Subsection 3: Examination and conditions of authorisation.

The Director General of the Agence nationale de sécurité du médicament et des produits de santé may, by a reasoned decision setting out the appeal procedures and deadlines, automatically vary, suspend, for a period not exceeding one year, or withdraw a marketing authorisation on the grounds mentioned in Article L. 5121-9. However, where the authorisation is suspended, either as a precautionary measure pending the outcome of a European Union arbitration procedure, or in accordance with a decision of the European Commission taken following this procedure, the suspension remains in force until the European Commission orders that it be terminated.

The marketing authorisation is also automatically varied, suspended or withdrawn by the Director General of the Agency:

1° Where it appears that the information provided at the time of application for marketing authorisation is incorrect or has not been amended in accordance with Articles R. 5121-37 and R. 5121-37-1, that the conditions laid down in this section are not or are no longer fulfilled or that the checks have not been carried out;

2° Where the labelling or package leaflet of the medicinal product or product does not comply with the general or specific requirements laid down in this Title;

3° Where the obligations imposed pursuant to articles R. 5121-36-1 and R. 5121-43 are not fulfilled;

4° When the authorisation must be brought into line with the decision taken by the European Commission following a European Union arbitration procedure;

5° Where the authorisation must be brought into line with an agreement reached by consensus within the coordination group referred to in Article 27 of Directive 2001/83/EC of the European Parliament and of the Council.

Except in emergencies, the compulsory variation, suspension or withdrawal may only take place after the objections have been communicated to the marketing authorisation holder and, in the case provided for in 2°, if the marketing authorisation holder, having been given formal notice to rectify the situation of the medicinal product or product, has not complied with this formal notice within the time limit set by the Director General of the Agency.

Without prejudice to the application of the provisions of the second paragraph of Article R. 5121-50, the decision to automatically vary, suspend or withdraw the authorisation is subject to the other publicity measures that the Director General of the Agency deems necessary to order.

When the authorisation is suspended or withdrawn, or when a decision to vary the authorisation ex officio makes this necessary, the proprietor must take all necessary steps, in particular with stockholders, to stop the distribution of the medicinal product. If these steps are not taken within a period of time compatible with the interests of public health, the Director General of the Agency will take all appropriate measures.