French Public Health Code
In forceI. - The application for authorisation provided for in Article L. 5138-1 shall be sent to the Agence nationale de sécurité du médicament et des produits de santé by the legal representatives of the establishment by any means that enables receipt to be acknowledged, at least sixty days before the planned date of commencement of the activity.
II. - It includes the following information :
1° Administrative information relating to the establishment, including the name, business name and address of the registered office to which the establishment belongs, the name of the legal representatives of the establishment and the address of the establishment which carries out the activity of manufacturing, importing or distributing active substances;
2° The active substances to be imported, manufactured or distributed;
3° The characteristics of the premises and technical equipment used in the course of their activity;
4° Technical information relating to the activities of manufacturing, importing or distributing active substances, in particular a list of these activities, the processes and quality assurance systems used to carry them out, and any sub-contractors.
The form and content of the document containing the list of administrative details and technical information are laid down by decision of the Director General of the Agency.
For manufacturers mentioned in 1° of Article R. 5124-2 and 1° of Article R. 5142-1 who, for their own use, repour distribute, limiting themselves to the purchase or storage of active substances, the mention of this activity in the statement provided for in Article R. 5124-46 or Article R. 5142-42 is equivalent to a declaration in respect of distribution.
III. - The Director General of the Agency may request any information or carry out an on-site inspection to enable him to ensure that the site complies with the standards in force with a view to starting their activity. To this end, it may extend the period provided for in the first paragraph by sixty days. In this case, it will notify the applicant of the extension.
If, within sixty days of receipt of the application for authorisation, the Director General of the Agency has not notified the applicant that an inspection will be carried out, authorisation is implicitly granted and the applicant may commence its activity.
IV. - Any change likely to affect the quality or safety of the raw materials for pharmaceutical use manufactured, imported or distributed is notified to the Agency by any means and without delay.
Any other change in any of the elements of the dossier shall be notified to the Agency by any means which allows receipt to be acknowledged, in the form of an annual summary report, the procedures for which shall be laid down by decision of the Director General of the Agency.
The cessation of activity of the establishment is communicated without delay in the same way.
V. - The Director General of the Agency may refuse to authorise all or part of the activity which is the subject of the initial application or any subsequent modification likely to have an impact on the quality or safety of the active substances manufactured, imported or distributed.
It may also suspend the authorisation following an inspection which has revealed non-compliance with the obligations set out in articles L. 5138-1 et seq. and in this chapter.
Except in an emergency, the suspension decision may only be taken after the person carrying out the activity of manufacturing, importing or distributing active substances has been invited to present their observations.
