French Public Health Code
In forceFor public health reasons, the Agence nationale de sécurité du médicament et des produits de santé may require a company to submit samples of each batch of the bulk product and the finished product for its inspection before the batch is put into circulation when it operates :
1° A live vaccine ;
2° An immunological medicinal product used for the primary immunisation of young children or persons belonging to risk groups;
3° An immunological medicinal product used in public vaccination programmes.
In the case of an immunological medicinal product which is new or manufactured using new or modified techniques or which is new for a particular manufacturer, the Director General of the Agency may specify in the marketing authorisation that samples of each batch of the bulk product and of the finished product must be submitted to its control for a specified period before it is put into circulation.
The National Agency for the Safety of Medicines and Health Products carries out the controls mentioned in the previous paragraphs within sixty days of receipt of the samples.
These tests may not be required in the case of a batch from another Member State of the European Community if the competent authority of that Member State has already tested the batch and found it to comply with the approved specifications.
