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List of inspectors

State institute for drug control appoints and recalls the inspectors of good manufacturing practice (GMP), good preparation practice for blood and blood components (GPPBP), good distribution practice (GDP), good clinical practice (GCP), good laboratory practice (GLP) and good pharmacy practice (GPharmP) in accordance with (§129 art. 2, r) of Act No. 362/2011 Coll. on Drugs and Medical Devices and on Amendment and Supplementing of Certain Acts as amended later.

Inspectors are authorized to inspect the following subjects:

 

  • Drug manufacturers which is in accordance with (§129 art. 2, r) of Act No. 362/2011 Coll. on Drugs and Medical Devices and on Amendment and Supplementing of Certain Acts as amended later and Decree of Ministry of Health of Slovak republic No. 147/2018 on requirements on good manufacturing practice and good distribution practice and on Amendment and Supplementing of Certain Acts as amended later.
  • Transfusion facilities which is in accordance with (§129 art. 2, r) of Act No. 362/2011 Coll. on Drugs and Medical Devices and on Amendment and Supplementing of Certain Acts as amended later and Decree of Ministry of Health of Slovak republic No. 334/2015 on requirements on good preparation practice for blood and blood components and Supplementing of Certain Acts as amended later, decree of Decree of Ministry of Health of Slovak republic No. 09812/2008-OL and No. 25118/2008-OL on requirements related to material and technical equipment and personal of healthcare facilities and of Ministry of Health of Slovak republic No. S06601-OL-2015 on requirments tracking of blood, blood components and transfusion medicines and on the manner of reporting the adverse and severe adverse events, evaluation of the events and on standards and specifications related to quality system in transfusion facilities.
  • Pharmacies and Hospital Pharmacies, Facilities for issuance of medical devices, Wholesale distributors and other healthcare and non-healthcare facilities which is in accordance with (§129 art. 2, r) of Act No. 362/2011 Coll. on Drugs and Medical Devices and on Amendment and Supplementing of Certain Acts as amended later and 34, b Act No. 139/1998 Coll. on Narcotics and Psychotropic Substances and Preparations as amended later and on Amendment and Supplementing of Certain Acts as amended later, § 3 art. 1 Act. No. 331/2005 Coll. on State Administrative Authorities in Matters of Drug Precursors and on Amendment and Supplementing of Certain Acts as amended later, Decree of Ministry of Health of Slovak republic No. 129/2012 on requirements on good pharmaceutical practice, good manufacturing practice and good distribution practice and on Amendment and Supplementing of Certain Acts as amended later.

Name of inspector Licence number Appointment
Inspection Section
Mgr. Matúš Pupák, PhD.
Head of Section
129

GMP (non-sterile, sterile production)
GPharmP

Department of Drug Manufacturing Inspection and Quality Control of Marketed Drugs
Mgr. Roman Dorčík 134 GPPBP
GMP (sterile, non-sterile production)
Ing. Mária Franková  135 GMP (sterile, non sterile production)
RNDr. Monika Kramoríšová 101 GPPBP
GDP
Mgr. Miroslava Lukáčová 137 GPPBP
GMP (sterile, non-sterile production)
PharmDr. Zuzana Skalská 125 GDP
Department of Drug Distribution Inspection and Pharmacy Inspection
Ing. Renáta Baďurová, PhD.                 
Head of Department                                   
139 GPPBP
GDP
PharmDr. Zuzana Bartáková 136 GPharmP
PharmDr. Kristýna Galková, PhD 133 GDP
GPharmP
PharmDr. Diana Leitmanová 128 GPharmP
GDP
RNDr. Viera Varinská 107 GPharmP
GDP
Department of Drug Distribution Inspection and Pharmacy Inspection - site Topoľčany
Mgr. Dana Mokošová 109 GPharmP
GDP
RNDr. Eva Kopecká 110 GPharmP
GDP
Ing. Monika Tomanová 123 GPharmP
Department of Drug Distribution Inspection and Pharmacy Inspection - site Zvolen
Mgr. Zuzana Vaňová 111 GPharmP
GDP
Ing. Bronislava Majerová 112 GPharmP
GDP
Mgr. Lucia Ležovičová 124 GPharmP
GDP
Ing. Eva Rajčanová 138 GPharmP
Department of Drug Distribution Inspection and Pharmacy Inspection - site Žilina
PharmDr. Vilma Šulavíková 116 GPharmP
GDP
PharmDr. Eva Valicová 117 GPharmP
GDP
Ing. Ľubomíra Janíčková 118 GPharmP
GDP
Mgr. Tatiana Brázdilová 132 GPharmP
GDP
RNDr. Veronika Gardoňová, PhD. 131 GPharmP
GDP
Mgr. Terézia Borovičková   GPharmP
Department of Drug Distribution Inspection and Pharmacy Inspection - site Košice
Mgr. Beáta Hlavatá 119 GPharmP
GDP
Mgr. Marcela Mihóková 120 GPharmP
RNDr. Valéria Štefanisková 121 GPharmP
GDP
MVDr. Mgr. Július Gondoľ 122

GPharmP

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