Planta Med 2006; 72 - WS_004
DOI: 10.1055/s-2006-949799

Implementation of the Guideline on non-clinical documentation for HMPs in applications for marketing authorisation and simplified registration

AJ Vlietinck 1, O Pelkonen 2, P Claeson 3, G Abel 4
  • 1Department of Pharmaceutical Sciences, University of Antwerp (UA), Antwerp, Belgium, Member HMPC, EMEA, London
  • 2University of Oulu, Finland, Member HMPC, EMEA, London
  • 3Swedish Medical Products Agency, Uppsala, Sweden, Member HMPC, EMEA; London
  • 4Bionorika, Germany

Half April 2006 the deadline for comments on the guideline on non-clinical documentation for herbal medicinal products in applications for marketing authorisation (bibliographic and mixed applications) and in applications for simplified registration (Doc. Ref. EMEA/HMPC/321 16/2005) expired.

The rapporteur will address the many comments which were sent to the Herbal Medicinal Products Committee of the EMEA and it is expected that the guideline will be finalised in one of next meetings of that Committee.

It is therefore appropiate in this workshop to explain the scope, legal basis and the different aspects of this guideline and to discuss its implementation at the level of the national authorities and the manufacturers of herbal medicinal products, especially in terms of legal basis, rational and feasibility.