natgillin/translations-raw huggingface dataset:
Such conditions should not unduly restrict the functioning of the internal market.
Ti pogoji ne bi smeli po nepotrebnem omejevati delovanja notranjega trga.
The public should be assisted in identifying websites which are legally offering medicinal products for sale at a distance to the public.
Javnosti bi bilo treba pomagati pri prepoznavanju spletnih mest, ki zakonito ponujajo zdravila v prodajo na daljavo.
A common logo should be established, which is recognisable throughout the Union, while allowing for the identification of the Member State where the person offering medicinal products for sale at a distance is established.
Oblikovati bi bilo treba skupni logotip, prepoznaven po vsej Uniji, pri tem pa omogočiti prepoznavo države članice, v kateri ima sedež oseba, ki ponuja zdravila v prodajo na daljavo.
The Commission should develop the design for such a logo.
Komisija bi morala pripraviti zasnovo tega logotipa.
Websites offering medicinal products for sale at a distance to the public should be linked to the website of the competent authority concerned.
Spletna mesta, ki javnosti ponujajo zdravila v prodajo na daljavo, bi morala biti povezana s spletnim mestom zadevnega pristojnega organa.
The websites of the competent authorities of Member States, as well as that of the European Medicines Agency (‘the Agency’), should give an explanation of the use of the logo.
Uporaba logotipa bi morala biti pojasnjena na spletnih mestih pristojnih organov držav članic, pa tudi na spletnem mestu Evropske agencije za zdravila (Agencija).
All those websites should be linked in order to provide comprehensive information to the public.
Vsa ta spletna mesta bi morala biti povezana, da bi javnosti zagotovili obsežne informacije.
In addition, the Commission should, in cooperation with the Agency and Member States, run awareness campaigns to warn of the risks of purchasing medicinal products from illegal sources via the Internet.
Poleg tega bi morala Komisija v sodelovanju z Agencijo in državami članicami organizirati kampanje ozaveščanja, da bi opozorila na tveganje spletnega nakupa zdravil pri nezakonitih virih.
Member States should impose effective penalties for acts involving falsified medicinal products taking into account the threat to public health posed by those products.
Države članice bi morale uvesti učinkovite kazni za dejanja, povezana s ponarejenimi zdravili, pri tem pa upoštevati njihovo tveganje za javno zdravje.
The falsification of medicinal products is a global problem, requiring effective and enhanced international coordination and cooperation in order to ensure that anti-falsification strategies are more effective, in particular as regards sale of such products via the Internet.
Ponarejanje zdravil je svetovni problem, ki zahteva učinkovito in okrepljeno mednarodno usklajevanje in sodelovanje, da bi zagotovili večjo učinkovitost strategij proti ponarejanju, zlasti glede spletne prodaje teh zdravil.
To that end, the Commission and the Member States should cooperate closely and support ongoing work in international fora on this subject, such as the Council of Europe, Europol and the United Nations.
V ta namen bi morale Komisija in države članice tesneje sodelovati in podpreti delo na to temo v mednarodnih forumih, kot so Svet Evrope, Europol in Združeni narodi.
In addition, the Commission, working closely with Member States, should cooperate with the competent authorities of third countries with a view to effectively combating the trade in falsified medicinal products at a global level.
Poleg tega bi morala Komisija v tesnem sodelovanju z državami članicami sodelovati s pristojnimi organi tretjih držav, da bi učinkovito preprečevala trgovanje s ponarejenimi zdravili na svetovni ravni.
This Directive is without prejudice to provisions concerning intellectual property rights.
Ta direktiva ne posega v določbe o pravicah intelektualne lastnine.
It aims specifically to prevent falsified medicinal products from entering the legal supply chain.
Njen izrecni cilj je preprečevati vstop ponarejenih zdravil v zakonito dobavno verigo.
The Commission should be empowered to adopt delegated acts in accordance with Article 290 TFEU in order to supplement the provisions of Directive 2001/83/EC, as amended by this Directive, concerning good manufacturing and distribution practices for active substances, concerning detailed rules for medicinal products introduced into the Union without being imported and concerning safety features.
Komisijo bi bilo treba pooblastiti, da v skladu s členom 290 PDEU sprejme delegirane akte, da bi dopolnila določbe Direktive 2001/83/ES, kakor je spremenjena s to direktivo, o dobrih proizvodnih in distribucijskih praksah za zdravilne učinkovine, o natančnih pravilih za zdravila, ki so vnesena v Unijo, vendar niso uvožena, ter o zaščitnih elementih.
The Commission, when preparing and drawing up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and Council.
Komisija bi morala pri pripravi in oblikovanju delegiranih aktov zagotoviti hkratno, pravočasno in ustrezno posredovanje ustreznih dokumentov Evropskemu parlamentu in Svetu.
In order to ensure uniform conditions for implementation, implementing powers should be conferred on the Commission as regards the adoption of measures for the assessment of the regulatory framework applicable to the manufacturing of active substances exported from third countries to the Union and as regards a common logo that identifies websites which are legally offering medicinal products for sale at a distance to the public.
Za zagotovitev enotnih pogojev izvajanja bi bilo treba na Komisijo prenesti izvedbena pooblastila v zvezi s sprejetjem ukrepov za oceno regulativnega okvira, veljavnega za proizvodnjo zdravilnih učinkovin, ki se izvažajo iz tretjih držav v Unijo, in v zvezi s skupnim logotipom, s katerimi se prepoznajo spletna mesta, ki javnosti zakonito ponujajo zdravila v prodajo na daljavo.
Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers [9].
Ta pooblastila bi bilo treba izvajati v skladu z Uredbo (EU) št. 182/2011 Evropskega parlamenta in Sveta z dne 16. februarja 2011 o določitvi splošnih pravil in načel, na podlagi katerih države članice nadzirajo izvajanje izvedbenih pooblastil Komisije [9].
The safety features for medicinal products introduced under this Directive require substantial adaptations to manufacturing processes.
Zaradi zaščitnih elementov zdravil, uvedenih v skladu s to direktivo, so potrebne velike prilagoditve proizvodnih procesov.
In order to enable manufacturers to make those adaptations, the time limits for the application of the provisions on the safety features should be sufficiently long and should be calculated as from the date of publication in the Official Journal of the European Union of the delegated acts setting out detailed rules in relation to those safety features.
Da bi proizvajalcem omogočili izvrševanje teh prilagoditev, bi morali biti roki za izvajanje pravil o zaščitnih elementih dovolj dolgi in bi se morali šteti od dneva objave delegiranega akta, ki podrobneje določa te zaščitne elemente, v Uradnem listu Evropske unije.
It should also be taken into account that some Member States already have a national system in place.
Poleg tega bi bilo treba upoštevati, da imajo nekatere države članic že vzpostavljen veljaven nacionalni sistem.
Those Member States should be granted an additional transitional period for adapting to the harmonised Union system.
Tem državam članicam bi bilo treba omogočiti dodatno prehodno obdobje za prilagoditev na usklajen sistem Unije.
Since the objective of this Directive, namely to safeguard the functioning of the internal market for medicinal products, whilst ensuring a high level of protection of public health against falsified medicinal products, cannot be sufficiently achieved by the Member States, and can, by reason of the scale of the measure, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union.
Ker cilja te direktive, in sicer zagotavljanja delovanja notranjega trga za zdravila ob zagotavljanju visoke ravni varovanja javnega zdravja pred ponarejenimi zdravili, države članice ne morejo zadovoljivo doseči in ker se ta cilj zaradi obsega ukrepa lažje doseže na ravni Unije, lahko Unija sprejme ukrepe v skladu z načelom subsidiarnosti iz člena 5 Pogodbe o Evropski uniji.
It is important that the competent authorities of the Member States, the Commission and the Agency cooperate to ensure the exchange of information on measures taken to combat the falsification of medicinal products and on the penalties systems that are in place.
Pomembno je, da pristojni organi držav članic, Komisija in Agencija sodelujejo, da zagotovijo izmenjavo informacij o sprejetih ukrepih za boj proti ponarejanju zdravil, vključno z veljavnimi sistemi kaznovanja.
Currently, such exchange takes place through the Working Group of Enforcement Officers.
Trenutno ta izmenjava poteka prek delovne skupine uradnikov za izvrševanje – Working Group of Enforcement Officers.
Member States should ensure that patients’ and consumers’ organisations are kept informed about enforcement activities to the extent that this is compatible with operational needs.
Države članice bi morale zagotoviti, da so organizacije bolnikov in potrošnikov obveščene o dejavnostih izvrševanja, v kolikor je to skladno z operativnimi potrebami.
In accordance with point 34 of the Interinstitutional Agreement on better law-making [10], Member States are encouraged to draw up, for themselves and in the interests of the Union, their own tables illustrating, as far as possible, the correlation between this Directive and the transposition measures, and to make them public.
V skladu s točko 34 Medinstitucionalnega sporazuma o boljši pripravi zakonodaje [10] se države članice poziva, da za lastne potrebe in v interesu Unije pripravijo tabele, ki naj kar najbolj nazorno prikazujejo korelacijo med to direktivo in ukrepi za prenos, ter da te tabele objavijo.
Directive 2001/83/EC was recently amended by Directive 2010/84/EU [11] as regards pharmacovigilance.
Direktiva 2001/83/ES je bila pred kratkim spremenjena z Direktivo 2010/84/EU [11], in sicer v zvezi s farmakovigilanco.
That Directive, inter alia, amended Article 111 with regard to inspections and Article 116 with regard to the suspension and revocation and variation of marketing authorisations under certain circumstances.
Navedena direktiva je med drugim spremenila člen 111 glede inšpekcijskih pregledov ter člen 116 glede začasnega preklica in razveljavitve ter sprememb dovoljenja za promet z zdravilom pod določenimi pogoji.
Furthermore, it inserted provisions on delegated acts in Articles 121a, 121b and 121c of Directive 2001/83/EC.
Poleg tega je uvedla določbe o delegiranih aktih v členih 121a, 121b in 121c Direktive 2001/83/ES.
This Directive requires some further and complementary changes to those Articles of Directive 2001/83/EC.
Ta direktiva zahteva nekatere nadaljnje in dopolnilne spremembe členov Direktive 2001/83/ES.
Directive 2001/83/EC should be amended accordingly,
Direktivo 2001/83/ES bi bilo treba ustrezno spremeniti –
Any substance or mixture of substances intended to be used in the manufacture of a medicinal product and that, when used in its production, becomes an active ingredient of that product intended to exert a pharmacological, immunological or metabolic action with a view to restoring, correcting or modifying physiological functions or to make a medical diagnosis.
Vsaka snov ali mešanica snovi, namenjena uporabi v proizvodnji zdravil, ki z uporabo v proizvodnji zdravila postane njegova zdravilna učinkovina, katere namen je farmakološko, imunološko ali presnovno delovanje, da bi se ponovno vzpostavile, izboljšale ali spremenile fiziološke funkcije ali da bi se določila diagnoza.
Excipient:
Pomožna snov:
Any constituent of a medicinal product other than the active substance and the packaging material.’;
Vsaka sestavina zdravila, ki ni zdravilna učinkovina ali ovojnina.“;
Brokering of medicinal products:
Posredovanje zdravil:
All activities in relation to the sale or purchase of medicinal products, except for wholesale distribution, that do not include physical handling and that consist of negotiating independently and on behalf of another legal or natural person.’;
Vse dejavnosti, ki so povezane s prodajo ali nabavo zdravil, razen prometa na debelo, ki ne vključujejo stika z zdravilom in predstavljajo neodvisno posredovanje v imenu druge pravne ali fizične osebe.“;
Falsified medicinal product:
Ponarejeno zdravilo:
Any medicinal product with a false representation of:
Vsako zdravilo, ki lažno predstavlja:
its identity, including its packaging and labelling, its name or its composition as regards any of the ingredients including excipients and the strength of those ingredients;
svojo istovetnost, vključno z ovojnino in oznako, imenom ali sestavo glede katere koli od svojih sestavin, vključno s pomožnimi snovmi, in jakostjo teh sestavin;
its source, including its manufacturer, its country of manufacturing, its country of origin or its marketing authorisation holder; or
svoj izvor, vključno s proizvajalcem, državo proizvodnje, državo izvora ali imetnikom dovoljenja za promet z njim, ali
its history, including the records and documents relating to the distribution channels used.
svojo zgodovino, vključno z zapisi in dokumentacijo o uporabljenih distribucijskih poteh.
This definition does not include unintentional quality defects and is without prejudice to infringements of intellectual property rights.’;
Ta opredelitev ne zajema nenamernih napak v kakovosti in ne posega v kršitve pravic intelektualne lastnine.“;
in Article 2, paragraph 3 is replaced by the following:
v členu 2 se odstavek 3 nadomesti z naslednjim:
Notwithstanding paragraph 1 of this Article and Article 3(4), Title IV of this Directive shall apply to the manufacture of medicinal products intended only for export and to intermediate products, active substances and excipients.
Ne glede na odstavek 1 tega člena in člen 3(4) se naslov IV te direktive uporablja za proizvodnjo zdravil, ki so namenjena samo za izvoz, in intermediate, zdravilne učinkovine ter pomožne snovi.
Paragraph 1 shall be without prejudice to Articles 52b and 85a.’;
Odstavek 1 ne posega v člena 52b in 85a.“;
in Article 8(3), the following point is inserted:
v členu 8(3) se vstavi naslednja točka:
A written confirmation that the manufacturer of the medicinal product has verified compliance of the manufacturer of the active substance with principles and guidelines of good manufacturing practice by conducting audits, in accordance with point (f) of Article 46.
Pisno potrdilo, da je proizvajalec zdravila preveril skladnost proizvajalca zdravilne učinkovine z načeli in smernicami dobre proizvodne prakse z izvedbo presoj v skladu s točko (f) člena 46.
The written confirmation shall contain a reference to the date of the audit and a declaration that the outcome of the audit confirms that the manufacturing complies with the principles and guidelines of good manufacturing practice.’;
Pisno potrdilo vsebuje sklicevanje na datum presoje in izjavo, da je izid presoje potrdil, da proizvodnja poteka v skladu z načeli in smernicami dobre proizvodne prakse.“;
in Article 40, paragraph 4 is replaced by the following:
v členu 40 se odstavek 4 nadomesti z naslednjim:
Member States shall enter the information relating to the authorisation referred to in paragraph 1 of this Article in the Union database referred to in Article 111(6).’;
Države članice vnesejo informacije v zvezi z dovoljenjem iz odstavka 1 tega člena v podatkovno bazo Unije iz člena 111(6).“;
in Article 46, point (f) is replaced by the following:
v členu 46 se točka (f) nadomesti z naslednjim:
to comply with the principles and guidelines of good manufacturing practice for medicinal products and to use only active substances, which have been manufactured in accordance with good manufacturing practice for active substances and distributed in accordance with good distribution practices for active substances.
upoštevati načela in smernice dobre proizvodne prakse za zdravila in uporabljati samo zdravilne učinkovine, ki so bile proizvedene v skladu s smernicami dobre proizvodne prakse za zdravilne učinkovine in je njihova distribucija potekala v skladu z dobro distribucijsko prakso za zdravilne učinkovine.
To this end, the holder of the manufacturing authorisation shall verify compliance by the manufacturer and distributors of active substances with good manufacturing practice and good distribution practices by conducting audits at the manufacturing and distribution sites of the manufacturer and distributors of active substances.
V ta namen imetnik dovoljenja za proizvodnjo preveri skladnost proizvajalca in distributerjev zdravilnih učinkovin z dobro proizvodno prakso in dobrimi distribucijskimi praksami, in sicer z opravljanjem revizij na kraju proizvodnje in distribucije proizvajalcev in distributerjev zdravilnih učinkovin.
The holder of the manufacturing authorisation shall verify such compliance either by himself or, without prejudice to his responsibility as provided for in this Directive, through an entity acting on his behalf under a contract.
Imetnik dovoljenja za proizvodnjo preveri takšno skladnost sam ali pa, ne da bi to posegalo v njegovo odgovornost iz te direktive, preko subjekta, ki preko pogodbe deluje v njegovem imenu.
The holder of the manufacturing authorisation shall ensure that the excipients are suitable for use in medicinal products by ascertaining what the appropriate good manufacturing practice is.
Imetnik dovoljenja za proizvodnjo zagotovi, da so pomožne snovi primerne za uporabo v zdravilih, in sicer z določitvijo, kaj je ustrezna dobra proizvodna praksa.
This shall be ascertained on the basis of a formalised risk assessment in accordance with the applicable guidelines referred to in the fifth paragraph of Article 47.
To se določi na podlagi formalizirane ocene tveganja v skladu z veljavnimi smernicami iz petega odstavka člena 47.
Such risk assessment shall take into account requirements under other appropriate quality systems as well as the source and intended use of the excipients and previous instances of quality defects.
Ta ocena tveganja upošteva zahteve drugih ustreznih sistemov kakovosti kakor tudi vir in predvideno uporabo pomožnih snovi ter predhodne primere napak v kakovosti.
The holder of the manufacturing authorisation shall ensure that the appropriate good manufacturing practice so ascertained, is applied.
Imetnik dovoljenja za proizvodnjo zagotovi, da se uporablja tako določena dobra proizvodna praksa.
The holder of the manufacturing authorisation shall document the measures taken under this paragraph;
Imetnik dovoljenja za proizvodnjo dokumentira ukrepe, povzete v skladu s tem odstavkom;
to inform the competent authority and the marketing authorisation holder immediately if he obtains information that medicinal products which come under the scope of his manufacturing authorisation are, or are suspected of being, falsified irrespective of whether those medicinal products were distributed within the legal supply chain or by illegal means, including illegal sale by means of information society services;
nemudoma obvestiti pristojni organ in imetnika dovoljenja za promet z zdravilom, če pridobi informacije, da so zdravila, ki sodijo v okvir njegovega dovoljenja za proizvodnjo, ponarejena ali zanje obstaja sum, da so ponarejena, ne glede na to, ali je distribucija teh zdravil potekala po zakoniti dobavni verigi ali na nezakonit način, vključno s tistimi, ki se nezakonito prodajajo s sredstvi storitev informacijske družbe;
to verify that the manufacturers, importers or distributors from whom he obtains active substances are registered with the competent authority of the Member State in which they are established;
preveriti, da so proizvajalci, uvozniki ali distributerji, od katerih so pridobili zdravilne učinkovine, registrirani pri pristojnem organu države članice, v kateri imajo sedež;
to verify the authenticity and quality of the active substances and the excipients.’;
preveriti avtentičnost in kakovost zdravilnih učinkovin in pomožnih snovi.“;
‘Article 46b
„Člen 46b
Member States shall take appropriate measures to ensure that the manufacture, import and distribution on their territory of active substances, including active substances that are intended for export, comply with good manufacturing practice and good distribution practices for active substances.
Države članice sprejmejo ustrezne ukrepe, da zagotovijo, da so proizvodnja, uvoz in distribucija zdravilnih učinkovin na njihovem ozemlju, vključno z zdravilnimi učinkovinami, namenjenimi izvozu, skladni z dobro proizvodno prakso in dobrimi distribucijskimi praksami za zdravilne učinkovine.
Active substances shall only be imported if the following conditions are fulfilled:
Zdravilne učinkovine se uvozijo samo, če so izpolnjeni naslednji pogoji:
the active substances have been manufactured in accordance with standards of good manufacturing practice at least equivalent to those laid down by the Union pursuant to the third paragraph of Article 47; and
zdravilne učinkovine so bile proizvedene v skladu s standardi dobre proizvodne prakse, ki so najmanj enakovredni tistim, ki jih določa Unija v skladu s tretjim odstavkom člena 47, ter
the active substances are accompanied by a written confirmation from the competent authority of the exporting third country of the following:
zdravilnim učinkovinam je priloženo pisno potrdilo pristojnega organa iz tretje države izvoza, da:
the standards of good manufacturing practice applicable to the plant manufacturing the exported active substance are at least equivalent to those laid down by the Union pursuant to the third paragraph of Article 47;
so standardi dobre proizvodne prakse, ki se uporabljajo za obrat, v katerem se izdeluje izvožena zdravilna učinkovina, vsaj enakovredni standardom, ki jih določa Unija v skladu s tretjim odstavkom člena 47;
the manufacturing plant concerned is subject to regular, strict and transparent controls and to the effective enforcement of good manufacturing practice, including repeated and unannounced inspections, so as to ensure a protection of public health at least equivalent to that in the Union; and
se na zadevnem proizvodnem obratu izvaja reden, strog in pregleden nadzor ter se v njem učinkovito izvršuje dobra proizvodnja praksa, vključno z večkratnimi in nenapovedanimi inšpekcijskimi pregledi, kar zagotavlja varovanje javnega zdravja na ravni, vsaj enakovredni tisti v Uniji, in
in the event of findings relating to non-compliance, information on such findings is supplied by the exporting third country to the Union without any delay.
v primeru ugotovitve neskladnosti, tretja država izvoznica informacije o tej ugotovitvi nemudoma pošlje Uniji.
This written confirmation shall be without prejudice to the obligations set out in Article 8 and in point (f) of Article 46.
Ta pisna izjava ne posega v obveznosti iz člena 8 ter točke (f) člena 46.
The requirement set out in point (b) of paragraph 2 of this Article shall not apply if the exporting country is included in the list referred to in Article 111b.
Zahteva, določena v točki (b) odstavka 2 tega člena, se ne uporablja, če je država izvoza uvrščena na seznam iz člena 111b.