natgillin/translations-raw huggingface dataset:
In order to verify whether the data submitted in order to obtain a conformity certificate comply with the monographs of the European Pharmacopoeia, the standardisation body of the nomenclatures and the quality norms within the meaning of the Convention relating to the elaboration of the European Pharmacopoeia (the European Directorate for the Quality of Medicines and Healthcare) may ask the Commission or the Agency to request such an inspection when the starting material concerned is the subject of a European Pharmacopoeia monograph.
Da se preveri, ali so podatki, predloženi za pridobitev certifikata ustreznosti, v skladu z monografijami Evropske farmakopeje, lahko organ za standardizacijo nomenklature in kakovostnih norm v smislu konvencije o razčlenitvi Evropske farmakopeje (Evropska direkcija za kakovost zdravil in zdravstva) zaprosi Komisijo ali Agencijo, naj zahteva tak inšpekcijski pregled, kadar zadevno vhodno snov obravnava monografija Evropske farmakopeje.
The competent authority of the Member State concerned may carry out inspections of starting material manufacturers at the specific request of the manufacturer.
Pristojni organ zadevne države članice lahko opravi inšpekcijske preglede pri proizvajalcih vhodnih snovi na posebno zahtevo posameznega proizvajalca.
Inspections shall be carried out by officials representing the competent authority who shall be empowered to:
Inšpekcijske preglede opravljajo uradne osebe, ki zastopajo pristojni organ in so pooblaščene za:
inspect the manufacturing or commercial establishments of manufacturers of medicinal products, of active substances or of excipients, and any laboratories employed by the holder of the manufacturing authorisation to carry out checks pursuant to Article 20;
inšpekcijski pregled proizvodnih ali poslovnih zgradb proizvajalcev zdravil, zdravilnih učinkovin ali pomožnih snovi in vseh laboratorijev, ki jih imetnik dovoljenja za proizvodnjo uporablja za izvajanje kontrole v skladu s členom 20;
take samples including with a view to independent tests being carried out by an Official Medicines Control Laboratory or a laboratory designated for that purpose by a Member State;
jemanje vzorcev, tudi za neodvisne preskuse, ki jih opravlja Uradni kontrolni laboratorij za preskušanje zdravil ali laboratorij, ki ga za ta namen določi država članica;
examine any documents relating to the object of the inspection, subject to the provisions in force in the Member States on 21 May 1975 placing restrictions on these powers with regard to the description of the manufacturing method;
pregled vseh dokumentov v zvezi s predmetom inšpekcijskega pregleda, ob upoštevanju določb, ki so bile v državah članicah v veljavi na dan 21. maja 1975 in ki omejujejo ta pooblastila glede na opis proizvodnega postopka;
inspect the premises, records, documents and pharmacovigilance system master file of the marketing authorisation holder or any firms employed by the marketing authorisation holder to perform the activities described in Title IX.
pregled prostorov, evidenc, dokumentov in glavne dokumentacije sistema farmakovigilance, ki jih imetnik dovoljenja za promet ali druga podjetja, ki jih imetnik uporablja, uporabljajo za izvajanje dejavnosti, opisanih v naslovu IX.
Inspections shall be carried out in accordance with the guidelines referred to in Article 111a.’;
Inšpekcijski pregledi se opravljajo v skladu s smernicami iz člena 111a.“;
paragraphs 3 to 6 are replaced by the following:
odstavki 3 do 6 se nadomestijo z naslednjim:
After every inspection as referred to in paragraph 1, the competent authority shall report on whether the inspected entity complies with the principles and guidelines of good manufacturing practice and good distribution practices referred to in Articles 47 and 84, as applicable, or on whether the marketing authorisation holder complies with the requirements laid down in Title IX.
Po vsakem inšpekcijskem pregledu iz odstavka 1 pristojni organ poroča, ali pregledani subjekt upošteva načela in smernice dobre proizvodne prakse in dobrih distribucijskih praks iz členov 47 in 84, kot je primerno, in ali imetnik dovoljenja za promet izpolnjuje zahteve, določene v naslovu IX.
Before adopting the report, the competent authority shall give the inspected entity concerned the opportunity to submit comments.
Pred sprejetjem poročila pristojni organ zadevnemu pregledanemu subjektu omogoči, da predloži pripombe.
Without prejudice to any arrangements which may have been concluded between the Union and third countries, a Member State, the Commission or the Agency may require a manufacturer established in a third country to submit to an inspection as referred to in this Article.
Brez poseganja v dogovore, ki bi utegnili biti sklenjeni med Unijo in tretjimi državami, lahko država članica, Komisija ali Agencija od proizvajalca s sedežem v tretji državi zahteva, da se pri njem opravi inšpekcijski pregled iz tega člena.
Within 90 days of an inspection as referred to in paragraph 1, a certificate of good manufacturing practice or good distribution practices shall, when applicable, be issued to the inspected entity if the outcome of the inspection shows that it complies with the principles and guidelines of good manufacturing practice or good distribution practices as provided for by Union legislation.
V 90 dneh od inšpekcijskega pregleda iz odstavka 1 se pregledanemu subjektu, kadar je to ustrezno, izda certifikat dobre proizvodne prakse ali dobrih distribucijskih praks, če rezultat inšpekcijskega pregleda pokaže, da upošteva načela in smernice dobre proizvodne prakse ali dobrih distribucijskih praks, kakor so določene v zakonodaji Unije.
If inspections are performed as part of the certification procedure for the monographs of the European Pharmacopoeia, a certificate shall be drawn up.
Če se inšpekcijski pregledi opravijo kot del postopka za izdajo certifikata ustreznosti za monografije Evropske farmakopeje, se pripravi certifikat.
Member States shall enter the certificates of good manufacturing practice and good distribution practices which they issue in a Union database managed by the Agency on behalf of the Union.
Države članice vnesejo certifikate dobre proizvodne prakse in dobrih distribucijskih praks, ki jih izdajo, v podatkovno bazo Unije, ki jo v njenem imenu upravlja Agencija.
Pursuant to Article 52a(7), Member States shall also enter information in that database regarding the registration of importers, manufacturers and distributors of active substances.
V skladu s členom 52a(7) države članice v to podatkovno bazo vnesejo tudi informacije o registraciji uvoznikov, proizvajalcev in distributerjev zdravilnih učinkovin.
The database shall be publicly accessible.’;
Podatkovna baza je javno dostopna.“;
paragraph 7 is amended as follows:
odstavek 7 se spremeni:
the words ‘paragraph 1’ are replaced by the words ‘paragraph 1g’;
besedilo „odstavka 1“ se nadomesti z besedilom „odstavka 1g“;
the words ‘used as starting materials’ are deleted;
besedilo „ ki se uporabljajo kot vhodne snovi“ se črta;
in the first subparagraph of paragraph 8, the words ‘paragraph 1(d)’ are replaced by the words ‘point (d) of paragraph 1g’;
v prvem pododstavku odstavka 8 se besedilo „točke (d) odstavka 1“ nadomesti z besedilom „točke (d) odstavka 1g“;
‘Article 111a
„Člen 111a
The Commission shall adopt detailed guidelines laying down the principles applicable to inspections referred to in Article 111.
Komisija sprejme podrobne smernice, v katerih so določena načela, ki se uporabljajo za inšpekcijske preglede iz člena 111.
Member States shall, in cooperation with the Agency, establish the form and content of the authorisation referred to in Articles 40(1) and 77(1), of the reports referred to in Article 111(3), of the certificates of good manufacturing practice and of the certificates of good distribution practices referred to in Article 111(5).
Države članice v sodelovanju z Agencijo določijo obliko in vsebino dovoljenja iz člena 40(1) in člena 77(1), poročil iz člena 111(3), certifikatov dobre proizvodne prakse in dobrih distribucijskih praks iz člena 111(5).
Article 111b
Člen 111b
At the request of a third country, the Commission shall assess whether that country’s regulatory framework applicable to active substances exported to the Union and the respective control and enforcement activities ensure a level of protection of public health equivalent to that of the Union.
Komisija na zahtevo tretje države oceni, ali ureditveni okvir te države, ki velja za zdravilne učinkovine, ki se izvozijo v Unijo, ter zadevni nadzor in dejavnosti izvrševanja zagotavljajo raven varovanja javnega zdravja, enakovredno ravni v Uniji.
If the assessment confirms such equivalence, the Commission shall adopt a decision to include the third country in a list.
Če ocena potrdi enakovrednost, Komisija sprejme odločitev o uvrstitvi tretje države na seznam.
The assessment shall take the form of a review of relevant documentation and, unless arrangements as referred to in Article 51(2) of this Directive are in place that cover this area of activity, that assessment shall include an on-site review of the third country’s regulatory system and, if necessary, an observed inspection of one or more of the third country’s manufacturing sites for active substances.
Ocena predstavlja pregled zadevne dokumentacije in, razen kadar obstajajo dogovori iz člena 51(2) te direktive, ki zajemajo to področje dejavnosti, ta ocena zajema tudi pregled na kraju samem regulativnega sistema tretje države, po potrebi pa tudi opazovan inšpekcijski pregled enega ali več proizvodnih mest za izdelavo zdravilnih učinkovin v tretji državi članici.
In the assessment particular account shall be taken of:
Pri tej oceni se upoštevajo predvsem:
the country’s rules for good manufacturing practice;
pravila države o dobri proizvodni praksi;
the regularity of inspections to verify compliance with good manufacturing practice;
rednost inšpekcijskih pregledov, da se preveri upoštevanje dobre proizvodne prakse;
the effectiveness of enforcement of good manufacturing practice;
učinkovitost izvrševanja dobre proizvodne prakse;
the regularity and rapidity of information provided by the third country relating to non-compliant producers of active substances.
rednost in hitrost tretjih držav pri pošiljanju informacij o neskladnih proizvajalcih zdravilnih učinkovin.
The Commission shall adopt the necessary implementing acts to apply the requirements set out in points (a) to (d) of paragraph 1 of this Article.
Komisija sprejme potrebne izvedbene akte za uporabo zahtev iz točk (a) do (d) odstavka 1 tega člena.
The Commission shall verify regularly whether the conditions laid down in paragraph 1 are fulfilled.
Komisija redno preverja, ali so izpolnjeni pogoji iz odstavka 1.
The first verification shall take place no later than 3 years after the country has been included in the list referred to in paragraph 1.
Prvo preverjanje se opravi najpozneje 3 leta po uvrstitvi države na seznam iz odstavka 1.
The Commission shall perform the assessment and verification referred to in paragraphs 1 and 3 in cooperation with the Agency and the competent authorities of the Member States.’;
Komisija izvede oceno in preverjanje iz odstavkov 1 in 3 v sodelovanju z Agencijo in pristojnimi organi držav članic.“;
in Article 116, the following paragraph is added:
v členu 116 se doda naslednji odstavek:
‘The second paragraph of this Article also applies in cases where the manufacture of the medicinal product is not carried out in compliance with the particulars provided pursuant to point (d) of Article 8(3), or where controls are not carried out in compliance with the control methods described pursuant to point (h) of Article 8(3).’;
„Drugi odstavek tega člena velja tudi v primerih, ko proizvodnja zdravil ni izvedena v skladu s podatki, predloženimi v skladu s točko (d) člena 8(3), oziroma ko kontrolni preskusi niso izvedeni v skladu s kontrolnimi metodami, opisanimi v točki (h) člena 8(3).“;
‘Article 117a
„Člen 117a
Member States shall have a system in place which aims at preventing medicinal products that are suspected to present a danger to health from reaching the patient.
Države članice imajo vzpostavljen sistem, da se zdravilom, ki vzbujajo sum, da so nevarna za zdravje, prepreči dostop do bolnika.
The system referred to in paragraph 1 shall cover the receipt and handling of notifications of suspected falsified medicinal products as well as of suspected quality defects of medicinal products.
Sistem iz odstavka 1 krije sprejemanje in obravnavanje uradnih obvestil o domnevno ponarejenih zdravilih ter o domnevnih odstopih od kakovosti zdravil.
The system shall also cover recalls of medicinal products by marketing authorisation holders or withdrawals of medicinal products from the market ordered by national competent authorities from all relevant actors in the supply chain both during and outside normal working hours.
Sistem krije tudi odpoklice zdravil s strani imetnikov dovoljenja ali umike zdravil s trga, ki jih zahtevajo nacionalni pristojni organi od vseh zadevnih subjektov v dobavni verigi, v rednem delovnem času in zunaj njega.
The system shall also make it possible to recall, where necessary with the assistance of health professionals, medicinal products from patients who received such products.
Sistem omogoča tudi odpoklic zdravil do bolnikov, ki taka zdravila prejmejo, po potrebi ob pomoči zdravstvenih delavcev.
If the medicinal product in question is suspected of presenting a serious risk to public health, the competent authority of the Member State in which that product was first identified shall, without any delay, transmit a rapid alert notification to all Member States and all actors in the supply chain in that Member State.
Če se za zadevno zdravilo domneva, da pomeni resno tveganje za javno zdravje, pristojni organ države članice, v kateri je bilo zdravilo najprej identificirano, nemudoma posreduje takojšnje opozorilo vsem državam članicam in subjektom v dobavni verigi v tej državi članici.
In the event of such medicinal products being deemed to have reached patients, urgent public announcements shall be issued within 24 hours in order to recall those medicinal products from the patients.
Če je verjetno, da so tovrstna zdravila že prišla do bolnikov, se v roku 24 ur izda nujna javna objava, da se ta zdravila do bolnikov odpokličejo.
Those announcements shall contain sufficient information on the suspected quality defect or falsification and the risks involved.
Te objave vsebujejo dovolj informacij o domnevni napaki v kakovosti ali ponareditvi in o tveganjih, povezanih s tem.
Member States shall by 22 July 2013 notify the Commission of the details of their respective national systems referred to in this Article.’;
Države članice do 22. julija 2013 uradno obvestijo Komisijo o podrobnostih svojih nacionalnih sistemov iz tega člena.“;
‘Article 118a
„Člen 118a
The Member States shall lay down the rules on penalties applicable to infringements of the national provisions adopted pursuant to this Directive and shall take all necessary measures to ensure that those penalties are implemented.
Države članice določijo predpise o kaznih za kršenje določb nacionalne zakonodaje, sprejetih v skladu s to direktivo, in sprejmejo vse potrebne ukrepe, da zagotovijo izvrševanje teh kazni.
Those penalties shall not be inferior to those applicable to infringements of national law of similar nature and importance.
Te kazni niso manjše od kazni za kršitve nacionalnega prava podobne narave in teže.
The rules referred to in paragraph 1 shall address, inter alia, the following:
Predpisi iz odstavka 1 med drugim urejajo:
the manufacturing, distribution, brokering, import and export of falsified medicinal products, as well as the sale of falsified medicinal products at a distance to the public by means of information society services;
proizvodnjo, distribucijo, posredovanje, uvoz in izvoz ponarejenih zdravil, ter prodajo ponarejenih zdravil na daljavo prek storitev informacijske družbe;
non-compliance with the provisions laid down in this Directive on manufacturing, distribution, import and export of active substances;
neskladnost z določbami te direktive o proizvodnji, distribuciji, uvozu in izvozu zdravilnih učinkovin;
non-compliance with the provisions laid down in this Directive on the use of excipients.
neskladnost z določbami te direktive o uporabi pomožnih snovi.
Where relevant, the penalties shall take into account the risk to public health presented by the falsification of medicinal products.
Pri kaznih se po potrebi upošteva tveganje za javno zdravje s ponarejanjem zdravil.
The Member States shall notify the national provisions adopted pursuant to this Article to the Commission by 2 January 2013 and shall notify any subsequent amendment of those provisions without delay.
Države članice obvestijo Komisijo o nacionalnih predpisih, sprejetih v skladu s tem členom, do 2. januarja 2013 in jo nemudoma obvestijo o kakršni koli poznejši spremembi teh predpisov.
By 2 January 2018, the Commission shall submit a report to the European Parliament and to the Council giving an overview of the transposition measures of Member States as regards this Article, together with an evaluation of the effectiveness of those measures.
Komisija Evropskemu parlamentu in Svetu do 2. januarja 2018 predloži poročilo o pregledu ukrepov držav članic za prenos glede tega člena, skupaj z oceno učinkovitosti teh ukrepov.
Member States shall organise meetings involving patients “and consumers” organisations and, as necessary, Member States’ enforcement officers, in order to communicate public information about the actions undertaken in the area of prevention and enforcement to combat the falsification of medicinal products.
Države članice organizirajo srečanja organizacij bolnikov in potrošnikov, po potrebi tudi organov pregona držav članic, da se javnost obvesti o izvedenih preventivnih in izvršilnih ukrepih v boju proti ponarejanju zdravil.
Member States, in applying this Directive, shall take the necessary measures to ensure cooperation between competent authorities for medicinal products and customs authorities.’;
Države članice pri uporabi te direktive storijo vse, kar je potrebno, da se zagotovi sodelovanje med pristojnimi organi za zdravila in carinskimi organi.“;
in Article 121a(1), the words ‘Article 22b’ are replaced by the words ‘Articles 22b, 47, 52b and 54a’;
v členu 121a(1) se besede „člena 22b“ nadomestijo z besedami „členov 22b, 47, 52b in 54a“;
in Article 121b(1), the words ‘Article 22b’ are replaced by the words ‘Articles 22b, 47, 52b and 54a’;
v členu 121b(1) se besede „člena 22b“ nadomestijo z besedami „členov 22b, 47, 52b in 54a“.
Member States shall apply those measures from 2 January 2013.
Države članice te predpise uporabljajo od 2. januarja 2013.
However, the Member States shall apply:
Vendar pa države članice uporabljajo:
the provisions necessary to comply with point 6 of Article 1 of this Directive in so far as it relates to Article 46b(2)(b) and Article 46b(3) and (4) of Directive 2001/83/EC as inserted by this Directive from 2 July 2013;
predpise, potrebne za uskladitev s točko 6 člena 1 te direktive, v kolikor se nanaša na člen 46b(2)(b), 46b(3) in 46b(4) Direktive 2001/83/ES, kakor je vstavljen s to direktivo, od 2. julija 2013;
the provisions necessary to comply with points 8, 9, 11 and 12 of Article 1 of this Directive from 3 years after the date of publication of the delegated acts referred to in point 12 of Article 1 of this Directive.
predpise, potrebne za uskladitev s točkami 8, 9, 11 in 12 člena 1 te direktive, tri leta od dneva objave delegiranih aktov iz točke 12 člena 1 te direktive.
Nevertheless, Member States which, on 21 July 2011, have systems in place for the purpose referred to in point 11 of Article 1 of this Directive shall apply the provisions necessary to comply with points 8, 9, 11 and 12 of Article 1 of this Directive at the latest from 6 years after the date of application of the delegated acts referred to in point 12 of Article 1 of this Directive;
Države članice, ki imajo 21. julija 2011 uveljavljene sisteme za namene iz točke 11 člena 1 te direktive, uporabljajo predpise, potrebne za uskladitev s točkami 8, 9, 11 in 12 člena 1 te direktive, šest let po dnevu začetka uporabe delegiranih aktov iz točke 12 člena 1 te direktive;
the provisions necessary to comply with point 20 of Article 1 of this Directive in so far as it relates to Article 85c of Directive 2001/83/EC as inserted by this Directive at the latest from 1 year after the date of publication of the implementing acts referred to in Article 85c(3) as inserted by this Directive.
predpise, potrebne za uskladitev s točko 20 člena 1 te direktive, v kolikor je povezan s členom 85c Direktive 2001/83/ES, kakor je vstavljen s to direktivo, eno leto po dnevu objave izvedbenih ukrepov iz člena 85c(3), kakor je vstavljen s to direktivo.
When Member States adopt the measures referred to in paragraph 1, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication.
Države članice se v sprejetih predpisih iz odstavka 1 sklicujejo na to direktivo ali pa sklic nanjo navedejo ob njihovi uradni objavi.
At the latest 5 years after the date of application of the delegated acts referred to in Article 54a(2) of Directive 2001/83/EC as inserted by this Directive, the Commission shall submit a report to the European Parliament and to the Council containing the following:
Komisija Evropskemu parlamentu in Svetu najpozneje pet let po dnevu začetka uporabe delegiranih aktov iz člena 54a(2) Direktive 2001/83/ES, kakor je vstavljen s to direktivo, predloži poročilo, ki zajema:
a description, where possible including quantitative data, of the trends in the falsification of medicinal products in terms of: categories of medicinal products affected, distribution channels including sale at a distance to the public by means of information society services, the Member States concerned, the nature of the falsifications, and the regions of provenance of these products; and
opis, ki je po možnosti količinsko razdelan, trendov pri ponarejanju zdravil, in sicer glede na: kategorije zdravil, distribucijske poti, vključno s prodajo na daljavo prek storitev informacijske družbe, zadevne države članice, naravo ponarejanja in območja izvora teh izdelkov, ter
an evaluation of the contribution of the measures provided for in this Directive regarding the prevention of the entry of falsified medicinal products in the legal supply chain.
oceno, koliko ukrepi iz te direktive prispevajo k preprečevanju vstopa ponarejenih zdravil v zakonito dobavno verigo.
That evaluation shall in particular assess point (o) of Article 54 and Article 54a of Directive 2001/83/EC as inserted by this Directive.
Pri oceni se ovrednotijo zlasti določbe iz točke (o) člena 54 in člena 54a Direktive 2001/83/ES, kakor sta bila vstavljena s to direktivo.
In order to adopt the delegated acts referred to in Article 54a(2) of Directive 2001/83/EC as inserted by this Directive, the Commission shall perform a study assessing at least the following aspects:
Za sprejetje delegiranih aktov iz člena 54a(2) Direktive 2001/83/ES, kakor je bil vstavljen s to direktivo, Komisija izvede študijo, v kateri oceni vsaj:
the technical options for the unique identifier of the safety features referred to in point (o) of Article 54 of Directive 2001/83/EC as inserted by this Directive;
tehnične možnosti za edinstveno oznako za zaščitne elemente iz točke (o) člena 54 Direktive 2001/83/ES, kakor je vstavljena s to direktivo;
the options for the extent and the modalities of verification of the authenticity of the medicinal product bearing the safety features.
možnosti za obseg in načine preverjanja avtentičnosti zdravila, ki nosi zaščitni element.
This assessment shall take into account the particular characteristics of the supply chains in the Member States;
Pri tem ocenjevanju se upoštevajo posebne značilnosti dobavnih verig v državah članicah;