Contacts

Jana Mladá, M.D.

Head of Marketing Authorisation Branch
tel.: +420 272 185 729
jana.mlada@sukl_cz

 

 

Radka Montoniová, M.D.

Head of Preclinical and Clinical Documentation Assessment Dpt.

+420 272 185 775
Queries related to the assessment of clinical and preclinical part of dossier and borderline products should be sent to the following address: r (marina.fertek@sukl_cz)adka.montoniova@sukl_cz

 

 

Helena Daněčková
Head of Pharmaceutical Documentation Assessment Dpt.
+420 272 185 805

Enquiries concerning specific issues of pharmaceutical assessment of individual applications (in particular specification of received comments on the documentation) should be sent to the following address: helena.daneckova@sukl_cz

 

Dana Donátová
Pharmaceutical Documentation Assessment Dpt.
+420 272 185 903 
Enquiries concerning parallel import of medicinal products should be sent to the following address: dana.donatova@sukl_cz

 

 

Eva Horová
Pharmaceutical Documentation Assessment Dpt.
+420 272 185 903       
Enquiries concerning variations to marketing authorisation (in particular identification of Type I variations) should be sent to the following address: eva.horova@sukl_cz

 

 

Jitka Vokrouhlická, M.D.

Head of Marketing Authorisations Coordination Dpt.
Queries related to mutual recognition procedures (MRP)  and decentralised procedures (DCP) and issues covered by the Coordination Group CMDh should be sent to the following address: jitka.vokrouhlicka@sukl_cz

 

 

Irena Lukáčová

Head of Administrative Support Dpt.

+420 272 185 226

Queries related to general procedural issues should be sent to the following address: irena.lukacova@sukl_cz

 

 

  • Queries related to submission of documentation for marketing authorisation applications (MAA) and applications for renewal of marketing authorisation of medicinal products, and queries related to fee payments for these applications should be sent to the following address: validace@sukl_cz  

 

  • Queries related to submission of documentation for MRP variations to marketing authorisations of medicinal products, queries related to fee payments for these applications and queries related to procedural issues of MRP variations to marketing authorisations should be sent to the following address: mrp@sukl_cz

 

  • Queries related to submission of documentation for national variations to marketing authorisations of medicinal products, queries related to fee payments for these applications and queries related to procedural issues of national variations to marketing authorisations should be sent to the following address: nar@sukl_cz

 

Lucie Mrázková

Secretariat of Head of Branch
+420 272 185 804

lucie.mrazkova@sukl_cz