Title II: Medicinal products for human use

The Director General of the Agency will take a decision within two hundred and ten days of the submission of a complete application. He may ask the applicant, in a letter stating the reasons for the request, for any additional information he considers necessary to reach a decision on the application. The period provided for in the first paragraph is suspended until receipt of the information requested.

Registration is valid for five years. It is renewable, where appropriate, without time limit, unless the Director General of the Agency decides at the time of renewal to proceed with an additional renewal for justified reasons relating to pharmacovigilance and on the basis of a reassessment of the quality, safety or homeopathic use of the medicinal product in the case of homeopathic medicinal products or of the risk-benefit balance of…

After registration, manufacturing methods and control techniques take account of scientific and technical progress. Any resulting changes must first be registered under the conditions set out in article R. 5121-100-1.

Amendments to the terms of the registration decision and the registration dossier are submitted and examined under the conditions laid down in Chapters I and IIa of Commission Regulation (EC) No 1234/2008 of 28 November 2008 concerning the examination of variations to the terms of a marketing authorisation for medicinal products for human use and veterinary medicinal products, in accordance with the amendment envisaged in the version in force on…

I. – The applicant or the holder of the registration shall forward to the Agency without delay, indicating the scope of the information, any new information which it has or becomes aware of after the application for registration has been submitted or after the registration has been granted, which could lead to a change in the registration dossier. This information concerns in particular the assessment of the quality, safety and…

By way of derogation from the provisions of article R. 5121-99, the registration lapses if it appears that it is not followed by the marketing of the medicinal product on the national territory within three years of registration or that the medicinal product, previously marketed on the national territory, is no longer marketed for three consecutive years. The three-year period is counted from the date of issue of the registration….

When registration is suspended or withdrawn, the holder informs the stockholders without delay. They must take all necessary steps to stop the distribution of the medicinal product. If these steps are not taken within a timeframe compatible with the interests of public health, the Director General of the Agency will take all appropriate measures. Independently of suspension or withdrawal decisions and for the reasons that justify them, the Director General…

Registration of homeopathic medicinal products and traditional herbal medicinal products, as well as suspension and withdrawal of registration, are made available to the public by the Director General of the Agency.