natgillin/translations-raw huggingface dataset:
Exceptionally and where necessary to ensure the availability of medicinal products, when a plant manufacturing an active substance for export has been inspected by a Member State and was found to comply with the principles and guidelines of good manufacturing practice laid down pursuant to the third paragraph of Article 47, the requirement set out in point (b) of paragraph 2 of this Article may be waived by any Member State for a period not exceeding the validity of the certificate of Good Manufacturing Practice.
Izjemoma in kjer je to potrebno za zagotovitev razpoložljivosti zdravil, kadar je obrat, v katerem se proizvaja zdravilna učinkovina za izvoz, pregledala država članica in ugotovila, da ravna v skladu z načeli in smernicami dobre proizvodne prakse, določene v skladu s tretjim odstavkom člena 47, lahko katera koli država članica odstopi od zahteve iz točke (b) odstavka 2 tega člena za obdobje, ki ne presega veljavnosti potrdila o dobri proizvodni praksi.
Member States that make use of the possibility of such waiver, shall communicate this to the Commission.’;
Države članice, ki uporabijo to možnost, o tem obvestijo Komisijo.“;
in Article 47, the third and fourth paragraphs are replaced by the following:
v členu 47 se tretji in četrti odstavek nadomestita z naslednjim:
‘The Commission shall adopt, by means of delegated acts in accordance with Article 121a and subject to the conditions laid down in Articles 121b and 121c, the principles and guidelines of good manufacturing practice for active substances referred to in the first paragraph of point (f) of Article 46 and in Article 46b.
„Komisija z delegiranimi akti v skladu s členom 121a in pod pogoji, določenimi v členih 121b in 121c, sprejme načela in smernice dobre proizvodne prakse za zdravilne učinkovine iz prvega odstavka točke (f) člena 46 in člena 46b.
The principles of good distribution practices for active substances referred to in the first paragraph of point (f) of Article 46 shall be adopted by the Commission in the form of guidelines.
Načela dobrih distribucijskih praks za zdravilne učinkovine iz prvega odstavka točke (f) člena 46 sprejme Komisija v obliki smernic.
The Commission shall adopt guidelines on the formalised risk assessment for ascertaining the appropriate good manufacturing practice for excipients referred to in the second paragraph of point (f) of Article 46.’;
Komisija sprejme smernice za formalizirano oceno tveganja za določitev ustrezne dobre proizvodne prakse za pomožne snovi iz drugega odstavka točke (f) člena 46.“;
‘Article 47a
„Člen 47a
The safety features referred to in point (o) of Article 54 shall not be removed or covered, either fully or partially, unless the following conditions are fulfilled:
Zaščitni elementi iz točke (o) člena 54 se ne smejo niti delno niti popolnoma odstraniti ali prekriti, razen če so izpolnjeni naslednji pogoji:
the manufacturing authorisation holder verifies, prior to partly or fully removing or covering those safety features, that the medicinal product concerned is authentic and that it has not been tampered with;
preden imetnik dovoljenja za proizvodnjo deloma ali v celoti odstrani ali prekrije te zaščitne elemente, preveri, da je zadevno zdravilo pristno in da ni bilo nedovoljeno spremenjeno;
the manufacturing authorisation holder complies with point (o) of Article 54 by replacing those safety features with safety features which are equivalent as regards the possibility to verify the authenticity, identification and to provide evidence of tampering of the medicinal product.
imetnik dovoljenja za proizvodnjo ravna skladno s točko (o) člena 54, tako da te zaščitne elemente nadomesti z zaščitnimi elementi, ki so enakovredni glede možnosti preverjanja avtentičnosti, identifikacije in zagotovitve dokazov o nedovoljenem spreminjanju zdravila.
Such replacement shall be conducted without opening the immediate packaging as defined in point 23 of Article 1.
Ta nadomestitev se izvede, ne da bi se odprla stična ovojnina, kakor je opredeljena v točki 23 člena 1.
Safety features shall be considered equivalent if they:
Za zaščitne elemente velja, da so enakovredni, če so:
comply with the requirements set out in the delegated acts adopted pursuant to Article 54a(2); and
v skladu z zahtevami iz delegiranih aktov, sprejetih v skladu s členom 54a(2), in
are equally effective in enabling the verification of authenticity and identification of medicinal products and in providing evidence of tampering with medicinal products;
enako učinkoviti pri zagotavljanju preverjanja avtentičnosti in identifikacije zdravila ter pri zagotavljanju dokazov o nedovoljenem spreminjanju zdravil;
the replacement of the safety features is conducted in accordance with applicable good manufacturing practice for medicinal products; and
nadomestitev zaščitnih elementov se opravi v skladu z veljavno dobro proizvodno prakso za zdravila; ter
the replacement of the safety features is subject to supervision by the competent authority.
nadomestitev zaščitnih elementov je predmet nadzora pristojnega organa.
Manufacturing authorisation holders, including those performing the activities referred to in paragraph 1 of this Article, shall be regarded as producers and therefore held liable for damages in the cases and under the conditions set forth in Directive 85/374/EEC.’;
Imetniki dovoljenja za proizvodnjo, vključno s tistimi, ki opravljajo dejavnosti, iz odstavka 1 tega člena, veljajo za proizvajalce in zato odgovarjajo za škodo v primerih in pod pogoji, ki so določeni v Direktivi 85/374/EGS.“;
in Article 51(1), the following subparagraph is inserted before the second subparagraph:
v členu 51(1) se vstavi naslednji pododstavek pred drugim pododstavkom:
‘The qualified person referred to in Article 48 shall in the case of medicinal products intended to be placed on the market in the Union, ensure that the safety features referred to in point (o) of Article 54 have been affixed on the packaging.’;
„Usposobljena oseba iz člena 48 zagotovi, da so pri zdravilih, namenjenih za dajanje v promet v Uniji, zaščitni elementi iz točke (o) člena 54 pritrjeni na ovojnino.“;
Importers, manufacturers and distributors of active substances who are established in the Union shall register their activity with the competent authority of the Member State in which they are established.
Proizvajalci, uvozniki in distributerji zdravilnih učinkovin, ki imajo sedež v Uniji, registrirajo svojo dejavnost pri pristojnem organu države članice, v kateri imajo sedež.
The registration form shall include, at least, the following information:
Obrazec za registracijo vključuje vsaj naslednje informacije:
name or corporate name and permanent address;
ime ali naziv podjetja in stalni naslov;
the active substances which are to be imported, manufactured or distributed;
zdravilne učinkovine, ki bodo predmet uvoza, proizvodnje ali distribucije;
particulars regarding the premises and the technical equipment for their activity.
podatke o prostorih in tehnični opremi za njihovo dejavnost.
The persons referred to in paragraph 1 shall submit the registration form to the competent authority at least 60 days prior to the intended commencement of their activity.
Osebe iz odstavka 1 predložijo obrazec za registracijo pristojnemu organu najmanj 60 dni pred nameravanim začetkom njihove dejavnosti.
The competent authority may, based on a risk assessment, decide to carry out an inspection.
Pristojni organ se lahko na podlagi ocene tveganja odloči, da opravi inšpekcijski pregled.
If the competent authority notifies the applicant within 60 days of the receipt of the registration form that an inspection will be carried out, the activity shall not begin before the competent authority has notified the applicant that he may commence the activity.
Če pristojni organ v 60 dneh od prejema obrazca za registracijo obvesti vlagatelja, da bo izveden inšpekcijski pregled, se dejavnost ne začne izvajati, dokler pristojni organ vlagatelja ne obvesti, da jo lahko začne izvajati.
If within 60 days of the receipt of the registration form the competent authority has not notified the applicant that an inspection will be carried out, the applicant may commence the activity.
Če pristojni organ 60 dni po prejemu obrazca za registracijo vlagatelja ne obvesti, da bo izveden inšpekcijski pregled, lahko vlagatelj začne izvajati dejavnost.
The persons referred to in paragraph 1 shall communicate annually to the competent authority an inventory of the changes which have taken place as regards the information provided in the registration form.
Osebe iz odstavka 1 pristojnemu organu letno sporočijo popis sprememb, ki so nastale glede informacij, zagotovljenih v obrazcu za registracijo.
Any changes that may have an impact on the quality or safety of the active substances that are manufactured, imported or distributed must be notified immediately.
Vse spremembe, ki bi lahko vplivale na kakovost ali varnost zdravilnih učinkovin, ki so predmet proizvodnje, uvoza ali distribucije, je treba nemudoma sporočiti.
Persons referred to in paragraph 1 who had commenced their activity before 2 January 2013 shall submit the registration form to the competent authority by 2 March 2013.
Osebe iz odstavka 1, ki so začele svojo dejavnost pred 2. januarjem 2013, pristojnemu organu obrazec za registracijo predložijo do 2. marca 2013.
Member States shall enter the information provided in accordance with paragraph 2 of this Article in the Union database referred to in Article 111(6).
Države članice informacije, zagotovljene v skladu z odstavkom 2 tega člena, vnesejo v podatkovno bazo Unije iz člena 111(6).
This Article shall be without prejudice to Article 111.
Ta člen ne posega v člen 111.
Article 52b
Člen 52b
Notwithstanding Article 2(1), and without prejudice to Title VII, Member States shall take the necessary measures in order to prevent medicinal products that are introduced into the Union, but are not intended to be placed on the market of the Union, from entering into circulation if there are sufficient grounds to suspect that those products are falsified.
Ne glede na člen 2(1) in brez poseganja v naslov VII države članice sprejmejo potrebne ukrepe za preprečitev, da se zdravila, ki so vnesena v Unijo, vendar niso namenjena dajanju v promet v Uniji, sprostijo v promet, če obstaja utemeljen sum, da so ta zdravila ponarejena.
In order to establish what the necessary measures referred to in paragraph 1 of this Article are, the Commission may adopt, by means of delegated acts in accordance with Article 121a, and subject to the conditions laid down in Articles 121b and 121c, measures supplementing paragraph 1 of this Article as regards the criteria to be considered and the verifications to be made when assessing the potential falsified character of medicinal products introduced into the Union but not intended to be placed on the market.’;
Za določitev, kaj so potrebni ukrepi iz odstavka 1 tega člena, lahko Komisija z delegiranimi akti v skladu s členom 121a in pod pogoji, določenimi v členih 121b in 121c, sprejme ukrepe, ki dopolnjujejo določbe odstavka 1 tega člena, kar zadeva merila, ki jih je treba upoštevati, ter preverjanje, ki ga je treba opraviti pri oceni verjetnosti, da gre za ponarejena zdravila, ki so bila vnesena v Unijo, vendar niso namenjena dajanju v promet.“;
in Article 54, the following point is added:
v členu 54 se doda naslednja točka:
for medicinal products other than radiopharmaceuticals referred to in Article 54a(1), safety features enabling wholesale distributors and persons authorised or entitled to supply medicinal products to the public to:
za zdravila, ki niso radiofarmacevtski izdelki iz člena 54a(1), zaščitni elementi, ki trgovcem na debelo in osebam z dovoljenjem ali pravico do izdajanja zdravil javnosti omogočajo, da:
verify the authenticity of the medicinal product, and
preverijo avtentičnost zdravila, in
identify individual packs,
identificirajo posamezne zavitke,
as well as a device allowing verification of whether the outer packaging has been tampered with.’;
ter tudi napravo, ki omogoča preverjanje, ali je bila zunanja ovojnina nedovoljeno spremenjena.“;
Medicinal products subject to prescription shall bear the safety features referred to in point (o) of Article 54, unless they have been listed in accordance with the procedure pursuant to point (b) of paragraph 2 of this Article.
Zdravila, ki se izdajajo na recept, nosijo zaščitne elemente iz točke (o) člena 54, razen če so bila uvrščena na seznam v skladu s postopkom iz točke (b) odstavka 2 tega člena.
Medicinal products not subject to prescription shall not bear the safety features referred to in point (o) of Article 54, unless, by way of exception, they have been listed in accordance with the procedure pursuant to point (b) of paragraph 2 of this Article, after having been assessed to be at risk of falsification.
Zdravila, ki se ne izdajajo na recept, ne nosijo zaščitnih elementov iz točke (o) člena 54, razen če so izjemoma uvrščena na seznam v skladu s postopkom iz točke (b) odstavka 2 tega člena, potem ko je bilo ocenjeno, da zanje velja tveganje ponarejanja.
The Commission shall adopt, by means of delegated acts in accordance with Article 121a and subject to the conditions laid down in Articles 121b and 121c, measures supplementing point (o) of Article 54 with the objective of establishing the detailed rules for the safety features referred to in point (o) of Article 54.
Komisija z delegiranimi akti v skladu s členom 121a in pod pogoji, določenimi v členih 121b in 121c, sprejme ukrepe, ki dopolnjujejo določbe iz točke (o) člena 54, z namenom, da bi določila podrobna pravila za zaščitne elemente iz točke (o) člena 54.
Those delegated acts shall set out:
Navedeni delegirani akti določajo:
the characteristics and technical specifications of the unique identifier of the safety features referred to in point (o) of Article 54 that enables the authenticity of medicinal products to be verified and individual packs to be identified.
značilnosti in tehnične specifikacije edinstvene oznake za zaščitne elemente iz točke (o) člena 54, ki omogočajo preverjanje avtentičnosti zdravil in identifikacijo posameznih pakiranj.
When establishing the safety features due consideration shall be given to their cost-effectiveness;
Pri določanju zaščitnih elementov se ustrezno upošteva njihova stroškovna učinkovitost;
the lists containing the medicinal products or product categories which, in the case of medicinal products subject to prescription shall not bear the safety features, and in the case of medicinal products not subject to prescription shall bear the safety features referred to in point (o) of Article 54.
sezname zdravil ali kategorij zdravil, katerim v primeru zdravil, ki se izdajajo na recept, ni treba nositi zaščitnih elementov, v primeru zdravil, ki se izdajajo brez recepta, pa morajo nositi zaščitne elemente iz točke (o) člena 54.
Those lists shall be established considering the risk of and the risk arising from falsification relating to medicinal products or categories of medicinal products.
Te sezname se oblikuje ob upoštevanju tveganja ponarejanja in tveganja, ki izvira iz ponareditve, povezanih z zdravili ali kategorijami zdravil.
To this end, at least the following criteria shall be applied:
V ta namen se uporabi vsaj naslednja merila:
the price and sales volume of the medicinal product;
ceno in obseg prodaje zdravila;
the number and frequency of previous cases of falsified medicinal products being reported within the Union and in third countries and the evolution of the number and frequency of such cases to date;
število in pogostost preteklih zabeleženih primerov ponarejenih zdravil v Uniji in tretjih državah ter razvoj števila in pogostosti takšnih primerov do danes;
the specific characteristics of the medicinal products concerned;
posebne značilnosti zadevnih zdravil;
the severity of the conditions intended to be treated;
resnost bolezni, katerih zdravljenju so namenjena;
other potential risks to public health;
druga možna tveganja za javno zdravje;
the procedures for the notification to the Commission provided for in paragraph 4 and a rapid system for evaluating and deciding on such notification for the purpose of applying point (b);
postopke iz odstavka 4 za obvestitev Komisije ter hiter sistem za ocenjevanje in odločanje o teh obvestilih za namene izvajanja točke (b);
the modalities for the verification of the safety features referred to in point (o) of Article 54 by the manufacturers, wholesalers, pharmacists and persons authorised or entitled to supply medicinal products to the public and by the competent authorities.
načine preverjanja zaščitnih elementov iz točke (o) člena 54, ki jih uporabljajo proizvajalci, trgovci na debelo, farmacevti in osebe, ki imajo dovoljenje ali pravico do izdajanja zdravil javnosti, ter pristojni organi.
Those modalities shall allow the verification of the authenticity of each supplied pack of the medicinal products bearing the safety features referred to in point (o) of Article 54 and determine the extent of such verification.
Ti načini omogočajo preverjanje avtentičnosti vsakega dobavljenega pakiranja zdravila, ki nosi zaščitne elemente iz točke (o) člena 54 ter določajo obseg preverjanja.
When establishing those modalities, the particular characteristics of the supply chains in Member States, and the need to ensure that the impact of verification measures on particular actors in the supply chains is proportionate, shall be taken into account;
Pri oblikovanju teh načinov se upošteva posebne značilnosti dobavnih verig v državah članicah ter potrebo po zagotovitvi, da bodo imeli ukrepi preverjanja sorazmeren učinek na posamezne udeležence v dobavni verigi;
provisions on the establishment, management and accessibility of the repositories system in which information on the safety features, enabling the verification of the authenticity and identification of medicinal products, as provided for in point (o) of Article 54, shall be contained.
določbe o oblikovanju, upravljanju in dostopnosti sistemov arhivov, v katerih so zbrane informacije o zaščitnih elementih, ki omogočajo preverjanje avtentičnosti in identifikacijo zdravil, kot je določeno v točki (o) člena 54.
The costs of the repositories system shall be borne by the manufacturing authorisation holders of medicinal products bearing the safety features.
Stroške sistemov arhivov krijejo imetniki dovoljenja za proizvodnjo zdravil, ki nosijo zaščitne elemente.
When adopting the measures referred to in paragraph 2, the Commission shall take due account of at least the following:
Pri sprejemanju ukrepov iz odstavka 2 Komisija primerno upošteva vsaj naslednje:
the protection of personal data as provided for in Union law;
varstvo osebnih podatkov, kot je določeno v zakonodaji Unije;
the legitimate interests to protect information of a commercially confidential nature;
legitimne interese glede varovanja poslovno zaupnih informacij;
the ownership and confidentiality of the data generated by the use of the safety features; and
lastništvo in zaupnost podatkov, ki nastanejo z uporabo zaščitnih elementov, in
the cost-effectiveness of the measures.
stroškovno učinkovitost ukrepov.
The national competent authorities shall notify the Commission of non-prescription medicinal products which they judge to be at risk of falsification and may inform the Commission of medicinal products which they deem not to be at risk according to the criteria set out in point (b) of paragraph 2 of this Article.
Pristojni nacionalni organi obvestijo Komisijo o neizdajanju zdravil, za katera domnevajo, da obstaja tveganje ponarejanja, ter jo lahko obvestijo o zdravilih, za katera menijo, da ni nevarnosti v skladu z merili iz točke (b) odstavka 2 tega člena.
Member States may, for the purposes of reimbursement or pharmacovigilance, extend the scope of application of the unique identifier referred to in point (o) of Article 54 to any medicinal product subject to prescription or subject to reimbursement.
Države članice lahko za namene povračila ali farmakovigilance razširijo področje uporabe edinstvene oznake iz točke (o) člena 54 na vsa zdravila, ki se izdajajo na recept ali za katera velja povračilo.
Member States may, for the purposes of reimbursement, pharmacovigilance or pharmacoepidemiology, use the information contained in the repositories system referred to in point (e) of paragraph 2 of this Article.
Države članice lahko za namene povračila, farmakovigilance ali farmakoepidemiologije uporabijo informacije iz sistema arhivov iz točke (e) odstavka 2 tega člena.
Member States may, for the purposes of patient safety, extend the scope of application of the anti-tampering device referred to in point (o) of Article 54 to any medicinal product.’;
Države članice lahko za namene varnosti bolnikov, razširijo področje uporabe sredstva za preprečevanje nedovoljenega spreminjanja iz točke (o) člena 54 na vsa zdravila.“;
in Article 57, the fourth indent of the first paragraph is replaced by the following:
v členu 57 se četrta alinea prvega odstavka nadomesti z naslednjim:
authenticity and identification in accordance with Article 54a(5).’;
avtentičnost in identifikacija v skladu s členom 54a(5).“;
the heading of title VII is replaced by the following:
naslov VII se nadomesti z naslednjim:
‘Wholesale distribution and brokering of medicinal products’;
„Promet z zdravili na debelo in posredovanje zdravil“;
in Article 76, paragraph 3 is replaced by the following:
v členu 76 se odstavek 3 nadomesti z naslednjim:
Any distributor, not being the marketing authorisation holder, who imports a medicinal product from another Member State shall notify the marketing authorisation holder and the competent authority in the Member State to which the medicinal product will be imported of his intention to import that product.
Vsak distributer, ki ni imetnik dovoljenja za promet z zdravilom, ki uvozi zdravilo iz druge države članice, o svoji nameri za uvoz zdravila uradno obvesti imetnika dovoljenja za promet in pristojni organ države članice, v katero se bo zdravilo uvozilo.
In the case of medicinal products which have not been granted an authorisation pursuant to Regulation (EC) No 726/2004, the notification to the competent authority shall be without prejudice to additional procedures provided for in the legislation of that Member State and to fees payable to the competent authority for examining the notification.
V primeru zdravil, za katera ni bilo pridobljeno dovoljenje v skladu z Uredbo (ES) št. 726/2004, uradna obvestitev pristojnega organa ne posega v dodatne postopke iz zakonodaje te države članice, in v pristojbine, ki se plačajo pristojnim organom za preučitev uradnega obvestila.
In the case of medicinal products which have been granted an authorisation pursuant to Regulation (EC) No 726/2004, the distributor shall submit the notification in accordance with paragraph 3 of this Article to the marketing authorisation holder and the Agency.
V primeru zdravil, za katera je bilo pridobljeno dovoljenje v skladu z Uredbo (ES) št. 726/2004, distributer v skladu z odstavkom 3 tega člena imetniku dovoljenja in Agenciji predloži uradno obvestilo.
A fee shall be payable to the Agency for checking that the conditions laid down in Union legislation on medicinal products and in the marketing authorisations are observed.’;
Agenciji se plača pristojbina, da preveri, ali so upoštevani pogoji, določeni v zakonodaji Unije glede zdravil in dovoljenj za promet.“;
Article 77 is amended as follows:
člen 77 se spremeni:
Member States shall take all appropriate measures to ensure that the wholesale distribution of medicinal products is subject to the possession of an authorisation to engage in activity as a wholesaler in medicinal products, stating the premises located on their territory for which it is valid.’;
Države članice sprejmejo vse ustrezne ukrepe, da zagotovijo, da je promet z zdravili na debelo mogoč le na podlagi dovoljenja za promet z zdravilom, ki trgovcu na debelo omogoča opravljanje dejavnosti prometa z zdravili na debelo z navedbo prostorov na njihovem ozemlju, za katerega velja.“;