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


Margit Plakso

General questions related to the MA applications
regulatory advice concerning DCP and MRP;
controversial issues and disagreements, proposals for change of procedures

Triin Mäesalu

Validation of new applications
Questions on electronic submission, electronic application forms (eAF), CESP

Kerli Ülper

Technical details of submission of documentation, state fees

Egne Marmor

Translations of product information (MRP/DCP)
Administration of MRP/DCP

Aiki Rümmel

Administrative variations of SPC and PIL;
administrative questions related to issuing of marketing authorisations and approval of product information

Kaiti Lehiste

Administration of safety variations

Bureau of Quality Assessment, Administrative issues and quality assessment

Aet Viispert

Administrative and chemical-pharmaceutical documentation

Laivi Saaremäel

Chemical-pharmaceutical documentation, quality of drug substance

Agne Vutt
Maie Palmeos

X Quality assessment and variations of veterinary products

Marje Zernant
Indrek Remmel
Maria Kukk

Quality assessment
X Quality assessment of biological products

Kairi Laius

Quality assessment, parallel import applications

Bureau of Clinical Assessment, Preclinical and clinical assessment

Liina Salur

MRP/DCP summaries of product characteristics, package leaflets

Ene Kenkmann

Translations of summaries of product characteristics, package leaflets (MRP/DCP)

Tuuli Lee Pabello

Summaries of product characteristics, package leaflets (national procedures)

Triin Teppor
Triinu Tereping

Clinical and pre-clinical assessment of veterinary medicines

Liilia Juhkason
Kristi Daum

Package labelling
Common Baltic Package


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

Vivika Peets

ADR reports, ICSR's, electronic submission of reports to EV-database
MRP/DC safety variations, MRP/DC renewals (product information)

Helve Vestman
Krõõt Aab

ADR reports
Assessment of periodic safety update reports

Last updated: 18.11.2021