natgillin/translations-raw huggingface dataset:
Member States shall enter the information relating to the authorisations referred to in paragraph 1 of this Article in the Union database referred to in Article 111(6).
Države članice informacije o dovoljenju iz odstavka 1 tega člena vnesejo v podatkovno bazo Unije iz člena 111(6).
At the request of the Commission or any Member State, Member States shall provide all appropriate information concerning the individual authorisations which they have granted under paragraph 1 of this Article.
Države članice na zahtevo Komisije ali katere koli države članice zagotovijo vse ustrezne informacije o posameznih dovoljenjih, ki so jih izdale v skladu z odstavkom 1 tega člena.
Checks on the persons authorised to engage in activity as a wholesaler in medicinal products, and the inspection of their premises, shall be carried out under the responsibility of the Member State which granted the authorisation for premises located on its territory.’;
Preverjanja oseb, ki so pooblaščene za opravljanje dejavnosti prometa z zdravili na debelo, ter inšpekcijski pregled njihovih prostorov potekajo pod odgovornostjo države članice, ki je izdala dovoljenje za prostore na njenem ozemlju.“;
Article 80 is amended as follows:
člen 80 se spremeni:
they must verify that the medicinal products received are not falsified by checking the safety features on the outer packaging, in accordance with the requirements laid down in the delegated acts referred to in Article 54a(2);’;
s preverjanjem zaščitnih elementov na zunanji ovojnini v skladu z zahtevami iz delegiranih aktov, navedenih v členu 54a(2), morajo preveriti, da zdravila, ki so jih dobili, niso ponarejena;“;
they must keep records either in the form of purchase/sales invoices or on computer, or in any other form, giving for any transaction in medicinal products received, dispatched or brokered at least the following information:
voditi morajo dokumentacijo v obliki nabavnih/prodajnih računov, na računalniku ali v kateri koli drugi obliki, ki vsebuje vsaj naslednje informacije o vsakem poslu, pri katerem se zdravila prejmejo, odpošljejo ali posredujejo:
date,
datum,
name of the medicinal product,
ime zdravila,
quantity received, supplied or brokered,
količina, ki je bila prejeta, dobavljena ali posredovana,
name and address of the supplier or consignee, as appropriate,
ime in naslov dobavitelja ali prejemnika, kot je primerno,
batch number of the medicinal products at least for products bearing the safety features referred to in point (o) of Article 54;’;
serijska številka zdravila vsaj za zdravila, ki nosijo zaščitne elemente, kot je določeno v točki (o) člena 54;“;
they must maintain a quality system setting out responsibilities, processes and risk management measures in relation to their activities;
vzdrževati morajo sistem kakovosti, ki določa odgovornosti, postopke in ukrepe obvladovanja tveganja v zvezi z njihovimi dejavnostmi;
they must immediately inform the competent authority and, where applicable, the marketing authorisation holder, of medicinal products they receive or are offered which they identify as falsified or suspect to be falsified.’;
nemudoma morajo pristojni organ in po potrebi imetnika dovoljenja za promet obvestiti o zdravilih, ki jih prejmejo ali jim jih ponudijo in za katera ugotovijo ali sumijo, da so ponarejena.“;
‘For the purposes of point (b), where the medicinal product is obtained from another wholesale distributor, wholesale distribution authorisation holders must verify compliance with the principles and guidelines of good distribution practices by the supplying wholesale distributor.
„Za namene točke (b) morajo imetniki dovoljenja za promet na debelo, kadar se zdravilo pridobi pri drugem trgovcu na debelo, preveriti skladnost z načeli in smernicami dobrih distribucijskih praks dobavitelja trgovca na debelo.
This includes verifying whether the supplying wholesale distributor holds a wholesale distribution authorisation.
To vključuje preverjanje, ali ima dobavitelj trgovca na debelo dovoljenje za promet na debelo.
Where the medicinal product is obtained from the manufacturer or importer, wholesale distribution authorisation holders must verify that the manufacturer or importer holds a manufacturing authorisation.
Kadar se zdravilo pridobi pri proizvajalcu ali uvozniku, morajo imetniki dovoljenja za promet na debelo preveriti, ali ima proizvajalec ali uvoznik dovoljenje za proizvodnjo.
Where the medicinal product is obtained through brokering, the wholesale distribution authorisation holders must verify that the broker involved fulfils the requirements set out in this Directive.’;
Kadar se zdravila pridobijo s posredovanjem, morajo imetniki dovoljenja za promet na debelo preveriti, da udeleženi posrednik izpolnjuje zahteve iz te direktive.“;
in the first paragraph of Article 82, the following indent is added:
v prvem odstavku člena 82 se doda naslednja alinea:
In the case of wholesale distribution of medicinal products to third countries, Article 76 and point (c) of Article 80 shall not apply.
Za promet z zdravili na debelo v tretje države se ne uporabljata člen 76 in točka (c) člena 80.
Moreover, points (b) and (ca) of Article 80 shall not apply where a product is directly received from a third country but not imported.
Poleg tega se ne uporabljata točki (b) in (ca) člena 80, kadar se izdelek prejme neposredno iz tretje države, vendar se ne uvozi.
The requirements set out in Article 82 shall apply to the supply of medicinal products to persons in third countries authorised or entitled to supply medicinal products to the public.
Zahteve iz člena 82 se uporabljajo za dobavo zdravil osebam v tretjih državah, ki imajo dovoljenje ali pravico do izdajanja zdravil javnosti.
Persons brokering medicinal products shall ensure that the brokered medicinal products are covered by a marketing authorisation granted pursuant to Regulation (EC) No 726/2004 or by the competent authorities of a Member State in accordance with this Directive.
Osebe, ki posredujejo zdravila, zagotovijo, da so zdravila, ki jih posredujejo, vključena v dovoljenje za promet, ki je bilo izdano v skladu z Uredbo (ES) št. 726/2004 ali so ga izdali pristojni organi države članice v skladu s to direktivo.
Persons brokering medicinal products shall have a permanent address and contact details in the Union, so as to ensure accurate identification, location, communication and supervision of their activities by competent authorities.
Osebe, ki posredujejo zdravila, imajo stalni naslov in kontaktne podatke v Uniji, zato da lahko pristojni organi ustrezno identificirajo, umestijo, sporočajo in nadzirajo njihove dejavnosti.
The requirements set out in points (d) to (i) of Article 80 shall apply mutatis mutandis to the brokering of medicinal products.
Zahteve iz točk (d) do (i) člena 80 se smiselno uporabljajo za posredovanje zdravil.
Persons may only broker medicinal products if they are registered with the competent authority of the Member State of their permanent address referred to in paragraph 1.
Osebe lahko zdravila posredujejo le, če imajo stalni naslov iz odstavka 1 registriran pri pristojnem organu države članice.
Those persons shall submit, at least, their name, corporate name and permanent address in order to register.
Za registracijo morajo te osebe predložiti vsaj svoje ime, naziv podjetja in stalni naslov.
They shall notify the competent authority of any changes thereof without unnecessary delay.
Če se navedeno spremeni, o tem brez nepotrebnega odlašanja obvestijo pristojni organ.
Persons brokering medicinal products who had commenced their activity before 2 January 2013 shall register with the competent authority by 2 March 2013.
Osebe, ki posredujejo zdravila in so začele svojo dejavnost pred 2. januarjem 2013, se pri pristojnem organu registrirajo do 2. marca 2013.
The competent authority shall enter the information referred to in the first subparagraph in a register that shall be publicly accessible.
Pristojni organ vnese informacije iz prvega pododstavka v javno dostopen register.
The guidelines referred to in Article 84 shall include specific provisions for brokering.
Smernice iz člena 84 vključujejo posebne določbe za posredovanje.
Inspections referred to in Article 111 shall be carried out under the responsibility of the Member State where the person brokering medicinal products is registered.
Za opravljanje inšpekcijskih pregledov iz člena 111 je pristojna država članica, v kateri je registrirana oseba, ki posreduje zdravila.
If a person brokering medicinal products does not comply with the requirements set out in this Article, the competent authority may decide to remove that person from the register referred to in paragraph 2.
Če oseba, ki posreduje zdravila, ne izpolnjuje zahtev iz tega člena, lahko pristojni organ odloči, da se ta oseba izbriše iz registra iz odstavka 2.
The competent authority shall notify that person thereof.’;
Pristojni organ to osebo obvesti o svoji odločitvi.“;
the following Title is inserted before Title VIII:
pred naslovom VIII se vstavi spodnji naslov:
‘TITLE VIIA
„NASLOV VIIA
SALE AT A DISTANCE TO THE PUBLIC
PRODAJA JAVNOSTI NA DALJAVO
Without prejudice to national legislation prohibiting the offer for sale at a distance of prescription medicinal products to the public by means of information society services, Member States shall ensure that medicinal products are offered for sale at a distance to the public by means of information society services as defined in Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations and of rules on Information Society services under the following conditions:(a) the natural or legal person offering the medicinal products is authorised or entitled to supply medicinal products to the public, also at a distance, in accordance with national legislation of the Member State in which that person is established;
Brez poseganja v nacionalno zakonodajo, ki prepoveduje ponujanje zdravil na recept v prodajo javnosti na daljavo prek storitev informacijske družbe, države članice zagotovijo, da se zdravila ponudijo v prodajo javnosti na daljavo prek storitev informacijske družbe, kakor določa Direktiva 98/34/ES Evropskega parlamenta in Sveta z dne 22. junija 1998 o določitvi postopka za zbiranje informacij na področju tehničnih standardov in tehničnih predpisov o storitvah informacijske družbe, pod naslednjimi pogoji:(a) fizična ali pravna oseba, ki ponuja zdravila, ima v skladu z nacionalno zakonodajo države članice, v kateri ima sedež, dovoljenje ali pravico za izdajanje zdravil javnosti tudi na daljavo;
the person referred to in point (a) has notified the Member State in which that person is established of at least the following information:
oseba iz točke (a) je državo članico, v kateri ima sedež, uradno obvestila vsaj o naslednjih informacijah:
name or corporate name and permanent address of the place of activity from where those medicinal products are supplied;
imenu ali nazivu podjetja ter stalnem naslovu kraja dejavnosti, od koder se zdravila dobavljajo;
the starting date of the activity of offering medicinal products for sale at a distance to the public by means of information society services;
datumu začetka dejavnosti ponujanja zdravil v prodajo javnosti na daljavo prek storitev informacijske družbe;
the address of the website used for that purpose and all relevant information necessary to identify that website;
naslovu spletnega mesta, ki se uporablja v ta namen, in vseh drugih zadevnih informacijah, ki so potrebne za identifikacijo tega spletnega mesta;
if applicable, the classification in accordance with Title VI of the medicinal products offered for sale at a distance to the public by means of information society services.
po potrebi o razvrstitvi zdravil, ki se ponudijo v prodajo javnosti na daljavo prek storitev informacijske družbe, v skladu z naslovom VI.
Where appropriate, that information shall be updated;
Te informacije se po potrebi posodobijo;
the medicinal products comply with the national legislation of the Member State of destination in accordance with Article 6(1);
zdravila so skladna z nacionalno zakonodajo namembne države članice v skladu s členom 6(1);
without prejudice to the information requirements set out in Directive 2000/31/EC of the European Parliament and of the Council of 8 June 2000 on certain legal aspects of information society services, in particular electronic commerce, in the Internal Market (Directive on electronic commerce), the website offering the medicinal products contains at least:
brez poseganja v informacijske zahteve iz Direktive 2000/31/ES Evropskega parlamenta in Sveta z dne 8. junija 2000 o nekaterih pravnih vidikih storitev informacijske družbe, zlasti elektronskega poslovanja na notranjem trgu (Direktiva o elektronskem poslovanju)), spletno mesto, ki ponuja zdravila, vsebuje vsaj:
the contact details of the competent authority or the authority notified pursuant to point (b);
kontaktne podatke pristojnega organa ali organa, uradno obveščenega v skladu s točko (b);
a hyperlink to the website referred to in paragraph 4 of the Member State of establishment;
hiperpovezavo do spletnega mesta iz odstavka 4 države članice sedeža;
the common logo referred to in paragraph 3 clearly displayed on every page of the website that relates to the offer for sale at a distance to the public of medicinal products.
skupni logotip iz odstavka 3, ki je jasno objavljen na vseh straneh spletnega mesta, povezanega s ponudbo zdravil v prodajo javnosti na daljavo.
The common logo shall contain a hyperlink to the entry of the person in the list referred to in point (c) of paragraph 4.
Skupni logotip ima hiperpovezavo na vnos osebe na seznamu iz točke (c) odstavka 4.
Member States may impose conditions, justified on grounds of public health protection, for the retail supply on their territory of medicinal products for sale at a distance to the public by means of information society services.
Države članice lahko postavijo pogoje, utemeljene iz razlogov varovanja javnega zdravja, za prodajo na drobno zdravil za prodajo javnosti na daljavo prek storitev informacijske družbe na svojem ozemlju.
A common logo shall be established that is recognisable throughout the Union, while enabling the identification of the Member State where the person offering medicinal products for sale at a distance to the public is established.
Oblikuje se skupni logotip, ki je prepoznaven po vsej Uniji, in ki hkrati omogoči prepoznavo države članice, v kateri ima sedež oseba, ki ponuja zdravila v prodajo javnosti na daljavo.
That logo shall be clearly displayed on websites offering medicinal products for sale at a distance to the public in accordance with point (d) of paragraph 1.
Logotip je vidno prikazan na spletnih mestih, ki ponujajo zdravila v prodajo javnosti na daljavo v skladu s točko (d) odstavka 1.
In order to harmonise the functioning of the common logo, the Commission shall adopt implementing acts regarding:
Komisija za uskladitev uporabe tega skupnega logotipa sprejme izvedbene akte glede:
the technical, electronic and cryptographic requirements for verification of the authenticity of the common logo;
tehničnih, elektronskih in kriptografskih zahtev za preverjanje avtentičnosti skupnega logotipa;
the design of the common logo.
zasnove skupnega logotipa.
Those implementing acts shall, where necessary, be amended to take account of technical and scientific progress.
Ti izvedbeni akti se po potrebi spremenijo, da se upošteva tehnični in znanstveni napredek.
Those implementing acts shall be adopted in accordance with the procedure referred to in Article 121(2).
Ti izvedbeni akti se sprejmejo v skladu s postopkom iz člena 121(2).
Each Member State shall set up a website providing at least the following:
Vsaka država članica oblikuje spletno mesto, ki zagotavlja vsaj:
information on the national legislation applicable to the offering of medicinal products for sale at a distance to the public by means of information society services, including information on the fact that there may be differences between Member States regarding classification of medicinal products and the conditions for their supply;
informacije o nacionalni zakonodaji, ki se uporablja za ponujanje zdravil v prodajo javnosti na daljavo prek storitev informacijske družbe, vključno z informacijami o tem, da utegne priti med državami članicami do razlik pri razvrščanju zdravil in pogojih za njihovo dobavo;
information on the purpose of the common logo;
informacije za namene skupnega logotipa;
the list of persons offering the medicinal products for sale at a distance to the public by means of information society services in accordance with paragraph 1 as well as their website addresses;
seznam oseb, ki ponujajo zdravila v prodajo javnosti na daljavo prek storitev informacijske družbe v skladu z odstavkom 1, in naslove njihovih spletnih mest;
background information on the risks related to medicinal products supplied illegally to the public by means of information society services.
osnovne informacije o tveganjih, povezanih z zdravili, ki se javnosti nezakonito izdajajo prek storitev informacijske družbe.
This website shall contain a hyperlink to the website referred to in paragraph 5.
To spletno mesto vsebuje tudi hiperpovezavo do spletnega mesta iz odstavka 5.
The Agency shall set up a website providing the information referred to in points (b) and (d) of paragraph 4, information on the Union legislation applicable to falsified medicinal products as well as hyperlinks to the Member States’ websites referred to in paragraph 4.
Agencija vzpostavi spletno mesto, ki zagotavlja informacije iz točk (b) in (d) odstavka 4, informacije o veljavni zakonodaji Unije o ponarejenih zdravilih in hiperpovezave do spletnih mest držav članic iz odstavka 4.
The Agency’s website shall explicitly mention that the Member States’ websites contain information on persons authorised or entitled to supply medicinal products at a distance to the public by means of information society services in the Member State concerned.
Na spletnem mestu Agencije je izrecno zapisano, da spletna mesta držav članic vsebujejo informacije o osebah, ki imajo dovoljenje ali pravico, da javnosti izdajajo zdravila na daljavo prek storitev informacijske družbe v zadevni državi članici.
Without prejudice to Directive 2000/31/EC and the requirements set out in this Title, Member States shall take the necessary measures to ensure that other persons than those referred to in paragraph 1 that offer medicinal products for sale at a distance to the public by means of information society services and that operate on their territory are subject to effective, proportionate and dissuasive penalties.
Brez poseganja v Direktivo 2000/31/ES in v zahteve, opredeljene v tem naslovu, države članice sprejmejo potrebne ukrepe, s katerimi zagotovijo, da za osebe, ki niso navedene v odstavku 1 in javnosti ponujajo v prodajo zdravila na daljavo prek storitev informacijske družbe ter poslujejo na njihovih ozemljih, veljajo učinkovite, sorazmerne in odvračilne kazni.
Without prejudice to the competences of the Member States, the Commission shall, in cooperation with the Agency and Member State authorities, conduct or promote information campaigns aimed at the general public on the dangers of falsified medicinal products.
Brez poseganja v pristojnosti držav članic Komisija v sodelovanju z Agencijo in organi držav članic izvede ali spodbudi splošni javnosti namenjene informacijske kampanje o tveganjih, povezanih s ponarejenimi zdravili.
Those campaigns shall raise consumer awareness of the risks related to medicinal products supplied illegally at a distance to the public by means of information society services and of the functioning of the common logo, the Member States’ websites and the Agency’s website.
Te kampanje ozaveščajo potrošnike o tveganjih, povezanih z zdravili, ki se javnosti nezakonito izdajajo na daljavo prek storitev informacijske družbe, ter o vlogi skupnega logotipa, spletnih mest držav članic in spletnem mestu Agencije.
The competent authority of the Member State concerned shall, in cooperation with the Agency, ensure that the legal requirements governing medicinal products are complied with, by means of inspections, if necessary unannounced, and, where appropriate, by asking an Official Medicines Control Laboratory or a laboratory designated for that purpose to carry out tests on samples.
Pristojni organ zadevne države članice v sodelovanju z Agencijo zagotovi z inšpekcijskimi pregledi, po potrebi nenapovedanimi, ter, kadar je to primerno, s prošnjo za testiranje vzorcev, naslovljeno na Uradni kontrolni laboratorij za preskušanje zdravil ali laboratorij, pooblaščen za ta namen, da so pravne zahteve, ki urejajo področje zdravil, izpolnjene.
This cooperation shall consist in sharing information with the Agency on both inspections that are planned and that have been conducted.
To sodelovanje zajema izmenjavo informacij z Agencijo tako o načrtovanih kot o izvedenih inšpekcijskih pregledih.
Member States and the Agency shall cooperate in the coordination of inspections in third countries.
Države članice in Agencija sodelujejo pri usklajevanju inšpekcijskih pregledov v tretjih državah.
The inspections shall include but not be limited to the ones mentioned in paragraphs 1a to 1f.
Ti pregledi zajemajo tudi preglede iz odstavkov 1a do 1f, vendar niso omejeni samo nanje.
Manufacturers, located in the Union or in third countries, and wholesale distributors of medicinal products shall be subject to repeated inspections.
Za proizvajalce zdravil s sedežem v Uniji ali v tretjih državah in trgovce na debelo se inšpekcijski pregledi izvajajo redno.
The competent authority of the Member State concerned shall have a system of supervision including by inspections at an appropriate frequency based on risk, at the premises of the manufacturers, importers, or distributors of active substances, located on its territory, and effective follow-up thereof.
Pristojni organ zadevne države članice ima nadzorni sistem, ki glede na tveganje vključuje ustrezno pogoste inšpekcijske preglede v prostorih proizvajalcev, uvoznikov ali distributerjev zdravilnih učinkovin na njihovem ozemlju, in učinkovito nadaljnje spremljanje.
Whenever it considers that there are grounds for suspecting non-compliance with the legal requirements laid down in this Directive, including the principles and guidelines of good manufacturing practice and good distribution practices referred to in point (f) of Article 46 and in Article 47, the competent authority may carry out inspections at the premises of:
Kadar meni, da obstaja utemeljen sum neupoštevanja pravnih zahtev iz te direktive, vključno načel in smernic dobre proizvodne prakse in dobrih distribucijskih praks iz točke (f) člena 46 in iz člena 47, lahko pristojni organ izvede inšpekcijske preglede v prostorih:
manufacturers or distributors of active substances located in third countries;
proizvajalcev ali distributerjev zdravilnih učinkovin s sedežem v tretjih državah;
manufacturers or importers of excipients.
proizvajalcev ali uvoznikov pomožnih snovi.
Inspections referred to in paragraphs 1a and 1b may also be carried out in the Union and in third countries at the request of a Member State, the Commission or the Agency.
Inšpekcijski pregledi iz odstavkov 1a in 1b se lahko v Uniji in tretjih državah izvedejo tudi na zahtevo države članice, Komisije ali Agencije.
Inspections may also take place at the premises of marketing authorisation holders and of brokers of medicinal products.
Inšpekcijski pregledi se lahko opravijo v prostorih imetnikov dovoljenja za promet in posrednikov zdravil.