natgillin/translations-raw huggingface dataset:
The marketing authorisation holder shall have in place one or more pharmacovigilance system master files describing in detail the pharmacovigilance system with respect to its authorised veterinary medicinal products.
Imetnik dovoljenja za promet ravna v skladu z dobro farmakovigilančno prakso v zvezi z zdravili za uporabo v veterinarski medicini.
For each veterinary medicinal product, the marketing authorisation holder shall not have more than one pharmacovigilance system master file.
Komisija z izvedbenimi akti sprejme potrebne ukrepe v zvezi z dobro farmakovigilančno prakso za zdravila za uporabo v veterinarski medicini, pa tudi v zvezi z obliko in vsebino glavnega dosjeja o sistemu farmakovigilance ter njenega povzetka.
The marketing authorisation holder shall designate a local or regional representative for the purpose of receiving reports of suspected adverse events who is able to communicate in the languages of the relevant Member States.
Kadar naloge na področju farmakovigilance za imetnika dovoljenja za promet pogodbeno izvaja tretja oseba, se navedena ureditev natančno opiše v glavnem dosjeju o sistemu farmakovigilance.
The marketing authorisation holder shall be responsible for the pharmacovigilance of the veterinary medicinal product for which it holds a marketing authorisation and shall continuously evaluate by appropriate means the benefit-risk balance of this veterinary medicinal product and, if necessary, take appropriate measures.
Imetnik dovoljenja za promet določi eno ali več usposobljenih oseb, odgovornih za farmakovigilanco, za opravljanje nalog iz člena 78.
The marketing authorisation holder shall comply with good pharmacovigilance practice for veterinary medicinal products.
Te usposobljene osebe prebivajo in delujejo v Uniji ter so ustrezno usposobljene in stalno na razpolago imetniku dovoljenja za promet.
The Commission shall, by means of implementing acts, adopt necessary measures on good pharmacovigilance practice for veterinary medicinal products and also on the format and content of the pharmacovigilance system master file and its summary.
Za vsak glavni dosje o sistemu farmakovigilance imetnik dovoljenja za promet imenuje samo eno takšno usposobljeno osebo.
Where the pharmacovigilance tasks have been contracted out by the marketing authorisation holder to a third party, those arrangements shall be set out in detail in the pharmacovigilance system master file.
V členu 78 določene naloge usposobljene osebe, odgovorne za farmakovigilanco, iz odstavka 8 tega člena lahko pogodbeno izvaja tretja oseba pod pogoji iz navedenega odstavka.
The marketing authorisation holder shall designate one or more qualified persons responsible for pharmacovigilance to carry out the tasks provided for in Article 78.
V takih primerih se navedena ureditev natančno opiše v pogodbi in vključi v glavni dosje o sistemu farmakovigilance.
Those qualified persons shall reside and operate in the Union and shall be appropriately qualified and be permanently at the disposal of the marketing authorisation holder.
Imetnik dovoljenja za promet na podlagi ocene podatkov o farmakovigilanci po potrebi brez nepotrebnega odlašanja predloži vlogo za spremembo pogojev dovoljenja za promet v skladu s členom 62.
Only one such qualified person shall be designated for each pharmacovigilance system master file.
Imetnik dovoljenja za promet ne objavi informacij o farmakovigilanci v zvezi s svojimi zdravili za uporabo v veterinarski medicini, ne da bi o svojem namenu predhodno ali istočasno obvestil pristojni organ, ki je izdal dovoljenje za promet, ali Agencijo, kakor je ustrezno.
The tasks, set out in Article 78, of the qualified person responsible for pharmacovigilance referred to in paragraph 8 of this Article may be outsourced to a third party under the conditions set out in that paragraph.
Imetnik dovoljenja za promet zagotovi, da je ta objava objektivna in ni zavajajoča.
In such cases, those arrangements shall be specified in detail in the contract and included in the pharmacovigilance system master file.
Člen 78
The marketing authorisation holder shall, based on the assessment of the pharmacovigilance data, and where necessary, submit without undue delay an application for a variation to the terms of a marketing authorisation in accordance with Article 62.
Usposobljena oseba, odgovorna za farmakovigilanco
The marketing authorisation holder shall not make a public announcement on pharmacovigilance information in relation to its veterinary medicinal products without giving prior or simultaneous notification of its intention to the competent authority having granted the marketing authorisation or to the Agency, as applicable.
Usposobljena oseba, odgovorna za farmakovigilanco, iz člena 77(8) poskrbi za opravljanje naslednjih nalog:
The marketing authorisation holder shall ensure that such public announcement is presented objectively and is not misleading.
oblikovanje in posodabljanje glavnega dosjeja o sistemu farmakovigilance;
Article 78
dodeljevanje referenčnih številk glavnemu dosjeju o sistemu farmakovigilance in pošiljanje te referenčne številke v zbirko podatkov o farmakovigilanci za vsako zdravilo;
Qualified person responsible for pharmacovigilance
obveščanje pristojnih organov in Agencije, kakor je ustrezno, o kraju delovanja;
The qualified person responsible for pharmacovigilance as referred to in Article 77(8) shall ensure that the following tasks are carried out:
vzpostavitev in vzdrževanje sistema, ki zagotavlja, da se vsi domnevni neželeni dogodki, o katerih je obveščen imetnik dovoljenja za promet, zberejo in evidentirajo, da so na voljo vsaj na enem mestu v Uniji;
elaborating and maintaining the pharmacovigilance system master file;
sestavljanje poročil o domnevnih neželenih dogodkih iz člena 76(2), njihova ocena, če je potrebna, in njihovo evidentiranje v zbirki podatkov o farmakovigilanci;
allocating reference numbers to the pharmacovigilance system master file and communicating that reference number to the pharmacovigilance database for each product;
zagotavljanje, da se v celoti in takoj odgovori na katero koli zahtevo pristojnih organov ali Agencije po dodatnih informacijah, ki so potrebne za oceno razmerja med tveganji in koristmi zdravila za uporabo v veterinarski medicini;
notifying the competent authorities and the Agency, as applicable, of the place of operation;
zagotavljanje kakršnih koli drugih informacij pristojnim organom ali Agenciji, kakor je ustrezno, ki so pomembne za odkrivanje sprememb razmerja med tveganji in koristmi zdravila za uporabo v veterinarski medicini, vključno z ustreznimi informacijami o študijah o varnosti zdravila po pridobitvi dovoljenja za promet;
establishing and maintaining a system which ensures that all suspected adverse events which are brought to the attention of the marketing authorisation holder are collected and recorded in order to be accessible at least at one site in the Union;
uporabo postopka obravnave signala iz člena 81 in zagotavljanje, da so vzpostavljeni vsi pogoji za izpolnjevanje odgovornosti iz člena 77(4);
compiling the suspected adverse event reports referred to in Article 76(2), evaluating them, where necessary, and recording them in the pharmacovigilance database;
spremljanje sistema farmakovigilance in zagotavljanje, da se po potrebi pripravi in izvaja ustrezen načrt preventivnih ali korektivnih ukrepov, ter po potrebi zagotavljanje vnosa sprememb v glavni dosje o sistemu farmakovigilance;
ensuring that any request from the competent authorities or the Agency for the provision of additional information necessary for the evaluation of the benefit-risk balance of a veterinary medicinal product is answered fully and promptly;
zagotavljanje, da se vse osebje imetnika dovoljenja za promet, ki je vključeno v izvajanje dejavnosti na področju farmakovigilance, stalno usposablja;
providing competent authorities or the Agency, as applicable, with any other information relevant to detecting a change to the benefit-risk balance of a veterinary medicinal product, including appropriate information on post-marketing surveillance studies;
obveščanje pristojnih organov in Agencije o vsakem regulativnem ukrepu, ki se sprejme v tretji državi in je povezan s podatki o farmakovigilanci, v 21 dneh od prejema takih informacij.
applying the signal management process referred to in Article 81 and ensuring that any arrangements for the fulfilment of responsibilities referred to in Article 77(4) are in place;
Usposobljena oseba iz člena 77(8) opravlja funkcijo kontaktne osebe imetnika dovoljenja za promet v zvezi z inšpekcijskimi pregledi farmakovigilance.
monitoring the pharmacovigilance system and ensuring that if needed, an appropriate preventive or corrective action plan is prepared, implemented and, where necessary, ensuring changes to the pharmacovigilance system master file;
Člen 79
ensuring that all personnel of the marketing authorisation holder involved in the performance of pharmacovigilance activities receives continued training;
Odgovornosti pristojnih organov in Agencije v zvezi s farmakovigilanco
communicating any regulatory measure that is taken in a third country and is related to pharmacovigilance data to the competent authorities and to the Agency within 21 days of receipt of such information.
Pristojni organi določijo potrebne postopke za oceno rezultatov in izidov postopka obravnave signala, evidentiranih v zbirki podatkov o farmakovigilanci v skladu s členom 81(2), pa tudi za oceno domnevnih neželenih dogodkov, o katerih so bili obveščeni, preučijo možnosti za obvladovanje tveganja in sprejmejo vse ustrezne ukrepe iz členov 129, 130 in 134 v zvezi z dovoljenji za promet.
The qualified person referred to in Article 77(8) shall be the contact point for the marketing authorisation holder regarding pharmacovigilance inspections.
Pristojni organi lahko uvedejo posebne zahteve v zvezi s poročanjem o domnevnih neželenih dogodkih za veterinarje in druge zdravstvene delavce.
Article 79
Agencija lahko organizira srečanja ali mrežo za skupine veterinarjev ali drugih zdravstvenih delavcev, kadar obstaja posebna potreba po zbiranju, združevanju ali analiziranju specifičnih podatkov o farmakovigilanci.
Pharmacovigilance responsibilities of the competent authorities and the Agency
Pristojni organi in Agencija objavijo vse pomembne informacije o neželenih dogodkih v zvezi z uporabo zdravila za uporabo v veterinarski medicini.
Competent authorities shall lay down the necessary procedures to evaluate the results and outcomes of the signal management process recorded in the pharmacovigilance database in accordance with Article 81(2) as well as suspected adverse events reported to them, consider options for risk management and take any appropriate measures referred to in Articles 129, 130 and 134 concerning marketing authorisations.
To storijo pravočasno, in sicer prek katerih koli javno dostopnih komunikacijskih sredstev, imetnika dovoljenja za promet pa o tem obvestijo prej ali istočasno.
Competent authorities may impose specific requirements on veterinarians and other healthcare professionals in respect of the reporting of suspected adverse events.
Pristojni organi z nadzorom in inšpekcijskimi pregledi iz členov 123 in 126 preverijo, ali imetniki dovoljenj za promet izpolnjujejo zahteve glede farmakovigilance, določene v tem oddelku.
The Agency may organise meetings or a network for groups of veterinarians or other healthcare professionals, where there is a specific need for collecting, collating or analysing specific pharmacovigilance data.
Agencija določi potrebne postopke za oceno domnevnih neželenih dogodkov v zvezi z zdravili za uporabo v veterinarski medicini, odobrenimi s centraliziranim postopkom, o katerih je bila obveščena, in Komisiji priporoča ukrepe za obvladovanje tveganja.
Competent authorities and the Agency shall make publicly available all important information on adverse events relating to the use of a veterinary medicinal product.
Komisija sprejme vse ustrezne ukrepe v zvezi z dovoljenji za promet iz členov 129, 130 in 134.
It shall be done in a timely manner by any publicly available means of communication with a prior or simultaneous notification to the marketing authorisation holder.
Pristojni organ ali Agencija, kakor je ustrezno, lahko od imetnika dovoljenja za promet kadar koli zahteva kopijo glavnega dosjeja o sistemu farmakovigilance.
Competent authorities shall verify, by means of controls and inspections referred to in Articles 123 and 126, that marketing authorisation holders comply with the requirements relating to pharmacovigilance laid down in this Section.
Imetnik dovoljenja za promet predloži to kopijo najpozneje v sedmih dneh od prejema zahteve.
The Agency shall lay down the necessary procedures to evaluate suspected adverse events reported to it regarding centrally authorised veterinary medicinal products, and recommend risk management measures to the Commission.
Člen 80
The Commission shall take any appropriate measures referred to in Articles 129, 130 and 134 concerning marketing authorisations.
Prenos nalog med pristojnimi organi
The competent authority or the Agency, as applicable, may at any time request the marketing authorisation holder to submit a copy of the pharmacovigilance system master file.
Pristojni organ lahko prenese katero koli od nalog, ki so mu dodeljene v skladu s členom 79, na pristojni organ v drugi državi članici na podlagi pisnega soglasja slednjega.
The marketing authorisation holder shall submit that copy at the latest within seven days of receipt of the request.
Pristojni organ, ki prenese naloge, o prenosu iz odstavka 1 pisno obvesti Komisijo, Agencijo in druge pristojne organe ter to informacijo objavi.
Delegation of tasks by competent authority
Postopek obravnave signala
A competent authority may delegate any of the tasks entrusted to it as referred to in Article 79 to a competent authority in another Member State subject to the written agreement of the latter.
Imetniki dovoljenj za promet po potrebi opravijo postopek obravnave signala za svoja zdravila za uporabo v veterinarski medicini, pri čemer upoštevajo podatke o prodaji in druge ustrezne podatke o farmakovigilanci, za katere se lahko upravičeno pričakuje, da jih poznajo, in bi lahko bili za ta postopek obravnave signala koristni.
The delegating competent authority shall inform the Commission, the Agency and other competent authorities of the delegation as referred to in paragraph 1 and make that information public.
Med temi podatki so lahko znanstvene informacije, pridobljene iz pregledov znanstvene literature.
Article 81
Kadar je v postopku obravnave signala ugotovljena sprememba razmerja med koristmi in tveganji ali novo tveganje, imetniki dovoljenja za promet o tem brez odlašanja in najpozneje v 30 dneh obvestijo pristojne organe ali Agencijo, kakor je ustrezno, in sprejmejo potrebne ukrepe v skladu s členom 77(10).
Signal management process
Imetnik dovoljenja za promet vsaj enkrat na leto v zbirko podatkov o farmakovigilanci evidentira vse rezultate in izide postopka obravnave signala, med drugim tudi ugotovitev o razmerju med koristmi in tveganji, po potrebi pa tudi sklice na ustrezno znanstveno literaturo.
Marketing authorisation holders shall carry out a signal management process for their veterinary medicinal products, if necessary, taking into account sales data and other relevant pharmacovigilance data of which they can reasonably be expected to be aware and which may be useful for that signal management process.
V primeru zdravil za uporabo v veterinarski medicini iz točke (c) člena 42(2) imetnik dovoljenja za promet v zbirko podatkov o farmakovigilanci evidentira vse rezultate in izide postopka obravnave signala, med drugim tudi ugotovitev o razmerju med koristmi in tveganji, po potrebi pa tudi sklice na ustrezno znanstveno literaturo, in sicer tako pogosto, kot je navedeno v dovoljenju za promet.
That data may include scientific information gathered from scientific literature reviews.
Pristojni organi in Agencija se lahko odločijo za izvajanje ciljno usmerjenega postopka obravnave signala za določeno zdravilo za uporabo v veterinarski medicini ali skupino teh zdravil.
Where the outcome of the signal management process identifies a change to the benefit-risk balance or a new risk, marketing authorisation holders shall notify it without delay and no later than within 30 days to the competent authorities or to the Agency, as applicable, and take the necessary action in accordance with Article 77(10).
Agencija in usklajevalna skupina si za namene odstavka 3 delita naloge v zvezi s ciljno usmerjenim postopkom obravnave signala in za vsako zdravilo za uporabo v veterinarski medicini ali skupino teh zdravil skupaj določita, ali bo za ta ciljno usmerjen postopek obravnave signala odgovoren pristojni organ ali Agencija (v nadaljnjem besedilu: vodilni organ).
The marketing authorisation holder shall record, at least annually, all results and outcomes of the signal management process, including a conclusion on the benefit-risk balance, and, if applicable, references to relevant scientific literature in the pharmacovigilance database.
Ko Agencija in usklajevalna skupina izbirata vodilni organ, pri tem upoštevata pravično razdelitev nalog in preprečita podvajanje dela.
In the case of veterinary medicinal products referred to in point (c) of Article 42(2), the marketing authorisation holder shall record in the pharmacovigilance database all results and outcomes of the signal management process, including a conclusion on the benefit-risk balance, and, if applicable, references to relevant scientific literature according to the frequency specified in the marketing authorisation.
Kadar pristojni organi ali Komisija, kakor je ustrezno, menijo, da so potrebni nadaljnji ukrepi, sprejmejo ustrezne ukrepe iz členov 129, 130 in 134.
The competent authorities and the Agency may decide to perform a targeted signal management process for a given veterinary medicinal product or a group of veterinary medicinal products.
Napotitev zaradi interesov Unije
For the purpose of paragraph 3, the Agency and the coordination group shall share the tasks related to the targeted signal management process and shall jointly select for each veterinary medicinal product or group of veterinary medicinal products a competent authority or the Agency as responsible for such targeted signal management process (‘lead authority’).
Člen 82
When selecting a lead authority, the Agency and the coordination group shall take into account the fair allocation of tasks and shall avoid duplication of work.
Področje uporabe napotitve zaradi interesov Unije
Where the competent authorities or the Commission, as applicable, consider that follow-up action is necessary, they shall take appropriate measures as referred to in Articles 129, 130 and 134.
Kadar gre za interese Unije in zlasti za interese javnega zdravja, zdravja živali ali okolja, ki so povezani s kakovostjo, varnostjo ali učinkovitostjo zdravil za uporabo v veterinarski medicini, lahko imetnik dovoljenja za promet, en ali več pristojnih organov v eni ali več državah članicah ali Komisija svojo zaskrbljenost sporoči Agenciji za uporabo postopka iz člena 83.
Union interest referral
Vprašanje, ki povzroča zaskrbljenost, mora biti jasno opredeljeno.
Article 82
Imetnik dovoljenja za promet, zadevni pristojni organ ali Komisija o tem ustrezno obvesti druge zadevne strani.
Scope of the Union interest referral
Pristojni organi v državah članicah in imetniki dovoljenj za promet Agenciji na njeno zahtevo predložijo vse razpoložljive informacije v zvezi z napotitvijo zaradi interesov Unije.
Where the interests of the Union are involved, and in particular the interests of public or animal health or of the environment related to the quality, safety or efficacy of veterinary medicinal products, the marketing authorisation holder, one or more of the competent authorities in one or more Member States or the Commission may refer its concern to the Agency for the application of the procedure laid down in Article 83.
Agencija lahko omeji napotitev zaradi interesov Unije na nekatere dele pogojev dovoljenja za promet.
The matter of concern shall be clearly identified.
Člen 83
The marketing authorisation holder, the concerned competent authority or the Commission shall inform the other parties concerned accordingly.
Napotitveni postopek zaradi interesov Unije
The competent authorities in the Member States and marketing authorisation holders shall forward to the Agency on its request all available information relating to the Union interest referral.
Agencija na svojem spletnem mestu objavi, da je bila uporabljena napotitev v skladu s členom 82 in zainteresirane strani pozove, naj predložijo pripombe.
The Agency may limit the Union interest referral to specific parts of the terms of the marketing authorisation.
Agencija Odbor iz člena 139 zaprosi za obravnavo predložene zadeve.
Article 83
Odbor izda obrazloženo mnenje v 120 dneh od dneva, ko mu je bila zadeva predložena.
Union interest referral procedure
Odbor to obdobje lahko podaljša za nadaljnje obdobje do največ 60 dni, ob upoštevanju stališč zadevnih imetnikov dovoljenj za promet.
The Agency shall publish on its website information that a referral has been made in accordance with Article 82 and shall invite interested parties to provide comments.
Preden poda mnenje, Odbor zadevnim imetnikom dovoljenja za promet da možnost, da v določenem roku predložijo obrazložitve.
The Agency shall request the Committee referred to in Article 139 to consider the referred matter.
Odbor lahko odloži rok iz odstavka 2, da zadevnim imetnikom dovoljenja za promet omogoči pripravo obrazložitev.
The Committee shall issue a reasoned opinion within 120 days of the matter being referred to it.
Za obravnavo zadeve Odbor enega od svojih članov imenuje za poročevalca.
That period may be extended by the Committee for a further period of up to 60 days, taking into account the views of the marketing authorisation holders concerned.
Odbor lahko imenuje neodvisne strokovnjake za svetovanje glede specifičnih vprašanj.
Before issuing its opinion, the Committee shall provide the marketing authorisation holders concerned with the opportunity to present explanations within a specified time limit.
Pri imenovanju takih strokovnjakov mora Odbor opredeliti njihove naloge ter določiti rok za izvedbo njihovih nalog.
The Committee may suspend the time limit referred to in paragraph 2 to allow the marketing authorisation holders concerned to prepare the explanations.
Agencija mora državam članicam, Komisiji ter zadevnim imetnikom dovoljenja za promet predložiti mnenje Odbora v 15 dneh od njegovega sprejetja v Odboru, skupaj s poročilom o oceni enega ali več zdravil za uporabo v veterinarski medicini in obrazložitvijo svojih ugotovitev.
In order to consider the matter, the Committee shall appoint one of its members to act as a rapporteur.
V 15 dneh od prejema mnenja Odbora lahko imetnik dovoljenja za promet v pisni obliki obvesti Agencijo, da namerava zahtevati ponovni pregled tega mnenja.
The Committee may appoint independent experts to give advice on specific questions.
V tem primeru mora imetnik dovoljenja za promet v 60 dneh od prejema mnenja Agenciji sporočiti podrobno opisane razloge za zahtevo za ponovni pregled.
When appointing such experts, the Committee shall define their tasks and specify the time limit for the completion of their tasks.
V 60 dneh od prejema zahteve iz odstavka 6 Odbor ponovno pregleda svoje mnenje.
Within 15 days of its adoption by the Committee, the Agency shall forward the opinion of the Committee to the Member States, the Commission and the marketing authorisation holders concerned, together with an assessment report on one or more veterinary medicinal products and the reasons for its conclusions.
Obrazložitev ugotovitev se priloži poročilu o oceni iz odstavka 5.
Within 15 days of receipt of the opinion of the Committee, the marketing authorisation holder may notify the Agency in writing of its intention to request a re-examination of that opinion.
Člen 84
In that case, the marketing authorisation holder shall forward to the Agency the detailed reasons for the request of re-examination within 60 days of receipt of the opinion.
Sklep po napotitvi zaradi interesov Unije