DEPARTMENT OF MARKETING AUTHORISATIONS |
Margit Plakso | General 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 Mäesalu | Validation 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 fees | documentation@ravimiamet.ee |
Birgit Uuvits Egne Marmor | Translations of product information (MRP/DCP) Administration of MRP/DCP | mrp@ravimiamet.ee |
Aiki Rümmel | Administrative variations of SPC and PIL; administrative questions related to issuing of marketing authorisations and approval of product information | aiki.rummel@ravimiamet.ee |
Kaiti Lehiste | Administration of safety variations | documentation@ravimiamet.ee |
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Bureau of Quality Assessment |
Administrative issues and quality assessment |
Aet Viispert | Administrative and chemical-pharmaceutical documentation | aet.viispert@ravimiamet.ee |
Laivi Saaremäel | Chemical-pharmaceutical documentation, quality of drug substance | laivi.saaremael@ravimiamet.ee |
Agne Vutt Kadri Kirsipuu Maie Palmeos | Variations | variations@ravimiamet.ee |
Hilkka Voll | Quality assessment and variations of veterinary products | hilkka.voll@ravimiamet.ee |
Marje Zernant Indrek Remmel Maria Kukk | Quality assessment | marje.zernant@ravimiamet.ee indrek.remmel@ravimiamet.ee maria.kukk@ravimiamet.ee |
Helerin Margus | Quality assessment of biological products | helerin.margus@ravimiamet.ee |
Kairi Laius | Quality assessment, parallel import applications | kairi.laius@ravimiamet.ee |
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Bureau of Clinical Assessment |
Preclinical and clinical assessment |
Liina Salur | MRP/DCP summaries of product characteristics, package leaflets | liina.salur@ravimiamet.ee |
Ene Kenkmann | Translations of summaries of product characteristics, package leaflets (MRP/DCP) | ene.kenkmann@ravimiamet.ee |
Tuuli Lee Pabello | Summaries 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 medicines | triin.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 |
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DEPARTMENT OF POST-AUTHORISATION SAFETY |
Bureau of Pharmacovigilance |
Maia Uusküla | Evaluation 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 Peets | ADR 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 |