Compulsory use of electronic application forms (eAF)
The currently used application forms in Word format published by the European Commission will no longer be available and only the latest version of the electronic application form will be used for all EU procedures, including CP, MRP/DCP and national procedures. The eAFs for centralized procedures were already successfully introduced on 1st of July 2015. Further guidance is available on the European Medicines Agency homepage. Please pay attention! National requirements regarding documentation submission must be followed in Latvia. If you are making a submission of the initial MA, renewal and variation via CESP platform, or using a compact disc (CD-R), a DVD disc, or a USB flash memory, the original documents must be submitted in parallel. The original documents shall be submitted in accordance with the normative acts in force in the Republic of Latvia, therefore, they have to be signed with a secure electronic signature or signed in paper format. For more details, please visit the SAM’s web page, section eSubmission/CESP.
|
Compulsory use of electronic application forms (eAF)
24.11.2015.
From 1 January 2016 the use of electronic application forms (eAF) for MRP/DCP and national procedures (initial MAs, renewals, variations) will be mandatory within electronic submissions. These eAFs are designed to reflect and capture the same content as the paper based application forms and offer a range of new possibilities, especially: 
