natgillin/translations-raw huggingface dataset:
Upon application of the manufacturer, the competent authority may grant a derogation from paragraph 1 in relation to the sampling and retention of starting material and for certain products manufactured individually or in small quantities, or when their storage could raise special problems.
Na zahtevo proizvajalca lahko pristojni organ odobri odstopanje od odstavka 1 v zvezi z vzorčenjem in hrambo vhodnih snovi in za nekatera zdravila, ki se proizvedejo posamezno ali v majhnih količinah ali katerih shranjevanje bi lahko povzročilo posebne težave.
Responsibilities of the qualified person
Pristojnosti usposobljene osebe
The qualified person referred to in Article 61(2)(b) of Regulation (EU) No 536/2014 shall be responsible for the following:
Usposobljena oseba iz člena 61(2)(b) Uredbe (EU) št. 536/2014 je pristojna za naslednje:
where investigational medicinal products are manufactured in the Member State concerned, verifying that each production batch has been manufactured and checked in compliance with the requirements of good manufacturing practice for investigational medicinal products laid down in this Regulation and the information provided pursuant to Article 25 of Regulation (EU) No 536/2014, taking into account the guidelines referred to in Article 63(1) of that Regulation;
če so zdravila v preskušanju proizvedena v zadevni državi članici, za preverjanje, ali je bila vsaka proizvodna serija proizvedena in preverjena v skladu z zahtevami dobre proizvodne prakse za zdravila v preskušanju, določenimi v tej uredbi, in informacijami, predloženimi v skladu s členom 25 Uredbe (EU) št. 536/2014, ob upoštevanju smernic iz člena 63(1) navedene uredbe;
where investigational medicinal products are manufactured in a third country, verifying that each production batch has been manufactured and checked in accordance with quality standards at least equivalent to those laid down in this Regulation and the information provided pursuant to Article 25 of Regulation (EU) No 536/2014 taking into account the guidelines referred to in Article 63(1) of that Regulation.
če so zdravila v preskušanju proizvedena v tretji državi, za preverjanje, ali je bila vsaka proizvodna serija proizvedena in preverjena v skladu s standardi kakovosti, vsaj enakovrednimi standardom iz te uredbe, in informacijami, predloženimi v skladu s členom 25 Uredbe (EU) št. 536/2014, ob upoštevanju smernic iz člena 63(1) navedene uredbe.
The qualified person shall certify in a register or equivalent document provided for that purpose that each production batch complies with the requirements laid down in paragraph 1.
Usposobljena oseba v registru ali enakovrednemu temu namenjenemu dokumentu potrdi, da vsaka proizvodna serija izpolnjuje zahteve iz odstavka 1.
The register or equivalent document shall be kept up to date as operations are carried out and shall remain at the disposal of the competent authority for at least five years after the completion of or the formal discontinuation of the last clinical trial in which the product batch was used.
Register ali enakovredni dokument se med izvajanjem postopkov posodablja in je pristojnemu organu na voljo najmanj pet let po zaključku ali uradni prekinitvi zadnjega kliničnega preskušanja, v katerem je bila serija zdravila uporabljena.
Where a manufacturing operation or operation linked thereto is outsourced, the outsourcing shall be the subject of a written contract.
Če proizvodni postopek ali z njim povezan postopek izvaja zunanji izvajalec, je zunanje izvajanje predmet pisne pogodbe.
The contract shall clearly lay down the responsibilities of each party.
V pogodbi so jasno opredeljene odgovornosti vsake stranke.
It shall lay down an obligation for the party to whom the operations are outsourced to follow good manufacturing practice and set out the manner in which the qualified person responsible for certifying each batch is to discharge his responsibilities.
Pogodba določa obveznost stranke, ki je zunanji izvajalec, da upošteva dobro proizvodno prakso in določi način, kako bo usposobljena oseba, odgovorna za sprostitev vsake serije v promet, izpolnjevala svoje odgovornosti.
The party to whom the operations are outsourced shall not subcontract any of the operations entrusted to him under the contract without written consent from the contract giver.
Stranka, ki je zunanji izvajalec, ne odda postopkov, ki so ji bili s pogodbo zaupani, drugemu podpogodbeniku brez pisnega dovoljenja naročnika.
The party to whom the operations are outsourced shall comply with the principles and guidelines of good manufacturing practice applicable to the operations concerned and shall submit to inspections carried out by the competent authority pursuant to Article 63(4) of Regulation (EU) No 536/2014.
Stranka, ki je zunanji izvajalec, ravna v skladu z načeli in smernicami dobre proizvodne prakse, ki veljajo za zadevne postopke, in dovoli preglede, ki jih izvaja pristojni organ v skladu s členom 63(4) Uredbe (EU) št. 536/2014.
Complaints, product recall and emergency unblinding
Pritožbe, odpoklic zdravil in razkritje v nujnih primerih
The manufacturer shall, in cooperation with the sponsor, implement a system for recording and reviewing complaints together with an effective system for recalling investigational medicinal products which have already entered the distribution network promptly and at any time.
Proizvajalec v sodelovanju s sponzorjem izvaja sistem evidentiranja in pregledovanja pritožb ter učinkovit sistem takojšnjega in stalnega odpoklica zdravil v preskušanju, ki so že v distribucijski mreži.
The manufacturer shall record and investigate any complaint concerning a defect and shall inform the sponsor and the competent authority of the Member States concerned of any defect that could result in a recall or abnormal restriction on supply.
Proizvajalec evidentira in razišče vse pritožbe v zvezi s pomanjkljivostmi ter sponzorja in pristojni organ zadevne države članice obvesti o pomanjkljivostih, ki bi lahko povzročile odpoklic ali neobičajno omejitev dobave.
All trial sites shall be identified and, in so far as possible, the countries of destination shall be indicated.
Opredelijo se vsa mesta preskušanja in navedejo se, kadar je to mogoče, namembne države.
In the case of an authorised investigational medicinal product, the manufacturer shall, in cooperation with the sponsor, inform the marketing authorisation holder of any defect that could be related to that product.
V primeru odobrenega zdravila v preskušanju proizvajalec v sodelovanju s sponzorjem obvesti imetnika dovoljenja za promet z zdravilom o vseh pomanjkljivostih, ki bi lahko bile povezane z navedenim zdravilom.
Where blinding of investigational medicinal products is required by the protocol of a clinical trial, the manufacturer in conjunction with the sponsor shall implement a procedure for the rapid unblinding of blinded products, where this is necessary for a prompt recall as referred to in paragraph 1.
Če je v skladu s protokolom kliničnega preskušanja potrebno zakrivanje zdravila v preskušanju, proizvajalec v povezavi s sponzorjem izvede postopek hitrega razkritja zakritih zdravil, kadar je to potrebno za takojšen odpoklic iz odstavka 1.
The manufacturer shall ensure that the procedure discloses the identity of the blinded product only in so far as it is necessary.
Proizvajalec zagotovi, da se s tem postopkom razkrije identiteta zakritega zdravila samo, če je to potrebno.
Self-inspection by the manufacturer
Notranji pregled proizvajalca
The manufacturer shall conduct regular inspections as part of the pharmaceutical quality system in order to monitor the implementation and respect of good manufacturing practice.
Proizvajalec v okviru sistema farmacevtske kakovosti izvaja redne notranje preglede, da bi tako spremljal izvajanje in upoštevanje dobre proizvodne prakse.
He shall take any necessary corrective action and to put in place any necessary preventive measures.
Sprejme vse potrebne korektivne ukrepe in uvede vse potrebne preventivne ukrepe.
The manufacturer shall maintain records of all such inspections and any corrective action or preventive measures subsequently taken.
Proizvajalec vodi evidenco vseh takšnih pregledov ter kakršnih koli posledično sprejetih korektivnih ali preventivnih ukrepov.
Advanced therapy investigational medicinal products
Zdravila za napredno zdravljenje v preskušanju
The good manufacturing principles shall be adapted to the specific characteristics of the advanced therapy medicinal products when used as investigational medicinal products.
Kadar se zdravila za napredno zdravljenje uporabljajo kot zdravila v preskušanju, se načela dobre proizvodne prakse prilagodijo posebnim lastnostim zdravil za napredno zdravljenje.
Investigational medicinal products, which are at the same time advanced therapy medicinal products, shall be manufactured in accordance with the guidelines referred to in Article 5 of Regulation (EC) No 1394/2007.
Zdravila v preskušanju, ki so hkrati zdravila za napredno zdravljenje, se proizvajajo v skladu s smernicami iz člena 5 Uredbe (ES) št. 1394/2007.
Supervision by inspection
Nadzor s pregledi
By means of regular inspections as referred to in Article 63(4) of Regulation (EU) No 536/2014 the Member State shall ensure that holders of an authorisation as referred to in Article 61(1) of that Regulation comply with the principles of good manufacturing practice laid down in this Regulation and takes into account the guidelines referred in second subparagraph of Article 63(1) of Regulation (EU) No 536/2014.
Države članice z rednimi pregledi iz člena 63(4) Uredbe (EU) št. 536/2014 zagotovijo, da imetniki dovoljenja iz člena 61(1) navedene uredbe ravnajo v skladu z načeli dobre proizvodne prakse iz te uredbe ter s smernicami iz drugega pododstavka člena 63(1) Uredbe (EU) št. 536/2014.
Without prejudice to any arrangements which may have been concluded between the Union and third countries, a competent authority may require a third country manufacturer to submit to an inspection as referred to in Article 63(4) of Regulation (EU) No 536/2014 and this Regulation.
Brez poseganja v morebitne dogovore med Unijo in tretjimi državami lahko pristojni organ zahteva, da proizvajalec iz tretje države dovoli pregled iz člena 63(4) Uredbe (EU) št. 536/2014 in te uredbe.
This Regulation applies mutatis mutandis to such inspections in third countries.
Ta uredba se smiselno uporablja za takšne preglede v tretjih državah.
Member States shall carry out inspections of third country manufacturers to ensure that investigational medicinal products imported into the Union are manufactured by applying quality standards at least equivalent to those laid down in the Union.
Države članice izvajajo preglede proizvajalcev iz tretjih držav ter tako zagotovijo, da so zdravila v preskušanju, uvožena v Unijo, proizvedena ob upoštevanju standardov kakovosti, ki so vsaj enakovredni standardom, določenim v Uniji.
The Member States are not obliged to routinely inspect third country manufacturers of investigational medicinal products.
Države članice niso obvezane rutinsko opravljati pregledov proizvajalcev zdravil v preskušanju iz tretjih držav.
The necessity of such inspections shall be based on an assessment of risk, but shall take place at least if the Member States have grounds for suspecting that the quality standards applied to the manufacture of the investigational medicinal products imported into the Union are lower than those laid down in this Regulation and in the guidelines referred to in the second subparagraph of Article 63(1) of Regulation (EU) No 536/2014.
Potreba po takšnih pregledih je odvisna od ocene tveganja, pregledi pa se izvedejo, takoj ko države članice utemeljeno sumijo, da so standardi kakovosti, ki se uporabljajo pri proizvodnji zdravil v preskušanju, uvoženih v Unijo, nižji od standardov, določenih v tej uredbi in v smernicah iz drugega pododstavka člena 63(1) Uredbe (EU) št. 536/2014.
Inspections may, if necessary, be unannounced.
Pregledi se lahko po potrebi izvedejo nenapovedano.
Following an inspection, an inspection report shall be drawn up by the inspector.
Po pregledu inšpektor pripravi poročilo o pregledu.
Before the report is adopted by competent authority, the manufacturer shall be afforded an opportunity to submit comments in relation to the findings of the report.
Preden pristojni organ poročilo sprejme, ima proizvajalec možnost, da predloži pripombe v zvezi z ugotovitvami iz poročila.
Where the findings of the final report show that the manufacturer complies with the good manufacturing practice for investigational medicinal products, the competent authority shall within a period of 90 days of the inspection issue a certificate of good manufacturing practice to the manufacturer.
Kadar je iz ugotovitev končnega poročila razvidno, da proizvajalec upošteva dobro proizvodno prakso za zdravila v preskušanju, pristojni organ v 90 dneh po pregledu proizvajalcu izda certifikat dobre proizvodne prakse.
The competent authority shall enter the certificate of good manufacturing practice which they issue into the Union database referred to in Article 111(6) of Directive 2001/83/EC of the European Parliament and of the Council [4].
Pristojni organ certifikat dobre proizvodne prakse, ki ga izda, vnese v podatkovno bazo Unije iz člena 111(6) Direktive 2001/83/ES Evropskega parlamenta in Sveta [4].
Where the outcome of the inspection is that the manufacturer does not comply with good manufacturing practice for investigational medicinal products, the competent authority shall enter this information into the Union database referred to in Article 111(6) of Directive 2001/83/EC.
Če se po zaključku pregleda izkaže, da proizvajalec ne ravna v skladu z dobro proizvodno prakso za zdravila v preskušanju, pristojni organ to informacijo vnese v podatkovno bazo Unije iz člena 111(6) Direktive 2001/83/ES.
The competent authority shall, upon receipt of reasoned request, send the inspection reports referred to in paragraph 5 electronically to the competent authorities of other Member States or to the European Medicines Agency (‘the Agency’).
Pristojni organ na utemeljeno zahtevo v elektronski obliki pošlje poročila o pregledih iz odstavka 5 pristojnim organom drugih držav članic ali Evropski agenciji za zdravila (v nadaljnjem besedilu: Agencija).
The competent authority shall enter the information relating to the authorisation referred to in Article 61(1) of Regulation (EU) No 536/2014 in the Union database referred to in Article 111(6) of Directive 2001/83/EC.
Pristojni organ vnese informacijo v zvezi z dovoljenjem iz člena 61(1) Uredbe (EU) št. 536/2014 v podatkovno bazo Unije iz člena 111(6) Direktive 2001/83/ES.
Cooperation and coordination of inspections
Sodelovanje in usklajevanje pregledov
The competent authorities shall cooperate with each other and with the Agency in relation to inspections.
Pristojni organi pri pregledih sodelujejo med seboj in z Agencijo.
They shall share information with the Agency on both inspections planned and conducted.
Agenciji posredujejo informacije o načrtovanih in izvedenih pregledih.
Recognition of inspection conclusions
Priznavanje ugotovitev pregleda
The conclusions reached in the inspection report referred to in Article 17(5) shall be valid throughout the Union.
Ugotovitve iz poročila o pregledu iz člena 17(5) so veljavne povsod v Uniji.
However, in exceptional cases, where a competent authority is unable, for reasons relating to public health, to recognise the conclusions reached following an inspection under Article 63(4) of Regulation (EU) No 536/2014, that competent authority shall forthwith inform the Commission and the Agency.
Vendar pa v izjemnih primerih, ko pristojni organ iz razlogov, povezanih z javnim zdravjem, ne more priznati ugotovitev, ki izhajajo iz pregleda iz člena 63(4) Uredbe (EU) št. 536/2014, navedeni pristojni organ o tem nemudoma obvesti Komisijo in Agencijo.
The Agency shall inform the other competent authorities concerned.
Agencija obvesti druge zadevne pristojne organe.
When the Commission is informed in accordance with the second subparagraph of paragraph 1, it may, after consulting the competent authority which was unable to accept the report, request the inspector who performed the inspection to perform a new inspection.
Ko je Komisija obveščena v skladu z drugim pododstavkom odstavka 1, lahko po posvetovanju s pristojnim organom, ki ni mogel sprejeti poročila, zahteva, da inšpektor, ki je izvedel pregled, izvede nov pregled.
The inspector may be accompanied by two inspectors from other competent authorities which are not parties to the disagreement.
Inšpektorja lahko spremljata še dva inšpektorja iz drugih pristojnih organov, ki niso stranke v tem sporu.
Empowerments of the inspectors
Pooblastitve inšpektorjev
The competent authority shall provide inspectors with suitable means of their identification.
Pristojni organ inšpektorjem zagotovi ustrezna sredstva za njihovo identifikacijo.
Inspectors shall be empowered to:
Inšpektorji so pooblaščeni, da:
enter and inspect the premises of the manufacturer and quality control laboratories having carried out checks pursuant to Article 10 for the manufacturer;
vstopijo v in pregledajo prostore proizvajalca in laboratorijev za kontrolo kakovosti, ki so opravili preglede za proizvajalca v skladu s členom 10;
take samples, including for independent tests to be carried out by an Official Medicines Control Laboratory or a laboratory designated for that purpose by the Member State, and
odvzamejo vzorce, tudi za neodvisne preskuse, ki jih opravlja Uradni kontrolni laboratorij za preskušanje zdravil ali laboratorij, ki ga za ta namen določi država članica, in
examine any documents relating to the object of inspection, make copies of records or printed documents, print electronic records and take photographs of the premises and equipment of the manufacturer.
proučijo kakršne koli dokumente, ki zadevajo predmet pregleda, kopirajo evidence ali natisnejo dokumente, natisnejo elektronske evidence ter fotografirajo prostore in opremo proizvajalca.
Competence and obligations of the inspectors
Usposobljenost in obveznosti inšpektorjev
The competent authority shall ensure that the inspectors possess adequate qualifications, experience and knowledge.
Pristojni organ zagotovi, da imajo inšpektorji ustrezne kvalifikacije, izkušnje in znanje.
In particular, the inspectors shall have the following:
Inšpektorji imajo zlasti:
experience and knowledge of the inspection process;
izkušnje in znanje s področja postopka pregleda;
the ability to make professional judgements as to the compliance with the requirements of good manufacturing practice;
sposobnost strokovne presoje o skladnosti z zahtevami dobre proizvodne prakse;
ability to apply the principles of quality risk management;
sposobnost uporabe načel obvladovanja tveganja na področju kakovosti;
knowledge of current technologies relevant for inspections;
znanje o sodobnih tehnologijah, ki so pomembne za preglede;
knowledge of the current technologies for the manufacture of the investigational medicinal products.
znanje o sodobnih tehnologijah, ki se uporabljajo za proizvodnjo zdravil v preskušanju.
Information acquired as a result of inspections shall remain confidential.
Informacije o rezultatih pregledov ostanejo zaupne.
The competent authorities shall ensure that inspectors receive the training necessary to maintain or improve their skills.
Pristojni organi zagotovijo, da se inšpektorji udeležijo usposabljanja, ki je potrebno za ohranjanje ali izboljšanje njihovih znanj in spretnosti.
Their training needs shall be assessed regularly by the persons appointed for that task.
Potrebe inšpektorjev po usposabljanju redno ocenjuje oseba, imenovana za to nalogo.
The competent authority shall document the qualifications, training and experience of each inspector.
Pristojni organ zabeleži kvalifikacije, usposabljanja in izkušnje vsakega inšpektorja.
Those records shall be kept up to date.
Ta evidenca se posodablja.
The competent authorities shall establish, implement and comply with a properly designed quality system for their inspectors.
Pristojni organi vzpostavijo, izvajajo in upoštevajo ustrezno zasnovan sistem kakovosti za svoje inšpektorje.
Each inspector shall be informed of the standard operating procedures and of his duties, responsibilities and ongoing training requirements.
Vsak inšpektor je obveščen o standardnih operativnih postopkih ter seznanjen s svojimi dolžnostmi, odgovornostmi in zahtevami glede stalnega usposabljanja.
Those procedures shall be kept up to date.
Ti postopki se posodabljajo.
Impartiality of inspectors
Nepristranskost inšpektorjev
The competent authority shall ensure that inspectors are free of any undue influence that could affect their impartiality and judgment.
Pristojni organ zagotovi, da inšpektorji niso pod kakršnim koli vplivom, ki bi lahko posegal v njihovo nepristranskost in presojo.
Inspectors shall be independent, in particular, of:
Inšpektorji so neodvisni, zlasti od:
the management and personnel of the clinical trial site;
vodstva in osebja mesta kliničnega preskušanja;
the investigators involved in the clinical trials where the investigational medicinal products manufactured by the inspected manufacturer are used;
raziskovalcev, ki sodelujejo pri kliničnem preskušanju, pri katerem se uporabljajo zdravila v preskušanju, ki jih proizvaja proizvajalec, ki je predmet pregleda;
the persons financing the clinical trial in which the investigational medicinal product is used;
oseb, ki financirajo klinično preskušanje, pri katerem se uporabljajo zdravila v preskušanju;
the manufacturer.
proizvajalca.
Inspectors shall make an annual declaration of their financial interests in the parties inspected or other links to them.
Inšpektorji sestavijo letno izjavo o svojih finančnih interesih in drugih povezavah s strankami, ki so predmet pregleda.
The competent authority shall take the declaration into consideration when assigning inspectors to specific inspections.
Pristojni organ izjavo upošteva pri dodelitvi pregledov posameznim inšpektorjem.
Access to premises
Dostop do prostorov
The manufacturer shall allow inspectors access to his premises and documentation at all times.
Proizvajalec ob katerem koli času dovoli inšpektorjem dostop do svojih prostorov in dokumentacije.
Suspension or revocation of manufacturing authorisation
Začasen odvzem ali preklic dovoljenja za proizvodnjo
If an inspection reveals that the holder of an authorisation as referred to in Article 61(1) of Regulation (EU) No 536/2014 fails to comply with good manufacturing practice as set out in Union law, the competent authority may, with regard to this manufacturer, suspend manufacture or imports from third countries of investigational medicinal products for human use, or suspend or revoke the authorisation for a category of preparations or all preparation.
Če se med pregledom izkaže, da imetnik dovoljenja iz člena 61(1) Uredbe (EU) št. 536/2014 ne ravna v skladu z dobro proizvodno prakso, kot je določena v zakonodaji Unije, lahko pristojni organ začasno ustavi proizvodnjo pri tem proizvajalcu ali uvoz zdravil za uporabo v humani medicini v preskušanju iz tretjih držav ali začasno odvzame oziroma prekliče dovoljenje za eno kategorijo pripravkov ali za vse pripravke.
The Member States may continue to apply national transposition measures adopted under Commission Directive 2003/94/EC [5] to the manufacture of investigational medicinal products used in clinical trials governed by Directive 2001/20/EC of the European Parliament and of the Council [6] in accordance with the transitional provisions laid down in Article 98 of Regulation (EU) No 536/2014.Article 27
Države članice lahko še naprej uporabljajo nacionalne ukrepe za prenos, sprejete v okviru Direktive Komisije 2003/94/ES [5], za proizvodnjo zdravil v preskušanju, ki se uporabljajo v kliničnih preskušanjih, ki jih ureja Direktiva 2001/20/ES Evropskega parlamenta in Sveta [6], v skladu s prehodnimi določbami iz člena 98 Uredbe (EU) št. 536/2014.Člen 27