Title III: Other regulated pharmaceutical products and substances

The following are authorised to investigate and record breaches of the provisions of Chapter I of Title III of Book I of Part Five, and of the regulatory measures adopted for the application of these provisions: – public health inspecting pharmacists and inspectors from regional health agencies who are qualified pharmacists, under the conditions set out in articles L. 5411-1 to L. 5411-4 ; – inspectors from the Agence nationale…

The following is punishable by two years’ imprisonment and a fine of €30,000: 1° For any person who manufactures or packages cosmetic products, to open or operate an establishment for the manufacture or packaging of these products, or to extend the activity of an establishment to include such operations, without first making the declaration provided for in Article L. 5131-2 to the Agence nationale de sécurité du médicament et des…

Natural persons guilty of the offences defined in article L. 5431-2 are also liable to the following additional penalties: 1° Dissemination of the sentence and one or more messages informing the public of the sentence, under the conditions set out in article 131-35 of the French Penal Code ; 2° Posting the sentence, under the conditions and subject to the penalties provided for in article 131-35 of the same code;…

Legal entities declared criminally liable, under the conditions set out in Article 121-2 of the French Penal Code, for the offences defined in Article L. 5431-2 shall be liable, in addition to a fine in accordance with the terms and conditions set out in Article 131-38 of the French Penal Code: 1° (Repealed) ; 2° Confiscation of the thing that was used or intended to be used to commit the…

The person responsible, as determined in Article 4 of Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products, for placing on the market, free of charge or for consideration, a cosmetic product which does not comply with the rules on the substances it contains, as set out in Article 14 and Article 15(1) and (2) of the same Regulation, shall…

The person responsible, as determined by Article 4 of Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products, shall be liable to one year’s imprisonment and a fine of 15,000 euros for: 1° Placing a cosmetic product on the market, whether free of charge or against payment, without making the information file provided for in paragraph 1 of Article 11…

A fine of 15,000 euros shall be imposed on the person responsible, as defined in Article 4 of Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009, for placing on the market, free of charge or for consideration, a cosmetic product whose container or packaging does not bear one of the indications provided for in Article 19 of the same Regulation.

The failure of the responsible person, as defined in Article 4 of Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009, and distributors, as defined in Article 2(1)(e) of the same Regulation, failing to report to the Agence nationale de sécurité du médicament et des produits de santé (French National Agency for the Safety of Medicines and Health Products), without delay and by…

Failure by the responsible person, as defined in Article 4 of Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009, to provide the Agence nationale de sécurité du médicament et des produits de santé with any of the information referred to in Article 24 of the aforementioned Regulation, despite a formal notice issued under the conditions laid down in Article L. 5131-6, shall…