e-Submission

Electronic submission of files

The document called 'Guidance for Industry on Providing Regulatory Information in Electronic format : Non-eCTD electronic Submissions (NeeS)' was published on the EMEA website on 22/02/2008: http://esubmission.ema.europa.eu/new.htm.

The national guideline has been adapted.

Moreover In the context of the EU's Better Regulation policy, the "eSubmission guidelines" concerning the electronic submission of dossiers for variation of marketing authorisation for medicines for human use has been updated.

The «eSubmission guideline v.2.11 (PDF, 278.54 Kb)» applies to any electronic dossier introduced from 1st September 2011.

Automatic mails
Document "Automatic mails (DOC, 320.5 Kb)".

Full compliance (Zero tolerance)
Since 01/02/07 each electronic file submitted to FAMHP (Federal Agency for Medicines and Heath Products) for medicines for human use undergoes two technical checks:

-         Compliance towards  the CTD tree structure
-         Compliance towards folder and file naming

Both technical checks are based on the “notice to applicants” requirements for module 1 (DOC, 1.02 MB), and the ICH requirements for modules 2 à 5 (PDF, 1.03 MB).

The score that a file must achieve for all technical checks in order to be accepted by  FAMHP is determined by a «road map (DOC, 20 Kb)» (up-dated May 2008). This road map should always be consulted before submitting a file so that you have the latest information about the minimum scores.

By means of checker v.2.9.c  (ZIP, 16.54 MB)(+ Checker change requests (DOC, 264 Kb) + Checker change requests-Part II (DOC, 228 Kb) + Checker change requests-Part III  (DOC, 231.5 Kb) + Checker change requests part IV (PDF, 282.03 Kb) + updated CTD structure (ZIP, 2.38 MB)) the two technical checks can be made before submitting the file in case of a national procedure or a DCP/MRP for which Belgium is CMS. (Checker v.2.9.c is a bug fix which allows variable parts in m3  32s42 and 32s43 and solves a performance problem in version 2.9.b. Please uninstall all versions of the checker before installing checker 2.9.c).

When a DCP/MRP NeeS dossier for which Belgium is RMS is to be submitted, this always has to be contain a valid Extedo or Lorenz NeeS report (for example: Nees Report (ZIP, 265.79 Kb)).

In case of an eCTD dossier, a valid eCTD report as to be supplied (always in context of the other sequences) with the actual versions of the Lorenz or Extedo tools.

On 27th March 207 FAMHP gave an  Information session (PPT, 6.34 MB) about full compliance. During this session, the CTD structure (ZIP, 1.25 MB) et le " Best verification report (DOC, 2.17 MB)" ont été expliqués. This "Best verification report" (DOC, 2.17 MB) shows errors made in the CTD structure and in the names of the files and documents.

Since 17/09/2007 the full compliance principle (zero tolerance) has been applied. That means that files submitted to AFMPS, where one or two scores from the road map are not reached, are rejected.

The Best Verification Report is sent as an appendix to the automatic mail created by the system with the comment “Refused”.

In this case the file must be resubmitted to AFMPS. If the minimum scores are achieved the Best Verification Report is sent with the comment “Accepted”.

Language
Information about the language to be used when submitting a file is shown in chapter 7 of the Notice to Applicants.
In practice:
-         National procedure : French or Dutch, according to the location of the (future) license holder
-         European procedures : English
The SPC (Summary of Product Characteristics), instructions and packaging should be submitted in French or Dutch, according to  the location of the (future) license holder 
 
Samples
Supplying samples is not necessary when submitting the file but the applicant must be able to supply them if requested by FAMHP (Federal Agency for Medicines and Health Products).

Fees
The fees for marketing authorisation for medicines are mentioned in article 25 of the law dated 3rd July 1969 relating to registration of medicines.
• Summary of fees
(PDF, 14.15 Kb)Le form for fees  (DOC, 27.5 Kb)must be completed.

Fees should be paid into the following account number: 679-0021942-20
At the following bank:
Poste financière
Chaussée d'Anvers, 59
B-1100 Bruxelles

 
Swift code : PCHQBEBB
IBAN code: BE28 6790 0219 4220

Being the bank of:
FAMHP- Federal Agency for Medicines and Health Products
Accounts - Eurostation
40, Place Victor Horta, bte 40
B - 1060 Brussels

Accounts (checking your account and your payments) :

Liesbet Verhaert
Thiérry Preaux
Tél. : +32 2 524 80 49
Fax : +32 2 524 80 47

Forms
• The form to request marketing authorisation: word format  (DOC, 432 Kb) or pdf format (PDF, 272.68 Kb)
• Form to request a change in the marketing authorisation: word format (DOC, 1.02 MB)
• Fee form (DOC, 27.5 Kb) (in French) 
• Form to request a five-year renewal (RQ): Word format  (DOC, 184 Kb)ou pdf format (PDF, 44.57 Kb)
• Form for marketing authorisation (in French)  (DOC, 277.5 Kb) + explanatory note - Appendix AMM (DOC, 226.5 Kb)  (in French)
• AMM simplifiée (DOC, 230.5 Kb)