natgillin/translations-raw huggingface dataset:
Directive 2004/9/EC of the European Parliament and of the Council of 11 February 2004 on the inspection and verification of good laboratory practice (GLP) (OJ L 50, 20.2.2004, p. 28).
Direktiva Evropskega parlamenta in Sveta 2004/9/ES z dne 11. februarja 2004 o inšpekcijskih pregledih in preverjanju dobre laboratorijske prakse (DLP) (UL L 50, 20.2.2004, str. 28).
Federal law of 7 October 1983 on the protection of the environment (RO 1984 1122) as last amended on 16 December 2005 (RO 2006 2677).
Zvezni zakon z dne 7. oktobra 1983 o varstvu okolja (RO 1984 1122), kakor je bil nazadnje spremenjen dne 16. decembra 2005 (RO 2006 2677)
Ordinance of 18 May 2005 on Good Laboratory Practice (RO 2005 2795).
Odlok z dne 18. maja 2005 o dobri laboratorijski praksi (RO 2005 2795)
In accordance with Article 12 of this Agreement, the Parties in particular provide each other at least annually with a list of the test facilities which, in the light of the results of the inspections and study audits, conform to Good Laboratory Practice, as well as of the dates of inspection or audit and their compliance status.
V skladu s členom 12 tega sporazuma pogodbenici predvsem druga drugi najmanj enkrat letno predložita seznam preskusnih laboratorijev, ki glede na rezultate pregledov in študijskih presoj ustrezajo načelom dobre laboratorijske prakse, ter datume pregledov ali presoj in njihovo stopnjo usklajenosti.
In accordance with Article 6 of the Agreement, the Parties shall inform each other in a timely manner when a test facility coming under the terms of section II of this sectoral Chapter which states that it applies Good Laboratory Practice fails to conform to such practice to an extent which may jeopardise the integrity or authenticity of any such studies it conducts.
V skladu s členom 6 tega sporazuma pogodbenici druga drugo pravočasno obvestita, če preskusni laboratorij, za katerega veljajo določbe iz oddelka II tega poglavja in ki trdi, da spoštuje načela dobre laboratorijske prakse, krši ta načela v tolikšni meri, da bi bili lahko ogroženi neoporečnost in verodostojnost študij, ki jih izvaja.
The Parties shall supply each other with any additional information on a test facility inspection or study audit in response to a reasonable request from the other Party.
Pogodbenici druga drugi zagotovita vse dodatne informacije o pregledu preskusnega laboratorija ali študijske presoje kot odziv na upravičeno zahtevo druge pogodbenice.
Test facility inspections
Pregledi preskusnih laboratorijev
Each Party may request further test facility inspection or study audits if there is a documented doubt as to whether a test was conducted in accordance with Good Laboratory Practice.
Vsaka pogodbenica lahko zahteva dodatne preglede preskusnih laboratorijev ali študijske presoje, če obstaja dokumentiran dvom, ali je pregled potekal v skladu z dobro laboratorijsko prakso.
If, in exceptional cases, doubts persist and the requesting Party can justify special concern, it may, in accordance with Article 8 of the Agreement, designate one or more experts of its GLP monitoring authorities to participate in a laboratory inspection or the audit of a study conducted by the authorities of the other Party.
Če v izjemnih primerih dvom še vedno obstaja in pogodbenica, ki je zahtevala dodatni pregled, upraviči svoje posebne pomisleke, lahko v skladu s členom 8 Sporazuma imenuje enega ali več strokovnjakov iz svojih nadzornih organov za dobro laboratorijsko prakso, da sodelujejo pri pregledih laboratorijev ali študijski presoji, ki jih izvedejo organi druge pogodbenice.
In conformity with Article 13 of the Agreement, the Parties shall keep confidential any information brought to their knowledge pursuant to this Sectoral Chapter or that came to their knowledge in the framework of participation in an inspection or study audit and which falls within the definition of a trade secret or confidential commercial or financial information.
V skladu s členom 13 Sporazuma pogodbenici varujeta tajnost vseh informacij, ki sta jih pridobili v skladu s tem poglavjem ali v okviru sodelovanja pri pregledih ali presojah študij in ki veljajo za poslovno skrivnost ali zaupne poslovne ali finančne informacije.
They shall treat such information with at least the same confidentiality as that accorded to it by the providing Party and ensure that any authority to whom the information is transmitted treats it in the same way.
Takšne podatke varujeta z enako zaupnostjo kot pogodbenica, ki jih je zagotovila, in zagotovita, da jih tudi vsi organi, katerim jih posredujeta, obravnavajo na enak način.
Cooperation
Sodelovanje
Based on Article 9 of the Agreement, each Party may, on request, participate as an observer in an inspection of a test facility conducted by the authorities of the other Party with the consent of the test facility concerned in order to maintain a continuing understanding of the other Party’s inspection procedures.
Zaradi ohranitve poznavanja pregledovalnih postopkov druge pogodbenice lahko vsaka pogodbenica na podlagi člena 9 Sporazuma ob soglasju zadevnega preskusnega laboratorija na zahtevo sodeluje kot opazovalka pri pregledu preskusnega laboratorija, ki ga izvajajo organi druge pogodbenice.
MEDICINAL PRODUCTS GMP INSPECTION AND BATCH CERTIFICATION
NADZOR NAD ZDRAVILI V SKLADU Z DOBRO PROIZVODNO PRAKSO IN CERTIFICIRANJE SERIJ
The provisions of this Sectoral Chapter cover all medicinal products which are industrially manufactured in Switzerland or the European Community, and to which Good Manufacturing Practice (GMP) requirements apply.
Določbe tega poglavja zajemajo vsa zdravila, ki se industrijsko proizvajajo v Švici ali Evropski skupnosti, in za katere veljajo zahteve dobre proizvodne prakse (Good Manufacturing Practice, GMP).
For medicinal products covered by this Chapter, each party shall recognise the conclusions of inspections of manufacturers carried out by the relevant inspection services of the other Party and the relevant manufacturing authorisations granted by the competent authorities of the other Party.
Za zdravila, zajeta v tem poglavju, vsaka pogodbenica priznava sklepe pregledov proizvajalcev, ki jih izvajajo ustrezne inšpekcijske službe druge pogodbenice, in ustrezna dovoljenja za proizvodnjo, ki jih izdajo pristojni organi druge pogodbenice.
The manufacturer’s certification of the conformity of each batch to its specifications shall be recognised by the other Party without re-control at import.
Druga pogodbenica brez ponovnega preverjanja ob uvozu prizna potrdilo proizvajalca o skladnosti vsake serije s svojimi specifikacijami.
In addition, official batch releases carried out by an authority of the exporting Party will be recognised by the other Party.
Poleg tega druga pogodbenica prizna uradna dovoljenja za serije, ki jih izda organ pogodbenice izvoznice.
“Medicinal products” means all products regulated by pharmaceutical legislation in the European Community and Switzerland as listed in Section I of this Chapter.
‚Zdravila‘ pomeni vse izdelke, ki jih ureja farmacevtska zakonodaja v Evropski skupnosti in Švici, ki je navedena v oddelku I tega poglavja.
The definition of medicinal products includes all human and veterinary products, such as chemical and biological pharmaceuticals, immunologicals, radio-pharmaceuticals, stable medicinal products derived from human blood or human plasma, premixes for the preparation of veterinary medicated feedingstuffs and, where appropriate, vitamins, minerals, herbal remedies and homeopathic medicinal products.
Opredelitev zdravil zajema vse izdelke za humano in veterinarsko uporabo, kot so kemični in biološki farmacevtski izdelki, imunološki izdelki, radiofarmacevtski izdelki, stabilna zdravila iz človeške krvi ali plazme, predmešanice za pripravo mediciranih dodatkov h krmilom in, kjer je ustrezno, vitamine, minerale, zeliščna zdravila in homeopatska zdravila.
“GMP” is that part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorisation and products specifications.
‚Dobra proizvodna praksa‘ je tisti del zagotavljanja kakovosti, ki zagotavlja dosledno proizvodnjo in nadzor nad izdelki v skladu z ustreznimi standardi kakovosti za njihovo nameravano uporabo in z dovoljenji za promet ter specifikacijami izdelkov.
For the purpose of this Chapter it includes the system whereby the manufacturer receives the specification of the product and the process from the marketing authorisation holder or applicant and ensures that the medicinal product is made in compliance with this specification.
Za namen tega poglavja vključuje sistem, po katerem proizvajalec prejme specifikacijo izdelka in postopka od nosilca dovoljenja za promet ali prosilca in zagotavlja, da so zdravila narejena v skladu s to specifikacijo.
With respect to medicinal products covered by the legislation of one Party but not the other, the manufacturing company can request, for the purpose of this Agreement, an inspection be made by the locally competent inspection service.
V zvezi z zdravili, ki jih zajema zakonodaja ene pogodbenice, druge pa ne, lahko proizvodno podjetje za namene tega sporazuma zahteva pregled, ki ga opravi pristojna lokalna inšpekcijska služba.
This provision shall apply i.a. to the manufacture of active pharmaceutical ingredients, intermediate products and investigational medicinal products, as well as to pre-marketing inspections.
Ta določba se med drugim uporablja za proizvodnjo aktivnih farmacevtskih sestavin, polizdelkov in zdravil v preizkušanju ter na preglede pred začetkom trženja.
Operational arrangements are detailed under section III, paragraph 3.
Operativni režimi so opredeljeni v oddelku III, odstavek 3.
Certification of manufacturers
Certificiranje proizvajalcev
At the request of an exporter, importer or the competent authority of the other Party, the authorities responsible for granting manufacturing authorisations and for supervision of the manufacture of medicinal products shall certify that the manufacturer:
Organi, pristojni za izdajanje proizvodnih dovoljenj in nadzor nad proizvodnjo zdravil, na zahtevo izvoznika, uvoznika ali pristojnega organa druge pogodbenice potrdijo, da je proizvajalec:
is appropriately authorised to manufacture the relevant medicinal product, or to carry out the relevant specified manufacturing operation,
ustrezno pooblaščen za proizvodnjo določenega zdravila ali izvajanje s specifikacijo določenega proizvodnega postopka,
is regularly inspected by the authorities,
deležen rednih inšpekcijskih pregledov s strani organov,
complies with the national GMP requirements recognised as equivalent by the two parties, and which are listed in Section I of this Chapter.
izpolnjuje državne zahteve v zvezi z dobro proizvodno prakso, ki jih pogodbenici priznavata kot enakovredne in so naštete v oddelku I tega poglavja.
Should different GMP requirements be used as reference, this is to be mentioned in the certificate.
Če se za referenco uporabijo drugačne zahteve dobre proizvodne prakse, je to treba navesti v potrdilu.
The certificates shall also identify the site(s) of manufacture (and contract quality control laboratories, if any).
V potrdilu so opredeljene tudi lokacije proizvodnje (in pogodbenih laboratorijev za nadzor kakovosti, če obstajajo).
Certificates shall be issued expeditiously, and the time taken should not exceed 30 calendar days.
Potrdila se izdajajo kar najhitreje, najpozneje pa v tridesetih koledarskih dneh.
In exceptional cases, i.a. when a new inspection has to be carried out, this period may be extended to 60 days.
V izjemnih primerih, med drugim ko je treba opraviti nov inšpekcijski pregled, se ta rok lahko podaljša na šestdeset dni.
Batch certification
Certificiranje serij
Each batch exported shall be accompanied by a batch certificate established by the manufacturer (self-certification) after a full qualitative analysis, a quantitative analysis of all the active ingredients and all the other tests or checks necessary to ensure the quality of the product in accordance with the requirements of the marketing authorisation.
Vsako izvoženo serijo mora spremljati potrdilo, ki ga zagotovi proizvajalec (samopotrdilo) po celoviti kvalitativni analizi, kvantitativni analizi vseh aktivnih sestavin in drugih preskušanjih ali preverjanjih, potrebnih za zagotavljanje kakovosti izdelka v skladu z zahtevami dovoljenja za promet.
This certificate shall attest that the batch meets its specifications and shall be kept by the importer of the batch.
To potrdilo jamči, da serija ustreza svojim specifikacijam, in ga hrani uvoznik serije.
It will be made available upon request of the competent authority.
Treba ga je predložiti na zahtevo pristojnih organov.
When issuing a certificate, the manufacturer shall take account of the provisions of the current WHO certification scheme on the quality of pharmaceutical products moving in international commerce.
Proizvajalec pri izdaji potrdila upošteva določbe veljavne sheme certificiranja WHO o kakovosti farmacevtskih izdelkov v mednarodni trgovini.
The certificate shall detail the agreed specifications of the product, the reference of the analytical methods and the analytical results.
Potrdilo natančno navaja dogovorjene specifikacije izdelka, analitične metode ter rezultate analiz.
It shall contain a statement that the batch processing and packaging records were reviewed and found in conformity with GMP.
Vsebuje tudi izjavo, da so podatki o predelavi in pakiranju preverjeni ter v skladu z dobro proizvodno prakso.
The batch certificate shall be signed by the person responsible for releasing the batch for sale or supply, i.e. in the European Community the “qualified person” referred to in Article 48 of Directive 2001/83/EC and Article 52 of Directive 2001/82/EC, and in Switzerland the “responsible person” referred to in Articles 5 and 10 of the Ordinance on establishment licences.
Potrdilo o seriji podpiše oseba, odgovorna za sprostitev serije v prodajo ali dobavo, tj. v Evropski skupnosti ‚odgovorna oseba‘ iz člena 48 Direktive 2001/83/ES in člena 52 Direktive 2001/82/ES, v Švici pa ‚odgovorna oseba‘ iz členov 5 in 10 Odloka o dovoljenjih.
Official batch release
Uradna sprostitev serije
When an official batch release procedure applies, official batch releases carried out by an authority of the exporting Party (listed in section II) will be recognised by the other Party.
Kadar se uporabi postopek za uradno sprostitev serije, druga pogodbenica prizna uradna dovoljenja za serije, ki jih izda organ pogodbenice izvoznice (naveden v oddelku II).
The manufacturer shall provide the certificate of the official batch release.
Potrdilo o uradni sprostitvi serije zagotovi proizvajalec.
For the Community, the official batch release procedure is specified in document “Control Authority Batch Release of Vaccination and Blood Products, 2001” or subsequent versions and in different specific batch release procedures.
Za Skupnost je postopek za uradno sprostitev serij opisan v dokumentu ‚Kontrolna/uradna sprostitev serij cepiv in krvnih izdelkov, 2001‘ ter naslednjih različic in v različnih specifičnih postopkih za sprostitev serij.
For Switzerland, the official batch release procedure is specified in Article 17 of the Federal Law on medicinal products and medical devices and in Articles 18–21 of the Ordinance of the Swiss Agency for Therapeutic Products on the requirements for the marketing authorisation of medicinal products.
Za Švico je postopek za uradno sprostitev serij določen v členu 17 Zveznega zakona o zdravilih in medicinskih pripomočkih ter v členih 18–21 Odloka Švicarskega urada za terapevtske izdelke o zahtevah za dovoljenje za promet z zdravili.
With regard to GMP, the relevant parts of the legislative, regulatory and administrative provisions listed below apply.
V zvezi z dobro proizvodno prakso veljajo ustrezni deli spodaj navedenih zakonskih in drugih predpisov.
However, the reference quality requirements of products to be exported, including their manufacturing method and product specifications, shall be those of the relevant marketing authorisation granted by the competent authority of the importing Party.
Vendar pa morajo biti referenčne zahteve glede kakovosti izdelkov za izvoz, vključno z načinom proizvodnje in specifikacijami izdelkov, enake kot na dovoljenju za trženje, ki ga izda pristojni organ pogodbenice uvoznice.
Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ L 136, 30.4.2004, p. 1).
Uredba (ES) št. 726/2004 Evropskega parlamenta in Sveta z dne 31. marca 2004 o postopkih Skupnosti za pridobitev dovoljenja za promet in nadzor zdravil za humano in veterinarsko uporabo ter o ustanovitvi Evropske agencije za zdravila (UL L 136, 30.4.2004, str. 1).
Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use, as last amended by Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use (OJ L 136, 30.4.2004, p. 34).
Direktiva Evropskega parlamenta in Sveta 2001/83/ES z dne 6. novembra 2001 o zakoniku Skupnosti o zdravilih za uporabo v humani medicini, kakor je bila nazadnje spremenjena z Direktivo 2004/27/ES Evropskega parlamenta in Sveta z dne 31. marca 2004 o spremembah Direktive 2001/83/ES o zakoniku Skupnosti o zdravilih za uporabo v humani medicini (UL L 136, 30.4.2004, str. 34).
Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC (OJ L 33, 8.2.2003, p. 30).
Direktiva evropskega parlamenta in Sveta 2002/98/ES z dne 27. januarja 2003 o določitvi standardov kakovosti in varnosti za zbiranje, preskušanje, predelavo, shranjevanje in razdeljevanje človeške krvi in komponent krvi ter o spremembi Direktive 2001/83/ES (UL L 33, 8.2.2003, str. 30).
Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products (OJ L 311, 28.11.2001, p. 1) as last amended by Directive 2004/28/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/82/EC on the Community code relating to veterinary medicinal products (OJ L 136, 30.4.2004, p. 58).
Direktiva Evropskega parlamenta in Sveta 2001/82/ES z dne 6. novembra 2001 o zakoniku Skupnosti o zdravilih za uporabo v veterinarski medicini (UL L 311, 28.11.2001, str. 1), kakor je bila nazadnje spremenjena z Direktivo Evropskega parlamenta in Sveta 2004/28/ES z dne 31. marca 2004 o spremembi Direktive 2001/82/ES o zakoniku Skupnosti o zdravilih za uporabo v veterinarski medicini (UL L 136, 30.4.2004, str. 58).
Commission Directive 2003/94/EC of 8 October 2003 laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use (OJ L 262, 14.10.2003, p. 22).
Direktiva Komisije 2003/94/ES z dne 8. oktobra 2003 o določitvi načel in smernic dobre proizvodne prakse v zvezi z zdravili za uporabo v humani medicini in zdravili za uporabo v humani medicini v preskušanju (UL L 262, 14.10.2003, str. 22).
Commission Directive 91/412/EEC of 23 July 1991 laying down the principles and guidelines of good manufacturing practice for veterinary medicinal products (OJ L 228, 17.8.1991, p. 70).
Direktiva Komisije z dne 23. julija 1991 o določitvi načel in smernic dobre proizvodne prakse za zdravila za uporabo v veterinarski medicini (91/412/EGS) (UL L 228, 17.8.1991, str. 70).
Guidelines on Good Distribution Practice of medicinal products for human use (OJ C 63, 1.3.1994, p. 4) (published on website of the European Commission).
Smernice o dobri distribucijski praksi za zdravila v humani medicini (UL C 63, 1.3.1994, str. 4) (objavljeno na spletni strani Evropske Komisije)
EudraLex Volume 4 — Medicinal Products for Human and Veterinary Use: EU Guidelines to Good Manufacturing Practice (published on website of the European Commission).
EudraLex zvezek 4 – Zdravila za humano in veterinarsko uporabo: Smernice o dobri proizvodni praksi EU (objavljeno na spletni strani Evropske Komisije)
Directive 2001/20/EC of 04 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use (OJ L 121, 1.5.2001, p. 34).
Direktiva 2001/20/ES Evropskega parlamenta in Sveta z dne 4. aprila 2001 o približevanju zakonov in drugih predpisov držav članic v zvezi z izvajanjem dobre klinične prakse pri kliničnem preskušanju zdravil za ljudi (UL L 121, 1.5.2001, str. 34).
Commission Directive 2005/28/EC of 8 April 2005 laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products (OJ L 91, 9.4.2005, p. 13).
Direktiva Komisije 2005/28/ES z dne 8. aprila 2005 o načelih in podrobnih smernicah za dobro klinično prakso v zvezi z zdravili v preskušanju za humano uporabo ter o zahtevah za pridobitev dovoljenja za proizvodnjo ali uvoz takšnih izdelkov (UL L 91, 9.4.2005, str. 13).
Federal law of December 15, 2000 on medicinal products and medical devices (RO 2001 2790) as last amended on 20 December 2006 (RO 2007 14 11).
Zvezni zakon z dne 15. decembra 2000 o zdravilih in medicinskih pripomočkih (RO 2001 2790), kakor je bil nazadnje spremenjen dne 20. decembra 2006 (RO 2007 14 11)
Ordinance of October 17, 2001 on authorisations in the field of medicines (RO 2001 3399) as last amended on 16 March 2006 (RO 2007 1961).
Odlok z dne 17. oktobra 2001 o dovoljenjih na področju zdravil (RO 2001 3399), kakor je bil nazadnje spremenjen dne 16. marca 2006 (RO 2007 1961)
Ordinance of the Swiss Agency for Therapeutic Products of November 9, 2001 on the requirements for the marketing authorisation of medicinal products (RO 2001 3437) as last amended on 22 June 2006 (RO 2006 3587).
Odloka Švicarskega urada za terapevtske izdelke z dne 9. novembra 2001 o zahtevah za dovoljenja za promet z zdravili (RO 2001 3437), kakor je bil nazadnje spremenjen 22. junija 2006 (RO 2006 3587)
Ordinance of October 17, 2001 on clinical trials of pharmaceutical products (RO 2001 3511) as last amended on 16 March 2007 (RO 2007 1961).
Odlok z dne 17. oktobra 2001 o kliničnem preskušanju farmacevtskih izdelkov (RO 2001 3511), kakor je bil nazadnje spremenjen 16. marca 2007 (RO 2007 1961)
For the purpose of this Chapter “Conformity Assessment Bodies” means the official GMP inspection services of each Party.
Za namene tega poglavja ‚Organi za ugotavljanje skladnosti‘ pomeni uradne inšpekcijske službe za dobro proizvodno prakso vsake od pogodbenic.
The Contact Details of the official GMP Inspection Services of the Member States of the European Union and of Switzerland can be found in the websites indicated below.
Kontaktni podatki uradnih inšpekcijskih služb za dobro proizvodno prakso držav članic Evropske unije in Švice so na voljo na spodaj navedenih spletnih straneh.
For Swiss conformity assessment bodies
Za švicarske organe za ugotavljanje skladnosti
For all products for human and veterinary use (except immunological products for veterinary use):
Za vse izdelke za humano in veterinarsko uporabo (razen imunobioloških izdelkov za veterinarsko uporabo):
For immunobiological products for veterinary use
Za imunobiološke izdelke za veterinarsko uporabo
For conformity assessment bodies of the European Community
Za organe Evropske skupnosti za ugotavljanje skladnosti
Transmission of inspection reports
Pošiljanje inšpekcijskih poročil