Guidelines on submission of Documentation for Registration of Veterinary Medicinal Products

These guidelines have been developed in pursuant to the Regulations Governing the Registration of Medicinal Products (N°CBD/TRG/010) to provide guidance to the applicants on the arrangement of information to be provided to the Authority in seeking marketing authorization for medicinal products for veterinary use. It also assists the Authority during the assessment and registration of VMPs.
After an introductory part defining the above mentioned scope of the Guidelines, a second part describes the different types of product application procedures (new applications, applications for renewal or variation of registration), the dossier assessment procedure as well as the timelines for the registration.
The text continues with 3 Modules dedicated, respectively, to administrative and prescribing information; to overviews and quality overall summaries concerning active substances and finished pharmaceutical Products, clinical and non clinical documentation; to non clinical study reports.