natgillin/translations-raw huggingface dataset:
Principles and guidelines of good manufacturing practice for medicinal products for human use should be set out in relation to quality management, personnel, premises and equipment, documentation, production, quality control, outsourced operations, complaints, product recall, and self-inspections.
Načela in smernice dobre proizvodne prakse za zdravila za uporabo v humani medicini bi bilo treba opredeliti v zvezi z upravljanjem kakovosti, osebjem, prostori, opremo, dokumentacijo, proizvodnjo, kontrolo kakovosti, delom zunanjih izvajalcev, pritožbami in odpoklicem zdravil ter notranjimi pregledi.
As regards the advanced therapy medicinal products those principles and guidelines should be adapted to the specific characteristic of those products in accordance with the risk-based approach.
Kar zadeva zdravila za napredno zdravljenje, bi bilo treba s pristopom, ki temelji na tveganju, navedena načela in smernice prilagoditi posebnim značilnostim navedenih zdravil.
Since many of the provisions of Directive 2003/94/EC need to be adjusted, for the sake of clarity, that Directive should be repealed.
Ker je potrebna prilagoditev več določb Direktive 2003/94/ES, bi bilo treba zaradi jasnosti navedeno direktivo razveljaviti.
The measures provided for in this Directive are in accordance with the opinion of the Standing Committee for Medicinal Products for Human Use,
Ukrepi iz te direktive so v skladu z mnenjem Stalnega odbora za zdravila za uporabo v humani medicini –
This Directive lays down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use whose manufacture or import requires the authorisation referred to in Article 40 of Directive 2001/83/EC.
Ta direktiva določa načela in smernice dobre proizvodne prakse v zvezi z zdravili za uporabo v humani medicini, za katere je potrebno dovoljenje za proizvodnjo ali uvoz iz člena 40 Direktive 2001/83/ES.
‘manufacturer’ means any person engaged in activities for which the authorisation referred to in Article 40(1) and (3) of Directive 2001/83/EC is required;
„proizvajalec“ pomeni vsako osebo, ki se ukvarja z dejavnostmi, za katere je potrebno dovoljenje iz člena 40(1) in (3) Direktive 2001/83/ES;
‘pharmaceutical quality system’ means the total sum of the organised arrangements made with the objective of ensuring that medicinal products are of the quality required for their intended use;
„sistem farmacevtske kakovosti“ pomeni skupek vseh organizacijskih ukrepov, sprejetih z namenom zagotavljanja, da so zdravila takšne kakovosti, kot je to zahtevano za njihovo predvideno uporabo;
‘good manufacturing practice’ means the part of the quality assurance which ensures that medicinal products are consistently produced, imported and controlled in accordance with the quality standards appropriate to their intended use.
„dobra proizvodna praksa“ pomeni tisti del zagotavljanja kakovosti, ki zagotavlja dosledno proizvodnjo, uvoz in kontrolo zdravil v skladu s standardi kakovosti, ustreznimi za njihovo predvideno uporabo.
By means of the repeated inspections referred to in Article 111(1a) of Directive 2001/83/EC, the Member States shall ensure that manufacturers authorised in accordance with Article 40(1) and (3) of Directive 2001/83/EC respect the principles and guidelines of good manufacturing practice laid down by this Directive.
Z večkratnimi inšpekcijskimi pregledi iz člena 111(1a) Direktive 2001/83/ES države članice zagotovijo, da proizvajalci, katerim je bilo izdano dovoljenje v skladu s členom 40(1) in (3) Direktive 2001/83/ES, spoštujejo načela in smernice dobre proizvodne prakse, določene v tej direktivi.
Member States shall also take into account the compilation, published by the Commission, of Union procedures on inspections and exchange of information.
Države članice prav tako upoštevajo zbirko postopkov Unije o inšpekcijskih pregledih in izmenjavi podatkov, ki jih izda Komisija.
For the interpretation of the principles and guidelines of good manufacturing practice, manufacturers and the competent authorities shall take into account the detailed guidelines referred to in the second paragraph of Article 47 of Directive 2001/83/EC.
Za razlago načel in smernic dobre proizvodne prakse proizvajalci in pristojni organi upoštevajo podrobne smernice iz drugega odstavka člena 47 Direktive 2001/83/ES.
In the case of advanced therapy medicinal products, the guidelines on good manufacturing practice specific to advanced therapy medicinal products referred to in Article 5 of Regulation (EC) No 1394/2007 on advanced therapy medicinal products shall be taken into account.
V primeru zdravil za napredno zdravljenje se upoštevajo smernice dobre proizvodne prakse, specifične za zdravila za napredno zdravljenje iz člena 5 Uredbe (ES) št. 1394/2007 Evropskega parlamenta in Sveta o zdravilih za napredno zdravljenje.
Member States shall establish and implement in their inspectorates a properly designed quality system that shall be complied with by inspectorates' personnel and management.
Države članice v okviru svojih inšpektoratov vzpostavijo in izvajajo ustrezno zasnovan sistem kakovosti, ki ga upoštevata osebje in uprava inšpektorata.
The quality system shall be updated as appropriate.
Sistem kakovosti se po potrebi posodablja.
The Member States shall ensure that the manufacturing operations are carried out by manufacturers in accordance with good manufacturing practice and with the manufacturing authorisation.
Države članice zagotovijo, da proizvodne postopke izvajajo proizvajalci v skladu z dobro proizvodno prakso in dovoljenjem za proizvodnjo.
This provision shall also apply to medicinal products intended only for export.
Ta določba velja tudi za zdravila, ki so namenjena samo za izvoz.
For medicinal products imported from third countries, the Member States shall ensure that the products have been manufactured in accordance with standards which are at least equivalent to the good manufacturing practice standards laid down in the Union and that such products have been manufactured by manufacturers duly authorised to do so.
Pri zdravilih, uvoženih iz tretjih držav, države članice zagotovijo, da so bila zdravila proizvedena v skladu s standardi, ki so najmanj enakovredni standardom dobre proizvodne prakse, določene na ravni Unije, in da so ta zdravila proizvedli proizvajalci, ki imajo za to ustrezna dovoljenja.
Compliance with marketing authorisation
Skladnost z dovoljenjem za promet
The Member States shall ensure that all manufacturing or import operations for medicinal products subject to a marketing authorisation are carried out by manufacturers in accordance with the information provided in the application for that marketing authorisation.
Države članice zagotovijo, da vse proizvodne ali uvozne postopke za zdravila, ki so predmet dovoljenja za promet, izvedejo proizvajalci v skladu z informacijami, navedenimi v vlogi za pridobitev navedenega dovoljenja za promet.
The Member States shall oblige the manufacturer to regularly review his manufacturing methods in light of scientific and technical progress.
Države članice proizvajalcu naložijo obveznost, da redno preverja svoje proizvodne postopke z vidika znanstvenega in tehničnega napredka.
If a variation to the marketing authorisation dossier is necessary, the variation shall take place by the arrangements established in accordance with Article 23b of Directive 2001/83/EC.
Če je potrebna sprememba dokumentacije za pridobitev dovoljenja za promet, se sprememba izvede ob upoštevanju ureditev, določenih v skladu s členom 23b Direktive 2001/83/ES.
Pharmaceutical quality system
Sistem farmacevtske kakovosti
The Member States shall ensure that the manufacturers establish, implement and maintain an effective pharmaceutical quality system, involving the active participation of the senior management and the personnel of the different departments.
Države članice zagotovijo, da proizvajalec vzpostavi, izvaja in vzdržuje učinkovit sistem farmacevtske kakovosti, pri katerem aktivno sodelujejo višje vodstvo in osebje različnih oddelkov.
The manufacturer shall be obliged to have at each manufacturing or import site a sufficient number of competent and appropriately qualified personnel at his disposal to achieve the objective of the pharmaceutical quality system.
Proizvajalec je zato, da doseže cilj sistema farmacevtske kakovosti, obvezan zagotoviti, da je na vsakem proizvodnem ali uvoznem mestu na voljo zadostno število kompetentnega in ustrezno usposobljenega osebja.
The duties of the managerial and supervisory staff, including the qualified persons referred to in Article 48 of Directive 2001/83/EC, responsible for implementing and operating good manufacturing practice, shall be defined in job descriptions.
Dolžnosti vodstvenega in nadzornega osebja, vključno z osebami iz člena 48 Direktive 2001/83/ES, odgovornimi za uvedbo in izvajanje dobre proizvodne prakse, se določijo v opisih del in nalog.
Their hierarchical relationships shall be defined in an organisation chart.
Njihovi hierarhični odnosi se določijo v organizacijski shemi.
Organisation charts and job descriptions shall be approved in accordance with the manufacturer's internal procedures.
Organizacijske sheme ter opisi del in nalog se potrdijo v skladu z notranjimi postopki proizvajalca.
The staff referred to in paragraph 2 shall be given sufficient authority to discharge their responsibility correctly.
Osebje iz odstavka 2 dobi dovolj pooblastil za ustrezno opravljanje svojih dolžnosti.
The personnel shall receive initial and ongoing training, the effectiveness of which shall be verified, covering in particular the theory and application of the concept of quality assurance and good manufacturing practice.
Osebje se udeleži začetnega in nadaljnjega izobraževanja, katerega učinkovitost se preverja in ki zlasti zajema teorijo in uporabo koncepta zagotavljanja kakovosti ter dobre proizvodne prakse.
Hygiene programmes adapted to the activities to be carried out shall be established and observed.
Pripravijo in preverjajo se higienski programi, prilagojeni dejavnostim, ki se bodo izvajale.
These programmes shall, in particular, include procedures relating to health, hygiene practice and clothing of personnel.
Ti programi zlasti vključujejo postopke, ki se nanašajo na zdravje, higiensko prakso in oblačila za osebje.
Premises and equipment
Prostori in oprema
As regards the premises and manufacturing equipment the manufacturer shall be obliged to ensure that they are located, designed, constructed, adapted and maintained to suit the intended operations.
Kar zadeva prostore in proizvodno opremo, je proizvajalec obvezan zagotoviti, da so ti nameščeni, načrtovani, izdelani, prilagojeni in vzdrževani tako, da ustrezajo predvidenim postopkom.
The Member States shall require that the premises and manufacturing equipment are laid out, designed and operated in such a way as to minimise the risk of error and to permit effective cleaning and maintenance in order to avoid contamination, cross contamination and, in general, any adverse effect on the quality of the product.
Države članice zahtevajo, da se prostori in proizvodna oprema razporedijo, načrtujejo in se z njimi upravlja tako, da se zmanjša tveganje napak na najmanjšo možno mero in omogoči učinkovito čiščenje in vzdrževanje z namenom izogibanja kontaminaciji, navzkrižni kontaminaciji in na splošno vsemu, kar bi lahko neugodno vplivalo na kakovost zdravila v preskušanju.
Premises and equipment to be used for manufacturing or import operations, which are critical to the quality of the products, shall be subjected to appropriate qualification and validation.
Prostore in opremo za uporabo v proizvodnih ali uvoznih postopkih, ki odločilno vplivajo na kakovost zdravil, je treba ustrezno opredeliti in validirati.
The manufacturer shall be obliged to establish and maintain a documentation system based upon specifications, manufacturing formulae and processing and packaging instructions, procedures and records covering the various manufacturing operations performed.
Proizvajalec je obvezan vzpostaviti in vzdrževati sistem dokumentiranja, ki temelji na specifikacijah, proizvodnih formulah, navodilih za obdelavo in pakiranje, postopkih ter poročilih, ki zajemajo različne proizvodne postopke.
The documentation system shall ensure data quality and integrity.
Sistem dokumentacije zagotavlja kakovost in celovitost podatkov.
Documents shall be clear, free from error and kept up to date.
Dokumenti morajo biti jasni, brez napak in se morajo posodabljati.
Pre-established procedures for general manufacturing operations and conditions shall be kept available, together with specific documents for the manufacture of each batch.
Na voljo so vnaprej določeni postopki za splošne proizvodne postopke in pogoje, skupaj s posebnimi dokumenti za proizvodnjo vsake serije.
That set of documents shall enable the history of the manufacture of each batch to be traced.
Navedeni sklop dokumentov omogoča sledljivost proizvodnje vsake serije.
The manufacturer shall be required to retain the batch documentation for at least 1 year after the expiry date of the batches to which it relates or at least 5 years after the certification referred to in Article 51(3) of Directive 2001/83/EC, whichever is the longer period.
Proizvajalec je zadolžen za hranjenje dokumentacije o vsaki seriji najmanj eno leto po datumu izteka roka uporabnosti zadevne serije ali najmanj pet let po izdaji potrdila iz člena 51(3) Direktive 2001/83/ES, odvisno od tega, katero obdobje je daljše.
When electronic, photographic or other data processing systems are used instead of written documents, the manufacturer shall be required to first validate the systems by showing that the data will be appropriately stored during the anticipated period of storage.
Kadar se namesto pisnih dokumentov uporabljajo elektronski, fotografski ali drugi sistemi obdelave podatkov, je proizvajalec obvezan te sisteme najprej validirati tako, da pokaže, da bodo podatki v času predvidenega obdobja shranjevanja ustrezno shranjeni.
Data stored by those systems shall be made readily available in legible form and shall be provided to the competent authorities upon request.
Podatki, shranjeni v navedenih sistemih, morajo biti pristojnim organom na njihovo zahtevo na voljo v čitljivi obliki.
The electronically stored data shall be protected, by techniques such as duplication or back-up and transfer to another storage system, against unlawful access, loss or damage of data, and audit trails shall be maintained.
Elektronsko shranjeni podatki so zaščiteni pred neupravičenimi dostopi, izgubo ali poškodovanjem podatkov, in sicer s pripravo dvojnika ali varnostne kopije in prenosom na drug sistem shranjevanja, obenem pa se ohranjajo tudi revizijske sledi.
The Member States shall ensure that the manufacturers carry out the different production operations in accordance with pre-established instructions and procedures and in accordance with good manufacturing practice.
Države članice zagotovijo, da proizvajalci izvajajo različne proizvodne dejavnosti v skladu s predhodno določenimi navodili in postopki ter v skladu z dobro proizvodno prakso.
Adequate and sufficient resources shall be made available by the manufacturer for the in-process controls.
Za kontrole faz postopka da proizvajalec na voljo ustrezna in zadostna sredstva.
All process deviations and product defects shall be documented and thoroughly investigated.
Vsi odmiki v postopku in neustreznosti zdravila se dokumentirajo in temeljito raziščejo.
The manufacturers shall be required to take appropriate technical and organisational measures to avoid cross contamination and mix-ups.
Proizvajalci so obvezani sprejeti ustrezne tehnične in organizacijske ukrepe, da se preprečijo navzkrižna kontaminacija in zamenjave.
Any new manufacturing or important modification of a manufacturing process of a medicinal product shall be validated.
Validira se vsak nov proizvodni postopek ali pomembna sprememba postopka proizvodnje zdravila.
Critical phases of manufacturing processes shall be regularly revalidated.
Kritične faze proizvodnega postopka se redno ponovno validirajo.
Quality control
Kontrola kakovosti
The manufacturer shall be obliged to establish and maintain a quality control system placed under the authority of a person who has the requisite qualifications and is independent of production.
Proizvajalec je obvezan vzpostaviti in vzdrževati sistem kontrole kakovosti, ki ga vodi oseba z zahtevanimi kvalifikacijami in ki deluje neodvisno od proizvodnje.
That person shall have at his disposal, or shall have access to, one or more quality control laboratories appropriately staffed and equipped to carry out the necessary examination and testing of starting materials and packaging materials and the testing of intermediate and finished medicinal products.
Ta oseba ima na voljo ali ima dostop do enega ali več laboratorijev za kontrolo kakovosti z ustreznim osebjem in opremo za izvajanje potrebnih pregledov in preskušanj vhodnih snovi in snovi ovojnine ter preskušanja vmesnih in končnih zdravil.
For medicinal products, including those imported from third countries, contract laboratories may be used if authorised in accordance with Article 12 of this Directive and point (b) of Article 20 of Directive 2001/83/EC.
Pri zdravilih, vključno s tistimi, ki so uvožena iz tretjih držav, se lahko uporabijo pogodbeni laboratoriji, če so odobreni v skladu s členom 12 te direktive in točko (b) člena 20 Direktive 2001/83/ES.
During the final control of the finished medicinal product before its release for sale or distribution, the quality control system shall take into account, in addition to analytical results, essential information such as the production conditions, the results of in-process controls, the examination of the manufacturing documents and the conformity of the product to its specifications, including the final finished pack.
Med končno kontrolo končnega zdravila pred sprostitvijo v promet ali distribucijo sistem kontrole kakovosti poleg analiznih rezultatov upošteva bistvene podatke, kot so proizvodni pogoji, rezultati kontrol faz postopka, pregled proizvodne dokumentacije in skladnost zdravila z njegovimi specifikacijami, vključno s končno zunanjo ovojnino.
Samples of each batch of finished medicinal product shall be retained for at least 1 year after the expiry date.
Vzorci vsake serije končnega zdravila se hranijo najmanj eno leto po datumu izteka roka uporabnosti.
Samples of starting materials, other than solvents, gases or water, used in the manufacturing process shall be retained for at least 2 years after the release of the product.
Vzorci vhodnih snovi, razen topil, plinov ali vode, uporabljenih v proizvodnem postopku, se hranijo najmanj dve leti po sprostitvi zdravila v promet.
That period may be shortened if the period of stability of the material, as indicated in the relevant specification, is shorter.
To obdobje se lahko skrajša, če je obdobje stabilnosti snovi, kot je navedeno v ustrezni specifikaciji, krajše.
All those samples shall be maintained at the disposal of the competent authorities.
Vsi navedeni vzorci so na voljo pristojnim organom.
Other conditions may be defined, by agreement with the competent authority, for the sampling and retaining of starting materials and certain products manufactured individually or in small quantities, or when their storage could raise special problems.
V dogovoru s pristojnim organom se lahko opredelijo drugi pogoji vzorčenja in shranjevanja vhodnih snovi in nekaterih zdravil, ki so proizvedena posamezno ali v majhnih količinah, ali kadar bi njihovo shranjevanje povzročilo posebne težave.
Outsourced operations
Postopki, oddani v zunanje izvajanje
The Member States shall require that any manufacturing or import operation or operation linked thereto which is outsourced is the subject of a written contract.
Države članice zahtevajo, da se za vse proizvodne ali uvozne postopke ali postopke, povezane z njimi, ki se oddajo v zunanje izvajanje, sklene pisna pogodba.
The contract shall clearly define the responsibilities of each party and shall define, in particular, the observance of good manufacturing practice to be followed by the contract-acceptor and the manner in which the qualified person referred to in Article 48 of Directive 2001/83/EC responsible for certifying each batch is to discharge his responsibilities.
V pogodbi morajo biti jasno opredeljene odgovornosti vsake stranke in zlasti upoštevanje dobre proizvodne prakse s strani pogodbenega izvajalca ter način, kako usposobljena oseba iz člena 48 Direktive 2001/83/ES, ki je odgovorna za sprostitev vsake serije v promet, prevzame svoje odgovornosti.
The contract-acceptor shall not subcontract any of the work entrusted to him under the contract without written authorisation from the contract-giver.
Pogodbeni izvajalec ne odstopi dela, ki mu je bilo s pogodbo zaupano, drugemu podpogodbeniku brez pisnega dovoljenja naročnika.
The contract-acceptor shall comply with the principles and guidelines of good manufacturing practice applicable to the operations concerned laid down in the Union and shall submit to inspections carried out by competent authorities pursuant to Article 111 of Directive 2001/83/EC.
Pogodbeni izvajalec upošteva načela in smernice dobre proizvodne prakse, ki se uporabljajo za zadevne operacije, ki jih je določila Unija, in dovoli preglede, ki jih izvajajo pristojni organi v skladu s členom 111 Direktive 2001/83/ES.
Complaints and product recall
Pritožbe in odpoklic zdravila
The Member States shall ensure that manufacturers implement a system for recording and reviewing complaints together with an effective system for recalling, promptly and at any time, medicinal products in the distribution network.
Države članice zagotovijo, da proizvajalci izvajajo sistem evidentiranja in pregledovanja pritožb skupaj z učinkovitim sistemom takojšnjega in stalnega odpoklica zdravil iz distribucijske mreže.
Any complaint concerning a defect shall be recorded and investigated by the manufacturer.
Proizvajalec evidentira in razišče vse pritožbe v zvezi s pomanjkljivostmi.
The manufacturer shall be required to inform the competent authority and, if applicable, the marketing authorisation holder of any defect that could result in a recall or an abnormal restriction on supply and, in so far as possible, indicate the countries of destination.
Proizvajalec je obvezan obveščati pristojne organe, in po potrebi imetnika dovoljenja za promet, o vseh pomanjkljivostih, ki bi lahko povzročile odpoklic ali nenavadno omejitev dobave in, kadar je to mogoče, navesti namembne države.
Any recall shall be made in accordance with the requirements referred to in Article 123 of Directive 2001/83/EC.
Vsak odpoklic se opravi v skladu z zahtevami iz člena 123 Direktive 2001/83/ES.
Self-inspection
Notranji pregled
The manufacturer shall be required to conduct repeated self-inspections as part of the pharmaceutical quality system in order to monitor the implementation and respect of good manufacturing practice and to propose any necessary corrective measures and/or preventive actions.
Proizvajalec je obvezan izvajati redne notranje preglede kot del sistema farmacevtske kakovosti, da bi tako spremljal izvajanje in upoštevanje dobre proizvodne prakse in predlagal vse potrebne korektivne ukrepe in/ali preventivne ukrepe.
Records shall be maintained of such self-inspections and any corrective actions subsequently taken.
O takih notranjih pregledih in vseh posledično sprejetih korektivnih ukrepih se vodi evidenca.
Repeal of Directive 2003/94/EC
Razveljavitev Direktive 2003/94/ES
Directive 2003/94/EC is repealed with effect from 6 months after the date of publication in the Official Journal of the European Union of the notice referred to in Article 82(3) of Regulation (EU) No 536/2014 or 1 April 2018, whichever is the later.
Direktiva 2003/94/ES se razveljavi z učinkom šest mesecev po datumu objave obvestila iz člena 82(3) Uredbe (EU) št. 536/2014 v Uradnem listu Evropske unije ali s 1. aprilom 2018, pri čemer se upošteva poznejši od teh datumov.