Contacts - Marketing authorisation of medicines
František Pavlík, MSc
Acting Director of the Marketing Authorisation Section
tel.: +420 272 185 784
frantisek.pavlik@sukl.gov.cz
Tomáš Radiměřský, M.D.
Head of Preclinical and Clinical Documentation Assessment Section
+420 272 185 284
Queries related to the assessment of clinical and preclinical part of dossier and borderline products should be sent to the following address: tomas.radimersky@sukl.gov.cz
Blanka Hirschlerová
Head of Pharmaceutical Documentation Assessment Section
+420 272 185 205
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: blanka.hirschlerova@sukl.gov.cz
Veronika Bártová
Pharmaceutical Documentation Assessment Section
+420 272 185 801
Enquiries concerning parallel import of medicinal products should be sent to the following address: veronika.bartova@sukl.gov.cz
Iva Strnadová
Pharmaceutical Documentation Assessment Section
+420 272 185 214
Enquiries concerning variations to marketing authorisation (in particular identification of Type I variations) should be sent to the following address: iva.strnadova@sukl.gov.cz
Jitka Vokrouhlická, M.D.
Head of Coordination and Regulation Section
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.gov.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.gov.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.gov.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.gov.cz
Enquiries concerning medicinal products, that are parallelly imported from the Czech Republic to other Member States should be sent to the following address: parallelimport@sukl.gov.cz
Queries regarding lists of medicinal products whose marketing authorisation has ceased to be valid or medicinal products jeopardised by sunset clause and the announcement that the 3 years period for placing of the generic medicinal product on the market begins to count ever since the market protection of the reference medicinal product expires (i.e. after 10 years from the first marketing authorisation of the reference medicinal product in any Member State or in the EU) should be sent to the following address: sunset@sukl.gov.cz. Do not use this address for submitting applications for exemption from the sunset clause, nor for the communication in the subsequent administrative proceedings regarding such application (you can use the electronic mailroom for those submissions: posta@sukl.gov.cz).
Queries related to names of medicinal products should be sent to the following address: nazvy@sukl.gov.cz .
Queries related to submission and assessment of the graphic proposals of medicinal product packaging (mock-ups) should be sent to the following address: mock-upy@sukl.gov.cz .