Changes in electronic submission in Baltic States

2015-11-27 15:07
In Baltic States – Estonia/Latvia/Lithuania there will be changes in electronic submission requirements in line with the HMA eSubmission Roadmap. From January 1st, 2016 it will be mandatory to use electronic application form for all procedures (human and veterinary MRP, DCP and national procedure applications for marketing authorisation, renewal and variations). In addition to this, new applications for DCPs (veterinary) shall be submitted in VNeeS and  new applications for DCPs (human) shall be submitted in eCTD format.

In Algol Pharma we can prepare all types of electronic applications and submissions on behalf of our clients. We have eCTD software for this purpose and have experience in eCTD/NeeS applications for e.g. EU countries, Switzerland and Canada. Submissions will take place via CESP. We can tailor our service according to your special needs. For more information, please contact our local Regulatory Affairs Specialists in Baltic States:

Estonia: Signe Raudleht
Latvia: Tatjana Kalagina
Lithuania: Ruta Urniekiene