French Public Health Code
In forceThe Agence nationale de sécurité du médicament et des produits de santé may, for the purposes of exporting cosmetic products to States which are neither members of the European Union nor parties to the Agreement on the European Economic Area, issue any establishment carrying out one of the activities mentioned in Article L. 5131-2 with a certificate stating that it complies with the good manufacturing practices mentioned in Article 8 of Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 concerning cosmetic products.
The certificate application is submitted by the company to which the establishment belongs. It must be accompanied by the documents required to ensure compliance with good manufacturing practice, which appear on a list drawn up by decision of the Director General of the Agence nationale de sécurité du médicament et des produits de santé.
The certificate, the model for which is defined by the Director General of the Agency, is issued for a period of three years.
When the Agence nationale de sécurité du médicament et des produits de santé finds that the activities of an establishment referred to in Article L. 5131-2 do not comply with good manufacturing practice, it terminates, after an adversarial procedure, the validity of the certificate previously issued. The company shall immediately inform the competent authorities of the countries to which it exports or has exported cosmetic products and shall send the Agency a list of these countries together with proof of this information.
