Here you can find a summary of the EMA requirements and new services we
have to consider implementing. For CPs submitted after 1 january 2015, the
clinical information of the dossier has to be submitted:
- Between
day 181 and 220 of the calendar by EMA gateway. - 2 eCTD sequences
must be submitted1. Redaction
proposal: proposal of redacted confidential information
2. Final
redaction: after revision by EMA, agreement on final texts that are going to be made publicly available must be submitted, together with a cover letter.
- Clinical
information involved:1. Clinical summaries
2. Clinical overview
3. Clinical study reports of module 5 plus 16.1.1,
16.1.2 and 16.1.9
- Evaluation
process:1. Internal receipt
/ distribution stage – 5 calendar day
2. Validation
stage – 11 days
3. Validation
of justification table + clarification if needed Assessment of CCI stage – 31
days
4. Request for
additional info via eudralink if needed, followed by agency final conclusion
If you have
any questions or need more information please contact us through this email:
info@asphalion.com
More info
from EMA: http://www.ema.europa.eu/ema/index.jsp?curl=pages/special_topics/general/general_content_000526.jsp&mid=WC0b01ac0580789730
