natgillin/translations-raw huggingface dataset:
Without prejudice to the requirements set out in Commission Regulation (EC) No 1234/2008 of 24 November 2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products [7], the marketing authorisation holder shall notify immediately the Agency of any change in the location of the pharmacovigilance system master file or changes to the contact details and name of the qualified person responsible for pharmacovigilance.
Imetnik dovoljenja za promet brez poseganja v zahteve, navedene v Uredbi Komisije (ES) št. 1234/2008 z dne 24. novembra 2008 o pregledu sprememb pogojev dovoljenj za promet z zdravili za uporabo v humani medicini in zdravil za uporabo v veterinarski medicini [7], Agencijo nemudoma obvesti o vsaki spremembi lokacije glavnega dosjeja o sistemu farmakovigilance ali spremembi kontaktnih podatkov in imena usposobljene osebe, odgovorne za farmakovigilanco.
The Agency shall update the Eudravigilance database referred to in Article 24(1) of Regulation (EC) No 726/2004 and, where necessary, the European medicines web-portal referred to in Article 26(1) of Regulation (EC) No 726/2004 accordingly.
Agencija ustrezno posodobi podatkovno zbirko Eudravigilance iz člena 24(1) Uredbe (ES) št. 726/2004 in po potrebi evropski spletni portal o zdravilih iz člena 26(1) Uredbe (ES) št. 726/2004.
Form of the documents contained in the pharmacovigilance system master file
Oblika dokumentov v glavnem dosjeju o sistemu farmakovigilance
Pharmacovigilance system master file documents shall be complete and legible.
Dokumenti v glavnem dosjeju o sistemu farmakovigilance morajo biti popolni in berljivi.
Where appropriate, information may be provided in the form of charts or flow diagrams.
Kadar je primerno, so lahko informacije podane v obliki grafov ali diagramov poteka.
All documents shall be indexed and archived so as to ensure their accurate and ready retrieval throughout the period for record-keeping.
Vsi dokumenti so razvrščeni in arhivirani tako, da je mogoče do njih natančno in enostavno dostopati v celotnem obdobju vodenja evidence.
The particulars and documents of the pharmacovigilance system master file may be presented in modules in accordance with the system delineated in detail in the guidance on good pharmacovigilance practices.
Podatki in dokumenti glavnega dosjeja o sistemu farmakovigilance so lahko predstavljeni v modulih v skladu s sistemom, podrobno začrtanem v smernicah o dobri praksi na področju farmakovigilance.
The pharmacovigilance system master file may be stored in electronic form provided that the media used for storage remain readable over time and a clearly arranged printed copy can be made available for audits and inspections.
Glavni dosje o sistemu farmakovigilance je lahko shranjen v elektronski obliki, če medij, na katerem je shranjen, ostane berljiv dlje časa in je mogoče za presoje in preglede kadar koli natisniti jasno urejeno kopijo.
The marketing authorisation holder shall record in the logbook referred to in point 8 of Article 3 any alteration of the content of the pharmacovigilance system master file made within the last five years, with the exception of the information referred to in point 1(b) to (e) of Article 2 and in Article 3.
Imetnik dovoljenja za promet v dnevnik iz točke 8 člena 3 evidentira vse spremembe vsebine glavnega dosjeja o sistemu farmakovigilance v zadnjih petih letih, razen informacij iz točk 1(b) do (e) člena 2 in iz člena 3.
The marketing authorisation holder shall indicate in the logbook the date, the person responsible for the alteration and, where appropriate, the reason for the alteration.
Imetnik dovoljenja za promet v dnevniku navede datum, osebo, odgovorno za spremembo, in razlog za spremembo, kadar je primerno.
Subcontracting
Oddaja v delo pogodbenikom
The marketing authorisation holder may subcontract certain activities of the pharmacovigilance system to third parties.
Imetnik dovoljenja za promet lahko nekatere dejavnosti na področju sistema farmakovigilance odda v delo pogodbenikom.
It shall nevertheless retain full responsibility for the completeness and accuracy of the pharmacovigilance system master file.
Kljub temu pa imetnik dovoljenja ohrani celotno odgovornost za popolnost in točnost glavnega dosjeja o sistemu farmakovigilance.
The marketing authorisation holder shall draw up a list of its existing subcontracts between it and the third parties referred to in paragraph 1, specifying the product(s) and territory(ies) concerned.
Imetnik dovoljenja za promet sestavi seznam obstoječih podizvajalskih pogodb med njim in pogodbeniki iz odstavka 1, pri čemer opredeli zadevna zdravila in območja.
Availability and location of the pharmacovigilance system master file
Razpoložljivost in lokacija glavnega dosjeja o sistemu farmakovigilance
The pharmacovigilance system master file shall be located either at the site in the Union where the main pharmacovigilance activities of the marketing authorisation holder are performed or at the site in the Union where the qualified person responsible for pharmacovigilance operates.
Glavni dosje o sistemu farmakovigilance je shranjen na kraju v Uniji, kjer imetnik dovoljenja za promet izvaja glavne dejavnosti na področju farmakovigilance, ali na kraju v Uniji, kjer deluje usposobljena oseba, odgovorna za farmakovigilanco.
The marketing authorisation holder shall ensure that the qualified person for pharmacovigilance has permanent access to the pharmacovigilance system master file.
Imetnik dovoljenja za promet zagotovi, da ima usposobljena oseba, odgovorna za farmakovigilanco, stalen dostop do glavnega dosjeja o sistemu farmakovigilance.
The pharmacovigilance system master file shall be permanently and immediately available for inspection at the site where it is kept.
Glavni dosje o sistemu farmakovigilance je stalno in takoj dostopen za nadzor na kraju, kjer je shranjen.
Where the pharmacovigilance system master file is kept in electronic form in accordance with Article 5(3), it is sufficient for the purposes of this Article that the data stored in electronic form is directly available at the site where the pharmacovigilance system master file is kept.
Kadar se glavni dosje o sistemu farmakovigilance hrani v elektronski obliki v skladu s členom 5(3), je za namene tega člena dovolj, da so elektronsko shranjeni podatki neposredno dostopni na kraju, kjer je shranjen glavni dosje o sistemu farmakovigilance.
For the purposes of Article 23(4) of Directive 2001/83/EC, the national competent authority may limit its request to specific parts or modules of the pharmacovigilance system master file and the marketing authorisation holder shall bear the costs of submitting the copy of the pharmacovigilance system master file.
Za namene člena 23(4) Direktive 2001/83/ES lahko pristojni nacionalni organ omeji zahteve na specifične dele ali module glavnega dosjeja o sistemu farmakovigilance, imetnik dovoljenja za promet pa prevzame stroške predložitve njegove kopije.
The national competent authority and the Agency may request the marketing authorisation holder to submit a copy of the logbook referred to in point 8 of Article 3 at regular intervals.
Pristojni nacionalni organ in Agencija lahko zahtevata, da imetnik dovoljenja za promet redno predlaga kopijo dnevnika iz točke 8 člena 3.
Minimum requirements for the quality systems for the performance of pharmacovigilance activities
Minimalne zahteve za sisteme kakovosti za izvajanje dejavnosti na področju farmakovigilance
Marketing authorisation holders, the national competent authorities and the Agency shall establish and use a quality system that is adequate and effective for the performance of their pharmacovigilance activities.
Imetniki dovoljenja za promet, pristojni nacionalni organi in Agencija vzpostavijo in uporabljajo sistem kakovosti, ki je primeren in učinkovit za izvajanje njihovih dejavnosti na področju farmakovigilance.
The quality system shall cover organisational structure, responsibilities, procedures, processes and resources, appropriate resource management, compliance management and record management.
Sistem kakovosti zajema organizacijsko strukturo, odgovornosti, postopke, procese in vire, ustrezno ravnanje z viri, zagotavljanje upoštevanja predpisov in upravljanje evidenc.
The quality system shall be based on all of the following activities:
Sistem kakovosti temelji na:
quality planning: establishing structures and planning integrated and consistent processes;
načrtovanju kakovosti: vzpostavitev struktur in načrtovanje usklajenih in doslednih procesov;
quality adherence: carrying out tasks and responsibilities in accordance with quality requirements;
upoštevanju kakovosti: izvajanje nalog in odgovornosti v skladu z zahtevami glede kakovosti;
quality control and assurance: monitoring and evaluating how effectively the structures and processes have been established and how effectively the processes are being carried out;
nadzoru in zagotavljanju kakovosti: spremljanju in ocenjevanju, kako učinkovito so bili strukture in procesi vzpostavljeni ter kako učinkovito so procesi izpeljani;
quality improvements: correcting and improving the structures and processes where necessary.
izboljšanju kakovosti: popravljanje in izboljševanje struktur in procesov, kjer je potrebno.
All elements, requirements and provisions adopted for the quality system shall be documented in a systematic and orderly manner in the form of written policies and procedures, such as quality plans, quality manuals and quality records.
Vsi elementi, zahteve in določbe, sprejeti za sistem kakovosti, so sistematsko in urejeno dokumentirani v obliki zapisanih pravil in postopkov, kot so načrti kakovosti ter navodila in evidence o kakovosti.
All persons involved in the procedures and processes of the quality systems established by the national competent authorities and the Agency for the performance of pharmacovigilance activities shall be responsible for the good functioning of those quality systems and shall ensure a systematic approach towards quality and towards the implementation and maintenance of the quality system.
Vse osebe, vpletene v postopke in procese sistemov kakovosti, ki so jih pristojni nacionalni organi in Agencija vzpostavili za izvajanje dejavnosti na področju farmakovigilance, so odgovorne za dobro delovanje navedenih sistemov kakovosti in zagotavljajo sistematični pristop h kakovosti ter izvajanju in vzdrževanju sistema kakovosti.
Performance indicators
Kazalniki uspešnosti
The marketing authorisation holder, national competent authorities and the Agency may use performance indicators to continuously monitor the good performance of pharmacovigilance activities.
Imetnik dovoljenja za promet, pristojni nacionalni organi in Agencija lahko uporabijo kazalnike uspešnosti za stalno spremljanje dobrega izvajanja dejavnosti na področju farmakovigilance.
The Agency may publish a list of performance indicators on the basis of a recommendation of the Pharmacovigilance Risk Assessment Committee.
Agencija lahko objavi seznam kazalnikov uspešnosti na podlagi priporočil odbora za oceno tveganja na področju farmakovigilance.
Minimum requirements for the quality systems for the performance of pharmacovigilance activities by marketing authorisation holders
Minimalne zahteve za sisteme kakovosti za dejavnosti na področju farmakovigilance, ki jih izvajajo imetniki dovoljenj za promet
Management of human resources
Upravljanje s človeškimi viri
The marketing authorisation holder shall have sufficient competent and appropriately qualified and trained personnel available for the performance of pharmacovigilance activities.
Imetnik dovoljenja za promet ima dovolj usposobljenega kadra, ki ima ustrezne pristojnosti in izobrazbo, za izvajanje dejavnosti na področju farmakovigilance.
For the purposes of the first subparagraph, the market authorisation holder shall ensure that the qualified person responsible for pharmacovigilance has acquired adequate theoretical and practical knowledge for the performance of pharmacovigilance activities.
Imetnik dovoljenja za promet za namene prvega pododstavka zagotovi, da je usposobljena oseba, odgovorna za farmakovigilanco, pridobila ustrezno teoretično in praktično znanje za izvajanje dejavnosti na področju farmakovigilance.
Where the qualified person has not completed basic medical training in accordance with Article 24 of Directive 2005/36/EC of the European Parliament and of the Council of 7 September 2005 on the recognition of professional qualifications [8], the market authorisation holder shall ensure that the qualified person responsible for pharmacovigilance is assisted by a medically trained person.
Kadar usposobljena oseba ni opravila osnovnega medicinskega usposabljanja v skladu s členom 24 Direktive 2005/36/ES Evropskega parlamenta in Sveta z dne 7. septembra 2005 o priznavanju poklicnih kvalifikacij [8], imetnik dovoljenja za promet zagotovi, da usposobljeni osebi, odgovorni za farmakovigilanco, pomaga medicinsko usposobljena oseba.
This assistance shall be duly documented.
Ta pomoč se ustrezno dokumentira.
The duties of the managerial and supervisory staff, including the qualified person responsible for pharmacovigilance, shall be defined in job descriptions.
Naloge vodstvenega in nadzornega osebja, vključno z usposobljeno osebo, odgovorno za farmakovigilanco, so opredeljene v njihovem opisu del in nalog.
Their hierarchical relationships shall be defined in an organisational chart.
Hierarhična razmerja se opredelijo v organizacijskem načrtu.
The marketing authorisation holder shall ensure that the qualified person responsible for pharmacovigilance has sufficient authority to influence the performance of the quality system and the pharmacovigilance activities of the marketing authorisation holder.
Imetnik dovoljenja za promet zagotovi, da ima usposobljena oseba, odgovorna za farmakovigilanco, dovolj pristojnosti, da lahko vpliva na izvajanje sistema kakovosti in dejavnosti na področju farmakovigilance imetnika dovoljenja za promet.
All personnel involved in the performance of pharmacovigilance activities shall receive initial and continued training in relation to their role and responsibilities.
Vse osebje, vključeno v izvajanje dejavnosti na področju farmakovigilance, se udeleži začetnega in nadaljevalnih usposabljanj v povezavi s svojo vlogo in odgovornostmi.
The marketing authorisation holder shall keep training plans and records for documenting, maintaining and developing the competences of personnel and make them available for audit or inspection.
Imetnik dovoljenja za promet hrani načrte in evidenco usposabljanj za dokumentiranje, vzdrževanje in razvoj kompetenc osebja ter jih da na razpolago za presojo ali nadzor.
The marketing authorisation holder shall provide appropriate instructions on the processes to be used in case of urgency, including business continuity.
Imetnik dovoljenja za promet zagotovi ustrezna navodila o procesih v nujnih primerih, vključno z neprekinjenim poslovanjem.
Compliance management
Zagotavljanje upoštevanja predpisov
Specific quality system procedures and processes shall be in place in order to ensure the following:
Uporabljajo se posebni postopki in procesi za sistem kakovosti za zagotavljanje, da:
the continuous monitoring of pharmacovigilance data, the examination of options for risk minimisation and prevention and appropriate measures are taken by the marketing authorisation holder;
imetnik dovoljenja za promet stalno spremlja podatke o farmakovigilanci, pregleda možnosti za zmanjšanje in preprečevanje tveganj ter sprejme ustrezne ukrepe;
the scientific evaluation by the marketing authorisation holder of all information on the risks of medicinal products, as referred to in the second subparagraph of Article 101(1) of Directive 2001/83/EC;
imetnik dovoljenja za promet znanstveno ovrednoti vse informacije o tveganjih zdravil iz drugega pododstavka člena 101(1) Direktive 2001/83/ES;
the submission of accurate and verifiable data on serious and non-serious adverse reactions to the Eudravigilance database within the time limits provided for in the first and second subparagraphs respectively of Article 107(3) of Directive 2001/83/EC;
se v podatkovno zbirko Eudravigilance v rokih iz prvega in drugega pododstavka člena 107(3) Direktive 2001/83/ES predložijo natančni in preverljivi podatki o resnih neželenih učinkih in neželenih učinkih, ki niso resni;
the quality, integrity and completeness of the information submitted on the risks of medicinal products, including processes to avoid duplicate submissions and to validate signals in accordance with Article 21(2);
so predložene informacije o tveganjih zdravil kakovostne, celovite in popolne, vključno s procesi za preprečevanje podvajanja poročanja in validiranje signalov v skladu s členom 21(2);
effective communication by the marketing authorisation holder with the national competent authorities and the Agency, including communication on new risks or changed risks, the pharmacovigilance system master file, risk management systems, risk minimisation measures, periodic safety update reports, corrective and preventive actions, and post-authorisation studies;
je komunikacija imetnika dovoljenja za promet s pristojnimi nacionalnimi organi in Agencijo učinkovita, vključno s komunikacijo o novih ali spremenjenih tveganjih, glavnem dosjeju o sistemu farmakovigilance, sistemu za obvladovanje tveganj, ukrepih za zmanjšanje tveganj, redno posodobljenih poročilih o varnosti zdravil, popravnih in preventivnih ukrepih ter študijah o varnosti zdravila po pridobitvi dovoljenja za promet;
the update of product information by the marketing authorisation holder in the light of scientific knowledge, including the assessments and recommendations made public via the European medicines web-portal, and on the basis of a continuous monitoring by the marketing authorisation holder of information published on the European medicines web-portal;
imetnik dovoljenja za promet posodablja informacije o zdravilu glede na znanstvena dognanja, vključno z ocenami in priporočili, javno dostopnimi prek evropskega spletnega portala o zdravilih, in na podlagi tega, da imetnik dovoljenja za promet stalno spremlja informacije, objavljene na evropskem spletnem portalu o zdravilih;
appropriate communication by the marketing authorisation holder of relevant safety information to healthcare professionals and patients.
imetnik dovoljenja za promet ustrezno sporoča zadevne varnostne informacije zdravstvenim delavcem in bolnikom.
Where a marketing authorisation holder has subcontracted some of its pharmacovigilance tasks, it shall retain responsibility for ensuring that an effective quality system is applied in relation to those tasks.
Tudi če imetnik dovoljenja za promet nekatere naloge na področju farmakovigilance odda v delo podizvajalcem, je še vedno odgovoren za zagotavljanje, da se v zvezi z navedenimi nalogami uporablja učinkovit sistem kakovosti.
Record management and data retention
Upravljanje dokumentov in hramba podatkov
Marketing authorisation holders shall record all pharmacovigilance information and ensure that it is handled and stored so as to allow for accurate reporting, interpretation and verification of that information.
Imetniki dovoljenj za promet evidentirajo vse informacije o farmakovigilanci in zagotavljajo, da se obdelujejo in shranjujejo tako, da omogočajo točno poročanje, razlago in preverjanje navedenih informacij.
Marketing authorisation holders shall put in place a record management system for all documents used for pharmacovigilance activities that ensures the retrievability of those documents as well as the traceability of the measures taken to investigate safety concerns, of the timelines for those investigations and of decisions on safety concerns, including their date and the decision-making process.
Vzpostavijo sistem za upravljanje dokumentov za vse dokumente, uporabljene za dejavnosti na področju farmakovigilance, ki zagotavljajo dostop do navedenih dokumentov ter sledljivost ukrepov za preiskovanje varnostnih vprašanj, časovnih potekov navedenih preiskav in odločitev o varnostnih vprašanjih, vključno z datumom in procesom odločanja.
Marketing authorisation holders shall establish mechanisms enabling the traceability and follow-up of adverse reaction reports.
Imetniki dovoljenj za promet vzpostavijo mehanizme, ki omogočajo sledljivost poročil o neželenih učinkih in njihovo spremljanje.
Marketing authorisation holders shall arrange for the elements referred to in Article 2 to be kept for at least five years after the system as described in the pharmacovigilance system master file has been formally terminated by the marketing authorisation holder.
Imetniki dovoljenj za promet zagotovijo, da se elementi iz člena 2 hranijo vsaj pet let po tem, ko imetnik dovoljenja za promet uradno odpove obstoj sistema, opisanega v glavnem dosjeju o sistemu farmakovigilance.
Pharmacovigilance data and documents relating to individual authorised medicinal products shall be retained as long as the product is authorised and for at least 10 years after the marketing authorisation has ceased to exist.
Podatki o farmakovigilanci in dokumenti, povezani s posameznimi odobrenimi zdravili, se hranijo, dokler je zdravilo odobreno in vsaj 10 let po izteku veljavnosti dovoljenja za promet.
However, the documents shall be retained for a longer period where Union law or national law so requires.
Vendar se dokumenti hranijo tudi dlje, če tako zahteva zakonodaja Unije ali nacionalna zakonodaja.
Audit
Presoja
Risk-based audits of the quality system shall be performed at regular intervals to ensure that the quality system complies with the quality system requirements set out in Articles 8, 10, 11 and 12 and to determine its effectiveness.
Presoje sistema kakovosti na podlagi analize tveganj se izvajajo redno, da se zagotovi skladnost sistema kakovosti z zahtevami glede sistema kakovosti iz členov 8, 10, 11 in 12 ter da se ugotovi njegova učinkovitost.
Those audits shall be conducted by individuals who have no direct involvement in or responsibility for the matters or processes being audited.
Navedene presoje opravljajo posamezniki, ki niso neposredno vpleteni v zadeve ali procese, ki so predmet presoje, oziroma odgovorni zanje.
Corrective action(s), including a follow-up audit of deficiencies, shall be taken where necessary.
Popravni ukrepi, vključno z naknadno presojo pomanjkljivosti, se sprejmejo po potrebi.
A report on the results of the audit shall be drawn up for each audit and follow-up audit.
Za vsako presojo in naknadno presojo se pripravi poročilo o rezultatih presoje.
The audit report shall be sent to the management responsible for the matters audited.
Poročilo o presoji se v pregled pošlje vodstvenim delavcem, odgovornim za zadeve, ki so bile predmet presoje.
The dates and results of audits and follow-up audits shall be documented in accordance with the second subparagraph of Article 104(2) of Directive 2001/83/EC.
V skladu z drugim pododstavkom člena 104(2) Direktive 2001/83/ES se dokumentirajo datumi in rezultati presoj in naknadnih presoj.
Minimum requirements for the quality systems for the performance of pharmacovigilance activities by national competent authorities and the Agency
Minimalne zahteve za sisteme kakovosti za dejavnosti na področju farmakovigilance, ki jih izvajajo pristojni nacionalni organi in Agencija
The national competent authorities and the Agency shall have sufficient competent and appropriately qualified and trained personnel available for the performance of pharmacovigilance activities.
Pristojni nacionalni organi in Agencija imajo za izvajanje dejavnosti na področju farmakovigilance dovolj usposobljenega kadra, ki ima ustrezne pristojnosti in izobrazbo.
The organisational structures and the distribution of tasks and responsibilities shall be clear and, to the extent necessary, accessible.
Organizacijska struktura in razporeditev nalog in odgovornosti je jasna in do potrebne mere dostopna.
Contact points shall be established.
Vzpostavijo se kontaktne točke.
All personnel involved in the performance of pharmacovigilance activities shall receive initial and continued training.
Vse osebje, vključeno v izvajanje dejavnosti na področju farmakovigilance, se udeleži začetnega in nadaljnjih usposabljanj.