1. Regulation (EU) No. 726/2004, Annex I, laying down community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency. https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:02004R0726-20190128&from=EN.
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. https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:02001L0083-20190726&from=EN.
3. https://www.ecdc.europa.eu/en.
4. Co-ordination Group for Mutual Recognition and Decentralised Procedures—human (CMDh). https://www.hma.eu/cmdh.html.
5. Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004. https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32007R1394.