Part five: Health products

Failure to comply with the rules of good practice defined in the decisions or orders issued in application of article L. 5121-5, failure to comply with which is likely to result in a serious risk to public health, is punishable by one year’s imprisonment and a fine of €150,000.

I. – It is an offence to market, broker or distribute, whether free of charge or for a consideration, wholesale or retail, a proprietary medicinal product, any other medicinal product manufactured industrially or according to a method involving an industrial process, as well as any generator, kit or precursor as defined respectively in 8°, 9° and 10° of article L. 5121-1, without a marketing authorisation, a temporary use authorisation, an…

I. – It is an offence to market, broker or distribute, whether free of charge or against payment, wholesale or retail, homeopathic medicinal products mentioned in 11° of article L. 5121-1 or traditional herbal medicinal products mentioned in article L. 5121-14-1 which have not been registered with the Agence nationale de sécurité du médicament et des produits de santé, or whose registration with this agency has been refused, suspended, withdrawn…

Failure by any person exploiting a medicinal product or product to communicate any new information likely to influence the assessment of the benefits and risks of the medicinal product or product concerned pursuant to article L. 5121-9-2 or to transmit the data requested by the Agency within the time limits set by it pursuant to article L. 5121-9-3 is punishable by two years’ imprisonment and a fine of €150,000.

Failure by any person exploiting a medicinal product or product to notify the Agence nationale de sécurité du médicament et des produits de santé of any prohibition or restriction imposed by the competent authorities of any country in which the medicinal product or product is marketed pursuant to article L. 5121-9-2 is punishable by two years’ imprisonment and a fine of €150,000.