natgillin/translations-raw huggingface dataset:
Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114, and point (c) of Article 168(4), thereof,
ob upoštevanju Pogodbe o delovanju Evropske unije ter zlasti člena 114 in točke (c) člena 168(4) Pogodbe,
Directive 2001/83/EC of the European Parliament and of the Council [4] lays down the rules for, inter alia, manufacturing, importing, placing on the market, and the wholesale distribution of medicinal products in the Union as well as rules relating to active substances.
V Direktivi 2001/83/ES Evropskega parlamenta in Sveta [4] so med drugim določena pravila za proizvodnjo, uvoz, dajanje zdravil v promet in za promet z zdravili na debelo v Uniji in pravila glede zdravilnih učinkovin.
There is an alarming increase of medicinal products detected in the Union which are falsified in relation to their identity, history or source.
V Uniji se je zaskrbljujoče povečalo število odkritih zdravil, ki so ponarejena, kar zadeva njihovo istovetnost, zgodovino ali vir.
Those products usually contain sub-standard or falsified ingredients, or no ingredients or ingredients, including active substances, in the wrong dosage thus posing an important threat to public health.
Ta zdravila ponavadi vsebujejo sestavine slabše kakovosti ali ponarejene sestavine, ne vsebujejo sestavin ali vsebujejo sestavine, vključno z zdravilnimi učinkovinami, v napačnih odmerkih, zaradi česar zelo ogrožajo javno zdravje.
Past experience shows that such falsified medicinal products do not reach patients only through illegal means, but via the legal supply chain as well.
Izkušnje kažejo, da taka ponarejena zdravila do bolnikov ne pridejo samo po nezakonitih poteh, ampak tudi po zakoniti dobavni verigi.
This poses a particular threat to human health and may lead to a lack of trust of the patient also in the legal supply chain.
To še zlasti ogroža zdravje ljudi in lahko povzroči, da bolniki izgubijo zaupanje tudi v zakonito dobavno verigo.
Directive 2001/83/EC should be amended in order to respond to this increasing threat.
Kot odziv na to vedno večjo grožnjo bi bilo treba spremeniti Direktivo 2001/83/ES.
The threat to public health is also recognised by the World Health Organisation (WHO), which set up the International Medical Products Anti-Counterfeiting Taskforce (‘IMPACT’).
Grožnjo za javno zdravje priznava tudi Svetovna zdravstvena organizacija (SZO), ki je ustanovila Mednarodno skupino za boj proti ponarejanju zdravil (International Medical Products Anti-Counterfeiting Taskforce – IMPACT).
A definition of ‘falsified medicinal product’ should be introduced in order to clearly distinguish falsified medicinal products from other illegal medicinal products, as well as from products infringing intellectual property rights.
Treba bi bilo vključiti opredelitev „ponarejeno zdravilo“, da bi ponarejena zdravila jasno razlikovali od drugih nezakonitih zdravil, kakor tudi od produktov, ki kršijo pravice intelektualne lastnine.
Furthermore, medicinal products with unintentional quality defects resulting from manufacturing or distribution errors should not be confused with falsified medicinal products.
Poleg tega bi bilo treba ločevati med zdravili z nenamernimi napakami v kakovosti, do katerih pride zaradi napak v proizvodnji ali distribuciji, in ponarejenimi zdravili.
To ensure uniform application of this Directive, the terms ‘active substance’ and ‘excipient’ should also be defined.
Za zagotovitev enotnega izvajanja te direktive bi bilo treba opredeliti tudi izraza „zdravilna učinkovina“ in „pomožna snov“.
Persons procuring, holding, storing, supplying or exporting medicinal products are only entitled to pursue their activities if they meet the requirements for obtaining a wholesale distribution authorisation in accordance with Directive 2001/83/EC.
Osebe, ki nabavljajo, hranijo, skladiščijo, dobavljajo ali izvažajo zdravila, lahko svoje dejavnosti opravljajo le, če izpolnjujejo zahteve za pridobitev dovoljenja za promet na debelo v skladu z Direktivo 2001/83/ES.
However, today’s distribution network for medicinal products is increasingly complex and involves many players who are not necessarily wholesale distributors as referred to in that Directive.
Današnja distribucijska mreža za zdravila pa je vedno bolj zapletena in vključuje številne udeležence, ki niso nujno trgovci na debelo, kakor so opredeljeni v navedeni direktivi.
In order to ensure the reliability of the supply chain, legislation in relation to medicinal products should address all actors in the supply chain.
Da se zagotovi zanesljivost dobavne verige, bi morali biti v zakonodaji o zdravilih obravnavani vsi udeleženci dobavne verige.
This includes not only wholesale distributors, whether or not they physically handle the medicinal products, but also brokers who are involved in the sale or purchase of medicinal products without selling or purchasing those products themselves, and without owning and physically handling the medicinal products.
To ne zajema le trgovcev na debelo, ne glede na to, ali so v dejanskem stiku z zdravili, temveč tudi posrednike, ki so vključeni v prodajo ali nakup zdravila, ne da bi bili sami prodajalci ali kupci, in ki nimajo zdravil v lasti in nimajo stika z njimi.
Falsified active substances and active substances that do not comply with applicable requirements of Directive 2001/83/EC pose serious risks to public health.
Ponarejene zdravilne učinkovine in zdravilne učinkovine, ki niso v skladu z veljavnimi zahtevami Direktive 2001/83/ES, pomenijo resno tveganje za javno zdravje.
Those risks should be addressed by strengthening the verification requirements applicable to the manufacturer of the medicinal product.
To tveganje bi bilo treba obravnavati tako, da se proizvajalcem zdravil naložijo strožje zahteve za preverjanje.
There is a range of different good manufacturing practices that are suitable for being applied to the manufacturing of excipients.
Obstaja več vrst dobre proizvodne prakse, ki je primerna za proizvodnjo pomožnih snovi.
In order to provide for a high level of protection of public health, the manufacturer of the medicinal product should assess the suitability of excipients on the basis of appropriate good manufacturing practices for excipients.
Da bi dosegli visoko raven varstva javnega zdravja, bi morali proizvajalci zdravil oceniti primernost pomožnih snovi na podlagi ustrezne dobre proizvodne prakse za pomožna zdravila.
In order to facilitate enforcement of and control of compliance with Union rules relating to active substances, the manufacturers, importers or distributors of those substances should notify the competent authorities concerned of their activities.
Za lažje izvrševanje in nadzorovanje usklajenosti s pravili Unije v zvezi z zdravilnimi učinkovinami bi morali proizvajalci, uvozniki ali distributerji teh učinkovin priglasiti svoje dejavnosti pri ustreznih pristojnih organih.
Medicinal products may be introduced into the Union while not being intended to be imported, i.e. not intended to be released for free circulation.
Zdravila se lahko vnesejo v Unijo brez namena, da bi jih uvozili, tj. sprostili v prosti promet v Uniji.
If those medicinal products are falsified they present a risk to public health within the Union.
Če so ta zdravila ponarejena, pomenijo tveganje za javno zdravje v Uniji.
In addition, those falsified medicinal products may reach patients in third countries.
Poleg tega lahko ta ponarejena zdravila dosežejo bolnike v tretjih državah.
Member States should take measures to prevent these falsified medicinal products, if introduced into the Union, from entering into circulation.
Države članice bi morale sprejeti ukrepe, da bi tem ponarejenim zdravilom, če so vnesena v Unijo, preprečili sprostitev v promet v Uniji.
When adopting provisions supplementing this obligation on Member States to take those measures, the Commission should take account of the administrative resources available and the practical implications, as well as the need to maintain swift trade flows for legitimate medicinal products.
Komisija bi morala pri sprejemanju določb, ki dopolnjujejo obveznost držav članic, da sprejmejo ukrepe, upoštevati razpoložljive upravne vire držav članic in praktične posledice, pa tudi potrebo, da se ohrani nemoten trgovinski pretok pravih zdravil.
Those provisions should be without prejudice to customs legislation, to the distribution of competences between the Union and the Member States and to the distribution of responsibilities within Member States.
Te določbe ne bi smele posegati v carinsko zakonodajo, delitev pristojnosti med Unijo in državami članicami ter porazdelitev pristojnosti znotraj držav članic.
Safety features for medicinal products should be harmonised within the Union in order to take account of new risk profiles, while ensuring the functioning of the internal market for medicinal products.
V Uniji bi bilo treba uskladiti zaščitne elemente zdravil, da bi upoštevali nove profile tveganja, obenem pa zagotovili delovanje notranjega trga za zdravila.
Those safety features should allow verification of the authenticity and identification of individual packs, and provide evidence of tampering.
Ti zaščitni elementi bi morali omogočati preverjanje avtentičnosti in identifikacijo posameznih pakiranj ter zagotavljati dokaze nedovoljenega spreminjanja.
The scope of these safety features should take due account of the particularities of certain medicinal products or categories of medicinal products, such as generic medicinal products.
Pri področju uporabe teh zaščitnih elementov bi morali ustrezno upoštevati posebne značilnosti nekaterih zdravil ali kategorij zdravil, kot so generična zdravila.
Medicinal products subject to prescription should as a general rule bear the safety features.
Zdravila, ki se izdajajo na recept, bi praviloma morala nositi zaščitni element.
However, in view of the risk of falsification and the risk arising from falsification of medicinal products or categories of medicinal products there should be the possibility to exclude certain medicinal products or categories of medicinal products subject to prescription from the requirement to bear the safety features by way of a delegated act, following a risk assessment.
Glede na tveganje ponarejanja in tveganja, ki izvirajo iz ponareditev zdravil ali kategorij zdravil, bi morala obstajati možnost, da se po oceni tveganja nekatera zdravila ali kategorije zdravil na recept z delegiranim aktom izvzamejo iz obveznosti nositi zaščitni znak.
Safety features should not be introduced for medicinal products or categories of medicinal products not subject to prescription unless, by way of exception, an assessment shows the risk of falsification, which leads to serious consequences.
Zaščitni elementi se ne bi smeli uvesti za zdravila ali kategorije zdravil, ki se izdajajo brez recepta, razen če ocena izjemoma pokaže tveganje ponarejanja, ki bi lahko imelo resne posledice.
Those medicinal products should accordingly be listed in a delegated act.
Ta zdravila bi bilo treba uvrstiti na ustrezen seznam v delegiranem aktu.
The risk assessments should consider aspects such as the price of the medicinal product; previous cases of falsified medicinal products being reported in the Union and in third countries; the implications of a falsification for public health, taking into account the specific characteristics of the products concerned; and the severity of the conditions intended to be treated.
Pri ocenah tveganja bi bilo treba upoštevati vidike, kot so cena zdravila, pretekli zabeleženi primeri ponarejenih zdravil v Uniji in v tretjih državah, posledice ponaredkov za javno zdravje ob upoštevanju posebnih značilnosti zadevnih zdravil in resnost bolezni, katerih zdravljenju so namenjena.
The safety features should allow the verification of each supplied pack of the medicinal products, regardless of how they are supplied including through sale at a distance.
Zaščitni elementi bi morali omogočiti preverjanje vsakega dobavljenega zavitka zdravila, ne glede na to, kako je dobavljen, vključno s prodajo na daljavo.
The unique identifier as well as the corresponding repositories system should apply without prejudice to Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data [5] and should retain clear and effective safeguards whenever personal data is processed.
Edinstveno oznako in ustrezni sistem arhivov bi bilo treba uporabljati brez poseganja v Direktivo Evropskega parlamenta in Sveta 95/46/ES z dne 24. oktobra 1995 o varstvu posameznikov pri obdelavi osebnih podatkov in o prostem pretoku takih podatkov [5] in bi morala, kadar se obdelujejo osebni podatki, vsebovati jasne in učinkovite zaščitne ukrepe.
The repositories system containing information on safety features might include commercially sensitive information.
Sistemi arhivov, ki vsebujejo informacije o zaščitnih elementih, bi lahko vsebovali trgovsko občutljive informacije.
This information must be appropriately protected.
Te informacije morajo biti primerno varovane.
When introducing the obligatory safety features, due account should be taken of the particular characteristics of the supply chains in Member States.(12) Any actor in the supply chain who packages medicinal products has to be a holder of a manufacturing authorisation.
Kadar se uvajajo obvezni zaščitni elementi, bi se moralo primerno upoštevati posebne značilnosti dobavnih verig v državah članicah.(12) Vsak udeleženec dobavne verige, ki pakira zdravila, mora biti imetnik dovoljenja za proizvodnjo.
In order for the safety features to be effective, a manufacturing authorisation holder who is not himself the original manufacturer of the medicinal product should only be permitted to remove, replace or cover those safety features under strict conditions.
Da bi bili zaščitni elementi učinkoviti, bi imetnik dovoljenja za proizvodnjo, ki sam ni izvirni proizvajalec zdravila, lahko odstranil, nadomestil ali prekril te zaščitne elemente samo pod strogimi pogoji.
In particular, the safety features should be replaced in the case of repackaging by equivalent safety features.
V primeru ponovnega pakiranja bi bilo zlasti treba nadomestiti zaščitne elemente z enakovrednimi zaščitnimi elementi.
To this end, the meaning of the term ‘equivalent’ should be clearly specified.
V ta namen bi bilo treba jasno navesti pomen izraza „enakovreden“.
Those strict conditions should provide adequate safeguards against falsified medicinal products entering the supply chain, in order to protect patients as well as the interests of marketing authorisation holders and manufacturers.
S temi strogimi pogoji bi zagotovili ustrezne zaščitne ukrepe pred vstopom ponarejenih zdravil v dobavno verigo, da bi zaščitili bolnike, pa tudi interese imetnikov dovoljenja za promet in proizvajalcev.
Manufacturing authorisation holders who repackage medicinal products should be liable for damages in the cases and under the conditions set out in Council Directive 85/374/EEC of 25 July 1985 on the approximation of the laws, regulations and administrative provisions of the Member States concerning liability for defective products [6].
Imetniki dovoljenja za proizvodnjo, ki zdravila prepakirajo, bi morali biti odgovorni za škodo v primerih in pod pogoji iz Direktive Sveta 85/374/EGS z dne 25. julija 1985 o približevanju zakonov in drugih predpisov držav članic v zvezi z odgovornostjo za proizvode z napako [6].
In order to increase reliability in the supply chain, wholesale distributors should verify that their supplying wholesale distributors are holders of a wholesale distribution authorisation.
Za povečanje zanesljivosti v dobavni verigi bi morali trgovci na debelo preveriti, ali imajo trgovci na debelo, ki dobavljajo njim, dovoljenje za promet na debelo.
The provisions applicable to the export of medicinal products from the Union and those applicable to the introduction of medicinal products into the Union with the sole purpose of exporting them need to be clarified.
Pojasniti je treba določbe, ki veljajo za izvoz zdravil iz Unije, in tiste, ki veljajo za vnos zdravil v Unijo z izključnim namenom izvoza.
Under Directive 2001/83/EC a person exporting medicinal products is a wholesale distributor.
V skladu z Direktivo 2001/83/ES je trgovec na debelo oseba, ki izvaža zdravila.
The provisions applicable to wholesale distributors as well as good distribution practices should apply to all those activities whenever they are performed on Union territory, including in areas such as free trade zones or free warehouses.
Določbe, ki se uporabljajo za trgovce na debelo ter dobre distribucijske prakse, bi se morale uporabljati za vse te dejavnosti, kadar koli se opravljajo na ozemlju Unije, vključno z območji, kot so prostotrgovinska območja ali skladišča.
In order to ensure transparency, a list of wholesale distributors for whom it has been established that they comply with applicable Union legislation by means of an inspection by a competent authority of a Member State, should be published in a database that should be established at Union level.
Za zagotovitev preglednosti bi bilo treba v podatkovni zbirki, ki bi se morala oblikovati na ravni Unije, objaviti seznam trgovcev na debelo, za katere je bilo po inšpekcijskem pregledu pristojnega organa države članice ugotovljeno, da so v skladu z veljavno zakonodajo Unije.
The provisions on inspections and controls of all actors involved in the manufacturing and supply of medicinal products and their ingredients should be clarified and specific provisions should apply to different types of actors.
Določbe za inšpekcijske preglede in kontrole vseh udeležencev v proizvodnji ter dobavi zdravil in njihovih sestavin bi bilo treba pojasniti in za različne vrste udeležencev bi morale veljati posebne določbe.
This should not prevent Member States from performing additional inspections, where considered appropriate.
To državam članicam ne bi smelo preprečiti, da opravijo dodatne inšpekcijske preglede, kadar so po njihovem mnenju ti potrebni.
In order to ensure a similar level of protection of human health throughout the Union, and to avoid distortions in the internal market, the harmonised principles and guidelines for inspections of manufacturers and wholesale distributors of medicinal products as well as of active substances should be strengthened.
Da bi se zagotovila podobna raven varovanja zdravja ljudi v vsej Uniji in preprečilo izkrivljanje na notranjem trgu, bi bilo treba okrepiti usklajena načela in smernice za inšpekcijske preglede proizvajalcev zdravil in trgovcev zdravil na debelo ter proizvajalcev zdravilnih učinkovin in trgovcev zdravilnih učinkovin na debelo.
Such harmonised principles and guidelines should also help to ensure the functioning of existing mutual recognition agreements with third countries whose application depends on efficient and comparable inspection and enforcement throughout the Union.
Ta usklajena načela in smernice bi morale prispevati tudi k zagotavljanju delovanja veljavnih sporazumov s tretjimi državami o vzajemnem priznavanju, katerih uporaba je odvisna od učinkovitih in primerljivih inšpekcijskih pregledov ter izvrševanja v vsej Uniji.
Manufacturing plants of active substances should be subject not only to inspections carried out on the grounds of suspected non-compliance but also on the basis of a risk-analysis.
V obratih za proizvodnjo zdravilnih učinkovin bi se morali izvajati inšpekcijski pregledi, ki ne potekajo le na podlagi suma o neizpolnjevanju zahtev, ampak tudi na podlagi analize tveganja.
The manufacture of active substances should be subject to good manufacturing practice regardless of whether those active substances are manufactured in the Union or imported.
Proizvodnja zdravilnih učinkovin bi morala biti skladna z dobrimi proizvodnimi praksami ne glede na to, ali se te zdravilne učinkovine proizvajajo v Uniji ali uvažajo.
With regard to the manufacture of active substances in third countries, it should be ensured that the legislative provisions applicable to the manufacturing of active substances intended for export to the Union, as well as inspections of facilities and enforcement of the applicable provisions, provide for a level of protection of public health equivalent to that provided for by Union law.
V zvezi s proizvodnjo zdravilnih učinkovin v tretjih državah bi bilo treba zagotoviti, da zakonodajne določbe, ki veljajo za proizvodnjo zdravilnih učinkovin, namenjenih za izvoz v Unijo, ter za inšpekcijske preglede objektov in izvrševanje veljavnih določb, omogočajo raven varovanja javnega zdravja, ki je enakovredna ravni, določeni v zakonodaji Unije.
The illegal sale of medicinal products to the public via the Internet is an important threat to public health as falsified medicinal products may reach the public in this way.
Nezakonita spletna prodaja zdravil javnosti je velika grožnja javnemu zdravju, saj lahko na ta način v javnost pridejo ponarejena zdravila.
It is necessary to address this threat.
To grožnjo je treba obravnavati.
In doing so, account should be taken of the fact that specific conditions for retail supply of medicinal products to the public have not been harmonised at Union level and, therefore, Member States may impose conditions for supplying medicinal products to the public within the limits of the Treaty on the Functioning of the European Union (TFEU).
Pri tem bi bilo treba upoštevati, da nekateri pogoji za promet z zdravili na drobno niso bili usklajeni na ravni Unije in lahko zato države članice uvedejo pogoje za izdajanje zdravil javnosti v okviru Pogodbe o delovanju Evropske unije (PDEU).
When examining the compatibility with Union law of the conditions for the retail supply of medicinal products, the Court of Justice of the European Union (‘the Court of Justice’) has recognised the very particular nature of medicinal products, whose therapeutic effects distinguish them substantially from other goods.
Pri preučevanju skladnosti pogojev za promet z zdravili na drobno s pravom Unije je Sodišče Evropske unije (Sodišče) priznalo posebno naravo zdravil, ki se po svojih zdravilnih učinkih bistveno razlikujejo od drugega blaga.
The Court of Justice has also held that health and life of humans rank foremost among the assets and interests protected by the TFEU and that it is for Member States to determine the level of protection which they wish to afford to public health and the way in which that level has to be achieved.
Sodišče je tudi potrdilo, da sta zdravje in življenje ljudi na prvem mestu med sredstvi in interesi, ki jih ščiti PDEU, ter da morajo države članice določiti raven varovanja, ki jo želijo zagotoviti javnemu zdravju, ter način, na katerega bo ta raven dosežena.
Since that level may vary from one Member State to another, Member States must be allowed discretion [7] as regards the conditions for the supply on their territory of medicinal products to the public.
Ker se lahko ta raven med državami članicami razlikuje, jim je treba dopustiti presojo [7] glede pogojev za izdajanje zdravil javnosti na njihovem ozemlju.
In particular, in the light of the risks to public health and given the power accorded to Member States to determine the level of protection of public health, the case-law of the Court of Justice has recognised that Member States may, in principle, restrict the retail sale of medicinal products to pharmacists alone [8].
S sodno prakso Sodišča je ob upoštevanju tveganja za javno zdravje in glede na pristojnost, dodeljeno državam članicam, da določijo raven varovanja javnega zdravja, zlasti priznano, da države članice načeloma lahko omejijo prodajo zdravil na drobno zgolj na farmacevte [8].
Therefore, and in the light of the case-law of the Court of Justice, Member States should be able to impose conditions justified by the protection of public health upon the retail supply of medicinal products offered for sale at a distance by means of information society services.
Zaradi tega in glede na sodno prakso Sodišča naj bi bilo državam članicam omogočeno, da uvedejo pogoje, utemeljene z razlogi varovanja javnega zdravja, za promet z zdravili na drobno, ki se ponujajo v prodajo na daljavo prek storitev informacijske družbe.