Traditional herbal medicinal products that meet the following criteria are not subject to marketing authorisation:
1° They are designed to be used without the intervention of a doctor for the purposes of diagnosis, prescription or monitoring of treatment;
2° They are exclusively intended to be administered according to a specified dose and dosage;
3° They are administered orally, externally or by inhalation;
4° The period of traditional use has elapsed;
5° There is sufficient data on the traditional use of the medicinal product.
Before being placed on the market or distributed free of charge, these medicinal products must be registered with the Agence nationale de sécurité du médicament et des produits de santé.
However, if the Agency considers that a traditional herbal medicinal product falls, in view of its characteristics, under the marketing authorisation system or the homeopathic medicinal product registration system, the registration provided for in the previous paragraph does not apply.
This registration is carried out if the criteria mentioned above are met and if the applicant is established in a Member State of the European Union or a party to the Agreement on the European Economic Area. Registration may be refused if there is a danger to public health.
Registration is valid for five years. It may be renewed, where appropriate for an unlimited period, under conditions laid down by decree in the Conseil d’Etat. This decree also determines the conditions under which it may lapse.
Registration may be amended by the Agence nationale de sécurité du médicament et des produits de santé.
Registration may be suspended or withdrawn by the Agency if the criteria and conditions to which it is subject are no longer met or if there is a danger to public health.
Completion of the formalities provided for in this article does not have the effect of exonerating the manufacturer and, if different, the registration holder, from the liability that either of them may incur under the conditions of ordinary law as a result of the manufacture or marketing of the medicinal product.