French Public Health Code
In forceThe marketing authorisation issued by the Agence nationale de sécurité du médicament et des produits de santé lapses if it transpires that:
1° That it is not followed by the marketing of the medicinal product on national territory within three years of its issue;
2° That the medicinal product, previously marketed on national territory, is no longer marketed for three consecutive years.
A derogation from these provisions may be granted by the Agency on an exceptional basis, either for public health reasons, or when the medicinal product cannot legally be marketed during the period in question, or when the medicinal product is intended exclusively for export to a State which is not a party to the Agreement on the European Economic Area, or when the medicinal product is marketed in at least one other Member State of the European Community or State party to the Agreement on the European Economic Area in which it has obtained authorisation under a mutual recognition procedure or a decentralised procedure for which France is designated as the reference Member State and at least one different strength or pharmaceutical form of this medicinal product is marketed in France.
II - For the application of I of this article, the period of three years before the marketing authorisation lapses is counted from :
1° the date of publication of Decree No. 2008-435 of 6 May 2008 for marketing authorisations issued up to that date, with the exception of those for herbal medicinal products for which an application for registration has been submitted under the conditions laid down in Article L. 5121-14-1, for which the three-year period is only counted from the date of notification of the decision by the Director General of the Agence nationale de sécurité du médicament et des produits de santé ;
2° The date of issue of marketing authorisations for authorisations issued after the date of publication of the aforementioned decree.
