FrancophonIA/DGT-Translation_Memory huggingface dataset:
English: An explanation shall be provided with regard to the choice of composition, constituents, immediate packaging, possible further packaging, outer packaging if relevant, the intended function of the excipients in the finished product and the method of manufacture of the finished product. This explanation shall be supported by scientific data on development pharmaceutics.
French: Le choix de la composition, des composants, du conditionnement primaire, d’un éventuel conditionnement supplémentaire et de l’emballage extérieur le cas échéant, de même que la fonction prévue des excipients dans le produit fini et le mode de fabrication du produit fini doivent être expliqués et justifiés par des données scientifiques relatives au développement galénique.
English: Documentation shall be supplied to demonstrate that the seed materials, cell seeds, batches of serum and other material originating from animal species relevant for the transmission of TSE comply with the Note for Guidance on minimising the risk of transmitting animal spongiform encephalopathy agents via human and veterinary medicinal products [12], as well as with the corresponding monograph of the European Pharmacopoeia. Certificates of Suitability issued by the European Directorate for the Quality of Medicines and HealthCare, with reference to the relevant monograph of the European Pharmacopoeia, may be used to demonstrate compliance.
Hungarian: Dokumentációt kell benyújtani annak bizonyítása érdekében, hogy az alaptenyészetek, sejtbankok, szérumtételek és a szivacsos agyvelőbántalom (TSE) átvitele tekintetében releváns állatfajoktól származó, egyéb anyagok megfelelnek a TSE emberi felhasználásra szánt és állatgyógyászati készítményeken keresztül történő átvitele kockázatának minimálisra csökkentéséről szóló iránymutatásra vonatkozó feljegyzésnek (»Note for guidance on minimising the risk of transmitting animal spongiform encephalopathy agents via human and veterinary medicinal products«) [12], valamint az Európai Gyógyszerkönyv megfelelő monográfiájának.
English: 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. All other part(s) are in accordance with the structure described in Part I of Title I of this Annex.
Hungarian: A vegyes forgalombahozatali engedély iránti kérelmek alatt olyan kérelmek értendők, ahol a dokumentáció 3. és/vagy 4. része a kérelmező által végzett biztonságossági és hatékonysági vizsgálatokból és a szakirodalmi hivatkozásokból áll. Minden egyéb rész megfelel az e melléklet I. részében ismertetett felépítésnek.
English: Information on the quality and control of those materials shall be provided. Information demonstrating that materials meet standards which are appropriate for their intended use shall be provided.
Italian: È opportuno fornire informazioni sulla qualità e sul controllo di tali materie, nonché informazioni a dimostrazione che le materie soddisfano le norme adeguate per l'utilizzazione prevista.
Portuguese: Devem ser fornecidas informações sobre a qualidade e o controlo dessas matérias, bem como informações que demonstrem que as matérias satisfazem os padrões adequados para o uso a que se destinam.
English: The maximum dose should normally be selected so as to bring harmful effects to light. The lowest dose level should not produce any evidence of toxicity.
Italian: È utile in genere che la dose più alta sia scelta in modo da far comparire effetti tossici; il dosaggio minimo non dovrebbe produrre alcun segno di tossicità.
English: These include effects on male and female fertility, mating, conception, implantation, ability to maintain pregnancy to term, parturition, lactation, survival, growth and development of the offspring from birth through to weaning, sexual maturity and the subsequent reproductive function of the offspring as adults. At least three dose levels shall be used.
Italian: Tali effetti riguardano la fertilità maschile e femminile, l'accoppiamento, la concezione, l'impianto, la capacità di portare a termine una gravidanza, il parto, l'allattamento, la sopravvivenza, la crescita e lo sviluppo della progenie dalla nascita allo svezzamento, la maturità sessuale e la funzione riproduttiva ulteriore della progenie in età adulta Si devono impiegare almeno tre livelli di dose.
English: The maximum dose should be selected so as to bring harmful effects to light. The lowest dose level should not produce any evidence of toxicity.
Italian: È utile che la dose più alta sia scelta in modo da far comparire effetti tossici; il dosaggio minimo non dovrebbe produrre alcun segno di tossicità.
English: The pathways for the excretion of the product from the target animal shall be described. The major metabolites shall be identified and characterised.
Italian: Si devono inoltre descrivere le vie di escrezione del prodotto dall'animale di destinazione e si devono identificare e caratterizzare i principali metaboliti.
English: details of the source of the materials, details of any processing, purification and inactivation applied, with data on the validation of these process and controls during production,
Italian: descrizione dettagliata di qualsiasi trattamento, purificazione e inattivazione applicati accompagnata da dati circa la convalida dei processi utilizzati e dei controlli durante la fabbricazione,
English: A description shall be given of the tests undertaken to support the shelf life proposed by the applicant. These tests shall always be real-time studies; 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); these tests include biological and physico-chemical stability tests.
Italian: Il richiedente deve descrivere le prove che hanno permesso di determinare il periodo di validità proposto; tali prove devono essere sempre studi in tempo reale e devono, inoltre, riguardare un numero sufficiente di lotti prodotti secondo il processo di fabbricazione descritto nonché su prodotti conservati nel/nei recipiente/i finale/i; tali studi comprendono prove di stabilità biologica e fisico-chimica.
English: Reproductive performance of males and non-pregnant and pregnant females shall be investigated with the recommended dose and by the most sensitive route of administration. In addition, harmful effects on the progeny, as well as teratogenic and abortifacient effects, shall be investigated.
Italian: In tal caso va esaminata la resa riproduttiva dei maschi e delle femmine non gravide e gravide, alla dose raccomandata e per la via di somministrazione più adatta; dovranno inoltre essere studiati gli effetti nocivi sulla prole nonché gli effetti teratogenici e abortivi.
English: If there is a compatibility statement with other veterinary immunological products in the summary of product characteristics the safety of the association shall be investigated. Any other known interactions with veterinary medicinal products shall be described.
Italian: Ove esista una dichiarazione di compatibilità con altri medicinali veterinari ad azione immunologica nel riassunto delle caratteristiche del prodotto, occorre esaminare l'innocuità dell'associazione e descrivere eventuali interazioni conosciute con medicinali veterinari.
English: If there is a compatibility statement with other immunological products in the summary of product characteristics, the efficacy of the association shall be investigated. Any other known interactions with any other veterinary medicinal products shall be described.
Italian: Ove esista una dichiarazione di compatibilità con altri medicinali ad azione immunologica nel riassunto delle caratteristiche del prodotto, occorre esaminare l'efficacia dell'associazione e descrivere qualsiasi altra interazione conosciuta con altri medicinali veterinari.
English: all general and individual observations and results obtained (with averages and standard deviations), whether favourable or unfavourable. The data shall be described in sufficient detail to allow the results to be critically evaluated independently of their interpretation by the author. The raw data shall be presented in tabular form. By way of explanation and illustration, the results may be accompanied by reproductions of recordings, photomicrographs, etc;
Italian: tutte le osservazioni collettive ed individuali e tutti i risultati ottenuti, favorevoli o sfavorevoli (con relativi scarti medi e deviazioni standard); i valori dovrebbero essere forniti in modo dettagliato al fine di permettere una valutazione critica dei risultati stessi, indipendentemente dall'interpretazione datane dall'autore; i dati originali dovranno essere presentati sotto forma di tabella; a scopo illustrativo i risultati potranno essere corredati di registrazioni, microfotografie, ecc.;
English: the constituent(s) of the excipients, whatever their nature or the quantity used, including preservatives, stabilisers, emulsifiers, colouring matter, flavouring, aromatic substances, markers, etc., the constituents of the pharmaceutical form administered to animals.
Lithuanian: pagalbinių medžiagų, nepaisant jų kilmės ir naudojamo kiekio, sudedamoji (-osios) dalis (-ys), įskaitant konservantus, stabilizatorius, emulsiklius, dažiklius, skonį ir kvapą suteikiančias medžiagas, žymenis ir kt.,
English: All documentation, both favourable and unfavourable, shall be communicated. With respect to the provisions on well-established veterinary use, it is in particular necessary to clarify that bibliographic reference to other sources of evidence (post-marketing studies, epidemiological studies etc.) and not just data related to tests and trials may serve as a valid proof of safety and efficacy of a product if an application explains and justifies the use of these sources of information satisfactorily.
Latvian: Dara zināmu visu dokumentāciju neatkarīgi no tā, vai tā ir zālēm labvēlīga vai nelabvēlīga; Attiecībā uz noteikumiem par “plašu lietošanu veterinārajā praksē” jo īpaši ir jāprecizē, ka bibliogrāfiskā atsauce uz citiem pierādījumu avotiem (pētījumi pēc laišanas tirgū, epidemioloģiskie pētījumi utt.) un nevis tikai uz datiem, kas saistīti ar testiem un izpēti, var būt derīgs preparāta drošuma un iedarbīguma apliecinājums, ja pieteikumā šo informācijas avotu izmantošana ir pietiekami paskaidrota un pamatota.
English: For particular groups of substances or if the effects observed during repeated dose studies in animals include changes indicative of e.g. immunotoxicity, neurotoxicity- or, endocrine dysfunction, further testing shall be required, e.g. sensitisation studies or delayed neurotoxicity tests. Depending on the nature of the product, it may be necessary to conduct additional studies to assess the underlying mechanism of the toxic effect or the irritation potential.
Maltese: Għal gruppi partikolari ta’ sustanzi jew jekk l-effetti osservati matul studji ta’ dożi ripetuti fuq l-annimali jinkludu bidliet indikattivi ta’ pereżempju l-immunotossiċità, in-newrotossiċità jew, disfunzjoni endokrinali, ikunu meħtieġ aktar ittestjar, pereżempju studji dwar is-sensitizzazzjoni jew testijiet differiti ta’ newrotossiċità Skont in-natura tal-prodott, jista’ jkun meħtieġ li jsiru studji addizzjonali biex jiġi vvalutat il-mekkaniżmu tal-effett tossiku jew il-potenzjal ta’ irritazzjoni.
English: The first phase of the assessment shall always be performed. The details of the assessment shall be provided in accordance with accepted guidance.
Polish: Pierwsza faza oceny jest przeprowadzana zawsze; szczegółowe informacje o ocenie podawane są zgodnie z przyjętymi wytycznymi.
English: The frequency of the tests which are not carried out routinely shall be stated. Release limits shall be indicated.
Portuguese: Deve indicar-se a frequência dos testes não efectuados por rotina, bem como os limites para a aprovação.
English: The purpose of these studies is to characterise signs of intolerance and to establish an adequate margin of safety using the recommended route(s) of administration. This may be achieved by increasing the therapeutic dose and/or the duration of treatment.
Portuguese: Estes estudos têm como objectivo caracterizar os sinais de intolerância e estabelecer uma margem de segurança adequada para a(s) via(s) de administração recomenda(s), o que pode ser conseguido aumentando a dose terapêutica e/ou a duração do tratamento.
English: The application for marketing authorisation shall list those tests, which are carried out on representative samples of each batch of finished product. The frequency of the tests, which are not carried out on each batch, shall be stated.
Portuguese: O pedido de autorização de introdução no mercado deve especificar os testes efectuados em amostras representativas de cada lote de produto acabado e indicar a frequência dos testes não efectuados em cada lote.
English: The general quality requirements shall apply to the homeopathic finished veterinary medicinal products. Any exception shall be duly justified by the applicant.
Portuguese: O requisitos gerais de qualidade aplicam-se aos medicamentos veterinários homeopáticos acabados, devendo qualquer excepção ser devidamente justificada pelo requerente.
English: Reversion to virulence shall be investigated with the master seed. If the master seed is not available in sufficient quantity the lowest passage seed used for the production shall be examined.
Swedish: Om ursprungsmaterialet inte är tillgängligt i den mängd som krävs ska man undersöka det ympmaterial som undergått minst antal passager och som används vid tillverkning.
Slovenian: Če matična kultura ni na voljo v zadostni količini, se pregleda matična snov iz najnižje ravni prenosa, ki se uporablja pri izdelavi.
English: Constituents fulfilling the requirements of the European Pharmacopoeia or the pharmacopoeia of one of the Member States shall be deemed to comply sufficiently with Article 12(3)(i). In this case the description of the analytical methods may be replaced by a detailed reference to the pharmacopoeia in question.
Swedish: Beståndsdelar som uppfyller kraven i Europeiska farmakopén eller farmakopén i någon medlemsstat ska anses uppfylla kraven i artikel 12.3 i. I sådana fall får beskrivningen av analysmetoderna ersättas med en utförlig hänvisning till aktuell farmakopé.