Other procedures

Marketing Authorisation

 

Progress of the files

Step 1: "Dispatching"

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 (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.

Strategy on the delivery status

Public consultation of the lists of medicinal products with restricted prescription

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).

"OTC Switch" guideline 

The "OTC Switch" guideline is here.

Step 3: "Administrative closure"

Person responsible: Iris Geussens  tel. (00 32) 2 528.41.86
E-mail: FAGG_closing_file@afmps.be

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

Exemptions : Procedure to be followed + Template requesting an exemption

Post approval commitment: Template

"Delegation of power" v 0.1 (09/2011)  : Template

Labelling of medicinal products

New definition of the approval date in SmPC and leaflet

 

 

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 + 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.

Forms

The following forms can be completed electronically:

AMM form  + explanations - appendix AMM (in french),

simplified AMM (in french),

variation form 

Fees form

Information session (19/05/2009)

Presentations

Information session (11/12/2009)

Presentations + document "Questions and answers" (in French)

 

Last updated on 21/01/2021