Title II: Medicinal products for human use

The procedures for submitting and examining applications for authorisation to open, for modification of initial authorisations and for transfer of authorisations to open, as provided for in Articles R. 5124-6, R. 5124-7, R. 5124-10, R. 5124-10-1, R. 5124-10-2, R. 5124-13 and R. 5124-14 , as well as the content of the file attached to the application, are laid down by decision of the Director General of the Agence nationale de…

The authorisation to open, provided for in the first paragraph of Article L. 5124-3, a pharmaceutical establishment, a company or a body mentioned in Article R. 5124-2 is issued by the Director General of the Agence nationale de sécurité du médicament et des produits de santé, after obtaining the opinion of the competent Central Council of the Ordre national des pharmaciens and after an administrative enquiry by one of the…

I.- The premises of a pharmaceutical establishment are located on the same site, the continuity of which is not interrupted by the presence of other premises occupied by third parties. Pharmaceutical establishments authorised under 1° and 4° of article R. 5124-2 may include, without separate authorisation, a storage room located close to the establishment. This room, placed under the responsibility of the pharmacist in charge or the delegated pharmacist of…

Unless expressly stated otherwise in the authorisation to open provided for in Article R. 5124-6, a pharmaceutical establishment benefiting from an authorisation granted under 5° of Article R. 5124-2 also benefits from authorisations granted under 6° of the same article, with the exception of intermediate products.

I.-The Director General of the Agence nationale de sécurité du médicament et des produits de santé issues the authorisation to open provided for in the first paragraph of Article L. 5124-3 in accordance with the procedure set out in Article R. 5124-6 and within the time limits set out in this Article. II.-The Director General of the Agence nationale de sécurité du médicament et des produits de santé verifies that…

For an authorised establishment, the addition of a new activity within the meaning of Article R. 5124-2 is subject to an application for authorisation examined under the conditions set out in Article R. 5124-9.

I.- Modifications to the authorisation to open a pharmaceutical establishment, as provided for in article L. 5124-3, which relate to one of the following, are subject to authorisation because of their substantial nature: 1° The manufacture or import of a new category of products among medicinal products for human use, experimental medicinal products for human use, products mentioned in 8°, 9° and 10° of article L. 5121-1, products mentioned in…

The following changes to the authorisation to open a pharmaceutical establishment must be declared, pursuant to the second paragraph of Article L. 5124-3: 1° Change in the corporate name of the company holding an authorisation to open ; 2° Change in the legal form of the company holding an authorisation to open; 3° Transfer of the registered office or change in the wording of the address of the registered office…

Changes other than those listed in articles R. 5124-10 and R. 5124-10-1 are declared in the annual statement provided for in article R. 5124-46.

The Director General of the Agence nationale de sécurité du médicament et des produits de santé may request the applicant to provide additional information necessary for the examination of the application. The deadlines set out in Articles R. 5124-9 and R. 5124-10 are then suspended until this information is received.