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, 2020 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 mutual recognition procedure
  • from 1 July 2018  for registrations in national registration procedure
  • from 1 January 2019 in decentralized, mutual recognition and national procedure

FULL INFORMATION

 

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

  • Trainings on Regulatory Affairs and eSubmissions topics
  • Medicines registration services
  • Our partner’s EXTEDO GmbH e-solutions for the electronic registration of medicinal products: e-CTD manager installation and training

More information: info@rephinebalticum.com