1. Regulation (EC) No 726/2004 of the European Parliament and of the Council of March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency.
2. Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use.
3. Guideline on good pharmacovigilance practices (GVP): module V—risk management systems (Rev 2). 2017.
4. Guideline on good pharmacovigilance practices (GVP): module XVI—risk minimisation measures: selection of tools and effectiveness indicators (Rev 2). 2017.
5. Francisca RDC, Zomerdijk IM, Sturkenboom MCJM, Straus SMJM. Measuring the impact of the 2012 European pharmacovigilance legislation on additional risk minimization measures. Expert Opin Drug Saf. 2018;17(10):975–82.