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3. Official Journal of European Union. Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 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. OJ L 136, 30.04.2004, p. 0001-0033. https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX: 32004R0726.[Accessed 10 December 2021].
4. European Medicines Agency (EMA). Good pharmacovigilance practices Annex IV - International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use topic E 2 D: Postapproval safety data management - Step 5. https://www.ema.europa.eu/en/human-regulatory/post-authorisation/pharmacovigilance/good-pharmacovigilance-practices.[Accessed 10 December 2021].
5. Official Journal of European Union. Directive 2010/84/EU of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal products for human use. OJ L 348, 31 December 2010, p. 0074-0099. https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L: 2010:348:0074:0099:EN:PDF.[Accessed 10 December 2021 (26 pp.)].