eCTD format only! From January 1, 2021 May 02, 2017

eCTD format only! From January 1, 2021

Latvian State Agency of Medicines informs that Latvia also currently is undergoing a gradual transition to all submission of regulatory documents in electronic form only - eCTD (electronic Common Technical Document) format.

January 1, 2021, is set up as deadline when all the circulation of documents must be done electronically - only eCTD format

Companies are encouraged to follow the recommendations of the EU Action Plan and provide only eCTD format for documentation:

  • from 1 January 2018 for the mutual recognition procedure
  • from 1 July 2018  for registrations in the national registration procedure
  • from 1 January 2019 in decentralized, mutual recognition and national procedure

In order to help companies adjust to new requirements, we offer assistance in the form of: