French Public Health Code
In forceI.- 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 2° of article L. 4211-1 ;
2° The manufacture or import of a new pharmaceutical form or a pharmaceutical product not mentioned in the authorisation currently in force;
3° The implementation of a new pharmaceutical manufacturing, import or operating operation;
4° The creation of premises in which pharmaceutical manufacturing, import, wholesale distribution or storage operations are carried out;
5° The removal of premises in which production and quality control operations are carried out, or any removal of premises in the cases provided for in article R. 5124-14 ;
6° Changes to the storage conditions for medicinal products classified as narcotics for the wholesale distributors mentioned in 4° to 15° of article R. 5124-2;
7° Changes to the distribution territory referred to in article R. 5124-59;
8° The relocation to the same site of a pharmaceutical establishment with operator status as provided for in 3° of article R. 5124-2;
9° The relocation to the same site of a pharmaceutical establishment with the status of manufacturer as provided for in 1° of Article R. 5124-2 or importer as provided for in 2° of Article R. 5124-2, when their activities are limited to the release of batches;
10° For manufacturers of gases for medical use, the addition of a conditioned gas storage room as provided for in 3° of Article R. 5124-7.
II - The Director General of the Agence nationale de sécurité du médicament et des produits de santé notifies the applicant of its decision within thirty days from the date of receipt of the application accompanied by a complete file.
The Director General may request any additional information from the applicant and have an administrative enquiry carried out by one of his agents or an on-site enquiry carried out by an inspector mentioned in Articles L. 5313-1 and L. 5313-3, to enable him to reach a decision on the application.
To this end, the Director General may extend the period provided for in the first paragraph of this II for a period of ninety days. In this case, he shall notify the applicant of the decision to extend.
This period is then suspended from the date of notification of the request for additional information to the pharmacist responsible by the Director General of the Agence nationale de sécurité du médicament et des produits de santé, until receipt of the information requested.
For pharmaceutical establishments dependent on companies or organisations mentioned in 1° and 2° of Article R. 5124-2, silence on the part of the Director General, either at the end of the thirty day period or, if he has requested additional information, at the end of the ninety day period, will be deemed to constitute refusal of authorisation.
In the case of other pharmaceutical establishments, silence on the part of the Director General at the end of the same periods will be deemed to constitute tacit authorisation.
