FrancophonIA/DGT-Translation_Memory huggingface dataset:
English: In cases where a specification or other provisions contained in a monograph of the European Pharmacopoeia or in the national pharmacopoeia of a Member State might be insufficient to ensure the quality of the substance, the competent authorities may request more appropriate specifications from the applicant for marketing authorization.
Slovenian: V primerih, če specifikacija, ali druga določila, ki jih vsebuje monografija Evropske farmakopeje, ali nacionalna farmakopeja države članice ne bi bila zadostna za zagotavljanje kakovosti snovi, lahko pristojni organi od predlagatelja dovoljenja za promet z zdravilom zahtevajo ustreznejše specifikacije.
English: The applicant for marketing authorization shall provide the authorities of that pharmacopoeia with the details of the alleged insufficiency and the additional specifications applied.
Slovenian: Predlagatelj dovoljenja za promet z zdravilom mora pristojnim organom predložiti podatke o domnevnih pomanjkljivostih ter o dodatnih uporabljenih specifikacijah.
English: In cases where a starting material is described neither in the European Pharmacopoeia nor in the pharmacopoeia of a Member State, compliance with the monograph of a third country pharmacopoeia can be accepted;
Slovenian: V primerih, kjer vhodna snov ni opisana niti v Evropski farmakopeji niti v farmakopeji države članice, se lahko sprejme skladnost z monografijo farmakopeje tretje države;
English: in such cases, the applicant shall submit a copy of the monograph accompanied where necessary by the validation of the test procedures contained in the monograph and by a translation where appropriate.
Slovenian: v takih primerih mora predlagatelj predložiti kopijo monografije ter priložiti validacijo postopkov preskušanj, ki jih monografija vsebuje, ter kjer je to potrebno, prevod.
English: For active ingredients, demonstration of the ability of the monograph adequately to control their quality shall be presented.
Slovenian: Za zdravilne učinkovine je treba dokazati, da je monografija ustrezna za kontrolo njihove kakovosti.
English: Starting materials not listed in a pharmacopoeia
Slovenian: Vhodne snovi, ki niso opisane v farmakopeji
English: Starting materials of biological origin
Slovenian: Vhodne snovi biološkega izvora
English: The description shall be given in the form of a monograph.
Slovenian: Opis je potreben v obliki monografije.
English: Whenever possible, vaccine production shall be based on a seed lot system and on established cell banks.
Slovenian: Kjer koli je to možno, mora izdelava cepiva temeljiti na sistemu matične serije ter na vzpostavljenih celičnih bankah.
English: For the production of immunological veterinary medicinal products consisting of serums, the origin, general health and immunological status of the producing animals shall be indicated;
Slovenian: Pri izdelavi imunoloških zdravil za uporabo v veterinarski medicini, izdelanih iz serumov, je treba prikazati izvor, splošno zdravstveno in imunološko stanje proizvodne živali;
English: defined pools of source materials shall be used.
Slovenian: treba je uporabljati opredeljeni zbir izvornega materiala.
English: The origin and history of starting materials shall be described and documented.
Slovenian: Treba je opisati in dokumentirati izvor in zgodovino vhodne snovi.
English: For genetically engineered starting materials this information shall include details such as the description of the starting cells or strains, the construction of the expression vector (name, origin, function of the replicon, promoter enhancer and other regulator elements), control of the sequence of DNA or RNA effectively inserted, oligonucleotidic sequences of plasmid vector in cells, plasmid used for cotransfection, added or deleted genes, biological properties of the final construct and the genes expressed, copy number and genetic stability.
Slovenian: Pri genetsko pridobljenih snoveh mora ta informacija vsebovati podatke, kot so opis začetnih celic ali sevov, pripravo ekspresijskega vektorja (ime, izvor, funkcija replikona, ojačevalec promotorja ter druge regulacijske elemente), kontrolo zaporedja učinkovito vrinjene DNK ali RNK, oligonukleotidno zaporedje plazmidnega vektorja v celicah, uporabljeni plazmid za kotransfekcijo, dodane ali izbrisane gene, biološke lastnosti končno spremenjenih celic ter izražene gene, število kopij ter gensko stabilnost.
English: Seed materials, including cell banks and raw serum for anti-serum production shall be tested for identity and adventitious agents.
Slovenian: Matični material, vključno s celičnimi bankami ter surovim serumom za proizvodnjo anti-seruma je treba preskusiti na istovetnost ter na prisotnost naključnih snovi.
English: Information shall be provided on all substances of biological origin used at any stage in the manufacturing procedure.
Slovenian: Treba je predložiti informacije o uporabljenih snoveh biološkega izvora za vsako fazo postopka izdelave.
English: The information shall include:
Slovenian: Te informacije morajo vsebovati naslednje:
English: details of the source of the materials,
Slovenian: podatke o izvoru materiala;
English: details of any processing, purification and inactivation applied, with data on the validation of these process and in-process controls,
Slovenian: podrobnosti o predelavi, čiščenju in inaktivaciji, skupaj s podatki o validaciji teh procesov ter kontrol med procesom;
English: details of any tests for contamination carried out on each batch of the substance.
Slovenian: podrobnosti o preskusih na onesnaženost, narejenih na vsaki seriji.
English: If the presence of adventitious agents is detected or suspected, the corresponding material shall be discarded or used in very exceptional circumstances only when further processing of the product ensures their elimination and/or inactivation;
Slovenian: Če se ugotovi ali sumi na prisotnost naključnih snovi, je treba material zavreči ali ga uporabiti le v izjemnih okoliščinah, le kadar nadaljnja predelava izdelka zagotavlja, da se te snovi lahko odstranijo in/ali inaktivirajo;
English: elimination and/or inactivation of such adventitious agents shall be demonstrated.
Slovenian: odstranitev in/ali inaktivacijo teh naključnih snovi je treba dokazati.
English: When cell banks are used, the cell characteristics shall be shown to have remained unchanged up to the highest passage level used for the production.
Slovenian: Pri uporabi celičnih bank, mora biti dokazano, da se lastnosti celic niso spremenile vse do najvišje ravni prenosa med procesom izdelave.
English: For live attenuated vaccines, proof of the stability of the attenuation characteristics of the seed has to be given.
Slovenian: Pri živih atenuiranih cepivih je treba podati dokaz o stabilnosti lastnosti atenuiranja matičnega materiala.
English: When required, samples of the biological starting material or reagents used in the testing procedures shall be provided to enable the competent authority to arrange for check tests to be carried out.
Slovenian: Na zahtevo je treba zagotoviti vzorce biološkega vhodne snovi ali reagentov, uporabljenih v postopkih preskušanja, da bi omogočili pristojnemu organu izvedbo preskusov preverjanja.
English: Starting materials of non-biological origin
Slovenian: Vhodna snov ne-biološkega izvora
English: The description shall be given in the form of a monograph under the following headings:
Slovenian: Opis je treba podati v obliki monografije po naslednjih postavkah:
English: the name of the starting material meeting the requirements of point 2 of Section A shall be supplemented by any trade or scientific synonyms,
Slovenian: ime vhodne snovi, ki izpolnjuje zahteve točke 2 dela A in mora biti dopolnjena z blagovnim ali znanstvenim sinonimom,
English: the description of the starting material, set down in a form similar to that used in a descriptive item in the European Pharmacopoeia,
Slovenian: opis vhodne snovi v podobni obliki, kakor jo Evropska farmakopeja uporablja za opisih snovi,
English: the function of the starting material,
Slovenian: funkcija vhodne snovi,
English: methods of identification,
Slovenian: metode identifikacije,
English: purity shall be described in relation to the sum total of predictable impurities, especially those which may have a harmful effect and, if necessary, those which, having regard to the combination of substances to which the application refers, may adversely effect the stability of the medicinal product or distort analytical results.
Slovenian: čistoto je treba opisati glede na celotno količino predvidenih nečistot, posebno tistih, ki bi utegnile imeti škodljive učinke in če je treba tudi tistih, ki bi v kombinaciji snovi, na katere se vloga nanaša, lahko imele neželen vpliv na stabilnost zdravila ali bi popačile rezultate analiz.
English: A brief description shall be provided of the tests undertaken to establish the purity of each batch of the starting material,
Slovenian: Treba je podati kratek opis o preskusih, ki se opravljajo za določanje čistoste vsake posamezne serije vhodne snovi,
English: any special precautions which may be necessary during storage of the starting material and, if necessary, its storage life shall be given.
Slovenian: vse možne posebne previdnostne ukrepe med shranjevanjem vhodne snovi in po potrebi rok uporabnosti.
English: SPECIFIC MEASURES CONCERNING THE PREVENTION OF THE TRANSMISSION OF ANIMAL SPONGIFORM ENCEPHALOPATHIES
Slovenian: POSEBNI UKREPI ZA PREPREČEVANJE PRENOSA ŽIVALSKE SPONGIFORMNE ENCEFALOPATIJE
English: The applicant must demonstrate that the veterinary medical product is manufactured in accordance with the Note for Guidance on minimising the risk of transmitting animal spongiform encephalopathy agents via veterinary medicinal products and its updates, published by the European Commission in Volume 7 of its publication "The rules governing medicinal products in the European Community".
Slovenian: Predlagatelj mora dokazati, da se zdravilo za uporabo v veterinarski medicini izdeluje v skladu z Navodili za zmanjšanje tveganja prenosa povzročiteljev živalske spongiformne encefalopatije z zdravili za uporabo v veterinarski medicini in z dopolnili navodil, ki jih je objavila Evropska skupnost v zvezku 7 publikacije "Pravil, ki urejajo zdravila v Evropski skupnosti".
English: CONTROL TESTS DURING PRODUCTION
Slovenian: KONTROLNI PRESKUSI NA VMESNIH FAZAH POSTOPKA IZDELAVE
English: The particulars and documents accompanying an application for marketing authorization, pursuant to Article 12(3)(i) and (j) and Article 13(1), shall include particulars relating to the control tests which are carried out on intermediate products with a view to verifying the consistency of the production process and the final product.
Slovenian: Podrobni podatki ter dokumentacija, ki spremlja vlogo za pridobitev dovoljenja za promet z zdravilom, v skladu z členom 12(3)(i) ter (j) in členom 13(1) mora vključevati podrobne podatke, ki se nanašajo na kontrolne preskuse, ki se izvajajo v vmesni fazi postopka izdelave zato, da se zagotovi konsistentnost procesa izdelave in končnega izdelka.
English: For inactivated or detoxified vaccines, inactivation or detoxification shall be tested during each production run immediately after the inactivation or detoxification process.
Slovenian: Pri inaktiviranih ali detoksificiranih cepivih, je treba inaktivacijo ali detoksifikacijo preskusiti med vsakim procesom izdelave, ki neposredno sledi procesu inaktivacije ali detoksifikacije.
English: The particulars and documents accompanying the application for marketing authorization pursuant to Article 12(3)(i) and (j) and Article 13(1), shall include particulars relating to control tests on the finished product.
Slovenian: Podrobni podatki ter dokumentacija, ki spremlja vlogo za pridobitev dovoljenja za promet z zdravilom v skladu s členom 13(3)(i) ter (j) in členom 13(1), mora vsebovati podrobne podatke, ki se nanašajo na preskuse končnega izdelka.
English: Where appropriate monographs exist, if test procedures and limits other than those mentioned in the monographs of the European Pharmacopoeia, or failing this, in the national pharmacopoeia of a Member State, are used, proof must be supplied that the finished product would, if tested in accordance with those monographs, meet the quality requirements of that pharmacopoeia for the pharmaceutical form concerned.
Slovenian: V primerih, kjer obstajajo ustrezne monografije, in če se uporabljajo postopki preskušanja ter mejne vrednosti, ki so drugačne od tistih, ki jih navaja monografija Evropske farmakopeje, ali v odsotnosti le-te, nacionalna farmakopeja države članice, je treba predložiti dokaz, da bi končni izdelek, če bi se preskus izvajal v skladu s temi monografijami, lahko ustrezal farmakopejskim zahtevam za zadevno farmacevtsko obliko.
English: The application for marketing authorization shall list those tests which are carried out on representative samples of each batch of finished product.
Slovenian: Vloga za pridobitev dovoljenja za promet mora vsebovati seznam preskusov, ki se izvajajo na reprezentativnih vzorcih za vsako serijo končnega izdelka.
English: The frequency of the tests which are not carried out on each batch shall be stated.
Slovenian: Treba je navesti pogostost preskusov, ki se ne izvajajo na vsaki seriji.
English: Release limits shall be indicated.
Slovenian: Navesti je treba meje za sproščanje.
English: Certain tests of the general characteristics of a product shall be included among the tests on the finished product, even if they have been carried out in the course of the manufacturing process.
Slovenian: Nekateri preskusi splošnih lastnosti izdelka morajo biti priloženi med preskuse končnega izdelka, tudi če so bili izvedeni med procesom izdelave.
English: These tests shall, wherever applicable, relate to the control of average masses and maximum deviations, to mechanical, physical, chemical or microbiological tests, physical characteristics such as density, pH, refractive index, etc. For each of these characteristics, specifications, with appropriate confidence limits, shall be established by the applicant in each particular case.
Slovenian: Ti preskusi se morajo, kjer koli to ustreza, nanašati na preskus enakomernosti mase in najvišja dovoljena odstopanja, na mehanske, fizikalne, kemijske ali mikrobiološke preskuse, fizikalne lastnosti kot so gostota, pH, lomni količnik itd. Za vsako od teh lastnosti mora predlagatelj za vsak primer posebej določiti specifikacije in meje odstopanja.
English: For all tests, the description of the techniques for analyzing the finished product shall be set out in sufficiently precise detail, so that they can be reproduced readily.
Slovenian: Za vse preskuse je treba pripraviti dovolj podrobne opise metod preskušanja končnega izdelka, tako da jih je mogoče takoj ponoviti.
English: The assay of biological activity of the active substance(s) shall be carried out either in a representative sample from the production batch or in a number of dosage-units analysed individually.
Slovenian: Preskus biološke aktivnosti zdravilne(ih) učinkovin(e) je treba izvesti bodisi na povprečnem reprezentativnem vzorcu proizvodne serije, ali pa na več odmernih enotah, ki se analizirajo posamično.
English: Where necessary, a specific test for identification shall also be carried out.
Slovenian: Kjer je to potrebno, je treba izvesti specifičen preskus identifikacije.
English: In certain exceptional cases where assay of active substances which are very numerous or present in very low amounts would necessitate an intricate investigation difficult to carry out in respect of each production batch, the assay of one or more active substances in the finished product may be omitted, on the express condition that such assays are made at intermediate stages as late as possible in the production process.
Slovenian: V nekaterih izjemnih primerih, kjer zaradi vsebnosti številnih zdravilnih učinkovin ali pa zaradi zelo nizkih vsebnosti potrebna zapletena raziskava, težko izvedljiva v vsaki proizvodni seriji, se določanje vsebnosti ene ali več bi preskušanje zdravilnih učinkovin v končnem izdelku lahko opusti, pod izrecnim pogojem, da se določanja vsebnosti izvedejo v vmesnih fazah postopka izdelave.
English: This relaxation may not be extended to the characterization of the substances concerned.
Slovenian: Opuščanje pa se ne sme razširiti na opredelitev zadevnih učinkovin.
English: This simplified technique shall be supplemented by a method of quantitative evaluation, enabling the competent authority to verify that the immunological veterinary medicinal product is in accordance with its formula after it has been placed on the market.
Slovenian: Ta poenostavljen način je treba dopolniti z metodo količinskega vrednotenja, ki pristojnemu organu omogoči, da preverjanje skladnosti imunološkega zdravilo za uporabo v veterinarski medicini s specifikacijo potem, ko je že bilo dano v promet.
English: Identification and assay of adjuvants
Slovenian: Identifikacija ter določanje vsebnosti dodatkov
English: In so far as testing procedures are available, the quantity and nature of the adjuvant and its components shall be verified on the finished product.
Slovenian: Če so postopki preskušanja na voljo, je treba količino in lastnosti dodatkov ter njihovih sestavin preskusiti na končnem proizvodu.
English: In so far as is necessary, the excipient(s) shall be subject at least to identification tests.
Slovenian: Če je treba, je treba za pomožne snovi opraviti najmanj preskus identifikacije.
English: The test procedure proposed for identifying colouring matters must enable a verification to be made that such matters are permitted under Directive 78/25/EEC.
Slovenian: Predlagani postopek za identifikacijo barvil mora omogočati, da se preveri ali so barvila dovoljena v skladu z Direktivo 78/25/EGS.
English: An upper and lower limit test shall be obligatory in respect of preserving agents;
Slovenian: Obvezen je preskus za določitev zgornje in spodnje mejne vrednosti za konzervansih;
English: an upper limit test for any other excipient components liable to give rise to an adverse reaction shall be obligatory.
Slovenian: obvezen je preskus zgornje meje za katero koli drugo pomožno snov, ki bi utegnila povzročiti škodljive učinke.
English: Apart from the results of tests submitted in accordance with Part 7 of this Annex, particulars of safety tests shall be submitted.
Slovenian: Poleg rezultatov preskusov, ki jih je treba predložiti v skladu z delom 7 te priloge, je treba predložiti podrobne podatke o preskusih varnosti.
English: These tests shall preferably be overdosage studies carried out in at least one of the most sensitive target species and by at least the recommended route of administration posing the greatest risk.
Slovenian: Prednostno so to študije o prevelikem odmerjanju, ki jih je treba opraviti na najmanj eni od najbolj občutljivih ciljnih živalskih vrst ter vsaj na tisti priporočeni način dajanja zdravila, ki predstavlja največje tveganje.
English: Sterility and purity test
Slovenian: Preskus sterilnosti in čistote
English: Appropriate tests to demonstrate the absence of contamination by adventitious agents or other substances shall be carried out according to the nature of the immunological veterinary medicinal product, the method and the conditions of manufacture.
Slovenian: Treba je opraviti ustrezne preskuse, da se dokaže odsotnost kontaminacije z naključnimi snovmi ali drugimi snovmi, glede na naravo imunološkega zdravila za uporabo v veterinarski medicini ter metode in pogoje izdelave.
English: Inactivation
Slovenian: Inaktivacija
English: Where applicable, a test to verify inactivation shall be carried out on the product in the final container.
Slovenian: Kjer to ustreza, je treba na izdelku v končnem vsebniku izvesti preskus preverjanja inaktivacije.
English: Residual humidity
Slovenian: Rezidualna vlaga
English: Each batch of lyophilised product shall be tested for residual humidity.
Slovenian: Vsaka serija lipofiliziranega proizvoda mora biti preskušena na rezidualno vlago.
English: Batch-to-batch consistency
Slovenian: Konsistentnost med serijami
English: In order to ensure that efficacy of the product is reproducible from batch to batch and to demonstrate conformity with specifications, potency tests based upon in vitro or in vivo methods, including appropriate reference materials whenever available, shall be carried out on each final bulk or each batch of finished product, with appropriate confidence limits;
Slovenian: Da se zagotovi, da je učinkovitost proizvoda ponovljiva med serijami in da se dokaže skladnosti s specifikacijami, je treba na vsaki končni količini ali vsaki seriji končnega proizvoda izvesti in vitro ter in vivo preskus potence, z ustreznimi mejami zaupanja, vključno z ustreznimi referenčnimi snovmi, kadar so te na voljo;
English: in exceptional circumstances, potency testing may be carried out at an intermediate stage, as late as possible in the production process.
Slovenian: v izjemnih okoliščinah, se lahko preskus potence izvede v vmesni fazi postopka izdelave, čim pozneje v postopku izdelave.
English: STABILITY TESTS
Slovenian: TESTI STABILNOSTI
English: The particulars and documents accompanying the application for marketing authorization pursuant to Article 12(3)(f) and (i) shall be submitted in accordance with the following requirements.
Slovenian: Podrobni podatki in dokumentacija, ki spremlja vlogo za pridobitev dovoljenja za promet z zdravilom v skladu s členom 12(3)(f) ter (i) mora biti predložena v skladu z naslednjimi zahtevami.
English: A description shall be given of the tests undertaken to support the shelf life proposed by the applicant.
Slovenian: Treba je podati opis preskusov glede predlagana roka uporabnosti.
English: These tests shall always be real-time studies;
Slovenian: Ti preskusi morajo biti obvezno študije v dejanskem času;
English: they shall be carried out on a sufficient number of batches produced according to the described production process and on products stored in the final container(s);
Slovenian: izvedene morajo biti na zadostnem številu serij, izdelanih v skladu z opisanim postopkom izdelave ter na izdelkih, ki so shranjeni v končnih vsebnikih.
English: these tests include biological and physico-chemical stability tests.
Slovenian: Ti preskusi morajo vključevati preskuse biološke in fizikalno-kemijske stabilnosti.
English: The conclusions shall contain the results of analyses, justifying the proposed shelf-life under all proposed storage conditions.
Slovenian: Sklepne ugotovitve morajo vsebovati rezultate preskušanj, ki opravičujejo predlagani rok uporabnosti pod vsemi predlaganimi pogoji shranjevanja.
English: In the case of products administered in the feed, information shall also be given as necessary on the shelf-life of the product, at the different stages of mixing, when mixed in accordance with the recommended instructions.
Slovenian: V primerih, ko se zdravila dajejo pomešana med hrano, je treba po potrebi podati informacijo o roku uporabnosti izdelka v različnih fazah mešanja, kadar se vmešavajo v skladu s priporočenimi navodili.
English: Where a finished product requires reconstitution prior to administration, details of the proposed shelf-life are required for the product reconstituted as recommended.
Slovenian: Če končni izdelek pred uporabo zahteva rekonstitucijo, so potrebni podatki o predlaganem roku uporabnosti za izdelek, rekonstituiran v skladu s priporočili.
English: Data in support of the proposed shelf-life for the reconstituted product shall be submitted.
Slovenian: Treba je predložiti podatke, ki podpirajo predlagani rok uporabnosti za rekonstituirani izdelek.
English: PART 7
Slovenian: DEL 7
English: Safety testing
Slovenian: Preskušanje varnosti
English: The safety tests shall show the potential risks from the immunological veterinary medicinal product which may occur under the proposed conditions of use in animals:
Slovenian: Preskusi varnostni morajo prikazati možna tveganja zaradi imunološkega zdravila za uporabo v veterinarski medicini, do katerih lahko pride pod predlaganimi pogoji uporabe pri živalih:
English: these shall be evaluated in relation to the potential benefits of the product.
Slovenian: tveganja je treba ovrednotiti glede na možne koristi zdravila.