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Contacts

24.10.2017
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If you need consultation about the documentation requirements, you can communicate with the staff by e-mail:

DEPARTMENT OF MARKETING AUTHORISATIONS
Margit PlaksoGeneral questions related to the MA applications
regulatory advice concerning DCP and MRP;
controversial issues and disagreements, proposals for change of procedures
margit.plakso@ravimiamet.ee
Triin MäesaluValidation of new applications
Questions on electronic submission, electronic application forms (eAF), CESP
triin.maesalu@ravimiamet.ee
Killu Koll
Kerli Ülper
Kristi Kõivisto
Technical details of submission of documentation, state feesdocumentation@ravimiamet.ee
Birgit Uuvits
Egne Marmor
Translations of product information (MRP/DCP)
Administration of MRP/DCP
mrp@ravimiamet.ee
Aiki RümmelAdministrative variations of SPC and PIL;
administrative questions related to issuing of marketing authorisations and approval of product information
aiki.rummel@ravimiamet.ee
Kaiti LehisteAdministration of safety variationsdocumentation@ravimiamet.ee
 
Bureau of Quality Assessment
Administrative issues and quality assessment
Aet ViispertAdministrative and chemical-pharmaceutical documentationaet.viispert@ravimiamet.ee
Laivi SaaremäelChemical-pharmaceutical documentation, quality of drug substancelaivi.saaremael@ravimiamet.ee
Agne Vutt
Kadri Kirsipuu
Maie Palmeos
Variationsvariations@ravimiamet.ee
Hilkka VollQuality assessment and variations of veterinary productshilkka.voll@ravimiamet.ee
Marje Zernant
Indrek Remmel
Maria Kukk
Quality assessmentmarje.zernant@ravimiamet.ee
indrek.remmel@ravimiamet.ee
maria.kukk@ravimiamet.ee
Helerin MargusQuality assessment of biological productshelerin.margus@ravimiamet.ee
Kairi LaiusQuality assessment, parallel import applicationskairi.laius@ravimiamet.ee
 
Bureau of Clinical Assessment
Preclinical and clinical assessment
Liina SalurMRP/DCP summaries of product characteristics, package leafletsliina.salur@ravimiamet.ee
Ene KenkmannTranslations of summaries of product characteristics, package leaflets (MRP/DCP)ene.kenkmann@ravimiamet.ee
Tuuli Lee PabelloSummaries of product characteristics, package leaflets (national procedures)tuulilee.pabello@ravimiamet.ee
Triin Teppor
Hedi Hellenurm-Sepp
Triinu Tereping
Clinical and pre-clinical assessment of veterinary medicinestriin.teppor@ravimiamet.ee
hedi.hellenurm-sepp@ravimiamet.ee
triinu.tereping@ravimiamet.ee
Liilia Juhkason
Kristi Daum
Package labelling
Common Baltic Package
liilia.juhkason@ravimiamet.ee
kristi.daum@ravimiamet.ee
labelling@ravimiamet.ee
 
DEPARTMENT OF POST-AUTHORISATION SAFETY
Bureau of Pharmacovigilance
Maia UuskülaEvaluation of detailed descriptions of pharmacovigilance systems, risk management plans and educational materials, direct healthcare professional communication letters, assessment of periodic safety update reports;
safety variations and renewals of nationally approved products (product information)
ADR-reports, safety communication
maia.uuskula@ravimiamet.ee
Vivika PeetsADR reports, ICSR's, electronic submission of reports to EV-database
MRP/DC safety variations, MRP/DC renewals (product information)
vivika.peets@ravimiamet.ee
Helve Vestman
Triin Leinemann
ADR reports
Assessment of periodic safety update reports
helve.vestman@ravimiamet.ee
triin.leinemann@ravimiamet.ee