FrancophonIA/DGT-Translation_Memory huggingface dataset:
English: When issuing such certificates Member States shall comply with the following conditions: (a) they shall have regard to the prevailing administrative arrangements of the World Health Organization;
Hungarian: Az igazolások kiállításakor a tagállamok betartják a következő feltételeket: a) figyelembe veszik az Egészségügyi Világszervezet érvényes közigazgatási intézkedéseit;
Maltese: Meta joħorġu dawn iċ-ċertifikati Stati Membri għandhom iħarsu l-kondizzjonijiet li ġejjin: (a) għandhom jirrispettaw l-arranġamenti amministrattivi korrenti ta' l-Għaqda Dinjija tas-Saħħa;
English: Constituents which are not given in any pharmacopoeia shall be described in the form of a monograph under the following headings: (a) the name of the substance, meeting the requirements of Section A, point 2, shall be supplemented by any trade or scientific synonyms;
Hungarian: Azokat az összetevőket, amelyek egyetlen gyógyszerkönyvben sem szerepelnek, a következő pontok alapján összefoglalva egy monográfiában kell ismertetni: a) az A.2. pont követelményeinek megfelelően az anyag neve, amelyet kiegészítenek a kereskedelmi vagy tudományos szinonimáival;
Maltese: Kostitwenti li mhumiex mogħtija f'ebda farmakopea għandhom ikunu deskritti fil-forma ta' monografu taħt it-titoli li ġejjin: (a) l-isem tas-sustanza, li tissodisfa l-ħtiġiet tat-Taqsima A, punt 2, għandu jkun supplimentat b'kull xorta ta' sinonimi kummerċjali jew xjentifiċi;
English: The toxicological and pharmacological tests must show: (a) 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;
Hungarian: A toxikológiai és farmakológiai kísérleteknek a következőket kell kimutatniuk: a) a termék lehetséges toxicitását és egyéb, nem kívánatos vagy veszélyes mérgező hatását, amely javasolt alkalmazási körülmények mellett az embereknél előfordulhat;
Maltese: It-testijiet tossikoloġiċi u farmakoloġiċi għandhom juru: it-tossiċità potenzjali tal-prodott u kull effett perikoluż jew mhux mixtieq li jista' jirriżulta taħt il-kondizzjonijiet proposti ta' l-użu fil-bnedmin;
English: Tests to reveal carcinogenic effects shall normally be required: (a) in respect of substances having a close chemical analogy with known carcinogenic or cocarcinogenic compounds;
Hungarian: A karcinogén hatást kimutató vizsgálatokat általában a következő esetekben kell elvégezni: a) ismert karcinogén vagy ko-karcinogén hatással rendelkező anyagokkal nagyon hasonló kémiai analógiát mutató anyagoknál;
Maltese: Testijiet biex jikxfu effetti karċinoġeniċi għandhom ikunu normalment mistennija li: (a) rigward sustanzi li għandhom analoġija kimika viċina b'komposti karċinoġeniċi jew ko-karċinoġeniċi magħrufa;
English: For the purpose of demonstrating, pursuant to Article 10(1)(a)(ii), that the component(s) of a medicinal product have a well established use, with an acceptable level of safety, the following specific rules shall apply: (a) Factors which have to be taken into account in order to establish a "well established medicinal use" of components of medicinal products are the time over which a substance has been used, quantitative aspects of the use of the substance, the degree of scientific interest in the use of the substance (reflected in the published scientific literature) and the coherence of scientific assessments.
Maltese: Għall-għan li juri, skond l-Artikolu 10(1)(a)(ii), li l-komponent(i) ta' prodott mediċinali għandu/hom użu stabbilit sew, b'livell aċċettabbli ta' sigurtà, ir-regoli speċifiċi li ġejjin għandhom japplikaw: (a) Fatturi li għandhom jittieħdu f'konsiderazzjoni sabiex ikun stabbilit "użu mediċinali stabbilit sew" ta' komponenti ta' prodotti mediċinali huma l-ħin li ma' tulu sustanza tkun intużat, l-aspetti kwantitattivi ta' l-użu tas-sustanza, il-grad ta' interess xjentifiku fl-użu tas-sustanza (rifless fil-letteratura xjentifika ppubblikata) u l-koerenza ta' stimi xjentifiċi.
English: The marketing authorization holder shall make arrangements for archiving of documentation. (a) The investigator shall arrange for the retention of the patient identification codes for at least 15 years after the completion or discontinuation of the trial.
Maltese: Dak li għandu l-awtorizzazzjoni għal tqegħid fis-suq għandu jagħmel arranġamenti għall-arkivjar tad-dokumentazzjoni. (a) L-investigatur għandu jirranġa biex jinżammu l-kodiċijiet ta' identifikazzjoni tal-pazjent għal mill-anqas 15-il sena wara t-tmiem jew il-waqfien tal-prova.
English: When, in respect of particular therapeutic indications, the applicant can show that he is unable to provide comprehensive data on the efficacy and safety under normal conditions of use, because: - the indications for which the product in question is intended are encountered so rarely that the applicant cannot reasonably be expected to provide comprehensive evidence, or
Hungarian: Amennyiben egy bizonyos terápiás javallattal kapcsolatban a kérelmező igazolni tudja, hogy nem tudja benyújtani a gyógyszernek a szokásos alkalmazása mellett az ártalmatlanságára és hatásosságára vonatkozó összehasonlító adatokat, mert: - az a javallat, amelyre a szóban forgó gyógyszert szánják, olyan ritkán fordul elő, hogy a kérelmezőtől ésszerűen nem várható el, hogy összehasonlító adatokat szolgáltasson, vagy
Maltese: Meta, fir-rigward ta' indikazzjonijiet terapewtiċi partikolari, l-applikant jista' juri li mhuwiex kapaċi jipprovdi informazzjoni sħiħa dwar l-effikaċja u s-sigurtà taħt kondizzjonijiet ta' użu normali, minħabba: (a) l-indikazzjonijiet li għalihom hu maħsub il-prodott in kwistjoni wieħed jiltaqa' magħhom daqshekk rarament li l-applikant ma jistax bir-raġuni jkun mistenni li jipprovdi evidenza sħiħa;
English: marketing authorization may be granted on the following conditions: (a) the applicant completes on identified programme of studies within a time period specified by the competent authority, the results of which shall form the basis of a reassessment of the benefit/risk profile,
Hungarian: akkor a forgalomba hozatali engedély a következő feltételekkel állítható ki: a) a kérelmező az illetékes hatóságok által megállapított határidőn belül egy meghatározott vizsgálati programot hajt végre, amelynek eredményei a haszon/kockázat profil újraelemzésének alapját képezik;
Maltese: awtorizzazzjoni għal tqegħid fis-suq tista' tingħata bil-kondizzjonijiet li ġejjin: (a) l-applikant ilesti programm identifikat ta' studji f'perjodu ta' żmien speċifikat mill-awtorità kompetenti, li r-riżultati tiegħu għndhom jiffurmaw il-bażi ta' stima mill-ġdid tal-profil ta' benefiċċju/riskju,
English: For the purpose of demonstrating, pursuant to Article 10(1)(a)(ii), that the component(s) of a medicinal product have a well established use, with recognised efficacy, the following specific rules shall apply: (a) Factors which have to be taken into account in order to establish a "well established medicinal use" of components of medicinal products are the time over which a substance has been used, quantitative aspects of the use of the substance, the degree of scientific interest in the use of the substance (reflected in the published scientific literature) and the coherence of scientific assessments.
Maltese: Għall-għan biex jipprova li, skond l-Artikolu 10(1)(a)(ii), il-komponent(i) ta' prodott mediċinali għandhom użu stabbilit sew, b'effikaċja magħrufa, ir-regoli speċifiċi li ġejjin għandhom japplikaw: (a) Fatturi li għandhom jittieħdu f'konsiderazzjoni biex ikun stabbilit "użu mediċinali stabbilit sew" ta' komponenti ta' prodotti mediċinali huma ż-żmien li ma' tulu sustanza tkun intużat, aspetti kwantitattivi ta' l-użu tas-sustanza, il-grad ta' interess xjentifiku fl-użu tas-sustanza (rifless fil-letteratura xjentifika ippubblikata) u l-koerenza ta' stimi xjentifiċi.
English: Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use
Slovenian: Direktiva 2001/83/ES Evropskega parlamenta in Sveta z dne 6. novembra 2001 o zakoniku Skupnosti o zdravilih za uporabo v humani medicini
English: Having regard to the proposal from the Commission;
Slovenian: ob upoštevanju predloga Komisije,
English: Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products(3), Council Directive 75/318/EEC of 20 May 1975 on the approximation of the laws of Member States relating to analytical, pharmaco-toxicological and clinical standards and protocols in respect of the testing of proprietary medicinal products(4),
Slovenian: Direktiva Sveta 65/65/EGS z dne 26. januarja 1965 o približevanju določb zakonov ali drugih predpisov o lastniških zdravilih [3], Direktiva Sveta 75/318/EGS z dne 20. maja 1975 o približevanju zakonodaje držav članic v zvezi z analiznimi, farmakološko-toksikološkimi in kliničnimi standardi ter protokoli, ki se nanašajo na preskušanje lastniških zdravil [4],
English: In the interests of clarity and rationality, the said Directives should therefore be codified by assembling them in a single text.
Slovenian: Zaradi jasnosti in smotrnosti je treba te direktive kodificirati tako, da se jih združi v enotno besedilo.
English: The essential aim of any rules governing the production, distribution and use of medicinal products must be to safeguard public health.
Slovenian: Osnovni cilj vseh predpisov, ki urejajo izdelavo, promet in uporabo zdravil, mora biti varovanje javnega zdravja.
English: However, this objective must be attained by means which will not hinder the development of the pharmaceutical industry or trade in medicinal products within the Community.
Slovenian: Ta cilj pa je treba doseči s sredstvi, ki ne bodo ovirala razvoja farmacevtske industrije ali prometa z zdravili v Skupnosti.
English: Trade in medicinal products within the Community is hindered by disparities between certain national provisions, in particular between provisions relating to medicinal products (excluding substances or combinations of substances which are foods, animal feeding-stuffs or toilet preparations), and such disparities directly affect the functioning of the internal market.
Slovenian: Promet z zdravili v Skupnosti ovirajo neskladja med nekaterimi določbami na ravni držav, zlasti med določbami v zvezi z zdravili (ki ne vključujejo snovi ali kombinacij snovi, ki so živila, živalska krma ali toaletni pripravki), taka neskladja pa neposredno vplivajo na delovanje notranjega trga.
English: Such hindrances must accordingly be removed;
Slovenian: Ovire je zato treba odpraviti;
English: In order to reduce the disparities which remain, rules should be laid down on the control of medicinal products and the duties incumbent upon the Member States' competent authorities should be specified with a view to ensuring compliance with legal requirements.
Slovenian: Za zmanjšanje neskladij, ki še ostajajo, je treba določiti predpise za nadzor zdravil in podrobno tudi dolžnosti, ki jih imajo pristojni organi držav članic za zagotavljanje skladnosti s pravnimi zahtevami.
English: The concepts of harmfulness and therapeutic efficacy can only be examined in relation to each other and have only a relative significance depending on the progress of scientific knowledge and the use for which the medicinal product is intended.
Slovenian: Koncepta škodljivost in terapevtska učinkovitost lahko preučujemo samo v medsebojni povezavi in imata samo relativen pomen, odvisno od napredka znanstvenih dognanj ter namena uporabe zdravila.
English: The particulars and documents which must accompany an application for marketing authorization for a medicinal product demonstrate that potential risks are outweighed by the therapeutic efficacy of the product.
Slovenian: Ostale podrobnosti in dokumenti, ki jih je treba priložiti vlogi za pridobitev dovoljenja za promet z zdravilom, morajo dokazovati, da je terapevtska učinkovitost izdelka veliko večja od možnih tveganj zdravila.
English: Standards and protocols for the performance of tests and trials on medicinal products are an effective means of control of these products and hence of protecting public health and can facilitate the movement of these products by laying down uniform rules applicable to tests and trials, the compilation of dossiers and the examination of applications.
Slovenian: Standardi in protokoli za izvajanje preskusov in preskušanj zdravil so učinkovito sredstvo za kontrolo zdravil in zato tudi za varovanje javnega zdravja, ter lahko olajšajo njihov pretok z določitvijo enotnih predpisov, ki veljajo za preskuse in preskušanja, pri sestavljanju dokumentacije ter preučevanju vlog.
English: Experience has shown that it is advisable to stipulate more precisely the cases in which the results of toxicological and pharmacological tests or clinical trials do not have to be provided with a view to obtaining authorization for a medicinal product which is essentially similar to an authorized product, while ensuring that innovative firms are not placed at a disadvantage.
Slovenian: Na podlagi izkušenj je priporočljivo bolj podrobno določiti primere, pri katerih rezultatov toksikoloških in farmakoloških preskusov ali kliničnih preskušanj ni treba predložiti v vlogi za pridobitev dovoljenja za promet z zdravilom, ki je bistveno podobno zdravilu, ki je že pridobilo dovoljenje za promet, pri tem pa je treba zagotoviti, da inovativna podjetja ne bodo prikrajšana.
English: However, there are reasons of public policy for not conducting repetitive tests on humans or animals without over-riding cause.
Slovenian: V interesu javnega reda je, da se preskusi na ljudeh ali živalih ne izvajajo ponovno brez utemeljenega razloga.
English: The adoption of the same standards and protocols by all the Member States will enable the competent authorities to arrive at their decisions on the basis of uniform tests and by reference to uniform criteria and will therefore help to avoid differences in evaluation.
Slovenian: Privzemanje enakih standardov in protokolov v vseh državah članicah bo pristojnim organom omogočilo sprejemanje odločitev na podlagi enotnih preskusov in z upoštevanjem enotnih meril, da se bo mogoče izogniti razlikam pri vrednotenju.
English: With the exception of those medicinal products which are subject to the centralized Community authorization procedure established by Council Regulation (EEC) No 2309/93 of 22 July 1993 laying down Community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products(14) a marketing authorization for a medicinal product granted by a competent authority in one Member State ought to be recognized by the competent authorities of the other Member States unless there are serious grounds for supposing that the authorization of the medicinal product concerned may present a risk to public health.
Slovenian: Z izjemo tistih zdravil, pri katerih se zahteva centraliziran postopek za pridobitev dovoljenja Skupnosti za promet, ki ga določa Uredba Sveta (EGS) št. 2309/93 z dne 22. julija 1993, ki določa postopke Skupnosti za pridobitev dovoljenja za promet in nadzor zdravil za ljudi in za uporabo v veterini ter ustanavlja Evropsko agencijo za vrednotenje zdravil [14], morajo dovoljenje za promet z zdravilom, ki ga izda pristojni organ v eni državi članici, priznati pristojni organi v drugih državah članicah, razen če obstajajo utemeljeni razlogi za domnevo, da pridobitev dovoljenja za promet z zadevnim zdravilom lahko predstavlja tveganje za javno zdravje.
English: In the event of a disagreement between Member States about the quality, the safety or the efficacy of a medicinal product, a scientific evaluation of the matter should be undertaken according to a Community standard, leading to a single decision on the area of disagreement binding on the Member States concerned.
Slovenian: Če pride do nesoglasij med državami članicami glede kakovosti, varnosti ali učinkovitosti zdravila, je treba izdelati znanstveno oceno v skladu s standardom Skupnosti, kar bo privedlo do enotne odločitve na spornem področju, ki bo zavezujoča za vpletene države članice.
English: Whereas this decision should be adopted by a rapid procedure ensuring close cooperation between the Commission and the Member States.
Slovenian: Ker je to odločitev treba sprejeti po hitrem postopku, je potrebno zagotoviti tesno sodelovanje med Komisijo in državami članicami.
English: For this purpose, a Committee for Proprietary Medicinal Products should be set up attached to the European Agency for the Evaluation of Medicinal Products established in the abovementioned Regulation (EEC) No 2309/93.
Slovenian: V ta namen je treba ustanoviti Odbor za lastniška zdravila v okviru Evropske agencije za vrednotenje zdravil, ustanovljene z zgoraj omenjeno Uredbo (EGS) št. 2309/93.
English: This Directive represents an important step towards achievement of the objective of the free movement of medicinal products.
Slovenian: Ta direktiva predstavlja pomemben korak k doseganju cilja prostega pretoka zdravil.
English: Further measures may abolish any remaining barriers to the free movement of proprietary medicinal products will be necessary in the light of experience gained, particularly in the abovementioned Committee for Proprietary Medicinal Products.
Slovenian: Nadaljnji ukrepi, ki bodo odpravili vse preostale ovire pri prostem pretoku lastniških zdravil, so potrebni z vidika pridobljenih izkušenj, zlasti zgoraj omenjenega Odbora za lastniška zdravila.
English: In order better to protect public health and avoid any unnecessary duplication of effort during the examination of application for a marketing authorization for medicinal products, Member States should systematically prepare assessment reports in respect of each medicinal product which is authorized by them, and exchange the reports upon request.
Slovenian: Za boljše varovanje javnega zdravja ter v izogib nepotrebnemu podvajanju naporov pri preučevanju vloge za pridobitev dovoljenja za promet z zdravilom, morajo države članice sistematično pripraviti poročila o oceni zdravila za vsako zdravilo, ki je pridobilo dovoljenje za promet in si, na zahtevo, poročila medsebojno izmenjavati.
English: Furthermore, a Member State should be able to suspend the examination of an application for authorization to place a medicinal product on the market which is currently under active consideration in another Member State with a view to recognizing the decision reached by the latter Member State.
Slovenian: Država članica bi morala biti sposobna opustiti preučevanje vloge za pridobitev dovoljenja za promet z zdravilom, ki ga hkrati aktivno preučuje druga država članica s ciljem, da bo priznala odločitev, ki jo bo ta država članica sprejela.
English: Following the establishment of the internal market, specific controls to guarantee the quality of medicinal products imported from third countries can be waived only if appropriate arrangements have been made by the Community to ensure that the necessary controls are carried out in the exporting country.
Slovenian: Po vzpostavitvi notranjega trga se je mogoče odreči posebnemu nadzoru za zagotavljanje kakovosti zdravil, ki se uvažajo iz tretjih držav samo, če se Skupnost ustrezno dogovori in zagotovi, da bo država izvoznica izvajala potrebni nadzor.
English: It is necessary to adopt specific provisions for immunological medicinal products, homeopathic medicinal products, radiopharmaceuticals, and medicinal products based on human blood or human plasma.
Slovenian: Sprejeti je treba posebne določbe za imunološka zdravila, homeopatska zdravila, radiofarmacevtske izdelke ter zdravila iz človeške krvi ali človeške plazme.
English: Any rules governing radiopharmaceuticals must take into account the provisions of Council Directive 84/466/Euratom of 3 September 1984 laying down basic measures for the radiation protection of persons undergoing medical examination or treatment(15).
Slovenian: Vsi predpisi, ki urejajo radiofarmacevtske izdelke, morajo upoštevati določbe Direktive Sveta 84/466/Euratom z dne 3. septembra 1984, ki določa osnovne ukrepe za varstvo ljudi pred sevanjem med zdravniškim pregledom ali zdravljenjem [15].
English: Account should also be taken of Council Directive 80/836/Euratom of 15 July 1980 amending the Directives laying down the basic safety standards for the health protection of the general public and workers against the dangers of ionizing radiation(16), the objective of which is to prevent the exposure of workers or patients to excessive or unnecessarily high levels of ionizing radiation, and in particular of Article 5c thereof, which requires prior authorization for the addition of radioactive substances to medicinal products as well as for the importation of such medicinal products.
Slovenian: Prav tako je treba upoštevati Direktivo Sveta 80/836/Euratom z dne 15. julija 1980, ki spreminja direktive o določitvi osnovnih varnostnih standardov za varovanje zdravja ljudi ter delavcev zaradi nevarnosti ionizirajočega sevanja [16], katere cilj je preprečiti izpostavljenost delavcev ali bolnikov prekomernim ali nepotrebno visokim ravnem ionizirajočega sevanja, in zlasti člen 5c navedene direktive, po kateri se zahteva predhodno dovoljenje za dodajanje radioaktivnih snovi zdravilom, kot tudi za uvoz tovrstnih zdravil.
English: The Community entirely supports the efforts of the Council of Europe to promote voluntary unpaid blood and plasma donation to attain self-sufficiency throughout the Community in the supply of blood products, and to ensure respect for ethical principles in trade in therapeutic substances of human origin.
Slovenian: Skupnost v celoti podpira napore Sveta Evrope pri spodbujanju prostovoljnega neplačanega krvodajalstva in darovanja plazme, s čimer se ohranja samozadostnost krvnih izdelkov na celotnem območju Skupnosti, ter zagotavlja spoštovanje etičnih načel v prometu s terapevtskimi snovmi človeškega izvora.
English: The rules designed to guarantee the quality, safety and efficacy of medicinal products derived from human blood or human plasma must be applied in the same manner to both public and private establishments, and to blood and plasma imported from third countries.
Slovenian: Predpisi, ki zagotavljajo kakovost, varnost in učinkovitost zdravil, pridobljenih iz človeške krvi ali človeške plazme, se morajo na enak način uporabljati v javnih in v zasebnih ustanovah, kot tudi za kri in plazmo, uvoženo iz tretjih držav.
English: Having regard to the particular characteristics of these homeopathic medicinal products, such as the very low level of active principles they contain and the difficulty of applying to them the conventional statistical methods relating to clinical trials, it is desirable to provide a special, simplified registration procedure for those homeopathic medicinal products which are placed on the market without therapeutic indications in a pharmaceutical form and dosage which do not present a risk for the patient.
Slovenian: Ob upoštevanju določenih značilnosti homeopatskih zdravil, kot so na primer zelo nizka raven učinkovin, ki jih vsebujejo, ter da je pri teh izdelkih težko uporabljati standardne statistične metode v zvezi s kliničnimi preskušanji, je zaželeno, da se uvede poseben, poenostavljen postopek registracije za tista homeopatska zdravila, ki se dajejo v promet brez terapevtskih indikacij, v farmacevtski obliki in odmerku, ki ne predstavljata tveganja za bolnika.
English: The anthroposophic medicinal products described in an official pharmacopoeia and prepared by a homeopathic method are to be treated, as regards registration and marketing authorization, in the same way as homeopathic medicinal products.
Slovenian: Antropozofska zdravila, opisana v uradni farmakopeji in pripravljena po homeopatskem postopku, je pri registraciji in pridobivanju dovoljenja za promet treba obravnavati enako kot homeopatska zdravila.