The checker used for the technical validation of market authorization files (MA) for medicines for human use has been adapted to reflect the new validation rules NeeS (non-eCTD electronic Submission) that will apply to from 01/09/2013. An "intermediate" (v.4) version of the checker has been developed. Applicants may wish to apply the new rules from 1st July 2013 and must then use this intermediate version checker.
Validation of the electronic MA files for medicines for human use: “Intermediate” version of the "checker".
From 1st July 2013 the famhp encourages the marketing authorization (MA) applicants for medicines to use the "Common European Submission Platform" (CEPA) for the electronic submission of MA dossiers of medicines for human or veterinary use as homeopathic or herbal medicines. This makes the submission quick, safe and easy.
Within the European Medicines Agency, the Coordination group for Mutual Recognition and Decentralized Procedures – veterinary medicines (CMDv), and the "Quality Review of Documents "(QRD) Working Group reviewed at the end of 2012 the templates for the Summary of Product Characteristics (SPC), package leaflet and labelling of veterinary medicines. The "QRD" templates Version 8 are now available.
The federal agency for medicines and health products (famhp) will soon launch a first satisfaction survey to assess the quality of its services and products. The results of this will be communicated at the end of 2013 and will be used to improve the delivery of FAMHP services.
In circular 596 the famhp reminds the relevant health professionals about the requirements for production and distribution activities for experimental medicines and clarifies its position on the concepts of delivery, packaging and recovery of these medicines.