Submissions
Irrespective of the type of your regulatory procedure your applications for marketing authorisation must be accompanied correctly by the required documentation.
QbD will help you to get your documents right.
Types of applications in the EU
- 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
- 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
- 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
How we support you
- Choose the right procedure for your product
- Advise on a regulatory strategy
- Make contact with the national competent authorities
- Organise and lead agency meetings
- Follow your application through to registration
Current Format for MAAs in the EU
Module 1: Administrative, regional or national information
Module 2: High-level summaries and overviews
Module 3: Chemical, pharmaceutical and biological documentation
Module 4: Non-clinical study reports
Module 5: Clinical study reports
Why QbD Group?
Benefit from our team of highly qualified consultants.
Full support from pre- to the post-marketing phase.
QbD operates globally, at QbD Austria with a special focus on Europe (EU) and China.
Constant evaluation, transparency and clear objectives.
Contact us
Contact us for more information or to request a free, no-obligation proposal.
