natgillin/translations-raw huggingface dataset:
The national competent authority shall provide the marketing authorisation holder with an opportunity to present written observations in response to the imposition of the obligation within a time limit which it shall specify, if the marketing authorisation holder so requests within 30 days of receipt of the written notification of the obligation.
Pristojni nacionalni organ imetniku dovoljenja za promet z zdravilom da možnost, da predloži pisne obrazložitve kot odgovor na naložitev obveznosti v roku, ki ga določi organ, če imetnik dovoljenja za promet z zdravilom to zahteva v 30 dneh od prejema pisnega uradnega obvestila o obveznosti.
On the basis of the written observations submitted by the marketing authorisation holder, the national competent authority shall withdraw or confirm the obligation.
Pristojni nacionalni organ na podlagi pisnih obrazložitev, ki jih predloži imetnik dovoljenja za promet z zdravilom, umakne ali potrdi obveznosti.
Where the national competent authority confirms the obligation, the marketing authorisation shall be varied to include the obligation as a condition of the marketing authorisation and the risk management system shall be updated accordingly.
Kadar pristojni nacionalni organ potrdi obveznost, se dovoljenje za promet z zdravilom spremeni tako, da se obveznost vključi kot pogoj dovoljenja za promet z zdravilom, sistem obvladovanja tveganj pa se ustrezno posodobi.
In order to determine the situations in which post-authorisation efficacy studies may be required under Articles 21a and 22a of this Directive, the Commission may adopt, by means of delegated acts in accordance with Article 121a, and subject to the conditions of Articles 121b and 121c, measures supplementing the provisions in Articles 21a and 22a.
Da bi določili razmere, v katerih je treba zahtevati izvedbo študije o učinkovitosti po pridobitvi dovoljenja na podlagi člena 21a in člena 22a te direktive, lahko Komisija z delegiranimi akti v skladu s členom 121a in pod pogoji iz členov 121b in 121c sprejme ukrepe, ki dopolnjujejo določbe členov 21a in 22a.
When adopting such delegated acts, the Commission shall act in accordance with the provisions of this Directive.
Komisija pri sprejemanju teh delegiranih aktov ravna v skladu z določbami te direktive.
Article 22c
Člen 22c
The marketing authorisation holder shall incorporate any conditions referred to in Articles 21a, 22 or 22a in his risk management system.
Od imetnika dovoljenja za promet z zdravilom se zahteva, da v sistem obvladovanja tveganj vključi vse pogoje iz členov 21a, 22 ali 22a.
The Member States shall inform the Agency of the marketing authorisations that they have granted subject to conditions pursuant to Articles 21a, 22 or 22a.’.
Države članice obvestijo Agencijo o dovoljenjih za promet z zdravilom, ki so jih izdale ob upoštevanju pogojev iz členov 21a, 22 ali 22a.“;
Article 23 is replaced by the following:
člen 23 se nadomesti z naslednjim:
After a marketing authorisation has been granted, the marketing authorisation holder shall, in respect of the methods of manufacture and control provided for in Article 8(3)(d) and (h), take account of scientific and technical progress and introduce any changes that may be required to enable the medicinal product to be manufactured and checked by means of generally accepted scientific methods.
Po izdaji dovoljenja za promet imetnik dovoljenja za promet z zdravilom glede postopkov proizvodnje in nadzora, predpisanih v točkah (d) in (h) členu 8(3), upošteva znanstveni in tehnični napredek in uvede vse zahtevane spremembe, da bi omogočil proizvodnjo in preverjanje zdravila po splošno sprejetih znanstvenih postopkih.
Those changes shall be subject to the approval of the competent authority of the Member State concerned.
Te spremembe odobri pristojni organ zadevne države članice.
The marketing authorisation holder shall forthwith provide the national competent authority with any new information which might entail the amendment of the particulars or documents referred to in Article 8(3), Articles 10, 10a, 10b and 11, or Article 32(5), or Annex I.
Imetnik dovoljenja za promet z zdravilom nemudoma pošlje pristojnemu nacionalnemu organu vsakršne nove informacije, ki bi lahko privedle do spremembe podatkov ali dokumentov iz člena 8(3), členov 10, 10a, 10b in 11 ali člena 32(5) ali Priloge I.
In particular, the marketing authorisation holder shall forthwith inform the national competent authority of any prohibition or restriction imposed by the competent authorities of any country in which the medicinal product is marketed and of any other new information which might influence the evaluation of the benefits and risks of the medicinal product concerned.
Zlasti pa imetnik dovoljenja za promet z zdravilom nemudoma obvesti pristojni nacionalni organ o vseh prepovedih ali omejitvah, ki so jih uvedli pristojni organi katere koli države, v kateri je zdravilo v prometu in o kakršnih koli drugih novih informacijah, ki bi lahko vplivale na oceno koristi in tveganj zadevnega zdravila.
The information shall include both positive and negative results of clinical trials or other studies in all indications and populations, whether or not included in the marketing authorisation, as well as data on the use of the medicinal product where such use is outside the terms of the marketing authorisation.
Informacije vključujejo pozitivne in negativne rezultate kliničnih preskušanj ali drugih študij za vse indikacije in populacije, ne glede na to, ali so vključene v dovoljenje za promet z zdravilom ali ne, ter podatke o uporabi zdravila, kadar je takšna uporaba izven okvira pogojev dovoljenja za promet z zdravilom.
The marketing authorisation holder shall ensure that the product information is kept up to date with the current scientific knowledge, including the conclusions of the assessment and recommendations made public by means of the European medicines web-portal established in accordance with Article 26 of Regulation (EC) No 726/2004.
Imetnik dovoljenja za promet z zdravilom zagotovi, da se informacije o zdravilu sproti dopolnijo z novimi znanstvenimi spoznanji, vključno s sklepi o oceni in priporočili, objavljenimi na evropskem spletnem portalu o zdravilih, vzpostavljenem v skladu s členom 26 Uredbe (ES) št. 726/2004.
In order to be able to continuously assess the risk-benefit balance, the national competent authority may at any time ask the marketing authorisation holder to forward data demonstrating that the risk-benefit balance remains favourable.
Da bi se lahko razmerje med tveganjem in koristjo stalno ocenjevalo lahko pristojni nacionalni organ od imetnika dovoljenja za promet z zdravilom kadar koli zahteva, da posreduje podatke, ki dokazujejo, da razmerje med tveganjem in koristjo ostaja ugodno.
The marketing authorisation holder shall answer fully and promptly any such request.
Imetnik dovoljenja za promet z zdravilom v celoti in takoj ugodi vsaki taki zahtevi.
The national competent authority may at any time ask the marketing authorisation holder to submit a copy of the pharmacovigilance system master file.
Pristojni nacionalni organ lahko od imetnika dovoljenja za promet z zdravilom kadar koli zahteva, da predloži izvod glavnega dosjeja o sistemu farmakovigilance.
The marketing authorisation holder shall submit the copy at the latest 7 days after receipt of the request.’.
Imetnik dovoljenja za promet z zdravilom izvod predloži najkasneje v sedmih dneh po prejetju zahtevka.“;
‘To this end, the marketing authorisation holder shall provide the national competent authority with a consolidated version of the file in respect of quality, safety and efficacy, including the evaluation of data contained in suspected adverse reactions reports and periodic safety update reports submitted in accordance with Title IX, and information on all variations introduced since the marketing authorisation was granted, at least 9 months before the marketing authorisation ceases to be valid in accordance with paragraph 1.’;
„V ta namen imetnik dovoljenja za promet z zdravilom pristojnemu nacionalnemu organu predloži konsolidirano različico dokumentacije glede kakovosti, varnosti in učinkovitosti, vključno z oceno podatkov iz poročil o domnevnih neželenih učinkih in rednih posodobljenih poročil o varnosti, predloženih v skladu z naslovom IX, in z vsemi spremembami, ki so bile uvedene od izdaje dovoljenja za promet z zdravilom, najmanj devet mesecev pred datumom izteka veljavnosti dovoljenja za promet z zdravilom v skladu z odstavkom 1.“;
Once renewed, the marketing authorisation shall be valid for an unlimited period, unless the national competent authority decides, on justified grounds relating to pharmacovigilance, including exposure of an insufficient number of patients to the medicinal product concerned, to proceed with one additional five-year renewal in accordance with paragraph 2.’.
Ko je dovoljenje za promet podaljšano, velja za nedoločen čas, razen če se pristojni nacionalni organ iz upravičenih razlogov v zvezi s farmakovigilanco, vključno z nezadostnim številom izpostavljenih bolnikov zadevnemu zdravilu, odloči, da nadaljuje z dodatnim petletnim obnovitvenim obdobjem v skladu z odstavkom 2.“;
The title ‘Chapter 4 Mutual recognition and decentralised procedure’ is deleted.
naslov „Poglavje 4 Postopek z medsebojnim priznavanjem in decentraliziran postopek“ se črta;
A coordination group shall be set up for the following purposes:
Ustanovi se skupina za usklajevanje za naslednje namene:
the examination of any question relating to a marketing authorisation of a medicinal product in two or more Member States in accordance with the procedures laid down in Chapter 4;
preučevanje vseh vprašanj, povezanih s pridobitvijo dovoljenj za promet z zdravilom v dveh ali več državah članicah v skladu s postopki, določenimi v poglavju 4;
the examination of questions related to the pharmacovigilance of medicinal products authorised by the Member States, in accordance with Articles 107c, 107e, 107g, 107k and 107q;
preučevanje vseh vprašanj, povezanih s farmakovigilanco zdravil, ki jih odobrijo države članice, v skladu s členi 107c, 107e, 107g, 107k in 107q;
the examination of questions relating to variations of marketing authorisations granted by the Member States, in accordance with Article 35(1).
preučevanje vseh vprašanj, povezanih s spremembami dovoljenj za promet z zdravilom, ki jih izdajo države članice, v skladu s členom 35(1).
The Agency shall provide the secretariat of this coordination group.
Agencija zagotovi sekretariat za to skupino za usklajevanje.
For the fulfilment of its pharmacovigilance tasks, including approving risk management systems and monitoring their effectiveness, the coordination group shall rely on the scientific assessment and the recommendations of the Pharmacovigilance Risk Assessment Committee provided for in Article 56(1)(aa) of Regulation (EC) No 726/2004.
Odbor za ocenjevanje tveganja na področju farmakovigilance iz točke (aa) člena 56(1) Uredbe (ES) št. 726/2004 s strokovnimi ocenami in priporočili pomaga skupini za usklajevanje pri izvajanju nalog farmakovigilance, vključno z odobritvijo sistemov obvladovanja tveganj in spremljanjem njihove učinkovitosti.
The coordination group shall be composed of one representative per Member State appointed for a renewable period of 3 years.
Skupina za usklajevanje je sestavljena iz enega predstavnika vsake države članice, imenovanega za obdobje treh let, ki se lahko podaljša.
Member States may appoint an alternate for a renewable period of 3 years.
Države članice lahko imenujejo namestnika za obdobje treh let, ki se lahko podaljša.
Members of the coordination group may arrange to be accompanied by experts.
Člane skupine za usklajevanje lahko spremljajo strokovnjaki.
Members of the coordination group and experts shall, for the fulfilment of their tasks, rely on the scientific and regulatory resources available to national competent authorities.
Člani skupine za usklajevanje in strokovnjaki se pri izvajanju svojih nalog opirajo na znanstvene in ureditvene vire, ki so na voljo pristojnim nacionalnim organom.
Each national competent authority shall monitor the level of expertise of the evaluations carried out and facilitate the activities of nominated coordination group members and experts.
Vsak pristojen nacionalni organ spremlja raven strokovnosti opravljenega vrednotenja ter olajša dejavnosti imenovanih članov skupine za usklajevanje in strokovnjakov.
Article 63 of Regulation (EC) No 726/2004 shall apply to the coordination group as regards transparency and the independence of its members.’;
Za skupino za usklajevanje se glede preglednosti in neodvisnosti njenih članov uporablja člen 63 Uredbe (ES) št. 726/2004.“;
The Executive Director of the Agency or his representative and representatives of the Commission shall be entitled to attend all meetings of the coordination group.
Izvršni direktor Agencije ali njegov predstavnik in predstavniki Komisije imajo pravico biti navzoči pri vseh srečanjih skupine za usklajevanje.
The members of the coordination group shall ensure that there is appropriate coordination between the tasks of that group and the work of national competent authorities, including the consultative bodies concerned with the marketing authorisation.
Člani skupine za usklajevanje zagotavljajo ustrezno koordinacijo med nalogami navedene skupine in delom pristojnih nacionalnih organov, vključno s posvetovalnimi organi, ki jih dovoljenje za promet z zdravilom zadeva.
Save where otherwise provided for in this Directive, the Member States represented within the coordination group shall use their best endeavours to reach a position by consensus on the action to be taken.
Razen če ni v tej direktivi določeno drugače, si države članice, zastopane v skupini za usklajevanje, kar najbolj prizadevajo, da s soglasjem dosežejo stališče o ukrepih, ki jih je treba sprejeti.
If such a consensus cannot be reached, the position of the majority of the Member States represented within the coordination group shall prevail.
Če takega soglasja ni mogoče doseči, prevlada stališče večine držav članic, zastopanih v skupini za usklajevanje.
Members of the coordination group shall be required, even after their duties have ceased, not to disclose information of the kind covered by the obligation of professional secrecy.’.
Od članov skupine za usklajevanje se tudi po prenehanju njihovih dolžnosti zahteva, da ne razkrijejo podatkov, ki jih zajema obveznost varovanja poslovne skrivnosti.“;
After Article 27 the following heading is inserted:
za členom 27 se vstavi naslednji naslov:
Mutual recognition and decentralised procedure’.
Postopek z medsebojnim priznavanjem in decentraliziran postopek“;
Article 31(1) is amended as follows:
člen 31(1) se spremeni:
‘The Member States, the Commission, the applicant or the marketing authorisation holder shall, in specific cases where the interests of the Union are involved, refer the matter to the Committee for application of the procedure laid down in Articles 32, 33 and 34 before any decision is reached on an application for a marketing authorisation or on the suspension or revocation of a marketing authorisation, or on any other variation of the marketing authorisation which appears necessary.’;
„Države članice, Komisija, predlagatelj ali imetnik dovoljenja za promet z zdravilom v posebnih primerih, kadar gre za interese Unije, zadevo predloži odboru za uporabo postopka iz členov 32, 33 in 34 pred sprejetjem odločitve glede vloge za izdajo dovoljenja za promet z zdravilom, glede začasnega preklica ali razveljavitve dovoljenja za promet z zdravilom ali kakršne koli spremembe dovoljenja za promet z zdravilom, ki je potrebna.“;
the following subparagraphs are inserted after the first subparagraph:
za prvim pododstavkom se vstavita naslednja pododstavka:
‘Where the referral results from the evaluation of data relating to pharmacovigilance of an authorised medicinal product, the matter shall be referred to the Pharmacovigilance Risk Assessment Committee and Article 107j(2) may be applied.
„Kadar je napotitev rezultat ocene podatkov v zvezi s farmakovigilanco zdravila, ki je pridobilo dovoljenje za promet, se zadeva posreduje Odboru za ocenjevanje tveganja na področju farmakovigilance in se lahko uporabi člen 107j(2).
The Pharmacovigilance Risk Assessment Committee shall issue a recommendation according to the procedure laid down in Article 32.
Odbor za ocenjevanje tveganja na področju farmakovigilance izda priporočilo v skladu s postopkom iz člena 32.
The final recommendation shall be forwarded to the Committee for Medicinal Products for Human Use or to the coordination group, as appropriate, and the procedure laid down in Article 107k shall apply.
Končno priporočilo se posreduje Odboru za zdravila za uporabo v humani medicini ali skupini za usklajevanje, uporabi pa se postopek iz člena 107k.
However, where urgent action is considered necessary, the procedure laid down in Articles 107i to 107k shall apply.’.
Kadar je potrebno nujno ukrepanje, se uporabi postopek iz členov 107i do 107k.“;
Article 36 is deleted.
člen 36 se črta;
Article 59 is amended as follows:
člen 59 se spremeni:
point (e) is replaced by:
točka (e) se nadomesti z naslednjim:
a description of the adverse reactions which may occur under normal use of the medicinal product and, if necessary, the action to be taken in such a case.’;
opis neželenih učinkov, ki se lahko pojavijo pri običajni uporabi zdravila in po potrebi ukrepe, ki jih je treba sprejeti v takem primeru.“;
‘For medicinal products included in the list referred to in Article 23 of Regulation (EC) No 726/2004, the following additional statement shall be included “This medicinal product is subject to additional monitoring”.
„Za zdravila s seznama iz člena 23 Uredbe (ES) št. 726/2004 se vključi naslednja dodatna izjava: ‚Za to zdravilo se izvaja dodatno spremljanje varnosti.‘.
For all medicinal products, a standardised text shall be included, expressly asking patients to communicate any suspected adverse reaction to his/her doctor, pharmacist, healthcare professional or directly to the national spontaneous reporting system referred to in Article 107a(1), and specifying the different ways of reporting available (electronic reporting, postal address and/or others) in compliance with the second subparagraph of Article 107a(1).’;
Vsem zdravilom se doda standardno besedilo, ki od bolnikov izrecno zahteva, naj vsak domnevni neželeni učinek sporočijo svojemu zdravniku, farmacevtu, zdravstvenemu delavcu ali neposredno nacionalnemu sistemu spontanega poročanja iz člena 107a(1), ob tem pa se navedejo različni načini poročanja, ki so na voljo (elektronsko poročanje, poštna številka in/ali drugo) v skladu z drugim pododstavkom člena 107a(1).“;
By 1 January 2013, the Commission shall present to the European Parliament and the Council an assessment report on current shortcomings in the summary of product characteristics and the package leaflet and how they could be improved in order to better meet the needs of patients and healthcare professionals.
Komisija do 1. januarja 2013 Evropskemu parlamentu in Svetu predloži poročilo o oceni trenutnih pomanjkljivostih v povzetku glavnih značilnosti zdravila in navodilu za uporabo ter predloge za njihovo izboljšanje, da bi bolje zadovoljili potrebe bolnikov in zdravstvenih delavcev.
The Commission shall, if appropriate, and on the basis of the report, and consultation with appropriate stakeholders, present proposals in order to improve the readability, layout and content of these documents. ’
Komisija, če je to primerno, na podlagi poročila in posvetovanja z zadevnimi stranmi, pripravi predloge za izboljšanje berljivosti, predstavitve in vsebine teh dokumentov.“;
Article 63(3) is replaced by the following:
člen 63(3) se nadomesti z naslednjim:
When the medicinal product is not intended to be delivered directly to the patient, or where there are severe problems in respect of the availability of the medicinal product, the competent authorities may, subject to measures they consider necessary to safeguard human health, grant an exemption to the obligation that certain particulars should appear on the labelling and in the package leaflet.
Kadar zdravilo ni namenjeno neposredni dobavi bolniku ali kadar obstajajo resne težave v zvezi z dostopnostjo zdravila, lahko pristojni organi ob upoštevanju ukrepov, za katere menijo, da so potrebni za varovanje zdravja ljudi, odobrijo izjemo od obveznosti, v skladu s katero bi morali biti na ovojnini in v navodilu za uporabo navedeni nekateri podatki.
They may also grant a full or partial exemption to the obligation that the labelling and the package leaflet must be in the official language or languages of the Member State in which the medicinal product is placed on the market.’.
Odobrijo lahko tudi celotno ali delno izjemo od obveznosti, da mora biti ovojnina in navodilo za uporabo v uradnem jeziku ali jezikih države članice, v kateri se zdravilo daje v promet.“;
Title IX is replaced by the following:
Naslov IX se nadomesti z naslednjim:
PHARMACOVIGILANCE
FARMAKOVIGILANCA
Member States shall operate a pharmacovigilance system for the fulfilment of their pharmacovigilance tasks and their participation in Union pharmacovigilance activities.
Države članice vodijo sistem farmakovigilance za opravljanje svojih nalog farmakovigilance in sodelovanje v farmakovigilančnih dejavnostih Unije.
The pharmacovigilance system shall be used to collect information on the risks of medicinal products as regards patients’ or public health.
Sistem farmakovigilance se uporablja za zbiranje informacij o tveganjih za zdravje bolnikov ali javno zdravje zaradi zdravil.
That information shall in particular refer to adverse reactions in human beings, arising from use of the medicinal product within the terms of the marketing authorisation as well as from use outside the terms of the marketing authorisation, and to adverse reactions associated with occupational exposure.
Te informacije se zlasti nanašajo na neželene učinke pri ljudeh, ki izhajajo iz uporabe zdravila v okviru pogojev dovoljenja za promet z zdravilom in uporabe zunaj okvira pogojev dovoljenja za promet z zdravilom, ter na neželene učinke, ki so povezani s poklicno izpostavljenostjo.
Member States shall, by means of the pharmacovigilance system referred to in paragraph 1, evaluate all information scientifically, consider options for risk minimisation and prevention and take regulatory action concerning the marketing authorisation as necessary.
S sistemom farmakovigilance iz odstavka 1 države članice znanstveno ovrednotijo vse informacije, preučijo možnosti za zmanjšanje in preprečevanje tveganj in, če je to potrebno, sprejmejo ureditvene ukrepe v zvezi z dovoljenjem za promet z zdravilom.
They shall perform a regular audit of their pharmacovigilance system and report the results to the Commission on 21 September 2013 at the latest and then every 2 years thereafter.
Sistem farmakovigilance redno presojajo in rezultate Komisiji sporočijo najpozneje 21. septembra 2013 in nato vsaki dve leti.
Each Member State shall designate a competent authority for the performance of pharmacovigilance tasks.
Vsaka država članica določi pristojni organ za opravljanje nalog farmakovigilance.
The Commission may request Member States to participate, under the coordination of the Agency, in international harmonisation and standardisation of technical measures in relation to pharmacovigilance.
Komisija lahko od držav članic zahteva, da sodelujejo v mednarodnem usklajevanju in standardizaciji tehničnih ukrepov v zvezi s farmakovigilanco, ki ju vodi Agencija.
take all appropriate measures to encourage patients, doctors, pharmacists and other healthcare professionals to report suspected adverse reactions to the national competent authority; for these tasks, organisations representing consumers, patients and healthcare professionals may be involved as appropriate;
sprejmejo vse ustrezne ukrepe za spodbujanje bolnikov, zdravnikov, farmacevtov in drugih zdravstvenih delavcev, da nacionalnemu pristojnemu organu poročajo o domnevnih neželenih učinkih; v opravljanje teh nalog se lahko po potrebi vključijo organizacije potrošnikov, bolnikov in zdravstvenih delavcev;