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:

• eCTD management software solution eCTDmanager in EAEU and CIS region
• Training 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

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