With the announcement made by TMMDA, “MODULE VI ANNEX I - Basic Requirements for Risk Management Plans of COVID-19 Vaccines” has entered into force as of 23 March 2022, as an annex to the Good Pharmacovigilance Practices (GPP) Guide.
The guide has been prepared for the planning of post-marketing follow-up of COVID-19 vaccines
and includes detailed explanations about the preparation of risk management plans.
You can reach the relevant announcement via the link below
https://www.titck.gov.tr/duyuru/covid-19-asilarinin-risk-yonetim-planlari-icin-temel-gereklilikler-kilavuzu-24032022103632