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 mutual recognition procedure
- from 1 July 2018 for registrations in 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:
- 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@inpharmatis.com