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.
Since 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