French Public Health Code
In forceThe lactarium is authorised for a period of five years by the director general of the regional health agency for the region in which the lactarium is located, after obtaining the opinion of the director general of the Agence nationale de sécurité du médicament et des produits de santé. The authorisation is notified within a maximum of two months from the date of receipt of the application. The authorisation is renewed under the same conditions.
The authorisation specifies the method of carrying out the activity as defined in article D. 2323-1, the site of the lactarium and, where applicable, the location of the branches. It specifies the distribution of the tasks performed by the main site and the branches.
When the main site and the branches of the lactarium are located in several regions, the lactarium is authorised by the Director General of the Regional Health Agency of the region in which the main site is located, after obtaining the opinion of the Director General of the Regional Health Agency of each region in which the branches are located and the Director General of the Agence nationale de sécurité du médicament et des produits de santé.
When it is established that the operating and organisational conditions of the lactarium endanger the life or health of children, the Director General of the regional health agency that issued the authorisation notifies the holder of the authorisation to operate the lactarium. The Director General will also forward the findings to the Director General of the Agence nationale de sécurité du médicament et des produits de santé. It asks the holder of the authorisation to make known, within eight days, its observations and the corrective measures adopted or envisaged. If there is no response within this period or if the response is insufficient, the Director General will issue an injunction to the authorisation holder to take all necessary steps to put a definitive end to the shortcomings within a specified period. The Director General of the Regional Health Agency will ensure that the injunction is complied with.
In an emergency involving the safety of the child, the staff, the mother or the donor, or where the injunction provided for in the previous paragraph has not been complied with within the time limit set, the Director General of the Regional Health Agency may order the partial or total suspension of the authorisation or the immediate cessation of operation of the technical resources of any kind contributing to the activity of the lactarium.
The decision is notified to the holder of the authorisation, together with the observations made and a formal notice to remedy the shortcomings within a specified period. The Director General of the Regional Health Agency shall inform the Director General of the Agence nationale de sécurité du médicament et des produits de santé of any decision to suspend or cease operation of the authorisation.
If, at the end of this period, it is established that the formal notice has been complied with, the Director General of the Regional Health Agency will put an end to the interruption.
If this is not the case, the Director General of the Regional Health Agency will take a definitive decision either to maintain the suspension until the planned measures have been completed, or to modify the content of the authorisation, or to withdraw it.
