Section 9: Medicinal products subject to registration

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…