Wednesday, January 13, 2021Authorities

ANSM : 1400 € the GMP certificate

ANSM : 1400 € le certificat BPF

Since the beginning of January 2021, all imports of cosmetic products into China must be accompanied by a GMP certificate issued by the control authority of the country of origin. In France, the Decree n°2020-1337 of November 2, 2020 officially allowed the ANSM to issue this certificate. And Decree 2020-1800 of 30 December has just set its price.

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Decree n°2020-1337 of 2 November 2020, published in the Official Journal of French Republic on 4 November officially allowed the French National Agency for the Safety of Medicines and Health Products (ANSM) to issue “a certificate attesting [that any exporting establishment] complies with the good manufacturing practices mentioned in Article 8 of Regulation (EC) No.1223/2009 relating to cosmetic products”.

This second Decree n°2020-1800 of 30 December 2020 “on the fee for the application for a certificate of conformity to good manufacturing practice for cosmetic products” provides that “the Agency’s instruction […] of the application for a certificate of good manufacturing practice […] shall give rise to the prior payment of a fee”.
The fee is set at €1,400 per application for a certificate.
This sum will be recovered for the benefit of the National Health Insurance Fund in accordance with the procedures in force for non-tax and non-industrial claims.

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