Subsection 2: Homeopathic medicinal products

A medicinal product or a series of medicinal products mentioned in Article L. 5121-13 may only be registered if the applicant is established in a Member State of the European Community or a party to the Agreement on the European Economic Area.

The application file for registration of a medicinal product or a series of medicinal products mentioned in article L. 5121-13 is sent to the Agency. It includes the following information and documents 1° The name and address of the applicant and the operator of the medicinal product and, where the latter does not manufacture the medicinal product, the name and address of the manufacturer and, where applicable, the name and…

I.-The registration of the medicinal products mentioned in article L. 5121-13 may be refused, amended, suspended or withdrawn by the Director General of the Agency. The period of suspension may not exceed one year. Decisions to refuse, amend, suspend or cancel registration shall state the reasons on which they are based. They are notified to the applicant or registration holder and state the appeal procedures and deadlines applicable. Such decisions…