natgillin/translations-raw huggingface dataset:
The regulation of medical devices does not fall within the scope of the European regulatory system for medicines.
Regulacija medicinskih pripomočkov ne spada med pristojnosti evropskega regulativnega sistema za zdravila.
Accession to the EU means a commitment to apply the “acquis communautaire” (the body of EU legislation and guidance) to ensure that all EU Member States operate to the same standards.
S pristopom k EU se država zaveže k izvajanju pravnega reda Skupnosti (zakonodaja in smernice EU), kar zagotavlja, da vse države članice EU upoštevajo iste standarde.
All manufacturing and importing licenses are entered into EudraGMDP, the publiclyavailable European database operated by EMA.
Vse proizvodne in uvozne licence so vnesene v EudraGMDP, javno dostopno evropsko bazo podatkov, ki jo upravlja agencija EMA.
This includes vaccines used in the WHO Expanded Programme on Immunization, or for protection against a public health priority disease, as well as medicines for WHO target diseases such as HIV/AIDS, malaria or tuberculosis.
Sem spadajo cepiva, ki se uporabljajo v razširjenem programu cepljenja SZO ali za zaščito pred boleznimi, ki imajo prednost pri obravnavi, kot tudi zdravila, s katerimi SZO ciljno obravnava bolezni, kot so HIV/aids, malarija in tuberkuloza.
Equivalence between Member States' inspectorates is ensured and maintained in a variety of ways, including common legislation, common good manufacturing practice (GMP), common procedures for inspectorates, technical support, meetings, trainings, and internal and external audits.
Enakovrednost inšpektoratov držav članic se zagotavlja in ohranja na več načinov, vključno s skupno zakonodajo, skupno dobro proizvodno prakso, skupnimi postopki za inšpektorate, tehnično podporo, srečanji, usposabljanji ter notranjimi in zunanjimi revizijami.
The national competent authorities (NCAs), responsible for the regulation of human and veterinary medicines in the EU, coordinate their work in a forum called Heads of Medicines Agencies (HMA).
Pristojni nacionalni organi, ki so odgovorni za regulacijo zdravil za uporabo v humani in veterinarski medicini v EU, usklajujejo svoje delo v okviru foruma z imenom Vodje agencij za zdravila (HMA).
Inspection outcomes can be accessed by all Member States and are made publicly available across the EU through EudraGMDP.
Vse države članice lahko dostopajo do rezultatov pregleda, ki so javno dostopni v vsej EU prek baze podatkov EudraGMDP.
The experts are chosen on the basis of their scientific expertise and many of them are made available to EMA by the NCAs in Member States.
Strokovnjaki so izbrani na podlagi svojega strokovnega znanja, večinoma pa jih na voljo agenciji EMA dajejo pristojni nacionalni organi v državah članicah.
EMA also gives product-specific scientific advice to companies for the development of medicines.
Agencija EMA prav tako podjetjem pri razvoju zdravil ponuja znanstvene nasvete za posamezne proizvode.
Public hearings
Javne predstavitve
This booklet explains how the European regulatory system for medicines operates.
V tej brošuri je opisano, kako deluje evropski regulativni sistem za zdravila.
The authorisation and oversight of a clinical trial is the responsibility of the Member State in which the trial is taking place.
Za odobritev in nadzor kliničnega preskušanja je od govorna država članica, v kateri preskušanje poteka.
All suspected side effects that are reported by patients and healthcare professionals must be entered into EudraVigilance, the EU web-based information system operated by EMA that collects, manages and analyses reports of suspected side effects of medicines.
Vsi morebitni neželeni učinki, o katerih poročajo bolniki in zdravstveni delavci, morajo biti vneseni v sistem EudraVigilance, to je spletni informacijski sistem EU, ki ga upravlja agencija EMA in ki zbira, upravlja in analizira poročila o možnih neželenih učinkih zdravil.
The Veterinary International Conference on Harmonisation (VICH) is the equivalent forum for veterinary medicines.
Mednarodna veterinarska konferenca za usklajevanje (VICH) je forum za zdravila za uporabo v veterinarski medicini z enako vlogo.
For the EU, one of the main forums for multilateral international cooperation is the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), which brings together medicines regulatory authorities and pharmaceutical industry from around the world.
Za EU je eden najpomembnejših forumov za večstransko mednarodno sodelovanje Mednarodni svet za usklajevanje tehničnih zahtev glede zdravil za uporabo v humani medicini (ICH), ki združuje regulativne organe za zdravila in farmacevtsko industrijo iz Evrope, Japonske in Združenih držav.
The European medicines regulatory system is based on a network of around 50 regulatory authorities from the 31 EEA countries (28 EU Member States plus Iceland, Liechtenstein and Norway), the European Commission and EMA.
ki jo sestavlja približno 50 regulativnih organov za zdra vila iz 31 držav Evropskega gospodarskega prostora (28 držav članic EU ter Islandija, Lihtenštajn in Norveška), Evropska komisija in Evropska agencija za zdravila.
If the product is manufactured outside the EU and has been imported, it needs to undergo full analytical testing in the EU, unless a mutual recognition agreement (MRA) is in place between the EU and the exporting country.
V kolikor je bil izdelek proizveden izven EU in je bil uvožen, ga mora EU v popolnosti analitično preskusiti, razen v primeru obstoječega sporazuma o vzajemnem priznavanju med EU in državo izvoznico.
Rules and requirements applicable to pharmaceuticals in the EU are the same, irrespective of the authorisation route for a medicine.
Pravila in zahteve, ki veljajo za zdravila v EU, so enaki ne glede na način pridobitve dovoljenja za promet z zdravilom.
• Committee for Advanced Therapies (CAT)
• Odbor za napredno zdravljenje (CAT)
The network is supported by a pool of thousands of experts drawn from across Europe, allowing it to source the best possible scientific expertise for the regulation of medicines in the EU and to provide scientific advice of the highest quality.
Mreža ima dostop do na tisoče strokovnjakov iz vse Evrope, kar ji omogoča razpolaganje z najboljšim možnim strokovnim znanjem za regulacijo zdravil v EU in strokovno svetovanje najvišje kakovosti.
EMA has a committee dedicated to the safety of medicines for human use - the Pharmacovigilance Risk Assessment Committee, or PRAC.
Agencija EMA ima poseben odbor, namenjen varnosti zdravil za uporabo v humani medicini - Odbor za ocenjevanje tveganja na področju farmakovigilance (PRAC).
EMA enables one application, one assessment, one market authorisation for the whole of the EU.
Agencija EMA omogoča eno prošnjo, eno oceno in eno dovoljenje za promet za celotno EU.
Transparency about how the system works and how it reaches its decisions is an important feature of the EU regulatory system for medicines.
Preglednost v zvezi z načinom dela in sprejemanjem odločitev je pomembna lastnost evropskega regulativnega sistema za zdravila.
Medicines regulatory authorities:
Organi za regulacijo zdravil:
The EU regulatory system for medicines
Regulativni sistem EU za zdravila
• the mutual-recognition procedure where companies that have a medicine authorised in one EU Member States can apply for this authorisation to be recognised in other EU countries.
• postopek z medsebojnim priznavanjem, pri čemer lahko podjetja, ki so za zdravilo pridobila dovoljenje za promet v eni državi članici EU, zaprosijo za priznanje dovoljenja v drugih državah EU.
Safety monitoring of medicines
Spremljanje varnosti zdravil
Manufacturers, importers and distributors of medicines in the EU must be licensed before they can carry out those activities.
Proizvajalci, uvozniki in distributerji zdravil v EU pot rebujejo licenco, preden lahko opravljajo svoje dejav nosti.
In addition to its role in risk assessment, the committee provides advice and recommendations to the European medicines regulatory network on risk management planning and benefit-risk assessment for medicines after marketing.
Poleg ocenjevanja tveganja odbor evropski regulativni mreži za zdravila zagotavlja nasvete in priporočila v zvezi z načrtovanjem obvladovanja tveganja in oceno razmerja med tveganji in koristmi po začetku trženja zdravil.
The Agency's Committee for Medicinal Products for Human Use (CHMP) or Committee for Medicinal Products for Veterinary Use (CVMP) then carries out a scientific assessment of the application and gives a recommendation to the European Commission on whether or not to grant a marketing authorisation.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji oziroma Odbor za zdravila za uporabo v veterinarski medicini (CVMP) nato opravi znanstveno oceno vloge in poda priporočilo Evropski komisiji, ali naj se dovoljenje za promet izda ali ne.
The European Clinical Trials Database (EudraCT) tracks which clinical trials have been authorised in the EU.
Evropska zbirka podatkov o kliničnih preskušanjih spremlja klinična preskušanja, ki so bila odobrena v EU.
The PRAC has a broad remit covering all aspects of pharmacovigilance.
Odbor za ocenjevanje tveganja na področju farmakovigilance (PRAC) ima širok obseg pristojnosti, ki pokrivajo vse vidike farmakovigilance.
EMA and the Member States cooperate and share expertise in the assessment of new medicines and of new safety information.
Evropska agencija za zdravila in države članice sodelujejo in si izmenjujejo strokovno znanje pri ocenjevanju novih zdravil in novih informacij o varnosti.
The majority of medicines authorised in the EU do not fall within the scope of the centralised procedure but are authorised by national competent authorities (NCAs) in the Member
Večina zdravil, za katera se izda dovoljenje za promet v EU, ne spada na področje uporabe centraliziranega postopka, temveč jih odobrijo nacionalni pristojni organi v državah članicah.
The CHMP can carry out scientific assessments and give opinions, in cooperation with WHO, on medicines for use exclusively outside the EU.
Odbor CHMP lahko v sodelovanju s SZO izvaja znanstvena ocenjevanja in podaja mnenja o zdravilih za uporabo izključno izven EU.
The HMA meets four times per year to address key strategic issues for the network, such as the exchange of information, IT developments and sharing of best practices, and to streamline mutual recognition and decentralised procedures.
Forum vodij agencij za zdravila se sreča štirikrat letno, da bi razpravljal o ključnih strateških vprašanjih, ki zadevajo mrežo, kot so izmenjava informacij, razvoj na področju IT in izmenjava najboljših praks, in poenostavil postopke medsebojnega priznavanja in decentralizirane postopke.
It describes how medicines are authorised and monitored in the European Union (EU) and how the European medicines regulatory network - a partnership between the European Commission, the medicines regulatory authorities in EU Member States and the European Economic Area (EEA), and the European Medicines Agency (EMA) - works to ensure that patients in the
Pojasnjeno je, kako so v Evropski uniji (EU) odobrena in nadzorovana zdravila1 in kako evropska regulativna mreža za zdravila - partnerstvo med Evropsko komisijo, regulativni organi za zdravila v državah članicah EU in v Evropskem gospodarskem prostoru (EGP) in Evropsko agencijo za zdravila (EMA) - bolnikom v EU zagotavlja dostop do visokokakovostnih, učinkovitih in varnih zdravil.
It is used by NCAs and clinical-trial sponsors to enter information protocols and results of clinical trials.
Uporabljajo jo pristojni nacionalni organi in naročniki kliničnih preskušanj za vnašanje informacijskih protokolov in rezultatov kliničnih preskušanj.
ICH is dedicated to harmonisation in safety, quality and efficacy as the main criteria for approving and authorising new medicines.
Svet ICH se posveča predvsem usklajevanju na področjih varnosti, kakovosti in učinkovitosti, kar so glavna merila za odobritev novih zdravil.
• the decentralised procedure where companies can apply for the simultaneous authorisation of a medicine in more than one EU Member State if it has not yet been authorised in any EU country and does not fall within the scope of the centralised procedure;
• decentralizirani postopek, pri čemer podjetje istočasno predloži vlogo za dovoljenje za promet z zdravilom v več kot eni državi članici EU, pod pogojem, da to zdravilo še ni prejelo dovoljenja za promet v nobeni državi EU in ne sodi v okvir centraliziranega postopka;
IT systems which connect all parties in the network facilitate the exchange of information on aspects such as safety monitoring of medicines, authorisation and supervision of clinical trials or compliance with good manufacturing and distribution practices.
IT sistemi, ki povezujejo vse člane mreže, olajšujejo izmenjavo informacij na področjih, kot so spremljanje varnost zdravili, odobritev in nadziranje kliničnega preskušanja ali skladnost z dobro proizvodno in distribucijsko prakso.
The centralised procedure allows the marketing of a medicine on the basis of a single EU-wide assessment and marketing authorisation which is valid throughout the EU.
Centralizirani postopek dovoljuje promet z zdravilom na podlagi enega ovrednotenja, ki velja za celotno EU, in dovoljenja za promet, ki velja za celotno EU.
For a medicine that is authorised by a Member State, details on the assessment of the medicine are also available in a Public Assessment Report.
Podrobnosti glede zdravil, ki so dovoljenje prejela s strani držav članic, so prav tako na voljo v javnem poročilu o oceni zdravila.
This network is what makes the EU regulatory system unique.
Regulativni sistem EU je zaradi te mreže edinstven.
30 Churchill Place Canary Wharf London E14 5EU United Kingdom
European Medicines Agency 30 Churchill Place Canary Wharf
Scientific advice can also be given by NCAs.
Tudi pristojni nacionalni organi lahko dajejo znanstvene nasvete.
• Paediatric Committee (PDCO)
• Odbor za pediatrijo (PDCO)
On the basis of scientific assessments carried out by EMA, it grants or refuses, changes or suspends marketing authorisations for medicines that have been submitted via the centralised procedure.
Komisija na podlagi strokovne ocene agencije EMA odobri, zavrne, spremeni ali začasno odvzame dovoljenje za promet z zdravilom, za katerega je bila vloga predložena v okviru centraliziranega postopka.
The European Economic Area (EEA) is formed of the 28 EU Member States plus:
Evropski gospodarski prostor (EGP) = 28 držav članic +
EMA provides public access to reports of suspected side effects for centrally-authorised medicines in the European database of suspected drug-reaction reports.
Agencija EMA zagotavlja javno dostopnost poročil o morebitnih neželenih učinkih centralno odobrenih zdravil v evropski bazi podatkov, ki vsebuje poročila o morebitnih učinkih zdravil.
The same rules and harmonised procedures apply to all the 28 Member States regarding the authorisation of medicines and the supervision of the safety medicines.
Ista pravila in usklajeni postopki veljajo za vse države članice tudi v zvezi z izdajanjem dovoljenj za promet z zdravili in spremljanjem varnosti zdravil.
They also rely on each other for exchange of information in the regulation of medicine, for example regarding the reporting of side effects of medicines, the oversight of clinical trials and the conduct of inspections of medicines' manufacturers and compliance with good clinical practice (GCP), good manufacturing practice (GMP), good distribution practice (GDP), and good pharmacovigilance practice (GVP).
Prav tako si medsebojno izmenjujejo informacije o regulaciji zdravila, na primer v zvezi s poročanjem o neželenih učinkih zdravil, nadzoru kliničnega preskušanja in izvajanja pregledov proizvajalcev zdravil ter o skladnosti glede dobre klinične prakse, dobre proizvodne prakse, dobre distribucijske prakse in dobre farmakovigilančne prakse.
A European Public Assessment Report, or EPAR, is published for every human or veterinary medicine that has been granted or refused a marketing authorisation following an assessment by EMA.
Evropsko javno poročilo o oceni zdravila ali EPAR se izda za vsako zdravilo za uporabo v humani ali veterinarski medicini, ki je na podlagi ocene agencije EMA prejelo dovoljenje za promet oziroma je bilo zanj dovoljenje za promet zavrnjeno.
Every batch of medicines must be certified as having been manufactured and tested in accordance with GMP and in conformance with the marketing authorisation before it can be released onto the market in the EU.
Za vsako serijo zdravil mora biti potrjeno, da je bila proizvedena in preskušena v skladu z dobro proizvodno prakso in da ima dovoljenje za promet, preden se lahko da na trg EU.
EMA prepares scientific guidelines in cooperation with experts from its scientific committees and working groups.
Agencija EMA v sodelovanju s strokovnjaki iz svojih znan stvenih odborov in delovnih skupin pripravlja znanstvene smernice.
This website allows users to view all suspected side effect reports submitted to EudraVigilance
Na tej spletni strani si uporabniki lahko ogledajo poročila o morebitnih neželenih učinkih, ki so bila vnesena v sistem EudraVigilance.
When assessing these medicines, the CHMP applies the same rigorous standards as for medicines intended for use inside the EU.
Pri ocenjevanju teh zdravil upošteva enake standarde kot pri zdravilih za uporabo v EU.
A waiver applies for some countries which have applied to have their regulatory systems for the supervision of manufacturers of active pharmaceutical ingredients assessed by the EU and have been found to be equivalent to the EU.
Iz te obveznosti so izvzete nekatere države, ki so podale vlogo, da EU oceni njihov regulativni sistem za nadzor nad proizvajalci zdravilnih učinkovin, EU pa je ugotovila, da je ta enakovreden evropskemu.
In order to be imported into the EU, an active pharmaceutical ingredient needs to be accompanied by a Written Confirmation issued by the competent authority of the country where it is produced, confirming that the good manufacturing practice (GMP) applied is at least equivalent to the recognised EU GMP standards.
Za uvoz v EU se mora zdravilni učinkovini priložiti pisno potrdilo s strani pristojnega organa države proizvodnje, ki potrjuje, da je upoštevana dobra proizvodna praksa vsaj enakovredna sprejetim standardom EU glede dobre proizvodne prakse.
encourages the exchange of knowledge, ideas and best practice between scientists striving for the highest standards for medicines'
vključenimi v regulacijo zdravil v EU, se spodbuja izmenjava znanja, zamisli in dobrih praks med znanstveniki v prizadevanju, da bi dosegli najvišje standarde za regulacijo zdravil.
It can also take EU-wide action when a safety issue has been identified for a nationally authorised product and when harmonised regulatory measures in all MSs are considered necessary following assessment by EMA's PRAC.
Prav tako lahko Komisija ukrepa na ravni EU v primeru odkrite varnostne grožnje v zvezi z nacionalno odobrenim zdravilom ali v primeru, da odbor agencije EMA za ocenjevanje tveganja na področju farmakovigilance oceni, da je potrebno uskladiti regulativne ukrepe v vseh državah članicah.
The heads of the NCAs work closely with EMA and the European Commission to maximise cooperation and ensure the European medicines regulatory network functions efficiently.
Vodje pristojnih nacionalnih organov so tesno povezani z agencijo EMA in Evropsko komisijo, da bi zagotovili učinkovito in uspešno sodelovanje znotraj evropske regulativne mreže za zdravila ter njeno delovanje.
• Pharmacovigilance Risk Assessment Committee (PRAC)
• Odbor za ocenjevanje tveganja na področju farmakovigilance (PRAC)
• Committee for Orphan Medicinal Products (COMP)
• Odbor za zdravila sirote (COMP)
EMA and many NCAs are also involved in the Pharmaceutical Inspection Convention and the Pharmaceutical Inspection Co-operation Scheme (jointly referred to as PIC/S), a close international cooperation between pharmaceutical inspection authorities in the field of GMP.
Agencija EMA in številni pristojni nacionalni organi so prav tako vključeni v Konvencijo za farmacevtski nadzor in Načrt za sodelovanje pri farmacevtskem nadzoru (s skupnim poimenovanjem PIC/S).
A subset of this information is made publicly available by EMA via the EU clinical trials register.
Agencija EMA javnosti omogoči dostop do dela teh informacij prek registra kliničnih preskusov zdravil.
In addition, the EU's pharmacovigilance legislation enables the PRAC to hold public hearings during safety reviews of medicines if deemed useful.
omogoča organizacijo javnih predstavitev v obdobju varnostnih pregledov zdravil, če se presodi, da bi bilo to koristno.
Pharmaceutical companies submit a single authorisation application to EMA.
Farmacevtska podjetja predložijo eno vlogo za pridobitev dovoljenja pri Evropski agenciji za zdravila.
If there is a safety issue with a medicine that is authorised in more than one Member State, the same regulatory action is taken across the EU and patients and healthcare professionals in all Member States are provided with the same guidance.
V primeru varnostne težave z zdravilom, ki ima dovoljenje za promet v več kot eni državi članici, obvelja enak regulativni postopek po vsej EU.
• Committee for Medicinal Products for Human Use (CHMP)
• Odbor za zdravila za uporabo v humani medicini (CHMP)
• Committee for Medicinal Products for Veterinary Use (CMVP)
• Odbor za zdravila za uporabo v veterinarski medicini
They are available to guide the development programmes of all medicine developers who wish to submit an application for a marketing authorisation in the EU, and to ensure that medicines are developed consistently and to the highest quality.
Na ta način jih vodijo skozi njihove razvojne programe ter zagotavljajo, da se zdravila po vsej EU razvijajo dosledno in na najvišji kakovostni ravni.
• Committee on Herbal Medicinal Products (HMPC)
• Odbor za zdravila rastlinskega izvora (HMPC)
This includes manufacturers located outside the EU unless a mutual recognition agreement (MRA) is in place between the European Union and the country of manufacture.
Proizvajalce, ki so našteti v dokumentaciji vloge za dovoljenje za promet z zdravilom v EU, preveri pristojen organ EU, vključno s tistimi, ki se nahajajo izven EU, razen v primeru obstoječega sporazuma o vzajemnem priznavanju med Evropsko unijo in državo proizvodnje.
Marketing authorisations
Dovoljenja za promet z zdravilom
18 months.
18 mesecev.
You can hold it in either your right or left hand.
Držite ga lahko v desni ali levi roki.
- Breathe out slowly.
- Počasi izdihnite.
Special patient groups:
Posebne skupine bolnikov:
The Reference and Concerned Member States rejected the variation to extend the indication on 3 August 2005.
Referenčna in zadevne države članice so 3. avgusta 2005 zavrnile spremembo za razširitev indikacij.
The overall study results showed:
V celoti so rezultati študije pokazali:
Plasma protein binding is 91%.
Vezava na beljakovine v plazmi je 91 %.
In the MRP Sweden is the Reference Member State and Austria, Belgium, Denmark, Finland, France, Greece, Germany, Italy, Ireland, Luxembourg, The Netherlands, Portugal, Spain and the UK are Concerned Member States.
V postopku medsebojnega priznavanja je Švedska referenčna država članica, medtem ko so Avstrija, Belgija, Danska, Finska, Francija, Grčija, Nemčija, Italija, Irska, Luksemburg, Nizozemska, Portugalska, Španija in Združeno kraljestvo zadevne države članice.
When you need to use it, follow these steps:
Ko ga morate uporabiti, ravnajte po naslednjih točkah:
- Hold your breath for about 10 seconds or for as long as is comfortable.
- Zadržite dih za približno 10 sekund oz. kolikor dolgo vam ni neprijetno.
- Remove the Diskus from your mouth.
- Odmaknite Diskus od ust.
The doctor will assess whether you can take Seretide during this time.
Zdravnik bo ocenil, ali lahko v tem obdobju uporabljate Seretide.
Instructions for proper use Your doctor, nurse or pharmacist should instruct you in the proper use of your inhaler.
Navodila za pravilno uporabo Zdravnik, medicinska sestra ali farmacevt vas morajo naučiti pravilne uporabe inhalatorja.