National Organization for Medicines (Greek agency): Instructions for Submitting Dossiers in electronic format via Google Translate

The National Medicines Agency (EMEA) in an effort to facilitate, for practical reasons, the procedures for approval, amendment and renewal of registration of Pharmaceutical and Biological products for human and veterinary use and to reduce the volume of paper you receive, manage, archive and destroy, seek the cooperation of the companies concerned and is prior to any submission to take into account the following guidelines:

Pharmaceutical and Biological Products for Human Use

The requirements for filing on paper limited to submission of Modules 1, 2, and 3 in accordance with current standards.In addition, we recommend the above be submitted in electronic format (e-CTD, or non-e-CTD) to three (3) copies.
Note that the documentation concerning the non-clinical (Module 4) and clinical part (Module 5, for example, clinical efficacy studies, safety, bioequivalence etc.) recommended be submitted only in electronic form (e-CTD or non e-CTD) and not on paper, unless specifically requested.

Notice to Applicants http://ec.europa.eu/enterprise/pharmaceuticals/eudralex For filing for approval, amendment and renewal based on the e-CTD is recommended to follow the instructions on the website of the Notice to Applicants http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/homev2.htm # 2b and on the website EMEA ( www.emea.europa.eu ), which have already been posted texts with questions and answers. About the specifications of the e-CTD (for all regions of the world) can be found at the ICH ( http://estri.ich.org/ectd/ ), while information on the specifications of the EU Module 1 can be found at: HTTP : / / ec.europa.eu/enterprise/pharmaceuticals/eudralex/homev2.htm
For electronic filing of applications are not compatible with standard e-CTD, ie non e-CTD Electronic Submissions, advised those concerned to follow the instructions posted on the EMEA website http://esubmission.emea.europa.eu and specific document: http://esubmission.emea.europa.eu/doc/eGuidance_Document% 201.4.pdf .

For more information please click here: National Organization for Medicines (Greek agency): Instructions for Submitting Dossiers in electronic format via Google Translate