1. Guideline on Good Pharmacovigilance Practices (GVP) - Module IX – Signal Management;EMA,2012
2. Guideline on Good Pharmacovigilance Practices (GVP) Module VI – Management and Reporting of Adverse Reactions to Medicinal Products (Rev 1);EMA,2014
3. Guideline on Good Pharmacovigilance Practices (GVP) Module VIII – Post-authorisation Safety Studies (Rev 2);EMA,2016
4. Guideline on Good Pharmacovigilance Practices: Module V – Risk Management Systems (Rev 2);EMA,2017
5. Guidance on Format of the Risk-management Plan in the European Union (Rev.2) – in Integrated Format, Referred to as “RMP Template”;EMA,2017