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
“Ongoing revision: Regulation proposals of the European Commission
In 2012, the Commission adopted a package of measures on innovation in health.
The package consisted of a Communication and two regulation proposals to revise existing legislation on general medical devices and in vitro diagnostic medical devices.
The revisions affected all kinds of medical devices including in vitro diagnostic medical devices, from home-use items like sticking plasters, pregnancy tests and contact lenses, to X-ray machines, pacemakers, breast implants, hip replacements and HIV blood tests.”
Read European Commission’s full article HERE.
This means changes in classification for Medical devices, requirements for registration and distribution. We would kindly invite you to register for our open class on 9- 10 November 2017, where all those topics are going to be looked through and discussed.