Subsection 3: Traditional herbal medicinal 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.

Registration of the traditional herbal medicinal product is refused by the Director General of the Agency if the application does not comply with the provisions of Articles L. 5121-14-1, R. 5121-97, R. 5121-107-4 and R. 5121-107-5, or if at least one of the following conditions is met: 1° The qualitative or quantitative composition of the medicinal product does not correspond to that declared; 2° The medicinal product could be harmful…

The Director General of the Agency may automatically vary, suspend or cancel a registration in the same cases and according to the same procedures as those laid down for a marketing authorisation in Article R. 5121-47. It shall immediately inform the European Medicines Agency. Decisions to refuse, vary, suspend or withdraw registration must state the reasons on which they are based. They may only be taken after the registration holder…

When a herbal substance, a herbal preparation or a combination of substances is withdrawn from the list drawn up by the Commission of the European Communities, any registration of traditional herbal medicinal products containing this substance is cancelled by the Director General of the Agency, unless the holder requests a modification of the registration dossier by providing, within three months of the withdrawal from the list by the Commission, the…

Where a Community herbal monograph has been established or where the herbal medicinal product consists of herbal substances, preparations or combinations thereof included in the list drawn up 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, registration is obtained in accordance…

Following the establishment of a new Community herbal monograph or the revision of an existing monograph, the registration holder shall submit a request for amendment of the registration dossier to the Agency without delay.