FrancophonIA/DGT-Translation_Memory huggingface dataset:
English: It is desirable in the first instance to provide users of these homeopathic medicinal products with a very clear indication of their homeopathic character and with sufficient guarantees of their quality and safety.
Slovenian: Zaželeno je, da se uporabnike homeopatskih zdravil najprej seznani z zelo jasno navedbo njihovih homeopatskih lastnosti in z ustreznim jamstvom o njihovi kakovosti in varnosti.
English: The rules relating to the manufacture, control and inspection of homeopathic medicinal products must be harmonized to permit the circulation throughout the Community of medicinal products which are safe and of good quality.
Slovenian: Predpisi v zvezi z izdelavo, kontrolo in nadzorom homeopatskih zdravil, morajo biti usklajena tako, da omogočajo dajanje v obtok varnih in kakovostnih zdravil na celotnem območju Skupnosti.
English: The usual rules governing the authorization to market medicinal products should be applied to homeopathic medicinal products placed on the market with therapeutic indications or in a form which may present risks which must be balanced against the desired therapeutic effect.
Slovenian: Običajni predpisi, ki urejajo pridobitev dovoljenja za promet, je treba uporabiti za homeopatska zdravila, ki se dajejo v promet s terapevtskimi indikacijami, ali v obliki, ki lahko predstavlja tveganja, kar je treba presojati v primerjavi z zaželenim terapevtskim učinkom.
English: In particular, those Member States which have a homeopathic tradition 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 provided that they notify them to the Commission.
Slovenian: Zlasti države članice s tradicijo v homeopatiji bi morale uporabljati posebne predpise za vrednotenje rezultatov preskusov in preskušanj, katerih namen je ugotoviti varnost in učinkovitost teh zdravil pod pogojem, da o tem obvestijo Komisijo.
English: In order to facilitate the movement of medicinal products and to prevent the controls carried out in one Member State from being repeated in another, minimum requirements should be laid down for manufacture and imports coming from third countries and for the grant of the authorization relating thereto.
Slovenian: Za lažji pretok zdravil in za preprečitev podvajanja nadzora, ki se že izvaja v eni državi članici, je treba določiti minimalne zahteve za izdelavo in uvoz zdravil iz tretjih držav, ter za izdajo dovoljenj v zvezi s temi zdravili.
English: It should be ensured that, in the Member States, the supervision and control of the manufacture of medicinal products is carried out by a person who fulfils minimum conditions of qualification.
Slovenian: Zagotoviti je treba, da v državah članicah nadzor in kontrolo izdelave zdravil izvaja oseba, ki izpolnjuje minimalne pogoje glede usposobljenosti.
English: Before an authorization to market an immunological medicinal product or derived from human blood or human plasma can be granted, the manufacturer must demonstrate his ability to attain batch-to-batch consistency.
Slovenian: Pred pridobitvijo dovoljenja za promet z imunološkim zdravilom ali izdelkom, pridobljenim iz človeške krvi ali človeške plazme, mora proizvajalec dokazati sposobnost doseganja konsistentnosti med serijami.
English: Before an authorization to market a medicinal product derived from human blood or human plasma can be granted, the manufacturer must also demonstrate the absence of specific viral contamination, to the extent that the state of technology permits.
Slovenian: Preden se lahko izda dovoljenje za promet z zdravilom, pridobljenim iz človeške krvi ali človeške plazme, mora proizvajalec tudi dokazati odsotnost kakršne koli specifične virusne kontaminacije v obsegu, ki ga dopušča stanje tehnologije.
English: The conditions governing the supply of medicinal products to the public should be harmonized.
Slovenian: Uskladiti je treba pogoje, ki urejajo izdajanje zdravil javnosti.
English: In this connection persons moving around within the Community have the right to carry a reasonable quantity of medicinal products lawfully obtained for their personal use.
Slovenian: S tem v zvezi imajo osebe, ki se gibljejo znotraj Skupnosti, pravico imeti pri sebi upravičeno količino zdravil, ki so jo za osebno uporabo pridobile na zakonit način.
English: It must also be possible for a person established in one Member State to receive from another Member State a reasonable quantity of medicinal products intended for his personal use.
Slovenian: Prav tako mora biti osebam, nastanjenim v eni državi članici, omogočeno prejemanje upravičene količine zdravil za osebno uporabo iz druge države članice.
English: In addition, by virtue of Regulation (EC) No 2309/93, certain medicinal products are the subject of a Community marketing authorization.
Slovenian: Na podlagi Uredbe (ES) št. 2309/93 za nekatera zdravila dovoljenje za promet z zdravilom izda Skupnost.
English: In this context, the classification for the supply of medicinal products covered by a Community marketing authorization needs to be established.
Slovenian: V tem okviru je treba pripraviti razvrstitev za izdajanje zdravil, ki imajo dovoljenje Skupnosti za promet z zdravilom.
English: It is therefore important to set the criteria on the basis of which Community decisions will be taken.
Slovenian: Pomembno je izoblikovati merila, na podlagi katerih bo Skupnost sprejemala odločitve.
English: It is therefore appropriate, as an initial step, to harmonize the basic principles applicable to the classification for the supply of medicinal products in the Community or in the Member State concerned, while taking as a starting point the principles already established on this subject by the Council of Europe as well as the work of harmonization completed within the framework of the United Nations, concerning narcotic and psychotropic substances.
Slovenian: Primerno je, da se najprej uskladijo osnovna načela, ki se nanašajo na razvrstitev za izdajanje zdravil v Skupnosti ali v zadevni državi članici, tako da se za izhodišče upoštevajo že uveljavljena načela, ki jih je s tem v zvezi sprejel Svet Evrope, kot tudi opravljeno delo na področju usklajevanja v okviru Združenih narodov v zvezi z narkotičnimi in psihotropnimi snovmi.
English: The provisions dealing with the classification of medicinal products for the purpose of supply do not infringe the national social security arrangements for reimbursement or payment for medicinal products on prescription.
Slovenian: Določbe, ki obravnavajo razvrščanje zdravil za namene izdajanja, ne kršijo nacionalnih dogovorov socialne varnosti glede nadomestila ali plačila zdravil na recept.
English: Many operations involving the wholesale distribution of medicinal products for human use may cover several Member States simultaneously.
Slovenian: Številni postopki, ki vključujejo promet z zdravili za ljudi na debelo, lahko hkrati zajemajo več držav članic.
English: It is necessary to exercise control over the entire chain of distribution of medicinal products, from their manufacture or import into the Community through to supply to the public, so as to guarantee that such products are stored, transported and handled in suitable conditions.
Slovenian: Izvajati je treba nadzor nad celotno verigo distribucije zdravil, od njihove izdelave ali uvoza v Skupnost do izdajanja javnosti, da se tako zagotovijo ustrezni pogoji shranjevanja, prevoza in rokovanja s tovrstnimi izdelki.
English: The requirements which must be adopted for this purpose will considerably facilitate the withdrawal of defective products from the market and allow more effective efforts against counterfeit products.
Slovenian: Zahteve, ki jih je treba sprejeti v ta namen, bodo znatno olajšale umik neustreznih izdelkov iz prometa ter omogočale učinkovitejši boj proti ponarejenim izdelkom.
English: Any person involved in the wholesale distribution of medicinal products should be in possession of a special authorization.
Slovenian: Vse osebe, vključene v promet z zdravili na debelo, morajo imeti posebno dovoljenje.
English: Pharmacists and persons authorized to supply medicinal products to the public, and who confine themselves to this activity, should be exempt from obtaining this authorization.
Slovenian: Farmacevtom in osebam, pooblaščenim za izdajanje zdravil javnosti in vsem tistim, ki so povezani s tovrstno dejavnostjo, ni treba pridobiti tega dovoljenja.
English: It is however necessary, in order to control the complete chain of distribution of medicinal products, that pharmacists and persons authorized to supply medicinal products to the public keep records showing transactions in products received.
Slovenian: Za vzdrževanje nadzora nad celotno verigo distribucije zdravil morajo farmacevti in osebe, pooblaščene za izdajanje zdravil javnosti, voditi evidenco, ki izkazuje poslovanje s prejetimi izdelki.
English: Authorization must be subject to certain essential conditions and it is the responsibility of the Member State concerned to ensure that such conditions are met;
Slovenian: Za izdajo dovoljenja morajo biti izpolnjeni nekateri bistveni pogoji in odgovornost zadevne države članice je, da zagotovi izpolnjevanje teh pogojev;
English: whereas each Member State must recognize authorizations granted by other Member States.
Slovenian: pri tem pa mora vsaka država članica priznati dovoljenja, ki so jih izdale druge države članice.
English: Certain Member States impose on wholesalers who supply medicinal products to pharmacists and on persons authorized to supply medicinal products to the public certain public service obligations.
Slovenian: Nekatere države članice trgovcem na debelo, ki zdravila dobavljajo lekarnam ter osebam z dovoljenjem za izdajanje zdravil širši javnosti, nalagajo določene obveznosti javnih storitev.
English: Those Member States must be able to continue to impose those obligations on wholesalers established within their territory.
Slovenian: Tem državam članicam mora biti omogočeno, da še naprej nalagajo te obveznosti trgovcem na debelo, ki opravljajo dejavnost na njihovem ozemlju.
English: They must also be able to impose them on wholesalers in other Member States on condition that they do not impose any obligation more stringent than those which they impose on their own wholesalers and provided that such obligations may be regarded as warranted on grounds of public health protection and are proportionate in relation to the objective of such protection.
Slovenian: Omogočeno jim mora biti, da te obveznosti nalagajo tudi trgovcem na debelo v drugih državah članicah pod pogojem, da obveznosti niso strožje od obveznosti, ki jih ta država nalaga svojim trgovcem na debelo in da se obveznosti lahko obravnavajo kot zajamčene na podlagi varovanja javnega zdravja ter, da so sorazmerne s cilji tovrstnega varovanja.
English: Rules should be laid down as to how the labelling and package leaflets are to be presented.
Slovenian: Določiti je treba predpise glede označevanja in navodil za uporabo.
English: The provisions governing the information supplied to users should provide a high degree of consumer protection, in order that medicinal products may be used correctly on the basis of full and comprehensible information.
Slovenian: Določbe, ki urejajo informacije za uporabnike, morajo zagotavljati visoko stopnjo varstva potrošnika, da se na podlagi popolnih in razumljivih informacij zdravila lahko pravilno uporabljajo.
English: The marketing of medicinal products whose labelling and package leaflets comply with this Directive should not be prohibited or impeded on grounds connected with the labelling or package leaflet.
Slovenian: Promet z zdravili, katerih označevanje in navodila za uporabo so v skladu s to direktivo, se ne sme prepovedati ali ovirati iz razlogov, povezanih z označevanjem ali navodilom za uporabo.
English: This Directive is without prejudice to the application of measures adopted pursuant to Council Directive 84/450/EEC of 10 September 1984 relating to the approximation of the laws, regulations and administrative provisions of the Member States concerning misleading advertising(17).
Slovenian: Ta direktiva ne posega v uporabo sprejetih ukrepov v skladu z Direktivo Sveta 84/450/EGS z dne 10. septembra 1984 o približevanje zakonov in drugih predpisov v državah članicah glede zavajajočega oglaševanja [17].
English: All Member States have adopted further specific measures concerning the advertising of medicinal products.
Slovenian: Vse države članice so sprejele dodatne posebne ukrepe v zvezi z oglaševanjem zdravil.
English: There are disparities between these measures.
Slovenian: Med temi ukrepi so neskladja.
English: These disparities are likely to have an impact on the functioning of the internal market, since advertising disseminated in one Member State is likely to have effects in other Member States.
Slovenian: Neskladja bi lahko vplivala na delovanje notranjega trga, saj ima oglaševanje v eni državi članici lahko vpliv v drugi državi članici.
English: Council Directive 89/552/EEC of 3 October 1989 on the coordination of certain provisions laid down by law, regulation or administrative action in Member States concerning the pursuit of television broadcasting activities(18) prohibits the television advertising of medicinal products which are available only on medical prescription in the Member State within whose jurisdiction the television broadcaster is located.
Slovenian: Direktiva Sveta 89/552/EGS z dne 3. oktobra 1989 o koordinaciji nekaterih določb, določenih z zakonom ali drugim predpisom v državah članicah glede izvajanja dejavnosti televizijskega oddajanja [18] prepoveduje televizijsko oglaševanje zdravil, ki se izdajajo le na zdravniški recept v državi članici, v katere pristojnost sodi televizijska postaja.
English: This principle should be made of general application by extending it to other media.
Slovenian: To načelo bi bilo treba razširiti na splošno še na druge medije.
English: Advertising to the general public, even of non-prescription medicinal products, could affect public health, were it to be excessive and ill-considered.
Slovenian: Tudi pri zdravilih brez recepta bi oglaševanje za širšo javnost lahko vplivalo na javno zdravje, če gre za prekomerno oglaševanje ali če je to slabo pripravljeno.
English: Advertising of medicinal products to the general public, where it is permitted, ought therefore to satisfy certain essential criteria which ought to be defined.
Slovenian: Oglaševanje zdravil širši javnosti bi moralo, kadar je dovoljeno, izpolnjevati nekatera pomembna merila, ki bi jih bilo treba opredeliti.
English: Furthermore, distribution of samples free of charge to the general public for promotional ends must be prohibited.
Slovenian: Prepovedati je treba brezplačno razdeljevanje vzorcev širši javnosti z namenom promocije.
English: The advertising of medicinal products to persons qualified to prescribe or supply them contributes to the information available to such persons.
Slovenian: Oglaševanje zdravil osebam, usposobljenim za predpisovanje ali izdajanje zdravil, prispeva k informiranosti teh oseb.
English: Nevertheless, this advertising should be subject to strict conditions and effective monitoring, referring in particular to the work carried out within the framework of the Council of Europe.
Slovenian: Kljub temu pa morajo za tovrstno oglaševanje veljati strogi pogoji in učinkovit nadzor, ki se nanaša zlasti na delo v okviru Sveta Evrope.
English: Advertising of medicinal products should be subject to effective, adequate monitoring.
Slovenian: Oglaševanje zdravil mora biti pod učinkovitim in ustreznim nadzorom.
English: Reference in this regard should be made to the monitoring mechanisms set up by Directive 84/450/EEC.
Slovenian: V tej zvezi je treba upoštevati mehanizme nadzora, ki jih opredeljuje Direktiva 84/450/EGS.
English: Medical sales representatives have an important role in the promotion of medicinal products.
Slovenian: Strokovni sodelavci za prodajo zdravil imajo pomembno vlogo pri promociji zdravil.
English: Therefore, certain obligations should be imposed upon them, in particular the obligation to supply the person visited with a summary of product characteristics.
Slovenian: Zato je treba tem osebam naložiti nekatere obveznosti, zlasti obvezno izročanje povzetka glavnih značilnosti zdravila osebi, ki jo obiščejo.
English: Persons qualified to prescribe medicinal products must be able to carry out these functions objectively without being influenced by direct or indirect financial inducements.
Slovenian: Osebe, usposobljene za predpisovanje zdravil, morajo biti sposobne opravljati svoje funkcije objektivno, nanje pa ne smejo vplivati posredni ali neposredni finančni motivi.
English: It should be possible within certain restrictive conditions to provide samples of medicinal products free of charge to persons qualified to prescribe or supply them so that they can familiarize themselves with new products and acquire experience in dealing with them.
Slovenian: V določenih omejenih pogojih bi moralo biti omogočeno dajanje brezplačnih vzorcev zdravil osebam, usposobljenim za predpisovanje ali izdajanje zdravil, da bi se lahko seznanile z novimi zdravili in pridobile izkušnje pri rokovanju z njimi.
English: Persons qualified to prescribe or supply medicinal products must have access to a neutral, objective source of information about products available on the market.
Slovenian: Osebe, usposobljene za predpisovanje ali izdajanje zdravil, morajo imeti dostop do nevtralnih, objektivnih virov informacij o zdravilih, ki so na voljo na trgu.
English: Whereas it is nevertheless for the Member States to take all measures necessary to this end, in the light of their own particular situation.
Slovenian: Kljub temu pa države članice same za ta namen sprejmejo vse potrebne ukrepe z vidika razmer v državi.
English: Each undertaking which manufactures or imports medicinal products should set up a mechanism to ensure that all information supplied about a medicinal product conforms with the approved conditions of use.
Slovenian: Vsa podjetja, ki izdelujejo ali uvažajo zdravila, bi morala vzpostaviti mehanizem za zagotavljanje skladnosti vseh informacij o zdravilu z odobrenimi pogoji uporabe.
English: In order to ensure the continued safety of medicinal products in use, it is necessary to ensure that pharmacovigilance systems in the Community are continually adapted to take account of scientific and technical progress.
Slovenian: Za zagotovitev stalne varnosti zdravil v uporabi je treba sisteme farmakovigilance v Skupnosti neprestano prilagajati ob upoštevanju znanstvenega in tehničnega napredka.
English: It is necessary to take account of changes arising as a result of international harmonisation of definitions, terminology and technological developments in the field of pharmacovigilance.
Slovenian: Upoštevati je treba spremembe, ki nastajajo kot posledica mednarodnega usklajevanja definicij, terminologije in tehnološkega razvoja na področju farmakovigilance.
English: The increasing use of electronic networks for communication of information on adverse reactions to medicinal products marketed in the Community is intended to allow competent authorities to share the information at the same time.
Slovenian: Naraščajoča uporaba elektronskih omrežij za posredovanje informacij o neželenih učinkih zdravil, ki so v prometu v Skupnosti, je namenjena pristojnim organom in omogoča, da so obveščeni vsi hkrati.
English: It is the interest of the Community to ensure that the pharmacovigilance systems for centrally authorised medicinal products and those authorised by other procedures are consistent.
Slovenian: V interesu Skupnosti je, da se zagotovi konsistentnost sistemov farmakovigilance za zdravila, ki so pridobila dovoljenje za promet po centraliziranem postopku in tista, ki so pridobila dovoljenje za promet po drugih postopkih.
English: Holders of marketing authorisations should be proactively responsible for on-going pharmacovigilance of the medicinal products they place on the market.
Slovenian: Imetniki dovoljenj za promet z zdravilom morajo biti proaktivno odgovorni za tekoče spremljanje farmakovigilance zdravil, ki so v prometu.
English: The measures necessary for the implementation of this Directive should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission(19).
Slovenian: Ukrepe, potrebne za izvajanje te direktive, je treba sprejeti v skladu z Odločbo Sveta 1999/468/ES z dne 28. junija 1999, ki določa postopke za izvrševanje pooblastil za izvajanje, danih Komisiji [19].
English: The Commission should be empowered to adopt any necessary changes to Annex I in order to take into account scientific and technical progress.
Slovenian: Komisijo je treba pooblastiti za sprejetje vseh potrebnih sprememb Priloge I ob upoštevanju znanstvenega in tehničnega napredka.
English: This Directive should be without prejudice to the obligations of the Member States concerning the time-limits for transposition of the Directives set out in Annex II, Part B.
Slovenian: Ta direktiva ne vpliva na obveznosti držav članic v zvezi s časovnimi roki za prenos direktiv, določenih v delu B Priloge II –
English: TITLE I
Slovenian: NASLOV 1
English: DEFINITIONS
Slovenian: OPREDELITVE POJMOV
English: For the purposes of this Directive, the following terms shall bear the following meanings:
Slovenian: V tej direktivi imajo naslednji izrazi naslednji pomen:
English: Any ready-prepared medicinal product placed on the market under a special name and in a special pack.
Slovenian: Vsako zdravilo, pripravljeno za uporabo, ki se daje v promet pod posebnim imenom in v posebni ovojnini.
English: Medicinal product:
Slovenian: Zdravilo :
English: Any substance or combination of substances presented for treating or preventing disease in human beings.
Slovenian: Vsaka snov ali kombinacija snovi, ki so namenjene za zdravljenje ali preprečevanje bolezni pri ljudeh.
English: Any substance or combination of substances which may be administered to human beings with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in human beings is likewise considered a medicinal product. 3. Substance:
Slovenian: Za zdravilo se šteje tudi vsaka snov ali kombinacija snovi, ki se lahko daje ljudem z namenom, da se določi diagnoza ali ponovno vzpostavijo, izboljšajo ali spremenijo fiziološke funkcije.
English: Any matter irrespective of origin which may be:
Slovenian: Snov - človeškega izvora, npr.
English: human, e.g. human blood and human blood products;
Slovenian: človeška kri in človeški krvni izdelki,
English: animal, e.g.
Slovenian: živalskega izvora, npr.
English: micro-organisms, whole animals, parts of organs, animal secretions, toxins, extracts, blood products;
Slovenian: mikroorganizmi, cele živali, deli organov, živalski izločki, strupi, izvlečki, krvni izdelki,
English: vegetable, e.g.
Slovenian: rastlinskega izvora, npr.
English: micro-organisms, plants, parts of plants, vegetable secretions, extracts;
Slovenian: mikroorganizmi, rastline, deli rastlin, rastlinski izločki, izvlečki,
English: chemical, e.g.
Slovenian: kemičnega izvora, npr.
English: elements, naturally occurring chemical materials and chemical products obtained by chemical change or synthesis. 4. Immunological medicinal product:
Slovenian: elementi, kemične snovi, ki se pojavljajo v določeni obliki v naravi, kemični izdelki, pridobljeni s kemično spremembo ali sintezo.
English: Any medicinal product consisting of vaccines, toxins, serums or allergen products: (a) vaccines, toxins and serums shall cover in particular:
Slovenian: Imunološka zdravila (a) cepiva, toksini in serumi zajemajo zlasti:
English: agents used to produce active immunity, such as cholera vaccine, BCG, polio vaccines, smallpox vaccine;
Slovenian: učinkovine, ki so sposobne izzvati aktivno imunost, kot npr. cepivo proti koleri, BCG, cepiva proti poliomielitisu, cepivo proti črnim kozam;