natgillin/translations-raw huggingface dataset:
(e) 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 , se z njimi trguje ali se jih posreduje :
(e) 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 , traded or brokered at least the following information:
– ime zdravila,
– name of the medicinal product,
– količina, ki je bila prejeta, dobavljena ali se je z njo trgovalo,
– quantity received, supplied or traded,
količina, ki je bila prejeta, dobavljena, se je z njo trgovalo ali je bila posredovana ,
– quantity received, supplied , traded or brokered ,
– ime in naslov dobavitelja ali prejemnika, kot je primerno;“.
– name and address of the supplier or consignee, as appropriate;’
– ime in naslov dobavitelja ali prejemnika, kot je primerno;“
– name and address of the supplier or consignee, as appropriate;’
Člen 1 – točka 13 – točka (a a) (novo)
Article 1 – point 13 – point a a (new)
Člen 80 – točka (g)
Article 80 – point g
(aa) Točka (g) se nadomesti z naslednjim besedilom:
(aa) Point (g) is replaced by the following:
„(g) ravnati morajo v skladu z načeli in smernicami dobre distribucijske prakse , prakse trgovanja in prakse posredovanja za zdravila, kot jih določa člen 84.“
'(g) they must comply with the principles and guidelines of good distribution , trading and brokering practice for medicinal products as laid down in Article 84.'
Glej prejšnjo obrazložitev.
See above justification.
Člen 1 – točka 13 – točka (b)
Article 1 – point 13 – point b
Člen 80 – točka i – uvodni del
Article 80 – point i – introductory part
(i) pristojni organ morajo obvestiti o zdravilih, ki jih prejmejo in za katera ugotovijo, da kršijo, ali sumijo, da kršijo kar koli od naslednjega:
(i) they must inform the competent authority of products they receive which they identify as infringing, or they suspect of infringing, either of the following:
Člen 80 – pododstavek 2
Article 80 – subparagraph 2
Za namen točke (b) morajo imetniki dovoljenja za promet na debelo, kadar se zdravilo pridobi pri drugem distributerju na debelo, sami ali prek organa, ki ga za to pooblasti pristojni organ države članice, preveriti skladnost dobaviteljskega distributerja na debelo z dobro distribucijsko prakso.
For the purpose of point (b), in the case where the product is obtained from another wholesale distributor, holders of the wholesale distribution authorisation must verify compliance with good distribution practices of the supplying wholesale distributor either by themselves or through a body accredited for that purpose by the competent authority of a Member State .
Za namen točke (b) morajo imetniki dovoljenja za promet na debelo, kadar se zdravilo pridobi pri drugem distributerju na debelo, preveriti skladnost dobaviteljskega distributerja na debelo z dobro distribucijsko prakso in da ima dovoljenje za promet na debelo .
For the purpose of point (b), in the case where the product is obtained from another wholesale distributor, holders of the wholesale distribution authorisation must verify compliance with good distribution practices of the supplying wholesale distributor and check that the latter holds a wholesale distribution authorisation .
Da se zagotovi skladnost z dobro proizvodno prakso, mora imeti vsak udeleženec dovoljenje za izvajanje svoje dejavnosti in biti strogo in redno inšpekcijsko pregledan.
To ensure compliance with good manufacturing practice, everyone involved must be duly authorised to conduct their specific business and must undergo thorough inspections on a regular basis.
„Člen 84
' Article 84
Komisija objavi smernice o dobri distribucijski praksi, praksi trgovanja in posredovanja za zdravila.
The Commission shall publish guidelines on good distribution , trading and brokering practice for medicinal products.
UL L 147, 9.6.1975, str.
OJ L 147, 9.6.1975, p.
(13b) Vstavi se naslednji člen 84a:
(13b) The following Article 84a is inserted:
„Člen 84a
"Article 84a
Komisija objavi posebne smernice za dobro proizvodno prakso za aktivne farmacevtske učinkovine in posebne smernice za dobro proizvodno prakso za pomožne snovi.
The Commission shall publish guidelines on specific good manufacturing practices for active pharmaceutical ingredients and specific good manufacturing practices for excipients.
V ta namen se posvetuje z Odborom za lastniška zdravila, ustanovljenim z Direktivo Sveta 75/319/EGS, in Farmacevtskim odborom, ustanovljenim s Sklepom Sveta 75/320/EGS .“
To this end, it shall consult the Committee for Proprietary Medicinal Products established by Council Directive 75/319/EEC and the Pharmaceutical Committee established by Council Decision 75/320/EEC."
Evropska komisija mora oblikovati posebna načela dobre proizvodnje za aktivne farmacevtske učinkovine in posebna načela dobre proizvodnje za pomožne snovi, pri čemer mora upoštevati značilnost teh dveh različnih kategorij sestavin, zlasti dejstvo, da pomožne snovi nimajo terapevtskega učinka.
The European Commission is called to develop specific GMP for APIs and specific GMPs for Excipeints taking into account the very characteristics of those two different categories of ingredients and specially the fact that excipients have no therapeutic activity.
Člen 88 b (novo)
Article 88 b (new)
(14a) Vstavi se naslednji člen 88b:
14a) The following Article 88b is inserted:
„Člen 88b
"Article 88b
Države članice v sodelovanju s Komisijo in po posvetovanju z zastopniki interesov pripravijo informacijsko strategijo v zvezi z varnostjo pošiljk zdravil.
Member States, in cooperation with the Commission and after consultation with representatives of stakeholders, shall devise an information strategy relating to the safety of consignments of medicinal products.
V strategiji se upoštevajo različni nacionalni predpisi, ki se nanašajo na dobavo zdravil, in tveganja, ki so povezana z nekaterimi načini dobave zdravil, kot je nezakonita trgovina na internetu.“
The strategy shall take account of the various national legal provisions concerning the supply of medicinal products and the risks associated with certain types of supply of medicinal products and with illegal trading on the Internet."
Internet je glavni vir nezakonitih zdravil.
The Internet is the main source of illegal medicinal products.
Državljanom bi bilo treba odsvetovati naročanje zdravil po nezakonitih poteh.
Citizens should be advised not to order medicinal products through illegal channels.
Zlasti bi bilo treba spodbujati ukrepe za obveščanje javnosti v državah članicah in po Evropi.
In particular, public information measures should be promoted in the Member States and throughout Europe.
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 osveščenosti o tveganjih, povezanih z nakupom ponarejenih zdravil prek interneta.“
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, Internet) to raise awareness of the risks connected with the purchase of falsified medicinal products on the Internet."
Javnost je treba osvestiti o tveganjih, povezanih z nakupom zdravil prek interneta 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 preverjal, 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.
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 pooblastijo 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 , where appropriate commissioning an official medicinal product test laboratory or another laboratory designated for that purpose to carry out sampling tests .
(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 authorisation with the task of carrying out checks pursuant to Article 20 ;
(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 relating to the object of the inspection, subject to the provisions in force in the Member States on 21 May 1975 which place restrictions on these powers with regard to the descriptions of the method of preparation.'
Člen 1 – točka 15 – točka (a a) (novo)
Article 1 – point 15 – point a a (new)
(aa) Odstavek 2 se nadomesti z naslednjim:
(aa) Paragraph 2 is replaced by the following:
Pristojni organi lahko izvedejo večkratne in po potrebi nenapovedane inšpekcijske preglede v prostorih proizvajalcev, distributerjev ali uvoznikov aktivnih učinkovin, ki se uporabijo kot vhodne snovi, v prostorih imetnikov dovoljenja za proizvodnjo, v prostorih trgovcev z zdravili in posrednikov zdravil ter prostorih proizvajalcev, uvoznikov in distributerjev neaktivnih sestavin, če na podlagi informacij, ki jih imajo organi, ali predhodnih primerov obstaja konkreten razlog za sum, da ni skladnosti z zakonskimi obveznostmi in/ali smernicami.
The competent authorities may carry out repeated, and where necessary unannounced, inspections of the premises of producers, distributors or importers of active ingredients used as starting materials, the premises of manufacturing authorisation holders, the premises of medicinal product traders and brokers or the premises of excipient producers, importers and distributors where there are sound grounds for suspecting, on the basis of information available to the authorities or of previous cases, that legal obligations and/or the guidelines are not being complied with.
Takšni inšpekcijski pregledi se lahko opravijo tudi na zahtevo države članice, Komisije ali Agencije.“
Such inspections may also be carried out at the request of a Member State , the Commission or the Agency.'
Člen 1 – točka 15 – točka (b)
Article 1 – point 15 – point b
Po vsakem inšpekcijskem pregledu iz odstavka 1 pristojni organ poroča, ali izdelovalec, uvoznik , distributer na debelo , trgovec ali posrednik ravna v skladu z načeli in smernicami dobre proizvodne, distribucijske , trgovske in posredniške 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, wholesale distributor , trader or broker complies with the principles and guidelines of good manufacturing practice and good distribution , trading and brokering practices 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, distributerju na debelo, pri katerem je bil opravljen inšpekcijski pregled , imetniku dovoljenja za promet ali imetniku dovoljenja za posredovanje .
The competent authority which carried out the inspection shall communicate the content of those reports to the manufacturer, importer, marketing authorisation holder, the wholesale distributor who has undergone the inspection or the trading or brokering authorisation holder .
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 authorisation holder, wholesale distributor , trader or broker concerned the opportunity to submit their comments.
V 90 dneh po inšpekcijskem pregledu iz odstavka 1 se proizvajalcu, uvozniku ali distributerju na debelo izda potrdilo o dobri proizvodni , distribucijski , trgovski ali posredniški praksi, če se pri inšpekcijskem pregledu izkaže, da ta oseba ravna v skladu z načeli in smernicami dobre proizvodne , distribucijske , trgovske in posredniške prakse iz zakonodaje Unije .
Within 90 days of an inspection as referred to in paragraph 1, a certificate of good manufacturing practice , good distribution practice , good trading practice or good brokering 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 , good distribution practice , good trading practice and good brokering practice as provided for by Union legislation.
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.
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 .
Države članice vnesejo potrdila o dobri proizvodni , distribucijski , trgovski in posredniški praksi, ki jih izdajo, v zbirko podatkov Unije , ki jo v imenu Unije upravlja Agencija.
Member States shall enter the certificates of good manufacturing practice , good distribution practice , good trading practice and good brokering practice which they issue in a Union database managed by the Agency on behalf of the Union .
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 , distribucijske, trgovske in posredniške prakse 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 .
Komisija sprejme podrobne smernice, v katerih so določena načela za inšpekcijske preglede iz člena 111 , in posebej o organih Unije in nacionalnih organih, odgovornih 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 and/or national bodies responsible for carrying out inspections .
Komisija predlaga, da se prvi inšpekcijski pregled opravi v treh let, po tem, ko je bila tretja država navedena v 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 inšpekcijski pregled opravi še preden se ta država vključi v seznam, saj v skladu s členom 51(2) odgovornim osebam znotraj podjetij EU ni treba opravljati nadzorov nad zdravili iz držav, s katerimi je Skupnost sprejela sporazum, ki zagotavlja, 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 – uvodni del
Article 111b – paragraph 1 – introductory part
Komisija na zahtevo tretje države z odločbo uvrsti to državo na seznam, če njen ureditveni okvir za zdravilne učinkovine, ki se izvozijo v Skupnost , ter zadevna nadzor in izvrševanje zagotavljajo raven varovanja javnega zdravja, enakovredno ravni v Skupnosti .
The Commission shall, following a request from a third country, list that country by way of a Decision if its regulatory framework for active substances exported to the Community and the respective control and enforcement ensure a protection of public health equivalent to that in the Community .
Predvsem se upoštevajo:
Particular account shall be taken of:
Komisija na zahtevo tretje države in po uspešno opravljenem inšpekcijskem pregledu, ki ga opravi pristojni organ na podlagi člena 111a, z odločbo uvrsti to državo na seznam, če njen ureditveni okvir za zdravilne učinkovine, ki se izvozijo v Unijo , ter zadevna nadzor in izvrševanje zagotavljajo raven varovanja javnega zdravja, enakovredno ravni v Uniji .
The Commission shall, following a request from a third country and the satisfactory conclusion of the inspection by the body responsible on the basis of Article 111a , list that country by way of a Decision if its regulatory framework for active substances exported to the Union and the respective control and enforcement ensure a protection of public health equivalent to that in the Union .
Glede na izjemo iz člena 51(2), ki zagotavlja, da se prvi inšpekcijski pregled opravi v treh letih po tem, ko je tretja država uvrščena v seznam iz člena 111b, bi pomenilo, da bodo zadevna zdravila umeščena na trg EU in se bodo razdeljevala širši javnosti brez predhodnega preverjanja.
In view of the exemption provided for in Article 51(2), the fact that the first inspection is scheduled to take place within three years of the third country being entered on the Article 111b list would mean that the products concerned would be placed on the EU market and distributed to the public without having been subjected to any form of checking.
Člen 111 b – odstavek 2
Article 111b – paragraph 2
Komisija skladno s postopkom iz člena 121(2) sprejme smernice, v katerih so podrobno opredeljene zahteve iz točk od (a) do (d) odstavka 1.
The Commission, in accordance with the procedure set out in Article 121(2), shall adopt guidelines defining in detail the requirements set out in points (a) to (d) of paragraph 1.
Komisija skladno s postopkom iz člena 121(2) sprejme smernice, v katerih so podrobno opredeljene zahteve iz točk od (a) do (d) odstavka 1 , ter prek ustrezni instrumentov in morebiti celo prek izrednih ukrepov zagotovi preverjanje in kasneje nadzor nad kakovostjo načel in varnostjo .
The Commission, in accordance with the procedure set out in Article 121(2), shall adopt guidelines defining in detail the requirements set out in points (a) to (d) of paragraph 1 , performing by means of the appropriate instruments, and possibly also by means of extraordinary measures, the verification and subsequent monitoring of the quality of the principles and safety .
Treba je povečati nadzor zlasti nad uvozom zdravilnih učinkovin iz tretjih držav, vendar je treba ločiti med nadzorom nad dobro proizvodno prakso, torej nad kakovostjo zdravilnih učinkovin, in preverjanjem tako imenovanih ponaredkov ali ponarejanja, ki zadeva morebitne imetnike patenta.
It is desirable to make monitoring more stringent, particularly in the case of imports of active principles from third countries, albeit without forgetting the requirement to distinguish monitoring of good manufacturing practices (and lastly of the quality of the active principles) from checking so-called falsity or falsification, which concerns any patent-holders.
Člen 111 b – odstavek 3
Article 111b – paragraph 3
Komisija v sodelovanju z Agencijo in pristojnimi organi držav članic redno preverja, ali so pogoji iz odstavka 1 izpolnjeni.
The Commission, in cooperation with the Agency and competent authorities of the Member States, shall verify regularly whether the conditions set out in paragraph 1 are fulfilled.
Prvo preverjanje se opravi najpozneje 3 leta po uvrstitvi države na seznam v skladu z odstavkom 1 .
The first verification shall take place no later than 3 years after the country has been listed in accordance with paragraph 1 .
Pristojni organi izdajo akreditacijo iz členov 46(f) in 80(b), če lahko vlagatelj dokaže, da je sposoben preverjati skladnost z dobro proizvodno prakso ali dobro distribucijsko prakso pri distributerjih na debelo ali v primerih trgovcev in posrednikov skladnost z dobro prakso trgovanja in skladnost z dobro prakso posredovanja.
The competent authorities shall issue the accreditation referred to in Articles 46(f) and 80(b) if the applicant can demonstrate that he is competent to carry out verification of compliance with good manufacturing practices or, in the case of wholesale distributors, good distribution practices or, in the case of traders, good trading practices or, in the case of brokers, good brokering practices .
Države članice obvestijo Komisijo o teh predpisih najpozneje do [vstaviti datum 18 mesecev po objavi] in jo nemudoma obvestijo o kakršni koli poznejši spremembi, ki vpliva nanje.
The Member States shall notify those provisions to the Commission by [insert concrete date 18 months after publication] at the latest and shall notify it without delay of any subsequent amendment affecting them.
Tako predpisane kazni so učinkovite, sorazmerne , odvračalne in enakovredne .
The penalties provided for must be effective, proportionate , dissuasive and equivalent .
Države članice obvestijo Komisijo o teh predpisih najpozneje do [vstaviti datum 6 mesecev po objavi] in jo nemudoma obvestijo o kakršni koli poznejši spremembi, ki vpliva nanje.
The Member States shall notify those provisions to the Commission by [insert concrete date 6 months after publication] at the latest and shall notify it without delay of any subsequent amendment affecting them.