Annual overview of test facilities inspected Country: Hungary Name of monitoring authority: National Institute of Pharmacy and Nutrition Date of submission: 30.03.2018 TEST FACILITY DATE OF INSPECTION STATUS NATURE OF INSPECTION AREA OF EXPERTISE REMARKS [Name (bold type) and full address of test facility] [mm.yyyy] [ic/ nic/ pen/rf p] [full/re- i/ fac/sa] [1-8, 9: specify] (for example: refer to nic notification) ADEXGO Industrial, Commercial and Consulting Ltd. Safety Pharmacology Unit H-4032 Debrecen, Nagyerdei Krt. 98. 11. 2005 04. 2007 ic ic rfp full full 9:Safety pharmacology testing 9: Safety pharmacology testing previously the name of the office appeared on the GLP certificate RFP: 24. 03. 2010 AdWare Research Ltd. H-8230 Balatonfüred Völgy u. 41. 06. 2008 12. 2010 02. 2013 03. 2016 ic ic ic ic full full full full 9: Metabolism and toxico-/pharmac okinetics 9: Statistical evaluation of pharmacology and toxicology study new address since 2009 1/37
Transcript
Annual overview of test facilities inspected
Country: Hungary
Name of monitoring authority: National Institute of Pharmacy and Nutrition
Date of submission: 30.03.2018
TEST FACILITY DATE OF INSPECTION STATUS NATURE OF
INSPECTIONAREA OF
EXPERTISE REMARKS
[Name (bold type) and full address of test facility]
[mm.yyyy] [ic/nic/ pen/rfp]
[full/re-i/ fac/sa]
[1-8, 9: specify]
(for example: refer to nic notification)
ADEXGO Industrial, Commercial and Consulting Ltd. Safety Pharmacology Unit H-4032 Debrecen, Nagyerdei Krt. 98.
11. 2005
04. 2007
ic
ic
rfp
full
full
9:Safety pharmacology testing
9: Safety pharmacology testing
previously the name of the office appeared
on the GLP certificate
RFP: 24. 03. 2010
AdWare Research Ltd. H-8230 Balatonfüred Völgy u. 41.
06. 2008
12. 2010
02. 2013
03. 2016
ic
ic
ic
ic
full
full
full
full
9: Metabolism and toxico-/pharmacokinet
ics
9: Statistical evaluation of
pharmacology and toxicology study
new address since 2009
Agricultural Office, Directorate of Plant Protection, Soil Conservation and Agri-environment, Pesticide Residue Analytical Laboratory, Kaposvár
H-7401 Kaposvár, Guba Sándor u.20.
10. 1993
04. 1996
05. 1998
11. 2000
02. 2003
03. 2005
10. 2007
09. 2009
ic
ic
ic
ic
ic
ic
ic
ic
rfp
full
full
full
full
full
full
full
full
6, 9: Biological efficacy and
selectivity studies
6, 9: Biological efficacy and
selectivity studies
6, 9: Biological efficacy and
selectivity studies
6
6
6:anal. phase
6:anal. phase
6:anal. phase, 8
new name and organization
since 01. 01. 2011
RFP: 31.07.2011
1/23
TEST FACILITY DATE OF INSPECTION STATUS NATURE OF
INSPECTIONAREA OF
EXPERTISE REMARKS
Agricultural Office of County Komárom- Esztergom Plant Protection and Soil Conservation Directorate, Plant Protection LaboratoryH-2890 Tata, Új u. 17. Hungary
08. 2003 &10. 2003
09. 2005
04. 2008
ic
ic
ic
rfp
full
full
full
6
9: Biological efficacy and selectivity studies
RFP: 06.08.2010
Agricultural Office of Vas County Plant Protection and Soil Conservation Directorate, Laboratory for Pest Diagnosis H-9762 Tanakajd, Ambrózy sétány 2.
03-04. 200407-08. 2006
07. 2008
ic
ic
icrfp
full
fullfull
6: field phase
6: field phase6: field phase, 9:
Biological efficacy and selectivity studies
RFP: 22. 03. 2010
Agrofil-SZMI EC. LTDH-9234 Kisbodak, Felszabadulás u. 23.
09. 2005
10. 2007
ic
ic
rfp
full
full
9: Biological efficacy and selectivity studies
RFP: 07.12.2009
Anadiag Hungary Ltd.
H-2921 Komárom, Petőfi Sándor út 67.
09. 2014
11. 2017.
ic
ic
full
full
6:field phase
6:field phase-
Analkrom Ltd. H-1116 Budapest, Fehérvári út 133-144.*
03. 200710. 201105. 2014
ic, penicic
fullfullfull
89: Bioanalytical study
*Change of street number:
11.02.2016
ATRC Aurigon Toxicological Research Center Limited Liability Company (ATRC Aurigon Ltd.)H-2120 Dunakeszi, Pálya u. 2. H-1045 Budapest, Berlini út 47-49.
09. 2009 ic full2, 3, 8, 9: Safety
pharmacology testing, Metabolism and
toxico-/pharmacokinetics, Reproduction
toxicology, Tolerance studies, In vitro
studies, Immuntoxicology studies, ADME
(Absorption, Distribution, Metabolism,
Elimination), contract archiving
2, 3, 8, 9: Safety
new name since December 2014
new name, organization and many changes
between December 2014 and February
2015.
2/23
TEST FACILITY DATE OF INSPECTION STATUS NATURE OF
INSPECTIONAREA OF
EXPERTISE REMARKS
11-12.2011
03. 2014
04. 201504. 2017
ic
ic
icic
full
full
facfull
pharmacology testing, Metabolism and
toxico-/pharmacokinetics, Reproduction
toxicology, Tolerance studies, In vitro
studies, Immuntoxicology studies, ADME
(Absorption, Distribution, Metabolism,
Elimination), contract archiving
2, 3, 8, 9: Safety pharmacology testing,
Metabolism and toxico-/pharmacokinet
ics, Reproduction toxicology, Tolerance
studies, In vitro studies,
Immuntoxicology studies, ADME
(Absorption, Distribution, Metabolism,
Elimination), contract archiving
2, 3, 8, 9: Safety pharmacology testing,
Metabolism and toxico-/pharmacokinet
ics, Reproduction toxicology, Tolerance
studies, In vitro studies,
Immuntoxicology studies, ADME
(Absorption, Distribution, Metabolism,
Elimination), contract archiving
3/23
TEST FACILITY DATE OF INSPECTION STATUS NATURE OF
INSPECTIONAREA OF
EXPERTISE REMARKS
Aurigon Drug Research Ltd. Large Animal Toxicology LaboratoryH-2120 Dunakeszi, Rétipálya u.2. (D1, D2, D3)
02. 200703. 2008
icicrfp
fullfull
22
RFP: 08. 03. 2010
“Béla Johan” National Institute of Public HealthDepartment of Morphology
H-1097 Budapest, Gyáli út 2-6.
11. 1995
10. 1996
ic
ic
rfp
full
full3
3, 9: Pathology studiesRFP: 07. 11. 1998
Biotek Agriculture Hungary Ltd. H-2141 Csömör, Széchenyi u. 132/A.
07.201008.201208. 201409. 2017
icicicic
fullfullfullfull
6666
-
Budapest University of Technology and Economics (BUTE) Laboratory of PharmacokineticsH-1111 Budapest, Gellért tér 4.
03. 2002
05. 2004
09. 2006
11. 2008
04. 2011.
ic
ic
ic
ic
pen*
ic
pen**
full
full
full
full
full
8
GLP inspection was postponed due to lack of GLP activity: -*05.
10. 2010-**09. 07. 2013
Central Service for Plant Protection and Soil Conservation, Analytical LaboratoryH-1118 Budapest, Budaörsi út 141-145.
10.199305. 199605. 1998
09. 200001. 2003
icicic
icicrfp
fullfullfull
fullfull
6, 9: Biological efficacy and
selectivity studies
66
RFP: 16. 02. 2005
4/23
TEST FACILITY DATE OF INSPECTION STATUS NATURE OF
INSPECTIONAREA OF
EXPERTISE REMARKS
CEVA-PHYLAXIA Veterinary Biologicals Co. Ltd.H-1107 Budapest, Szállás u. 5.
Chemical works of Gedeon Richter Ltd. Dorog Plant H-2510 Dorog, Esztergomi u. 27.
06. 1998 icrfp
full 1
RFP: 30. 06. 2000 expired
Chemical Works of Gedeon Richter Plc. Research Directorate, Pharmacological and Drug Safety Research Division, Developmental Drug Metabolism & Pharmacokinetics H-1103 Budapest, Gyömrői út 19-21.
EGIS Pharmaceuticals Plc., Department of PharmacokineticsH-1106 Budapest, Keresztúri út 30-38., Bld. 25/A;Archives: H-1116 Budapest, Bökényföldi út 118-120., Bld. 834.
11. 1998
06. 1999
06. 2001
09. 2003
11. 2005
11. 2007
06. 2015
nic
ic
ic
ic
ic
ic
pen*
ic
full
re-I, full
full
full
full
full
full
2, 9: Safety pharmacology testing,
Metabolism and toxico-/pharmacokinet
ics
2, 9: Safety pharmacology testing
2, 9: Safety pharmacology testing,
Metabolism and toxico-/pharmacokinet
ics
8, 9: Safety pharmacology testing
9: Bioanalytical testing and validation
to human pharmacokinetic
evaluation
*postponed due to lack of GLP activity
since 17.12.2009
name change since 05. 12. 2014.
Eurofins Agroscience Services Kft. H-8000 Székesfehérvár, Új Váralja sor 16.
09. 2009
09. 2011
09. 2013
09. 2016
ic
ic
ic
ic
full
full
full
full
6: field phase5&6: field phase
5&6: field phase
5&6: field phase
new address since 2011
7/23
TEST FACILITY DATE OF INSPECTION STATUS NATURE OF
INSPECTIONAREA OF
EXPERTISE REMARKS
Fodor József National Center of Public Health, National Institute of Occupational Health, Department of Experimental Occupational HygieneH-1096 Budapest, Nagyvárad tér 2.
04. 199906.1999*
10. 200103. 2004
ic
ic icrfp
re-i*, full
fullfull
2, 3, 9. Pathology studies
22
RFP: 11. 09. 2006
Food Chain Safety Centre Non-profit Ltd.,Pesticide Residue Analytical Laboratory, HódmezővásárhelyH-6801 Hódmezővásárhely, Rárósi út 110.
- - - -
new name since 21. 03. 2017.
Food Chain Safety Centre Non-profit Ltd.,Pesticide Residue Analytical Laboratory, Miskolc
H-3526 Miskolc Blaskovics László u. 24.
- - - -
new name since 21. 03. 2017.
Food Chain Safety Centre Non-profit Ltd.,Pesticide Residue Analytical Laboratory, Szolnok
H-5000 Szolnok, Vízpart krt.32.
- - - -
new name since 21. 03. 2017.
Fumoprep Ltd.
H-1044 Budapest, Ipari park utca 10.
02. 2014
02. 2017
ic
ic
full
full
1, 8
1, 8-
8/23
TEST FACILITY DATE OF INSPECTION STATUS NATURE OF
INSPECTIONAREA OF
EXPERTISE REMARKS
Gedeon Richter Plc., Environmental Protection, Dorog, Development GroupH-2510 Dorog, Esztergomi út 27.Archives: H-1103 Budapest, Gyömrői út 19-21.
05. 2015. ic full 4, 8*8*:analytical
chemistry
Government Office of Baranya County
District Office of Pécs, Department for
Agricultural MattersPlant Protection and
Soil Conservation Unit(H-7634 Pécs, Kodó dűlő 1.)
- - - -new name since 03.
04. 2017
Government Office for Baranya County Food Chain Safety, Plant Protection and Soil Conservation Department, Plant Protection and Soil Conservation UnitH-7634 Pécs, Kodó dűlő 1.
04. 2004 04. 2006 &
05.200608. 200608.2008
08-09.201004. 2013 06.2016
-
ic
icicicicicic
rfp*
full
re-ifullfullfullfullfull
-
6: 9: field phase, Biological efficacy
and selectivity studies
new name and organization
since 01. 01. 2011
new name since01.04.2015.
*new name since 03. 04. 2017
Government Office of Baranya County District Office of Pécs, Department for Agricultural
MattersPlant Protection and
Soil Conservation Unit
(H-7634 Pécs, Kodó dűlő 1.)
Government Office for Fejér County Directorate of Plant Protection and Soil Conservation, Pest Diagnostic Department
H-2481 Velence, Ország u.23.
05. 2003
04. 2005
05 2007
04. 2009
08-09. 2011
09. 2013
ic
ic
ic
ic
ic
ic
pen*
full
full
full
full
full
full
6
6: field phase
6: field phase, 9: Biological efficacy
and selectivity studies
new name and organization
since 01. 01. 2011
*postponed due to lack of GLP activity since: 01. 01. 2016.
9/23
TEST FACILITY DATE OF INSPECTION STATUS NATURE OF
INSPECTIONAREA OF
EXPERTISE REMARKS
Government Office for Zala County Plant Protection and Soil Conservation Directorate, Department for Pest Diagnosis
H-8900 Zalaegerszeg, Kinizsi u. 81.
12.2003 &03.2004
04. 2006
04. 2007
04. 200910.2009
ic
ic
ic
penic
rfp
full
full
full
full
6: field phase
9: Biological efficacy and selectivity studies
new name and organization
since 01. 01. 2011
RFP: 16.02.2012
Government Office of B-A-Z County, County District Office of Miskolc, Food Chain Safety, Plant Protection and Soil Conservation Division, Plant Protection and Soil Conservation Department
H-3501 Miskolc Blaskovics László u. 24.
03. 2004
06. 200607. 200601. 2007
09.2009
07.2012
05. 2016.
ic
ic
ic
ic
ic
full
full
full
full
full
6: field phase
6: field phase
6: field phase
6: field phase
6: field phase
new name and organization
since 01. 01. 2011
new name since 01.04.2015.
new name since 01.01.2017
Government Office of Csongrad County Food-chain Safety and Agricultural DepartmentPlant Protection and Soil Conservation DivisionH-6800 Hódmezővásárhely, Rárósi út 110.
04. 2006
08. 200704. 200905. 201109. 2013
ic
icicicic
pen*
full
fullfullfullfull
9: Biological efficacy and selectivity studies
6: field phase, 9: Biological efficacy
and selectivity studies
new name and organization
since 01. 01. 2011
new name since11.02.2016
*postponed due to lack of GLP activity since 11. 02. 2016.
10/23
TEST FACILITY DATE OF INSPECTION STATUS NATURE OF
INSPECTIONAREA OF
EXPERTISE REMARKS
Government Office of Jász-Nagykun-Szolnok County, Authority Department of Food Chain Safety and Agricultural Administration, Department of Plant Protection and Soil Conservation
H-5001 Szolnok, Vízpart krt.32.
05. 2004
06. 2006
05. 2008
05. 2010
09. 2013
09. 2016.
ic
ic
ic
ic
ic
ic
rfp*
full
full
full
full
full
full
6: field phase
6: field phase, 9: Biological efficacy
and selectivity studies
new name and organization
since 01. 01. 2011
new name since 01.04.2015
*rfp: new name since 01.01.2017.
Government Office of Jász-Nagykun-Szolnok County Szolnok District Office, Agricultural Administration Main Department, Plant Protection and Soil Conservation Department
Government Office of Jász-Nagykun-Szolnok County Szolnok District Office, Agricultural Administration Main Department, Plant Protection and Soil Conservation DepartmentH-5000 Szolnok, Vízpart krt.32.
- - - -
new name since 01.01.2017.
GR Goodwill Research Ltd. Bioanalytical Laboratory H-1134 Budapest, Diószegi út 64.
01. 200602. 2006
ic
rfpfull 8 RFP: 20. 11. 2008
Hisztolabor Pannonia Ltd.H-9024 Győr, Pogány I. u. 38.
08. 199102. 1992
nicicrfp
fullre-I,full
9: Preparation of microscopic tissue
sections RFP: 08. 03. 1995
11/23
TEST FACILITY DATE OF INSPECTION STATUS NATURE OF
INSPECTIONAREA OF
EXPERTISE REMARKS
Hydrobiological Laboratory of the Plant Protection and Soil Conservation Service of Pest County H-2100 Gödöllő, Kotlán Sándor u.3.
05. 199709. 199909. 2001
10. 2004
02. 2007
icicic
pen*ic
penicrfp
fullfull full
full
re-I, full
444
4
4
* pen: 12.12.2003-25.01.2005
pen: Oct/2006 –Feb/2007
RFP: 08.10.2007
Institute of Diagnostics Imaging and Radiation Oncology, University of Kaposvár
H-7400 Kaposvár, Guba Sándor u. 40.
11. 2016.
10. 2017.
pen*
ic
full
re-i
Testing of toxicological
properties of operative procedures and
equipment
Testing of toxicological
properties of operative procedures and
equipment
*new test facility
Institute of Toxicology PSS of Zala CountyH-8360 Keszthely, Újmajori út
09.199111. 199203. 199406. 1996
nicicicicrfp
fullfullfullfull
2*
2,3,61,2,6, 9: Metabolism
and toxico-/pharmacokinet
ics
*not defined study type
RFP: 31.05.1998
12/23
TEST FACILITY DATE OF INSPECTION STATUS NATURE OF
INSPECTIONAREA OF
EXPERTISE REMARKS
IVAX Drug Research Institute Ltd. H-1045 Budapest, Berlini u. 47-49.
11. 199109. 199308. 1995
01.1997
09. 199703. 200005. 2002
10. 200203. 2005
01. 2006
07. 2008
01. 2008
icicic
ic
icicic
icic
ic
ic
ic
rfp
fullfullfull
full
fullfullfull
re-ifull
full
full
full
**
2, 3, 8, 9: Metabolism and toxico-/pharmacokinetics
9: Safety pharmacology testing,
General pharmacology
2, 3, 8, 9: Metabolism and
toxico-/pharmacokinetics
2, 3 Safety pharmacology testing,
Metabolism and toxico-/pharmacokinet
ics-
2, 9: Safety pharmacology testing,
Metabolism and toxico-/pharmacokinet
ics2, 9: Metabolism and
toxico-/pharmacokinetics
2, 9: Safety pharmacology testing,
Metabolism and toxico-/pharmacokinet
ics2,8, 9: Safety
pharmacology testing, Metabolism and
toxico-/pharmacokinetics
*not defined study type
RFP: 04.07.2008
Medinspect Kft. Toxikológiai Analitikai LaboratóriumH-2151 Fót, Csipányok u. 2.
01.2008 nicrfp
full 8
RFP: 13.01.2009
13/23
TEST FACILITY DATE OF INSPECTION STATUS NATURE OF
INSPECTIONAREA OF
EXPERTISE REMARKS
National Food Chain Safety Office Directorate of Plant Protection, Soil Conservation and Agri-environment, Laboratory of Hydrobiology
H-1118 Budapest, Budaörsi út 141-145.
-
05. 2017
-
ic
-
full
-
4
new name and address since 04. 08.
2016
National Food Chain Safety Office Directorate of Plant Protection, Soil Conservation and Agri-environment, Laboratory of Hydrobiology, Gödöllő
H-2100 Gödöllő, Kotlán Sándor u. 3.
03. 2008
04. 2010
06. 2012
06. & 10. 2014
ic
ic
ic
ic
rfp*
full
full
full
full
4
4
4
4
new name
since 01. 01. 2011 and 15.03.2012
*new name and address since 04. 08.
2016
National Food Chain Safety Office Directorate of Plant Protection, Soil Conservation and Agri-environment, Laboratory of Hydrobiology
H-1118 Budapest, Budaörsi út 141-145
National Food Chain Safety Office Directorate of Plant Protection, Soil Conservation and Agri-environment Pesticide Residue Analytical Laboratory, Hódmezővásárhely
H-6801 Hódmezővásárhely, Rárósi út 110.
07. 1998
01. 2001
03.2003
06.2005
08.2007
09.2008
09. 2010
09. 2013
11. 2016
ic
ic
ic
ic
ic
ic
ic
ic
ic
rfp*
full
full
full
full
full
full
full
full
full
6, 9: Biological efficacy and
selectivity studies
6
6
6:anal. phase
6:anal. phase
6:anal. phase
6,8
6, 8
6, 8
new name
since 15. 03. 2012
*rfp: new name since 01. 01. 2017
14/23
TEST FACILITY DATE OF INSPECTION STATUS NATURE OF
INSPECTIONAREA OF
EXPERTISE REMARKS
National Food Chain Safety Office Directorate of Plant Protection, Soil Conservation and Agri-environment Pesticide Residue Analytical Laboratory, Miskolc
H-3526 Miskolc Blaskovics László u. 24.
10.1993
05. 1996
06. 1998
12. 2000
04. 2003
05. 2005
09. 2007
10. 2009
09. 2011
11. 2013
ic
ic
ic
ic
ic
ic
ic
ic
ic
ic
rfp*
full
full
full
full
full
full
full
full
full
full
6, 9: Biological efficacy and
selectivity studies
6
6
6:anal. phase
6:anal. phase
6:analytical phase, 8
6:analytical phase, 8
6:analytical phase, 8
new name
since 15. 03. 2012.
rfp: new name since 01. 01. 2017
National Food Chain Safety Office, Food Chain Safety Centre Non-profit Ltd.,
Pesticide Residue Analytical
Laboratory, Miskolc
National Food Chain Safety Office Directorate of Plant Protection, Soil Conservation and Agri-environment Pesticide Residue Analytical Laboratory, SzolnokH-5000 Szolnok, Vízpart krt.32.
06. 1998
11. 2000
02. 2003
05. 2005
09. 2007
10. 2009
10. 2011
10. 2013
09. 2016
ic
ic
ic
ic
ic
ic
ic
ic
ic
rfp*
full
full
full
full
full
full
full
full
full
6, 9: Biological efficacy and
selectivity studies66
6:anal. phase
6:anal. phase
6:anal. phase, 8
6:anal. phase, 8, 9: contract archiving
new name
since 15. 03. 2012
*rfp: new name since 01. 01. 2017
National Food Chain Safety Office Food Chain Safety Centre Non-profit Ltd.,Pesticide Residue Analytical Laboratory, Szolnok
National Food Chain Safety Office Directorate of Plant Protection, Soil Conservation and Agri-environment, Pesticide Analytical Laboratory, Velence
H-2481 Velence, Ország u.23.
06. 1998
11. 2000
02. 2003
04. 2005
09. 2007
12. 2008
10. 2010
10. 2012
10. 2015
ic
ic
ic
ic
ic
ic
ic
ic
ic
full
full
full
full
full
full
full
full
full
6, 9: Biological efficacy and
selectivity studies
6
6
6:anal. phase
6:anal. phase
6:anal. phase
6, 8
6, 8
6,8
new name
since 15. 03. 2012
15/23
TEST FACILITY DATE OF INSPECTION STATUS NATURE OF
INSPECTIONAREA OF
EXPERTISE REMARKS
National Food Chain Safety Office, Food Chain Safety Centre Non-profit Ltd.,Pesticide Residue Analytical Laboratory, HódmezővásárhelyH-6801 Hódmezővásárhely, Rárósi út 110.
-
-
-
rfp*
-
-
-
-
new name since 01. 01. 2017
*new name since 21. 03. 2017 Food Chain Safety Centre Non-
National Food Chain Safety Office, Food Chain Safety Centre Non-profit Ltd.,Pesticide Residue Analytical Laboratory, MiskolcH-3526 Miskolc Blaskovics László u. 24.
-
-
pen*
rfp**
-
-
-
-
new name since 01. 01. 2017
*postponed due to lack of GLP activity since 01. 01. 2017
** new name since 21. 03. 2017. Food Chain Safety Centre Non-profit Ltd.,Pesticide Residue Analytical Laboratory, Miskolc
H-3526 Miskolc Blaskovics László u.
24.
National Food Chain Safety Office Food Chain Safety Centre Non-profit Ltd.,Pesticide Residue Analytical Laboratory, Szolnok
H-5000 Szolnok, Vízpart krt.32.
-
-
-
rfp*
-
-
- new name since 01. 01. 2017
*new name since 21. 03. 2017 Food Chain Safety Centre Non-
National Public Health Center National Directorate of Chemical Safety H-1097 Budapest, Nagyvárad tér 2.
11. 201011. 201211. 2015
icicic
fullfullfull
2, 3
2, 3, 9: In vitro studies 2, 3, 9: In vitro studies
new name since31.03.2015
National Public Health Center National Directorate of Environmental HealthH-1097 Budapest, Albert Flórián út 2-6.
09. 2010
02. 2013
ic
ic
rfp
full
full
2, 4, 5, 9: In vitro studies
2, 4, 5, 9: In vitro studies
new address in 2014
new name since 31. 03. 2015
RFP: 23. 09. 2016.
Pannon University of Agricultural Sciences Keszthely, Department of Hygiene, Institute of Plant Protection, Georgikon FacultyH-8360 Keszthely, Deák Ferenc u. 36.
09.199107.199203.199402.199704. 1999
nicicicicicrfp
fullfullfullfullfull
-*222
*not defined study type
new name since 1999RFP: 08. 01.2002
Pharmaceutical Control and Development Laboratory Ltd. Toxicological Department, Microbiological Assay GroupH-1149 Budapest, Mexikói út 9.
10. 199101. 199301. 1995
12. 1996
11. 1998
03. 2001
04. 2002
04. 2004
02. 200602. 2008
ic
icicic
ic
ic
ic
ic
icic
pen*
full
fullfullfull
full
fullfull
full
fullfull
--2
2, 9: Safety pharmacology testing
2, 9: Safety pharmacology testing
22, 9: Safety
pharmacology testing2, 9: Safety
pharmacology testing2,32, 3
*postponed due to lack of GLP activity since 28. 09. 2009
Plant Protection and Soil Conservation Service of Bács-Kiskun County, Analytical LaboratoryH-6000 Kecskemét, Halasi út 36.
02. 200006. 200206. 2003
icpenicrfp
full-
full
6-6
RFP: 17. 02. 2005
17/23
TEST FACILITY DATE OF INSPECTION STATUS NATURE OF
INSPECTIONAREA OF
EXPERTISE REMARKS
Plant Protection and Soil Conservation Service of Bács-Kiskun County, Laboratory for Pest DiagnosisH-6000 Kecskemét, Halasi út 36.
06. 200405. 2006
icic
rfp
fullfull
6: field phase6: field phase 9:
Biological efficacy and selectivity studies RFP: 12. 12. 2007
Plant Protection and Soil Conservation Service of Somogy County, Laboratory for Pest DiagnosisH-7401 Kaposvár, Guba Sándor u.20.
04. 200406. 2006
icic
rfp
fullfull
6: field phase6: field phase, 9:
Biological efficacy and selectivity studies RFP: 09. 06. 2008
Plant Protection and Soil Conservation Service of Szabolcs- Szatmár- Bereg County, Laboratory for Pest DiagnosisH-4401 Nyíregyháza, Kótaji u. 33.
04. 200404. 2006
icic
rfp
fullfull
6:anal. phase9: Biological efficacy and selectivity studies
RFP: 31. 10. 2008
Plant Protection and Soil Conservation Service of Szabolcs- Szatmár- Bereg County, Pesticide Residue Analytical Laboratory H-4401 Nyíregyháza, Kótaji u. 33.
9: In vivo safety testing of vaccines 6, 9: In vivo safety testing of vaccines,
Metabolism and toxico-/pharmacokinet
ics6, 9: In vivo safety testing of vaccines,
Metabolism and toxico-/pharmacokinet
ics: animal phase6, 9: In vivo safety testing of vaccines,
Metabolism and toxico-/pharmacokinet
ics: animal phase6, 9: In vivo safety testing of vaccines,
Metabolism and toxico-/pharmacokinet
ics: animal phase
*additional new test site in 2014
Radiopharmacy Laboratories Ltd. H-2040 Budaörs Gyár utca 2.
04.2010 icpen*
full 9: Metabolism and toxico-/pharmacokinet
ics*postponed due to
lack of GLP activity since 20. 12. 2012
19/23
TEST FACILITY DATE OF INSPECTION STATUS NATURE OF
INSPECTIONAREA OF
EXPERTISE REMARKS
Rytmion Ltd. Cellular Electrophysiology LaboratoryH-6720 Szeged, Dóm tér 12.
07. 200410&12. 2006
10. 2008
icicic
pen*
fullfullfull
9: Safety pharmacology testing
Former name until 2008
*postponed due to lack of GLP activity since 07. 12. 2009
Selex AnalitikcenterH-8200 Veszprém, Házgyári u. 21.
06.1995 icrfp
full 1,6,8RFP: 02. 06. 1997
Semmelweis University, Faculty of Medicine, Cardiology Center, Research LaboratoryH-1122 Budapest, Városmajor u. 68.
10. 199701. 200110. 200411. 200606. 200912. 2012
icicicicicic
pen*
fullfullfullfullfullfull
9: Testing of toxicological
properties of operative procedures and
equipment
Former name until 2009
*postponed due to lack of GLP activity since 09. 11. 2016.
Semmelweis University, Faculty of Medicine, Department of Forensic and Insurance Medicine, Toxicology LaboratoryH-1091 Budapest, Üllői út 93.
10. 2005
06-07.201007. 2013
icpen*
icic
pen**
full
fullfull
8
88
* postponed due to lack of GLP activity:
04.01.2008-29.06.2010
**postponed due to lack of GLP activity since 15. 12. 2015
SGS Hungária Ltd. GLP Test Facility, Nyíregyháza
H-4400 Nyíregyháza, Ipari Park, Északi 1 u. 5.
08. 2013
07. 2016.
ic
ic
full
full
6, 8
6, 8-
Staphyt Hungary Ltd.
H-5000 Szolnok, Piroskai út 2.
12. 2017. ic full 6: field phase -
20/23
TEST FACILITY DATE OF INSPECTION STATUS NATURE OF
INSPECTIONAREA OF
EXPERTISE REMARKS
SynTech Research Hungary Ltd. H-9700 Szombathely, Török Ignác u. 30.
H-1045 Budapest, Berlini utca 45-47.*
04. 2009 &07. 2009
06. 2011
05. 2013
09. 2016.
10. 2017.
ic
ic
ic
ic
ic
full
full
full
full
full
5 field phase, 6 field phase5 field phase, 6 field phase5 field phase, 6 field phase5 field phase, 6 field phase, 4
6 field phase, 4, 5, 8
New address since 2013
*new test site (2017)
Szent István University Faculty of Agricultural and Environmental Sciences Institute of Aquaculture and Environmental Safety Department of AquacultureH-2103 Gödöllő, Práter Károly u. 1.
01.2015 ic full 4
-
Szent István University, Faculty of Veterinary Science, Department of Pharmacology and Toxicology H-1078 Budapest, István u. 2.
11. 199812. 199805. 200101. 2004
03. &07. 2006
nicicicic
icrfp
fullre-ifullfull
full
2222
2
New name since 2001
RFP: 09. 04. 2008
TEVA Pharmaceutical Works Private Limited Company, Innovative R&D Bioanalytical Laboratory and Biological Testing DepartmentH-4042 Debrecen, Pallagi út 13.
01. 1998
11. 1999
10. 2000
10. 2003
10. 2005
11. 2007
11. 2009
11. 2011
11. 2013
10. 2016.
ic
nic
ic
ic
ic
ic
ic
ic
ic
ic
full
full
full
full
full
full
full
full
full
full
888
2,82,8
8, 9: Metabolism and toxico-/pharmacokinet
ics
8, 9: Immuntoxicology studies, In vitro
studies
New name since 2012
21/23
TEST FACILITY DATE OF INSPECTION STATUS NATURE OF
INSPECTIONAREA OF
EXPERTISE REMARKS
TOXI-COOP Toxicological Research Center Zrt.H-1103 Budapest, Cserkesz u. 90.H-1045 Budapest, Berlini u. 47-49.*H-8230 Balatonfüred, Arácsi u. 97.H-8230 Balatonfüred, Arácsi u. 99.*H-8230 Balatonfüred, Galamb u. 12/A*H-8230 Balatonfüred, Vasút u. 3.*H-8237 Tihany, Klebelsberg Kuno u. 3.
02. 2003
07. 2005
06. 2007
06. 2009
07. 2011
11. 2013
01. 2016.
ic
ic
ic
ic
ic
ic
ic
full
full
full
full
full
full
full
22,32,3
1,2,3,4,5,8, 9: Reproduction
toxicology, Tolerance studies
1,2,3,4,5,8, 9: Safety pharmacology testing,
Reproduction toxicology, Tolerance
studies, In vitro studies,
inhalation toxicology
*new test site (2016)
University of Debrecen, Institute of Nuclear Medicine and Health Science Center, Toxicokinetics and metabolism LaboratoryH-4032 Debrecen, Nagyerdei krt. 98.
11. 2007 icpen*
full 9: Metabolism and toxico-/pharmacokinet
ics
*postponed due to lack of GLP activity since 31. 03. 2010
University of Szeged, Faculty of Medicine, Department of Public Health, Safety Pharmacology and Toxicology LaboratoryH-6720 Szeged, Dóm tér 10.
07. 200412. 2006
02. 200702. 200805. 2010
icic
icicic
pen*rfp**
fullfull
re-i, fullfullfull
9: Safety pharmacology testing
2, 9: Safety pharmacology testing
New name since 2010
*postponed due to lack of GLP activity since 17. 08. 2012
**rfp: removal on voluntary basis, effective from
01/01/2018University of Szeged, Faculty of Pharmacy, Department of Pharmacodynamics and Biopharmacy H-6720 Szeged, Eötvös u. 6.
12. 199811. 2004
10.2006 &
12. 200603. 200801. 2011
nicic
icicic
pen*
full
full
fullfullfull
-
9: Safety pharmacology testing
2, 9: Safety pharmacology testing
*postponed due to lack of GLP activity
since 24.06.2014
22/23
TEST FACILITY DATE OF INSPECTION STATUS NATURE OF
INSPECTIONAREA OF
EXPERTISE REMARKS
University of Szeged, Faculty of Science and Informatics, Department of Physiology, Anatomy and Neuroscience
H-6726 Szeged, Közép fasor 52.
10. 2013ic
pen*full 2
-
*postponed due to lack of GLP activity since 01. 01. 2018.
University of Veterinary Medicine, Department of Food Hygiene,Food Toxicological Laboratorybase facility: H-1078 Budapest, István u. 2.Animal house: H-2225 Üllő, Dóra major
07. 200109. 200111.200310. 200506. 200702.2008
03. 2010 & 04. 201012. 201212.2015.
icicicic
penic
icicic
prefullfullfullfullre-i
fullfullfull
62,62,62,62,62,6
2,62,62,6
New name since 01. 07. 2016
Wessling Hungary Enviromental, Food safety, Health and Quality Service Ltd. Pharmacological Laboratory H-1047 Budapest, Fóti út 56.
