1. 7 Types of Marketing Authorisation Applications

1.1. Full (Stand-alone) application

For full applications the results of pharmaceutical tests (physico-chemical, biological or microbiological), pre-clinical tests (pharmacological and toxicological), and clinical trials need to be submitted. Detailed data requirements are set-out in Annex I to Directive 2001/83/EC, as amended by Commission Directive 2003/63/EC.
(all CTD Modules as described above in detail).

Legal basis: Article 8(3) of Directive 2001/83 (EC)