Progress of the files
Step 1: "Dispatching"E-mail: email@example.com
The application file for marketing authorisation must be sent initially to the Dispatching department, whose tasks are as follows :
- Validating the files: checking that all sections of the file and that the legal requirements are present
- Validating EDMF (European Drug Master File) /ASMF (Active Substance Master file) files.
Step 2: "Assessment/Management"
The management of the files and the assessment of the quality, safety and efficacy are conducted by different file managers and experts.
The Commission for Medicines for human use (CMH - La Commission pour les médicaments à usage humain) was established to provide advice about applications for marketing authorisation, about the availability of medicines to patients and for scientific questions concerning medicines.
The Commission also set up an Committee to coordinate these tasks.
Furthermore the Commission functions according to an internal regulation (in french) which has been approved by Madam Laurette Onkelinx, Minister for Social Affairs and Public Health.
Instructions for the readability testing of the PIL.
Narcotic drugs used for pain treatment : strategy (v.5.2 - January 2020) to restrict the pack sizes available in public pharmacies.
FAMHP guideline on the mode of delivery of antidepressants, antipsychotics, hypnotics, sedatives, anxiolytics and antiepileptics (version 6.2).
The "OTC Switch" guideline is here.
Step 3: "Administrative closure"
Person responsible: Iris Geussens tel.
The check-list shows all the documents needed for finalising the following procedures :
- mutual recognition procedure
- decentralised procedure
- national procedure
Note to finalise SPC-PIL-labeling : a note concerning the way to finalise a RCP proposal – labeling for a procedure of national variation or mutual recognition.
Auto-evaluation checklist: This checklist can be used as an auto-evaluation and should be added to the documents for administrative closing at the FAMHP.
Declaration of conformity : MRP/DCP
Declaration of conformity : NP
Post approval commitment: Template
"Delegation of power" v 0.1 (09/2011) : Template
Step 4: "Updating the MeSea database"
Person responsible: Iris Geussens
The Law dated 25th March 1964 (French version) about medicines.
Circular 521 + deactivating files that are being closed.
Circular 522 + simplified AMM (in french) + check-list English version : simplified Marketing Authorisation (AMM in French) for medicines for human use – a single national registration number for medicines for human use.
The following forms can be completed electronically:
simplified AMM (in french),
Information session (19/05/2009)
Information session (11/12/2009)