The appropriate legal basis will depend the type of application you are making. The legal bases are:
- full application – Regulation 50 (previously Article 8(3) of Directive 2001/83/EC)
- generic application – Regulation 51 (previously Article 10.1 of Directive 2001/83/EC)
- hybrid application – Regulation 52 (previously Article 10.3 of Directive 2001/83/EC)
- similar biological application – Regulation 53 (previously Article 10.4 of Directive 2001/83/EC)
- well-established use application – Regulation 54 (previously Article 10a of Directive 2001/83/EC)
- fixed-combination application – Regulation 55 (previously Article 10b of Directive 2001/83/EC)
- informed consent application – Regulation 56 (previously Article 10c of Directive 2001/83/EC)
- traditional herbal registrations – Regulation 125 & 126 (previously Article 16a of Directive 2001/83/EC)
- certificate of homeopathic medicinal products (called Simplified Registration scheme) – Regulation 102 (previously Article 14(1) of Directive 2001/83/EC)
- national homeopathic products (called the National Rules Scheme) – Regulation 50(6)(g) and Schedule 10 (previously Article 16(2) of Directive 2001/83/EC)
For details, please refer to below link
