FrancophonIA/DGT-Translation_Memory huggingface dataset:
English: As in any scientific work, the dossier of safety tests shall include the following: (a) an introduction defining the subject, accompanied by any useful bibliographical references;
Hungarian: Mint minden tudományos munkának, az ártalmatlansági vizsgálatok dokumentációjának is a következőket kell tartalmaznia: a) bevezetés, amely meghatározza a vizsgálat tárgyát és tartalmazza az összes hasznos szakirodalmi hivatkozást;
Maltese: Bħal f'kull xogħol xjentifiku, id-dokument ta' testijiet ta' sigurtà għandu jinkludi li ġej: (a) introduzzjoni li tiddefinixxi s-suġġett, flimkien ma' kull referenzi biblijografiċi utli;
English: As in any scientific work, the dossier of residue tests shall include the following: (a) an introduction defining the subject, accompanied by any useful bibliographical references;
Hungarian: Mint minden tudományos munkának, az ártalmatlansági vizsgálatok dokumentációjának a következőket kell tartalmaznia: a) bevezetés, amely tartalmazza a tárgy megjelölését és a hasznos szakirodalmi hivatkozásokat;
Maltese: Bħal f'kull xogħol xjentifiku, id-dokument dwar it-testijiet ta' residwi għandu jinkludi dawn li ġejjin: (a) introduzzjoni li tiddefinixxi s-suġġett, flimkien ma' kull referenza biblijografika utli;
English: Where, in respect of particular therapeutic indications, the applicant can show that he is unable to provide comprehensive data on therapeutic effect because: (a) the indications for which the medicinal product in question is intended are encountered so rarely that the applicant cannot reasonably be expected to provide comprehensive evidence;
Hungarian: Amennyiben bizonyos terápiás javallatok tekintetében a kérelmező igazolni tudja, hogy képtelen a terápiás hatás minden részletére kiterjedő eredményt benyújtani, mert: a) azon javallatok, amelyekre a terméket szánták, olyan ritkán fordulnak elő, hogy a kérelmezőtől ésszerűen nem várható el, hogy minden részletére kiterjedő eredményeket nyújtson be, vagy
Maltese: Billi, dwar indikazzjonijiet terapewtiċi partikolari, l-applikant jista' juri li mhuwiex kapaċi jipprovdi data komprensivi dwar l-effett terapewtiku minħabba li: (a) l-indikazzjonijiet li għalihom il-prodott mediċinali in kwistjoni huma maħsuba narawhom hekk rarament li l-applikant ma jistax b'mod raġjonevoli jkun mistenni li jipprovdi evidenza komprensiva;
English: the marketing authorization may only be granted subject to the following conditions: (a) the medicinal product in question is to be supplied on veterinary prescription only and may, in certain cases, be administered only under strict veterinary supervision;
Maltese: l-awtorizzazzjoni ta' marketing tista' tingħata biss bla ħsara għall-kondizzjonijiet li ġejjin: (a) il-prodott mediċinali in kwistjoni għandu jingħata fuq preskrizzjoni veterinarja biss u jista', f'xi każi, ikun amministrat biss taħt sorveljanza veterinarja stretta;
English: Wherever possible, particulars shall be given of the results of: (a) tests demonstrating pharmacological actions;
Hungarian: Amennyiben lehetséges, a következőkre vonatkozó eredményeket kell megadni: a) a farmakológiai hatást bemutató kísérletek;
Maltese: Kull meta possibbli, għandhom jingħataw dettalji tar-riżultati ta': (a) testijiet li juru azzjonijiet farmakoloġiċi;
English: Additionally the following particulars shall be provided in all pre-clinical studies: (a) a summary;
Hungarian: Ezenkívül a pre-klinikai vizsgálatok esetében az alábbi részleteket kell megadni: a) összefoglalás;
Maltese: Barra minn hekk id-dettalji li ġejjin għandhom ikunu provduti fl-istudji prekliniċi kollha: (a) sommarju;
English: The particulars supplied shall take the following form: (a) name, address, function and qualifications of investigator in charge;
Hungarian: A megadott adatoknak a következő formában kell szerepelniük: a) a felelős kísérletet végző neve, címe, beosztása, képesítése;
Maltese: id-dettalji mogħtija għandhom ikunu fil-forma li ġejja: (a) isem, indirizz, funzjoni u kwalifiki ta' l-investigatur responsabbli;
English: In respect of each clinical trial, the clinical observations shall be summarized in a synopsis of the trials and the results thereof, indicating in particular: (a) the number of controls, the number of animals treated either individually or collectively, with a breakdown according to species, breed or strain, age and sex;
Hungarian: A klinikai megfigyeléseket minden egyes klinikai kipróbálás tekintetében össze kell foglalni, és a kipróbálásról és eredményeiről összefoglalót kell készíteni, amelynek elsősorban a következőket kell tartalmaznia: a) a kontrollállatok és az egyedileg vagy csoportosan kezelt állatok száma, faja, fajtája vagy tenyészete, életkor és ivar szerinti bontásban;
Maltese: Dwar kull prova klinika, l-osservazzjonijiet kliniċi għandhom ikunu miġbura f'sinopsi tal-provi u r-riżultati tagħhom, li jindikaw partikolarment: (a) in-numru ta' kontrolli, in-numru ta' annimali ttrattati individwalment jew kollettivament, b'dettalji skond l-ispeċi, razza jew tip, età u sess;
English: Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products
Slovenian: Direktiva 2001/82/ES Evropskega parlamenta in Sveta z dne 6. novembra 2001 o zakoniku Skupnosti o zdravilih za uporabo v veterinarski medicini
English: Having regard to the opinion of the Economic and Social Committee(1),
Slovenian: ob upoštevanju mnenja Ekonomsko-socialnega odbora [1],
English: Acting in accordance with the procedure laid down in Article 251 of the Treaty(2),
Slovenian: v skladu s postopkom, določenim v členu 251 Pogodbe [2],
English: Council Directive 81/851/EEC of 28 September 1981 on the approximation of the laws of the Member States relating to veterinary medicinal products(3), Council Directive 81/852/EEC of 28 September 1981 on the approximation of the laws of the Member States relating to analytical, pharmaco-toxicological and clinical standards and protocols in respect of the testing of veterinary medicinal products(4), Council Directive 90/677/EEC of 13 December 1990 extending the scope of Directive 81/851/EEC on the approximation of the laws of the Member States relating to veterinary medicinal products and laying down additional provisions for immunological veterinary medicinal products(5), and Council Directive 92/74/EEC of 22 September 1992 widening the scope of Directive 81/851/EEC on the approximation of provisions laid down by law, regulation or administrative action relating to veterinary medicinal products and laying down additional provisions on homeopathic veterinary medicinal products(6) have been frequently and substantially amended;
Slovenian: Direktiva Sveta 81/851/EGS z dne 28. septembra 1981 o prilagajanju zakonodaj držav članic, ki se nanaša na zdravila za uporabo v veterinarski medicini [3], Direktiva Sveta 81/852/EGS z dne 28. Septembra 1981 o prilagajanju zakonodaj držav članic, ki se nanaša na analitske, farmakološko-toksikološke in klinične standarde ter protokole v zvezi s preskušanjem zdravil za uporabo v veterinarski medicini [4], Direktiva Sveta 90/677/EGS z dne 13. decembra 1990 o razširitvi področje uporabe Direktive 81/851/EGS o prilagajanju zakonodaj držav članic, ki se nanaša na zdravila za uporabo v veterinarski medicini in o določitvi dodatnih določb za imunološka zdravila za uporabo v veterinarski medicini [5], in Direktiva Sveta 92/74/EGS z dne 22. septembra 1992 o razširitvi področje uporabe Direktive 81/851/EGS o prilagajanju zakonov in drugih predpisov, ki se nanašajo na zdravila za uporabo v veterinarski medicini in ki določa dodatne predpise za homeopatska zdravila za uporabo v veterinarski medicini [6], so bile pogosto in znatno spremenjene;
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 navedene direktive kodificirati tako, da se jih je združit v enotno besedilo.
English: The primary purpose of any rules for the production and distribution of veterinary medicinal products must be the safeguarding of public health.
Slovenian: Osnovni namen vseh predpisov, ki urejajo izdelavo in promet zdravil za uporabo v veterinarski medicini mora biti varovanje javnega zdravja.
English: However, this objective must be achieved by means which will not hinder the development of industry and trade in medicinal products within the Community.
Slovenian: Vendar pa je ta cilj treba doseči s sredstvi, ki ne bodo ovirala razvoja farmacevtske industrije in prometa z zdravili znotraj Skupnosti.
English: In so far as the Member States already have certain provisions laid down by law, regulation or administrative action governing veterinary medicinal products, such provisions differ in essential principles.
Slovenian: Trenutno pa se ta določila razlikujejo v osnovni principih, ker države članice že imajo pogoje, ki urejajo zdravila za uporabo v veterinarski medicini, določene z zakonom ali drugim predpisom.
English: This results in the hindering of trade in medicinal products within the Community, thereby directly affecting the functioning of the internal market.
Slovenian: To ima za posledico oviranje prometa z zdravili znotraj Skupnosti, kar neposredno vpliva na delovanje notranjega trga.
English: Such hindrances must, accordingly, be removed;
Slovenian: Ovire je zato treba odpraviti;
English: whereas this entails approximation of the relevant provisions.
Slovenian: to pa ima za posledico približevanje ustreznih določb.
English: It is necessary from the point of view of public health and the free movement of veterinary medicinal products for the competent authorities to have at their disposal all useful information on authorized veterinary medicinal products in the form of approved summaries of the characteristics of products.
Slovenian: Z vidika javnega zdravja in prostega pretoka zdravil za uporabo v veterinarski medicini je treba, da pristojni organi razpolagajo s koristnimi podatki o zdravilih za uporabo v veterinarski medicini z dovoljenjem za promet v obliki odobrenih povzetkov glavnih značilnostih zdravila.
English: With the exception of those medicinal products which are subject to the centralised 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(7), a marketing authorization in one Member State ought to be recognized by the competent authority of the other Member States unless there are serious grounds for supposing that the authorization of the veterinary medicinal product concerned may present a risk to human or animal health, or to the environment;
Slovenian: Z izjemo tistih zdravil, za katera se zahteva centralizirani postopek pridobitve dovoljenja Skupnosti za promet, ki je bil uveljavljen z Uredbo Sveta (EGS) št. 2309/93 z dne 22. julija 1993 in ki določa postopke Skupnosti za pridobitev dovoljenja za promet z zdravili in nadzor nad zdravili za uporabo v humani in veterinarskim medicini ter ustanavlja Evropsko agencijo za vrednotenje zdravil [7], morajo dovoljenje za promet v eni državi članici priznati pristojni organi drugih držav članic, razen če obstajajo utemeljeni razlogi za domnevo, da bi pridobitev dovoljenja za promet z zadevnim zdravilom za uporabo v veterinarski medicini lahko predstavljala tveganje za zdravje ljudi ali živali, ali za okolje;
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 at a Community level, lead to a single decision on the area of disagreement, binding on the Member States concerned.
Slovenian: v primeru nesoglasja med državami članicami mora biti o zadevi opravljeno znanstveno ovrednotenje glede kakovosti, varnosti ali učinkovitosti zdravila na nivoju Skupnosti, ki mora privesti do enotne odločitve na spornem področju in ki bo obvezujoča za države članice.
English: This Decision should be adopted by a rapid procedure ensuring close cooperation between the Commission and the Member States.
Slovenian: To odločitev je treba sprejeti po hitrem postopku, zato je potrebno tesno sodelovanje med Komisijo ter državami članicami.
English: For this purpose, a Committee for Veterinary Medicinal Products should be set up in accordance with the European Agency for the Evaluation of Medicinal Products laid down in the aforementioned Regulation (EEC) No 2309/93.
Slovenian: V ta namen je treba ustanoviti Odbor za zdravila za uporabo v veterinarski medicini v okviru Evropske agencije za vrednotenje zdravil, določeno z zgoraj navedeno Uredbo (EGS) št. 2309/93.
English: This Directive is only one stage in the achievement of the aim of freedom of movement of veterinary medicinal products.
Slovenian: Ta direktiva predstavlja le eno stopnjo za doseganje cilja prostega pretoka zdravil za uporabo v veterinarski medicini.
English: However, for this purpose, new measures will prove necessary, in the light of experience gained - especially within the Committee for Veterinary Medicinal Products - for the removal of the remaining barriers to freedom of movement.
Slovenian: S tem v zvezi ter na podlagi izkušenj, posebno znotraj Odbora za zdravila za uporabo v veterinarski medicini, pa se bo izkazalo, da so potrebni novi ukrepi za odpravo preostalih ovir pri prostem pretoku.
English: Medicated feedingstuffs do not come within the scope of this Directive.
Slovenian: Medicinirana krma ne spadajo v področje uporabe te direktive.
English: However, it is necessary, for both public health and economic reasons, to prohibit the use of unauthorized medicinal products in the manufacture of medicated feedingstuffs.
Slovenian: Kljub temu pa je treba tako za javno zdravje, kakor zaradi ekonomskih razlogov, prepovedati uporabo zdravil, ki nimajo dovoljenja za promet v proizvodnji medicinirane krme.
English: The concepts of harmfulness and therapeutic efficacy can be examined only in relation to one another and have only a relative significance, depending on the progress of scientific knowledge and the use for which the medicinal product is intended.
Slovenian: Pojma škodljivost in terapevtska učinkovitost lahko preučujemo le v medsebojni povezavi ter imata le relativen pomen, odvisno od napredka znanstvenih dognanj ter uporabe, za katero je zdravilo namenjeno.
English: The particulars and documents which must accompany an application for marketing authorization must demonstrate that potential hazards are outweighed by the benefits due to efficacy.
Slovenian: Ostale podrobnosti ter dokumentacija, ki morajo biti priloženi vlogi za pridobitev dovoljenja za promet z zdravilom morajo dokazovati, da so koristi zaradi učinkovitosti večje od možnih tveganj.
English: Failing such demonstration, the application must be rejected.
Slovenian: Če takih dokazov ni, se vloga zavrne.
English: Marketing authorization should be refused where a medicinal product lacks therapeutic effect or where there is insufficient proof of such effect.
Slovenian: Dovoljenja za promet z zdravilom se ne izda, če zdravilo nima terapevtskega učinka ali če ni zadostnih dokazov za tak učinek.
English: The concept of therapeutic effect must be understood as being the effect promised by the manufacturers.
Slovenian: Pojem terapevtski učinek je treba razumeti kot učinek, ki ga navaja proizvajalec.
English: Such marketing authorization should also be refused where the withdrawal period indicated is not long enough to eliminate health hazards arising from residues.
Slovenian: Tovrstnega dovoljenja za promet z zdravilom se prav tako ne izda, če karenca ni dovolj dolga, da zaostanki ne bi predstavljali tveganja za zdravje.
English: Before an authorization to market an immunological veterinary medicinal product can be granted, the manufacturer must demonstrate his ability to attain batch-to-batch consistency.
Slovenian: Pred izdajo dovoljenja za promet z imunološkim zdravilom za uporabo v veterinarski medicini mora izdelovalec dokazati sposobnost zagotavljanja konsistenosti med serijami.
English: The competent authorities should also be empowered to prohibit the use of an immunological veterinary medicinal product when the immunological responses of the treated animal will interfere with a national or Community programme for the diagnosis, eradication or control of animal disease.
Slovenian: Pristojni organi morajo imeti pooblastila za prepoved uporabe imunološkega zdravila za uporabo v veterinarski medicini, ko je imunski odziv zdravljene živali v neskladju z nacionalnim programom ali programom Skupnosti za ugotavljanje, izkoreninjanje ali kontrolo živalske bolezni.
English: It is desirable in the first instance to provide users of homeopathic medicinal products with a very clear indication of their homeopathic character and with sufficient guarantees of their quality and safety.
Slovenian: Predvsem je zaželeno dati uporabnikom homeopatskih zdravil jasno sliko o homeopatskih značilnostih zdravila ter zadostna zagotovila glede njegove kakovosti in varnosti.
English: The rules relating to the manufacture, control and inspection of homeopathic veterinary medicinal products must be harmonised to permit the circulation throughout the Community of medicinal products which are safe and of good quality.
Slovenian: Predpisi, ki se nanašajo na izdelavo, kontrolo ter nadzor homeopatskih zdravil za uporabo v veterinarski medicini morajo biti usklajeni, da bi bil možen promet varnih in kakovostnih zdravil znotraj Skupnosti.
English: Having regard to the particular characteristics of these homeopathic veterinary 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 traditional 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 animal.
Slovenian: Glede na nekatere značilnosti teh homeopatskih zdravil za uporabo v veterinarski medicini, kot so 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 določi poseben, poenostavljen postopek registracije za tista tradicionalna homeopatska zdravila, ki so bila dana v promet brez terapevtskih indikacij, v farmacevtski obliki ter odmerkih, ki ne predstavljajo tveganja za živali.
English: The usual rules governing the authorization to market veterinary medicinal products must be applied to homeopathic veterinary medicinal products marketed with therapeutic indications or in a form which may present risks which must be balanced against the desired therapeutic effect.
Slovenian: Običajna pravila, ki urejajo dovoljenje za promet z zdravili za uporabo v veterinarski medicini se morajo uporabljati pri homeopatskih zdravilih za uporabo v veterinarski medicini, ki se dajejo v promet s terapevtskimi indikacijami, ali pa v obliki, ki lahko predstavlja tveganje, kar je treba presojati v primerjavi z zaželenimi terapevtskimi učinki.
English: Member States should be able to apply particular rules for the evaluation of the results of tests and trials intended to establish the safety and efficacy of these medicinal products for pet animals and exotic species, provided that they notify them to the Commission.
Slovenian: Države članice, bi morale uporabljati posebne predpise za ovrednotenje rezultatov preskusov in preskušanj z namenom zagotavljanja varnosti in učinkovitosti teh zdravil, namenjenih hišnim živalim ter eksotičnim živalskim vrstam, pod pogojem, da o njih uradno obvestijo Komisijo.
English: In order to better protect human and animal health and avoid any unnecessary duplication of effort during the examination of application for a marketing authorization, Member States should systematically prepare assessment reports in respect of each veterinary medicinal product which is authorized by them, and exchange the reports upon request.
Slovenian: Da bi bolje zaščitili zdravje ljudi in živali ter v izogib nepotrebnemu podvajanju naporov med preverjanjem vlog za pridobitev dovoljenja za promet, bi morale države članice sistematično pripraviti poročilo o oceni zdravila za vsako zdravilo za uporabo v veterinarski medicini, za katerega so izdale dovoljenje za promet ter si na zahtevo poročila medsebojno izmenjati.
English: Furthermore, a Member State should be able to suspend the examination of an application for authorization to place a veterinary 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: Poleg tega bi morala država članica biti sposobna opustiti preučevanje vloge za pridobitev dovoljenja za promet z zdravilom za uporabo v veterinarski medicini, ki ga hkrati aktivno proučuje druga država članica z namenom, da prizna odločitev, ki jo bo sprejela ta država članica.
English: In order to facilitate the movement of veterinary medicinal products and to prevent the checks carried out in one Member State from being repeated in another, minimum requirements for manufacture and imports from third countries, and the grant of corresponding authorizations, should be applied to veterinary medicinal products.
Slovenian: Da bi olajšali pretok zdravil za uporabo v veterinarski medicini ter da bi preprečili podvajanje kontrole, ki se že izvaja v eni državi članici, se morajo določiti minimalne zahteve za izdelavo ter uvoz zdravil iz tretjih držav ter za izdajo ustreznih dovoljenj za zdravila za uporabo v veterinarski medicini.
English: The quality of veterinary medicinal products manufactured within the Community should be guaranteed by requiring compliance with the principles of good manufacturing practice for medicinal products irrespective of the final destination of the medicinal products.
Slovenian: Kakovost zdravil za uporabo v veterinarski medicini, izdelanih v Skupnosti mora biti zajamčena z zahtevo po skladnosti z načeli dobre prakse v proizvodnji zdravil, ne glede na končno destinacijo zdravil.
English: Measures should also be taken to ensure that distributors of veterinary medicinal products are authorized by Member States and maintain adequate records.
Slovenian: Prav tako je treba uvesti ukrepe, da se zagotovi, da so distributerji zdravil za uporabo v veterinarski medicini odobreni v državah članicah ter da se vzdržuje ustrezne evidence.
English: Standards and protocols for the performance of tests and trials on veterinary 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 the compilation of dossiers, allowing the competent authorities to arrive at their decisions on the basis of uniform tests and by reference to uniform criteria, and therefore helping to obviate differences in evaluation.
Slovenian: Standardi in protokoli za izvajanje preskusov in preskušanj zdravili za uporabo v veterinarski medicini so učinkovito sredstvo za kontrolo le-teh, in posledično tudi za varovanje javnega zdravja ter lahko olajšajo pretok teh zdravil z določitvijo enotnih pravil za preskuse in sestavo dokumentacije, kar omogoča pristojnim organom, da na podlagi enotnih preskusov in upoštevaje enotne referenčna merila sprejmejo odločitev; s tem je pristojnim organom olajšano tudi preprečevanje razlik pri vrednotenju.