02 April 2014
Human Medicines Evaluation Division
Formatted Table Template
To be inserted in each referral procedural submission cover letter.
Formatted Table TemplateEMA/207283/2014 / Page 1/3
1* / Applicant/MAH name
2* / INN / active substance
3* / Procedure number and procedure name / Procedure name EMEA/H/A-XX/XXXX
or
Procedure nameEMEA/H/A-XX/XXXX/C/xxxx/xx
4* / This submission is for (if you have both NAPs and CAPs, please tick both boxes): / NAPs / CAPs
If you are submitting separate submissions for NAPs and CAPs, please tick this box to confirm that the data is identical in all submissions
5 / Product(s) covered by this submission and Marketing Authorisation type / Product Name(s)(Marketing Authorisation type)
(list products and marketing authorisations here or attach your list of products and marketing authorisations to the submission)
6* / EMA Procedure Manager
7 / Type of submission (please tick one): / A submission to a List of Questions / A response to:
1st List of Outstanding Issues
2nd List of Outstanding Issues
3rd List of Outstanding Issues
Other (specify: (brief description)
8 / eCTD sequence (if applicable) / Related sequence
9 / Contact Persons’ details
(include email address) / A) Regarding the content of the submission:
Name:
Email address:
Phone number:
B) Regarding eCTD technical questions (if applicable):
Name:
Email address:
Phone number:
C) Regarding financial queries (if applicable):
Name:
Email address:
Phone number:
10 / Any other info (if applicable): / (brief description)
11 / I confirm I have submitted the full enclosed information also to the appropriate committee members
* please see explanatory notes
1.MAH: Marketing Authorisation Holder
2.CAP: Centrally Authorised Product
NAP: Nationally Authorised Product
3.This is a procedure number provided by the Agency, which is assigned at the start of the procedure and is specified in the Agency cover letter
4.Procedure name as specified in the Agency cover letter, for example “INN - containing medicinal products”
5.As identified in the Agency cover letter at the start of the procedure
Formatted Table TemplateEMA/207283/2014 / Page 1/3
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Formatted Table TemplateEMA/207283/2014 / Page 1/3