Chapter VIII: Raw materials for pharmaceutical use

The certificate of compliance with good manufacturing practice referred to in article L. 5138-4 is issued following an inspection of the establishment if the good practices provided for in article L. 5138-3 are complied with. This certificate may not be used to guarantee the purity or quality of individual batches of products manufactured. It is issued within ninety days of the inspection. If no response is received from the Agency…

The application for the certificate provided for in the second paragraph of Article L. 5138-4 is sent to the Agence nationale de sécurité du médicament et des produits de santé by a person authorised to bind the establishment.

When the inspection reveals that the manufacture or repackaging and relabelling carried out in the context of the distribution of a raw material for pharmaceutical use does not comply with the good practices provided for in Article L. 5138-3, the inspected establishment shall immediately inform the manufacturers of the medicinal products in which this raw material is used. If a certificate has previously been issued to this establishment, the Director…

The Agence nationale de sécurité du médicament et des produits de santé shall transmit to the European Medicines Agency, for recording in the Community database, the certificates of good manufacturing practice that it issues. Where an inspection reveals non-compliance with good manufacturing practice, this information is also transmitted for recording in the Community database.