Part five: Health products

I.-The period of traditional medical use provided for in 4° of Article L. 5121-14-1 is thirty years, including at least fifteen years in a Member State of the European Community or in another State party to the European Economic Area, as attested by bibliographical evidence or expert reports; thirty-year medical use is established even if the product has not been marketed with a specific authorisation or if the number of…

The registration application file includes the following information and documents, presented in accordance with the order referred to in Article R. 5121-11 : 1° The name and address of the applicant and, where applicable, those of the company exploiting the medicinal product as well as those of the manufacturer when neither the applicant nor the company exploiting the medicinal product manufactures the medicinal product; 2° The name of the medicinal…

The detailed summaries of the tests accompanying the application for registration and the expert reports are drawn up and signed by persons with the necessary qualifications and experience as mentioned in Article R. 5121-33.

Where the application for registration concerns a herbal substance, a herbal preparation or a combination thereof included in the list drawn up for use in traditional herbal medicinal products by the Commission of the European Communities pursuant to Article 16f of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use, the applicant is exempt…

Where the application for registration concerns a product which has been the subject of a Community herbal monograph established by the Committee for Herbal Medicinal Products of the European Medicines Agency, the Director General of the Agency shall take the monograph into account when examining the application. Where no Community monograph has been established for the product concerned, he may refer to other appropriate monographs, publications or data.