The Choice of Legal Basis
In the European Union (EU), the legal basis of a MAA is laid down in Directive 2001/83/EC as amended. The choice of legal basis in turn will determine the dossier content, paediatric requirements and data exclusivity. Legal basis is therefore of critical importance from a regulatory perspective. Under Directive 2001/83/EC, the available legal basis are as follows:Article 8 | Full application |
Article 10 (1) | Generic |
Article 10 (3) | Hybrid (Generic + additional data) |
Article 10 (4) | Biosimilar |
Article 10a | Well established use |
Article 10b | Fixed combination |
Article 10c | Informed consent |