Procedures
Marketing Authorisation
The « Marketing Authorisation » department is responsible for evaluating and managing in the broad sense the requests for marketing authorisation of medicines. The department also handles requests to modify the authorisations.
The department’s role is to grant and follow the marketing authorisations of medicines.
The CallCenter was set up to answer questions about the files requesting marketing authorisation of medicines (state of progress and requests for priority), see circular 474 (PDF, 23.89 Kb) (in french).
E-mail address: registration@fagg-afmps.be
Telephone: (00 32) 2 524.80.04 from 10 am till midday and from 2 pm to 4 pm.
Questions should preferably be sent by e-mail to the above address with all the relevant details: product name, ID number, procedural number, date of introduction…
Please use the following form for all requests for priority : « Product information sheet (DOC, 48.5 Kb) ».
The Call Center answers questions as quickly as possible, at least within 10 working days.
Requests for giving priority status must be justified by reasons of public health or financial reasons.
Because of the large number of priority files at step 2 (assessment/management), we have decided to stop prioritizing at this step in order to reduce the current workload. Prioritization will resume as soon as the situation has returned to normal
Types of application :
- full applications : full and bibliographic files
- abridged applications : « informed consent », generic and "biosimilar" files
- presubmission meeting: procedure (PDF, 18.38 Kb)
Types of procedure
- centralised procedure
- mutual recognition procedure and decentralised MRP/DCP (PPT, 248 Kb)
; Notice to applicants(AFMPS=RMS) (PDF, 9.27 Kb) ; Template for DCP Request (DOC, 121 Kb)
- national procedure
Progress of the files
Step 1: "Dispatching"
Person responsible: Sophie Colyn - tel. (0032) 2 524.80.87
E-mail: dispatching@afmps.be
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"
E-mail: Gestion.Fagg-Afmps@afmps.be
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 (PDF, 354.41 Kb) (in french) which has been approved by Madam Laurette Onkelinx, Minister for Social Affairs and Public Health.
Instructions (PDF, 103.15 Kb) for the readability testing of the PIL.
Strategy on the delivery status (PDF, 28.88 Kb)
Narcotic drugs used for pain treatment : strategy (PDF, 33.29 Kb) to restrict the pack sizes available in public pharmacies.
FAMHP guideline (PDF, 51.02 Kb) on the mode of delivery of antidepressants, antipsychotics, hypnotics, sedatives, anxiolytics and antiepileptics (version 6.2).
"OTC Switch" guideline (DOC, 46 Kb)
The "OTC Switch" guideline is here (DOC, 46 Kb).
Step 3: "Administrative closure"
Person responsible: Iris Geussens tel. (00 32) 2 524.81.86
E-mail: FAGG_closing_file@afmps.be
The check-list (DOC, 230 Kb) shows all the documents needed for finalising the following procedures :
- mutual recognition procedure
- decentralised procedure
- national procedure
Note to finalise SPC-PIL-labeling (DOC, 229 Kb) : a note concerning the way to finalise a RCP proposal – labeling for a procedure of national variation or mutual recognition.
Auto-evaluation checklist (PDF, 44.76 Kb): 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 (DOC, 221.5 Kb)
Declaration of conformity : NP (DOC, 221.5 Kb)
Derogations (DOC, 228 Kb) : Procedure
Post approval commitment (DOC, 19.5 Kb): Template
"Delegation of power" v 0.1 (09/2011) (DOC, 21 Kb) (DOC, 26.5 Kb): Template
Step 4: "Updating the MeSea database"
Person responsible: Iris Geussens
Legal text:
The Royal Decree dated 14th December 2006 (French version) (part 1 - part 2) concerning medicines for human and veterinary use.
The Law dated 25th March 1964 (French version) about medicines.
Circulars
Circular 521 (PDF, 152.98 Kb) + deactivating files that are being closed.
Circular 522 (PDF, 527.92 Kb) + simplified AMM (DOC, 231 Kb) + check-list English version (DOC, 230 Kb) : simplified Marketing Authorisation (AMM in French) for medicines for human use – a single national registration number for medicines for human use.
Forms
The following forms can be completed electronically:
AMM form (DOC, 277.5 Kb) + explanations - appendix AMM (DOC, 226.5 Kb) (in french),
simplified AMM (DOC, 231 Kb) (in french),
Information session (19/05/2009)
Presentations (PDF, 511.37 Kb)
Information session (11/12/2009)
Presentations (PDF, 794.6 Kb) + document "Questions and answers (PDF, 72.91 Kb)" (in French)