Chapter III: Manufacturing and wholesale distribution.

The following is punishable by two years’ imprisonment and a fine of €150,000: 1° Owning or managing a company with at least one pharmaceutical establishment without being a pharmacist or without having appointed a pharmacist as its general manager or manager; 2° Owning or managing an enterprise comprising at least one pharmaceutical establishment and leased to a company that is not owned by a pharmacist or that does not include…

Carrying out the drug brokering activity referred to in article L. 5124-19, without having registered with the Agence nationale de sécurité du médicament et des produits de santé under the conditions set out in article L. 5124-20, is punishable by one year’s imprisonment and a fine of €75,000.

Opening or operating an establishment mentioned in Article L. 5124-1 without the administrative authorisation mentioned in Article L. 5124-3 is punishable by two years’ imprisonment and a fine of €150,000.

Failure to comply with a ban on the export of a medicinal product issued by the Agence nationale de sécurité du médicament et des produits de santé in application of article L. 5124-11 is punishable by five years’ imprisonment and a fine of €375,000.

Failure by a wholesaler-distributor to comply with the public service obligations defined in application of article L. 5124-17-2 is punishable by two years’ imprisonment and a fine of €150,000.

Failure to comply with the rules on advertising for pharmaceutical companies and establishments laid down by decree in the Conseil d’Etat in accordance with the provisions of article L. 5124-18 is punishable by a fine of €150,000. The same penalties shall apply, irrespective of the method of advertising used, to persons who profit from irregular advertising and to agents disseminating such advertising. The provisions of the previous paragraph apply when…

When the judicial authority receives a prosecution in application of the articles of this chapter, with the exception of article L. 5423-6, the representative of the State in the département may order the temporary closure of the establishment. Natural persons guilty of an offence under the articles of this chapter, with the exception of article L. 5423-6, incur the additional penalty of temporary or permanent closure of the establishment.

The following constitutes a breach subject to a financial penalty: 1° (Repealed) 2° (Repealed) 3° Failure by a pharmaceutical company exploiting a medicinal product or product subject to the marketing authorisation provided for in article L. 5121-8 to communicate the date of marketing of the medicinal product or product to the Agence nationale de sécurité du médicament et des produits de santé; 4° Managing a company with at least one…

The following constitutes a breach subject to a financial penalty: 1° Failure by a marketing authorisation holder or a pharmaceutical company exploiting a medicinal product to constitute the safety stock intended for the national market in application of the second paragraph of article L. 5121-29; 2° Any marketing authorisation holder or pharmaceutical company exploiting a medicinal product of major therapeutic interest mentioned in article L. 5111-4 for which there are…