natgillin/translations-raw huggingface dataset:
Države članice zagotovijo stalno spremljanje prodaje zdravil in v primeru kršitev te direktive pravno ukrepajo.
Member States shall ensure that the internet is continuously monitored with regard to the selling of medicinal products and shall take legal actions in the event of non-compliance with this Directive.
Določbe te direktive ne posegajo v pravico držav članic, da omejijo ali prepovejo trgovino z zdravili, ki se izdajajo na recept, na spletu.
The provisions of this Directive shall be without prejudice to the right of the Member States to restrict of prohibit trading in prescription medicinal products over the internet.
Do ...* Komisija v sodelovanju z Agencijo in organi držav članic izdela kakovostno in količinsko študijo o spletni prodaji ponarejenih zdravil v EU.
By ... * , t he Commission shall, in cooperation with the Agency and the Member State authorities, produce a qualitative and quantitative study of i nternet sales of falsified medicinal products in the EU .
*UL: 12 mesecev po datumu objave te direktive
* OJ: 12 months after the date of publication of this Directive
Sporazumni predlog spremembe vključuje predloge sprememb 39, 41 (Matias), 167 (Chatzimarkakis, Leinen), 168 (Rapti), 330 (Roth-Behrendt), 331 (Chatzimarkakis), 332 (Matias), 333 (Yannakoudakis), 334 (Rossi), 339 (Tremopulos, Rivasi), 370 (Bartolozzi), 373 (Ulmer) in 374 (Rivellini) ter drugi del predloga spremembe 338 (Chatzimarkakis).
This compromise amendment covers AM 39, 41 (Matias), 167 (Chatzimarkakis/Leinen), 168 (Rapti), 330 (Roth-Behrendt), 331(Chatzimarkakis), 332 (Matias), 333 (Yannakoudakis), 334 (Rossi), 339 (Tremopoulos,Rivasi), 370 (Bartolozzi), 373 (Ulmer), 374(Rivellini), 2 nd part of 338(Chatzimarkakis)
Člen 85 d (novo)
Article 85 d (new)
(14b) Vstavi se naslednji člen 85d:
(14 b ) The following Article 85 d is inserted:
„Člen 85d
'Article 85 d
Države članice zagotovijo, da vse zakonite lekarne, ki prodajajo po pošti in delujejo na notranjem trgu, upoštevajo strokovne standarde in smernice za lekarniške storitve prek spleta, ter določene etične kodekse.
Member States shall ensure that all legitimate mail-order pharmacies operating in the internal market adhere to professional standards and guidance for internet pharmacy services, including a specific code of ethics.
Vse lekarne, ki prodajajo po pošti, morajo na svojih spletnih straneh jasno objaviti kodeks ravnanja in kontaktne podatke za pritožbe.“
All mail-order pharmacies are obliged to clearly display the code of conduct on their websites and display contact details for complaints.
Evropsko združenje lekarn, ki prodajajo po pošti bi moralo izdelati še etični kodeks, po tem ko je že določilo niz standardov, ki temeljijo na standardih britanskega farmacevtskega združenja Royal Pharmaceutical Society of Great Britain.
The EAMSP should develop a code of ethics, having already developed a set of standards based on those of the Royal Pharmaceutical Society of Great Britain.
Od leta 2003 so to nacionalni standardi v Nemčiji (11a ApoG, 17 ApoBetrO).
They are, since 2003, the national standard in Germany (11a ApoG, 17 ApoBetrO).
Pristojni organi za spremljanje bi morali ohranjati stike z izvajalci spletnih storitev, da bi se preprečile nezakonite spletne strani.
Designated monitoring bodies must liaise with internet service providers to prevent illegitimate websites.
V tej direktivi morajo biti določeni strogi kazenski ukrepi, ki vključujejo denarne in zaporne kazni.
Severe punitive measures involving fines and prison sentencing must be outlined in the Directive.
Odstavek bi bilo treba v ta namen razširiti.
The paragraph should be extended to elaborate on them.
Člen 85 e (novo)
Article 85 e (new)
(14c) Vstavi se naslednji člen 85e:
(14 c ) The following Article 85 e is inserted:
Člen 85e
Article 85 e
Komisija v sodelovanju z Agencijo in organi držav članic začne izvajati kampanjo obveščanja širše javnosti o nevarnostih ponarejenih zdravil.
The Commission shall, in cooperation with the Agency and Member State authorities, launch an information campaign aimed at the general public on the dangers of falsified medicinal products .
Kampanja poveča ozaveščenost potrošnikov o že obstoječih ukrepih za preverjanje, zaščitnih elementih (kot so hologrami in zaščitni pečati) na ovojnini zdravil, ter o tveganjih, povezanih z nakupom ponarejenih zdravil.
The campaign shall raise consumer awareness of the authentication measures already in place, of the safety features (such as holograms and safety seals) on the packaging of medicinal products, and of the risks involved in purchasing falsified medicinal products.
Komisija sprejme z delegiranimi akti v skladu s členom 121a in pod pogoji iz členov 121b in 121c ukrepe za ozaveščanje širše javnosti o tveganjih, povezanih s spletnim nakupom zdravil, ki lahko vključujejo:
The Commission shall, by means of delegated acts in accordance with Article 121a and subject to the conditions of Article 121b and 121c, adopt measures to increase awareness among the general public on the risks related to purchasing medicinal products on the internet, which may include:
– opozorila na vrhu spletne strani v iskalnikih pri iskanju zdravil na spletu;
- warnings appearing on top of the internet page in search engines in the event of a search for medicinal products on the internet;
– splošne kampanje obveščanja v sodelovanju z državami članicami;
- general information campaigns, in cooperation with the Member States;
– nasvete o preverjanju verodostojnosti spletnih strani;
- advi c e on how to check the authenticity of websites ;
– lahko dostopne sezname pooblaščenih e-lekarn.
- easily accessible lists of accredited e-pharmacies .
Ti ukrepi zagotavljajo uravnotežen in realen opis omenjenih tveganj.
Those measures shall provide a balanced and realistic description of the risks concerned.
Sporazumni predlog spremembe vključuje predloge sprememb 329 (Bartolozzi), 335 (Chatzimarkakis), 336 (Matias), 333 (Yannakoudakis), 334 (Rossi) in 337 (Yannakoudakis).
This compromise amendment covers 329(Bartolozzi), 335 (Chatzimarkakis), 336 (Matias), 333 (Yannakoudakis), 334 (Rossi), 337 (Yannakoudakis)
Člen 97 – odstavek 5 a (novo)
Article 97 – paragraph 5 a (new)
(14b) V členu 97 se doda naslednji odstavek 5a:
(14b) In Article 97, the following paragraph 5a is added:
Komisija v sodelovanju z Agencijo in nacionalnimi organi zagotovi, da proizvajalci, uvozniki, distributerji na debelo, trgovci in posredniki skupaj ali posamezno podpirajo javne kampanje obveščanja v različnih medijih (tisk, televizija, radio, internet) za dvig ozaveščenosti o tveganjih, povezanih z nakupom ponarejenih zdravil prek spleta.“
The Commission shall ensure, in cooperation with the Agency and national authorities, that manufacturers, importers, wholesale distributors, traders and brokers, either collectively or individually, promote public information campaigns in the various media (press, television, radio, i nternet) to raise awareness of the risks connected with the purchase of falsified medicinal products on the i nternet."
Javnost je treba osvestiti o tveganjih, povezanih s spletnim nakupom zdravil in jo obvestiti, kako naj ločuje med pooblaščenimi spletnimi lekarnami in nezakonitimi distributerji.
The public needs to be made aware of the risks attached to purchases of medicinal products over the internet and given information on how to distinguish between authorised on-line pharmacies and illicit distributors.
Glede na finančna sredstva, s katerimi razpolagajo proizvajalci, uvozniki, distributerji na debelo, trgovci in posredniki, ter glede na to, da je varstvo potrošnikov in lastnega ugleda v njihovo korist, bi kampanje obveščanja moral voditi sektor, Komisija pa bi imela zgolj vlogo nadzornika, ki bi zagotavljal, da se kampanja izvaja.
Given the financial resources available to manufacturers, importers, wholesale distributors, traders and brokers and given that it is in their best interest to protect their consumers and their reputation, information campaigns should be industry-led with the Commission having a supervisory role to ensure that campaigns are carried out.
Člen 1 – točka 15 – točka (–a) (novo)
Article 1 – point 15 – point -a (new)
Člen 111 – odstavek 1
Article 111 – paragraph 1
(-a) Odstavek 1 se nadomesti z naslednjim:
(-a) Paragraph 1 is replaced by the following:
Pristojni organi zadevne države članice pod nadzorom Agencije s ponavljajočimi in po potrebi nenapovedanimi inšpekcijskimi pregledi zagotovijo , da se pravne zahteve, ki urejajo področje zdravil, izpolnjujejo , in po potrebi pooblasti uradni laboratorij za preizkus zdravil ali drug laboratorij za tak namen, da izvedejo vzorčne teste.
The competent authorities of the Member State concerned shall , under the Agency's coordination, ensure by means of repeated, and where necessary unannounced, inspections, that the legal requirements governing medicinal products are complied with , and shall, where appropriate, commission an official medicinal product test laboratory, or another laboratory designated for that purpose, to carry out sampling tests .
Inšpekcijske preglede opravljajo uradne osebe, ki predstavljajo pristojni organ, in so pooblaščene za:
Such inspections shall be carried out by officials representing the competent authority who shall be empowered to:
(a) inšpekcijski pregled proizvodnih ali poslovnih zgradb in laboratorijev, ki jim je imetnik dovoljenja za proizvodnjo zaupal nalogo izvajanja nadzora v skladu s členom 20;
(a) inspect manufacturing or commercial establishments and any laboratories entrusted by the holder of the manufacturing authorization with the task of carrying out checks pursuant to Article 20;
(b) jemanje vzorcev;
(b) take samples;
(c) pregled vseh dokumentov v zvezi s predmetom inšpekcijskega pregleda ob upoštevanju določb, ki so v državah članicah bile v veljavi na dan 21. maja 1975 in ki omejujejo ta pooblastila glede na opis metode priprave .“
(c) examine any documents which relate to the object of the inspection, subject to the provisions in force in the Member States on 21 May 1975, and which place restrictions on these powers with regard to the descriptions of the method of preparation.'
Za zagotovitev varnosti farmacevtskih proizvodov je treba dogovore glede inšpekcijskih pregledov še izpopolniti in enotno uporabljati.
To ensure the safety of pharmaceutical products, the inspection arrangements need to be fleshed out and applied across the board.
Člen 111 – odstavek 1 – pododstavek 2
Article 111 – paragraph 1 - subparagraph 2
(aa) V členu 111(1) se pododstavek 2 nadomesti z naslednjim:
(aa) In Article 111 (1) , subparagraph 2 is replaced by the following:
Pristojni organi ob usklajevanju z Agencijo opravijo redne in po potrebi nenapovedane inšpekcijske preglede tudi v prostorih proizvajalcev , distributerjev ali uvoznikov zdravilnih učinkovin, uporabljenih kot vhodne snovi, ali v prostorih imetnikov dovoljenja za promet z zdravili, če so mnenja, da obstajajo razlogi za sum o neupoštevanju načel in smernic dobre proizvodne prakse iz člena 47.
The competent authorities shall, under the Agency's coordination, also carry out repeated, and where necessary unannounced , inspections of the premises of manufacturers , distributors or importers of active substances used as starting materials, at the premises of marketing authorisation holders whenever it considers that there are grounds for suspecting non-compliance with the principles and guidelines of good manufacturing practice s referred to in Article 47.
Taki inšpekcijski pregledi se opravijo tudi na zahtevo države članice, Komisije ali Agencije.
Such inspections shall also be carried out if so requested by a Member State , the Commission or the Agency.
Ob upravičenem sumu pristojni organi opravijo nenapovedane inšpekcijske preglede tudi v prostorih proizvajalcev zdravilnih učinkovin, ki se uporabljajo kot vhodne snovi, in pomožnih snovi v tretjih državah.
In the case of justified concerns, the competent authorities shall also carry out unannounced inspections at the premises of manufacturers of active substances used as starting materials and of excipients based in third countries.
Sporazumni predlog spremembe vključuje predloge sprememb 42, 344 (Matias), 342 (Gutierrez-Cortines, Sartori, Grossetête, Ulmer), 343 (Gutiérrez-Cortines, Sartori, Grossetête, Ulmer), 345 (Tremopulos, Rivasi), 346 (Perello Rodriguez) in 355 (Roth-Behrendt).
This compromise amendment covers AM 42, 344 (Matias), 342 (Gutierrez-Cortines, Sartori, Grossetête, Ulmer),343 (Gutiérrez-Cortines/Sartori/Grossetête/Ulmer), 345 (Tremopoulos/Rivasi), 346 (Perello Rodriguez),355(Roth-Behrendt)
Člen 111 – odstavek 3
Article 111 – paragraph 3
Po vsakem inšpekcijskem pregledu iz odstavka 1 pristojni organ poroča, ali proizvajalec, uvoznik ali distributer na debelo ravna v skladu z načeli in smernicami dobre proizvodne prakse in dobre distribucijske prakse iz členov 47 in 84 oziroma ali imetnik dovoljenja za promet izpolnjuje zahteve, določene v naslovu IX.
After every inspection as referred to in paragraph 1, the competent authority shall report on whether the manufacturer, importer, or wholesale distributor complies with the principles and guidelines of good manufacturing practice and good distribution practices referred to in Articles 47 and 84 or on whether the marketing authorization holder complies with the requirements laid down in Title IX.
Po vsakem inšpekcijskem pregledu iz odstavka 1 pristojni organ poroča, ali proizvajalec, uvoznik , distributer na debelo , trgovec ali posrednik ravna v skladu z načeli in smernicami dobre proizvodne prakse , dobre distribucijske prakse , dobre prakse trgovanja ali dobre prakse posredovanja iz členov 47 in 84 oziroma ali imetnik dovoljenja za promet izpolnjuje zahteve, določene v naslovu IX.
After every inspection as referred to in paragraph 1, the competent authority shall report on whether the manufacturer, importer, wholesale distributor , trader or broker complies with the principles and guidelines of good manufacturing practice s , good distribution practices , good trading practice s , or good brokerage practice s referred to in Articles 47 and 84 or on whether the marketing authorization holder complies with the requirements laid down in Title IX.
Pristojni organ, ki je opravil inšpekcijski pregled, sporoči vsebino teh poročil proizvajalcu, uvozniku, imetniku dovoljenja za promet ali distributerju na debelo, pri katerem je bil opravljen inšpekcijski pregled.
The competent authority which carried out the inspection shall communicate the content of those reports to the manufacturer, importer, marketing authorization holder, or to the wholesale distributor who has undergone the inspection.
Pristojni organ, ki je opravil inšpekcijski pregled, vsebino navedenih poročil pošlje proizvajalcu, uvozniku, imetniku dovoljenja za promet , distributerju na debelo, imetniku dovoljenja za trgovanje ali za posredovanje, pri katerem je bil opravljen inšpekcijski pregled.
The competent authority which carried out the inspection shall communicate the content of those reports to the manufacturer, importer, marketing authorization holder, wholesale distributor, trading authorisation holder or brokerage authorisation holder who has undergone the inspection.
Pristojni organ pred sprejetjem poročila zadevnemu proizvajalcu, uvozniku, imetniku dovoljenja za promet ali distributerju na debelo omogoči, da predloži svoje pripombe.
Before adopting the report, the competent authority shall give the manufacturer, importer, marketing authorization holder, or wholesale distributor concerned the opportunity to submit their comments.’
Pristojni organ pred sprejetjem poročila zadevnemu proizvajalcu, uvozniku, imetniku dovoljenja za promet , distributerju na debelo , trgovcu ali posredniku omogoči, da predloži svoje pripombe.
Before adopting the report, the competent authority shall give the manufacturer, importer, marketing authorization holder, wholesale distributor, trader or broker concerned the opportunity to submit their comments.
Proizvajalci morajo ravnati v skladu z dobro proizvodno prakso, distributerji na debelo pa z dobro distribucijsko prakso, vendar trgovcem in posrednikom ni treba ravnati v skladu s standardi dobre prakse.
Currently manufacturers must comply with Good Manufacturing Practices (GMP), wholesale distributors must comply with Good Distribution Practices (GDP) however traders and brokers do not have to comply with any standard good practices.
Zato je za nadaljnje obravnavanje „najšibkejšega člena“ v distribucijski verigi pomembno, da trgovci in posredniki upoštevajo smernice, kot so dobre prakse trgovanja in dobre prakse posredovanja, ki so oblikovane zlasti za osebe ali subjekte, vključene v trgovanje in posredovanje zdravil.
Therefore, to further address the “weakest link” in the distribution chain it is important that traders and brokers comply with guidelines such as “Good Trade Practices (GTP) and “Good Brokerage Practices” (GBP), which are specifically established for persons or entities involved in the trading and brokering of medicinal products.
Člen 111 – odstavek 5 – pododstavek 1
Article 111 – paragraph 5 – subparagraph 1
V 90 dneh po inšpekcijskem pregledu iz odstavka 1 se proizvajalcu, uvozniku ali distributerju na debelo izda potrdilo o dobri proizvodni praksi ali dobri distribucijski praksi, če se pri inšpekcijskem pregledu izkaže, da ta oseba ravna v skladu z načeli in smernicami dobre proizvodne prakse ali dobre distribucijske prakse iz zakonodaje Skupnosti .
Within 90 days of an inspection as referred to in paragraph 1, a certificate of good manufacturing practice or good distribution practice shall be issued to the manufacturer, importer, or wholesale distributor if the outcome of the inspection shows that the person complies with the principles and guidelines of good manufacturing practice or good distribution practice as provided for by Community legislation.
V 90 dneh po inšpekcijskem pregledu iz odstavka 1 se proizvajalcu, uvozniku , distributerju na debelo , trgovcu ali posredniku izda potrdilo o dobri proizvodni praksi , dobri distribucijski praksi, dobri praksi trgovanja ali posredovanja, če se pri inšpekcijskem pregledu izkaže, da ta oseba ravna v skladu z načeli in smernicami dobre proizvodne prakse , dobre distribucijske prakse , dobre prakse trgovanja ali posredovanja iz zakonodaje Unije.
Within 90 days of an inspection as referred to in paragraph 1, a certificate of good manufacturing practice s , good distribution practice s , good trading practices, or good brokerage practice s shall be issued to the manufacturer, importer, wholesale distributor , trader or broker if the outcome of the inspection shows that the person complies with the principles and guidelines of good manufacturing practice s , good distribution practice s , good trading practice s , or good brokering practice s as provided for by Union legislation.
Člen 1 – točka 15 – točka (c)
Article 1 – point 15 – point c
Člen 111 – odstavek 6
Article 111 – paragraph 6
(6) Države članice vnesejo potrdila o dobri proizvodni praksi in dobri distribucijski praksi, ki jih izdajo, v zbirko podatkov Skupnosti , ki jo v imenu Skupnosti upravlja Agencija.
(6) Member States shall enter the certificates of good manufacturing practice and good distribution practice which they issue in a Community database managed by the Agency on behalf of the Community .
(6) Države članice vnesejo potrdila o dobri proizvodni praksi, dobri distribucijski praksi , dobri praksi trgovanja in dobri praksi posredovanja , ki jih izdajo, v zbirko podatkov Unije , ki jo v imenu Unije upravlja Agencija.
(6) Member States shall enter the certificates of good manufacturing practice s , good distribution practice s , good trading practice s and good brokering practice s which they issue in a Union database managed by the Agency on behalf of the Union .
Za zagotovitev, da imajo vsi udeleženci v dobavni verigi dovoljenja, mora vsak udeleženec preveriti upoštevanje določb svojih partnerjev v dobavni verigi prek centralne zbirke podatkov, ki jo je vzpostavila in jo vzdržuje Agencija (Evropska agencija za zdravila).
In order to ensure that all supply chain participants are licensed, each supply chain participant should verify compliance of their supply chain partners through the Central database established and maintained by the Agency (EMA).
Člen 111 – odstavek 7
Article 111 – paragraph 7
Če se pri inšpekcijskem pregledu iz odstavka 1 izkaže, da oseba ne ravna v skladu z načeli in smernicami dobre proizvodne prakse ali dobre distribucijske prakse iz zakonodaje Skupnosti , se ta informacija vnese v zbirko podatkov Skupnosti iz odstavka 6.
If the outcome of the inspection as referred to in paragraph 1 is that the person does not comply with the principles and guidelines of good manufacturing practices or good distribution practices as provided for by Community legislation, the information shall be entered in the Community database referred to in paragraph 6.
Če se pri inšpekcijskem pregledu iz odstavka 1 izkaže, da oseba ne ravna v skladu z načeli in smernicami dobre proizvodne prakse , dobre distribucijske prakse , dobre prakse trgovanja ali dobre prakse posredovanja iz zakonodaje Unije , se ta informacija vnese v zbirko podatkov Unije iz odstavka 6 , proizvodnjo in distribucijo pa je treba nemudoma ustaviti .
If the outcome of the inspection as referred to in paragraph 1 is that the person does not comply with the principles and guidelines of good manufacturing practices , good distribution practices , good trading practices or good brokering practices as provided for by Union legislation, the information shall be entered in the Union database referred to in paragraph 6 and the manufacturing and distribution processes shall cease forthwith .
Informacija navaja, katera načela, smernice in pravila so kršena.
Such information shall specify the principles, guidelines and rules not complied with.
V to zbirko podatkov se vnesejo tudi primeri, ko so bila ponarejena zdravila odkrita na trgu Unije.
Cases where falsified medicin al products have been discovered on the Union market shall also be reported to this database.
Člen 111a
Article 111a
Komisija sprejme podrobne smernice, v katerih so določena načela za inšpekcijske preglede iz člena 111.
The Commission shall adopt detailed guidelines laying down the principles for inspections referred to in Article 111.
Komisija sprejme podrobne smernice, v katerih so določena načela za inšpekcijske preglede iz člena 111 in zlasti organe na ravni Unije in na nacionalni ravni, odgovorne za izvajanje inšpekcijskih pregledov .
The Commission shall adopt detailed guidelines laying down the principles for inspections referred to in Article 111 and, in particular, the Union or national bodies responsible for carrying out inspections .
Komisija predlaga, da se prvi inšpekcijski pregled opravi v treh letih po uvrstitvi tretje države na seznam iz člena 111b.
The Commission is proposing that the first inspection be carried out within three years of the third country being entered on the Article 111b list.
Namesto tega bi bilo bolje, da se opravi še pred vključitvijo te države v seznam, saj v skladu s členom 51(2) odgovornim osebam v podjetjih EU ni treba opravljati nadzora nad zdravili iz držav, s katerimi je Skupnost sprejela sporazume, ki zagotavljajo, da zdravila izpolnjujejo zahtevane standarde.
It should instead be carried out prior to that country's inclusion on the list, not least because under Article 51(2) the qualified persons within EU firms are not required to carry out checks on products from countries with which the Community has concluded agreements guaranteeing that the products are of the required standard.
Člen 111 b – odstavek 1 – točka b
Article 111b – paragraph 1 – point b
(b) rednost inšpekcijskih pregledov dobre proizvodne prakse;
(b) the regularity of inspections of good manufacturing practices;
(b) rednost stalnih in nenapovedanih inšpekcijskih pregledov dobre proizvodne prakse;
(b) the regularity of repeated and unannounced inspections of good manufacturing practices;
Člen 111 b – odstavek 2
Article 111b - paragraph 2