Additional risk minimisation measures (aRMM) - Submission of educational materials [5] [6](updated 05.08.2020)
Direct Healthcare Porfessional Communication (DHPC) - Submission of text and communication plan for approval by SAM [7](updated 05.08.2020)
Publication of Educational Materials and DHPC letters in the Register of Medicinal Products [8]
Changes in reporting adverse drug reactions to Eudravigilance [9] (updated 08.12.2017)
Submission of safety variations following signal and PSUR assessment outcome [10]
Links:
[1] https://www.ravimiamet.ee/en/pharmacovigilance
[2] https://www.riigiteataja.ee/en/eli/526112014001/consolide
[3] http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2012:159:0005:0025:EN:PDF
[4] https://www.ravimiamet.ee/en/reporting-requirements-individual-case-safety-reports-icsrs-applicable-marketing-authorisation-0
[5] https://www.ravimiamet.ee/sites/default/files/rmm_materials_eng2020-08.docx
[6] https://www.ravimiamet.ee/sites/default/files/rmm_materjalide_esitamine_eng2020-08.pdf
[7] https://www.ravimiamet.ee/sites/default/files/dhpc_eng2020-08.docx
[8] https://www.ravimiamet.ee/sites/default/files/publication_of_educational_materials_and_dhpc_letters_in_the_register_of_medicinal_products_0.pdf
[9] https://www.ravimiamet.ee/en/changes-reporting-adverse-drug-reactions-eudravigilance
[10] https://www.ravimiamet.ee/en/submission-safety-variations-following-signal-and-psur-assessment-outcome
[11] http://www.ravimiamet.ee/en/post-authorisation-non-interventional-safety-studies