Liaison with Competent Authorities


The content of the Common Technical Documents as well as country-specific elements to be submitted therewith are provided in Directive 2001/83/EC as amended, and Volume 2B of the Notice To Applicants.

The format currently required for centralized procedures as well as for MR/DC procedures is eCTD. NeeS formatted Common Technical Documents are yet continued to be accepted by Competent Authorities in national procedures. Submission of the documentation on paper is only sparsely accepted, and is expected to disappear from daily practice.

When liaising with competent Authorities on behalf of its clients during either new Marketing Authorization applications or variations and/or renewals thereof, AccepTher can prepare, convert from NTA and/or submit Regulatory documentation in NeeS or eCTD format.

Investigational Medicinal Products

AccepTher assumes to review or prepare and/or submit Clinical Trial Applications in Europe.