Book I: Pharmaceutical products

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When a herbal substance, a herbal preparation or a combination of substances is withdrawn from the list drawn up by the Commission of the European Communities, any registration of traditional herbal medicinal products containing this substance is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.

Where, following the establishment of a new Community herbal monograph, the revision of an existing monograph or the revision of the list drawn up by the European Commission in application of Article 16f of Directive 2001/83/EC, a herbal medicinal product which is the subject of a marketing authorisation now falls wholly or partly under the registration system, the holder sends the National Agency for the Safety of Medicines and Health…

If, after a traditional herbal medicinal product has been registered, the proprietor considers, on the basis of new data available to him, that, given its characteristics, the medicinal product is now covered by the marketing authorisation system or the registration system for homeopathic medicinal products, he shall submit an application for a marketing authorisation or registration to the National Agency for the Safety of Medicines and Health Products under the…