Submissions

Irrespective of the type of procedure chosen an application for marketing authorisation in the EU must be accompanied by the documents listed in Annex I of Directive 2003/83/EC (as amended).

Three types of applications are possible:

1. Complete/full and independent applications (original products)

For complete applications the MA must be accompanied by the particulars and documents set out in article 8 of directive 2001/83/EC including

• Physio-chemical, biological or microbiological tests
• Pharmacological and toxocological tests and
• Clinical trials

2. Abridged applications (generics)

• These are either with informed consent form the originator or essentially similar to a product authorised for 6 to 10 years (10 years according to the new regulation) – Generic application
• The applicant is NOT required to provide the results of pharmacological and toxicological tests or the results of the clinical trials if the application is abridged. Abridged applications refer to information that is contained in the dossier of another "original" authorisation
• This information is NOT completely available in the public domain
• Generic and Informed consent applications are thus linked to the original product

3. Application for a fixed combination product

• Strictly speaking, any fixed combination is a new and unique medicinal product requiring a separate Marketing Authorisation and SmPC
• It can be considered as a complete/full independent application
• Generic /Informed consent applications referring to fixed combination dossiers are acceptable

Current Format for MAAs in the EU:

• Module 1: administrative, regional or national information
• Module 2: contains high-level summaries and overviews
• Module 3: provides chemical, pharmaceutical and biological documentation
• Module 4: consists of the non-clinical study reports
• Module 5: consists of the clinical study reports