1. Council Regulation (EEC) No. 2309/93, July 22, 1993, laying down community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products (OJ No L 214 of 24. 8. 1993).
2. Centralized Procedure: Directive (EC) No. 726/2004.
3. Mutual Recognition Procedure: Directive 2001/83/EC.
4. Decentralized Procedure: Directive 2004/27/EC.
5. International Conference on Harmonization. https://doi.org/www.ich.org.