FrancophonIA/DGT-Translation_Memory huggingface dataset:
English: A special attention shall be paid to the following items: a) Information shall be provided on the relevant characteristics of the gene therapy medicinal product including its expression in the target cell population.
Hungarian: Külön figyelmet kell szentelni az alábbiaknak: a) Információt kell szolgáltatni a génterápiás gyógyszer releváns jellemzőiről, a célzott sejtpopulációbeli expresszióját is beleértve.
English: the potential toxicity of the product and any dangerous or undesirable toxic effects that may occur under the proposed conditions of use in human beings;
Portuguese: a toxicidade potencial do produto, bem como, quaisquer eventuais efeitos tóxicos perigosos ou indesejáveis nas condições de utilização previstas no homem;
Finnish: tuotteen toksisuusrajat ja kaikki mahdolliset vaaralliset vaikutukset tai haittavaikutukset, jotka voivat esiintyä esitetyissä käyttöolosuhteissa ihmisillä;
Greek: τη δυνητική τοξικότητα του προϊόντος και οποιονδήποτε επικίνδυνων ή ανεπιθύμητων τοξικών αποτελεσμάτων που ενδέχεται να εμφανιστούν υπό τις προτεινόμενες συνθήκες χρήσης σε ανθρώπους·
Czech: možnou toxicitu přípravku a jakékoliv nebezpečné nebo nežádoucí toxické účinky, které se mohou objevit při navržených podmínkách použití u lidí;
Slovak: potenciálnu toxicitu výrobku a jeho všetky nebezpečné alebo nežiadúce toxické účinky, ktoré sa môžu vyskytnúť u ľudí pri navrhovaných podmienkach použitia;
Polish: potencjalną toksyczność produktu leczniczego oraz każdy niebezpieczny lub niepożądany skutek, który może wystąpić w przypadku stosowania u ludzi przy zastosowaniu proponowanych warunków;
Slovenian: morebitno toksičnost zdravila in vse nevarne ali neželene toksične učinke, ki lahko nastopijo v predlaganih pogojih uporabe pri ljudeh;
Romanian: toxicitatea potențială a produsului și orice efecte toxice periculoase sau nedorite care pot apărea la oameni în condițiile propuse de utilizare;
Bulgarian: потенциалната токсичност на продукта и всякакви опасни и нежелателни токсични въздействия, които могат да възникнат в предложените условия на приложение при хора;
Estonian: preparaadi võimalikku mürgisust ning selle mis tahes ohtlikku või soovimatut toksilist toimet, mis võib ilmneda inimtervishoius kasutamiseks kavandatud tingimustes;
Latvian: zāļu potenciālā toksicitāte un jebkura bīstamā vai nevēlamā toksiskā iedarbība, kas var rasties, cilvēkiem tās lietojot saskaņā ar ieteiktajiem nosacījumiem;
Lithuanian: galimą vaisto toksiškumą ir bet kokį kitokį pavojingą arba nepageidaujamą toksišką poveikį, kuris gali atsirasti tam tikromis sąlygomis, kai vaistą vartoja žmonės;
Maltese: it-tossiċità potenzjali tal-prodott u kwalunkwe effetti tossiċi perikolużi jew mhux mixtieqa li jistgħu iseħħu taħt il-kondizzjonijiet proposti ta’ użu fi bnedmin;
English: Subject's medical files should be retained in accordance with applicable legislation and in accordance with the maximum period of time permitted by the hospital, institution or private practice. The documents can be retained for a longer period, however, if required by the applicable regulatory requirements or by agreement with the sponsor.
Bulgarian: Медицинските документации на субекта следва да се задържат съгласно приложимото законодателство и в съответствие с максималния период от време, разрешен от болничното заведение, институция или частно здравно заведение.
English: For radio-nuclides, the nuclear reactions involved shall be discussed. In a generator, both mother and daughter radio-nuclides shall be considered as active substances.
Bulgarian: В генератора за активни вещества се считат както първичните радионуклиди, така и вторичните радионуклиди.
English: Tissues, organs or biological fluids from which cells are derived as well as the autologous, allogeneic, or xenogeneic nature of the donation and its geographical origin shall be documented. Collection of the cells, sampling and storage prior further processing shall be detailed.
Bulgarian: Документират се тъканите, органите и биологичните вещества, от които идват клетките, както и автологичният, алогенният или ксеногенният характер на материала от донора, както и географският му произход.
English: Non-clinical (pharmaco-toxicological) studies shall be carried out in conformity with the provisions related to Good Laboratory Practice laid down in Council Directives 87/18/EEC on the harmonisation of regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their application for tests in chemical substances(4) and 88/320/EEC on the inspection and verification of good laboratory practice (GLP).
Romanian: Studiile (toxico-farmacologice) non-clinice se realizează în conformitate cu dispozițiile referitoare la buna practică de laborator stabilite de Directiva 87/18/CEE a Consiliului privind armonizarea actelor cu putere de lege și a actelor administrative cu privire la aplicarea principiilor bunelor practici de laborator și verificarea aplicării acestora la testele efectuate asupra substanțelor chimice și de Directiva 88/320/CEE a Consiliului privind inspecția și verificarea bunei practici de laborator (BPL).
English: Medicinal products containing or using in the manufacturing process materials of animal and/or human origin (TSE procedure) -
Romanian: Produsele medicamentoase care conțin sau utilizează în procesul de fabricație materiale de origine animală și/sau umană (procedură EST)
English: Reports of Post-marketing Experience - Literature references
Romanian: Rapoartele experienței după introducerea pe piață
English: Genetically modified animals (methods of creation, characterisation of transgenic cells, nature of the inserted or excised (knock out) gene) -
Romanian: Animalele modificate genetic [metode de creare, caracterizarea celulelor transgenice, natura genei inserate sau a genei excizate (doborâte)]
English: Measures to prevent and monitor infections in the source/donor animals -
Romanian: Măsurile de prevenire și monitorizare a infecțiilor la animalele sursă/donatoare
English: Testing for infectious agents -
Romanian: Testarea în vederea decelării agenților infecțioși
English: Facilities -
Romanian: Dotarea
English: Control of starting and raw materials -
Romanian: Controlul materialelor de bază și al materiilor prime
English: In order to simplify the existing procedures for the assessment of such vaccines, both for the granting of a first marketing authorisation and for subsequent changes to it due to modifications to the manufacturing process and testing of individual antigens involved in combined vaccines, a new system based on the concept of a vaccine antigen master file (VAMF) should be introduced. This VAMF will allow the pooling of national expertise, and through the coordination by the EMEA, a single evaluation of the concerned vaccine antigen. The VAMF should serve as a stand-alone part of the marketing authorisation dossier and provide all relevant information of a biological and chemical nature related to one specific antigen, which constitutes one of the active substances of one or several combined vaccines.
Maltese: Sabiex jiġu simplifikati l-proċeduri eżistenti għall-istima ta’ dawn it-tilqimiet, kemm biex tingħata l-ewwel awtorizzazzjoni għal tqegħid fis-suq kif ukoll għal bidliet sussegwenti għaliha dovuti għal modifiki ghall-proċess ta’ fabbrikazzjoni u t-testing ta’ antiġeni individwali involuti f’tilqimiet kombinati, sistema ġdida bbażata fuq il-kunċett ta’ master file ta’ antiġenu ta’ tilqima, il-VAMF għandu jservi bħala parti singolari tad-dossier ta’ awtorizzazzjoni għat-tqegħid fis-suq li jipprovdi l-informazzjoni rilevanti kollha ta’ natura bijoloġika u kimika relatata għal antiġenu speċifiku wieħed, li jikkostitwixxi waħda mis-sustanzi attivi ta’ tilqima waħda jew diversi kkombinati.
English: A brief overview of the clinical findings, including important limitations as well as an evaluation of benefits and risks based on the conclusions of the clinical studies shall be provided. An interpretation of the way the efficacy and safety findings support the proposed dose and target indications and an evaluation of how the summary of product characteristics and other approaches will optimise the benefits and manage the risks is required.
Maltese: Idea ġenerali fil-qosor tar-riżultati kliniċi, inklużi limitazzjonijiet importanti kif ukoll valutazzjoni ta’ benefiċċji u riskji bbażati fuq il-konklużjonijiet ta’ l-istudji kliniċi għandhom jiġu pprovduti, Interpretazzjoni tal-mod li bih l-effikaċja u r-riżultati ta’ sigurtà jappoġġaw id-doża proposta u l-indikazzjonjiet mira u valutazzjoni ta’ kif il-ġabra fil-qosor tal-karatteristiċi tal-prodott u approċċi oħra jottimizzaw il-benefiċċji u jamministraw ir-riskji meħtieġa.
English: Reports of human pharmaco-kinetic studies a) The following pharmaco-kinetic characteristics shall be described:
Maltese: Rapporti ta’ studji umani farmako kinetiċi (a) Il-karatteristiċi farmako kinetiċi li ġejjin għandhom jiġudeskritti:
English: absorption (rate and extent), - distribution, - metabolism, - excretion.
Maltese: assorbiment (rata u limitu), - distribuzzjoni, - metaboliżmu, - excretion.
English: Study Reports of Controlled Clinical Studies Pertinent to the Claimed Indication In general, clinical trials shall be done as "controlled clinical trials" if possible, randomised and as appropriate versus placebo and versus an established medicinal product of proven therapeutic value; any other design shall be justified.
Maltese: Rapporti ta’ studju ta’ Studji Kliniċi Kkonstrollati Pertinenti għall-Indikazzjoni Dikjarata In ġenerali, provi kliniċi għandhom isiru bħala "provi kliniċi kkontrollati" jekk possibbli, saltwarji u approprjati versus il-plaċebo u versus prodott mediċinali stabbilit ta’ valur terapewtiku ippruvat; kwalunkwe diċinn ieħor għandu jiġi ġustifikat.
English: Reports of post-marketing experience If the medicinal product is already authorised in third countries, information shall be given in respect of adverse reactions of the medicinal product concerned and medicinal products containing the same active substance(s), in relation to the usage rates if possible.
Maltese: Rapporti ta’ esperjenza post tqegħid fis-suq Fil-każ li l-prodott mediċinali huwa diġà awtorizzat f’pajjiżi terzi, għandha tingħata informazzjoni fir-rigward ta’ reazzjonijiet kuntrarji tal-prodott mediċinali kkonċernat u prodotti mediċinali li jikkontjenu l-istess sustanza(i) attiva(i), fir-rigward tar-rati ta’ użu jekk possibbli.
English: Case reports forms and individual patient listings When submitted in accordance with the relevant Guideline published by the Agency, case report forms and individual patient data listings shall be provided and presented in the same order as the clinical study reports and indexed by study.
Maltese: Formoli ta’ rapporti ta’ każijiet u elenki ta’ pazjenti individwali Meta sottomessi skond il-Linja gwida rilevanti ppubblikata mill-Aġenzija, formoli ta’ rapporti ta’ każijiet u elenki ta’ data ta’ pazjenti individwali għandhom jiġu pprovduti u ppreżentati fl-istess ordni bħal rapporti ta’ studju kliniku u indikati skond l-istudju.
English: PART II SPECIFIC MARKETING AUTHORISATION DOSSIERS AND REQUIREMENTS
Maltese: PARTI II DOSSIERS U ĦTIĠIET SPEĊIFIĊI TA’ AWTORIZZAZZJONI GĦAL TQEGĦID FIS-SUQ
English: an update of published literature relevant to the substance and the present application. It may be acceptable for articles in "peer review" journals to be annotated for this purpose;
Maltese: aġġornament ta’ litteratura ppubblikata rilevanti għas-sustanza u għall-applikazzjoni preżenti. Jista’ jkun aċċettabbli għal artikoli f’ġurnali ta’ "reviżjoni tal-pari" li jiġu annotati għal dan l-iskop;
English: The evaluation of the viral safety as well as the traceability of the products from the donor to the finished medicinal product, are an essential part of the documentation to be supplied. E.g., the presence of replication competent virus in stocks of non-replication competent viral vectors must be excluded.
Lithuanian: Būtinai pateikiami dokumentai, rodantys saugumo nuo virusų įvertinimą ir vaisto atsekamumą nuo donoro iki gatavo vaisto, t. y. turi būti išvengta replikacinio viruso patekimo į nereplikacinių virusinių vektorių koloniją.
Maltese: Il-valutazzjoni tas-sigurtà virali kif ukoll l-intraċċabilità tal-prodotti mid-donatur għall-prodott mediċinali lest, huma parti essenzjali mid-dokumentazzjoni li għandha tiġi fornita, eż. il-preżenza ta’ viru kompetenti ta’ replikazzjoni fi stokkijiet ta’ vetturi virali kompetenti mhux ta’ replikazzjoni għandha tiġi eskluża.