC) No 1084/2003 or (EC) No 1085/2003 for veterinary medicinal products authorised as defined in Article 1 of those Regulations, respectively.
A. UPRAVNE INFORMACIJE
The environmental risk assessment connected with the release of veterinary medicinal products containing or consisting of Genetically Modified Organisms (GMOs) within the meaning of Article 2 of Directive 2001/18/EC of the European Parliament and of the Council shall be provided in the dossier.
Zdravilo za uporabo v veterinarski medicini, na katerega se nanaša vloga, se identificira s svojim imenom, imeni učinkovin, jakostjo, farmacevtsko obliko, potjo in načinom uporabe (glej člen 12(3)(f) Direktive) ter opisom končnega pakiranja zdravila, vključno z ovojnino, oznakami in navodilom za uporabo (glej člen 12(3)(l) Direktive).
The information shall be presented in accordance with the provisions of Directive 2001/18/EC and Regulation (EC) No 726/2004 of the European Parliament and of the Council, taking into account guidance documents published by the Commission.
Predložijo se ime in naslov predlagatelja, ime in naslov proizvajalcev in obratov, vključenih v različne stopnje proizvodnje, preskušanja in sproščanja (vključno z proizvajalcem končnega zdravila ter proizvajalci učinkovin), ter, kadar je potrebno, ime in naslov uvoznika.
In cases of applications for marketing authorisations for veterinary medicinal products indicated for animal species and indications representing smaller market sectors, a more flexible approach may be applicable.
Predlagatelj navede število in naslove zvezkov dokumentacije, ki je priložena vlogi, ter kateri vzorci, če ti obstajajo, so priloženi.
In such cases, relevant scientific guidelines and/or scientific advice should be taken into account.
K upravnim informacijam se priloži dokument, ki dokazuje, da proizvajalec ima dovoljenje za izdelavo zadevnih zdravil za uporabo v veterinarski medicini, opredeljenih v členu 44, seznam držav, v katerih je bilo dovoljenje izdano, kopije vseh povzetkov glavnih značilnosti zdravila v skladu s členom 14, kot so ga odobrile države članice, ter seznam držav, v katerih je bila vloga vložena ali zavrnjena.
This Annex is divided in four titles:
B. POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA, OZNAČEVANJE IN NAVODILO ZA UPORABO
Title I describes the standardised requirements for applications for veterinary medicinal products other than immunological veterinary medicinal products.
Predlagatelj predlaga povzetek glavnih značilnosti zdravila v skladu s členom 14 te direktive.
Title II describes the standardised requirements for applications for immunological veterinary medicinal products.
Predlagano besedilo oznake na stični in zunanji ovojnini ter navodilo za uporabo, kadar je zahtevano v skladu s členom 61, se pripravita v skladu z naslovom V te direktive.
Title III describes specific types of marketing authorisation dossiers and requirements.
Poleg tega predlagatelj predloži enega ali več vzorcev ali osnutkov končnih pakiranj zdravila za uporabo v veterinarski medicini v vsaj enem uradnem jeziku Evropske unije; osnutek je lahko črno-bel in v elektronski obliki, kadar je bilo pridobljeno soglasje pristojnega organa.
Title IV describes the dossier requirements for particular types of veterinary medicinal products.
C. PODROBNI IN KRITIČNI POVZETKI
TITLE I
V skladu s členom 12(3) se predložijo podrobni in kritični povzetki rezultatov farmacevtskih (fizikalno-kemijskih, bioloških ali mikrobioloških) preskusov, preskusov varnosti in ostankov, predkliničnih in kliničnih preskušanj ter preskusov, ki ocenjujejo mogoča tveganja zdravila za uporabo v veterinarski medicini za okolje.
Requirements for veterinary medicinal products other than immunological veterinary medicinal products
Vsak podroben in kritičen povzetek se pripravi ob upoštevanju trenutnih znanstvenih spoznanj ob predložitvi vloge.
The following requirements shall apply to veterinary medicinal products other than immunological veterinary medicinal products, except where otherwise set out in Title III.
Povzetek vsebuje oceno raznih preskusov in preskušanj iz vloge za pridobitev dovoljenja za promet z zdravilom ter obravnava vse točke v zvezi z oceno kakovosti, varnosti in učinkovitosti zdravila za uporabo v veterinarski medicini.
PART 1
V njem se navedejo podrobni rezultati predloženih preskusov in preskušanj ter natančna bibliografska sklicevanja.
summary of the dossier
Vsi pomembni podatki se povzamejo v dodatku, če je le mogoče v obliki tabel ali grafov.
A. ADMINISTRATIVE INFORMATION
Podrobni in kritični povzetki ter dodatki vsebujejo natančna sklicevanja na informacije, ki jih vsebuje glavna dokumentacija.
The veterinary medicinal product, which is the subject of the application, shall be identified by its name and by the name of the active substance(s), together with the strength, the pharmaceutical form, the route and method of administration (see Article 12(3)(f) of Directive) and a description of the final presentation of the product, including packaging, labelling and package leaflet (see Article 12(3)–(l) of Directive).
Podrobni in kritični povzetki se podpišejo in datirajo ter se priložijo informacije o izobrazbi, usposabljanju ter poklicnih izkušnjah izvedenca.
The name and address of the applicant shall be given, together with the name and address of the manufacturers and the sites involved in the different stages of the manufacture, testing and release (including the manufacturer of the finished product and the manufacturer(s) of the active substance(s)), and where relevant the name and address of the importer.
Z izjavo se opredeli tudi poslovna povezava med izvedencem in predlagateljem.
The applicant shall identify the number and titles of volumes of documentation submitted in support of the application and indicate what samples, if any, are also provided.
Kadar je učinkovina vključena v zdravilo za uporabo v humani medicini, odobreno v skladu z zahtevami iz Priloge I k Direktivi 2001/83/ES Evropskega parlamenta in Sveta, se lahko celoten povzetek o kakovosti zdravila iz modula 2 oddelka 2.3 navedene priloge nadomesti s povzetkom dokumentacije o učinkovini ali zdravilu, kakor je primerno.
Annexed to the administrative information shall be a document showing that the manufacturer is authorised to produce the veterinary medicinal products concerned, as defined in Article 44, together with a list of countries in which authorisation has been granted, copies of all the summaries of product characteristics in accordance with Article 14 as approved by Member States and a list of countries in which an application has been submitted or refused.
Kadar je pristojni organ javno objavil, da se lahko kemijske, farmacevtske in biološke/mikrobiološke informacije končnega zdravila vključijo v vlogo v obliki skupnega tehničnega dokumenta (STD), se lahko podroben in kritičen povzetek rezultatov farmacevtskih preskusov predloži v obliki celotnega povzetka o kakovosti zdravila.
B. SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET
Pri vlogi za zdravilo, ki je namenjeno živalskim vrstam ali indikacijam, ki predstavljajo manjše tržne sektorje, se lahko celoten povzetek o kakovosti zdravila uporabi brez predhodnega dovoljenja pristojnega organa.
The applicant shall propose a summary of the product characteristics, in accordance with Article 14 of this Directive.
DEL 2
A proposed labelling text for the immediate and outer packaging shall be provided in accordance with Title V of this Directive, together with a package leaflet where one is required pursuant to Article 61.
Farmacevtske (fizikalno-kemijske, biološke ali mikrobiološke informacije (kakovost))
In addition the applicant shall provide one or more specimens or mock-ups of the final presentation(s) of the veterinary medicinal product in at least one of the official languages of the European Union; the mock-up may be provided in black and white and electronically where prior agreement from the competent authority has been obtained.
Temeljna načela in zahteve
C. DETAILED AND CRITICAL SUMMARIES
Podrobni podatki in dokumenti, ki se priložijo vlogi za pridobitev dovoljenja za promet z zdravilom v skladu s prvo alineo člena 12(3)(j), se predložijo v skladu s spodaj navedenimi zahtevami.
In accordance with Article 12(3), detailed and critical summaries shall be provided on the results of pharmaceutical (physico-chemical, biological or microbiological) tests, of the safety tests and residue tests, of the pre-clinical and clinical trials and of the tests assessing the potential risks posed by the veterinary medicinal product for the environment.
Za učinkovine in končna zdravila za uporabo v veterinarski medicini se poleg farmacevtskih (fizikalno-kemijskih, bioloških ali mikrobioloških) podatkov navedejo informacije o proizvodnem postopku, lastnostih in značilnostih, postopkih in zahtevah za nadzor kakovosti, stabilnosti ter opis sestave, razvoja in pakiranja zdravila za uporabo v veterinarski medicini.
Each detailed and critical summary shall be prepared in the light of the state of scientific knowledge at the time of submission of the application.
Uporabljajo se vse monografije, vključno s splošnimi monografijami in splošnimi poglavji iz Evropske farmakopeje ali, kadar ta ne obstaja, farmakopeje države članice.
It shall contain an evaluation of the various tests and trials, which constitute the marketing authorisation dossier, and shall address all points relevant to the assessment of the quality, safety and efficacy of the veterinary medicinal product.
Vsi postopki preskušanja izpolnjujejo merila za analizo in nadzor kakovosti vhodnih snovi in končnih zdravil ter upoštevajo uveljavljene smernice in zahteve.
It shall give detailed results of the tests and trials submitted and precise bibliographic references.
Predložijo se rezultati potrditvenih študij.
All important data shall be summarised in an appendix, whenever possible in tabular or graphic form.
Vsi postopki preskušanja se opišejo natančno, da se lahko ponovijo v kontrolnih preskusih, ki jih lahko zahteva pristojni organ.
The detailed and critical summaries and the appendices shall contain precise cross references to the information contained in the main documentation.
Ustrezno podrobno se opišejo kakršne koli posebne naprave in oprema, po možnosti s shemo.
The detailed and critical summaries shall be signed and dated, and information about the author’s educational background, training and occupational experience shall be attached.
Dodajo se formule laboratorijskih reagentov in po potrebi metoda priprave.
The professional relationship of the author with the applicant shall be declared.
Pri postopkih preskušanja, vključenih v Evropsko farmakopejo ali farmakopejo države članice, se lahko ta opis nadomesti s podrobnim sklicem na zadevno farmakopejo.
Where the active substance has been included in a medicinal product for human use authorised in accordance with the requirements of Annex I to Directive 2001/83/EC of the European Parliament and of the Council the overall quality summary provided for in Module 2, section 2.3 of that Annex may replace the summary regarding the documentation related to the active substance or the product, as appropriate.
Kadar je ustrezno, se uporablja kemijska in biološka referenčna snov iz Evropske farmakopeje.
Where the competent authority has publicly announced that the chemical, pharmaceutical and biological/microbiological information for the finished product may be included in the dossier in the Common Technical Document (CTD) format only, the detailed and critical summary on the results of pharmaceutical tests may be presented in the quality overall summary format.
Kadar se uporabijo drugi referenčni pripravki in standardi, se opredelijo in podrobno opišejo.
In the case of application for an animal species or for indications representing smaller market sectors, the quality overall summary format may be used without prior agreement of the competent authorities.
Kadar je učinkovina vključena v zdravilo za uporabo v humani medicini, odobreno v skladu z zahtevami iz Priloge I k Direktivi 2001/83/ES, lahko kemijske, farmacevtske in biološke/mikrobiološke informacije iz modula 3 navedene direktive nadomestijo dokumentacijo o učinkovini ali končnem zdravilu, kakor je primerno.
PART 2
Kemijske, farmacevtske in biološke/mikrobiološke informacije o učinkovini ali končnem zdravilu se lahko vključijo v dokumentacijo v obliki skupnega tehničnega dokumenta le, kadar je pristojni organ javno objavil to možnost.
Pharmaceutical (physico-chemical, biological or microbiological information (quality))
Pri vlogi za zdravilo, ki je namenjeno živalskim vrstam ali indikacijam, ki predstavljajo manjše tržne sektorje, se lahko oblika skupnega tehničnega dokumenta uporabi brez predhodnega dovoljenja pristojnega organa.
Basic principles and requirements
A. PODROBNI PODATKI O KAKOVOSTNI IN KOLIČINSKI SESTAVI ZDRAVILA
The particulars and documents which shall accompany the application for marketing authorisation pursuant to the first indent of Article 12(3)(j) shall be submitted in accordance with the requirements below.
Podatki o kakovostni sestavi
The pharmaceutical (physico-chemical, biological or microbiological) data shall include for the active substance(s) and for the finished veterinary medicinal product information on the manufacturing process, the characterisation and properties, the quality control procedures and requirements, the stability as well as a description of the composition, the development and presentation of the veterinary medicinal product.
„Podrobni podatki o kakovostni sestavi“ vseh sestavin zdravila pomenijo navedbo ali opis:
All monographs, including general monographs and general chapters of the European Pharmacopoeia, or failing that, of a Member State are applicable.
učinkovin,
All test procedures shall fulfil the criteria for analysis and control of the quality of the starting materials and the finished product and should take account of established guidance and requirements.
sestavin pomožnih snovi, ne glede na lastnosti ali uporabljeno količino, vključno z barvili, konzervansi, dodatki, stabilizatorji, zgoščevalci, emulgatorji, snovmi za izboljšanje okusa in aromami,
The results of the validation studies shall be provided.
sestavin, ki jih žival zaužije ali se kako drugače dajejo živalim, ki jih vsebuje zunanji del zdravil za uporabo v veterinarski medicini – kapsul, želatinskih kapsul.
All the test procedure(s) shall be described in sufficiently precise detail so as to be reproducible in control tests, carried out at the request of the competent authority; any special apparatus and equipment, which may be used shall be described in adequate detail, possibly accompanied by a diagram.
Ti podrobni podatki se dopolnijo z vsemi ustreznimi podatki o zunanji ovojnini in po potrebi sekundarni ovojnini in, kadar je to primerno, načinu zapiranja ovojnine, ter podatki o pripomočkih, s katerimi se zdravilo uporablja ali daje in bodo priloženi zdravilu.
The formulae of the laboratory reagents shall be supplemented, if necessary, by the method of preparation.
Običajna terminologija
In the case of test procedures included in the European Pharmacopoeia or the pharmacopoeia of a Member State, this description may be replaced by a detailed reference to the pharmacopoeia in question.
„Običajna terminologija“, ki se uporablja pri opisovanju sestavin zdravil za uporabo v veterinarski medicini, pomeni ne glede na uporabo drugih določb člena 12(3)(c):
Where relevant, chemical and biological reference material of the European Pharmacopoeia shall be used.
pri sestavinah, ki so navedene v Evropski farmakopeji ali, kadar ta ne obstaja, farmakopeji ene od držav članic, glavni naslov v zadevni monografiji s sklicem na zadevno farmakopejo,
If other reference preparations and standards are used, they shall be identified and described in detail.
pri ostalih sestavinah, mednarodno nelastniško ime (INN), ki ga priporoča Svetovna zdravstvena organizacija, ki ga lahko spremlja drugo nelastniško ime, ali če tega ni, natančna znanstvena oznaka; pri sestavinah, ki nimajo mednarodnega nelastniškega imena ali natančne znanstvene oznake, se opiše, kako in iz česa so pripravljene, in kadar je ustrezno, se dodajo še drugi ustrezni podatki,
In cases where the active substance has been included in a medicinal product for human use authorised in accordance with the requirements of Annex I to Directive 2001/83/EC the chemical, pharmaceutical and biological/microbiological information provided for in Module 3 of that Directive may replace the documentation related to the active substance or the finished product, as appropriate.
barvila s kodami iz Direktive Sveta 78/25/EGS se označijo s kodo „E“.
The chemical, pharmaceutical and biological/microbiological information for the active substance or the finished product may be included in the dossier in CTD format only where the competent authority has publicly announced this possibility.
Podatki o količinski sestavi
In the case of any application for an animal species or for indications representing smaller market sectors the CTD format may be followed without prior agreement of the competent authorities.
Za „podrobne podatke o količinski sestavi“ vseh učinkovin v zdravilu za uporabo v veterinarski medicini je treba glede na zadevno farmacevtsko obliko za vsako učinkovino navesti maso ali število enot biološke aktivnosti na enoto odmerka ali enoto mase ali volumna.
A. QUALITATIVE AND QUANTITATIVE PARTICULARS OF THE CONSTITUENTS
Enote biološke aktivnosti se uporabljajo za snovi, ki jih ni mogoče kemijsko opredeliti.
Qualitative particulars
Kadar je Svetovna zdravstvena organizacija opredelila mednarodno enoto biološke aktivnosti, se ta uporablja.
‘Qualitative particulars’ of all the constituents of the medicinal product shall mean the designation or description of:
Kadar mednarodna enota ni opredeljena, se enote biološke aktivnosti izrazijo tako, da nedvoumno izražajo aktivnost učinkovin s pomočjo enot Evropske farmakopeje, kadar je to primerno.
active substance(s),
Kadar koli je mogoče, se označi biološka aktivnost na enoto mase ali volumna.
the constituents of the excipients, whatever their nature or the quantity used, including colouring matter, preservatives, adjuvants, stabilisers, thickeners, emulsifiers, flavouring and aromatic substances,
Ti podatki se dopolnijo:
the constituents, intended to be ingested or otherwise administered to animals, of the outer covering of the veterinary medicinal products, such as capsules, gelatine capsules.
pri pripravkih z enkratnim odmerkom z maso ali z enotami biološke aktivnosti za vsako učinkovino v enem vsebniku, ob upoštevanju uporabnega volumna zdravila po rekonstituciji, kadar je primerno,
These particulars shall be supplemented by any relevant data concerning the immediate packaging and if relevant the secondary packaging and, where appropriate, its manner of closure, together with details of devices with which the medicinal product will be used or administered and which will be supplied with the medicinal product.
pri zdravilih za uporabo v veterinarski medicini, ki se dajejo po kapljicah, z maso ali enotami biološke aktivnosti za vsako učinkovino, ki jo vsebuje kapljica ali tako število kapljic, ki ustreza 1 ml ali 1 g pripravka,
Usual terminology
pri sirupih, emulzijah, granulatih ter drugih farmacevtskih oblikah, ki se dajejo v odmerjenih količinah, z maso ali enotami biološke aktivnosti za vsako učinkovino na odmerjeno količino.