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.

Why QbD Group?

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

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

How we support you

Advise on dossier content and structure for EU submissions
Perform gap analysis
Compile technical dossiers
Prepare application packages ready for submission to EU authorities, EMEA (European Medicines Agency) or the National Competent Authorities (CA)
Prepare electronic submissions

Why opt for the QbD Group?

EXCEPTIONAL RA SERVICES THAT MEET YOUR NEEDS

10+ years of experience

Benefit from our team of highly qualified consultants.

Full life cycle support

Full support from pre- to the post-marketing phase.

Global presence

QbD operates globally, at QbD Austria with a special focus on Europe (EU) and China.

Customer satisfaction

Constant evaluation, transparency and clear objectives.

Contact us

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