Académique Documents
Professionnel Documents
Culture Documents
<Address>
<Address>
<Post code> <Town>
<Country>
<Date>
<Reference>
<National Agency>
<Address>
<Address>
<Post code> <Town>
<Country>
Subject: Submission of Variation Application Dossier(s) for <Product Name(s) in the MS where the
application(s) for variation is submitted> <Procedure Number(s)>
Dear Sirs,
We are pleased to submit our Variation Application Dossier(s) for <Type IAIN / Type IA / Type IB
unforeseen / Type IB foreseen / Type II > Procedure(s).
The application concerns <Single variation / Grouping of variations / Grouping of variations including a line
extension / Worksharing>.
The details are as follows:
Name of the medicinal product(s) (in the RMS): ...........................................................................................
Pharmaceutical form(s) and strength(s): ....................................
INN/active substance(s):....
Page 1/3
You will find enclosed with the submission dossier the documentation hereafter:
If the submission dossier is provided electronically,
eCTD format
Sequence number: < Four digit number >
NeeS format
Submission number (if used): < Four digit number >
- <Number> media units per application and <number> copies are provided.
Sequence Tracking Table is attached (mandatory for eCTD, recommended for NeeS)
We confirm that all future submissions for this specific product will be submitted in this same format
(NeeS format may be upgraded to eCTD later).
The <eCTD><NeeS> has passed the applicants internal technical validation (all P/F criteria) and all BP
criteria have been fulfilled up to our best knowledge using <name and version number of the validation
software>
- The submission is checked with an up-to-date and state-of-the-art virus checker
The dossier is submitted in paper format (Note: Full paper dossiers can only be submitted to NCAs still accepting paper
submissions and should only be used exceptionally when a valid electronic format dossier really could not be provided.)
When duplicates are submitted, a reference to the first application should be given.
Page 2/3
Yours sincerely,
<Signature>
<Name>
<Title>
Page 3/3