Administrative simplification of the procedures for homoeopathic and (traditional) herbal medicines

From May 1, 2018 the FAMHP is simplifying a number of procedures for homoeopathic and (traditional) herbal medecines with the intention of streamlining the process and reducing the administrative load for companies and the government.

Innovations for marketing authorization (MA) or registration of a homoeopathic or (traditional) herbal medicine

  • The marketing authorization or registration of homoeopathic remedies: in the final decision, from now on you will receive a shortened version of the marketing authorization or registration, a so-called MA light.
  • The registration of (traditional) herbal remedies: in the final decision, you will now receive a MA light instead of a registration with the submitted application form.
  • The marketing authorization for marketing of herbal remedies based on a complete file or a so-called bibliographic file: in the final decision, you will now receive an MA light instead of an MA.

Guidelines for the submission of a file for a (traditional) herbal medicine

We prefer that you submit all files and all answers to questions via CESP.

For all types of files, as well as for a new application, a variation type II/IA/IB, and administrative variation (AC), a notification (request to amend an element in connection with labelling or the package insert that has nothing to do with the SPC) and a renewal, always check Herbal MP application as the Regulatory Activity.

In the Comment field in CESP, you must indicate the type of file (new request, variation, renewal) and the specific legal basis.

You can submit the dossier or responses via prelicensing@fagg-afmps.be.

A grouping/worksharing of variations with herbal medicines and non-herbal medicines must always be submitted to the Dispatching Entity of the Marketing Authorisation Division
(Variations & Renewals)
of the DG POST authorization via dispatching@fagg-afmps.be.

In the case of CESP indicate variation IA, IB or II as the Regulatory Activity.

Guidelines for the submission of a file for a homoeopathic medicine

We prefer that you submit all files and all answers to questions via CESP.

For all types of files (new application including reference files, variation type II/IA/IB, AC, notification and renewal) always check Homoeopathic MP application as the Regulatory Activity.

In the Comment field in CESP, you must indicate the type of file (new request, variation, renewal) and the specific legal basis.

You can submit the dossier or responses via homeo@fagg-afmps.be.

These new procedures will be applicable as of 01.05.2018.

Last updated on
30/04/2018