LT: SMCA releases national eSubmission requirements

The State Medicines Control Agency (SMCA) of Lithuania has published their national eSubmission Guidance on the website of the agency. According to the Guidance, electronic submissions for human medicinal products will be accepted for initial and lifecycle submissions starting with January 2011. Electronic submission formats accepted will be eCTD (preferred format) and NeeS. Reference is made to the European Guidance documents and specifications for both submission standards.

In case applicants should not be in the position to provide a valid eCTD or NeeS, paper dossiers according to the CTD standard will still be accepted. 

The following documents must be provided as paper originals in addition to valid eCTD or NeeS applications:

• Cover letter with original signature
• Application form with original signature
• Proof of payment. In cases when payment for multiple applications was made, detailed explanations must be attached.
• Power of attorney (from the marketing authorization holder), originally signed
• Technical eCTD / NeeS validation report including validation date, time and validation tool used.

The SMCA furthermore informs applicants that the agency has started archiving eCTD sequences since middle of 2010. Hence, it might occur during the assessment of future sequences that previous sequences need to be re-submitted on request of the agency by the applicant. Further information can be obtained from the SMCA website (see link at the bottom of this article).

[Source: SMCA website]

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