natgillin/translations-raw huggingface dataset:
a completed conflicts of interest questionnaire established by the FDA signed by a principal of the authority;
FDA sprejme odločitev o tem, ali se bo odpovedala kateremu koli dokumentu za ocenjevanje, za vsak primer posebej.
a total of four inspection reports including the report from the inspections observed during the Joint Audit Program audit;
Ob prejemu vseh potrebnih informacij iz odstavka II(A) od organa države članice namerava FDA take informacije predložiti v uradni prevod v angleščino v razumnem roku.
standard operating procedures or a description on how the authority finalizes inspection reports;
Uprava FDA bo zaključila ocenjevanje in določila sposobnost organa države članice najpozneje v 70 koledarskih dneh od datuma, na katerega prejme prevod vseh potrebnih informacij iz odstavka II(A) za organ države članice.
standard operating procedures related to training and inspector qualification, including training files for all inspectors who conducted the inspections in the reports provided to the FDA (pursuant to subparagraph (iii)); and
Uprava FDA bo oblikovala dve skupini za ocenjevanje sposobnosti, tako bo v katerem koli trenutku izvajala ocenjevanje dveh organov držav članic.
its most recent inventory of manufacturing facilities within its territory and under the authority's jurisdiction, including type of manufacturing facility of products falling within the product coverage of this Annex, and upon request, completion of a table provided by the FDA detailing types of manufacturing facilities.
B. Ocenjevanje FDA, ki ga opravi EU
During a capability assessment, the FDA may require additional information or further clarification from the Member State authority.
EU bo opravila ocenjevanje FDA na podlagi:
The FDA may waive the requirement to submit certain information listed under II.A.1 and may request alternative information from the Member State authority.
izvedene revizije v skladu z elementi skupnega revizijskega programa, ob upoštevanju revizij, izvedenih v okviru konvencij/shem v zvezi s farmacevtskimi inšpekcijskimi pregledi („Pharmaceutical Inspection Convention/Scheme“), in revizij, izvedenih v okviru člena 111(b)(1) Direktive 2001/83/ES;
The decision to waive any assessment materials will be made by the FDA on a case by case basis.
ocene enakovrednosti zakonskih in regulativnih zahtev glede dobrih proizvodnih praks.
Upon receipt of all requisite information specified in paragraph II.A from a Member State authority, the FDA intends to submit such information for official translation into English within a reasonable timeframe.
C. Ponovna ocena organov
The FDA will complete assessments and determine capability of the Member State authority no later than 70 calendar days from the date the FDA receives a translation of all requisite information specified in paragraph II.A for the Member State authority.
Če pogodbenica, ki izvaja ocenjevanje, izda negativno odločitev ali začasno prekliče priznavanje organa druge pogodbenice, lahko ta organ ponovno oceni.
The FDA will dedicate two capability assessment teams; therefore, the FDA shall conduct assessments of two Member State authorities at any given time.
Obseg ponovne ocene mora ustrezati razlogom za negativno odločitev ali začasni preklic priznavanja.
B. Assessment of FDA by the EU
OHRANJANJE PRIZNAVANJA
The EU will carry out its assessment of FDA based on:
Za ohranjanje priznavanja mora organ še naprej izpolnjevati merila iz odstavka I(A) in zanj se morajo izvajati dejavnosti spremljanja, opisane v členu 12, za katere za organe držav članic FDA zahteva spremljanje prek revizijskega programa, ki vključuje revizijo (ki jo lahko FDA opazuje) vsakega priznanega organa države članice vsakih pet do šest let.
The performance of an audit in line with the elements of the Joint Audit Programme taking into account audits performed in the framework of the Pharmaceutical Inspection Convention/Scheme (PIC/S) and audits performed in the context of Article 111(b)(1) of Directive 2001/83/EC.
Če organ ni bil predmet revizije v obdobju 6 let, ima druga pogodbenica pravico, da izvede revizijo takega organa.
An assessment of the equivalence of legislative and regulatory GMP requirements.
Dodatek 5
C. Reassessment of authorities
ČASOVNI RAZPORED ZAČETNEGA OCENJEVANJA ORGANOV DRŽAV ČLANIC
In the event an assessing Party issues a negative determination or suspension of an authority of the other Party, it may reassess the authority.
Organi držav članic za farmacevtske izdelke za humano rabo iz Dodatka 2 predložijo popolno dokumentacijo za oceno sposobnosti, ki vsebuje informacije iz odstavka II(A)(1) Dodatka 4, po naslednjem časovnem razporedu:
The scope of the reassessment shall relate to the reasons for the negative determination or suspension.
najpozneje 1. januarja 2017: dokumentacija za oceno sposobnosti od štirih organov držav članic,
MAINTAINING RECOGNITION
najpozneje 15. februarja 2017: dokumentacija za oceno sposobnosti od treh dodatnih organov držav članic,
To maintain recognition, it is required that the authority continue to meet the criteria set out in paragraph I.A and remain subject to the monitoring activities described in Article 12 which for Member State authorities the FDA requires monitoring through an audit program that includes an audit (that the FDA has the option to observe) of each recognized Member State authority every five to six years.
najpozneje 1. aprila 2017: dokumentacija za oceno sposobnosti od dveh dodatnih organov držav članic,
In case an authority has not been subject to an audit for a period of 6 years, the other Party shall have the right to audit such authority.
najpozneje 15. maja 2017: dokumentacija za oceno sposobnosti od dveh dodatnih organov držav članic,
Appendix 5
najpozneje 15. septembra 2017: dokumentacija za oceno sposobnosti od dveh dodatnih organov držav članic,
SCHEDULE FOR INITIAL ASSESSMENT OF MEMBER STATE AUTHORITIES
najpozneje 15. decembra 2017: dokumentacija za oceno sposobnosti od štirih dodatnih organov držav članic,
Member State authorities for human pharmaceuticals listed in Appendix 2 shall submit complete capability assessment packages containing the information specified in paragraph II.A.1 of Appendix 4 according to the following schedule:
najpozneje 15. marca 2018: dokumentacija za oceno sposobnosti od štirih dodatnih organov držav članic,
No later than January 1, 2017: capability assessment packages from four Member State authorities
najpozneje 15. junija 2018: dokumentacija za oceno sposobnosti od sedmih dodatnih organov držav članic.
No later than February 15, 2017: capability assessment packages from three additional Member State authorities
FDA zaključi ocenjevanje na podlagi te priloge za organe držav članic za farmacevtske izdelke za humano rabo iz Dodatka 2, kot je določeno v odstavku (II)(A)(4) in po naslednjem časovnem razporedu, če FDA prejme popolno dokumentacijo za oceno sposobnosti za take organe, ki vsebuje informacije iz odstavka II(A)(1) Dodatka 4, po časovnem razporedu iz odstavka 1:
No later than April 1, 2017: capability assessment packages from two additional Member State authorities.
1. novembra 2017: osem ocen,
No later than May 15, 2017: capability assessment packages from two additional Member State authorities
1. marca 2018: štiri dodatne ocene,
No later than September 15, 2017: capability assessment packages from two additional Member State authorities
1. junija 2018: dve dodatni oceni,
No later than December 15, 2017: capability assessment packages from four additional Member State authorities
1. decembra 2018: šest dodatnih ocen,
No later than March 15, 2018: capability assessment packages from four additional Member State authorities
15. julija 2019: osem dodatnih ocen.
No later than June 15, 2018: capability assessment packages from seven additional Member State authorities
Za vsak organ države članice:
The FDA shall complete assessments under this Annex of Member State authorities for human pharmaceuticals listed in Appendix 2 as set out in paragraph II.A.4 and according to the following schedule, provided that the FDA receives complete capability assessment packages for such authorities containing the information specified in paragraph II.A.1 of Appendix 4 according to the schedule set out in paragraph 1:
EU predloži FDA končno revizijsko poročilo najpozneje 60 dni pred rokom za predložitev dokumentacije za oceno sposobnosti za organ;
November 1, 2017: eight assessments
FDA zagotovi organu dokončan kontrolni seznam za dokumentacijo za oceno sposobnosti najpozneje 20 dni po tem, ko FDA prejme revizijsko poročilo;
March 1, 2018: four additional assessments
organ upravi FDA predloži dokumentacijo za oceno sposobnosti najpozneje 40 dni po tem, ko organ prejme kontrolni seznam za dokumentacijo za oceno sposobnosti.
June 1, 2018: two additional assessments
ZDRUŽENE DRŽAVE AMERIKE
December 1, 2018: six additional assessments
Uprava za hrano in zdravila (Food and Drug Administration)
July 15, 2019: eight additional assessments
Inštitut za državni nadzor bioloških pripravkov in zdravil za uporabo v veterini/Ústav štátnej kontroly veterinárnych biopreparátov a liečiv (USKVBL)
For each Member State authority:
Zvezni zakon o živilih, zdravilih in kozmetiki (Federal Food, Drug, and Cosmetic Act), 21 U.S.C.
The EU shall submit a final audit report to the FDA no later than 60 days before the due date of the capability assessment package for the authority.
301 in naslednji.
Decision No 45/2016 of the Joint Committee established under the Agreement on mutual recognition between the European Community and the United States of America
Sklep št. 45/2016 Skupnega odbora, ustanovljenega v okviru Sporazuma o vzajemnem priznavanju med Evropsko skupnostjo in Združenimi državami Amerike
related to the listing of Conformity Assessment Bodies under the Sectoral Annex for Electromagnetic Compatibility [2017/465]
v zvezi z uvrstitvijo organov za ugotavljanje skladnosti na seznam v področni prilogi o elektromagnetni združljivosti [2017/465]
Having regard to the Agreement on Mutual Recognition between the European Community and the United States of America, and in particular Articles 7 and 14;
ob upoštevanju Sporazuma o vzajemnem priznavanju med Evropsko skupnostjo in Združenimi državami Amerike in zlasti členov 7 in 14 Sporazuma,
The Conformity Assessment Body in Attachment A is added to the list of Conformity Assessment Bodies under column ‘EC access to the US market’ in Section V of the Sectoral Annex for Electromagnetic Compatibility.
Organ za ugotavljanje skladnosti iz Dodatka A se doda na seznam organov za ugotavljanje skladnosti v stolpec „Dostop ES na trg ZDA“ oddelka V področne priloge o elektromagnetni združljivosti.
Signed in Washington DC, on 13 February 2017
Podpisano v Washingtonu, DC, 13. februarja 2017
Signed in Brussels, on 1 March 2017
Podpisano v Bruslju, 1. marca 2017
EC Conformity Assessment Body added to the list of Conformity Assessment Bodies under column ‘EC access to the US market’ in Section V of the Sectoral Annex for Electromagnetic Compatibility
Organ ES za ugotavljanje skladnosti, dodan na seznam organov za ugotavljanje skladnosti v stolpec „Dostop ES na trg ZDA“ oddelka V področne priloge o elektromagnetni združljivosti
Decision No 46/2016 of the Joint Committee established under the Agreement on Mutual Recognition between the European Community and the United States of America
Sklep št. 46/2016 Skupnega odbora, ustanovljenega v okviru Sporazuma o vzajemnem priznavanju med Evropsko skupnostjo in Združenimi državami Amerike
related to the listing of conformity assessment bodies under the sectoral annex for telecommunication equipment [2017/466]
o uvrstitvi organov za ugotavljanje skladnosti na seznam sektorske priloge o telekomunikacijski opremi [2017/466]
Whereas the Joint Committee is to take a decision to list a conformity assessment body or bodies under a sectoral annex,
ob upoštevanju, da Skupni odbor odloča o uvrstitvi organov za ugotavljanje skladnosti na seznam v področni prilogi –
The conformity assessment body in Attachment A is added to the list of conformity assessment bodies under column ‘EC access to the US market’ in Section V of the sectoral annex for telecommunication equipment.
Organ za ugotavljanje skladnosti iz Dodatka A se doda na seznam organov za ugotavljanje skladnosti v stolpec „Dostop ES na trg ZDA“ oddelka V področne priloge za telekomunikacijsko opremo.
The specific scope of listing, in terms of products and conformity assessment procedures, of the conformity assessment body indicated in Attachment A has been agreed by the Parties and will be maintained by them.
Pogodbenici sta se dogovorili o posebnih pristojnostih organa za ugotavljanje skladnosti iz Dodatka A v zvezi z izdelki in postopki za ugotavljanje skladnosti in bosta poskrbeli za njihovo izvajanje.
This Decision, done in duplicate, shall be signed by representatives of the Joint Committee who are authorised to act on behalf of the Parties for purposes of amending the Agreement.
Ta sklep, sestavljen v dveh izvodih, podpišejo predstavniki Skupnega odbora, pooblaščeni, da v imenu pogodbenic spremenijo Sporazum.
EC conformity assessment body added to the list of conformity assessment bodies under column ‘EC access to the US market’ in Section V of the sectoral annex for telecommunication equipment
Organ EU za ugotavljanje skladnosti, dodan na seznam organov za ugotavljanje skladnosti v stolpec „Dostop EU na trg ZDA“ oddelka V področne priloge za telekomunikacijsko opremo
Decision No 47/2016 of the Joint Committee established under the Agreement on Mutual Recognition between the European Community and the United States of America
Sklep št. 47/2016 Skupnega odbora, ustanovljenega v okviru Sporazuma o vzajemnem priznavanju med Evropsko skupnostjo in Združenimi državami Amerike
related to the listing of conformity assessment bodies under the sectoral annex for electromagnetic compatibility [2017/467]
v zvezi z uvrstitvijo organov za ugotavljanje skladnosti na seznam v področni prilogi o elektromagnetni združljivosti [2017/467]
The conformity assessment body in Attachment A is added to the list of conformity assessment bodies under column ‘EC access to the US market’ in Section V of the sectoral annex for electromagnetic compatibility.
Organ za ugotavljanje skladnosti iz Dodatka A se doda na seznam organov za ugotavljanje skladnosti v stolpec „Dostop ES na trg ZDA“ oddelka V področne priloge o elektromagnetni združljivosti.
of 25 September 2015
z dne 25. septembra 2015
amending Annex I (Veterinary and phytosanitary matters) to the EEA Agreement [2017/504]
o spremembi Priloge I (Veterinarske in fitosanitarne zadeve) k Sporazumu EGP [2017/504]
Regulation (EC) No 1069/2009 of the European Parliament and of the Council of 21 October 2009 laying down health rules as regards animal by-products and derived products not intended for human consumption and repealing Regulation (EC) No 1774/2002 (Animal by-products Regulation) [1] is to be incorporated into the EEA Agreement.
Uredbo (ES) št. 1069/2009 Evropskega parlamenta in Sveta z dne 21. oktobra 2009 o določitvi zdravstvenih pravil za živalske stranske proizvode in pridobljene proizvode, ki niso namenjeni prehrani ljudi, ter razveljavitvi Uredbe (ES) št. 1774/2002 (Uredba o živalskih stranskih proizvodih) [1] je treba vključiti v Sporazum EGP.
Commission Regulation (EU) No 790/2010 of 7 September 2010 amending Annexes VII, X and XI to Regulation (EC) No 1774/2002 of the European Parliament and of the Council laying down health rules concerning animal by-products not intended for human consumption [2] is to be incorporated into the EEA Agreement.
Uredbo Komisije (EU) št. 790/2010 z dne 7. septembra 2010 o spremembi prilog VII, X in XI k Uredbi (ES) št. 1774/2002 Evropskega parlamenta in Sveta o določitvi zdravstvenih pravil za živalske stranske proizvode, ki niso namenjeni prehrani ljudi [2], je treba vključiti v Sporazum EGP.
Commission Regulation (EU) No 142/2011 of 25 February 2011 implementing Regulation (EC) No 1069/2009 of the European Parliament and of the Council laying down health rules as regards animal by-products and derived products not intended for human consumption and implementing Council Directive 97/78/EC as regards certain samples and items exempt from veterinary checks at the border under that Directive [3] is to be incorporated into the EEA Agreement.
Uredbo Komisije (EU) št. 142/2011 z dne 25. februarja 2011 o izvajanju Uredbe (ES) št. 1069/2009 Evropskega parlamenta in Sveta o določitvi zdravstvenih pravil za živalske stranske proizvode in pridobljene proizvode, ki niso namenjeni prehrani ljudi, ter o izvajanju Direktive Sveta 97/78/ES glede nekaterih vzorcev in predmetov, ki so izvzeti iz veterinarskih pregledov na meji v skladu z navedeno direktivo [3], je treba vključiti v Sporazum EGP.
Commission Regulation (EU) No 749/2011 of 29 July 2011 amending Regulation (EU) No 142/2011 implementing Regulation (EC) No 1069/2009 of the European Parliament and of the Council laying down health rules as regards animal by-products and derived products not intended for human consumption and implementing Council Directive 97/78/EC as regards certain samples and items exempt from veterinary checks at the border under that Directive [4] is to be incorporated into the EEA Agreement.
Uredbo Komisije (EU) št. 749/2011 z dne 29. julija 2011 o spremembi Uredbe Komisije (EU) št. 142/2011 o izvajanju Uredbe (ES) št. 1069/2009 Evropskega parlamenta in Sveta o določitvi zdravstvenih pravil za živalske stranske proizvode in pridobljene proizvode, ki niso namenjeni prehrani ljudi, ter o izvajanju Direktive Sveta 97/78/ES glede nekaterih vzorcev in predmetov, ki so izvzeti iz veterinarskih pregledov na meji v skladu z navedeno direktivo [4], je treba vključiti v Sporazum EGP.
Commission Regulation (EU) No 1063/2012 of 13 November 2012 amending Regulation (EU) No 142/2011 implementing Regulation (EC) No 1069/2009 of the European Parliament and of the Council laying down health rules as regards animal by-products and derived products not intended for human consumption and implementing Council Directive 97/78/EC as regards certain samples and items exempt from veterinary checks at the border under that Directive [5] is to be incorporated into the EEA Agreement.
Uredbo Komisije (EU) št. 1063/2012 z dne 13. novembra 2012 o spremembi Uredbe (EU) št. 142/2011 o izvajanju Uredbe (ES) št. 1069/2009 Evropskega parlamenta in Sveta o določitvi zdravstvenih pravil za živalske stranske proizvode in pridobljene proizvode, ki niso namenjeni prehrani ljudi, ter o izvajanju Direktive Sveta 97/78/ES glede nekaterih vzorcev in predmetov, ki so izvzeti iz veterinarskih pregledov na meji v skladu z navedeno direktivo [5], je treba vključiti v Sporazum EGP.
Commission Regulation (EU) No 555/2013 of 14 June 2013 amending Regulation (EU) No 142/2011 as regards the transit of certain animal by-products from Bosnia and Herzegovina [6] is to be incorporated into the EEA Agreement.
Uredbo Komisije (EU) št. 555/2013 z dne 14. junija 2013 o spremembi Uredbe (EU) št. 142/2011 glede tranzita nekaterih stranskih živalskih proizvodov iz Bosne in Hercegovine [6] je treba vključiti v Sporazum EGP.
Commission Regulation (EU) No 592/2014 of 3 June 2014 amending Regulation (EU) No 142/2011 as regards the use of animal by-products and derived products as a fuel in combustion plants [7] is to be incorporated into the EEA Agreement.
Uredbo Komisije (EU) št. 592/2014 z dne 3. junija 2014 o spremembi Uredbe (EU) št. 142/2011 glede uporabe živalskih stranskih proizvodov in pridobljenih proizvodov kot goriva v kurilnih napravah [7] je treba vključiti v Sporazum EGP.
Regulation (EC) No 1069/2009 repeals Regulation (EC) No 1774/2002 of the European Parliament and of the Council [8], which is incorporated into the EEA Agreement and which is consequently to be repealed under the EEA Agreement.
Uredba (ES) št. 1069/2009 razveljavlja Uredbo (ES) št. 1774/2002 Evropskega parlamenta in Sveta [8], ki je vključena v Sporazum EGP in jo je zato treba v okviru Sporazuma EGP razveljaviti.
Regulation (EU) No 142/2011 repeals Commission Regulations (EC) No 811/2003 [9], (EC) No 878/2004 [10], (EC) No 79/2005 [11], (EC) No 92/2005 [12], (EC) No 181/2006 [13], (EC) No 197/2006 [14], (EC) No 1192/2006 [15], (EC) No 2007/2006 [16] and Commission Decisions 2003/322/EC [17], 2003/324/EC [18] and 2004/407/EC [19], which are incorporated into the EEA Agreement and which are consequently to be repealed under the EEA Agreement.
Uredba (EU) št. 142/2011 razveljavlja uredbe Komisije (ES) št. 811/2003 [9], (ES) št. 878/2004 [10], (ES) št. 79/2005 [11], (ES) št. 92/2005 [12], (ES) št. 181/2006 [13], (ES) št. 197/2006 [14], (ES) št. 1192/2006 [15], (ES) št. 2007/2006 [16] in odločbe Komisije 2003/322/ES [17], 2003/324/ES [18] in 2004/407/ES [19], ki so vključene v Sporazum EGP in jih je zato treba v okviru Sporazuma EGP razveljaviti.
Annex I to the EEA Agreement should therefore be amended accordingly,
Prilogo I k Sporazumu EGP bi bilo zato treba ustrezno spremeniti –
Chapter I of Annex I to the EEA Agreement shall be amended as follows:
Poglavje I Priloge I k Sporazumu EGP se spremeni:
the text of point 9b (Regulation (EC) No 1774/2002 of the European Parliament and of the Council) in Part 7.1 is replaced by the following:
besedilo v točki 9b (Uredba (ES) št. 1774/2002 Evropskega parlamenta in Sveta) dela 7.1 se nadomesti z naslednjim:
‘32009 R 1069: Regulation (EC) No 1069/2009 of the European Parliament and of the Council of 21 October 2009 laying down health rules as regards animal by-products and derived products not intended for human consumption and repealing Regulation (EC) No 1774/2002 (Animal by-products Regulation) (OJ L 300, 14.11.2009, p. 1).
„32009 R 1069: Uredba (ES) št. 1069/2009 Evropskega parlamenta in Sveta z dne 21. oktobra 2009 o določitvi zdravstvenih pravil za živalske stranske proizvode in pridobljene proizvode, ki niso namenjeni prehrani ljudi, ter razveljavitvi Uredbe (ES) št. 1774/2002 (Uredba o živalskih stranskih proizvodih) (UL L 300, 14.11.2009, str. 1).
The provisions of the Regulation shall, for the purpose of this Agreement, be read with the following adaptations:
Za namene tega sporazuma se določbe Uredbe uporabljajo z naslednjima prilagoditvama:
The date referred to in Article 55 shall for the EFTA States be the date of entry into force of the EEA Joint Committee Decision incorporating Regulation (EC) No 1069/2009 into the EEA Agreement.
Kot datum iz člena 55 se za države Efte uporablja datum začetka veljavnosti Sklepa Skupnega odbora EGP o vključitvi Uredbe (ES) št. 1069/2009 v Sporazum EGP.
This act applies to Iceland for the areas referred to in paragraph 2 of the Introductory Part.’;
Ta akt se uporablja za Islandijo za področja iz odstavka 2 uvodnega dela.“;
the following is inserted after point 9b (Regulation (EC) No 1069/2009 of the European Parliament and of the Council) in Part 7.1:
za točko 9b (Uredba (ES) št. 1069/2009 Evropskega parlamenta in Sveta) dela 7.1 se vstavi naslednja točka:
32011 R 0142: Commission Regulation (EU) No 142/2011 of 25 February 2011 implementing Regulation (EC) No 1069/2009 of the European Parliament and of the Council laying down health rules as regards animal by-products and derived products not intended for human consumption and implementing Council Directive 97/78/EC as regards certain samples and items exempt from veterinary checks at the border under that Directive (OJ L 54, 26.2.2011, p. 1),
32011 R 0142: Uredba Komisije (EU) št. 142/2011 z dne 25. februarja 2011 o izvajanju Uredbe (ES) št. 1069/2009 Evropskega parlamenta in Sveta o določitvi zdravstvenih pravil za živalske stranske proizvode in pridobljene proizvode, ki niso namenjeni prehrani ljudi, ter o izvajanju Direktive Sveta 97/78/ES glede nekaterih vzorcev in predmetov, ki so izvzeti iz veterinarskih pregledov na meji v skladu z navedeno direktivo (UL L 54, 26.2.2011, str. 1),
as amended by:
kakor jo spreminjajo:
32011 R 0749: Commission Regulation (EU) No 749/2011 of 29 July 2011 (OJ L 198, 30.7.2011, p. 3),
32011 R 0749: Uredba Komisije (EU) št. 749/2011 z dne 29. julija 2011 (UL L 198, 30.7.2011, str. 3),