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    Contacts

    24.04.2017
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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
    Sirli Paistu
    Killu Koll
    Kerli Ülper
    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