List of inspectors
Obsah
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 |
||
|
Ing. Renáta Baďurová, PhD. (Head of section) |
139 |
GPharmP GDP GPPBP |
|
Department of Manufacturing and Transfusiology |
||
|
RNDr. Miroslava Zahorcová, PhD. |
153 |
GMP |
|
MVDr. Vladimíra Vrchovská |
|
GMP |
|
Ing. Barbora Jánska |
|
GPPBP |
|
Department of Distribution and Pharmacy |
||
|
PharmDr. Juraj Valuška |
147 |
GPharmP |
|
PharmDr. Diana Leitmanová |
128 |
GPharmP |
|
MVDr. Ingrid Ivaničková |
144 |
GDP |
|
Mgr. Jana Spišáková |
214 |
GDP |
| Mgr. Miroslava Lauková | 229 |
GDP |
| Department of Distribution and Pharmacy - Topoľčany | ||
|
Mgr. Dana Mokošová |
109 |
GPharmP GDP |
|
Ing. Monika Tomanová |
123 |
GPharmP GDP |
|
Department of Distribution and Pharmacy - Zvolen |
||
|
Mgr. Eva Mária Pramuková |
113 |
GPharmP |
|
Ing. Bronislava Majerová |
112 |
GPharmP GDP |
|
PharmDr. Ľubica Bartová |
151 |
GPharmP |
|
Department of Distribution and Pharmacy - Žilina |
||
|
PharmDr. Eva Valicová |
117 |
GPharmP GDP |
|
Mgr. Tatiana Brázdilová |
132 |
GPharmP GDP |
|
RNDr. Veronika Gardoňová, PhD. |
131 |
GPharmP GDP |
|
RNDr. Terézia Kočišková |
141 |
GPharmP GDP |
|
Department of Distribution and Pharmacy - Košice |
||
|
Mgr. Beáta Hlavatá |
119 |
GPharmP GDP |
|
Mgr. Marcela Mihoková |
120 |
GPharmP GDP |
|
PharmDr. Zita Sitková |
150 |
GPharmP GDP |
|
PharmDr. Janka Partilová |
155 |
GPharmP |