Procedure for submission of electronic documents
Latvia National Agency please be informed that the future of electronic documentation for medicine registration, renewal and change, State Agency of Medicines will also be submitted by e - mail, signed with secure electronic signatures and CD and DVD discs.
Electronic documents for medicine registration, renewal and changes submitted through the following electronic media:
Option No. 1
E-mail: eCTD@zva.gov.lv (Amount of up to 10 Mb), signed with secure electronic signature * (created by a secure electronic signature and shall be certified by a qualified certificate).
Option No. 2
Compact discs (CD-R) and DVD discs, which were to accompany the hard copy signed by:
- cover letter (one copy). If documents are submitted to RSA in person, and requires approval of the submission, the two copies.
- Application for registration or re-registration of changes;
- RSA copy of the invoice and proof of payment, stating the invoice number of the RSA.
Documents to be submitted in electronic form
Documentation eCTD Language An electronic copy number
Registration Modules 1-5 √ EN/LV 1
Answers √ EN/LV 1
Renewal Module 1,2,5 √
EN/LV 1
Answers √
Changes if the above documentation submitted eCTD format
Change in the supporting
documentation √ EN/LV 1
Answers √ EN/LV 1
Non-eCTD (Nees) is submitted, upon request, documentation must be submitted on paper.
Still accept any documentation on paper.
* Electronic document circulation of State Agency of Medicines is provided, subject to Cabinet of Ministers No. 473 "Electronic document preparation, presentation, storage and circulation of state and local government institutions and procedures for the electronic circulation of documents between the state and local government authorities or between these institutions and natural and legal persons " and "Electronic Documents Act".
For More Information Please click: Latvia National Agency eSubmission Updates
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