natgillin/translations-raw huggingface dataset:
The minimum requirements for the quality system for the performance of pharmacovigilance activities should ensure that marketing authorisation holders, national competent authorities and the European Medicines Agency (hereinafter ‘the Agency’) establish an adequate and effective quality system, which provides for an effective monitoring of compliance and the accurate and proper documentation of all measures taken.
Minimalne zahteve za sistem kakovosti za izvajanje dejavnosti na področju farmakovigilance bi morale zagotoviti, da imetniki dovoljenj za promet, pristojni nacionalni organi in Evropska agencija za zdravila (v nadaljnjem besedilu: Agencija) vzpostavijo ustrezen in učinkovit sistem kakovosti, ki zagotavlja učinkovito spremljanje skladnosti ter točno in ustrezno dokumentiranje sprejetih ukrepov.
They should also ensure that marketing authorisation holders, national competent authorities and the Agency have at their disposal sufficient competent, appropriately qualified and trained staff.
Zagotoviti bi morale tudi, da imajo imetniki dovoljenja za promet, pristojni nacionalni organi in Agencija na razpolago dovolj usposobljenega kadra, ki ima ustrezne pristojnosti in izobrazbo.
Adherence to a well-defined quality system should ensure that all pharmacovigilance activities are conducted in such a way that they are likely to produce the desired results or quality objectives for the fulfilment of pharmacovigilance tasks.
Skladnost z dobro opredeljenim sistemom kakovosti bi morala zagotoviti, da se vse dejavnosti na področju farmakovigilance izvajajo tako, da po vsej verjetnosti dajejo rezultate ali cilje kakovosti za izpolnjevanje nalog na področju farmakovigilance.
As part of their quality system, national competent authorities and the Agency should establish contact points to facilitate interaction between national competent authorities, the Agency, the Commission, marketing authorisation holders and persons reporting information on the risks of medicinal products, as referred to in the second subparagraph of Article 101(1) of Directive 2001/83/EC.
Pristojni nacionalni organi in Agencija bi morali v okviru sistema kakovosti vzpostaviti kontaktne točke za lažjo izmenjavo informacij med pristojnimi nacionalnimi organi, Agencijo, Komisijo, imetniki dovoljenj za promet in osebami, ki sporočajo informacije o tveganjih zdravil v skladu z drugim pododstavkom člena 101(1) Direktive 2001/83/ES.
If marketing authorisation holders, national competent authorities and the Agency use performance indicators to monitor the good performance of pharmacovigilance activities, those indicators should be documented.
Če imetniki dovoljenj za promet, pristojni nacionalni organi in Agencija uporabijo kazalnike uspešnosti za spremljanje dobrega izvajanja dejavnosti na področju farmakovigilance, bi bilo treba te kazalnike dokumentirati.
Pharmacovigilance activities rely increasingly on the periodic monitoring of large databases, such as the Eudravigilance database.
Dejavnosti na področju farmakovigilance se vse bolj zanašajo na redno spremljanje velikih podatkovnih zbirk, kot je zbirka Eudravigilance.
Whereas the Eudravigilance database is expected to be a major source of pharmacovigilance information, account should also be taken of pharmacovigilance information coming from other sources.
Čeprav se pričakuje, da je podatkovna zbirka Eudravigilance pomemben vir informacij o farmakovigilanci, bi bilo treba upoštevati tudi informacije iz drugih virov.
Marketing authorisation holders, national competent authorities and the Agency should continuously monitor the data in the Eudravigilance database to determine whether there are new risks or whether risks have changed and whether those risks have an impact on the risk-benefit balance of the medicinal product.
Imetniki dovoljenj za promet, pristojni nacionalni organi in Agencija bi morali stalno spremljati podatke v podatkovni zbirki Eudravigilance, da bi določili, ali obstajajo nova tveganja oziroma ali so se tveganja spremenila in ali so navedena tveganja vplivala na razmerje med tveganjem in koristjo zdravila.
They should validate and confirm signals, as appropriate, based on an examination of individual case safety reports, aggregated data from active surveillance systems or studies, literature information or other data sources.
Po potrebi bi morali validirati in potrjevati signale na podlagi pregleda posameznih poročil o neželenih učinkih zdravil, zbranih podatkov iz sistemov ali študij aktivnega nadzora, informacij iz literature ali drugih virov podatkov.
It is therefore necessary to establish common requirements for signal detection, to clarify the respective monitoring roles of marketing authorisation holders, national competent authorities and the Agency, to clarify how signals are validated and confirmed where appropriate and to specify the signal management process.
Zato je treba vzpostaviti skupne zahteve za zaznavanje signalov, da se razjasnijo vloge, ki jih imajo pri spremljanju imetniki dovoljenj za promet, pristojni nacionalni organi in Agencija, da se razjasni, kako se signali validirajo in, kadar je primerno, potrjujejo, in da se natančno določi postopek ukrepanja ob zaznanem signalu.
As a general principle, signal detection should follow a recognised methodology.
Po splošnem načelu bi bilo treba za zaznavanje signalov uporabljati priznano metodologijo.
However, the methodology may vary depending on the type of medicinal product it is intended to cover.
Vendar se lahko metodologija razlikuje glede na vrsto zdravila, ki naj bi ga zajemala.
The use of internationally agreed terminology, format and standards should facilitate the interoperability of systems used for the performance of pharmacovigilance activities and avoids the duplication of encoding activities concerning the same information.
Uporaba mednarodno dogovorjene terminologije, oblik in standardov bi morala olajšati interoperabilnost sistemov, ki se uporabljajo za izvajanje dejavnosti na področju farmakovigilance, in preprečiti podvajanje kodiranja istih informacij.
It should also allow for an easier information exchange between regulatory authorities on an international level.
Prav tako bi morala omogočati enostavnejšo izmenjavo informacij med regulativnimi organi na mednarodni ravni.
In order to simplify the reporting of suspected adverse reactions, the marketing authorisation holder and the Member States should report those reactions only to the Eudravigilance database.
Za poenostavitev poročanja o domnevnih neželenih učinkih bi morali imetnik dovoljenja za promet in države članice te učinke sporočiti samo v podatkovno zbirko Eudravigilance.
The Eudravigilance database should be equipped to immediately forward reports on suspected adverse reactions received from marketing authorisation holders to the Member States on whose territory the reaction occurred.
Zbirka Eudravigilance bi morala biti zasnovana tako, da lahko poročila o domnevnih neželenih učinkih, ki jih prejme od imetnikov dovoljenj za promet, nemudoma posreduje državam članicam, na ozemlju katerih se je učinek pojavil.
It is therefore necessary to establish a common electronic format for the transmission of suspected adverse reaction reports by marketing authorisation holders and Member States to the Eudravigilance database.
Zato je treba vzpostaviti skupno elektronsko obliko, ki jo imetniki dovoljenj za promet in države članice uporabljajo za predložitev poročil o domnevnih neželenih učinkih v podatkovno zbirko Eudravigilance.
Periodic safety update reports are an important instrument to monitor the development of the safety profile of a medicinal product after it has been placed on the Union market, including an integrated (re-)evaluation of the risk-benefit balance.
Redno posodobljena poročila o varnosti zdravila so pomemben instrument za spremljanje razvoja varnostnega profila zdravila po tem, ko je bilo dano na trg v Uniji, vključno s celostno (ponovno) oceno razmerja med tveganjem in koristjo.
In order to facilitate their processing and evaluation, common format and content requirements should be established.
Za poenostavitev njihove obdelave in ocene bi bilo treba vzpostaviti skupne zahteve glede oblike in vsebine.
Risk management plans are required for all new marketing authorisation applications.
Za vse nove vloge za pridobitev dovoljenja za promet z zdravilom so potrebni načrti za obvladovanje tveganj.
They contain a detailed description of the risk management system used by the marketing authorisation holder.
Vsebujejo podroben opis sistema za obvladovanje tveganj, ki ga uporablja imetnik dovoljenja za promet.
In order to facilitate the production of risk management plans and their evaluation by the competent authorities, common format and content requirements should be established.
Da se olajša priprava načrtov za obvladovanje tveganj in njihovo vrednotenje s strani pristojnih organov, bi bilo treba vzpostaviti skupne zahteve glede oblike in vsebine.
Where competent authorities have concerns as to the safety of a medicinal product, they should be able to impose on marketing authorisation holders the obligation to conduct post-authorisation safety studies.
Kadar imajo pristojni organi vprašanja glede varnosti zdravila, bi morali imeti možnost, da od imetnika dovoljenja za promet z zdravilom zahtevajo izvedbo študije o varnosti po pridobitvi dovoljenja za promet.
The marketing authorisation holder should submit a draft protocol before those studies are conducted.
Imetnik dovoljenja za promet bi moral pred opravljanjem navedenih študij predložiti osnutek protokola.
Moreover, the marketing authorisation holder should provide, at the appropriate stage, a study abstract and a final study report.
Poleg tega bi moral imetnik dovoljenja za promet v primernem trenutku zagotoviti izvleček študije in končno poročilo o študiji.
It is appropriate to provide that the protocol, the abstract and the final study report follow a common format in order to facilitate the approval and oversight of those studies by the Pharmacovigilance Risk Assessment Committee or the competent authorities in case of studies to be conducted in only one Member State that requests the study according to Article 22a of Directive 2001/83/EC.
Primerno je, da se v primeru študij, opravljenih samo v eni državi članici, ki to zahteva v skladu s členom 22a Direktive 2001/83/ES, zagotovi, da protokol, izvleček in končno poročilo o študiji upoštevajo enotno obliko, s čimer se odboru za oceno tveganja na področju farmakovigilance ali pristojnim organom olajša odobritev navedenih študij in pregled nad njimi.
This Regulation should apply without prejudice to Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data [5] and Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies and on the free movement of such data [6].
To uredbo bi bilo treba uporabljati brez poseganja v Direktivo 95/46/ES Evropskega parlamenta in Sveta z dne 24. oktobra 1995 o varstvu posameznikov pri obdelavi osebnih podatkov in o prostem pretoku takih podatkov [5] ter Uredbo (ES) št. 45/2001 Evropskega parlamenta in Sveta z dne 18. decembra 2000 o varstvu posameznikov pri obdelavi osebnih podatkov v institucijah in organih Skupnosti in o prostem pretoku takih podatkov [6].
The fundamental right to protection of personal data should be fully and effectively guaranteed in all pharmacovigilance activities.
V vseh dejavnostih na področju farmakovigilance bi bilo treba popolnoma in učinkovito zagotoviti temeljno pravico do varstva osebnih podatkov.
The purpose of safeguarding public health constitutes a substantial public interest and consequently the processing of personal data should be justified if identifiable personal data are processed only where necessary and only where the parties involved assess this necessity at every stage of the pharmacovigilance process.
Namen varovanja javnega zdravja pomeni bistven javni interes, zato bi morala biti obdelava osebnih podatkov upravičena, če se osebno določljivi osebni podatki obdelujejo samo takrat, kadar je potrebno in kadar vpletene strani to potrebo ocenijo na vsaki stopnji postopka farmakovigilance.
National competent authorities and marketing authorisation holders may apply pseudonymisation where appropriate, thereby replacing identifiable personal data with pseudonyms.
Pristojni nacionalni organi in imetniki dovoljenj za promet lahko razpoznavne osebne podatke po potrebi nadomestijo s psevdonimi.
Pharmacovigilance system master file
Glavni dosje o sistemu farmakovigilance
Structure of the pharmacovigilance system master file
Zgradba glavnega dosjeja o sistemu farmakovigilance
The information in the pharmacovigilance system master file shall be accurate and reflect the pharmacovigilance system in place.
Informacije v glavnem dosjeju o sistemu farmakovigilance so točne in odražajo trenuten sistem farmakovigilance.
The marketing authorisation holder may, where appropriate, use separate pharmacovigilance systems for different categories of medicinal products.
Kadar je primerno, lahko imetnik dovoljenja za promet za različne kategorije zdravil uporablja ločene sisteme farmakovigilance.
Each such system shall be described in a separate pharmacovigilance system master file.
Vsak tak sistem je opisan v posebnem glavnem dosjeju o sistemu farmakovigilance.
All medicinal products for which the marketing authorisation holder obtained a marketing authorisation in accordance with Directive 2001/83/EC or Regulation (EC) No 726/2004 shall be covered by a pharmacovigilance system master file.
Glavni dosje o sistemu farmakovigilance zajema vsa zdravila, za katera je imetnik pridobil dovoljenje za promet v skladu z Direktivo 2001/83/ES ali Uredbo (ES) št. 726/2004.
Content of the pharmacovigilance system master file
Vsebina glavnega dosjeja o sistemu farmakovigilance
The pharmacovigilance system master file shall contain at least all of the following elements:
Glavni dosje o sistemu farmakovigilance vsebuje vsaj:
the following information relating to the qualified person responsible for pharmacovigilance:
naslednje informacije o usposobljeni osebi, odgovorni za farmakovigilanco:
a description of the responsibilities demonstrating that the qualified person responsible for pharmacovigilance has sufficient authority over the pharmacovigilance system in order to promote, maintain and improve compliance with pharmacovigilance tasks and responsibilities;
opis odgovornosti, ki dokazuje, da ima usposobljena oseba, odgovorna za farmakovigilanco, dovolj pristojnosti glede sistema farmakovigilance, da lahko spodbuja, ohranja in izboljšuje skladnost z nalogami na področju farmakovigilance in odgovornostmi, povezanimi z njo;
a summary curriculum vitae of the qualified person responsible for pharmacovigilance, including proof of registration with the Eudravigilance database;
povzetek življenjepisa usposobljene osebe, odgovorne za farmakovigilanco, vključno z dokazilom o registraciji v podatkovni zbirki Eudravigilance;
contact details of the qualified person responsible for pharmacovigilance;
kontaktne podatke usposobljene osebe, odgovorne za farmakovigilanco;
details of back-up arrangements to apply in the absence of the qualified person responsible for pharmacovigilance;
podrobnosti o sistemu nadomeščanja, ki se uporablja v odsotnosti usposobljene osebe, odgovorne za farmakovigilanco;
responsibilities of the contact person for pharmacovigilance issues where such a person has been nominated at national level in accordance with Article 104(4) of Directive 2001/83/EC, including contact details;
odgovornosti kontaktne osebe za vprašanja o farmakovigilanci, kadar je bila taka oseba imenovana na nacionalni ravni v skladu s členom 104(4) Direktive 2001/83/ES, vključno s kontaktnimi podatki;
a description of the organisational structure of the marketing authorisation holder, including the list of the site(s) where the following pharmacovigilance activities are undertaken: individual case safety report collection, evaluation, safety database case entry, periodic safety update report production, signal detection and analysis, risk management plan management, pre- and post-authorisation study management, and management of safety variations to the terms of a marketing authorisation;
opis organizacijske strukture imetnika dovoljenja za promet, vključno s seznamom mest, na katerih se izvajajo naslednje dejavnosti farmakovigilance: zbiranje posameznih poročil o neželenih učinkih zdravil, ocena, vnos poročil v varnostno podatkovno zbirko, priprava redno posodobljenih poročil o varnosti zdravila, zaznavanje in analiza signalov, upravljanje načrta za obvladovanje tveganja, upravljanje študije pred pridobitvijo dovoljenja za promet in po njem ter upravljanje varnostnih sprememb v pogojih za pridobitev dovoljenja za promet;
a description of the location of, functionality of and operational responsibility for computerised systems and databases used to receive, collate, record and report safety information and an assessment of their fitness for purpose;
opis lokacije, funkcionalnosti in operativne odgovornosti za računalniške sisteme in podatkovne zbirke za sprejemanje, primerjanje in evidentiranje varnostnih informacij ter poročanje o njih in ocena primernosti sistemov in zbirk za namen;
a description of data handling and recording and of the process used for each of the following pharmacovigilance activities:
opis ravnanja s podatki in evidentiranja podatkov ter opis procesa za naslednje dejavnosti na področju farmakovigilance:
the continuous monitoring of the risk-benefit balance of the medicinal product(s), the result of that monitoring and the decision-making process for taking appropriate measures;
stalno spremljanje razmerja med tveganjem in koristjo zdravil, rezultat navedenega spremljanja in proces odločanja za sprejemanje ustreznih ukrepov;
operation of the risk management system(s) and of the monitoring of the outcome of risk minimisation measures;
delovanje sistemov za obvladovanje tveganj in spremljanje izidov ukrepov za zmanjšanje tveganj;
collection, assessment and reporting of individual case safety reports;
zbiranje in ocenjevanje posameznih poročil o neželenih učinkih zdravil ter poročanje o njih;
drafting and submission of periodic safety update reports;
priprava redno posodobljenih poročil o varnosti zdravil in njihova predložitev;
procedures for communicating safety concerns and safety variations to the summary of product characteristics and package leaflet to healthcare professionals and the general public;
postopki za sporočanje zdravstvenim delavcem in širši javnosti o varnostnih vprašanjih in varnostnih spremembah povzetkov glavnih značilnosti zdravila, povezanih z varnostjo, ter navodila za uporabo, namenjena zdravstvenim delavcem in širši javnosti;
a description of the quality system for the performance of pharmacovigilance activities, including all of the following elements:
opis sistema kakovosti za izvajanje dejavnosti na področju farmakovigilance, vključno z:
a description of the management of human resources referred to in Article 10 containing the following elements: a description of the organisational structure for the performance of pharmacovigilance activities with a reference to the location of qualification records of the personnel; a summary description of the training concept, including a reference to the location of training files; instructions on critical processes;
opisom upravljanja s človeškimi viri iz člena 10, ki vsebuje: opis organizacijske zgradbe z dejavnostmi na področju farmakovigilance, kje so shranjena potrdila o usposobljenosti osebja; zbirni opis zasnove usposabljanja, vključno z navedbo lokacije dokumentov o usposabljanju; navodila za kritične procese;
a description of the record management system referred to in Article 12, including the location of the documents used for pharmacovigilance activities;
opisom sistema za upravljanje evidenc iz člena 12, vključno z lokacijo dokumentov, uporabljenih za dejavnosti farmakovigilance;
a description of the system for monitoring the performance of the pharmacovigilance system and for the compliance with Article 11;
opisom sistema za spremljanje izvajanja sistema farmakovigilance in za skladnost s členom 11;
where applicable, a description of the activities and/or services subcontracted by the marketing authorisation holder in accordance with Article 6(1).
kadar je primerno, opis dejavnosti in/ali storitev, ki jih je imetnik dovoljenja za promet oddal v delo pogodbenikom v skladu s členom 6(1).
Content of the Annex to the pharmacovigilance system master file
Vsebina priloge h glavnemu dosjeju o sistemu farmakovigilance
The pharmacovigilance system master file shall have an Annex containing the following documents:
Glavnemu dosjeju o sistemu farmakovigilance je priložena priloga, ki vsebuje naslednje dokumente:
a list of medicinal products covered by the pharmacovigilance system master file, including the name of the medicinal product, the international non-proprietary name (INN) of the active substance(s), and the Member State(s) in which the authorisation is valid;
seznam zdravil, zajetih v glavnem dosjeju o sistemu farmakovigilance, vključno z imenom zdravila, mednarodnim nelastniškim imenom (INN) zdravilnih učinkovin ter državami članicami, v katerih je dovoljenje veljavno;
a list of written policies and procedures for the purpose of complying with Article 11(1);
seznam pisnih politik in postopkov za namene skladnosti s členom 11(1);
the list of subcontracts referred to in Article 6(2);
seznam podizvajalskih pogodb iz člena 6(2);
a list of the tasks that have been delegated by the qualified person for pharmacovigilance;
seznam nalog, ki jih je prenesla usposobljena oseba, odgovorna za farmakovigilanco;
a list of all scheduled and completed audits;
seznam načrtovanih in opravljenih presoj;
where applicable, a list of the performance indicators referred to in Article 9;
kadar je primerno, seznam kazalnikov uspešnosti iz člena 9;
where applicable, a list of other pharmacovigilance system master files held by the same marketing authorisation holder;
kadar je primerno, seznam drugih glavnih dosjejev o sistemu farmakovigilance, ki jih ima isti imetnik dovoljenja za promet;
a logbook containing the information referred to in Article 5(4).
dnevnik, ki vsebuje informacije iz člena 5(4).
The marketing authorisation holder shall keep the pharmacovigilance system master file up to date and, where necessary, revise it to take account of experience gained, of technical and scientific progress and of amendments to Directive 2001/83/EC and Regulation (EC) No 726/2004.
Imetnik dovoljenja za promet redno posodablja glavni dosje o sistemu farmakovigilance in ga po potrebi pregleda, da se upoštevajo pridobljene izkušnje, strokovni in znanstveni napredek ter spremembe Direktive 2001/83/ES in Uredbe (ES) št. 726/2004.
The pharmacovigilance system master file and its Annex shall be subject to version control and shall indicate the date when it was last updated by the marketing authorisation holder.
V glavnem dosjeju o sistemu farmakovigilance in njegovi prilogi se navedeta številka različice in datum zadnje posodobitve imetnika dovoljenja za promet.
Any deviations from the pharmacovigilance procedures, their impact and their management shall be documented in the pharmacovigilance system master file until resolved.
Vsako odstopanje od postopkov farmakovigilance, njihovega učinka in upravljanja se dokumentira v glavnem dosjeju o sistemu farmakovigilance, dokler se ta vprašanja ne rešijo.