French Public Health Code
In forceAny pharmaceutical company exploiting a medicinal product or product subject to the provisions of Chapter I of this Title which takes the decision to suspend or cease marketing thereof or which has knowledge of facts likely to lead to the suspension or cessation of such marketing shall inform the Agence nationale de sécurité du médicament et des produits de santé, specifying the reasons for its action, at least one year before the planned or foreseeable date in the case of medicinal products of major therapeutic interest referred to in Article L. 5111-4. Marketing may not be discontinued before the end of the period required to introduce alternative solutions to cover this need. If the medicinal product is not a medicinal product of major therapeutic interest mentioned in the same article L. 5111-4, the Agence nationale de sécurité du médicament et des produits de santé is informed, with reasons, no later than two months before the suspension or cessation of marketing. In all cases, the pharmaceutical company must specify whether the suspension or discontinuation of marketing of the medicinal product is based on one of the grounds mentioned in 1° to 5° of Article L. 5121-9. In the event of an emergency requiring the suspension or discontinuation to take place before the expiry of the deadlines set out above, the company shall immediately inform the Agency, giving reasons for the emergency.
The pharmaceutical company exploiting a medicinal product or product subject to the provisions of Chapter I of this Title shall immediately inform the Agency of any action taken to withdraw a given batch.
