- About SAM
- Human medicines
- Marketing authorisation
- Drug information
- Clinical trials
- European Pharmacopoeia
- Pharmacovigilance
- Classification of medicinal products
- Statistics
- Manufacture, distribution, pharmacy
- Travelling with medicinal products
- The import and export of goods that require a special authorization
- Sending of medicinal products
- Advertising
- Marketing authorisation
- Veterinary medicines
- Department of Biologicals
- Blood handling
- Procurement and handling of cells, tissues and organs
- Biovigilance
- Application of cells, tissues and organs licence
- List of licensed procurers and handlers of cells, tissues and organs (tissue establishments)
- Legislation for procurement and handling cells, tissues and organs
- Special authorisation for import and export and notification of import and export of cells, tissues and organs
- Advanced therapies medicinal products
- The import and export of goods that require a special authorisation
- Legislation
- Supervision
- Laboratory
Contacts
24.10.2017
If you need consultation about the documentation requirements, you can communicate with the staff by e-mail:
| 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 |
| 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 |
| 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 |
| 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 |
State Agency of Medicines
