Regulation
Food products and nutraceuticals
Food products and nutraceuticals
Pharmaceutical products
Pharmaceutical products
Cosmetics
Cosmetics
Animal nutrition
Animal nutrition
Biocides
Biocides
Médicaments à base de plantes

Pharmaceutical products - Herbal medicinal products

Herbal medicinal products are regulated by:

  • Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 instituting a Community code relating to medicinal products for human use.
  • Directive 2004/24/EC of the European Parliament and of the Council of 31 March 2004 amending, as regards traditional herbal medicinal products, Directive 2001/83/EC which institutes a Community code relating to medicinal products for human use.

icone-mainSince the European regulation establishing a list of permitted health claims made on foods (see Health claims) came into effect in 2012, developing a range of herbal medicinal products can prove to be a highly strategic exercise.

 

 Pharmanager Development assists you with:

  • Drafting the various modules to include in the application for marketing authorization, in the CTD format, according to ICH guidelines
  • Registering your applications
  • Liaising with the relevant French authority: ANSM
  • Responding to requests for additional information from ANSM
  • Drafting monographs
  • Developing new products:
    • – For traditional use
    • – For Well-Established Medicinal Use