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Pharmacovigilance [1]

03.04.2019

Minister of Social Affairs Regulation No. 26 “Procedure for providing safety information about a medicinal product and the calculation of fee payable for safety and quality surveillance of a medicinal product" [2]

Commission Implementation Regulation (EU) No 520/2012 on the performance of pharmacovigilance activities provided for in Regulation (EC) No 726/2004 of the European Parliament and of the Council and Directive 2001/83/EC of the European Parliament and of the Council [3]

Reporting requirements of Individual Case Safety Reports (ICSRs) applicable to Marketing Authorisation Holders [4]

Additional risk minimisation measures (aRMM) - Submission of educational materials [5] (updated 27.02.2019)

Direct Healthcare Porfessional Communication (DHPC) - Submission of text and communication plan for approval by SAM [6] (updated 21.03.2019)

Publication of Educational Materials and DHPC letters in the Register of Medicinal Products [7]

Changes in reporting adverse drug reactions to Eudravigilance [8] (updated 08.12.2017)

Submission of safety variations following signal and PSUR assessment outcome [9]

Post-authorisation non-interventional safety studies [10]

Source URL: https://www.ravimiamet.ee/en/pharmacovigilance

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_materjalide_esitamine_eng2019-02.pdf
[6] https://www.ravimiamet.ee/sites/default/files/dhpc_esitamine_eng2019-03.pdf
[7] https://www.ravimiamet.ee/sites/default/files/publication_of_educational_materials_and_dhpc_letters_in_the_register_of_medicinal_products_0.pdf
[8] https://www.ravimiamet.ee/en/changes-reporting-adverse-drug-reactions-eudravigilance
[9] https://www.ravimiamet.ee/en/submission-safety-variations-following-signal-and-psur-assessment-outcome
[10] http://www.ravimiamet.ee/en/post-authorisation-non-interventional-safety-studies