France

Policy

Herbal medicines have been regulated in France on 1985 using the same laws and regulations used for conventional pharmaceuticals. However, there are no national policies regarding use of and practice of TM/CAM, or are there any plans to develop such policies. There are no laws governing food supplements specifically. There is a small positive list of botanicals that can be sold as food.  Some foods supplements are sold dietetic foods. Claims that reference diseases are prohibited on any nutritional product. Herbs - There is a positive list of herbs that can be used as food in combination of up to 8 botanicals with the same indication/usage.  There is a smaller list of algae that may also be used. There is a larger list of traditional botanicals and claims that must undergo a simplified pharmaceutical registration procedure with the Ministry of Health. Typically up to four botanicals from this list may be used in combination with justification if their use is similar or complimentary.  Other botanicals not on these positive lists must go through a full pharmaceutical registration process.  No national pharmacopoeia is used. Fortified or Functional Foods - The fortification of foods is for the most part restricted to products approved as dietetic foods. The addition of herbs is unregulated. A post-marketing surveillance system is in place for botanicals. France has implemented the reformed EU Common Agriculture Policy, which focuses on the establishment of a common organisation of agricultural markets across member countries, which also covers the sector of medicinal plants and herbs. A major new reform of the CAP is currently being prepared for the period after 2013.

Contact

Ministry of Health, France
Website: http://www.sante.gouv.fr/
 

Laws & Regulations

Herbal medicines have been regulated in France in 1985 using the same laws and regulations as are used for conventional pharmaceuticals.

There are no laws governing food supplements specifically.  There is a small positive list of botanicals that can be sold as food.  Some foods supplements are sold dietetic foods.  Claims that reference diseases are prohibited on any nutritional product.

Herbs - There is a positive list of herbs that can be used as food in combination of up to 8 botanicals with the same indication/usage.  There is a smaller list of algae that may also be used.  There is a larger list of traditional botanicals and claims that must undergo a simplified pharmaceutical registration procedure with the Ministry of Health.  Typically up to four botanicals from this list may be used in combination with justification if their use is similar or complimentary.  Other botanicals not on these positive lists must go through a full pharmaceutical registration process.  No national pharmacopoeia is used.

Fortified or Functional Foods - The fortification of foods is for the most part restricted to products approved as dietetic foods. The addition of herbs is unregulated.

A post-marketing surveillance system is in place for botanicals.

Contact

Ministry of Health            
http://www.sante.gouv.fr/

 

Standards & Regulations

In 1987, the Ministry of Health published the first "Avis aux fabricants" (advice to manufacturers) taking into account the fact that the directives of the European Commission (EC) which define pharmacotoxicological and clinical criteria required for a marketing authorization are not applicable for most herbal remedies, and the fact that frequently their efficacy cannot be demonstrated on the basis of bibliographical data. To give a better defined status to plant-based medicinal products, a list was drawn up of vegetable drugs which could be registered according to an abridged dossier. Their safety, with an optimum benefit-risk ratio, was taken into account as well as historical proof of their widespread traditional use and their well-established use in self-medication. These guidelines were completed in 1990, and cover applications for marketing authorizations for new products and the validation of products already on the market.

This guideline includes a list of 174 plants and parts of plants with approved therapeutic indications, a list of 35 accepted therapeutic indications for minor ailments (17 for oral use, 9 for external use and 9 for both uses) with a low indication level which is introduced by "Traditionellement utilisé dans..." ("Traditionally used in ...").This guideline also include a list of fixed combinations of plants is available and a special section on laxative herbs. The guideline is completed by a detailed description of the content of the dossier, a list of toxicological recommendations according to the preparations concerned (with special recommendations for laxatives), and rules for labelling and packaging of herbal medicines.

France is also one of EU and OECD member countries, and follows the simplified regulatory approval process on Traditional herbal medicinal products under the EU Directive on Traditional Herbal Medicinal Products (THMPD) formally known as The Directive 2004/24/EC.

Contact

Ministry of Health & Solidarity
Website:  http://www.sante.gouv.fr/
Address: GIRI (International research group on very low dose effects), Laboratoire d'Immunologie, Faculte de Pharmacie, 15 Ave Charles Flahault, F34060 Montpellier Cedex 1, France
Telephone: -
Fax: + 33 67 54 7533
Website: http://www.giriweb.com/