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.emea.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 "e-submission v.2.9" applies to any electronic dossier introduced from 1 June 2010.
Since 01/02/07 each electronic file submitted to FAMHP (Federal Agency for Medicines and Heath Products) for herbal medicinal products use undergoes two technical checks:
- Compliance towards the CTD tree structure
- Compliance towards folder and file naming
The score that a file must achieve for all technical checks in order to be accepted by FAMHP is determined by a “road map” (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.2.6.a (+ Checker change requests ) the two technical checks can be made before submitting the file, which allows you to adapt it so that it is acceptable to FAMHP as far as the two technical checks are concerned.
On 27th March 207 FAMHP gave an Information Session about full compliance. During this session the CTD structure and the “Best Verification Report” were explained. This Best Verification Report shows errors made in the CTD structure and in the names of the files and documents.
Since 17/09/2007 the full compliance principle 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”.
Information about the language to be used when submitting a file is shown in chapter 7 of the Notice to Applicants.
- 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
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).
The fees for registration or marketing authorisation for medicines are mentioned in article 25 of the law dated 3rd July 1969 relating to registration of medicines.
Summary of fees (2014)
The form for fees (in french) must be completed.
Fees should be paid into the following account number
IBAN code: BE28 6790 0219 4220
Swift code : PCHQBEBB
At the following bank:
Chaussée d'Anvers, 59
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) :
Tél. : +32 2 524 80 49
Fax : +32 2 524 80 47
The form to request registration or marketing authorisation :
« Fee » form (in french)
Form to request a five-year renewal (RQ) :
Form for registration or marketing authorisation (AMM) (in french) + explanatory note - Appendix AMM (in french)