Chapter IV: Manufacturing and wholesale distribution

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.

The closure of a pharmaceutical establishment belonging to the companies and organisations mentioned in 1° to 3° of R. 5124-2 must be notified to the Agence nationale de sécurité du médicament et des produits de santé no later than six months before the definitive closure of this establishment. The closure of a pharmaceutical establishment of the companies and organisations mentioned in 4° to 15° of R. 5124-2 gives rise to…

Any change in the holder of an authorisation to open a pharmaceutical establishment is subject to prior authorisation. However, the Director General of the Agence nationale de sécurité du médicament et des produits de santé may, at the joint request of the two pharmacists in charge concerned, authorise the transfer of the initial opening authorisation. If the establishment is leased under management, the lessee-manager must apply under the same conditions…

The change of holder of part of the authorisation to open a pharmaceutical establishment is subject to a modification of the initial authorisation to open under the conditions set out in article R. 5124-10 and the issue of an authorisation to open granted to the acquirer under the conditions set out in articles R. 5124-6 and R. 5124-7.

The suspension, which may not exceed one year, and the withdrawal of the authorisation to open, provided for in article L. 5124-3, are decided by the Director General of the Agence nationale de sécurité du médicament et des produits de santé. These decisions may concern all or part of the authorised activity and may only be taken after the party concerned has been informed of the nature of the infringements…